Sample records for safety concerns raised

  1. 78 FR 38771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... information that raises significant identity theft, personal safety, or privacy concerns that are not... raises personal safety or privacy concerns is released to the public when considering whether to release... customer information or information that raises identity theft, personal safety or privacy concerns that do...

  2. Factors influencing nurses' decisions to raise concerns about care quality.

    PubMed

    Attree, Moira

    2007-05-01

    To explore factors that influence nurses' decisions to raise concerns about standards of practice. Health care practitioners have a key role in monitoring care quality. Nurses are required by their professional body to raise concerns about standards; however, under-reporting is the norm. Grounded theory was used to collect and analyse data from semi-structured interviews with 142 practising nurses, theoretically sampled from three Acute NHS Trusts in England. Fear of repercussions, retribution, labelling and blame for raising concerns, about which they predicted nothing would be done, were identified as disincentives to raising concerns. Reporting was perceived as a high-risk:low-benefit action. Nurses lacked confidence in reporting systems. Disincentives to reporting need to be addressed if an open culture, which promotes quality, safety and learning, is to be developed. Findings give cause for concern and indicate a need to review organizational and professional guidelines, and organizational reporting systems.

  3. The effect of leader communication style on safety-conscious work environments at domestic nuclear power plants

    NASA Astrophysics Data System (ADS)

    Goldberg, Edward Michael

    Public risk from unsafe nuclear power plant operations increases when plant workers are reluctant to raise issues and concerns. The effect of leader communication style on the safety-conscious work environment (SCWE) at domestic nuclear power plants was evaluated using a descriptive quantitative research study. A sample of 379 plant employees was surveyed to determine leader communication style elements that foster SCWE. The results reveal that leader communication style significantly affects a safety-conscious work environment. Specific attributes such as wit, articulation, self-disclosure, and social composure, confirmation, and experience, were proven to directly affect worker's likelihood to raise issues and concerns. The direct effect of leader, communication style on safe plant operations and the communication actions leaders can take to improve the safety of those operations is discussed.

  4. Office of Safety and Mission Assurance Review Report

    NASA Technical Reports Server (NTRS)

    2000-01-01

    This document summarizes questions and concerns raised during the 1999 IV&V Facility's Annual Review Presentation to the Office of Safety and Mission Assurance (OSMA). Recommendations are provided for issues and action items identified.

  5. Nanotechnology in cosmetics.

    PubMed

    Katz, Linda M; Dewan, Kapal; Bronaugh, Robert L

    2015-11-01

    Nanomaterials are being used in cosmetic products for various effects. However, their use also raises potential safety concerns. Some of these concerns can be addressed by determining the type of nanomaterials used, as well as stability, potential for skin absorption, route of exposure, and how they are formulated in cosmetic products. There has been considerable effort internationally to harmonize approaches in order to address definitional issues and safety concerns related to the use of nanomaterials in cosmetic products. Published by Elsevier Ltd.

  6. Safety assessment and detection methods of genetically modified organisms.

    PubMed

    Xu, Rong; Zheng, Zhe; Jiao, Guanglian

    2014-01-01

    Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

  7. Developing patient safety in dentistry.

    PubMed

    Pemberton, M N

    2014-10-01

    Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

  8. Scary Science: Ondansetron Safety in Pregnancy-Two Opposing Results From the Same Danish Registry.

    PubMed

    Koren, Gideon

    2014-01-09

    While perceived safe in pregnancy, several recent studies raise concerns about both fetal and maternal safety of ondansetron. Until more data are available, it should not be a first-line medication for morning sickness.

  9. Safety review of Washington Metropolitan Area Transit Authority (WMATA) metrorail operations

    DOT National Transportation Integrated Search

    1997-09-01

    A recent series of accidents and incidents at the Washington Metropolitan Area Transit Authority (WMATA) have raised concerns about the Authority's commitment to safety as its top priority. In January 1996, a train operator was killed at an end-of-th...

  10. Summary of School Safety Statistics. National Institute of Justice Report

    ERIC Educational Resources Information Center

    Carlton, Mary Poulin

    2017-01-01

    Several high-profile incidents of violence at U.S. schools have, understandably, raised concerns about the safety of students while at school. Just one incident of violence causes significant harm. In light of this, it is important to examine commonly held beliefs about school safety and violence because they sometimes reflect a misperception or…

  11. Advanced Test Reactor Safety Basis Upgrade Lessons Learned Relative to Design Basis Verification and Safety Basis Management

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    G. L. Sharp; R. T. McCracken

    The Advanced Test Reactor (ATR) is a pressurized light-water reactor with a design thermal power of 250 MW. The principal function of the ATR is to provide a high neutron flux for testing reactor fuels and other materials. The reactor also provides other irradiation services such as radioisotope production. The ATR and its support facilities are located at the Test Reactor Area of the Idaho National Engineering and Environmental Laboratory (INEEL). An audit conducted by the Department of Energy's Office of Independent Oversight and Performance Assurance (DOE OA) raised concerns that design conditions at the ATR were not adequately analyzedmore » in the safety analysis and that legacy design basis management practices had the potential to further impact safe operation of the facility.1 The concerns identified by the audit team, and issues raised during additional reviews performed by ATR safety analysts, were evaluated through the unreviewed safety question process resulting in shutdown of the ATR for more than three months while these concerns were resolved. Past management of the ATR safety basis, relative to facility design basis management and change control, led to concerns that discrepancies in the safety basis may have developed. Although not required by DOE orders or regulations, not performing design basis verification in conjunction with development of the 10 CFR 830 Subpart B upgraded safety basis allowed these potential weaknesses to be carried forward. Configuration management and a clear definition of the existing facility design basis have a direct relation to developing and maintaining a high quality safety basis which properly identifies and mitigates all hazards and postulated accident conditions. These relations and the impact of past safety basis management practices have been reviewed in order to identify lessons learned from the safety basis upgrade process and appropriate actions to resolve possible concerns with respect to the current ATR safety basis. The need for a design basis reconstitution program for the ATR has been identified along with the use of sound configuration management principles in order to support safe and efficient facility operation.« less

  12. What's the Harm in Asking about Suicidal Ideation?

    ERIC Educational Resources Information Center

    Mathias, Charles W.; Furr, Michael; Sheftall, Arielle H.; Hill-Kapturczak, Nathalie; Crum, Paige; Dougherty, Donald M.

    2012-01-01

    Both researchers and oversight committees share concerns about patient safety in the study-related assessment of suicidality. However, concern about assessing suicidal thoughts can be a barrier to the development of empirical evidence that informs research on how to safely conduct these assessments. A question has been raised if asking about…

  13. ‘Saying it without words’: a qualitative study of oncology staff's experiences with speaking up about safety concerns

    PubMed Central

    Schwappach, D L B; Gehring, K

    2014-01-01

    Objectives To explore the experiences of oncology staff with communicating safety concerns and to examine situational factors and motivations surrounding the decision whether and how to speak up using semistructured interviews. Setting 7 oncology departments of six hospitals in Switzerland. Participants Diverse sample of 32 experienced oncology healthcare professionals. Results Nurses and doctors commonly experience situations which raise their concerns and require questioning, clarifying and correcting. Participants often used non-verbal communication to signal safety concerns. Speaking-up behaviour was strongly related to a clinical safety issue. Most episodes of ‘silence’ were connected to hygiene, isolation and invasive procedures. In contrast, there seemed to exist a strong culture to communicate questions, doubts and concerns relating to medication. Nearly all interviewees were concerned with ‘how’ to say it and in particular those of lower hierarchical status reflected on deliberate ‘voicing tactics’. Conclusions Our results indicate a widely accepted culture to discuss any concerns relating to medication safety while other issues are more difficult to voice. Clinicians devote considerable efforts to evaluate the situation and sensitively decide whether and how to speak up. Our results can serve as a starting point to develop a shared understanding of risks and appropriate communication of safety concerns among staff in oncology. PMID:24838725

  14. College Rampage Renews School Safety Concerns

    ERIC Educational Resources Information Center

    Maxwell, Lesli A.

    2007-01-01

    Coming just four days before the anniversary of the Columbine school shootings, the mass slayings by a student gunman at Virginia Polytechnic Institute last week revived vexing questions and raised familiar fears for educators across the country who grapple daily with ensuring the safety of their students and staffs. The April 16 killings provoked…

  15. Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds: Status Report

    EPA Science Inventory

    Over the past several years, parents, athletes, schools, and communities have raised concerns about the safety of recycled tire crumb rubber used as infill for playing fields and playgrounds in the United States. The public has expressed concerns that the use of these fields coul...

  16. Defining contamination control requirements for non-human research on Space Station Freedom

    NASA Technical Reports Server (NTRS)

    Corbin, Barbara J.; Funk, Glenn A.

    1992-01-01

    The use of non-human biological specimens for life sciences research on Space Station Freedom has generated concerns about spacecraft internal contamination, crew safety and hardware utility. Various NASA organizations convened to discuss the concerns and determine how they should be addressed. This paper will present the issues raised at this meeting, the process by which safety concerns were identified, and the means by which contamination control requirements for all biological payloads were recommended for incorporation into Space Station Freedom safety requirements. The microbiological, toxicological and particulate contamination criteria for long-term spaceflight will be based on realistic assessment of risk and hardware will be designed to meet established contamination criteria while facilitating crew operations, thereby meeting the needs of the investigator.

  17. 78 FR 40396 - Safety Zone; America's Cup Safety Zone and No Loitering Area, San Francisco, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-05

    ... were issued for this series of races. Only after the Coast Guard learned that the racing vessels.... Additionally, members of the deep-draft commercial shipping community raised concerns pertaining to the... associated with the viewing of the America's Cup in vicinity of buoys ``1'' and ``2'', marking the deep water...

  18. The Challenges of Balancing Safety and Security in Implantable Medical Devices.

    PubMed

    Katzis, Konstantinos; Jones, Richard W; Despotou, George

    2016-01-01

    Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.

  19. Food and agricultural biotechnology: a summary and analysis of ethical concerns.

    PubMed

    Thompson, Paul B; Hannah, William

    2008-01-01

    The range of social and ethical concerns that have been raised in connection with food and agricultural biotechnology is exceedingly broad. Many of these deal with risks and possible outcomes that are not unique to crops or animals developed using recombinant DNA. Food safety, animal welfare, socio-economic and environmental impacts, as well as shifts in power relations or access to technology raise concerns that might be generalized to many technologies. These aspects of the controversy over biotechnology are analyzed below as elements of general technological ethics, and key norms or values pertinent to each of these categories are specified in some detail. However, a number of special concerns unique to the use of rDNA in manipulating plant and animal genomes have been raised, and these are reviewed as well. The chapter concludes by reviewing two broad policy strategies for responding to the issues, one involving labels and consumer consent, the other applying the precautionary principle.

  20. Assessing mandatory HPV vaccination: who should call the shots?

    PubMed

    Javitt, Gail; Berkowitz, Deena; Gostin, Lawrence O

    2008-01-01

    In 2007, many legislatures considered, and two enacted, bills mandating HPV vaccination for young girls as a condition of school attendance. Such mandates raise significant legal, ethical, and social concerns. This paper argues that mandating HPV vaccination for minor females is premature since long-term safety and effectiveness of the vaccine has not been established, HPV does not pose imminent and significant risk of harm to others, a sex specific mandate raises constitutional concerns, and a mandate will burden financially existing government health programs and private physicians. Absent careful consideration and public conversation, HPV mandates may undermine coverage rates for other vaccines.

  1. Safety assessment in schools: beyond risk: the role of child psychiatrists and other mental health professionals.

    PubMed

    Rappaport, Nancy; Pollack, William S; Flaherty, Lois T; Schwartz, Sarah E O; McMickens, Courtney

    2015-04-01

    This article presents an overview of a comprehensive school safety assessment approach for students whose behavior raises concern about their potential for targeted violence. Case vignettes highlight the features of 2 youngsters who exemplify those seen, the comprehensive nature of the assessment, and the kind of recommendations that enhance a student's safety, connection, well-being; engage families; and share responsibility of assessing safety with the school. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Learning from error: leading a culture of safety.

    PubMed

    Gibson, Russell; Armstrong, Alexander; Till, Alex; McKimm, Judy

    2017-07-02

    A recent shift towards more collective leadership in the NHS can help to achieve a culture of safety, particularly through encouraging frontline staff to participate and take responsibility for improving safety through learning from error and near misses. Leaders must ensure that they provide psychological safety, organizational fairness and learning systems for staff to feel confident in raising concerns, that they have the autonomy and skills to lead continual improvement, and that they have responsibility for spreading this learning within and across organizations.

  3. Other Foodborne Helminths

    USDA-ARS?s Scientific Manuscript database

    The relationship between parasites and food safety has all but fallen off the radar in most developed countries with respect to consumer concern. Modern inspection methods coupled with the understanding and acknowledgment that commercially raised animals and properly prepared foods offer products to...

  4. Preventing Mitochondrial Diseases: Embryo-Sparing Donor-Independent Options.

    PubMed

    Adashi, Eli Y; Cohen, I Glenn

    2018-05-01

    Mutant mitochondrial DNA gives rise to a broad range of incurable inborn maladies. Prevention may now be possible by replacing the mutation-carrying mitochondria of zygotes or oocytes at risk with donated unaffected counterparts. However, mitochondrial replacement therapy is being held back by theological, ethical, and safety concerns over the loss of human zygotes and the involvement of a donor. These concerns make it plain that the identification, validation, and regulatory adjudication of novel embryo-sparing donor-independent technologies remains a pressing imperative. This Opinion highlights three emerging embryo-sparing donor-independent options that stand to markedly allay theological, ethical, and safety concerns raised by mitochondrial replacement therapy. Copyright © 2018 Elsevier Ltd. All rights reserved.

  5. 14 CFR 11.73 - How does FAA process petitions for rulemaking?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... safety or security concerns you raise; (2) The priority of other issues the FAA must deal with; and (3... dismiss your petition. Your comments and arguments for a rule change will be placed in a database, which...

  6. Causes and prevention of splitting/bursting failure of concrete crossties: a computational study

    DOT National Transportation Integrated Search

    2017-09-17

    Concrete splitting/bursting is a well-known failure mode of concrete crossties that can compromise the crosstie integrity and raise railroad maintenance and track safety concerns. This paper presents a computational study aimed at better understandin...

  7. Food and drug administration regulation of drugs that raise blood pressure.

    PubMed

    Blankfield, Robert P; Iftikhar, Imran H

    2015-01-01

    Although it is recognized that a systolic blood pressure (SBP) increase ≥ 2 mm Hg or a diastolic blood pressure (DBP) increase ≥ 1 mm Hg increases the risk of heart attacks and strokes in middle-aged adults, the Food and Drug Administration (FDA) lacks an adequate policy for regulating medications that increase blood pressure (BP). Some FDA reviewers consider a clinically significant increase in BP to occur only if a drug raises SBP ≥ 20 mm Hg or if a drug raises DBP ≥ 10 to 15 mm Hg. In recent years, numerous drugs have been regulated or taken off the market due to cardiovascular safety concerns. The list includes rofecoxib (Vioxx), valdecoxib (Bextra), nonselective nonsteroidal anti-inflammatory drugs, sibutramine (Meridia), and phenylpropanolamine. It is probable that the hypertensive effect of these drugs explains why they increase the risk of adverse cardiovascular events. Other drugs, notably serotonin-norepinephrine reuptake inhibitors and drugs used to treat attention deficit hyperactivity disorder, were approved without cardiovascular safety data despite the fact that they raise BP comparable to valdecoxib and sibutramine. It is the responsibility of the FDA to ensure that drugs are properly labeled regarding risk. Even if a drug raises BP only modestly, FDA guidelines for new drug approvals should include a requirement for cardiovascular safety data. However, such guidelines will not address the problem of how to obtain cardiovascular safety data for the many already approved drugs that increase BP. The FDA should play a role in obtaining cardiovascular safety data for such drugs. © The Author(s) 2014.

  8. The Role of Employee Whistleblowing and Raising Concerns in an Organizational Learning Culture – Elusive and Laudable?

    PubMed Central

    Jones, Aled

    2016-01-01

    It is inevitable that healthcare workers throughout their careers will witness actual or potential threats to patient safety in the course of their work. Some of these threats will result in serious harm occurring to others, whilst at other times such threats will result in minimal harm, or a ‘near miss’ where harm is avoided at the last minute. Despite organizations encouraging employees to ‘speak up’ about such threats, healthcare systems globally struggle to engage their staff to do so. Even when staff do raise concerns they are often ignored by those with a responsibility to listen and act. Learning how to create the conditions where employees continuously raise and respond to concerns is essential in creating a continuous and responsive learning culture that cherishes keeping patients and employees safe. Workplace culture is a real barrier to the creation of such a learning system but examples in healthcare exist from which we can learn. PMID:26673654

  9. The occupational health and safety of flight attendants.

    PubMed

    Griffiths, Robin F; Powell, David M C

    2012-05-01

    In order to perform safety-critical roles in emergency situations, flight attendants should meet minimum health standards and not be impaired by factors such as fatigue. In addition, the unique occupational and environmental characteristics of flight attendant employment may have consequential occupational health and safety implications, including radiation exposure, cancer, mental ill-health, musculoskeletal injury, reproductive disorders, and symptoms from cabin air contamination. The respective roles of governments and employers in managing these are controversial. A structured literature review was undertaken to identify key themes for promoting a future agenda for flight attendant health and safety. Recommendations include breast cancer health promotion, implementation of Fatigue Risk Management Systems, standardization of data collection on radiation exposure and health outcomes, and more coordinated approaches to occupational health and safety risk management. Research is ongoing into cabin air contamination incidents, cancer, and fatigue as health and safety concerns. Concerns are raised that statutory medical certification for flight attendants will not benefit either flight safety or occupational health.

  10. Exclusive lanes for trucks and passenger vehicles on interstate highways in Virginia : an economic evaluation.

    DOT National Transportation Integrated Search

    1997-01-01

    Increases in heavy truck traffic on Virginia's highways in recent years have raised concerns about both safety and capacity, particularly on the interstate system. Transportation agencies have developed a number of strategies for dealing with the imp...

  11. Promoting social responsibility amongst health care users: medical tourists' perspectives on an information sheet regarding ethical concerns in medical tourism.

    PubMed

    Adams, Krystyna; Snyder, Jeremy; Crooks, Valorie A; Johnston, Rory

    2013-12-06

    Medical tourists, persons that travel across international borders with the intention to access non-emergency medical care, may not be adequately informed of safety and ethical concerns related to the practice of medical tourism. Researchers indicate that the sources of information frequently used by medical tourists during their decision-making process may be biased and/or lack comprehensive information regarding individual safety and treatment outcomes, as well as potential impacts of the medical tourism industry on third parties. This paper explores the feedback from former Canadian medical tourists regarding the use of an information sheet to address this knowledge gap and raise awareness of the safety and ethical concerns related to medical tourism. According to feedback provided in interviews with former Canadian medical tourists, the majority of participants responded positively to the information sheet and indicated that this document prompted them to engage in further consideration of these issues. Participants indicated some frustration after reading the information sheet regarding a lack of know-how in terms of learning more about the concerns discussed in the document and changing their decision-making. This frustration was due to participants' desperation for medical care, a topic which participants frequently discussed regarding ethical concerns related to health care provision. The overall perceptions of former medical tourists indicate that an information sheet may promote further consideration of ethical concerns of medical tourism. However, given that these interviews were performed with former medical tourists, it remains unknown whether such a document might impact upon the decision-making of prospective medical tourists. Furthermore, participants indicated a need for an additional tool such as a website for continued discussion about these concerns. As such, along with dissemination of the information sheet, future research implications should include the development of a website for ongoing discussion that could contribute to a raised awareness of these concerns and potentially increase social responsibility in the medical tourism industry.

  12. Promoting social responsibility amongst health care users: medical tourists’ perspectives on an information sheet regarding ethical concerns in medical tourism

    PubMed Central

    2013-01-01

    Background Medical tourists, persons that travel across international borders with the intention to access non-emergency medical care, may not be adequately informed of safety and ethical concerns related to the practice of medical tourism. Researchers indicate that the sources of information frequently used by medical tourists during their decision-making process may be biased and/or lack comprehensive information regarding individual safety and treatment outcomes, as well as potential impacts of the medical tourism industry on third parties. This paper explores the feedback from former Canadian medical tourists regarding the use of an information sheet to address this knowledge gap and raise awareness of the safety and ethical concerns related to medical tourism. Results According to feedback provided in interviews with former Canadian medical tourists, the majority of participants responded positively to the information sheet and indicated that this document prompted them to engage in further consideration of these issues. Participants indicated some frustration after reading the information sheet regarding a lack of know-how in terms of learning more about the concerns discussed in the document and changing their decision-making. This frustration was due to participants’ desperation for medical care, a topic which participants frequently discussed regarding ethical concerns related to health care provision. Conclusions The overall perceptions of former medical tourists indicate that an information sheet may promote further consideration of ethical concerns of medical tourism. However, given that these interviews were performed with former medical tourists, it remains unknown whether such a document might impact upon the decision-making of prospective medical tourists. Furthermore, participants indicated a need for an additional tool such as a website for continued discussion about these concerns. As such, along with dissemination of the information sheet, future research implications should include the development of a website for ongoing discussion that could contribute to a raised awareness of these concerns and potentially increase social responsibility in the medical tourism industry. PMID:24314027

  13. Complementary and alternative medicine in child and adolescent psychiatry: legal considerations.

    PubMed

    Cohen, Michael H; Natbony, Suzanne R; Abbott, Ryan B

    2013-07-01

    The rising popularity of complementary and alternative medicine (CAM) in child and adolescent psychiatry raises unique ethical and legal concerns for psychiatrists and other conventional health care providers. This article explores these concerns and provides clinical advice for promoting patient health and safety while minimizing the psychiatrist's risk. Although any departure from the conventional standard of care is a potential risk, the risk of malpractice liability for practicing integrative medicine in child and adolescent psychiatry is low. CAM is most safely recommended from a legal standpoint when there is some published evidence of safety and efficacy. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Teaching Chemistry Lab Safety through Comics

    NASA Astrophysics Data System (ADS)

    di Raddo, Pasquale

    2006-04-01

    As a means for raising students' interest in aspects pertaining to chemistry lab safety, this article presents a novel approach to teaching this important subject. Comic book lab scenes that involve fictional characters familiar to many students are presented and discussed as to the safety concerns represented in those images. These are discussed in a safety prelab session. For the sake of comparison, students are then shown images taken from current chemistry journals of safety-conscious contemporary chemists at work in their labs. Finally the need to adhere to copyright regulations for the use of the images is discussed so as to increase students' awareness of academic honesty and copyright issues.

  15. Developing a short range vehicle to infrastructure communication system to enhance the safety at STOP sign intersections : final report.

    DOT National Transportation Integrated Search

    2016-05-01

    Stop sign controlled unsignalized intersections raise a public safe concern. Even though various strategies, such as engineering, education, and policy, have been applied in practice, there are a number of fatal crashes occurred at unsignalized inter...

  16. Northwest forest plants defeat pests and diseases!

    Treesearch

    Natasha Vizcarra; Rick Kelsey; Joe Karchesy

    2017-01-01

    Societies use biologically active chemicals as medicines and pesticides to protect human and agricultural health. But widespread use of synthetic compounds raises concerns about their safety, and resistance development in targeted pests.To find safer alternatives, scientists turned to native plants and trees in Pacific Northwest forests...

  17. Fatigue evaluation of the increased weight limit on transit railway bridges.

    DOT National Transportation Integrated Search

    2014-09-01

    The recent increase of freight railcar weight limits from 263,000 lbs. to 286,000 lbs. raises concerns for the safety of bridges : on transit passenger rail systems, since they were not designed for this weight increase. Thus, there is a need to asse...

  18. ASSESSING CHILDREN'S EXPOSURES TO THE WOOD PRESERVATIVE CCA (CHROMATED COPPER ARSENATE) ON TREATED PLAYSETS AND DECKS

    EPA Science Inventory

    Concerns have been raised regarding the safety of young children contacting arsenic and chromium residues while playing on and around Chromated Copper Arsenate (CCA) treated wood playground structures and decks. Although CCA registrants voluntarily canceled treated wood for re...

  19. Characterization of Formaldehyde Emissions from Tire Crumb Rubber in Small Environmental Chambers - 2

    EPA Science Inventory

    Concerns have been raised about the safety of recycled rubber tire crumbs used in synthetic turf fields and playgrounds in the United States. To support federal efforts to better characterize recycled tire-derived surface materials, dynamic small chamber tests were conducted at...

  20. Communication between office-based primary care providers and nurses working within patients' homes: an analysis of process data from CAPABLE.

    PubMed

    Smith, Patrick D; Boyd, Cynthia; Bellantoni, Julia; Roth, Jill; Becker, Kathleen L; Savage, Jessica; Nkimbeng, Manka; Szanton, Sarah L

    2016-02-01

    To examine themes of communication between office-based primary care providers and nurses working in private residences; to assess which methods of communication elicit fruitful responses to nurses' concerns. Lack of effective communication between home health care nurses and primary care providers contributes to clinical errors, inefficient care delivery and decreased patient safety. Few studies have described best practices related to frequency, methods and reasons for communication between community-based nurses and primary care providers. Secondary analysis of process data from 'Community Aging in Place: Advancing Better Living for Elders (CAPABLE)'. Independent reviewers analysed nurse documentation of communication (phone calls, letters and client coaching) initiated for 70 patients and analysed 45 letters to primary care providers to identify common concerns and recommendations raised by CAPABLE nurses. Primary care providers responded to 86% of phone calls, 56% of letters and 50% of client coaching efforts. Primary care providers addressed 86% of concerns communicated by phone, 34% of concerns communicated by letter and 41% of client-raised concerns. Nurses' letters addressed five key concerns: medication safety, pain, change in activities of daily living, fall safety and mental health. In letters, CAPABLE nurses recommended 58 interventions: medication change; referral to a specialist; patient education; and further diagnostic evaluation. Effective communication between home-based nurses and primary care providers enhances care coordination and improves outcomes for home-dwelling elders. Various methods of contact show promise for addressing specific communication needs. Nurses practicing within patients' homes can improve care coordination by using phone calls to address minor matters and written letters for detailed communication. Future research should explore implementation of Situation, Background, Assessment and Recommendation in home care to promote safe and efficient communication. Nurses should empower patients to address concerns directly with providers through use of devices including health passports. © 2016 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.

  1. Science, safety, and trust: the case of transgenic food.

    PubMed

    Martinelli, Lucia; Karbarz, Małgorzata; Siipi, Helena

    2013-02-01

    Genetically modified (GM) food is discussed as an example of the controversial relation between the intrinsic uncertainty of the scientific approach and the demand of citizen-consumers to use products of science innovation that are known to be safe. On the whole, peer-reviewed studies on GM food safety do not note significant health risks, with a few exceptions, like the most renowned "Pusztai affair" and the recent "Seralini case." These latter studies have been disregarded by the scientific community, based on incorrect experimental designs and statistic analysis. Such contradictory results show the complexity of risk evaluation, and raise concerns in the citizen-consumers against the GM food. A thoughtful consideration by scientific community and decision makers of the moral values that are present in risk evaluation and risk management should be the most trustable answer to citizen-consumers to their claim for clear and definitive answers concerning safety/un-safety of GM food.

  2. A simulation analysis of traffic flow elements for restricted truck lanes on interstate highways in Virginia.

    DOT National Transportation Integrated Search

    1999-01-01

    In recent years, increases in truck traffic on Virginia's highways have raised issues concerning safety and capacity on interstates such as I-81 and I-95. Lane restrictions represent a strategy that is intended to reduce conflicts between trucks and ...

  3. Characterization of Semi-Volatile Organic Chemicals from Tire Crumb Rubber

    EPA Science Inventory

    Recycled tire crumb rubber (TCR) is often used as infill material in synthetic turf playing fields as well as some playgrounds. Concerns have been raised about the safety of this material and a multi-agency Federal Research Action Plan on Recycled Tire Crumb Used on Playing Field...

  4. Balancing Competing Rights: A Stakeholder Model for Democratic Schools

    ERIC Educational Resources Information Center

    Shariff, Shaheen

    2006-01-01

    In this article, I discuss a Canadian public school controversy and Supreme Court of Canada decision involving competing stakeholder rights to freedom of religion, safety and equality. Policy considerations that allowed one group of stakeholders to express their constitutional rights raised concerns among other stakeholders. A policy vacuum and a…

  5. STOCHASTIC HUMAN EXPOSURE AND DOSE SIMULATION MODEL FOR THE WOOD PRESERVATIVE SCENARIO (SHEDS-WOOD), VERSION 2 MODEL SAS CODE

    EPA Science Inventory

    Concerns have been raised regarding the safety of young children contacting arsenic and chromium residues while playing on and around Chromated Copper Arsenate (CCA) treated wood playground structures and decks. Although CCA registrants voluntarily canceled treated wood for resi...

  6. Release and toxicity comparison between industrial- and sunscreen-derived nano-ZnO particles

    EPA Science Inventory

    Many consumer products containing ZnO have raised concern for safety in regards toenvironmental impact and the public health. Widely used sunscreens for protectingagainst UV and avoiding sunburns represent a great exposure to nano-ZnO, one of theingredients commonly applied in su...

  7. General linear model-predicted and observed toxicity of three organo-coated silver nanoparticles: Impacts of particle size, surface charge and dose

    EPA Science Inventory

    Intrinsic to the myriad of nano-enabled products are atomic-size multifunctional engineered nanomaterials, which upon release contaminate the environments, raising considerable health and safety concerns. Despite global research efforts, mechanism underlying nanotoxicity has rema...

  8. The Role of Employee Whistleblowing and Raising Concerns in an Organizational Learning Culture - Elusive and Laudable?: Comment on "Cultures of Silence and Cultures of Voice: The Role of Whistleblowing in Healthcare Organisations".

    PubMed

    Jones, Aled

    2015-10-05

    It is inevitable that healthcare workers throughout their careers will witness actual or potential threats to patient safety in the course of their work. Some of these threats will result in serious harm occurring to others, whilst at other times such threats will result in minimal harm, or a 'near miss' where harm is avoided at the last minute. Despite organizations encouraging employees to 'speak up' about such threats, healthcare systems globally struggle to engage their staff to do so. Even when staff do raise concerns they are often ignored by those with a responsibility to listen and act. Learning how to create the conditions where employees continuously raise and respond to concerns is essential in creating a continuous and responsive learning culture that cherishes keeping patients and employees safe. Workplace culture is a real barrier to the creation of such a learning system but examples in healthcare exist from which we can learn. © 2016 by Kerman University of Medical Sciences.

  9. Emerging legal concerns with chronic diseases in the Australian workplace: pre-employment medicals, functional capacity evaluations, workers' compensation and disability discrimination.

    PubMed

    Guthrie, Robert; Westaway, Jennifer

    2009-05-01

    Although considerable attention is paid to injury and disease sustained or contracted through work causes, by far the most prolific cause of diminished health in the Australian workplace is chronic illness, which is not caused by work but which may have significant effects upon the work environment. Employers' concerns in relation to loss of productivity through poor health are reflected in a number of practices such as pre-employment screening, on-the-job drug testing and other health and safety requirements. In turn, workers' concerns regarding discrimination, workers' compensation and privacy are frequently raised in relation to discussions on workplace fitness for work. This article reflects on the issues of chronic illness and the legal issues which arise through the interaction of employers' obligations for safety and efficiency and workers' concerns with fairness and privacy.

  10. [Nanomaterials in cosmetics--present situation and future].

    PubMed

    Masunaga, Takuji

    2014-01-01

    Cosmetics are consumer products intended to contribute to increasing quality of life and designed for long-term daily use. Due to such features of cosmetics, they are required to ensure quality and safety at a high level, as well as to perform well, in response to consumers' demands. Recently, the technology associated with nanomaterials has progressed rapidly and has been applied to various products, including cosmetics. For example, nano-sized titanium dioxide has been formulated in sunscreen products in pursuit of improving its performance. As some researchers and media have expressed concerns about the safety of nanomaterials, a vague feeling of anxiety has been raised in society. In response to this concern, the Japan Cosmetic Industry Association (JCIA) has begun original research related to the safety assurance of nanomaterials formulated in cosmetics, to allow consumers to use cosmetics without such concerns. This paper describes the activities of the JCIA regarding safety research on nanomaterials, including a survey of the actual usage of nanomaterials in cosmetics, analysis of the existence of nanomaterials on the skin, and assessment of skin carcinogenicity of nano-sized titanium dioxide. It also describes the international status of safety assurance and regulation regarding nanomaterials in cosmetics.

  11. Concentration of Cadmium in Cacao Beans and its Relationship with Soil Cadmium in Southern Ecuador

    USDA-ARS?s Scientific Manuscript database

    The concentration of cadmium (Cd) in cacao (Theobroma cacao, L.) beans above a critical level (0.6 mg kg-1 established by the European Union) has raised concerns of safety in the consumption of cacao-based chocolate (dark chocolate). Currently, little is available regarding Cd concentration in soil,...

  12. Chemical speciation of cadmium: an approach to evaluate plant-available cadmium in Ecuadorian soils under cacao production

    USDA-ARS?s Scientific Manuscript database

    Elevated concentration of cadmium (Cd) in cacao beans has raised serious concerns about the safety of chocolate consumption. Accumulation of Cd cacao bean in southern Ecuador has been reported to relate soil contamination. In this study, soil fractionation was conducted to identify available Cd poo...

  13. Hybrid Food Preservation Program Improves Food Preservation and Food Safety Knowledge

    ERIC Educational Resources Information Center

    Francis, Sarah L.

    2014-01-01

    The growing trend in home food preservation raises concerns about whether the resulting food products will be safe to eat. The increased public demand for food preservation information led to the development of the comprehensive food preservation program, Preserve the Taste of Summer (PTTS). PTTS is a comprehensive hybrid food preservation program…

  14. Undergraduates' Experience of Preparedness for Engaging with Sensitive Research Topics Using Qualitative Research

    ERIC Educational Resources Information Center

    Simpson, Kerri L.; Wilson-Smith, Kevin

    2017-01-01

    This research explored the experience of five undergraduates who engaged with qualitative research as part of their final dissertation project. There have been concerns raised over the emotional safety of researchers carrying out qualitative research, which increases when researchers are inexperienced making this a poignant issues for lectures…

  15. Update on the Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds

    EPA Science Inventory

    Concerns have been raised by the public about the safety of recycled tire crumb rubber used in synthetic turf fields and playgrounds in the United States. Several studies have been identified that examine exposure to tire crumb rubber infill in these settings. While, in general, ...

  16. A multi-site recycled tire crumb rubber characterization study: recruitment strategy and field sampling approach

    EPA Science Inventory

    Recently, concerns have been raised by the public about the safety of tire crumb rubber infill used in synthetic turf fields. In response, the 2016 Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds (FRAP) was developed to examine key envir...

  17. Is mipomersen ready for clinical implementation? A transatlantic dilemma.

    PubMed

    Sjouke, Barbara; Balak, Deepak M W; Beuers, Ulrich; Ratziu, Vlad; Stroes, Erik S G

    2013-08-01

    Mipomersen has been approved by the US Food and Drug Administration as an orphan drug for patients with homozygous familial hypercholesterolemia (HoFH). In contrast, the European Medicines Agency advised negatively on the use of mipomersen. In this review, we discuss the efficacy and safety considerations for this discrepancy. On the basis of the results of clinical trials with mipomersen, safety concerns have been raised regarding cardiovascular risk reduction and development of hepatic steatosis. In addition, (long-term) tolerability concerns have been raised predominantly regarding injection site reactions. A pooled analysis of cardiovascular events in phase III trials with mipomersen did not provide evidence for either a positive or negative effect on cardiovascular disease. Although long-term studies with mipomersen are eagerly awaited, hepatic fat content appears to stabilize after 6-12 months notwithstanding continued mipomersen administration. HoFH is a disease with an unmet medical need for new lipid-lowering therapies. On the basis of a mean 2.9 mmol/l LDL-cholesterol reduction, mipomersen is expected to reduce cardiovascular risk in HoFH. Available evidence suggests that the fat accumulation associated with this treatment differs from steatohepatitis, which is a progressive and damaging liver disease. No evidence is available suggesting that injection site reactions because of mipomersen treatment will result in safety issues.

  18. An optimist's view on limiting necrotic enteritis and maintaining broiler gut health and performance in today's marketing, food safety, and regulatory climate.

    PubMed

    Hofacre, Charles L; Smith, John A; Mathis, Greg F

    2018-06-01

    The future poultry nutritionist, veterinarian, and husbandryman will have many new regulatory requirements and consumer preferences to navigate in addition to their normal responsibility of raising birds in a cost-efficient and wholesome manner. New challenges include changes to antibiotic use, increased food safety regulations, and more concern over how birds are raised and how to dispose of poultry house waste. All of these new programs and new regulations will alter how we have been raising birds for the last 60 years since the inception of the integrated poultry industry. The most significant change may be the voluntary or regulatory withdrawal of the use of antibiotics in poultry production. In North America, this withdrawal of antibiotic use includes removal of in-ovo antibiotics, performance-improving antibiotics or antibiotic growth promotors (AGP), and the polyether ionophore antibiotics (ionophore anticoccidials).The removal of antibiotics in poultry production may result in welfare concerns due to elevated mortality and less efficient feed conversion, resulting in greater environmental impacts from increased manure production and more use of grain per unit of meat produced. There also may be concerns with greater intestinal disease in the birds resulting in increased numbers of foodborne illness-causing bacteria such as Salmonella sp. or Campylobacter sp. on the carcass. A major impact will be the disease necrotic enteritis (NE). This review will focus on the pathophysiology of NE, the management of the disease, and the additional effects on growth rate, feed efficiency, and body weight that may be associated with NE.

  19. Ethics and safety in home care: perspectives on home support workers.

    PubMed

    Storch, Janet; Curry, Cherie Geering; Stevenson, Lynn; Macdonald, Marilyn; Lang, Ariella

    2014-03-01

    Home support workers (HSWs) encounter unique safety issues in their provision of home care. These issues raise ethical concerns, affecting the care workers provide to seniors and other recipients. This paper is derived from a subproject of a larger Canada-wide study, Safety at Home: A Pan-Canadian Home Care Safety Study, released in June 2013 by the Canadian Patient Safety Institute. Semi-structured, face-to-face, audiotaped interviews were conducted with providers, clients and informal caregivers in British Columbia, Manitoba and New Brunswick to better understand their perceptions of patient safety in home care. Using the BC data only, we then compared our findings to findings of other BC studies focusing on safety in home care that were conducted over the past decade. Through our interviews and comparative analyses it became clear that HSWs experienced significant inequities in providing home care. Utilizing a model depicting concerns of and for HSWs developed by Craven and colleagues (2012), we were able to illustrate the physical, spatial, interpersonal and temporal concerns set in the context of system design that emphasized the ethical dilemmas of HSWs in home care. Our data suggested the necessity of adding a fifth domain, organizational (system design). In this paper, we issue a call for stronger advocacy for home care and improved collaboration and resource equity between institutional care and community care.

  20. Raising Teenagers in Hostile Environments: How Race, Class, and Gender Matter for Mothers' Protective Carework

    ERIC Educational Resources Information Center

    Elliott, Sinikka; Aseltine, Elyshia

    2013-01-01

    In contemporary discourse, children are imagined with "surplus risk," and parents often feel pressure to protect their children from danger. Drawing on interviews with 40 Latina, White, and Black mothers of teenagers, the authors examine the factors that shape these mothers' concerns for their teens' safety, how they articulate these…

  1. 76 FR 12295 - James Luehman; Denial of Petition for Rulemaking

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-07

    ... retaliation for raising safety concerns. Union Electric Co. (Callaway Plant, Units 1&2), ALAB-527, 9 NRC 126... was decided by the Commission in the Tennessee Valley Authority (Watts Bar Nuclear Plant, Unit 1; Sequoyah Nuclear Plant, Units 1 and 2; Browns Ferry Nuclear Plant, Units 1, 2, and 3), CLI-04-24, 60 NRC...

  2. A PROBABILISTIC ARSENIC EXPOSURE ASSESSMENT FOR CHILDREN WHO CONTACT CAA - TREATED PLAYSETS AND DECKS: PART 1. MODEL METHODOLOGY, VARIABILITY RESULTS, AND MODEL EVALUATION

    EPA Science Inventory

    Concerns have been raised regarding the safety of young children who may contact arsenic residues while playing on and around chromated copper arsenate (CCA)-treated wood playsets and decks. Although CCA registrants voluntarily canceled the production of treated wood for residen...

  3. Different responses to soy and estradiol in the reproductive system of prepubertal male rats and neonatal male pigs

    USDA-ARS?s Scientific Manuscript database

    Concerns have been raised regarding the safety of soy infant formula based on phytochemical components such as genistein, structurally similar to estradiol (E2). To examine potential estrogenic actions on male development, we fed weanling male rats casein-based or soy protein isolate (SPI)-based die...

  4. The Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds - Background and Exposure Research Goals.

    EPA Science Inventory

    Concerns have been raised by the public about the safety of recycled tire crumb rubber used in synthetic turf fields and playgrounds in the United States (U.S.). Several studies have been identified that examine potential exposure to tire crumb rubber infill in these settings. Th...

  5. Toxicology: Bee P450s Take the Sting out of Cyanoamidine Neonicotinoids.

    PubMed

    Feyereisen, René

    2018-05-07

    The neonicotinoid insecticides have raised concerns regarding the health of bee pollinators. New research has identified a P450 enzyme that protects honey bees and bumble bees from the toxicity of two neonicotinoids, thiacloprid and acetamiprid. This P450 enzyme provides a margin of safety to bees. Copyright © 2018 Elsevier Ltd. All rights reserved.

  6. The Debreather and NuTech: A Reply to Kleespies

    ERIC Educational Resources Information Center

    Ogden, Russel D.

    2010-01-01

    This article responds to Phillip Kleespies's (2010/this issue) commentary on NuTech fieldworkers and their use of the debreather. Non-medical assistance with suicide raises legitimate concerns about accountability, public safety, and care for those who are suffering. Given that suicide is not a crime, an outcome of the NuTech movement may be that…

  7. Problems and Delays Overshadow NRC's Initial Success in Improving Reactor Operators' Capabilities.

    ERIC Educational Resources Information Center

    General Accounting Office, Washington, DC.

    The nuclear power plant accident at Three Mile Island raised many questions concerning the safety of nuclear power plant operations and the ability of nuclear plant reactor operators to respond to abnormal or accident conditions. In response, the Nuclear Regulatory Commission (NRC) developed a plan, which included short- and long-term actions to…

  8. Unconventional oil and gas extraction and animal health.

    PubMed

    Bamberger, M; Oswald, R E

    2014-08-01

    The extraction of hydrocarbons from shale formations using horizontal drilling with high volume hydraulic fracturing (unconventional shale gas and tight oil extraction), while derived from methods that have been used for decades, is a relatively new innovation that was introduced first in the United States and has more recently spread worldwide. Although this has led to the availability of new sources of fossil fuels for domestic consumption and export, important issues have been raised concerning the safety of the process relative to public health, animal health, and our food supply. Because of the multiple toxicants used and generated, and because of the complexity of the drilling, hydraulic fracturing, and completion processes including associated infrastructure such as pipelines, compressor stations and processing plants, impacts on the health of humans and animals are difficult to assess definitively. We discuss here findings concerning the safety of unconventional oil and gas extraction from the perspectives of public health, veterinary medicine, and food safety.

  9. Food safety concerns of fast food consumers in urban Ghana.

    PubMed

    Omari, Rose; Frempong, Godfred

    2016-03-01

    In Ghana, out-of-home ready-to-eat foods including fast food generally have been associated with food safety problems. Notwithstanding, fast food production and consumption are increasing in Ghana and therefore this study sought to determine the food safety issues of importance to consumers and the extent to which they worry about them. First, through three focus group discussions on consumers' personal opinions about food safety issues, some emergent themes were obtained, which were used to construct an open-ended questionnaire administered face-to-face to 425 respondents systematically sampled from 20 fast food restaurants in Accra. Findings showed that most fast food consumers were concerned about food hazards such as pesticide residue in vegetables, excessive use of artificial flavour enhancers and colouring substances, bacterial contamination, migrated harmful substances from plastic packages, and general unhygienic conditions under which food is prepared and sold. Consumers also raised concerns about foodborne diseases such as cholera, typhoid, food poisoning, diarrhoea, bird flu and swine flu. The logistic regression model showed that being male increased the likelihood of worrying about general food safety issues and excessive use of flavour enhancers than in females while being youthful increased the likelihood of being worried about typhoid fever than in older consumers. These findings imply that consumers in urban Ghana are aware and concerned about current trends of food safety and foodborne disease challenges in the country. Therefore, efforts targeted at improving food safety and reducing incidences of foodborne diseases should not only focus on public awareness creation but should also design more comprehensive programmes to ensure the making of food safety rules and guidelines and enforcing compliance to facilitate availability and consumers' choice of safe foods. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. The case of H.S.: the ethics of reporting alcohol dependence in a bus driver.

    PubMed

    Karol, David E; Schuermeyer, Isabel N; Brooker, Craig A

    2007-01-01

    The physician's duty to preserve patient confidentiality is challenged when doing so may endanger third parties. We present the case of a bus driver whose alcohol dependence raised concerns of a risk not only to his own health and safety, but to public safety as well. We first examine the legal and ethical obligations to report his alcohol use to his employer and then stress the importance of weighing the potential harm of violating patient-physician confidentiality against the severity of risk to the general public.

  11. Chemical Manufacturing and Refining Industry Legitimacy: Reflective Management, Trust, Precrisis Communication to Achieve Community Efficacy.

    PubMed

    Heath, Robert L; Lee, Jaesub

    2016-06-01

    Calls for emergency right-to-know in the 1980s, and, in the 1990s, risk management planning, motivated U.S. chemical manufacturing and refining industries to operationalize a three-pronged approach to risk minimization and communication: reflective management to increase legitimacy, operational safety programs to raise trust, and community engagement designed to facilitate citizens' emergency response efficacy. To assess these management, operational, and communication initiatives, communities (often through Local Emergency Planning Committees) monitored the impact of such programs. In 2012, the fourth phase of a quasi-longitudinal study was conducted to assess the effectiveness of operational change and community outreach in one bellwether community. This study focuses on legitimacy, trust, and response efficacy to suggest that an industry can earn legitimacy credits by raising its safety and environmental impact standards, by building trust via that change, and by communicating emergency response messages to near residents to raise their response efficacy. As part of its campaign to demonstrate its concern for community safety through research, planning, and implementation of safe operations and viable emergency response systems, this industry uses a simple narrative of risk/emergency response-shelter-in-place-communicated by a spokes-character: Wally Wise Guy. © 2015 Society for Risk Analysis.

  12. Forest worker exposure to airborne herbicide residues in smoke from prescribed fires in the Southern United States

    Treesearch

    Charles K. McMahon; Parshall B. Bush

    1992-01-01

    Occupational safety and health concerns have been raised in a number of southern states by workers conducting prescribed burns on forested lands treated with herbicides. Modeling assessments coupled with laboratory experiments have shown that the risk of airborne herbicide residues to workers is insignificant, even if the fire occurs immediately after herbicide...

  13. Should you recommend a low-carb, high-protein diet?

    PubMed

    Tapper-Gardzina, Yvonne; Cotugna, Nancy; Vickery, Connie E

    2002-04-01

    Despite the billions of dollars spent each year on weight-loss diets and products, few individuals maintain their weight loss after initiating popular diet programs. One diet that has raised safety concerns among the scientific community is the low-carbohydrate, high-protein diet. This article evaluates the scientific validity of this diet so that clinicians can appropriately advise patients.

  14. The Victim-Offender Overlap and Fear of In-School Victimization: A Longitudinal Examination of Risk Assessment Models

    ERIC Educational Resources Information Center

    Melde, Chris; Esbensen, Finn-Aage

    2009-01-01

    Reports of serious violence in schools have raised general awareness and concern about safety in America's schools. In this article, the authors examine the extent to which in-school victimization is associated with students' perceived risk and fear of victimization. By expanding on Ferraro's risk assessment framework, the current study explores…

  15. Vectors for Inhaled Gene Therapy in Lung Cancer. Application for Nano Oncology and Safety of Bio Nanotechnology

    PubMed Central

    Zarogouldis, Paul; Karamanos, Nikos K.; Porpodis, Konstantinos; Domvri, Kalliopi; Huang, Haidong; Hohenforst-Schimdt, Wolfgang; Goldberg, Eugene P.; Zarogoulidis, Konstantinos

    2012-01-01

    Novel aerosol therapeutic modalities have been investigated for lung cancer. Inhaled gene therapy has presented safety and effectiveness previously in cystic fibrosis. However, safety concerns have been raised regarding the safety of non-viral vectors for inhaled gene therapy in lung cancer, and therefore small steps have been made towards this multifunctional treatment modality. During the last decade, numerous new nanocomplexes have been created and investigated as a safe gene delivery nano-vehicle. These formulations are multifunctional; they can be used as either local therapy or carrier for an effective inhaled gene therapy for lung cancer. Herein, we present current and future perspectives of nanocomplexes for inhaled gene therapy treatment in lung cancer. PMID:23109824

  16. Safety Considerations in the Use of Ketorolac for Postoperative Pain.

    PubMed

    Maslin, Benjamin; Lipana, Lawrence; Roth, Brandon; Kodumudi, Gopal; Vadivelu, Nalini

    2017-01-01

    Ketorolac use has significantly expanded for postoperative pain management since it first became available in the United States, primarily due to well established effects on patient pain scores and its ability to reduce perioperative opioid requirements. As an inhibitor of cyclooxygenase, ketorolac use has raised clinical concern including particular controversy regarding its potential effects on bone healing, postoperative kidney function and perioperative bleeding. To review the supporting data from clinical studies addressing the safety of ketorolac use for postoperative pain. This review highlights the most up-to-date research from clinical trials as well as from retrospective studies and meta-analyses regarding the effects of perioperative use of ketorolac on bone healing, kidney function and blood loss. Based on the most up-to-date literature, ketorolac in normal doses has been demonstrated to be safe with respect to bone healing. In patients with normal kidney function, numerous studies have established the safety of Ketorolac; however other studies have raised safety concerns in patients with comorbid kidney, heart and liver disease. While there is evidence that ketorolac may cause prolonged bleeding time and may be associated with increased postoperative blood loss after tonsillectomy, large scale prospective randomized controlled trials and subsequent meta-analyses have failed to establish an association of ketorolac use and perioperative blood loss. Perioperative administration of ketorolac has been demonstrated to be safe and effective in healthy patients and is particularly beneficial as an opioid-sparing agent in vulnerable patient groups. However, in certain surgical and medical contexts, proper patient selection based on the multidisciplinary collaboration between perioperative clinician specialists will optimize patient safety and pain management outcomes. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  17. Patient safety in the care of mentally ill people in Switzerland: Action plan 2016

    PubMed

    Richard, Aline; Mascherek, Anna C; Schwappach, David L B

    2017-01-01

    Background: Patient safety in mental healthcare has not attracted great attention yet, although the burden and the prevalence of mental diseases are high. The risk of errors with potential for harm of patients, such as aggression against self and others or non-drug treatment errors is particularly high in this vulnerable group. Aim: To develop priority topics and strategies for action to foster patient safety in mental healthcare. Method: The Swiss patient safety foundation together with experts conducted round table discussions and a Delphi questionnaire to define topics along the treatment pathway, and to prioritise these topics. Finally, fields of action were developed. Results: An action plan was developed including the definition and prioritization of 9 topics where errors may occur. A global rating task revealed errors concerning diagnostics and structural errors as most important. This led to the development of 4 fields of action (awareness raising, research, implementation, and education and training) including practice-oriented potential starting points to enhance patient safety. Conclusions: The action plan highlights issues of high concern for patient safety in mental healthcare. It serves as a starting point for the development of strategies for action as well as of concrete activities.

  18. Alternatives to currently used antimalarial drugs: in search of a magic bullet.

    PubMed

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2016-11-04

    Malaria is a major cause of morbidity and mortality in many African countries and parts of Asia and South America. Novel approaches to combating the disease have emerged in recent years and several drug candidates are now being tested clinically. However, it is long before these novel drugs can hit the market, especially due to a scarcity of safety and efficacy data.To reduce the malaria burden, the Medicines for Malaria Venture (MMV) was established in 1999 to develop novel medicines through industry and academic partners' collaboration. However, no reviews were focused following various preclinical and clinical studies published since the MMV initiation (2000) to till date.We identify promising approaches in the global portfolio of antimalarial medicines, and highlight challenges and patient specific concerns of these novel molecules. We discuss different clinical studies focusing on the evaluation of novel drugs against malaria in different human trials over the past five years.The drugs KAE609 and DDD107498 are still being evaluated in Phase I trials and preclinical developmental studies. Both the safety and efficacy of novel compounds such as KAF156 and DSM265 need to be assessed further, especially for use in pregnant women. Synthetic non-artemisinin ozonides such as OZ277 raised concerns in terms of its insufficient efficacy against high parasitic loads. Aminoquinoline-based scaffolds such as ferroquine are promising but should be combined with good partner drugs for enhanced efficacy. AQ-13 induced electrocardiac events, which led to prolonged QTc intervals. Tafenoquine, the only new anti-relapse scaffold for patients with a glucose-6-phosphate dehydrogenase deficiency, has raised significant concerns due to its hemolytic activity. Other compounds, including methylene blue (potential transmission blocker) and fosmidomycin (DXP reductoisomerase inhibitor), are available but cannot be used in children.At this stage, we are unable to identify a single magic bullet against malaria. Future studies should focus on effective single-dose molecules that can act against all stages of malaria in order to prevent transmission. Newer medicines have also raised concerns in terms of efficacy and safety. Overall, more evidence is needed to effectively reduce the current malaria burden. Treatment strategies that target the blood stage with transmission-blocking properties are needed to prevent future drug resistance.

  19. The inverse benefit law: how drug marketing undermines patient safety and public health.

    PubMed

    Brody, Howard; Light, Donald W

    2011-03-01

    Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.

  20. Imbuing medical professionalism in relation to safety: a study protocol for a mixed-methods intervention focused on trialling an embedded learning approach that centres on the use of a custom designed board game.

    PubMed

    Ward, Marie; McAuliffe, Eilish; Ní Shé, Éidín; Duffy, Ann; Geary, Una; Cunningham, Una; Holland, Catherine; McDonald, Nick; Egan, Karen; Korpos, Christian

    2017-07-17

    Healthcare organisations have a responsibility for ensuring that the governance of workplace settings creates a culture that supports good professional practice. Encouraging such a culture needs to start from an understanding of the factors that make it difficult for health professionals to raise issues of concern in relation to patient safety. The focus of this study is to determine whether a customised education intervention, developed as part of the study, with interns and senior house officers (SHOs) can imbue a culture of medical professionalism in relation to patient safety and support junior doctors to raise issues of concern, while shaping a culture of responsiveness and learning. We will use quantitative and qualitative methods to collect data. The sample size will be approximately 200 interns and SHOs across the two hospital sites. Two surveys will be included with one measuring leadership inclusiveness and psychological safety and a second capturing information on safety concerns that participants may have witnessed in their places of work. The PlayDecide embedded learning intervention will be developed with key stakeholders. This will be trialled in the middle stage of data collection for both interns and SHOs. A detailed content analysis will be conducted on the surveys to assess any changes in reporting following the PlayDecide intervention. This will be compared with the incident reporting levels and the results of the preintervention and postintervention leadership inclusiveness and psychological safety survey. Statistical analysis will be conducted using SPSS. Differences will be considered statistically significant at p<0.05. Semistructured interviews using a critical incident technique will be used for the ongoing analysis and evaluation of the project. These will be transcribed, de-identified and coded into themes. The study has been granted ethics approval from University College Dublin (Ref. LS-15-19-Ward-McAuliffe: Imbuing Medical Professionalism in Relation to Safety). The study results will be disseminated through peer-reviewed publications. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. Cognitive safety of intracranial electrodes for epilepsy.

    PubMed

    Meador, Kimford J; Halpern, Casey H; Hermann, Bruce P

    2018-06-01

    Two recent articles in Epilepsia have raised concerns about adverse cognitive effects associated with intracranial electrode implantation. However, both studies have important limitations, and their results contrast with studies that report no adverse cognitive effects of intracranial electrodes for diagnosis or neurostimulation in epilepsy. Furthermore, no data are provided on the relative safety of depth electrodes implanted along the longitudinal axis of the hippocampus vs other electrode locations or types of electrodes. Instituting changes in the use of depth electrodes based solely on these 2 studies is not clinically indicated. Further research is needed. Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.

  2. Software Safety Assurance of Programmable Logic

    NASA Technical Reports Server (NTRS)

    Berens, Kalynnda

    2002-01-01

    Programmable Logic (PLC, FPGA, ASIC) devices are hybrids - hardware devices that are designed and programmed like software. As such, they fall in an assurance gray area. Programmable Logic is usually tested and verified as hardware, and the software aspects are ignored, potentially leading to safety or mission success concerns. The objective of this proposal is to first determine where and how Programmable Logic (PL) is used within NASA and document the current methods of assurance. Once that is known, raise awareness of the PL software aspects within the NASA engineering community and provide guidance for the use and assurance of PL form a software perspective.

  3. Perceptions about safety and risks in gender-based violence research: implications for the ethics review process.

    PubMed

    Sikweyiya, Yandisa; Jewkes, Rachel

    2011-10-01

    Does research on gender-based violence (GBV) pose greater than minimal risk to researchers and participants? This question needs to be understood particularly in light of hesitancy by Institutional Review Boards to approve research on GBV. The safety and risks of doing GBV studies and the implications for the ethical review process have not been a focus of much research. This qualitative study collected data through in-depth interviews with 12 experienced GBV researchers from various countries and a desk review. This paper explores researchers' interpretation of and meanings of the safety recommendations as provided in the WHO guidelines and whether there is empirical evidence on the presence of risks and safety concerns unique to GBV research. Informants raised a number of safety concerns about GBV research, yet in the interviews there were very few examples of problems having occurred, possibly because of the precautions applied. This paper argues that the notion that GBV studies carry greater than minimal risk when ethics precautions are followed is based on speculation, not evidence. It highlights the need for empirical evidence to support assertions of risk in research.

  4. Nuclear health and safety

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Glenn, J.

    1991-02-01

    There has been concern over the Department of Energy's (DOE) dual role of producing nuclear weapons and assessing the potential health hazards associated with operating its facilities has raised questions about DOE's ability to effectively manage its health and health effects (epidemiology) research programs. In March 1990, the secrecy of Energy announced several initiatives to address these concerns. These initiatives include, among others, the development of an occupational health and epidemiology program, the transfer of long-term health effects' studies to the Department of Health and Human Services (HHS), the establishment of an advisory committee to oversee DOE's environmental, safety, andmore » health activities, and the design of a data base to store and retrieve health data. This paper provides a brief description of DOE's initiatives, including their status as of December 1990 and general observations of these initiatives.« less

  5. Safety Assessment of Achillea millefolium as Used in Cosmetics.

    PubMed

    Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2016-11-01

    Cosmetic ingredients derived from Achillea millefolium function in cosmetics as skin-conditioning agents-miscellaneous, skin-conditioning agents-humectants, and fragrance ingredients. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data to determine their safety in cosmetics and raised concerns about cosmetics containing linalool, thujone, quercetin, hydroquinone, or α-peroxyachifolid. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these components and to avoid reaching levels that may be hazardous to consumers. Additionally, industry was advised to use good manufacturing practices to limit impurities. The Panel concluded that achillea millefolium extract, achillea millefolium flower extract, and achillea millefolium flower/leaf/stem extract are safe in the present practices of use and concentration in cosmetics when formulated to be nonsensitizing. © The Author(s) 2016.

  6. Specific features of medicines safety and pharmacovigilance in Africa

    PubMed Central

    Pal, Shanthi N.; Olsson, Sten; Dodoo, Alexander; Bencheikh, Rachida Soulayami

    2012-01-01

    The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern. PMID:25083223

  7. Phytotoxins: environmental micropollutants of concern?

    PubMed

    Bucheli, Thomas D

    2014-11-18

    Natural toxins such as mycotoxins or phytotoxins (bioactive compounds from fungi and plants, respectively) have been widely studied in food and feed, where they are stated to out-compete synthetic chemicals in their overall human and animal toxicological risk. A similar perception and awareness is yet largely missing for environmental safety. This article attempts to raise concern in this regard, by providing (circumstantial) evidence that phytotoxins in particular can be emitted into the environment, where they may contribute to the complex mixture of organic micropollutants. Exposures can be orders-of-magnitude higher in anthropogenically managed/affected (agro-)ecosystems than in the pristine environment.

  8. National pilot audit of intermediate care.

    PubMed

    Hutchinson, Tom; Young, John; Forsyth, Duncan

    2011-04-01

    The National Service Framework for Older People resulted in the widespread introduction of intermediate care (IC) services. However, although these services have shared common aims, there has been considerable diversity in their staffing, organisation and delivery. Concerns have been raised regarding the clinical governance of IC with a paucity of data to evaluate the effectiveness, quality and safety of these services. This paper presents the results of a national pilot audit of IC services focusing particularly on clinical governance issues. The results confirm these concerns and provide support for a larger scale national audit of IC services to monitor and improve care quality.

  9. What do health consumers want to know about childhood vaccination? An evaluation of data from an Australian medicines call centre.

    PubMed

    Mus, Marnix; Kreijkamp-Kaspers, Sanne; McGuire, Treasure; Deckx, Laura; van Driel, Mieke

    2017-02-01

    Immunisation is crucial to population health. This study aimed to identify the information needs and concerns of health consumers regarding childhood vaccination. We analysed 1,342 calls concerning childhood vaccination to an Australian pharmacist-operated medicines call centre (MCC). Data were available from September 2002 until June 2010. We identified key themes and compared these for callers from high and low immunisation coverage areas. Most calls related to safety concerns (60.4%), with many questions about vaccine constituents (31.6%). In low immunisation areas, a higher level of concern persisted about vaccine preservatives (mercury and thiomersal) despite their removal from vaccines in 2000. Of specific vaccines, the measles, mumps and rubella vaccine raised most questions (29.9%). Common motivations to call the MCC were 'inadequate information' (54%), 'second opinion' (21%) 'conflicting information' (9%) and 'worrying symptom' (6%). The consistent number of vaccine-related calls, particularly about safety, demonstrates an information gap that can contribute to vaccination hesitancy. Health professionals need to know their local immunisation rate and associated carer concerns, to proactively address these information-related barriers to vaccination. © 2016 The Authors.

  10. Immunogenicity of therapeutics: a matter of efficacy and safety.

    PubMed

    Nechansky, Andreas; Kircheis, Ralf

    2010-11-01

    The unwanted immunogenicity of therapeutic proteins is a major concern regarding patient safety. Furthermore, pharmacokinetic, pharmacodynamic and clinical efficacy can be seriously affected by the immunogenicity of therapeutic proteins. Authorities have fully recognized this issue and demand appropriate and well-characterized assays to detect anti-drug antibodies (ADAs). We provide an overview of the immunogenicity topic in general, the regulatory background and insight into underlying immunological mechanisms and the limited ability to predict clinical immunogenicity a priori. Furthermore, we comment on the analytical testing approach and the status-quo of appropriate method validation. The review provides insight regarding the analytical approach that is expected by regulatory authorities overseeing immunogenicity testing requirements. Additionally, the factors influencing immunogenicity are summarized and key references regarding immunogenicity testing approaches and method validation are discussed. The unwanted immunogenicity of protein therapeutics is of major concern because of its potential to affect patient safety and drug efficacy. Analytical testing is sophisticated and requires more than one assay. Because immunogenicity in humans is hardly predictable, assay development has to start in a timely fashion and for clinical studies immunogenicity assay validation is mandatory prior to analyzing patient serum samples. Regarding ADAs, the question remains as to when such antibodies are regarded of clinical relevance and what levels are, if at all, acceptable. In summary, the detection of ADAs should raise the awareness of the physician concerning patient safety and of the sponsor/manufacture concerning the immunogenic potential of the drug product.

  11. Use of animals in the development and control of viral vaccines.

    PubMed

    Minor, P D

    1996-01-01

    Animal models were central to the development of poliovaccines and remain essential in some form in the routine quality control of both live and killed vaccines. The necessity of an animal model is illustrated by the examples of mumps and measles vaccines where the existing materials, while satisfactory, have a number of drawbacks and where changes in current practice raise concerns for safety and efficacy.

  12. AIDS in the workplace: current practices and possible implications.

    PubMed

    Nykodym, N; Miners, I A; Simonetti, J L; Patel, N S

    1989-01-01

    The testing of Acquired Immune Deficiency Syndrome (AIDS) remains a political factor. Questions are being raised as to an individual's right to privacy and the public's concern for safety. Despite the controversy, the law protects contagious disease sufferers from employment discrimination. Along with AIDS testing, drug testing remains a controversial issue. Mandatory drug testing remains in both the public and private sectors. Legislative activity in California continues to the present.

  13. The U.S. Food and Drug Administration's Evaluation of the Safety of Animal Clones: A Failure to Recognize the Normativity of Risk Assessment Projects

    ERIC Educational Resources Information Center

    Meghani, Zahra; de Melo-Martin, Inmaculada

    2009-01-01

    The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to…

  14. The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health

    PubMed Central

    Light, Donald W.

    2011-01-01

    Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing. PMID:21233426

  15. Analysis of Factors Determining Ergonomic Conditions of Driver's Workplace and Safety in Transport of Dangerous Goods

    NASA Astrophysics Data System (ADS)

    Grabarek, Iwona; Beczkowska, Sylwia

    2012-09-01

    The article concerns issues connected with the safety of the carriage of dangerous goods. Raising a subject was justified with the rising number of cartages of these goods and the same height of the probability of the appearance of the environmental risk and remaining road users. A specificity of the arrangement was analyzed driver-vehicleenvironment, paying special attention to ergonomic determinants of working conditions of the driver. In the article data of the National Police Headquarters concerning causes of accident involving dangerous goods in the road transport was also described. Exceeding the permissible speed, the non-observance of traffic regulations, as well as the tiredness which resulted in reducing the psychophysical efficiency for the driver were regarded as the root cause of accidents. Conducted analyses allowed to effect the preliminary selection of factors, which accepting the wrong level can constitute the cause of accidents.

  16. Exposure to the BPA-Substitute Bisphenol S Causes Unique Alterations of Germline Function

    PubMed Central

    Chen, Yichang; Qiu, Zhiqun; Lee, Dong Yeon; Telesca, Donatello; Yang, Xia; Allard, Patrick

    2016-01-01

    Concerns about the safety of Bisphenol A, a chemical found in plastics, receipts, food packaging and more, have led to its replacement with substitutes now found in a multitude of consumer products. However, several popular BPA-free alternatives, such as Bisphenol S, share a high degree of structural similarity with BPA, suggesting that these substitutes may disrupt similar developmental and reproductive pathways. We compared the effects of BPA and BPS on germline and reproductive functions using the genetic model system Caenorhabditis elegans. We found that, similarly to BPA, BPS caused severe reproductive defects including germline apoptosis and embryonic lethality. However, meiotic recombination, targeted gene expression, whole transcriptome and ontology analyses as well as ToxCast data mining all indicate that these effects are partly achieved via mechanisms distinct from BPAs. These findings therefore raise new concerns about the safety of BPA alternatives and the risk associated with human exposure to mixtures. PMID:27472198

  17. Best practices for preventing musculoskeletal disorders in masonry: stakeholder perspectives.

    PubMed

    Entzel, Pamela; Albers, Jim; Welch, Laura

    2007-09-01

    Brick masons and mason tenders report a high prevalence of work-related musculoskeletal disorders (WMSDs), many of which can be prevented with changes in materials, work equipment or work practices. To explore the use of "best practices" in the masonry industry, NIOSH organized a 2-day meeting of masonry stakeholders. Attendees included 30 industry representatives, 5 health and safety researchers, 4 health/safety specialists, 2 ergonomic consultants, and 2 representatives of state workers' compensation programs. Small groups discussed ergonomic interventions currently utilized in the masonry industry, including factors affecting intervention implementation and ways to promote diffusion of interventions. Meeting participants also identified various barriers to intervention implementation, including business considerations, quality concerns, design issues, supply problems, jobsite conditions and management practices that can slow or limit intervention diffusion. To be successful, future diffusion efforts must not only raise awareness of available solutions but also address these practical concerns.

  18. The second “time-out”: a surgical safety checklist for lengthy robotic surgeries

    PubMed Central

    2013-01-01

    Robotic surgeries of long duration are associated with both increased risks to patients as well as distinct challenges for care providers. We propose a surgical checklist, to be completed during a second “time-out”, aimed at reducing peri-operative complications and addressing obstacles presented by lengthy robotic surgeries. A review of the literature was performed to identify the most common complications of robotic surgeries with extended operative times. A surgical checklist was developed with the goal of addressing these issues and maximizing patient safety. Extended operative times during robotic surgery increase patient risk for position-related complications and other adverse events. These cases also raise concerns for surgical, anesthesia, and nursing staff which are less common in shorter, non-robotic operations. Key elements of the checklist were designed to coordinate operative staff in verifying patient safety while addressing the unique concerns within each specialty. As robotic surgery is increasingly utilized, operations with long surgical times may become more common due to increased case complexity and surgeons overcoming the learning curve. A standardized surgical checklist, conducted three to four hours after the start of surgery, may enhance perioperative patient safety and quality of care. PMID:23731776

  19. The Japan Flavour and Fragrance Materials Association's (JFFMA) safety assessment of acetal food flavouring substances uniquely used in Japan.

    PubMed

    Okamura, Hiroyuki; Abe, Hajime; Hasegawa-Baba, Yasuko; Saito, Kenji; Sekiya, Fumiko; Hayashi, Shim-Mo; Mirokuji, Yoshiharu; Maruyama, Shinpei; Ono, Atsushi; Nakajima, Madoka; Degawa, Masakuni; Ozawa, Shogo; Shibutani, Makoto; Maitani, Tamio

    2015-01-01

    Using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), we performed safety evaluations on five acetal flavouring substances uniquely used in Japan: acetaldehyde 2,3-butanediol acetal, acetoin dimethyl acetal, hexanal dibutyl acetal, hexanal glyceryl acetal and 4-methyl-2-pentanone propyleneglycol acetal. As no genotoxicity study data were available in the literature, all five substances had no chemical structural alerts predicting genotoxicity. Using Cramer's classification, acetoin dimethyl acetal and hexanal dibutyl acetal were categorised as class I, and acetaldehyde 2,3-butanediol acetal, hexanal glyceryl acetal and 4-methyl-2-pentanone propyleneglycol acetal as class III. The estimated daily intakes for all five substances were within the range of 1.45-6.53 µg/person/day using the method of maximised survey-derived intake based on the annual production data in Japan from 2001, 2005, 2008 and 2010, and 156-720 µg/person/day using the single-portion exposure technique (SPET), based on the average use levels in standard portion sizes of flavoured foods. The daily intakes of the two class I substances were below the threshold of toxicological concern (TTC) - 1800 μg/person/day. The daily intakes of the three class III substances exceeded the TTC (90 μg/person/day). Two of these, acetaldehyde 2,3-butanediol acetal and hexanal glyceryl acetal, were expected to be metabolised into endogenous products after ingestion. For 4-methyl-2-pentanone propyleneglycol acetal, one of its metabolites was not expected to be metabolised into endogenous products. However, its daily intake level, based on the estimated intake calculated by the SPET method, was about 1/15 000th of the no observed effect level. It was thus concluded that all five substances raised no safety concerns when used for flavouring foods at the currently estimated intake levels. While no information on in vitro and in vivo toxicity for all five substances was available, their metabolites were judged as raising no safety concerns at the current levels of intake.

  20. Young people's views on sharing health-related stories on the Internet.

    PubMed

    Yu, Juping; Taverner, Nicki; Madden, Kim

    2011-05-01

    There is an increasing interest in the use of stories in healthcare practice and education. However, there are few stories from young people concerning health and little is known about their views on sharing such stories on the Internet. The aim of this study was to explore young people's perspectives in this area. A qualitative method was used and a project website was purposely built to facilitate data collection. An online focus group with 13 young people was carried out in an asynchronous format. Participants valued highly the therapeutic effect of storytelling and the use of digital stories to share feelings and experiences with a wide range of audiences, suggesting that well-produced stories could be a useful learning resource. A number of concerns were also raised, including embarrassment, reaction of other people and online safety. Having stories available on the Internet can be beneficial; however, concerns especially about safety associated with Internet use and support for storytellers should be taken into consideration. A better understanding of young people's perceptions can provide valuable insights for future work with this age group on storytelling. © 2011 Blackwell Publishing Ltd.

  1. Raised crosswalks on entrance to the roundabout-a case study on effectiveness of treatment on pedestrian safety and convenience.

    PubMed

    Candappa, Nimmi; Stephan, Karen; Fotheringham, Nicola; Lenné, Michael G; Corben, Bruce

    2014-01-01

    A common concern in the use of a roundabout is providing adequately for the pedestrian. This unique roundabout layout, which introduces raised crosswalks directly at the roundabout entrance, as opposed to at a car length back, aims at improving safety and convenience for pedestrians at roundabouts. A preliminary evaluation of the layout was undertaken to establish its effectiveness in meeting study objectives. A quasi-experimental before-and-after study design was used to compare speeds on approach and immediately prior to the crossing to ascertain potential impact speed and implications for pedestrian safety. Compliance to crossing and crossing time were also compared in relation to safety and convenience outcomes. A questionnaire assessed pedestrian perception of the safety and convenience at the roundabout before and after treatment. Results from this case study indicate that mean approach speeds (free speeds 30 m from crossing) reduced from 32.7 to 30.7 km/h and immediately prior to crossing, mean speeds reduced from 19.1 to 16.3 km/h. There was also a marked reduction in proportions of vehicles traveling at speeds that could elevate risk to pedestrians. Total crossing time after treatment reduced by around 4 s, and crossing compliance increased from approximately half to approximately 90 percent. Survey of pedestrians indicated positive response to the perceived safety and convenience posttreatment. Preliminary results of the case study suggest positive safety and convenience outcomes. Implications for pedestrian safety include less exposure to traffic and lower risk of serious injury, particularly for elderly pedestrians; convenience outcomes include shorter waiting times to cross and greater compliance to the crossing. A larger study is required to substantiate the findings.

  2. The Immunogenicity and Immune Tolerance of Pluripotent Stem Cell Derivatives

    PubMed Central

    Liu, Xin; Li, Wenjuan; Fu, Xuemei; Xu, Yang

    2017-01-01

    Human embryonic stem cells (hESCs) can undergo unlimited self-renewal and differentiate into all cell types in human body, and therefore hold great potential for cell therapy of currently incurable diseases including neural degenerative diseases, heart failure, and macular degeneration. This potential is further underscored by the promising safety and efficacy data from the ongoing clinical trials of hESC-based therapy of macular degeneration. However, one main challenge for the clinical application of hESC-based therapy is the allogeneic immune rejection of hESC-derived cells by the recipient. The breakthrough of the technology to generate autologous-induced pluripotent stem cells (iPSCs) by nuclear reprogramming of patient’s somatic cells raised the possibility that autologous iPSC-derived cells can be transplanted into the patients without the concern of immune rejection. However, accumulating data indicate that certain iPSC-derived cells can be immunogenic. In addition, the genomic instability associated with iPSCs raises additional safety concern to use iPSC-derived cells in human cell therapy. In this review, we will discuss the mechanism underlying the immunogenicity of the pluripotent stem cells and recent progress in developing immune tolerance strategies of human pluripotent stem cell (hPSC)-derived allografts. The successful development of safe and effective immune tolerance strategy will greatly facilitate the clinical development of hPSC-based cell therapy. PMID:28626459

  3. Whistle-blowing and workplace culture in older peoples' care: qualitative insights from the healthcare and social care workforce.

    PubMed

    Jones, Aled; Kelly, Daniel

    2014-09-01

    Inquiries in the UK into mistreatment of older people by healthcare employees over the last 30 years have focused on introducing or supporting employee whistle-blowing. Although whistle-blowers have made an important contribution to patient safety it remains a controversial activity. The fate of whistle-blowers is bleak, often resulting in personal and professional sacrifices. Here we draw on the views of healthcare and social care employees working with older people to explore perceptions of whistle-blowing as well as alternative strategies that may be used to raise concerns about the mistreatment of patients by co-workers. Whistle-blowing was perceived as a negative term. Managers said they promoted open cultures underpinned by regular team meetings and an open-door ethos. Others described workplace norms that were somewhat at odds with these open culture ideals. Whistle-blowing was considered risky, and this led to staff creating informal channels through which to raise concerns. Those who witnessed wrongdoing were aware that support was available from external agencies but preferred local solutions and drew upon personal ethics rather than regulatory edicts to shape their responses. We argue that the importance of workplace relationships and informal channels for raising concerns should be better understood to help prevent the mistreatment of vulnerable groups. © 2014 The Authors. Sociology of Health & Illness © 2014 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

  4. Women's safety alerts in maternity care: is speaking up enough?

    PubMed

    Rance, Susanna; McCourt, Christine; Rayment, Juliet; Mackintosh, Nicola; Carter, Wendy; Watson, Kylie; Sandall, Jane

    2013-04-01

    Patients' contributions to safety include speaking up about their perceptions of being at risk. Previous studies have found that dismissive responses from staff discouraged patients from speaking up. A Care Quality Commission investigation of a maternity service where serious incidents occurred found evidence that women had routinely been ignored and left alone in labour. Women using antenatal services hesitated to raise concerns that they felt staff might consider irrelevant. The Birthplace in England programme, which investigated the quality and safety of different places of birth for 'low-risk' women, included a qualitative organisational case study in four NHS Trusts. The authors collected documentary, observational and interview data from March to December 2010 including interviews with 58 postnatal women. A framework approach was combined with inductive analysis using NVivo8 software. Speaking up, defined as insistent and vehement communication when faced with failure by staff to listen and respond, was an unexpected finding mentioned in half the women's interviews. Fourteen women reported raising alerts about safety issues they felt to be urgent. The presence of a partner or relative was a facilitating factor for speaking up. Several women described distress and harm that ensued from staff failing to listen. Women are speaking up, but this is not enough: organisation-focused efforts are required to improve staff response. Further research is needed in maternity services and in acute and general healthcare on the effectiveness of safety-promoting interventions, including real-time patient feedback, patient toolkits and patient-activated rapid response calls.

  5. School climate factors contributing to student and faculty perceptions of safety in select Arizona schools.

    PubMed

    Bosworth, Kris; Ford, Lysbeth; Hernandaz, Diley

    2011-04-01

    To ensure that schools are safe places where students can learn, researchers and educators must understand student and faculty safety concerns. This study examines student and teacher perceptions of school safety. Twenty-two focus groups with students and faculty were conducted in 11 secondary schools. Schools were selected from a stratified sample to vary in location, proximity to Indian reservations, size, and type. The data analysis was based on grounded theory. In 9 of 11 schools, neither faculty nor students voiced overwhelming concerns about safety. When asked what makes school safe, students tended to report physical security features. School climate and staff actions also increased feelings of safety. Faculty reported that relationships and climate are key factors in making schools safe. High student performance on standardized tests does not buffer students from unsafe behavior, nor does living in a dangerous neighborhood necessarily lead to more drug use or violence within school walls. School climate seemed to explain the difference between schools in which students and faculty reported higher versus lower levels of violence and alcohol and other drug use. The findings raise provocative questions about school safety and provide insight into elements that lead to perceptions of safety. Some schools have transcended issues of location and neighborhood to provide an environment perceived as safe. Further study of those schools could provide insights for policy makers, program planners, and educational leaders. © 2011, American School Health Association.

  6. Characterization, Exposure Measurement and Control for Nanoscale Particles in Workplaces and on the Road

    NASA Astrophysics Data System (ADS)

    Wang, Jing; Pui, David Y. H.

    2011-07-01

    The amount of engineered nanoparticles is increasing at a rapid rate and more concerns are being raised about the occupational health and safety of nanoparticles in the workplace, and implications of nanotechnology on the environment and living systems. At the same time, diesel engine emissions are one of the serious air pollution sources in urban area. Ultrafine particles on the road can result in harmful effects on the health of drivers and passengers. Research on characterization, exposure measurement and control is needed to address the environmental, health and safety issues of nanoscale particles. We present results of our studies on airborne particles in workplaces and on the road.

  7. Role of the nurse immuniser in implementing and maintaining the National Human Papillomavirus 'Cervical Cancer' Vaccine rollout through a school-based program in Victoria.

    PubMed

    Kent, Helen; Heffernan, Margaret E; Silvers, Julie; Moore, Elya; Garland, Suzanne M

    2010-09-01

    In an effort to understand the strengths and limitations of current approaches to human papillomavirus vaccine (HPV) delivery in schools, we conducted an audit of nurse immunisers (NI). In this survey of 159 Victorian NI, the NI perceived that knowledge, safety and side effects were among the most important issues raised by parents, schoolgirls, and teachers in the school setting. The most common concern identified by NIs was the physical layout of the vaccination setting (41%), followed by safety, then knowledge of the vaccine. There is a need for ongoing assessment of factors that improve or impede the delivery of HPV vaccines.

  8. Ebola: Facing a New Transboundary Animal Disease?

    PubMed Central

    Feldmann, F.; Feldmann, H.

    2016-01-01

    Ebola viruses are zoonotic pathogens with the potential of causing severe viral hemorrhagic fever in humans and nonhuman primates. Bats have been identified as a reservoir for Ebola viruses but it remains unclear if transmission to an end host involves intermediate hosts. Recently, one of the Ebola species has been found in Philippine pigs raising concerns regarding animal health and food safety. Diagnostics have so far focused on human application, but enhanced pig surveillance and diagnostics, particularly in Asia, for Ebola virus infections seem to be needed to establish reasonable guidelines for public and animal health and food safety. Livestock vaccination against Ebola seems currently not justified but proper preparedness may include experimental vaccine approaches. PMID:23689898

  9. Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States

    PubMed Central

    2015-01-01

    Millions of people in the United States consume dietary supplements hoping to maintain or improve their health; however, extensive research has failed to demonstrate the efficacy of numerous supplements in disease prevention. In addition, concerns about the safety of routine and high-dose supplementation have been raised. The Food and Drug Administration regulates dietary supplement quality, safety, and labeling, and the Federal Trade Commission monitors advertisements and marketing; still, vast enforcement challenges remain, and optimal governmental oversight has not been achieved. If the composition and quality of ingredients cannot be reliably ensured, the validity of research on dietary supplements is questionable. Moreover, the health of the US public is put at risk. PMID:25602879

  10. Bioresorbable Vascular Scaffold Korean Expert Panel Report

    PubMed Central

    Park, Duk-Woo; Ahn, Young Keun; Kim, Won-Jang; Hong, Soon Jun; Kang, Do-Yoon; Chun, Woo Jung; Heo, Jung Ho; Cho, Deok-Kyu; Kim, Jin Won; Her, Sung-Ho; Kim, Sang Wook; Yoo, Sang-Yong; Tahk, Seung-Jea; Kim, Kee-Sik; Kim, Moo Hyun

    2017-01-01

    Bioresorbable vascular scaffold (BRS) is an innovative device that provides structural support and drug release to prevent early recoil or restenosis, and then degrades into nontoxic compounds to avoid late complications related with metallic drug-eluting stents (DESs). BRS has several putative advantages. However, recent randomized trials and registry studies raised clinical concerns about the safety and efficacy of first generation BRS. In addition, the general guidance for the optimal practice with BRS has not been suggested due to limited long-term clinical data in Korea. To address the safety and efficacy of BRS, we reviewed the clinical evidence of BRS implantation, and suggested the appropriate criteria for patient and lesion selection, scaffold implantation technique, and management. PMID:29171214

  11. Regulatory Compliance in Multi-Tier Supplier Networks

    NASA Technical Reports Server (NTRS)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

    Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

  12. [Anthropogenic sources of radiation hazard in the near-Earth space].

    PubMed

    Fedoseev, G A

    2004-01-01

    All plausible artificial radioactive sources entering the near-Earth space (NES) were systematized and consequences of various large radiation accidents and catastrophes to Earth and NES were analyzed. Aggressive "population" of near-Earth orbits by space stations with rotating crews, unmanned research platforms and observatories extends "borderlines" of the noosphere raising at the same time concerns about the noosphere radiation safety and global radioecology. Specifically, consideration is given to the facts of negative effects of space power reactor facilities on results of orbital astrophysical investigations.

  13. High performance Li-ion sulfur batteries enabled by intercalation chemistry.

    PubMed

    Lv, Dongping; Yan, Pengfei; Shao, Yuyan; Li, Qiuyan; Ferrara, Seth; Pan, Huilin; Graff, Gordon L; Polzin, Bryant; Wang, Chongmin; Zhang, Ji-Guang; Liu, Jun; Xiao, Jie

    2015-09-11

    The unstable interface of lithium metal in high energy density Li sulfur (Li-S) batteries raises concerns of poor cycling, low efficiency and safety issues, which may be addressed by using intercalation types of anode. Herein, a new prototype of Li-ion sulfur battery with high performance has been demonstrated by coupling a graphite anode with a sulfur cathode (2 mA h cm(-2)) after successfully addressing the interface issue of graphite in an ether based electrolyte.

  14. Unknown Safety and Efficacy of Smartphone Bolus Calculator Apps Puts Patients at Risk for Severe Adverse Outcomes.

    PubMed

    Hirsch, Irl B; Parkin, Christopher G

    2016-07-01

    Manual calculation of bolus insulin dosages can be challenging for individuals treated with multiple daily insulin injections (MDI) therapy. Automated bolus calculator capability has recently been made available via enhanced blood glucose meters and smartphone apps. Use of this technology has been shown to improve glycemic control and reduce glycemic variability without changing hypoglycemia; however, the clinical utility of app-based bolus calculators has not been demonstrated. Moreover, recent evidence challenges the safety and efficacy of these smartphone apps. Although the ability to automatically calculate bolus insulin dosages addresses a critical need of MDI-treated individuals, this technology raises concerns about efficacy of treatment and the protection of patient safety. This article discusses key issues and considerations associated with automated bolus calculator use. © 2016 Diabetes Technology Society.

  15. Paediatric dental chair sedation: An audit of current practice in Gauteng, South Africa.

    PubMed

    Bham, F; Perrie, H; Scribante, J; Lee, C-A

    2015-06-01

    Procedural sedation and analgesia (PSA) is often required to perform dental procedures in children. Serious adverse outcomes, while rare, are usually preventable. To determine the proportion of dental practitioners making use of paediatric dental chair PSA in Gauteng Province, South Africa, describe their PSA practice, and determine compliance with recommended safety standards. A prospective, contextual, descriptive study design was used, with 222 randomly selected dental practitioners contacted to determine whether they offered paediatric dental chair PSA. Practitioners offering PSA were then asked to complete a web-based questionnaire assessing their practice. Of the 213 dental practitioners contacted, 94 (44.1%; 95% confidence interval 37 - 51) provided PSA to children. Most patients were 1 - 5 years old, although there were practices that offered PSA to infants. While most procedures were performed under minimal to moderate sedation, deep sedation and general anaesthesia were also administered in dental rooms. Midazolam was the most frequently used sedative agent, often in conjunction with inhaled nitrous oxide; 28.1% of PSA providers administered a combination of three or more agents. Presedation patient assessment was documented in 83.0% of cases, and informed consent for sedation was obtained in 75.6%. The survey raised several areas of concern regarding patient safety: 41.3% of dental practices did not use any monitoring equipment during sedation; the operator was responsible for the sedation and monitoring of the patient in 41.3%; 43.2% did not keep any recommended emergency drugs; and 19.6% did not have any emergency or resuscitation equipment available. Most respondents (81.8%) indicated an interest in sedation training. Paediatric dental chair PSA was offered by 44.1% of dental practitioners interviewed in Gauteng. Modalities of PSA provided varied between practices, with a number of safety concerns being raised.

  16. HIV protease inhibitors in pregnancy : pharmacology and clinical use.

    PubMed

    Andany, Nisha; Loutfy, Mona R

    2013-03-01

    The impact of antiretroviral therapy (ART) on the natural history of HIV-1 infection has resulted in dramatic reductions in disease-associated morbidity and mortality. Additionally, the epidemiology of HIV-1 infection worldwide is changing, as women now represent a substantial proportion of infected adults. As more highly effective and tolerable antiretroviral regimens become available, and as the prevention of mother-to-child transmission becomes an attainable goal in the management of HIV-infected individuals, more and more HIV-positive women are choosing to become pregnant and have children. Consequently, it is important to consider the efficacy and safety of antiretroviral agents in pregnancy. Protease inhibitors are a common class of medication used in the treatment of HIV-1 infection and are increasingly being used in pregnancy. However, several studies have raised concerns regarding pharmacokinetic alterations in pregnancy, particularly in the third trimester, which results in suboptimal drug concentrations and a theoretically higher risk of virologic failure and perinatal transmission. Drug level reductions have been observed with each individual protease inhibitor and dose adjustments in pregnancy are suggested for certain agents. Furthermore, studies have also raised concerns regarding the safety of protease inhibitors in pregnancy, particularly as they may increase the risk of pre-term birth and metabolic disturbances. Overall, protease inhibitors are safe and effective for the treatment of HIV-infected pregnant women. Specifically, ritonavir-boosted lopinavir- and atazanavir-based regimens are preferred in pregnancy, while ritonavir-boosted darunavir- and saquinavir-based therapies are reasonable alternatives. This paper reviews the use of protease inhibitors in pregnancy, focusing on pharmacokinetic and safety considerations, and outlines the recommendations for use of this class of medication in the HIV-1-infected pregnant woman.

  17. The relationship between safety net activities and hospital financial performance

    PubMed Central

    2010-01-01

    Background During the 1990's hospitals in the U.S were faced with cost containment charges, which may have disproportionately impacted hospitals that serve poor patients. The purposes of this paper are to study the impact of safety net activities on total profit margins and operating expenditures, and to trace these relationships over the 1990s for all U.S urban hospitals, controlling for hospital and market characteristics. Methods The primary data source used for this analysis is the Annual Survey of Hospitals from the American Hospital Association and Medicare Hospital Cost Reports for years 1990-1999. Ordinary least square, hospital fixed effects, and two-stage least square analyses were performed for years 1990-1999. Logged total profit margin and operating expenditure were the dependent variables. The safety net activities are the socioeconomic status of the population in the hospital serving area, and Medicaid intensity. In some specifications, we also included uncompensated care burden. Results We found little evidence of negative effects of safety net activities on total margin. However, hospitals serving a low socioeconomic population had lower expenditure raising concerns for the quality of the services provided. Conclusions Despite potentially negative policy and market changes during the 1990s, safety net activities do not appear to have imperiled the survival of hospitals. There may, however, be concerns about the long-term quality of the services for hospitals serving low socioeconomic population. PMID:20074367

  18. Testosterone Replacement Therapy: Long-Term Safety and Efficacy

    PubMed Central

    Corona, Giovanni; Sforza, Alessandra

    2017-01-01

    Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG) or late-onset hypogonadism (LOH). The former is the consequence of congenital or acquired “organic” damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T) therapy (TTh). In addition, concerns related to cardiovascular (CV) safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long term safety. A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an “ex-juvantibus” criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws. When HG is properly diagnosed and TTh correctly performed no CV and prostate risk have been documented. PMID:28497912

  19. Acceptability and preferences for safer conception HIV prevention strategies: A qualitative study

    PubMed Central

    Schwartz, Sheree; West, Nora; Phofa, Rebecca; Yende, Nompumelelo; Sanne, Ian; Bassett, Jean; Van Rie, Annelies

    2016-01-01

    Safer conception strategies to reduce HIV transmission risk include antiretroviral therapy (ART) for HIV-positive partners, pre-exposure prophylaxis (PrEP) for HIV-negative partners, condomless sex limited to fertile periods, and home-based self-insemination. Resistance to taking treatment or cultural concerns may limit uptake of strategies and intervention success. Understanding the acceptability and preferences between different approaches is important to optimize service delivery. Between February-July 2013, 42 adults (21 HIV-positive and 21 HIV-negative) receiving primary care at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, participated in focus group discussions or in-depth interviews. Themes were analyzed using a grounded theory approach. Acceptability of antiretroviral-based (ARV) strategies varied. Concerns over side effects, ARV treatment duration, and beliefs that treatment is only for the sick were common barriers, however desperation for a child was noted as a facilitator for uptake. HIV-negative men and HIV-positive women had favorable attitudes towards self-insemination, though paternity and safety concerns were raised. Self-insemination was generally preferred over PrEP by HIV-negative men, and ARV-based strategies were preferred by couples with HIV-negative female partners, despite concerns raised about condomless sex while virally suppressed. Knowledge about the fertile window was low. A strong counselling component will be required for effective uptake and adherence to safer conception services. PMID:26384950

  20. Acceptability and preferences for safer conception HIV prevention strategies: a qualitative study.

    PubMed

    Schwartz, Sheree R; West, Nora; Phofa, Rebecca; Yende, Nompumelelo; Sanne, Ian; Bassett, Jean; Van Rie, Annelies

    2016-10-01

    Safer conception strategies to reduce the HIV transmission risk include antiretroviral therapy for HIV-positive partners, pre-exposure prophylaxis for HIV-negative partners, condomless sex limited to fertile periods, and home-based self-insemination. Resistance to taking treatment or cultural concerns may limit uptake of strategies and intervention success. Understanding the acceptability and preferences between different approaches is important to optimise service delivery. Between February and July 2013, 42 adults (21 HIV-positive and 21 HIV-negative) receiving primary care at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, participated in focus group discussions or in-depth interviews. Themes were analysed using a grounded theory approach. Acceptability of antiretroviral-based strategies varied. Concerns over side effects, antiretroviral treatment duration and beliefs that treatment is only for the sick were common barriers; however, desperation for a child was noted as a facilitator for uptake. HIV-negative men and HIV-positive women had favourable attitudes towards self-insemination, though paternity and safety concerns were raised. Self-insemination was generally preferred over pre-exposure prophylaxis by HIV-negative men, and antiretroviral-based strategies were preferred by couples with HIV-negative female partners, despite concerns raised about condomless sex while virally suppressed. Knowledge about the fertile window was low. A strong counselling component will be required for effective uptake and adherence to safer conception services. © The Author(s) 2016.

  1. Regulatory concerns in the development of biologic-biomaterial combinations. United States Food and Drug Administration.

    PubMed

    Chapekar, M S

    1996-01-01

    Several biologic-biomaterial combinations are currently under development in an attempt to modulate tissue or organ function in patients. The FDA regulations on combination products and the intercenter agreements among the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drugs Evaluation and Research (CDER) provide further guidance on center jurisdiction of combination products and other products where there are jurisdictional concerns. The biological component of biologic-biomaterial combinations raises a number of issues that relate to the safety and bioactivity of the final product. For example, transmission of adventitious agents to patients via somatic cells, tissue, or cell-derived products is a major safety concern as are in vivo inflammatory responses elicited by the biomaterial component. CBER has drafted a number of "Points to Consider" documents to provide further guidance in the development of biological products. The intent of this article is to provide the highlights of the FDA regulations for combination products and the intercenter agreement between CBER and CDRH delineating the responsibilities of each center for medical device activities. In addition, the article focuses on the CBER's concerns related to the development of somatic cell-biomaterial combinations for therapeutic use.

  2. Driving safety in elderly individuals.

    PubMed

    Marottoli, R A

    1993-05-01

    Driving safety in elderly individuals is becoming an increasingly important issue in geriatrics and in medical practice. The number of elderly drivers is increasing as the population ages, and especially as current generations of female drivers age. Concern is raised about their safe operation of motor vehicles because of the increasing likelihood with advancing age of developing conditions that may adversely affect the visual, cognitive, and motor abilities integral to driving. But this issue is not only a medical one, since there are social and political components as well. This discussion will describe the background of this issue, focus on the changes that may occur with aging and their potential relationship to driving ability, and, finally, will outline an approach that physicians may employ in their practice.

  3. Cyclooxygenase-2 inhibitors: promise or peril?

    PubMed Central

    Mengle-Gaw, Laurel J; Schwartz, Benjamin D

    2002-01-01

    The discovery of two isoforms of the cyclooxygenase enzyme, COX-1 and COX-2, and the development of COX-2-specific inhibitors as anti-inflammatories and analgesics have offered great promise that the therapeutic benefits of NSAIDs could be optimized through inhibition of COX-2, while minimizing their adverse side effect profile associated with inhibition of COX-1. While COX-2 specific inhibitors have proven to be efficacious in a variety of inflammatory conditions, exposure of large numbers of patients to these drugs in postmarketing studies have uncovered potential safety concerns that raise questions about the benefit/risk ratio of COX-2-specific NSAIDs compared to conventional NSAIDs. This article reviews the efficacy and safety profiles of COX-2-specific inhibitors, comparing them with conventional NSDAIDs. PMID:12467519

  4. Chew on This: Not All First Finger Foods Are Created Equal.

    PubMed

    Awadalla, Nicol; Pham, Tammy; Milanaik, Ruth

    2017-10-01

    The American Academy of Pediatrics (AAP) recommends when to start first finger foods (FFFs) and what types of foods to start with, but it is unclear whether products marketed as FFF comply with these recommendations. We evaluated FFF products for compliance with AAP recommendations and product safety using 41 adult product testers, who were asked to dissolve each product in their mouth. Product characteristics, comments pertaining to product safety, and time to dissolve each product were recorded. Only 2 products met all AAP criteria, and safety concerns were raised for an additional 2 products. One product showed a large change in dissolvability after being left out of original packaging. Consumers should not assume that products marketed for infant/toddler consumption comply with AAP recommendations. Also, products left out of original packaging may change consistency, presenting a choking hazard. Additional research is warranted to guide the development of regulations surrounding labeling and marketing of these foods.

  5. Genetic modification of hematopoietic cells using retroviral and lentiviral vectors: safety considerations for vector design and delivery into target cells.

    PubMed

    Dropulic, Boro

    2005-07-01

    The recent development of leukemia in three patients following retroviral vector gene transfer in hematopoietic stem cells, resulting in the death of one patient, has raised safety concerns for the use of integrating gene transfer vectors for human gene therapy. This review discusses these serious adverse events from the perspective of whether restrictions on vector design and vector-modified target cells are warranted at this time. A case is made against presently establishing specific restrictions for vector design and transduced cells; rather, their safety should be ascertained by empiric evaluation in appropriate preclinical models on a case-by-case basis. Such preclinical data, coupled with proper informed patient consent and a risk-benefit ratio analysis, provide the best available prospective evaluation of gene transfer vectors prior to their translation into the clinic.

  6. Addressing safety liabilities of TfR bispecific antibodies that cross the blood-brain barrier.

    PubMed

    Couch, Jessica A; Yu, Y Joy; Zhang, Yin; Tarrant, Jacqueline M; Fuji, Reina N; Meilandt, William J; Solanoy, Hilda; Tong, Raymond K; Hoyte, Kwame; Luk, Wilman; Lu, Yanmei; Gadkar, Kapil; Prabhu, Saileta; Ordonia, Benjamin A; Nguyen, Quyen; Lin, Yuwen; Lin, Zhonghua; Balazs, Mercedesz; Scearce-Levie, Kimberly; Ernst, James A; Dennis, Mark S; Watts, Ryan J

    2013-05-01

    Bispecific antibodies using the transferrin receptor (TfR) have shown promise for boosting antibody uptake in brain. Nevertheless, there are limited data on the therapeutic properties including safety liabilities that will enable successful development of TfR-based therapeutics. We evaluate TfR/BACE1 bispecific antibody variants in mouse and show that reducing TfR binding affinity improves not only brain uptake but also peripheral exposure and the safety profile of these antibodies. We identify and seek to address liabilities of targeting TfR with antibodies, namely, acute clinical signs and decreased circulating reticulocytes observed after dosing. By eliminating Fc effector function, we ameliorated the acute clinical signs and partially rescued a reduction in reticulocytes. Furthermore, we show that complement mediates a residual decrease in reticulocytes observed after Fc effector function is eliminated. These data raise important safety concerns and potential mitigation strategies for the development of TfR-based therapies that are designed to cross the blood-brain barrier.

  7. A qualitative investigation of Hispanic construction worker perspectives on factors impacting worksite safety and risk

    PubMed Central

    2011-01-01

    Background Hispanic workers have higher rates of injury and death on construction worksites than workers of other ethnicities. Language barriers and cultural differences have been hypothesized as reasons behind the disparate rates. Methods We conducted two series of focus groups with union and non-union Hispanic construction workers to ask them about their perceptions of the causes for the unequal rates. Spanish transcripts were translated and coded in QSR NVivo software for common themes. Results Workers reported a difficult work environment characterized by supervisor pressure, competition for jobs and intimidation with regard to raising safety concerns. Language barriers or cultural factors were not strongly represented as causative factors behind the rates. Conclusion The results of this study have informed the development of an intervention trial that seeks to prevent falls and silica dust exposure by training contractors employing Hispanic construction workers in the elements of safety leadership, including building respect for their Hispanic workers and facilitating their participation in a safety program. PMID:21962128

  8. New method for distance-based close following safety indicator.

    PubMed

    Sharizli, A A; Rahizar, R; Karim, M R; Saifizul, A A

    2015-01-01

    The increase in the number of fatalities caused by road accidents involving heavy vehicles every year has raised the level of concern and awareness on road safety in developing countries like Malaysia. Changes in the vehicle dynamic characteristics such as gross vehicle weight, travel speed, and vehicle classification will affect a heavy vehicle's braking performance and its ability to stop safely in emergency situations. As such, the aim of this study is to establish a more realistic new distance-based safety indicator called the minimum safe distance gap (MSDG), which incorporates vehicle classification (VC), speed, and gross vehicle weight (GVW). Commercial multibody dynamics simulation software was used to generate braking distance data for various heavy vehicle classes under various loads and speeds. By applying nonlinear regression analysis to the simulation results, a mathematical expression of MSDG has been established. The results show that MSDG is dynamically changed according to GVW, VC, and speed. It is envisaged that this new distance-based safety indicator would provide a more realistic depiction of the real traffic situation for safety analysis.

  9. The U.S. Commercial Air Tour Industry: A Review of Aviation Safety Concerns

    PubMed Central

    Ballard, Sarah-Blythe

    2016-01-01

    The U.S. Title 14 Code of Federal Regulations defines commercial air tours as “flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing.” The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators. PMID:24597160

  10. The U.S. commercial air tour industry: a review of aviation safety concerns.

    PubMed

    Ballard, Sarah-Blythe

    2014-02-01

    The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

  11. Nuclear energy: salvation or suicide. [Contains glossary

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Collins, C.C.

    A collection of 700 editorials and feature articles collected from 125 US newspapers addresses the dominant areas of concern about nuclear power: plant safety, radioactive wastes, proliferation, and cost. The editorial debates present the pros and cons of Three Mile Island and other accidents, ocean dumping, evacuation plans, radioactive waste transport and storage, nuclear fuel processing, the Karen Silkwood case, and breeder reactors. The appendix raises the question of the future for fission and the possibility of nuclear fusion as an alternative. There is a subject index and a glossary of basic terms.

  12. Study of application of ERTS-A imagery to fracture-related mine safety hazards in the coal mining industry

    NASA Technical Reports Server (NTRS)

    Wier, C. E.; Wobber, F. J. (Principal Investigator); Russell, O. R.; Amato, R. V.; Leshendok, T. V.

    1974-01-01

    The author has identified the following significant results. The mine refuse inventory maps were prepared in response to a need by both the State and the coal industry. The lack of information on the scope of the problem handicapped all people concerned in drafting realistic legislation for a severance tax on coal production to raise funds for restoration of refuse sites. The inventory was conducted rapidly and economically, and demonstrated the benefits which can be derived through remote sensing methods.

  13. Salang Hospital: Lack of Water and Power Severely Limits Hospital Services, and Major Construction Deficiencies Raise Safety Concerns

    DTIC Science & Technology

    2014-01-01

    November 27, 2013 SIGAR 14-31-IP/Salang Hospital Page 3 • Hospital staff stated they believe the hospital’s septic tank is leaking. The staff told...us that, to the best of their knowledge, no leach field2 was built for the septic tank . • The statement of work required the contractor to provide...2 A leach field is typically installed with a septic tank for subsurface disposal of liquid waste. Multiple perforated pipes buried under ground

  14. Federal Research Action Plan on Recycled Tire Crumb Used ...

    EPA Pesticide Factsheets

    Over the past several years, parents, athletes, schools, and communities have raised concerns about the safety of recycled tire crumb rubber used as infill for playing fields and playgrounds in the United States. The public has expressed concerns that the use of these fields could potentially be related to certain health effects. Studies to date have not shown an elevated health risk from playing on fields with tire crumb rubber, but these studies have limitations and do not comprehensively evaluate the concerns about health risks from exposure to tire crumb rubber. This status report provides a summary of activities to date, including: (1) stakeholder outreach, (2) the tire crumb rubber manufacturing industry, (3) the final peer-reviewed Literature Review/Gaps Analysis (LRGA), (4) progress on the research activities, and (5) next steps and a timeline for completion of the final report. The status report does not include research findings.

  15. Moving forward in plant food safety and security through NanoBioSensors: Adopt or adapt biomedical technologies?

    PubMed

    Sharma, Tarun K; Ramanathan, Rajesh; Rakwal, Randeep; Agrawal, Ganesh K; Bansal, Vipul

    2015-05-01

    Plant-based foods are integral part of our day-to-day diet. Increasing world population has put forth an ever increasing demand for plant-based foods, and food security remains a major concern. Similarly, biological, chemical, and physical threats to our food and increasing regulatory demands to control the presence of foreign species in food products have made food safety a growing issue. Nanotechnology has already established its roots in diverse disciplines. However, the food industry is yet to harness the full potential of the unique capabilities offered by this next-generation technology. While there might be safety concerns in regards to integration of nanoproducts with our food products, an aspect of nanotechnology that can make remarkable contribution to different elements of the food chain is the use of nanobiosensors and diagnostic platforms for monitoring food traceability, quality, safety, and nutritional value. This brings us to an important question that whether existing diagnostic platforms that have already been well developed for biomedical and clinical application are suitable for food industry or whether the demands of the food industry are altogether different that may not allow adoption/adaptation of the existing technology. This review is an effort to raise this important "uncomfortable" yet "timely" question. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  16. Testosterone Replacement Therapy: Long-Term Safety and Efficacy.

    PubMed

    Corona, Giovanni; Sforza, Alessandra; Maggi, Mario

    2017-08-01

    Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG) or late-onset hypogonadism (LOH). The former is the consequence of congenital or acquired "organic" damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T) therapy (TTh). In addition, concerns related to cardiovascular (CV) safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long term safety. A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an "ex-juvantibus" criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws. When HG is properly diagnosed and TTh correctly performed no CV and prostate risk have been documented. Copyright © 2017 Korean Society for Sexual Medicine and Andrology.

  17. Update on antibacterial soaps: the FDA takes a second look at triclosans.

    PubMed

    Bergstrom, Kendra Gail

    2014-04-01

    In December of 2013 the Food and Drug Administration announced it would look further into the safety and efficacy of the biocide triclosan and requested further safety data as part of a new review with the Environmental Protection Agency. The use of triclosan has increased exponentially since its introduction in in 1972, to the point that 75% of commercial soap brands contain triclosan and 76% of a nationwide sample of adults and children excrete triclosan in the urine. This announcement raised an important dialog about the appropriate use of all over the counter biocides. Particular concerns include whether these biocides are more effective than regular soaps, whether they may create new drug resistant bacteria, and whether they may also act as hormone disruptors in humans or the environment.

  18. Influence of occupational safety management on the incidence rate of occupational accidents in the Spanish industrial and ornamental stone mining.

    PubMed

    Sanmiquel, Lluís; Rossell, Josep M; Vintró, Carla; Freijo, Modesto

    2014-01-01

    Mines are hazardous and workers can suffer many types of accidents caused by fire, flood, explosion or collapse. Injury incidence rates in mining are considerably higher than those registered by other economic sectors. One of the main reasons for this high-level incidence rate is the existence of a large number of dangerous workplaces. This work analyzes the influence that occupational safety management had on the accidents that took place in Spanish mining of industrial and ornamental stone during the period 2007-2008. Primary data sources are: (a) Results from a statistical study of the occupational health and safety management practices of 71 quarries defined by a questionnaire of 41 items; and (b) Occupational accidents registered in the Spanish industrial and ornamental stone mining throughout the period 2007-2008. The obtained results indicate that workplaces with a low average score in the analysis of occupational safety management have a higher incidence rate of accidents. Studies on mining workplaces are very important to help detect occupational safety concerns. Results from this study help raise awareness and will encourage the adoption of appropriate measures to improve safety.

  19. Consumer Choice between Food Safety and Food Quality: The Case of Farm-Raised Atlantic Salmon

    PubMed Central

    Haghiri, Morteza

    2016-01-01

    Since the food incidence of polychlorinated biphenyls in farm-raised Atlantic salmon, its market demand has drastically changed as a result of consumers mistrust in both the quality and safety of the product. Policymakers have been trying to find ways to ensure consumers that farm-raised Atlantic salmon is safe. One of the suggested policies is the implementation of integrated traceability methods and quality control systems. This article examines consumer choice between food safety and food quality to purchase certified farm-raised Atlantic salmon, defined as a product that has passed through various stages of traceability systems in the province of Newfoundland and Labrador, Canada. PMID:28231118

  20. A safety assessment of biological therapies targeting the IL-23/IL-17 axis in inflammatory bowel diseases.

    PubMed

    Verstockt, Bram; Deleenheer, Barbara; Van Assche, Gert; Vermeire, Séverine; Ferrante, Marc

    2017-07-01

    Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies. Areas covered: A literature search until March 2017 was performed to collect safety data on different compounds targeting this pathway, with emphasis on ustekinumab and secukinumab. Firstly, the authors discuss briefly how genetics can inform about potential safety issues. Secondly, they extensively describe safety issues (common adverse events, infections, malignancies…), immunogenicity, exposure to ustekinumab in specific populations and provide advice for vaccination. Finally, they address safety profiles of secukinumab and other biological targeting the IL-23/17 axis in IBD. Expert opinion: Current evidence suggests that ustekinumab therapy overweigh the potential drug-related risks. Additional safety data beyond randomized-controlled trials, derived from statistically powered, large prospective studies with long-term follow-up are urgently needed to assess the real-life ustekinumab-related risks and to establish the correct position of these novel class of biologicals in IBD treatment. Combining immunomodulators with ustekinumab seems to be safe, though prospective data specifically addressing this topic are currently missing. Similarly, the combination of different biological therapies still has to be studied.

  1. The ethics of molecular memory modification.

    PubMed

    Hui, Katrina; Fisher, Carl E

    2015-07-01

    Novel molecular interventions have recently shown the potential to erase, enhance and alter specific long-term memories. Unique features of this form of memory modification call for a close examination of its possible applications. While there have been discussions of the ethics of memory modification in the literature, molecular memory modification (MMM) can provide special insights. Previously raised ethical concerns regarding memory enhancement, such as safety issues, the 'duty to remember', selfhood and personal identity, require re-evaluation in light of MMM. As a technology that exploits the brain's updating processes, MMM helps correct the common misconception that memory is a static entity by demonstrating how memory is plastic and subject to revision even in the absence of external manipulation. Furthermore, while putatively safer than other speculative technologies because of its high specificity, MMM raises notable safety issues, including potential insidious effects on the agent's emotions and personal identity. Nonetheless, MMM possesses characteristics of a more permissible form of modification, not only because it is theoretically safer, but because its unique mechanism of action requires a heightened level of cooperation from the agent. Discussions of memory modification must consider the specific mechanisms of action, which can alter the weight and relevance of various ethical concerns. MMM also highlights the need for conceptual accuracy regarding the term 'enhancement'; this umbrella term will have to be differentiated as new technologies are applied to a widening array of purposes. 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.

  2. Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective.

    PubMed

    Lewis, James H

    2010-02-01

    Irritable bowel syndrome affects 5-10% of North Americans, with an estimated one-third having a diarrhea-predominant form. Alosetron hydrochloride (Lotronex) is a serotonin receptor type 3 antagonist approved in early 2000 for use in women with diarrhea-predominant irritable bowel syndrome (IBS-D). Initial use was widespread, but infrequent serious adverse events of ischemic colitis and severe constipation-related complications prompted alosetron's voluntary withdrawal from the US market in November 2000. Unprecedented public request prompted its reintroduction in 2002 under a Risk Management Plan, including a more restricted indication and a Prescribing Program for Lotronex. Despite these measures, the use of alosetron has been very limited since its reintroduction. Possible deterrents to its use include concerns over safety and the possible medical-legal implications raised by the Risk Management Plan. It is also possible that changes in the natural history and/or diagnosis of IBS-D have reduced the target population. Given the unique regulatory history of alosetron, these issues continue to engender controversy. This article profiles these concerns and reviews the pharmacology, clinical efficacy and safety, and post-marketing experience with alosetron. Myths and misconceptions related to alosetron use, or lack thereof, are addressed to provide the reader with the evidence needed to make informed treatment decisions for their female patients with severe IBS-D.

  3. Four common herbs seen in dental practice: properties and potential adverse effects.

    PubMed

    Shankland, Wesley E

    2009-04-01

    The use of herbal supplements in North America is steadily growing and raises concerns about safety, efficacy, and how they affect safe patient care. The most notable and direct health risks associated with herbal supplements include hypertension, prolonged bleeding, and the potential for drug-herb interactions, which is of particular concern for patients undergoing anesthesia, both general and local anesthesia. In this article, four of the most commonly used herbs today in North America will be discussed: garlic, gingko, ginseng, and ginger. The pharmacology, benefits, and possible side effects of these herbs will be presented. Awareness of the rising use of herbs is important to prevent, recognize, and treat potential problems that can arise from herbal preparations taken alone or in conjunction with prescription medications.

  4. Mars ain't the kind of place to raise your kid: ethical implications of pregnancy on missions to colonize other planets.

    PubMed

    Schuster, Haley; Peck, Steven L

    2016-12-01

    The colonization of a new planet will inevitably bring about new bioethical issues. One is the possibility of pregnancy during the mission. During the journey to the target planet or moon, and for the first couple of years before a colony has been established and the colony has been accommodated for children, a pregnancy would jeopardize the safety of the crew and the wellbeing of the child. The principal concern with a pregnancy during an interplanetary mission is that it could put the entire crew in danger. Resources such as air, food, and medical supplies will be limited and calculated to keep the crew members alive. We explore the bioethical concerns of near-future space travel.

  5. A review of seafood safety after the deepwater horizon blowout.

    PubMed

    Gohlke, Julia M; Doke, Dzigbodi; Tipre, Meghan; Leader, Mark; Fitzgerald, Timothy

    2011-08-01

    The Deepwater Horizon (DH) blowout resulted in fisheries closings across the Gulf of Mexico. Federal agencies, in collaboration with impacted Gulf states, developed a protocol to determine when it is safe to reopen fisheries based on sensory and chemical analyses of seafood. All federal waters have been reopened, yet concerns have been raised regarding the robustness of the protocol to identify all potential harmful exposures and protect the most sensitive populations. We aimed to assess this protocol based on comparisons with previous oil spills, published testing results, and current knowledge regarding chemicals released during the DH oil spill. We performed a comprehensive review of relevant scientific journal articles and government documents concerning seafood contamination and oil spills and consulted with academic and government experts. Protocols to evaluate seafood safety before reopening fisheries have relied on risk assessment of health impacts from polycyclic aromatic hydrocarbon (PAH) exposures, but metal contamination may also be a concern. Assumptions used to determine levels of concern (LOCs) after oil spills have not been consistent across risk assessments performed after oil spills. Chemical testing results after the DH oil spill suggest PAH levels are at or below levels reported after previous oil spills, and well below LOCs, even when more conservative parameters are used to estimate risk. We recommend use of a range of plausible risk parameters to set bounds around LOCs, comparisons of post-spill measurements with baseline levels, and the development and implementation of long-term monitoring strategies for metals as well as PAHs and dispersant components. In addition, the methods, results, and uncertainties associated with estimating seafood safety after oil spills should be communicated in a transparent and timely manner, and stakeholders should be actively involved in developing a long-term monitoring strategy.

  6. Drug interactions between hormonal contraceptives and psychotropic drugs: a systematic review.

    PubMed

    Berry-Bibee, Erin N; Kim, Myong-Jin; Simmons, Katharine B; Tepper, Naomi K; Riley, Halley E M; Pagano, H Pamela; Curtis, Kathryn M

    2016-12-01

    To examine whether the co-administration of hormonal contraceptives (HC) and psychotropic drugs commonly used to treat anxiety and/or depression results in safety or efficacy concerns for either drug. We searched PubMed and Cochrane libraries for clinical or pharmacokinetic (PK) studies that examined co-administration of any HC with psychotropic drugs [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), oral benzodiazepines, bupropion, mirtazapine, trazadone, buspirone, hydroxyzine, monoamine oxidase inhibitors (MAOIs), or atypical antipsychotics] in reproductive aged women. Of 555 articles identified, 22 articles (18 studies) met inclusion criteria. We identified 5 studies on SSRIs, four on TCAs, one on bupropion, three on atypical antipsychotics and five on oral benzodiazepines. No articles met inclusion criteria for SNRIs, mirtazapine, trazadone, buspirone, hydroxyzine or MAOIs. Overall, clinical studies did not demonstrate differences in unintended pregnancy rates when HCs were administered with and without psychotropic drugs or in psychotropic drug treatment outcomes when psychotropic drugs were administered with and without HCs. PK studies did not demonstrate changes in drug exposure related to contraceptive safety, contraceptive effectiveness or psychotropic drug effectiveness for most classes of psychotropic drugs. However, limited PK data raise concern for HCs increasing systemic exposure of amitriptyline and imipramine (both TCAs), theoretically posing safety concerns. Limited quality and quantity evidence on use of psychotropic drugs and HCs suggests low concern for clinically significant interactions, though no data exist specifically for non-oral formulations of HC. Given the high frequency of use for both HCs and psychotropic drugs among reproductive-age women in the US, this review highlights a need for further research in this area. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Adventitious viruses in insect cell lines used for recombinant protein expression.

    PubMed

    Geisler, Christoph; Jarvis, Donald L

    2018-04-01

    Insect cells are widely used for recombinant protein expression, typically as hosts for recombinant baculovirus vectors, but also for plasmid-mediated transient transfection or stable genetic transformation. Insect cells are used to express proteins for research, as well as to manufacture biologicals for human and veterinary medicine. Recently, several insect cell lines used for recombinant protein expression were found to be persistently infected with adventitious viruses. This has raised questions about how these infections might affect research performed using those cell lines. Furthermore, these findings raised serious concerns about the safety of biologicals produced using those cell lines. In response, new insect cell lines lacking adventitious viruses have been isolated for use as improved research tools and safer biological manufacturing platforms. Here, we review the scientific and patent literature on adventitious viruses found in insect cell lines, affected cell lines, and new virus-free cell lines. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Avirulent Bacillus anthracis Strain with Molecular Assay Targets as Surrogate for Irradiation-Inactivated Virulent Spores.

    PubMed

    Plaut, Roger D; Staab, Andrea B; Munson, Mark A; Gebhardt, Joan S; Klimko, Christopher P; Quirk, Avery V; Cote, Christopher K; Buhr, Tony L; Rossmaier, Rebecca D; Bernhards, Robert C; Love, Courtney E; Berk, Kimberly L; Abshire, Teresa G; Rozak, David A; Beck, Linda C; Stibitz, Scott; Goodwin, Bruce G; Smith, Michael A; Sozhamannan, Shanmuga

    2018-04-01

    The revelation in May 2015 of the shipment of γ irradiation-inactivated wild-type Bacillus anthracis spore preparations containing a small number of live spores raised concern about the safety and security of these materials. The finding also raised doubts about the validity of the protocols and procedures used to prepare them. Such inactivated reference materials were used as positive controls in assays to detect suspected B. anthracis in samples because live agent cannot be shipped for use in field settings, in improvement of currently deployed detection methods or development of new methods, or for quality assurance and training activities. Hence, risk-mitigated B. anthracis strains are needed to fulfill these requirements. We constructed a genetically inactivated or attenuated strain containing relevant molecular assay targets and tested to compare assay performance using this strain to the historical data obtained using irradiation-inactivated virulent spores.

  9. Electronic Health Records: VAs Efforts Raise Concerns about Interoperability Goals and Measures, Duplication with DOD, and Future Plans

    DTIC Science & Technology

    2016-07-13

    ELECTRONIC HEALTH RECORDS VA’s Efforts Raise Concerns about Interoperability Goals and Measures, Duplication with DOD...Agencies, Committee on Appropriations, U.S. Senate July 13, 2016 ELECTRONIC HEALTH RECORDS VA’s Efforts Raise Concerns about Interoperability Goals...initiatives with the Department of Defense (DOD) that were intended to advance the ability of the two departments to share electronic health records , the

  10. Hospital board oversight of quality and safety: a stakeholder analysis exploring the role of trust and intelligence.

    PubMed

    Millar, Ross; Freeman, Tim; Mannion, Russell

    2015-06-16

    Hospital boards, those executive members charged with developing appropriate organisational strategies and cultures, have an important role to play in safeguarding the care provided by their organisation. However, recent concerns have been raised over boards' ability to enact their duty to ensure the quality and safety of care. This paper offers critical reflection on the relationship between hospital board oversight and patient safety. In doing so it highlights new perspectives and suggestions for developing this area of study. The article draws on 10 interviews with key informants and policy actors who form part of the 'issue network' interested in the promotion of patient safety in the English National Health Service. The interviews surfaced a series of narratives regarding hospital board oversight of patient safety. These elaborated on the role of trust and intelligence in highlighting the potential dangers and limitations of approaches to hospital board oversight which have been narrowly focused on a risk-based view of organisational performance. In response, a need to engage with the development of trust based organisational relationships is identified, in which effective board oversight is built on 'trust' characterised by styles of leadership and behaviours that are attentive to the needs and concerns of both staff and patients. Effective board oversight also requires the gathering and triangulating of 'intelligence' generated from both national and local information sources. We call for a re-imagination of hospital board oversight in the light of these different perspectives and articulate an emerging research agenda in this area.

  11. An assessment of food hygiene and safety at farmers' markets.

    PubMed

    Worsfold, D; Worsfold, P M; Griffith, C J

    2004-04-01

    Farmers' markets are becoming a more significant part of the food-retailing sector. A survey of farmers' markets was conducted to assess aspects of food hygiene and safety. The views of the public using the markets were also examined. The range of farm products was wide and the methods utilised varied. The markets were usually temporary outdoor events with few facilities. Traders had received elementary food hygiene training and rated their hygiene standards highly. Less than half had risk management procedures in place, most did not perceive their produce as high-risk. They believed consumers to be mainly interested in food quality and to regard food safety issues highly. Consumers shopped at the markets because of the quality of the products sold. Their overall satisfaction with the markets was high and they raised no concerns about food safety. Given the restricted facilities at farmers' markets and the early phase of implementation of hygiene management systems by market traders, it may be precautionary to restrict the sale of farm products at farmers markets to those that are regarded as low-risk.

  12. Investigation of the impact of low cost traffic engineering measures on road safety in urban areas.

    PubMed

    Yannis, George; Kondyli, Alexandra; Georgopoulou, Xenia

    2014-01-01

    This paper investigates the impact of low cost traffic engineering measures (LCTEMs) on the improvement of road safety in urban areas. A number of such measures were considered, such as speed humps, woonerfs, raised intersections and other traffic calming measures, which have been implemented on one-way, one-lane roads in the Municipality of Neo Psychiko in the Greater Athens Area. Data were analysed using the before-and-after safety analysis methodology with large control group. The selected control group comprised of two Municipalities in the Athens Greater Area, which present similar road network and land use characteristics with the area considered. The application of the methodology showed that the total number of crashes presented a statistically significant reduction, which can be possibly attributed to the introduction of LCTEMs. This reduction concerns passenger cars and single-vehicle crashes and is possibly due to the behavioural improvement of drivers of 25 years old or more. The results of this research are very useful for the identification of the appropriate low cost traffic engineering countermeasures for road safety problems in urban areas.

  13. Current safety issues with quadrivalent meningococcal conjugate vaccines.

    PubMed

    Myers, Tanya R; McNeil, Michael M

    2018-05-04

    Invasive meningococcal disease, although rare, can present as sudden, life-threatening disease with high risk of mortality or severe long-term sequelae. The main prevention strategy for invasive meningococcal disease in the United States is the routine vaccination of adolescents and other persons at increased risk of meningococcal disease with quadrivalent meningococcal conjugate vaccines. Two such vaccines are currently licensed and available in the United States, Menactra® (Sanofi Pasteur) and Menveo® (GlaxoSmithKline), and usage in the adolescent population has steadily increased since their introduction. Although early reports raised concerns about a possible association of Menactra with Guillain-Barré syndrome, a comprehensive safety review determined that if such risk existed it was no more than 0.66 cases per 1 million vaccinations. More recently, a study found an elevated risk of Bell's palsy when Menveo was administered concomitantly with other vaccines but no association was found when the vaccine was administered alone. In this commentary, we describe the current state of knowledge with respect to the safety of quadrivalent meningococcal conjugate vaccines, and we identify potential areas for safety research for these vaccines.

  14. Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

    PubMed Central

    2016-01-01

    Rift Valley Fever (RVF) is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA), a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control. PMID:27689098

  15. Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

    PubMed

    Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

    2016-04-01

    Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

  16. Oral contraceptives in polycystic ovary syndrome.

    PubMed

    Helvaci, N; Yildiz, B O

    2014-09-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of reproductive age and combined oral contraceptives (OCs) are often the first-line treatment of the syndrome by improving hyperandrogenism and regulating menstrual cycles. Oral contraceptives have some cardiovascular and metabolic effects that varies among different formulations depending upon the dose and type of the both estrogen and progestin components. These cardiometabolic effects of OCs raise some concerns about their long-term use in PCOS, but available data suggest that the benefits outweigh the risks. More studies are needed to clarify the safety of long-term use of OCs in PCOS.

  17. Management of a hyperactive teen and cardiac safety.

    PubMed

    Sowinski, Heather; Karpawich, Peter P

    2014-02-01

    Since the earliest descriptions of the condition, controversy has prevailed as to the existence of as well as appropriate management of attention deficit hyperactivity disorder. Often diagnosed in childhood, symptoms of attention deficit hyperactivity disorder can continue into adolescence and adulthood, requiring lifelong therapy. Effective therapeutic interventions include stimulant medications with all their respective potential side effects, including the cardiovascular system. However, although initial studies raised concerns for an increase in serious adverse cardiovascular effects among children receiving these drugs, more recent and extensive reports have failed to substantiate those findings among young patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. HANFORD DOUBLE SHELL TANK (DST) THERMAL & SEISMIC PROJECT BUCKLING EVALUATION METHODS & RESULTS FOR THE PRIMARY TANKS

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    MACKEY, T.C.

    2006-03-17

    This report documents a detailed buckling evaluation of the primary tanks in the Hanford double shell waste tanks. The analysis is part of a comprehensive structural review for the Double-Shell Tank Integrity Project. This work also provides information on tank integrity that specifically responds to concerns raise by the Office of Environment, Safety, and Health (ES&H) Oversight (EH-22) during a review (in April and May 2001) of work being performed on the double-shell tank farms, and the operation of the aging waste facility (AWF) primary tank ventilation system.

  19. Editorial: ERCP-Related Radiation Cataractogenesis: Is It Time to Be Concerned?

    PubMed

    Mekaroonkamol, Parit; Keilin, Steven

    2017-05-01

    With the growing number of fluoroscopic guided endoscopic procedures, radiation-related risk needs to be further assessed. Recent evidence indicates that radiation cataractogenesis occurs at a lower dose threshold than previously believed. While body aprons and thyroid shields are well-established standard protection during fluoroscopy, ocular safety and the use of protective eyewear are not as well defined. This prospective study answered two important questions: Does the standard body dosimeter provide an accurate ocular dosimetry? And what is the time of fluoroscopy needed to warrant using lens protection? It also raises the question whether current guidelines need to be updated.

  20. When Whistle-blowers Become the Story: The Problem of the ‘Third Victim’

    PubMed Central

    Waring, Justin

    2016-01-01

    In the healthcare context, whistleblowing has come to the fore of political, professional and public attention in the wake of major service scandals and mounting evidence of the routine threats to safety that patients face in their care. This paper offers a commentary and wider contextualisation of Mannion and Davies, ‘Cultures of silence and cultures of voice: the role of whistleblowing in healthcare organisations.’ It argues that closer attention is needed to the way in which whistle-blowers can become the focus and victim of raising concerns and speaking up. PMID:26927403

  1. Should states and local governments regulate dietary supplements?

    PubMed

    Starr, Ranjani

    2016-01-01

    Federal regulation of dietary supplements in the United States is governed by the Dietary Supplement Health and Education Act of 1994. The law has been criticized as weak and ineffective. Alarming research has emerged demonstrating that supplements may be mislabelled, contaminated, adulterated with dangerous or unknown compounds, or sold at toxic doses. As a result, the health community has raised concerns about the safety and quality of dietary supplements. Increased federal oversight is an important avenue for improving supplement safety; however, states and local governments may also pursue strategies to strengthen the overall regulatory control of dietary supplements. States and local governments have substantial experience in regulating other products that pose a risk to public health, such as tobacco. Additionally, much has been learned about the tactics the tobacco industry has employed to protect its interests. Lessons learned may be applied to new regulatory efforts aimed at improving the safety of dietary supplements at the state and local levels. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  2. Clinical imaging in regenerative medicine

    PubMed Central

    Naumova, Anna V; Modo, Michel; Moore, Anna; Murry, Charles E; Frank, Joseph A

    2014-01-01

    In regenerative medicine, clinical imaging is indispensable for characterizing damaged tissue and for measuring the safety and efficacy of therapy. However, the ability to track the fate and function of transplanted cells with current technologies is limited. Exogenous contrast labels such as nanoparticles give a strong signal in the short term but are unreliable long term. Genetically encoded labels are good both short- and long-term in animals, but in the human setting they raise regulatory issues related to the safety of genomic integration and potential immunogenicity of reporter proteins. Imaging studies in brain, heart and islets share a common set of challenges, including developing novel labeling approaches to improve detection thresholds and early delineation of toxicity and function. Key areas for future research include addressing safety concerns associated with genetic labels and developing methods to follow cell survival, differentiation and integration with host tissue. Imaging may bridge the gap between cell therapies and health outcomes by elucidating mechanisms of action through longitudinal monitoring. PMID:25093889

  3. Safety of nicergoline as an agent for management of cognitive function disorders.

    PubMed

    Saletu, Bernd; Garg, Amit; Shoeb, Ahsan

    2014-01-01

    Nicergoline is a semisynthetic ergot derivative and has a selective alpha-1A adrenergic receptor blocking property and also other additional mechanisms of actions, both in the brain and in the periphery. It is in clinical use for over three decades in over fifty countries for conditions such as cerebral infarction, acute and chronic peripheral circulation disorders, vascular dementia, and Alzheimer's disease and has been found to be beneficial in a variety of other conditions. However, concerns about its safety have been raised, especially after the European medicines agency's (EMEA's) restriction in the use of all ergot derivatives including nicergoline. But, most of the available literature and data suggest that the adverse events with nicergoline are mild and transient. Further, none of the available treatment options for cognitive disorders afford definitive resolution of symptoms. In this backdrop, we discuss the pharmacology of nicergoline with special emphasis on the safety of this compound, especially when used in patients suffering from cognitive function disorders.

  4. Safety of Nicergoline as an Agent for Management of Cognitive Function Disorders

    PubMed Central

    2014-01-01

    Nicergoline is a semisynthetic ergot derivative and has a selective alpha-1A adrenergic receptor blocking property and also other additional mechanisms of actions, both in the brain and in the periphery. It is in clinical use for over three decades in over fifty countries for conditions such as cerebral infarction, acute and chronic peripheral circulation disorders, vascular dementia, and Alzheimer's disease and has been found to be beneficial in a variety of other conditions. However, concerns about its safety have been raised, especially after the European medicines agency's (EMEA's) restriction in the use of all ergot derivatives including nicergoline. But, most of the available literature and data suggest that the adverse events with nicergoline are mild and transient. Further, none of the available treatment options for cognitive disorders afford definitive resolution of symptoms. In this backdrop, we discuss the pharmacology of nicergoline with special emphasis on the safety of this compound, especially when used in patients suffering from cognitive function disorders. PMID:25243157

  5. The Fukushima Dai-ichi Accident and its implications for the safety of nuclear power

    NASA Astrophysics Data System (ADS)

    Barletta, William

    2016-05-01

    Five years ago the dramatic events in Fukushima that followed the massive earthquake and subsequent tsunami that struck Japan on March 11, 2011 sharpened the focus of scientists, engineers and general public on the broad range of technical, environmental and societal issues involved in assuring the safety of the world's nuclear power complex. They also called into question the potential of nuclear power to provide a growing, sustainable resource of CO2-free energy. The issues raised by Fukushima Dai-ichi have provoked urgent concern, not only because of the potential harm that could result from severe accidents or from intentional damage to nuclear reactors or to facilities involved in the nuclear fuel cycle, but also because of the extensive economic impact of those accidents and of the measures taken to avoid them.

  6. Using supercomputers for the time history analysis of old gravity dams

    NASA Astrophysics Data System (ADS)

    Rouve, G.; Peters, A.

    Some of the old masonry dams that were built in Germany at the beginning of this century are a matter of concern today. In the course of time certain deterioration caused or amplified by aging has appeared and raised questions about the safety of these old dams. The Finite Element Method, which in the past two decades has found a widespread application, offers a suitable tool to re-evaluate the safety of these old gravity dams. The reliability of the results, however, strongly depends on the knowledge of the material parameters. Using historical records and observations a numerical back-analysis models has been developed to simulate the behaviour of these old masonry structures and to estimate their material properties by calibration. Only an implementation on a fourth generation vector computer made the application of this large model possible in practice.

  7. Dynamic Deformation of Theatrical Flats

    NASA Astrophysics Data System (ADS)

    Walton, Jamiahus; Martell, Eric; Martell, Verda

    2013-03-01

    In theatre, flats are used as walls and background scenery. During construction, flats are often built on the ground and then ``walked up,'' where a group of stagehands manually lift one end while another anchors the other end in place. When flats are very large, they can deform during this process. Stiffeners are used to decrease the amount of deformation in the flat. The purpose of this research is to determine the strain along the flat during the process of raising it up with and without stiffeners. We will also explore the effect of the person anchoring the pivot edge of the flat and discuss the safety concerns this presents. This research is part of the Physics of Theatre Project, an interdisciplinary collaboration designed to improve safety, reduce costs, and increase knowledge of physics principles within the technical theatre community.

  8. 78 FR 55137 - Federal Motor Vehicle Safety Standards; Ejection Mitigation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ...This document responds to petitions for reconsideration of a 2011 final rule that established Federal Motor Vehicle Safety Standard (FMVSS) No. 226, ``Ejection mitigation.'' The standard is intended to reduce complete and partial ejections of vehicle occupants through side windows in crashes, particularly rollover crashes. Generally, the issues raised by the petitioners are of two types. The petitioners ask for reconsideration of policy issues relating to the agency's implementation of the standard, and of technical issues concerning engineering aspects of the rule, particularly as to how the compliance test procedure should be conducted or improved. Most of the requested changes were of the latter type. In general, NHTSA is denying the petitions for reconsideration. The few changes we have made in response to the petitions are minor, mostly to clarify the requirements of the standard.

  9. Diabetes Drugs and Cardiovascular Safety

    PubMed Central

    2016-01-01

    Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration. PMID:27302713

  10. Preclinical safety assessments of nano-sized constructs on cardiovascular system toxicity: A case for telemetry.

    PubMed

    Cheah, Hoay Yan; Kiew, Lik Voon; Lee, Hong Boon; Japundžić-Žigon, Nina; Vicent, Marίa J; Hoe, See Ziau; Chung, Lip Yong

    2017-11-01

    While nano-sized construct (NSC) use in medicine has grown significantly in recent years, reported unwanted side effects have raised safety concerns. However, the toxicity of NSCs to the cardiovascular system (CVS) and the relative merits of the associated evaluation methods have not been thoroughly studied. This review discusses the toxicological profiles of selected NSCs and provides an overview of the assessment methods, including in silico, in vitro, ex vivo and in vivo models and how they are related to CVS toxicity. We conclude the review by outlining the merits of telemetry coupled with spectral analysis, baroreceptor reflex sensitivity analysis and echocardiography as an appropriate integrated strategy for the assessment of the acute and chronic impact of NSCs on the CVS. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  11. Workers' 9/11 in Pakistan: neglected sparks causing conflagration.

    PubMed

    Mirza, Muhammad Zeeshan; Bashir, Sajid

    2015-01-01

    A deadly factory fire in Karachi, Pakistan caused the death of 289 workers on September 11, 2012. The havoc played by fire could have been avoided if the concerned authorities had better fire safety measures and strategy. This article presents an exploratory study designed to obtain first-hand information about this issue in which data were collected from 135 organizations within various industries of Pakistan. The results of this study are alarming because most of the organizations are not even equipped with basic fire safety equipment and are devoid of fire exit paths. Incompetence and negligence on the part of government agencies and many stakeholders frequently allows fire to play havoc with the lives of workers in Pakistani organizations, confirming the famous saying 'Parva saepe scintilla contempta magnum excitavit incendium' (A spark neglected has often raised a conflagration).

  12. Understanding Medicare Hospital Readmission Rates And Differing Penalties Between Safety-Net And Other Hospitals.

    PubMed

    Sheingold, Steven H; Zuckerman, Rachael; Shartzer, Adele

    2016-01-01

    Since the implementation of Medicare's Hospital Readmissions Reduction Program in 2012, concerns have been raised about the effect its payment penalties for excess readmissions may have on safety-net hospitals. A number of policy solutions have been proposed to ensure that the program does not unfairly penalize safety-net institutions, which treat a disproportionate number of patients with low socioeconomic status. We examined the extent to which the program's current risk-adjustment factors, measures of patient socioeconomic status, and hospital-level factors explain the observed differences in readmission rates between safety-net and other hospitals. Our analyses suggest that patient socioeconomic status can explain some of the difference in readmission rates but that unmeasured factors such as hospitals' performance may also play a role. We also found that safety-net hospitals have experienced only slightly higher readmission penalties under the program than other hospitals have. Together, these findings suggest the need for a careful evaluation of policy alternatives that factor socioeconomic status into penalty calculations for excess readmissions to determine whether such alternatives could have a significant impact on penalties while remaining consistent with overall objectives for delivery system transformation. Project HOPE—The People-to-People Health Foundation, Inc.

  13. Nanotechnology: An Untapped Resource for Food Packaging.

    PubMed

    Sharma, Chetan; Dhiman, Romika; Rokana, Namita; Panwar, Harsh

    2017-01-01

    Food commodities are packaged and hygienically transported to protect and preserve them from any un-acceptable alteration in quality, before reaching the end-consumer. Food packaging continues to evolve along-with the innovations in material science and technology, as well as in light of consumer's demand. Presently, the modern consumers of competitive economies demands for food with natural quality, assured safety, minimal processing, extended shelf-life and ready-to-eat concept. Innovative packaging systems, not only ascertains transit preservation and effective distribution, but also facilitates communication at the consumer levels. The technological advances in the domain of food packaging in twenty-first century are mainly chaired by nanotechnology, the science of nano-materials. Nanotechnology manipulates and creates nanometer scale materials, of commercial and scientific relevance. Introduction of nanotechnology in food packaging sector has significantly addressed the food quality, safety and stability concerns. Besides, nanotechnology based packaging intimate's consumers about the real time quality of food product. Additionally, nanotechnology has been explored for controlled release of preservatives/antimicrobials, extending the product shelf life within the package. The promising reports for nanotechnology interventions in food packaging have established this as an independent priority research area. Nanoparticles based food packages offer improved barrier and mechanical properties, along with food preservation and have gained welcoming response from market and end users. In contrary, recent advances and up-liftment in this area have raised various ethical, environmental and safety concerns. Policies and regulation regarding nanoparticles incorporation in food packaging are being reviewed. This review presents the existing knowledge, recent advances, concerns and future applications of nanotechnology in food packaging sector.

  14. Nanotechnology: An Untapped Resource for Food Packaging

    PubMed Central

    Sharma, Chetan; Dhiman, Romika; Rokana, Namita; Panwar, Harsh

    2017-01-01

    Food commodities are packaged and hygienically transported to protect and preserve them from any un-acceptable alteration in quality, before reaching the end-consumer. Food packaging continues to evolve along-with the innovations in material science and technology, as well as in light of consumer's demand. Presently, the modern consumers of competitive economies demands for food with natural quality, assured safety, minimal processing, extended shelf-life and ready-to-eat concept. Innovative packaging systems, not only ascertains transit preservation and effective distribution, but also facilitates communication at the consumer levels. The technological advances in the domain of food packaging in twenty-first century are mainly chaired by nanotechnology, the science of nano-materials. Nanotechnology manipulates and creates nanometer scale materials, of commercial and scientific relevance. Introduction of nanotechnology in food packaging sector has significantly addressed the food quality, safety and stability concerns. Besides, nanotechnology based packaging intimate's consumers about the real time quality of food product. Additionally, nanotechnology has been explored for controlled release of preservatives/antimicrobials, extending the product shelf life within the package. The promising reports for nanotechnology interventions in food packaging have established this as an independent priority research area. Nanoparticles based food packages offer improved barrier and mechanical properties, along with food preservation and have gained welcoming response from market and end users. In contrary, recent advances and up-liftment in this area have raised various ethical, environmental and safety concerns. Policies and regulation regarding nanoparticles incorporation in food packaging are being reviewed. This review presents the existing knowledge, recent advances, concerns and future applications of nanotechnology in food packaging sector. PMID:28955314

  15. Microbicide research in developing countries: have we given the ethical concerns due consideration?

    PubMed

    Moodley, Keymanthri

    2007-09-19

    HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally. Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike.

  16. Regulating the market for human eggs.

    PubMed

    Resnik, D B

    2001-02-01

    This essay provides a rationale for a regulated market for human oocytes. Although the commodification of human oocytes raises important moral concerns, these concerns do not justify laws banning commerce in human eggs. Given the burgeoning ART industry and the growing oocyte market, the most prudent course of action is to develop regulations for the human oocyte market that are designed to protect and promote important social values, such as health, safety, liberty, and respect for human life. Other responses, such as banning the sale of eggs altogether or allowing donors to be compensated only for their services, would either create a black market or would lead to corruption and abuse. Society still needs to debate specific rules and policies that should govern the human egg market, but further discussion of that important task is best left to legislative bodies and other commentators.

  17. Which Dengue Vaccine Approach Is the Most Promising, and Should We Be Concerned about Enhanced Disease after Vaccination? Questions Raised by the Development and Implementation of Dengue Vaccines: Example of the Sanofi Pasteur Tetravalent Dengue Vaccine.

    PubMed

    Guy, Bruno

    2018-06-01

    Dengue is a still-growing public health concern in many tropical and subtropical regions of the world. The development and implementation of an effective dengue vaccine in these regions is a high priority. This insight focuses on the expected characteristics of a safe and efficacious vaccine, referring to the clinical experience obtained during the development of the first tetravalent dengue vaccine from Sanofi Pasteur, now licensed in several endemic countries. Safety and efficacy data from both short- and long-term follow-up of large-scale efficacy studies will be discussed, as well as the next steps following vaccine introduction. Copyright © 2018 Cold Spring Harbor Laboratory Press; all rights reserved.

  18. Space resources. Volume 4: Social concerns

    NASA Technical Reports Server (NTRS)

    Mckay, Mary Fae (Editor); Mckay, David S. (Editor); Duke, Michael B. (Editor)

    1992-01-01

    Space resources must be used to support life on the Moon and exploration of Mars. This volume, Social Concerns, covers some of the most important issues which must be addressed in any major program for the human exploration of space. The volume begins with a consideration of the economics and management of large scale space activities. Then the legal aspects of these activities are discussed, particularly the interpretation of treaty law with respect to the Moon and asteroids. The social and cultural issues of moving people into space are considered in detail, and the eventual emergence of a space culture different from the existing culture is envisioned. The environmental issues raised by the development of space settlements are faced. Some innovative approaches are proposed to space communities and habitats and self-sufficiency is considered along with human safety at a lunar base or outpost.

  19. Endocrine disrupting effects of butylated hydroxyanisole (BHA - E320)

    PubMed Central

    POP, ANCA; KISS, BELA; LOGHIN, FELICIA

    2013-01-01

    Butylated hydroxyanisole (BHA) is extensively used as antioxidant in foods, food packaging, cosmetics and pharmaceuticals. In the past years, it raised concerns regarding its possible endocrine disrupting effect. The existing in vitro studies indicate that BHA presents a weak estrogenic effect and also anti-androgenic properties while an in vivo study found it to have antiestrogenic properties. There is no sufficient data available at the moment to draw a conclusion regarding the safety of BHA when referring to its endocrine disrupting effect. Since a fraction of the population might be exposed to doses superior to the acceptable daily intake (ADI), it is important to gather more in vitro and in vivo data concerning the potential effects that BHA might have alone, but also in mixtures with natural hormones or other endocrine disrupting compounds. PMID:26527908

  20. Challenges and issues concerning mycotoxins contamination in oil seeds and their edible oils: Updates from last decade.

    PubMed

    Bhat, Rajeev; Reddy, Kasa Ravindra Nadha

    2017-01-15

    Safety concerns pertaining towards fungal occurrence and mycotoxins contamination in agri-food commodities has been an issue of high apprehension. With the increase in evidence based research knowledge on health effects posed by ingestion of mycotoxins-contaminated food and feed by humans and livestock, concerns have been raised towards providing more insights on screening of agri-food commodities to benefit consumers. Available reports indicate majority of edible oil-yielding seeds to be contaminated by various fungi, capable of producing mycotoxins. These mycotoxins can enter human food chain via use of edible oils or via animals fed with contaminated oil cake residues. In this review, we have decisively evaluated available data (from the past decade) pertaining towards fungal occurrence and level of mycotoxins in various oil seeds and their edible oils. This review can be of practical use to justify the prevailing gaps, especially relevant to the research on presence of mycotoxins in edible plant based oils. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Risk perceptions of smokeless tobacco among adolescents and adult users and nonusers

    PubMed Central

    Liu, Sherry T.; Nemeth, Julianna M.; Klein, Elizabeth G.; Ferketich, Amy K.; Kwan, Mei-Po; Wewers, Mary Ellen

    2015-01-01

    The recent growth in smokeless tobacco (ST) consumption has raised questions about consumer risk perceptions of ST products, especially in high-risk vulnerable populations. This qualitative study examined risk perceptions of ST among adolescent and adult users and non-users in Ohio Appalachia. Focus groups and interviews were held with adolescents (n=53; mean age of 17 years) and adults (n=63; mean age of 34 years) from four Ohio Appalachian counties. Participants were asked about their perceptions of ST-related health risks, ST safety, and the relative safety of ST compared to cigarettes. Transcriptions were coded independently by two individuals. Overall, participants were knowledgeable about health problems from ST use (e.g., oral cancers, periodontal disease). Nearly all participants stated that ST use is not safe; however, there was disagreement about its relative safety. Some perceived all tobacco products as equally harmful; others believed that ST is safer than cigarettes for either the user or those around the user. Disagreements about ST relative safety may reflect mixed public health messages concerning the safety of ST. Comprehensive consumer messages about the relative safety of ST compared to cigarettes are needed. Messages should address the effect of ST on the health of the user as well as those exposed to the user. PMID:25832126

  2. The impact of nursing work environments on patient safety outcomes: the mediating role of burnout/engagement.

    PubMed

    Spence Laschinger, Heather K; Leiter, Michael P

    2006-05-01

    To test a theoretical model of professional nurse work environments linking conditions for professional nursing practice to burnout and, subsequently, patient safety outcomes. The 2004 Institute of Medicine report raised serious concerns about the impact of hospital restructuring on nursing work environments and patient safety outcomes. Few studies have used a theoretical framework to study the nature of the relationships between nursing work environments and patient safety outcomes. Hospital-based nurses in Canada (N = 8,597) completed measures of worklife (Practice Environment Scale of the Nursing Work Index), burnout (Maslach Burnout Inventory-Human Service Scale), and their report of frequency of adverse patient events. Structural equation modeling analysis supported an extension of Leiter and Laschinger's Nursing Worklife Model. Nursing leadership played a fundamental role in the quality of worklife regarding policy involvement, staffing levels, support for a nursing model of care (vs medical), and nurse/physician relationships. Staffing adequacy directly affected emotional exhaustion, and use of a nursing model of care had a direct effect on nurses' personal accomplishment. Both directly affected patient safety outcomes. The results suggest that patient safety outcomes are related to the quality of the nursing practice work environment and nursing leadership's role in changing the work environment to decrease nurse burnout.

  3. Response to issues on GM agriculture in Africa: Are transgenic crops safe?

    PubMed

    Adenle, Ademola A

    2011-10-08

    The controversies surrounding transgenic crops, often called Genetically Modified Organisms (GMOs), call for a need to raise the level of public awareness of Genetic Modification (GM) technology in Africa. This should be accomplished by educating the public about the potential benefits and risks that may be associated with this new technology. In the last 15 years, GM crop producing countries have benefited from adoption of this new technology in the form of improved crop productivity, food security, and quality of life. The increased income to resource-poor farmers is a key benefit at the individual level especially as most countries using this technology are in the developing world, including three African countries (South Africa, Burkina Faso and Egypt). Despite clear benefits to countries and farmers who grow GMOs, many people are concerned about suspected potential risks associated with GMOs. This sparks debate as to whether GM technology should be adopted or not. Given the concerns regarding the safety of GMO products, thorough scientific investigation of safe application of GMOs is required. The objective of this paper is to respond to the issues of GM agriculture in Africa and some of the issues surrounding the adoption of GM crops between developed and developing countries. In this article, I analyse relevant papers relating to the adoption of GM technology particularly in developing countries including the few African countries that have adopted GM crops. The issues discussed span a wide range including: safety; potential benefits and risks; disputes between the United States of America (USA) and the European Union (EU) over adoption of GM crops with a focus on Africa continent. This article is concluded by summarising the issues raised and how GM technology can be adopted for agricultural development in Africa.

  4. Response to issues on GM agriculture in Africa: Are transgenic crops safe?

    PubMed Central

    2011-01-01

    The controversies surrounding transgenic crops, often called Genetically Modified Organisms (GMOs), call for a need to raise the level of public awareness of Genetic Modification (GM) technology in Africa. This should be accomplished by educating the public about the potential benefits and risks that may be associated with this new technology. In the last 15 years, GM crop producing countries have benefited from adoption of this new technology in the form of improved crop productivity, food security, and quality of life. The increased income to resource-poor farmers is a key benefit at the individual level especially as most countries using this technology are in the developing world, including three African countries (South Africa, Burkina Faso and Egypt). Despite clear benefits to countries and farmers who grow GMOs, many people are concerned about suspected potential risks associated with GMOs. This sparks debate as to whether GM technology should be adopted or not. Given the concerns regarding the safety of GMO products, thorough scientific investigation of safe application of GMOs is required. The objective of this paper is to respond to the issues of GM agriculture in Africa and some of the issues surrounding the adoption of GM crops between developed and developing countries. In this article, I analyse relevant papers relating to the adoption of GM technology particularly in developing countries including the few African countries that have adopted GM crops. The issues discussed span a wide range including: safety; potential benefits and risks; disputes between the United States of America (USA) and the European Union (EU) over adoption of GM crops with a focus on Africa continent. This article is concluded by summarising the issues raised and how GM technology can be adopted for agricultural development in Africa. PMID:21981823

  5. Casting a global safety net--a framework for food safety in the age of globalization.

    PubMed

    Chyau, James

    2009-01-01

    In mid-March 2007, Ontario-based Menu Foods Inc. started recalling its "cuts and gravy" style pet food, after receiving information that pets that had eaten the product had fallen ill. Within a week, the company was inundated with complaints and expressions of concern from about 200,000 of its customers. The Food and Drug Administration (FDA) determined in late March 2007 that the most likely culprit in the illness, and in some cases death of the pet animals, was contaminated wheat gluten, a vegetable protein imported from China. One of the FDA identified contaminants was an industrial chemical called melamine. Reports of widespread adulteration of animal feed with melamine in China raised concern of similar contamination in the human food supply. In response, on April 27, 2007, FDA announced the detention of all vegetable proteins imported from China, whether for animal or for human consumption. But, FDA's action came too late. On May 1, 2007, officials from FDA and the U.S. Department of Agriculture (USDA) indicated that between 2.5 to 3 million people in the United States had consumed chickens that had been fed with contaminated vegetable proteins imported from China. The 2007 pet food recall incident provided an ominous early warning that, unless the international community can come up with a better food safety mechanism, more such food contamination disasters could happen in the future.

  6. Qianliguang (Senecio scandens) safety dilemma: dose is the key?

    PubMed

    Lin, Ge; Li, Song-Lin; Li, Mi; Li, Na; Sun-Kin Chan, Sunny; Chan, Wood-Yee; Zhao, Zhong-Zhen

    2009-08-01

    Qianliguang ( SENECIO SCANDENS) is a common Chinese medicinal herb. Qianliguang-containing herbal proprietary products are registered as over-the-counter remedies in China and exported to Western countries. The safety of using Qianliguang and its products has raised general concerns because of a potential risk of the presence of hepatotoxic pyrrolizidine alkaloids (PAs). A systematic toxicological study is thus required to verify this public concern. In the present article, we report, for the first time, that S. SCANDENS contains nine hepatotoxic PAs with a content of 6.95-7.19 microg/g. At a dose equivalent to the daily intake recommended by the Pharmacopoeia of China, the total content of toxic PAs in Qianliguang was determined to be 3.48 microg/kg/day, which is far below the lowest dose to cause hepatotoxicity (15 microg/kg/day) suggested by the International Program on Chemical Safety. No significant hepatotoxic effects were observed in rats fed with the extract at this human-equivalent dose for 14 consecutive days. However, a single overdose of the herbal water extract (6 g/kg), which was about 8-fold higher than the recommended dose, produced typical PA-induced hepatotoxicity in rats. Therefore, appropriate dosage guidelines should be implemented for the herbal industry, for export/import retailers, and for herbal medicine practitioners to ensure the safe and beneficial use of these herbal medicines. Georg Thieme Verlag KG Stuttgart.New York.

  7. Development of a consortium for water security and safety: Planning for an early warning system

    USGS Publications Warehouse

    Clark, R.M.; Adam, N.R.; Atluri, V.; Halem, M.; Vowinkel, E.F.; ,

    2004-01-01

    The events of September 11, 2001 have raised concerns over the safety and security of the Nation's critical infrastructure including water and waste water systems. In June 2002, the U.S. EPA's Region II Office (New York City), in response to concerns over water security, in collaboration with Rutgers University agreed to establish a Regional Drinking Water Security and Safety Consortium (RDWSSC). Members of the consortium include: Rutgers University's Center for Information Management, Integration and Connectivity (CIMIC), American Water (AW), the Passaic Valley Water Commission (PVWC), the North Jersey District Water Supply Commission (NJDWSC), the N.J. Department of Environmental Protection, the U.S. Geological Survey (USGS), and the U.S. Environmental Protection Agencies, Region II Office. In December of 2002 the consortium members signed a memorandum of understanding (MOU) to pursue activities to enhance regional water security. Development of an early warning system for source and distributed water was identified as being of primary importance by the consortium. In this context, an early warning system (EWS) is an integrated system of monitoring stations located at strategic points in a water utilities source waters or in its distribution system, designed to warn against contaminants that might threaten the health and welfare of drinking water consumers. This paper will discuss the consortium's progress in achieving these important objectives.

  8. The potential effects of Ocimum basilicum on health: a review of pharmacological and toxicological studies.

    PubMed

    Sestili, Piero; Ismail, Tariq; Calcabrini, Cinzia; Guescini, Michele; Catanzaro, Elena; Turrini, Eleonora; Layla, Anam; Akhtar, Saeed; Fimognari, Carmela

    2018-07-01

    Basil (Ocimum basilicum L., OB) is a plant world widely used as a spice and a typical ingredient of the healthy Mediterranean diet. In traditional medicine, OB is indicated for many maladies and conditions; OB-containing nutritional supplements are increasingly sold. Conversely, safety concerns have been raised about the promutagens and procarcinogens alkenylbenzenes contained in OB. Areas covered: A critical review of the current status of OB as a nutraceutical, the pharmacology of its bioactive components, the rationale for its indications, and its safety. Expert opinion: Due to the polyphenolic and flavonoidic content, OB can be considered as an important ingredient in healthy diets; OB preparations may be effective as chemopreventive agents or adjunctive therapy in the treatment of different clinical conditions. From a toxicological perspective, since the tumorigenic potential of alkenylbenzenes is counteracted by other OB constituents such as nevadensin, it can be concluded that OB consumption in food and preparations is safe. The only concern relates to OB essential oils: in this case, a concentration limit for alkenylbenzenes should be precautionary defined, and the use of plant chemotypes with no or low levels of these alkylbenzenes for the preparation of essential oils should be made compulsory.

  9. Managing antidepressant treatment in pregnancy and puerperium. Careful with that axe, Eugene.

    PubMed

    Gentile, Salvatore

    2015-07-01

    Until 2005, selective serotonin reuptake inhibitors (SSRIs), the class of antidepressants most frequently used in clinical practice, had been deemed devoid of any teratogenic effects. However, in recent years several concerns have been raised about their reproductive safety, including: disturbed fetal development, increased rates of congenital anomalies, increased risks of neonatal complications, neuro-motor delay and even autism. Specific concerns are also arising about the safety of SSRIs for infants breastfed by mothers who take such medications in puerperium. Such considerations have led to the 'bad reproductive reputation' of SSRIs, whose utilization during pregnancy and breastfeeding is deemed incautious. Specific reproductive problems also involve tricyclic antidepressants, especially clomipramine. Thus, any conclusion about what antidepressant should be considered the safest during pregnancy must be stated and read with great caution. However, the risks associated with pharmacological treatment must be balanced with the effects of untreated antenatal maternal depression on the mother-fetus dyad, which are likely to be devastating. During puerperium, it is mandatory to weigh the risks to the infant of antidepressant exposure through breast milk against the disadvantage of not receiving mother's milk and being exposed to a relapse of maternal mood symptoms (which may also have tragic consequences for the patient).

  10. An overview on safety issues related to erythropoiesis-stimulating agents for the treatment of anaemia in patients with chronic kidney disease.

    PubMed

    Del Vecchio, Lucia; Locatelli, Francesco

    2016-08-01

    Erythropoiesis stimulating agents (ESA) are effective drugs, which have been used for decades in patients with chronic kidney disease (CKD) with few side effects. More recently, concern has been raised around their safety, from higher cardiovascular and thrombosis risk to cancer progression and increased mortality. We made a literature search on PubMed looking for adverse effects of ESA in CKD patients. The topics covered are cardiovascular adverse events, thrombosis, increased mortality, hypertension, cancer progression, diabetic retinopathy, pure red cell aplasia and anaphylactic reactions. Concerns around ESA therapy have questioned treatment indications in high-risk CKD patients (those with cancer, diabetes and cardiovascular comorbidities). A more cautious approach has then prevailed. In our opinion, intermediate Hb values (Hb 10-12 g/dl) should be aimed with ESA therapy, being more cautious in high-risk patients. As a consequence, IV iron is administered more frequently. However, excessive iron use may cause iron overload and in rare cases severe anaphylactic reactions. There are expectations of new erythropoietic agents, such as those manipulating the hypoxia-inducible transcription factors (HIF) system. Differing from ESAs, they stimulate the production of endogenous EPO, avoiding over-physiological plasmatic levels.

  11. Recent advances in the management of neuropsychiatric symptoms in dementia.

    PubMed

    Forlenza, Orestes V; Loureiro, Júlia Cunha; Pais, Marcos Vasconcelos; Stella, Florindo

    2017-03-01

    The present article addresses intriguing questions related to the clinical intervention in distinct neuropsychiatric syndromes of patients with dementia. We reviewed 154 articles published between 2015 and 2016 targeting psychopharmacological and nonpharmacological interventions, and safety-tolerability concerns. We selected 115 articles addressing the purpose of this study. Of these, 33 were chosen because they were dedicated to subtopics: agitation (42), depression (33), apathy (18), sleep disorders/anxiety (8), and psychosis (4). Clinical studies using both pharmacological (70) and nonpharmacological (37) interventions were considered; others were included for theoretical support. Regarding the methodological design, we found double-blind RCTs (17), single-blinded RCTs (4), open-label studies (18), case reports (5), cross-sectional or cohort studies (25), epidemiological papers (2), and expert reviews (44). This observation raises concerns about the overall methodological adequacy of a substantial proportion of studies in this field, which limits the potential of generalization of the findings. Finally, 18 studies were designed to determine safety-tolerability issues of psychotropic medications (6 were discussed). Effective and well tolerated treatment of neuropsychiatric syndromes in dementia remains a critically unsolved challenge. We understand that this is an extremely important area of research, and critically required to guide clinical decisions in geriatric neuropsychiatry.

  12. [Comparative evaluation of maternity hospitals in Auvergne: from planning to contracting].

    PubMed

    Gerbaud, L; Biolay, S; Venet, M; Pomey, M P; Belgacem, B; Jacquetin, B; Glanddier, P Y

    1998-01-01

    Two reforms of public hospitals have been launched by the French government in 1991 and 1996 aimed at lowering costs and increasing the quality of services and ultimately the safety of patients. As concerns maternity hospitals, several new rules have been imposed upon. For example, those who performed less than 300 births a year should be closed. The basic idea was to concentrate technical resources and human skills in middle-size and important hospitals for saving money, and simultaneously, raising the safety level for mothers and babies. However, negative adverse effects fastly appeared: to avoid closure, some small maternity homes tried to convince future mothers not to go to well-equipped hospitals, even if their cases appeared complex and their health at risk. An experience of partnership between maternity hospitals (care providers), the Sickness Insurance Fund (the financing body) and the Administration was carried out in the Auvergne region. It was based on the observation of a large number of indicators concerning the activity of hospitals, the size and quality of their equipment, the satisfaction of their patients ... etc ... for designing the rights and duties of each partner. Instead of planning from the summit, a process of mutually-agreed contract was established.

  13. Assessing the Safety of Vitamin A Delivered Through Large-Scale Intervention Programs: Workshop Report on Setting the Research Agenda.

    PubMed

    Tanumihardjo, Sherry A; Mokhtar, Najat; Haskell, Marjorie J; Brown, Kenneth H

    2016-06-01

    Vitamin A (VA) deficiency (VAD) is still a concern in many parts of the world, and multiple intervention strategies are being implemented to reduce the prevalence of VAD and associated morbidity and mortality. Because some individuals within a population may be exposed to multiple VA interventions, concerns have been raised about the possible risk of hypervitaminosis A. A consultative meeting was held in Vienna, Austria, in March 2014 to (1) review current knowledge concerning the safety and effectiveness of large-scale programs to control VAD, (2) develop a related research agenda, and (3) review current available methods to assess VA status and risk of hypervitaminosis A. Multiple countries were represented and shared their experiences using a variety of assessment methods, including retinol isotope dilution (RID) techniques. Discussion included next steps to refine assessment methodology, investigate RID limitations under different conditions, and review programmatic approaches to ensure VA adequacy and avoid excessive intakes. Fortification programs have resulted in adequate VA status in Guatemala, Zambia, and parts of Cameroon. Dietary patterns in several countries revealed that some people may consume excessive preformed VA from fortified foods. Additional studies are needed to compare biomarkers of tissue damage to RID methods during hypervitaminosis A and to determine what other biomarkers can be used to assess excessive preformed VA intake. © The Author(s) 2016.

  14. On the safety of ITER accelerators.

    PubMed

    Li, Ge

    2013-01-01

    Three 1 MV/40A accelerators in heating neutral beams (HNB) are on track to be implemented in the International Thermonuclear Experimental Reactor (ITER). ITER may produce 500 MWt of power by 2026 and may serve as a green energy roadmap for the world. They will generate -1 MV 1 h long-pulse ion beams to be neutralised for plasma heating. Due to frequently occurring vacuum sparking in the accelerators, the snubbers are used to limit the fault arc current to improve ITER safety. However, recent analyses of its reference design have raised concerns. General nonlinear transformer theory is developed for the snubber to unify the former snubbers' different design models with a clear mechanism. Satisfactory agreement between theory and tests indicates that scaling up to a 1 MV voltage may be possible. These results confirm the nonlinear process behind transformer theory and map out a reliable snubber design for a safer ITER.

  15. Case and commentary: using simulation to address hierarchy issues during medical crises.

    PubMed

    Calhoun, Aaron W; Boone, Megan C; Miller, Karen H; Pian-Smith, May C M

    2013-02-01

    Medicine is hierarchical, and both positive and negative effects of this can be exposed and magnified during a crisis. Ideally, hierarchies function in an orderly manner, but when an inappropriate directive is given, the results can be disastrous unless team members are empowered to challenge the order. This article describes a case that uses misdirection and the possibility of simulated "death" to facilitate learning among experienced clinicians about the potentially deadly effects of an unchallenged, inappropriate order. The design of this case, however, raises additional questions regarding both ethics and psychological safety. The ethical concerns that surround the use of misdirection in simulation and the psychological ramifications of incorporating patient death in this context are explored in the commentary. We conclude with a discussion of debriefing strategies that can be used to promote psychological safety during potentially emotionally charged simulations and possible directions for future research.

  16. Child Labor and Environmental Health: Government Obligations and Human Rights

    PubMed Central

    Amon, Joseph J.; Buchanan, Jane; Cohen, Jane; Kippenberg, Juliane

    2012-01-01

    The Convention concerning the Prohibition and Immediate Action for the Elimination of the Worst Forms of Child Labour was adopted by the International Labour Organization in 1999. 174 countries around the world have signed or ratified the convention, which requires countries to adopt laws and implement programs to prohibit and eliminate child labor that poses harms to health or safety. Nonetheless, child labor continues to be common in the agriculture and mining sectors, where safety and environmental hazards pose significant risks. Drawing upon recent human rights investigations of child labor in tobacco farming in Kazakhstan and gold mining in Mali, the role of international human rights mechanisms, advocacy with government and private sector officials, and media attention in reducing harmful environmental exposures of child workers is discussed. Human rights-based advocacy in both cases was important to raise attention and help ensure that children are protected from harm. PMID:23316246

  17. On the safety of ITER accelerators

    PubMed Central

    Li, Ge

    2013-01-01

    Three 1 MV/40A accelerators in heating neutral beams (HNB) are on track to be implemented in the International Thermonuclear Experimental Reactor (ITER). ITER may produce 500 MWt of power by 2026 and may serve as a green energy roadmap for the world. They will generate −1 MV 1 h long-pulse ion beams to be neutralised for plasma heating. Due to frequently occurring vacuum sparking in the accelerators, the snubbers are used to limit the fault arc current to improve ITER safety. However, recent analyses of its reference design have raised concerns. General nonlinear transformer theory is developed for the snubber to unify the former snubbers' different design models with a clear mechanism. Satisfactory agreement between theory and tests indicates that scaling up to a 1 MV voltage may be possible. These results confirm the nonlinear process behind transformer theory and map out a reliable snubber design for a safer ITER. PMID:24008267

  18. Spinacia oleracea L. Leaf Stomata Harboring Cryptosporidium parvum Oocysts: a Potential Threat to Food Safety ▿ †

    PubMed Central

    Macarisin, Dumitru; Bauchan, Gary; Fayer, Ronald

    2010-01-01

    Cryptosporidium parvum is a cosmopolitan microscopic protozoan parasite that causes severe diarrheal disease (cryptosporidiosis) in mammals, including humans and livestock. There is growing evidence of Cryptosporidium persistence in fresh produce that may result in food-borne infection, including sporadic cases as well as outbreaks. However, drinking and recreational waters are still considered the major sources of Cryptosporidium infection in humans, which has resulted in prioritization of studies of parasite etiology in aquatic environments, while the mechanisms of transmission and parasite persistence on edible plants remain poorly understood. Using laser scanning confocal microscopy together with fluorescein-labeled monoclonal antibodies, C. parvum oocysts were found to strongly adhere to spinach plants after contact with contaminated water, to infiltrate through the stomatal openings in spinach leaves, and to persist at the mesophyll level. These findings and the fact that this pathogenic parasite resists washing and disinfection raise concerns regarding food safety. PMID:19933348

  19. Acceptance of wearable technology by people with Alzheimer's disease: issues and accommodations.

    PubMed

    Mahoney, Edward L; Mahoney, Diane F

    2010-09-01

    The increasing number of cognitively impaired older adults who exhibit wandering tendencies raises safety concerns. The purpose of the current study was to research the State-of the-Art in Wearable Technologies for persons with Alzheimer's Disease and identify challenges unique to this population and lessons learned. Inclusion criteria specified systems/devices that completed laboratory testing and were commercially available for usage by community-based Alzheimer's family caregivers. Methods included a series of Internet product searches and telephone interviews with related corporate representatives and participant's referrals. Results indicated many products in development or academic research use but only a limited number were available that met the study criteria. The interviews with key informants revealed features necessary to consider when making products to be worn by persons with cognitive impairment. In conclusion, there is no ideal solution and opportunities remain for marketplace innovations and for addressing the challenges associated with balancing safety and security.

  20. Preventing tuberculosis in healthcare workers of the radiology department: a Malaysian perspective.

    PubMed

    Tan, Lh; Kamarulzaman, A

    2006-01-01

    Tuberculosis (TB) is a well recognised occupational hazard for healthcare workers (HCWs). Concerns on the safety of healthcare settings in Malaysia was raised following a report of 25 HCWs working in 11 general hospitals in Malaysia who were infected with TB in 2004 being publicised in the media recently. As the disease burden in general is high in Malaysia, due attention should be given to this disease in our healthcare facilities including the radiology department, an often neglected area in TB infection control programmes. This article focuses on the key control measures that can be implemented in radiology departments in a developing country with limited resources.

  1. Playing Hockey, Riding Motorcycles, and the Ethics of Protection

    PubMed Central

    2012-01-01

    Ice hockey and motorcycle riding are increasingly popular activities in the United States that are associated with high risks of head and facial injuries. In both, effective head and facial protective equipment are available. Yet the debates about safety policies regarding the use of head protection in these activities have taken different forms, in terms of the influence of epidemiological data as well as of the ethical concerns raised. I examine these debates over injury prevention in the context of leisure activities, in which the public health duty to prevent avoidable harm must be balanced with the freedom to assume voluntary risks. PMID:23078472

  2. Quality Assessment of Compounded 17-hydroxyprogesterone Caproate

    PubMed Central

    Chang, Justine; Zhao, Yang; Zhao, WenChen; Venkataramanan, Raman; Caritis, Steve N.

    2013-01-01

    Objective To evaluate the quality of compounded 17-hydroxyprogesterone caproate (17-OHPC) Study Design Compounded 17-OHPC was obtained from 15 compounding pharmacies throughout the U.S. and analyzed for potency, impurities, sterility, and pyrogen status. Results Eighteen samples were supplied by 15 compounding pharmacies. The concentration of 17-OHPC in all samples was within the specification limits and all tested samples passed sterility and pyrogen testing. Only 1 of 18 samples was out of specification limits for impurities. Conclusion Compounded 17-OHPC obtained from 15 pharmacies throughout the U.S. did not raise safety concerns when assessed for potency, sterility, pyrogen status or impurities. PMID:24200163

  3. ITC commentary on the prediction of digoxin clinical drug-drug interactions from in vitro transporter assays.

    PubMed

    Lee, C A; Kalvass, J C; Galetin, A; Zamek-Gliszczynski, M J

    2014-09-01

    The "P-glycoprotein" IC50 working group reported an 18- to 796-fold interlaboratory range in digoxin transport IC50 (inhibitor concentration achieving 50% of maximal inhibition), raising concerns about the predictability of clinical transporter-based drug-drug interactions (DDIs) from in vitro data. This Commentary describes complexities of digoxin transport, which involve both uptake and efflux processes. We caution against attributing digoxin transport IC50 specifically to P-glycoprotein (P-gp) or extending this composite uptake/efflux IC50 variability to individual transporters. Clinical digoxin interaction studies should be interpreted as evaluation of digoxin safety, not P-gp DDIs.

  4. Understanding the complexities of private standards in global agri-food chains as they impact developing countries.

    PubMed

    Henson, Spencer; Humphrey, John

    2010-01-01

    The increasing prevalence of private standards governing food safety, food quality and environmental and social impacts of agri-food systems has raised concerns about the effects on developing countries, as well as the governance of agri-food value chains more broadly. It is argued that current debates have been 'clouded' by a failure to recognise the diversity of private standards in terms of their institutional form, who develops and adopts these standards and why. In particular, there is a need to appreciate the close inter-relationships between public regulations and private standards and the continuing ways in which private standards evolve.

  5. Ethical and Safety Issues of Stem Cell-Based Therapy.

    PubMed

    Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

    2018-01-01

    Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells.

  6. Ethical and Safety Issues of Stem Cell-Based Therapy

    PubMed Central

    Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

    2018-01-01

    Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells. PMID:29333086

  7. Distracted Biking: An Observational Study.

    PubMed

    Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Breeze, Janis L; Salzler, Matthew J

    2016-01-01

    Commuting via bicycle is a very popular mode of transportation in the Northeastern United States. Boston, MA, has seen a rapid increase in bicycle ridership over the past decade, which has raised concerns and awareness about bicycle safety. An emerging topic in this field is distracted bicycle riding. This study was conducted to provide descriptive data on the prevalence and type of distracted bicycling in Boston at different times of day. This was a cross-sectional study in which observers tallied bicyclists at 4 high traffic intersections in Boston during various peak commuting hours for 2 types of distractions: auditory (earbuds/phones in or on ears), and visual/tactile (electronic device or other object in hand). Nineteen hundred seventy-four bicyclists were observed and 615 (31.2%), 95% CI [29, 33%], were distracted. Of those observed, auditory distractions were the most common (N = 349; 17.7%), 95% CI [16, 19], p = .0003, followed by visual/tactile distractions (N = 266; 13.5%), 95% CI [12, 15]. The highest proportion (40.7%), 95% CI [35, 46], of distracted bicyclists was observed during the midday commute (between 13:30 and 15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost a third of all bicyclists exhibited distracted behavior. Education and public awareness campaigns should be designed to decrease distracted bicycling behaviors and promote bicycle safety in Boston. An awareness of the prevalence of distracted biking can be utilized to promote bicycle safety campaigns dedicated to decreasing distracted bicycling and to provide a baseline against which improvements can be measured.

  8. Distracted Biking: An Observational Study

    PubMed Central

    Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Breeze, Janis L; Salzler, Matthew J.

    2016-01-01

    Commuting via bicycle is a very popular mode of transportation in the Northeastern United States (US). Boston, MA has seen a rapid increase in bicycle ridership over the past decade which has raised concerns and awareness about bicycle safety. An emerging topic in this field is distracted bicycle riding. This study was conducted to provide descriptive data on the prevalence and type of distracted bicycling in Boston at different times of day. This was a cross-sectional study in which observers tallied bicyclists at four high traffic intersections in Boston during various peak commuting hours for two types of distractions: auditory (ear buds/phones in or on ears), and visual/tactile (electronic device or other object in hand). Nineteen hundred seventy-four bicyclists were observed and 615 (31.2%, 95% CI: 29%-33%) were distracted. Of those observed, auditory distractions were the most common (N= 349 [17.7%, 95% CI: 16%-19%], p=0.0003) followed by visual/tactile distractions (N= 266 [13.5%, 95% CI: 12%-15%]). The highest proportion (40.7%, 95% CI: 35%-46%) of distracted bicyclists was observed during the midday commute (between 13:30-15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost one-third of all bicyclists exhibited distracted behavior. Education and public awareness campaigns should be designed to decrease distracted bicycling behaviors and promote bicycle safety in Boston. An awareness of the prevalence of distracted biking can be utilized to promote bicycle safety campaigns dedicated to decreasing distracted bicycling and to provide a baseline against which improvements can be measured. PMID:26953533

  9. 30 CFR 77.405 - Performing work from a raised position; safeguards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... designed as elevated mobile work platforms. (b) No work shall be performed under machinery or equipment... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Performing work from a raised position... LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS...

  10. Raising Confident Kids

    MedlinePlus

    ... First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para niños How the Body ... Videos for Educators Search English Español Raising Confident Kids KidsHealth / For Parents / Raising Confident Kids What's in ...

  11. What’s the Harm in Asking about Suicidal Ideation?

    PubMed Central

    Mathias, Charles W.; Furr, R. Michael; Sheftall, Arielle H.; Hill-Kapturczak, Nathalie; Crum, Paige; Dougherty, Donald M.

    2013-01-01

    Both researchers and oversight committees share concerns about patient safety in the study-related assessment of suicidality. However, concern about assessing suicidal thoughts can be a barrier to the development of empirical evidence that informs research on how to safely conduct these assessments. A question has been raised if asking about suicidal thoughts can result in iatrogenic increases of such thoughts, especially among at-risk samples. The current study repeatedly tested suicidal ideation at 6-month intervals for up to 2-years. Suicidal ideation was measured with the Suicidal Ideation Questionnaire Junior, and administered to adolescents who had previously received inpatient psychiatric care. Change in suicidal ideation was tested using several analytic techniques, each of which pointed to a significant decline in suicidal ideation in the context of repeated assessment. This and previous study outcomes suggest that asking an at-risk population about suicidal ideation is not associated with subsequent increases in suicidal ideation. PMID:22548324

  12. Biologically-Inspired Concepts for Autonomic Self-Protection in Multiagent Systems

    NASA Technical Reports Server (NTRS)

    Sterritt, Roy; Hinchey, Mike

    2006-01-01

    Biologically-inspired autonomous and autonomic systems (AAS) are essentially concerned with creating self-directed and self-managing systems based on metaphors &om nature and the human body, such as the autonomic nervous system. Agent technologies have been identified as a key enabler for engineering autonomy and autonomicity in systems, both in terms of retrofitting into legacy systems and in designing new systems. Handing over responsibility to systems themselves raises concerns for humans with regard to safety and security. This paper reports on the continued investigation into a strand of research on how to engineer self-protection mechanisms into systems to assist in encouraging confidence regarding security when utilizing autonomy and autonomicity. This includes utilizing the apoptosis and quiescence metaphors to potentially provide a self-destruct or self-sleep signal between autonomic agents when needed, and an ALice signal to facilitate self-identification and self-certification between anonymous autonomous agents and systems.

  13. Impacts of weatherization on indoor air quality: A field study of 514 homes.

    PubMed

    Pigg, S; Cautley, D; Francisco, P W

    2018-03-01

    Residential energy efficiency retrofits continue to be common in the United States, especially through governmental and utility programs. Because of the potential for reduced air exchange, there have been concerns raised regarding the potential for negative impacts on health and safety of residents when air sealing occurs. To address this concern, a study was undertaken in 2009-2010 to evaluate the indoor air quality impacts of weatherization performed through the U.S. Department of Energy's Weatherization Assistance Program. Testing was conducted on 514 homes throughout the United States. The results show that weatherization, as performed at the time of the study, could result in small but statistically significant increases in some indoor contaminants such as radon and humidity, while also reducing exposures to elevated carbon monoxide in some homes. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Medicalized Female Genital Mutilation/Cutting: Contentious Practices and Persistent Debates.

    PubMed

    Kimani, Samuel; Shell-Duncan, Bettina

    2018-01-01

    Female genital cutting/mutilation (FGM/C) performed by health care professionals (medicalization) and reduced severity of cutting have been advanced as strategies for minimizing health risks, sparking acrimonious ongoing debates. This study summarizes key debates and critically assesses supporting evidence. While medicalization is concentrated in Africa, health professionals worldwide have faced requests to perform FGM/C. Whether medicalization is hindering the decline of FGM/C is unclear. Factors motivating medicalization include, but are not limited to, safety concerns. Involvement of health professionals in advocacy to end FGM/C can address both the supply and demand side of medicalization, but raises ethical concerns regarding dual loyalty. Ongoing debates need to address competing rights claims. Polarizing debates have brought little resolution. We call for a focus on common goals of protecting the health and welfare of girls living in communities where FGM/C is upheld and encourage more informed and open dialog.

  15. A special report of current state of the medical physicist workforce — results of the 2012 ASTRO Comprehensive Workforce Study

    PubMed Central

    Arnone, Anna; Sillanpaa, Jussi K; Yu, Yan; Mills, Michael D.

    2015-01-01

    The medical physics profession is undergoing significant changes. Starting in 2014, candidates registering for certification exams by the American Board of Radiology must have completed a CAMPEP‐accredited residency. This requirement, along with tightened state regulations, uncertainty in future reimbursement, and a stronger emphasis on board certification, have raised questions concerning the state of the medical physics workforce and its ability to adapt to changing requirements. In 2012, ASTRO conducted a workforce study of the comprehensive field of radiation oncology. This article reviews the findings of the medical physics section of the study, including age and gender distribution, educational background, workload, and primary work setting. We also report on job satisfaction, the perceived supply and demand of medical physicists, and the medical physicists' main concerns pertaining to patient safety and quality assurance. PACS number: 87.90 PMID:26103483

  16. Intake of arsenic and mercury from fish and seafood in a Northern Italy community.

    PubMed

    Filippini, Tommaso; Malavolti, Marcella; Cilloni, Silvia; Wise, Lauren A; Violi, Federica; Malagoli, Carlotta; Vescovi, Luciano; Vinceti, Marco

    2018-06-01

    Regular consumption of fish is generally recommended by authorities because fish is an important source of essential nutrients. However, the presence of potentially toxic contaminants in fish has raised many concerns about the food's safety for human health. In the present study, we used a validated semi-quantitative food frequency questionnaire to assess the dietary habits of a representative sample of 719 individuals (319 males and 400 females) aged 18-87 years residing in Northern Italy. We estimated weekly dietary intakes of Arsenic (As) and Mercury (Hg), and we compared them with safety standards set by the European Food Safety Authority. In this population, fish was the main contributor to As and Hg intake. The highest levels of As were in sardine, sole/flounder and cephalopods, and of Hg in the biggest, predatory fish. About the other foods, cereals were the second contributor to the intake of these elements, especially rice for As and bread for Hg, and high levels of As and Hg were also found in mushrooms, coffee and wine. Average weekly intake of both contaminants was below recommended safety limits. Copyright © 2018 Elsevier Ltd. All rights reserved.

  17. Safety of ceftriaxone in paediatrics: a systematic review protocol.

    PubMed

    Zeng, Linan; Choonara, Imti; Zhang, Lingli; Xue, Song; Chen, Zhe; He, Miaomiao

    2017-08-21

    Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups. MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen. Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings. CRD42017055428. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. 47 CFR 101.203 - Communications concerning safety of life and property.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Communications concerning safety of life and... concerning safety of life and property. (a) Handling and transmission of messages concerning the safety of... person may knowingly cause to be transmitted any false or fraudulent message concerning the safety of...

  19. Indicators of club management practices and biological measurements of patrons' drug and alcohol use.

    PubMed

    Byrnes, Hilary F; Miller, Brenda A; Johnson, Mark B; Voas, Robert B

    2014-12-01

    Electronic music and dance events in nightclubs attract patrons with heavy alcohol/drug use. Public health concerns are raised from risks related to these behaviors. Practices associated with increased risk in these club settings need to be identified. The relationship between club management practices and biological measures of patrons' alcohol/drug use is examined. Observational data from 25 events across six urban clubs were integrated with survey data (N = 738 patrons, 42.8% female) from patrons exiting these events, 2010-2012. Five indicators of club management practices were examined using mixed model regressions: club security, bar crowding, safety signs, serving intoxicated patrons, and isolation. Analyses revealed that serving intoxicated patrons and safety signs were related to substance use. Specifically, serving intoxicated patrons was related to heavy alcohol and drug use at exit, while safety signs were marginally related to less exit drug use. CONCLUSIONS/IMPORTANCE: Findings indicate observable measures in nightclubs provide important indicators for alcohol/drug use, suggesting practices to target. Study strengths include the use of biological measures of substance use on a relatively large scale. Limitations and future directions are discussed.

  20. An update on anesthetics and impact on the brain.

    PubMed

    Fodale, Vincenzo; Tripodi, Vincenzo F; Penna, Olivia; Famà, Fausto; Squadrito, Francesco; Mondello, Epifanio; David, Antonio

    2017-09-01

    While anesthetics are indispensable clinical tools and generally considered safe and effective, a growing concern over the potential neurotoxicity of anesthesia or specific anesthetic agents has called into question the safety of general anesthetics, especially when administered at extremes of age. Areas covered: This article reviews and updates research findings on the safety of anesthesia and anesthetics in terms of long-term neurotoxicity, with particular focus on postoperative cognitive dysfunctions, Alzheimer's disease and dementias, developing brain, post-operative depression and autism spectrum disorder. Expert opinion: Exposure to general anesthetics is potentially harmful to the human brain, and the consequent long-term cognitive deficits should be classified as an iatrogenic pathology, and considered a public health problem. The fact that in laboratory and clinical research only certain anesthetic agents and techniques, but not others, appear to be involved, raises the problem on what is the safest and the least safe anesthetic to maximize anesthesia efficiency, avoid occurrence of adverse events, and ensure patient safety. New trends in research are moving toward the theory that neuroinflammation could be the hallmark of, or could have a pivotal role in, several neurological disorders.

  1. Opinion of the Scientific Committee on Consumer safety (SCCS) - Opinion on the safety of the use of Methylisothiazolinone (MI) (P94), in cosmetic products (sensitisation only).

    PubMed

    Giménez-Arnau, A M

    2016-04-01

    The information provided does not support the safe use of MI as a preservative in rinse-off cosmetic products up to a concentration limit of 100 ppm from the view of induction of contact allergy. For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the point of view of induction of contact allergy. The information provided does not support the safe use of MI as a preservative in leave-on hair cosmetic products up to a concentration limit of 100 ppm from the point of view of induction of contact allergy. The concerns and opinions raised in SCCS Opinion SCCS/1521/13 (12 December 2013 with revision 27 March 2014) remain. The results of the recent Scandinavian study do not support safety of MI in rinse-off products at either 100 ppm or at 50 ppm for elicitation or induction. Copyright © 2016. Published by Elsevier Inc.

  2. Evaluation of safety effect of turbo-roundabout lane dividers using floating car data and video observation.

    PubMed

    Kieć, Mariusz; Ambros, Jiří; Bąk, Radosław; Gogolín, Ondřej

    2018-06-01

    Roundabouts are one of the safest types of intersections. However, the needs to meet the requirements of operation, capacity, traffic organization and surrounding development lead to a variety of design solutions. One of such alternatives are turbo-roundabouts, which simplify drivers' decision making, limit lane changing in the roundabout, and induce low driving speed thanks to raised lane dividers. However, in spite of their generally positive reception, the safety impact of turbo-roundabouts has not been sufficiently studied. Given the low number of existing turbo-roundabouts and the statistical rarity of accident occurrence, the prevalent previously conducted studies applied only simple before-after designs or relied on traffic conflicts in micro-simulations. Nevertheless, the presence of raised lane dividers is acknowledged as an important feature of well performing and safe turbo-roundabouts. Following the previous Polish studies, the primary objective of the present study was assessment of influence of presence of lane dividers on road safety and developing a reliable and valid surrogate safety measure based on field data, which will circumvent the limitations of accident data or micro-simulations. The secondary objective was using the developed surrogate safety measure to assess and compare the safety levels of Polish turbo-roundabout samples with and without raised lane dividers. The surrogate safety measure was based on speed and lane behaviour. Speed was obtained from video observations and floating car data, which enabled the construction of representative speed profiles. Lane behaviour data was gathered from video observations. The collection of the data allowed for a relative validation of the method by comparing the safety performance of turbo-roundabouts with and without raised lane dividers. In the end, the surrogate measure was applied for evaluation of safety levels and enhancement of the existing safety performance functions, which combine traffic volumes, and speeds as a function of radii). The final models may help quantify the safety impact of different turbo-roundabout solutions. Copyright © 2018 Elsevier Ltd. All rights reserved.

  3. Trust, temporality and systems: how do patients understand patient safety in primary care? A qualitative study.

    PubMed

    Rhodes, Penny; Campbell, Stephen; Sanders, Caroline

    2016-04-01

    Patient safety research has tended to focus on hospital settings, although most clinical encounters occur in primary care, and to emphasize practitioner errors, rather than patients' own understandings of safety. To explore patients' understandings of safety in primary care. Qualitative interviews were conducted with patients recruited from general practices in northwest England. Participants were asked basic socio-demographic information; thereafter, topics were largely introduced by interviewees themselves. Transcripts were coded and analysed using NVivo10 (qualitative data software), following a process of constant comparison. Thirty-eight people (14 men, 24 women) from 19 general practices in rural, small town and city locations were interviewed. Many of their concerns (about access, length of consultation, relationship continuity) have been discussed in terms of quality, but, in the interviews, were raised as matters of safety. Three broad themes were identified: (i) trust and psycho-social aspects of professional-patient relationships; (ii) choice, continuity, access, and the temporal underpinnings of safety; and (iii) organizational and systems-level tensions constraining safety. Conceptualizations of safety included common reliance on a bureaucratic framework of accreditation, accountability, procedural rules and regulation, but were also individual and context-dependent. For patients, safety is not just a property of systems, but personal and contingent and is realized in the interaction between doctor and patient. However, it is the systems approach that has dominated safety thinking, and patients' individualistic and relational conceptualizations are poorly accommodated within current service organization. © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  4. Practicality of Using a Tether for Electrodynamic Reboost of the International Space Station

    NASA Technical Reports Server (NTRS)

    Blumer, J. H.; Donahue, Benjamin B.; Bangham, Michal E.; Roth, A. (Technical Monitor)

    2001-01-01

    ElectroDynamic (ED) Tethers can generate continuous low thrust in a low Earth orbit. An induced current running through the length of the tether reacts with the geomagnetic field to produce thrust. The amount of thrust scales with tether lens!th and current. The International Space Station (ISS) requires periodic reboost to maintain an approximately circular orbit t above the Earth. The baseline reboost method is a traditional bi-propellant rocket thruster and tankage system which must to be refueled via Soyuz / Progress or other launch vehicle. The estimated propellant costs associated with keeping ISS in the designated orbit over a 10-year life have been extremely high. The ED Tether would draw energy from the renewable ISS Solar Array electrical power system. Propulsion requirements for ISS vary depending on solar wind and other conditions. It is projected that a ED Tether could provide the majority of the required reboost thrust for ISS for a nominal solar year. For above nominal solar wind years the ISS would have to use the rocket reboost system, but at a greatly reduced level. Thus resulting in substantial cost savings, via the reduction in the number of Earth-to-orbit launch vehicle flights to the ISS that must bring reboost propellant. However, the purposes of this paper is to further Previous research on an ISS ED Tether and examine the operational and technical issues working against using a ED Tether on ISS. Issues such as Shuttle rendezvous and flight path concerns raise serious safety concerns and restrictions on tether use. Tether issues such as tether librations and off angle thrust raise concerns about impacts to microgravity payloads and the long-term effect on ISS orbital path and inclination. Operational issues such as peak power available to an ED Tether and allowable duty cycle may impose severe restrictions on tether design and ultimately limit the practicality of an ED Tether on ISS. Thus while at first glance the cost numbers appear to be strongly in favor of an ED Tether the limitations imposed by safety, operations and technical concerns may severely undermine the economic model. Possible Solutions to these problems have been investigated and proposed, however some items like off angle thrust are still being actively investigated for an adequate solution.

  5. 76 FR 71081 - Public Aircraft Oversight Safety Forum

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... NATIONAL TRANSPORTATION SAFETY BOARD Public Aircraft Oversight Safety Forum The National Transportation Safety Board (NTSB) will convene a Public Aircraft Oversight Safety Forum which will begin at 9 a... ``Public Aircraft Oversight Forum: Ensuring Safety for Critical Missions'', are to (1) raise awareness of...

  6. Other Safety Concerns and Self-Neglect

    MedlinePlus

    ... Program Application Frequently Asked Questions DONATE Other Safety Concerns and Self-Neglect Other safety concerns focus on ... for additional information. When To Report Other Safety Concerns and Self-Neglect? If you witness a life- ...

  7. Big pharma and health care: unsolvable conflict of interests between private enterprise and public health.

    PubMed

    Brezis, Mayer

    2008-01-01

    A landmark paper on Game Theory showed that individual maximization of profit necessarily endangers the public good, and since the problem has no technical solution, "it requires a fundamental extension in morality" (1). We propose here that public health, as a public good, now emerges as a grave example of this problem. Recent events and reports increasingly suggest misalignment between the interests of the pharmaceutical industry and those of public health. Johnson & Johnson illegally and effectively promoted Propulsid off-label for children despite internal company documents raising safety concerns. Death in drug trial has been described as a "trade secret." On Vioxx, Topol wrote: "Sadly, it is clear that Merck's commercial interest exceeded its concern about the drug's toxicity" (2). More and more concerns are raised by scholars and major journal editors about the type and the quality of published evidence, often biased towards efficacy of new products. The industry, funding over 80% of trials, sets up a research agenda guided more by marketing than by clinical considerations. Smart statistical and epidemiological tactics help obtain the desired results. Budget for marketing is by far greater than for research. Massive advertising to physicians and to the public gets increasingly sophisticated: ghost writing, professional guidelines, targeting of consumer groups and manipulating media for disease mongering. Pervasive lobbying and political ties limit the independence of regulatory bodies. Obligation to shareholders overriding public health considerations is not unique to the pharmaceutical industry. The chemical, tobacco and food industries share similar tactics: proclaiming doubts about safety issues, buying researchers, infiltrating universities, boards, media and legislative agencies. By contrast, powerful and cheap health promoting activities, poorly supported by industry because they are too cheap and not patented, are markedly underutilized: technologies for changing behavior (e.g., cardiac rehabilitation), palliative care and use of old, effective and safe drugs - all could benefit from industry's tools of marketing and quality. As those most affected are the sick, the poor and the least educated, free market successes appear to pose unsolvable challenges to social justice in public health.

  8. Investigative bronchoprovocation and bronchoscopy in airway diseases.

    PubMed

    Busse, William W; Wanner, Adam; Adams, Kenneth; Reynolds, Herbert Y; Castro, Mario; Chowdhury, Badrul; Kraft, Monica; Levine, Robert J; Peters, Stephen P; Sullivan, Eugene J

    2005-10-01

    Basic and clinical research strategies used for many lung diseases have depended on volunteer subjects undergoing bronchoscopy to establish access to the airways to collect biological specimens and tissue, perhaps with added bronchoprovocation in asthma syndromes. These procedures have yielded a wealth of important scientific information. Since the last critical review more than a decade ago, some of the techniques and applications have changed, and untoward events have occurred, raising safety concerns and increasing institutional review scrutiny. To reappraise these investigational methods in the context of current knowledge, the National Heart, Lung, and Blood Institute and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health convened a working group to review these procedures used for airway disease research, emphasizing asthma and chronic obstructive pulmonary disease. The group reaffirmed the scientific importance of investigative bronchoscopy and bronchoprovocation, even as less invasive technologies evolve. The group also considered the safety of bronchoscopy and bronchoprovocation with methacholine and antigen to be acceptable for volunteer subjects and patients, but stressed the need to monitor this closely and to emphasize proper training of participating medical research personnel. Issues were raised about vulnerable volunteers, especially children who need surrogates for informed consent. This review of investigative bronchoscopy and bronchoprovocation could serve as the basis for future guidelines for the use of these procedures in the United States.

  9. Message design strategies to raise public awareness of social determinants of health and population health disparities.

    PubMed

    Niederdeppe, Jeff; Bu, Q Lisa; Borah, Porismita; Kindig, David A; Robert, Stephanie A

    2008-09-01

    Raising public awareness of the importance of social determinants of health (SDH) and health disparities presents formidable communication challenges. This article reviews three message strategies that could be used to raise awareness of SDH and health disparities: message framing, narratives, and visual imagery. Although few studies have directly tested message strategies for raising awareness of SDH and health disparities, the accumulated evidence from other domains suggests that population health advocates should frame messages to acknowledge a role for individual decisions about behavior but emphasize SDH. These messages might use narratives to provide examples of individuals facing structural barriers (unsafe working conditions, neighborhood safety concerns, lack of civic opportunities) in efforts to avoid poverty, unemployment, racial discrimination, and other social determinants. Evocative visual images that invite generalizations, suggest causal interpretations, highlight contrasts, and create analogies could accompany these narratives. These narratives and images should not distract attention from SDH and population health disparities, activate negative stereotypes, or provoke counterproductive emotional responses directed at the source of the message. The field of communication science offers valuable insights into ways that population health advocates and researchers might develop better messages to shape public opinion and debate about the social conditions that shape the health and well-being of populations. The time has arrived to begin thinking systematically about issues in communicating about SDH and health disparities. This article offers a broad framework for these efforts and concludes with an agenda for future research to refine message strategies to raise awareness of SDH and health disparities.

  10. Message Design Strategies to Raise Public Awareness of Social Determinants of Health and Population Health Disparities

    PubMed Central

    Niederdeppe, Jeff; Bu, Q Lisa; Borah, Porismita; Kindig, David A; Robert, Stephanie A

    2008-01-01

    Context Raising public awareness of the importance of social determinants of health (SDH) and health disparities presents formidable communication challenges. Methods This article reviews three message strategies that could be used to raise awareness of SDH and health disparities: message framing, narratives, and visual imagery. Findings Although few studies have directly tested message strategies for raising awareness of SDH and health disparities, the accumulated evidence from other domains suggests that population health advocates should frame messages to acknowledge a role for individual decisions about behavior but emphasize SDH. These messages might use narratives to provide examples of individuals facing structural barriers (unsafe working conditions, neighborhood safety concerns, lack of civic opportunities) in efforts to avoid poverty, unemployment, racial discrimination, and other social determinants. Evocative visual images that invite generalizations, suggest causal interpretations, highlight contrasts, and create analogies could accompany these narratives. These narratives and images should not distract attention from SDH and population health disparities, activate negative stereotypes, or provoke counterproductive emotional responses directed at the source of the message. Conclusions The field of communication science offers valuable insights into ways that population health advocates and researchers might develop better messages to shape public opinion and debate about the social conditions that shape the health and well-being of populations. The time has arrived to begin thinking systematically about issues in communicating about SDH and health disparities. This article offers a broad framework for these efforts and concludes with an agenda for future research to refine message strategies to raise awareness of SDH and health disparities. PMID:18798887

  11. Parvovirus transmission by blood products - a cause for concern?

    PubMed

    Norja, Päivi; Lassila, Riitta; Makris, Mike

    2012-11-01

    The introduction of dual viral inactivation of clotting factor concentrates has practically eliminated infections by viruses associated with significant pathogenicity over the last 20 years. Despite this, theoretical concerns about transmission of infection have remained, as it is known that currently available viral inactivation methods are unable to eliminate parvovirus B19 or prions from these products. Recently, concern has been raised following the identification of the new parvoviruses, human parvovirus 4 (PARV4) and new genotypes of parvovirus B19, in blood products. Parvoviruses do not cause chronic pathogenicity similar to human immunodeficiency virus or hepatitis C virus, but nevertheless may cause clinical manifestations, especially in immunosuppressed patients. Manufacturers should institute measures, such as minipool polymerase chain reaction testing, to ensure that their products contain no known viruses. So far, human bocavirus, another new genus of parvovirus, has not been detected in fractionated blood products, and unless their presence can be demonstrated, routine testing during manufacture is not essential. Continued surveillance of the patients and of the safety of blood products remains an important ongoing issue. © 2012 Blackwell Publishing Ltd.

  12. Development of E-Learning Materials for Machining Safety Education

    NASA Astrophysics Data System (ADS)

    Nakazawa, Tsuyoshi; Mita, Sumiyoshi; Matsubara, Masaaki; Takashima, Takeo; Tanaka, Koichi; Izawa, Satoru; Kawamura, Takashi

    We developed two e-learning materials for Manufacturing Practice safety education: movie learning materials and hazard-detection learning materials. Using these video and sound media, students can learn how to operate machines safely with movie learning materials, which raise the effectiveness of preparation and review for manufacturing practice. Using these materials, students can realize safety operation well. Students can apply knowledge learned in lectures to the detection of hazards and use study methods for hazard detection during machine operation using the hazard-detection learning materials. Particularly, the hazard-detection learning materials raise students‧ safety consciousness and increase students‧ comprehension of knowledge from lectures and comprehension of operations during Manufacturing Practice.

  13. Improving Employees' Safety Awareness in Healthcare Organizations Using the DMAIC Quality Improvement Approach.

    PubMed

    Momani, Amer; Hirzallah, Muʼath; Mumani, Ahmad

    Occupational injuries and illnesses in healthcare can cause great human suffering, incur high cost, and have an adverse impact on the quality of patient care. One of the most effective solutions for addressing health and safety issues and improving decisions at the point of care rests in raising employees' safety awareness to recognize, avoid, or respond to potential problems before they arise. In this article, the DMAIC Six Sigma model (Define, Measure, Analyze, Improve, Control) is used as a systematic program to measure, improve, and sustain employees' safety awareness in healthcare organizations. We report on a case study using the model, which was implemented and validated at a local hospital. First, the occupational health and safety knowledge that each job requires was identified. Next, the degree of competence of jobholders to meet these requirements was assessed. Based on the assessment, different awareness-raising efforts were proposed and implemented. The results showed significant improvement in the overall safety awareness compliance assessed: from 74.2% to 84.4% (p < .001) after the intervention. The proposed model ensures that the organization's awareness-raising efforts serve its actual needs and produce optimized and sustained results that eventually lead to safer healthcare service.

  14. When Whistle-blowers Become the Story: The Problem of the 'Third Victim': Comment on "Cultures of Silence and Cultures of Voice: The Role of Whistleblowing in Healthcare Organisations".

    PubMed

    Waring, Justin

    2015-11-01

    In the healthcare context, whistleblowing has come to the fore of political, professional and public attention in the wake of major service scandals and mounting evidence of the routine threats to safety that patients face in their care. This paper offers a commentary and wider contextualisation of Mannion and Davies, 'Cultures of silence and cultures of voice: the role of whistleblowing in healthcare organisations.' It argues that closer attention is needed to the way in which whistle-blowers can become the focus and victim of raising concerns and speaking up. © 2016 by Kerman University of Medical Sciences.

  15. Hydroxyeyhyl starch: Controversies revisited

    PubMed Central

    Datta, Rashmi; Nair, Rajeev; Pandey, Anil; Kumar, Nitish; Sahoo, Tapan

    2014-01-01

    Hydroxyethyl starch (HES) family has been one of the cornerstones in fluid management for over four decades. Recent evidence from clinical studies and meta-analyses has raised few concerns about the safety of these fluids, especially in certain subpopulations of patients. High-quality clinical trials and meta-analyses have emphasized nephrotoxic effects, increased risk of bleeding, and a trend toward higher mortality in these patients after the use of HES solutions. Scientific evidence was derived from international guidelines, aggregated research literature, and opinion-based evidence was obtained from surveys and other activities (e.g., internet postings). On critical analysis of the current data available, it can be summarized that further large scale trials are still indicated before HES can be discarded. PMID:25425769

  16. Radioactivity of the soil in Vojvodina (northern province of Serbia and Montenegro).

    PubMed

    Bikit, I; Slivka, J; Conkić, Lj; Krmar, M; Vesković, M; Zikić-Todorović, N; Varga, E; Curcić, S; Mrdja, D

    2005-01-01

    The widespread public belief that during the bombardment of Vojvodina (Yugoslavia) this region was contaminated by depleted uranium has recently raised public concern with respect to the potential contamination of agricultural products due to soil radioactivity. Based on the gamma-spectrometric analysis of 50 soil samples taken from the region of Vojvodina we concluded that there is no increase of radioactivity that could endanger the food production. Taking into account the transfer factors of 137Cs to plants, the measured activity concentrations of this isotope should not endanger the health safety of the produced food. No traces of depleted uranium have been found. The natural radioactivity levels are compared with the results form other countries.

  17. Balancing Ethical Pros and Cons of Stem Cell Derived Gametes.

    PubMed

    Segers, Seppe; Mertes, Heidi; de Wert, Guido; Dondorp, Wybo; Pennings, Guido

    2017-07-01

    In this review we aim to provide an overview of the most important ethical pros and cons of stem cell derived gametes (SCD-gametes), as a contribution to the debate about reproductive tissue engineering. Derivation of gametes from stem cells holds promising applications both for research and for clinical use in assisted reproduction. We explore the ethical issues connected to gametes derived from embryonic stem cells (both patient specific and non-patient specific) as well as those related to gametes derived from induced pluripotent stem cells. The technology of SCD-gametes raises moral concerns of how reproductive autonomy relates to issues of embryo destruction, safety, access, and applications beyond clinical infertility.

  18. The oral and craniofacial relevance of chemically modified RNA therapeutics.

    PubMed

    Elangovan, Satheesh; Kormann, Michael S D; Khorsand, Behnoush; Salem, Aliasger K

    2016-01-01

    Several tissue engineering strategies in the form of protein therapy, gene therapy, cell therapy, and their combinations are currently being explored for oral and craniofacial regeneration and repair. Though each of these approaches has advantages, they all have common inherent drawbacks of being expensive and raising safety concerns. Using RNA (encoding therapeutic protein) has several advantages that have the potential to overcome these limitations. Chemically modifying the RNA improves its stability and mitigates immunogenicity allowing for the potential of RNA to become an alternative to protein and gene based therapies. This brief review article focuses on the potential of RNA therapeutics in the treatment of disorders in the oral and craniofacial regions.

  19. Inactivation of Zika virus in human breast milk by prolonged storage or pasteurization.

    PubMed

    Pfaender, Stephanie; Vielle, Nathalie J; Ebert, Nadine; Steinmann, Eike; Alves, Marco P; Thiel, Volker

    2017-01-15

    Zika virus infection during pregnancy poses a serious risk for pregnant women as it can cause severe birth defects. Even though the virus is mainly transmitted via mosquitos, human-to-human transmission has been described. Infectious viral particles have been detected in breast milk of infected women which raised concerns regarding the safety of breastfeeding in areas of Zika virus transmission or in case of a suspected or confirmed Zika virus infection. In this study, we show that Zika virus is effectively inactivated in human breast milk after prolonged storage or upon pasteurization of milk. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  20. The Oral and Craniofacial Relevance of Chemically Modified RNA Therapeutics

    PubMed Central

    Kormann, Michael S.D.; Khorsand, Behnoush

    2016-01-01

    Several tissue engineering strategies in the form of protein therapy, gene therapy, cell therapy and its combinations are currently being explored for oral and cranio-facial regeneration and repair. Though each of these approaches has advantages, they all have common inherent drawbacks of being expensive and raising safety concerns. Using RNA (encoding therapeutic protein) has several advantages that have the potential to overcome these limitations. Chemically modifying the RNA improves its stability and mitigates immunogenicity allowing for the potential of RNA to become an alternative to protein and gene based therapies. This brief review article focuses on the potential of RNA therapeutics in the treatment of disorders in the oral and craniofacial regions. PMID:26896600

  1. Low birth weight: Is it related to assisted reproductive technology or underlying infertility?

    PubMed Central

    Kondapalli, Laxmi A.; Perales-Puchalt, Alfredo

    2013-01-01

    Since 1978, we have witnessed a successful evolution of assisted reproductive technology (ART), with improvement of the pregnancy rates and a growing demand. However, in recent years, there has been increasing concern regarding its safety due to the potential health impact on its infants. The raise of the developmental origins of adult disease has positioned low birth weight (LBW) as a significant health issue. Despite multiple studies have associated ART with LBW, the etiology of this association remains largely unknown. This paper reviews the potential association between different components of ART and infertility with LBW, while acknowledging the limitations to interpretation of the existing literature. PMID:23375144

  2. Dyspnoea after antiplatelet agents: the AZD6140 controversy.

    PubMed

    Serebruany, V L; Stebbing, J; Atar, D

    2007-03-01

    Recent randomised studies suggest that experimental oral reversible platelet P2Y12 receptor inhibitor, AZD6140, causes dyspnoea. This also raises similar concerns about the parent compound, and another adenosine triphosphate (ATP) analogue (AR-69931MX or cangrelor), which is currently in Phase 3 trial in patients undergoing coronary interventions. We analysed package inserts, and available clinical trials safety data for antiplatelet agents with regard to the incidence of dyspnoea. We found that dyspnoea is a very rare complication of the presently approved platelet inhibitors, mostly caused by underlying disease, rather than antiplatelet therapy per se. The main reasons for respiratory distress after oral (AZD6140), and intravenous (cangrelor) agents may be the development of mild asymptomatic thrombotic thrombocytopenic purpura, fluid retention and dyspnoea because of the reversible nature of these drugs. Also, these agents are ATP analogues, which rapidly metabolise to adenosine, a well-known bronchoprovocator causing dyspnoea as well. In summary, dyspnoea is seldom considered, there are no treatment algorithms when it does occur, plausible mechanisms exist and despite these plausible mechanisms, the true cause of dyspnoea in these exposed individuals is unknown. Additional pulmonary function testing, immunological investigations and platelet receptor studies are urgently needed to determine the cause of dyspnoea after AZD6140, and to point out how such serious adverse reactions can be prevented, or at least minimised, raising potential concerns about this drug.

  3. On the effect of grain burnback on STS-SRM fragment velocity

    NASA Astrophysics Data System (ADS)

    Eck, Marshall B.; Mukunda, Meera

    Concerns raised during the Ulysses Final Safety Analysis Review (FSAR) process called the solid rocket motor (SRM) fragment velocity prediction model into question. The specific area of concern was that there was a section of the SRM casing which was exposed to SRM chamber pressure as the grain (fuel) was consumed. These questions centered on the velocity of fragments which originated from the field joint region given that failure occurred between 37 and 72 seconds mission elapsed time (MET). Two dimensional coupled Eulerian-Lagrangian calculations were performed to assess the hot gas flow field which resulted from SRM casing fragmentation. The fragment to gas interface-pressure time-history obtained from these analyses was reduced to a boundary condition algorithm which was applied to an explicit-time-integration, finite element, three dimensional shell model of the SRM casing and unburned fuel. The results of these calculations showed that the velocity of fragments originating in the field joint was adequately described by the range of velocities given in the Shuttle Data Book (1988). Based on these results, no further analyses were required, and approval was obtained from the Launch Abort Subpanel of the Interagency Nuclear Safety Review Panel to use the SRM fragment velocity environments presented in the Ulysses FSAR (1990).

  4. On the effect of grain burnback on STS-SRM fragment velocity

    NASA Astrophysics Data System (ADS)

    Eck, Marshall B.; Mukunda, Meera

    1991-01-01

    Concerns raised during the Ulysses Final Safety Analysis Review (FSAR) process called the solid rocket motor (SRM) fragment velocity prediction model into question. The specific area of concern was that there was a section of the SRM casing which was exposed to SRM chamber pressure as the grain (fuel) was consumed. These questions centered on the velocity of fragments which originated from the field joint region given that failure occurred between 37 and 72 seconds mission elapsed time (MET). Two dimensional coupled Eulerian-Lagrangian calculations were performed to assess the hot gas flow field which resulted from SRM casing fragmentation. The fragment to gas interface-pressure time-history obtained from these analyses was reduced to a boundary condition algorithm which was applied to an explicit-time-integration, finite element, three dimensional shell model of the SRM casing and unburned fuel. The results of these calculations showed that the velocity of fragments originating in the field joint was adequately described by the range of velocities given in the Shuttle Data Book (1988). Based on these results, no further analyses were required, and approval was obtained from the Launch Abort Subpanel of the Interagency Nuclear Safety Review Panel to use the SRM fragment velocity environments presented in the Ulysses FSAR (1990).

  5. Herbal medicines: challenges in the modern world. Part 4. Canada and United States.

    PubMed

    Job, Kathleen M; Kiang, Tony K L; Constance, Jonathan E; Sherwin, Catherine M T; Enioutina, Elena Yu

    2016-12-01

    Similar to other nations North American people used herbs for thousands of years to treat diseases and purify their spirits. By the middle of the 1900s, evidence-based conventional medicine received wide acceptance in Canada and the United States (US). Nowadays, people are going back to their roots and actively using herbal medicines (HMs) and natural health products (NHPs). Areas covered: This article is focusing on use and regulation of the HMs and NHPs in Canada and the US, raises concerns regarding HM and NHP safety and efficacy, offers suggestions on how to overcome these problems. Materials available from legislative and governmental websites, PubMed and news media were used. Expert commentary: Use of HMs, especially dietary supplements is widespread among adults in Canada and US. HMs and NHPs are regulated in both countries, but minimum criteria for product approval and post-market surveillance have been set. Concerns of quality, contamination, adulteration, and efficacy in are of central importance in the discussion of HMs and NHPs. Detailed product description and research are of vital importance to ensure safety and efficacy of these products. Additionally, 'herbal' education of healthcare providers and patients is needed to guarantee further successful integration of HM and conventional medicines.

  6. Strategy for the lowering and the assessment of exposure to nanoparticles at workspace - Case of study concerning the potential emission of nanoparticles of Lead in an epitaxy laboratory

    NASA Astrophysics Data System (ADS)

    Artous, Sébastien; Zimmermann, Eric; Douissard, Paul-Antoine; Locatelli, Dominique; Motellier, Sylvie; Derrough, Samir

    2015-05-01

    The implementation in many products of manufactured nanoparticles is growing fast and raises new questions. For this purpose, the CEA - NanoSafety Platform is developing various research topics for health and safety, environment and nanoparticles exposure in professional activities. The containment optimisation for the exposition lowering, then the exposure assessment to nanoparticles is a strategy for safety improvement at workplace and workspace. The lowering step consists in an optimisation of dynamic and static containment at workplace and/or workspace. Generally, the exposure risk due to the presence of nanoparticles substances does not allow modifying the parameters of containment at workplace and/or workspace. Therefore, gaseous or nanoparticulate tracers are used to evaluate performances of containment. Using a tracer allows to modify safely the parameters of the dynamic containment (ventilation, flow, speed) and to study several configurations of static containment. Moreover, a tracer allows simulating accidental or incidental situation. As a result, a safety procedure can be written more easily in order to manage this type of situation. The step of measurement and characterization of aerosols can therefore be used to assess the exposition at workplace and workspace. The case of study, aim of this paper, concerns the potential emission of Lead nanoparticles at the exhaust of a furnace in an epitaxy laboratory. The use of Helium tracer to evaluate the performance of containment is firstly studied. Secondly, the exposure assessment is characterised in accordance with the French guide “recommendations for characterizing potential emissions and exposure to aerosols released from nanomaterials in workplace operations”. Thirdly the aerosols are sampled, on several places, using collection membranes to try to detect traces of Lead in air.

  7. Safety assessment of personal care products/cosmetics and their ingredients.

    PubMed

    Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.

  8. Safety assessment of personal care products/cosmetics and their ingredients

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nohynek, Gerhard J., E-mail: gnohynec@rd.loreal.co; Antignac, Eric; Re, Thomas

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed,more » the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO{sub 2} and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.« less

  9. Vaccine hesitancy among healthcare workers in Europe: A qualitative study.

    PubMed

    Karafillakis, Emilie; Dinca, Irina; Apfel, Franklin; Cecconi, Sabrina; Wűrz, Andrea; Takacs, Judit; Suk, Jonathan; Celentano, Lucia Pastore; Kramarz, Piotr; Larson, Heidi J

    2016-09-22

    Healthcare workers (HCWs) are often referred to as the most trusted source of vaccine-related information for their patients. However, the evidence suggests that a number of HCWs are vaccine-hesitant. This study consists of 65 semi-structured interviews with vaccine providers in Croatia, France, Greece, and Romania to investigate concerns HCWs might have about vaccination. The results revealed that vaccine hesitancy is present in all four countries among vaccine providers. The most important concern across all countries was the fear of vaccine side effects. New vaccines were singled out due to perceived lack of testing for vaccine safety and efficacy. Furthermore, while high trust in health authorities was expressed by HCWs, there was also strong mistrust of pharmaceutical companies due to perceived financial interests and lack of communication about side effects. The notion that it is a doctor's responsibility to respond to hesitant patients was reported in all countries. Concerns were also seen to be country- and context-specific. Strategies to improve confidence in vaccines should be adapted to the specific political, social, cultural and economic context of countries. Furthermore, while most interventions focus on education and improving information about vaccine safety, effectiveness, or the need for vaccines, concerns raised in this study identify other determinants of hesitancy that need addressing. The representativeness of the views of the interviewed HCWs must be interpreted with caution. This a qualitative study with a small sample size that included geographical areas where vaccination uptake was lower or where hesitancy was more prevalent and it reflects individual participants' beliefs and attitudes toward the topic. As HCWs have the potential of influencing patient vaccination uptake, it is crucial to improve their confidence in vaccination and engage them in activities targeting vaccine hesitancy among their patients. Copyright © 2016. Published by Elsevier Ltd.

  10. Environmental development plan for transportation programs: FY80 update

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Saricks, C.L.; Singh, M.K.; Bernard, M.J. III

    1980-09-01

    This is the second annual update of the environmental development plan (EDP) for transportation programs. It has been prepared as a cooperative effort of the Assistant Secretaries for Conservation and Solar Energy (ASCS) Office of Transportation Programs (CS/TP) and the Environment (ASEV) Office of Environmental Assessments. EDPs identify the ecosystem, resource, physical environment, health, safety, socioeconomic, and environmental control concerns associated with DOE programs. The programs include the research, development, demonstration, and assessment (RDD and A) of 14 transportation technologies and several strategy implementation projects. This EDP update presents a research and assessment plan for resolving any potentially adverse environmentalmore » concerns arising from these programs. The EDP process provides a framework for: incorporating environmental concerns into CS/TP planning and decision processes early to ensure they are assigned the same importance as technological, fiscal, and institutional concerns in decision making; resolving environmental concerns concurrently with energy technology and strategy development; and providing a research schedule that mitigates adverse environmental effects through sound technological design or policy analysis. This EDP also describes the status of each environmental concern and the plan for its resolution. Much of ongoing DOE reseirch and technology development is aimed at resolving concerns identified in this EDP. Each EDP is intended to be so comprehensive that no concerns escape notice. Care is taken to include any CS/TP action that may eventually require an Environmental Impact Statement. Because technology demonstration and commercialization tend to raise more environmental concerns than other portions of the transportation program, most of this EDP addresses these concerns.« less

  11. New challenges in assuring vaccine quality.

    PubMed Central

    Dellepiane, N.; Griffiths, E.; Milstien, J. B.

    2000-01-01

    In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

  12. Safety evaluation of phytosterol esters. Part 8. Lack of genotoxicity and subchronic toxicity with phytosterol oxides.

    PubMed

    Lea, L J; Hepburn, P A; Wolfreys, A M; Baldrick, P

    2004-05-01

    Vegetable oil spreads containing phytosterol-esters are marketed as a cholesterol-lowering functional food in more than 20 countries worldwide. An extensive package of safety data has shown phytosterol-esters to be safe for human use. However, even though phytosterols are very stable molecules, oxidation may occur at low levels under extreme heating conditions, resulting in phytosterol oxides. As there is some suggestion of adverse biological effects in the literature for the related cholesterol oxidation products, safety data have been generated for phytosterol oxides. A phytosterol oxide concentrate (POC) was generated by prolonged heating of phytosterol-esters in the presence of oxygen. The genotoxicity and subchronic toxicity of this mixture was assessed in a series of in vitro genotoxicity assays (bacterial mutation, chromosome aberration and micronucleus) and a subchronic feeding study in the rat. Results showed that a phytosterol oxide concentrate containing approximately 30% phytosterol oxides did not possess genotoxic potential and no obvious evidence of toxicity when administered in the diet of the rat for 90 consecutive days. In the latter study, a NOEL was established at an estimated dietary level of phytosterol oxides of 128 mg/kg/day for males and 144 mg/kg/day for females. In conclusion, these materials have been shown to raise no obvious concerns for human safety.

  13. Comparative physicochemical evaluation of a marketed herbomineral formulation: naga bhasma.

    PubMed

    Garg, M; Das, S; Singh, G

    2012-11-01

    In the practice of Ayurveda, where herbomineral formulations are said to be made biocompatible through specific processes like Shodhana and Marana, the western medical science on the contrary has raised the safety concerns of these formulations in the recent past. In the present study, comparative physico-chemical analysis of Naga bhasma, a herbo-mineral preparation having a reputation of miraculous drug commonly used to treat several health disorders, was carried out using five marketed formulations through analytical methods like differential scanning calorimetry, X-ray difraction, thermogravimetric analysis, Fourier Transform infrared spectroscopy and also subjected for particle size analysis and estimation of trace and heavy metals to access the safety of these formulation. The results revealed variable observations regarding particle size, metal form and content of lead. The presence of free lead in five different formulations indicated towards the possible risk of severe side effects to the consumer. Present findings certainly put doubt over the safety of this formulation but at the same time, variation in the results with all five formulations also indicated that these formulations were not prepared as per the mentioned Ayurvedic text. Hence, enforcement of strict regulatory guidelines is strongly warranted before launching into the market. Further, a series of biological studies need to be conducted before taking any final verdict on the safety of this formulation.

  14. Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

    PubMed

    Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

    2018-04-01

    Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

  15. How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms.

    PubMed

    O'Hara, Jane Kathryn; Armitage, Gerry; Reynolds, Caroline; Coulson, Claire; Thorp, Liz; Din, Ikhlaq; Watt, Ian; Wright, John

    2017-01-01

    Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. Applications and toxicity of graphene family nanomaterials and their composites

    PubMed Central

    Singh, Zorawar

    2016-01-01

    Graphene has attracted much attention of scientific community due to its enormous potential in different fields, including medical sciences, agriculture, food safety, cancer research, and tissue engineering. The potential for widespread human exposure raises safety concerns about graphene and its derivatives, referred to as graphene family nanomaterials (GFNs). Due to their unique chemical and physical properties, graphene and its derivatives have found important places in their respective application fields, yet they are being found to have cytotoxic and genotoxic effects too. Since the discovery of graphene, a number of researches are being conducted to find out the toxic potential of GFNs to different cell and animal models, finding their suitability for being used in new and varied innovative fields. This paper presents a systematic review of the research done on GFNs and gives an insight into the mode and action of these nanosized moieties. The paper also emphasizes on the recent and up-to-date developments in research on GFNs and their nanocomposites for their toxic effects. PMID:27051278

  17. Energy Drinks: A Contemporary Issues Paper.

    PubMed

    Higgins, John P; Babu, Kavita; Deuster, Patricia A; Shearer, Jane

    2018-02-01

    Since their introduction in 1987, energy drinks have become increasingly popular and the energy drink market has grown at record pace into a multibillion-dollar global industry. Young people, students, office workers, athletes, weekend warriors, and service members frequently consume energy drinks. Both health care providers and consumers must recognize the difference between energy drinks, traditional beverages (e.g., coffee, tea, soft drinks/sodas, juices, or flavored water), and sports drinks. The research about energy drinks safety and efficacy is often contradictory, given the disparate protocols and types of products consumed: this makes it difficult to draw firm conclusions. Also, much of the available literature is industry-sponsored. After reports of adverse events associated with energy drink consumption, concerns including trouble sleeping, anxiety, cardiovascular events, seizures, and even death, have been raised about their safety. This article will focus on energy drinks, their ingredients, side effects associated with their consumption, and suggested recommendations, which call for education, regulatory actions, changes in marketing, and additional research.

  18. Regulatory guidelines for biosimilars in Malaysia.

    PubMed

    Abas, Arpah

    2011-09-01

    The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.

  19. Safe use of epidural corticosteroid injections: recommendations of the WIP Benelux workgroup.

    PubMed

    Van Boxem, Koen; Rijsdijk, Mienke; Hans, Guy; de Jong, Jasper; Kallewaard, Jan Willem; Vissers, Kris; van Kleef, Maarten; Rathmell, James P; Van Zundert, Jan

    2018-05-14

    Epidural corticosteroid injections are used frequently worldwide in the treatment of radicular pain. Concerns have risen involving rare major neurologic injuries after this treatment. Recommendations to prevent these complications have been published, but local implementation is not always feasible due to local circumstances and necessitating local recommendations based on literature review. A workgroup of 4 stakeholder pain societies in Belgium, The Netherlands and Luxembourg (Benelux) has reviewed the literature involving neurological complications after epidural corticosteroid injections and possible safety measures to prevent these major neurologic injuries. Twenty-six considerations and recommendations were selected by the workgroup. These involve the use of imaging, injection equipment particulate and non-particulate corticosteroids, epidural approach and maximal volume to be injected. Raising awareness about possible neurological complications and adoption of safety measures recommended by the work group aim at reducing the risks of these devastating events. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  20. Toxicological Implications of Released Particulate Matter during Thermal Decomposition of Nano-Enabled Thermoplastics

    PubMed Central

    Watson-Wright, Christa; Singh, Dilpreet; Demokritou, Philip

    2017-01-01

    Nano-enabled thermoplastics are part of the growing market of nano-enabled products (NEPs) that have vast utility in several industries and consumer goods. The use and disposal of NEPs at their end of life has raised concerns about the potential release of constituent engineered nanomaterials (ENMs) during thermal decomposition and their impact on environmental health and safety. To investigate this issue, industrially relevant nano-enabled thermoplastics including polyurethane, polycarbonate, and polypropylene containing carbon nanotubes (0.1 and 3% w/v, respectively), polyethylene containing nanoscale iron oxide (5% w/v), and ethylene vinyl acetate containing nanoscale titania (2 and 5% w/v) along with their pure thermoplastic matrices were thermally decomposed using the recently developed lab based Integrated Exposure Generation System (INEXS). The life cycle released particulate matter (called LCPM) was monitored using real time instrumentation, size fractionated, sampled, extracted and prepared for toxicological analysis using primary small airway epithelial cells to assess potential toxicological effects. Various cellular assays were used to assess reactive oxygen species and total glutathione as measurements of oxidative stress along with mitochondrial function, cellular viability, and DNA damage. By comparing toxicological profiles of LCPM released from polymer only (control) with nano-enabled LCPM, potential nanofiller effects due to the use of ENMs were determined. We observed associations between NEP properties such as the percent nanofiller loading, host matrix, and nanofiller chemical composition and the physico-chemical properties of released LCPM, which were linked to biological outcomes. More specifically, an increase in percent nanofiller loading promoted a toxicological response independent of increasing LCPM dose. Importantly, differences in host matrix and nanofiller composition were shown to enhance biological activity and toxicity of LCPM. This work highlights the importance of assessing the toxicological properties of LCPM and raises environmental health and safety concerns of nano-enabled products at their end of life during thermal decomposition/incineration. PMID:29333505

  1. Toxicological Implications of Released Particulate Matter during Thermal Decomposition of Nano-Enabled Thermoplastics.

    PubMed

    Watson-Wright, Christa; Singh, Dilpreet; Demokritou, Philip

    2017-01-01

    Nano-enabled thermoplastics are part of the growing market of nano-enabled products (NEPs) that have vast utility in several industries and consumer goods. The use and disposal of NEPs at their end of life has raised concerns about the potential release of constituent engineered nanomaterials (ENMs) during thermal decomposition and their impact on environmental health and safety. To investigate this issue, industrially relevant nano-enabled thermoplastics including polyurethane, polycarbonate, and polypropylene containing carbon nanotubes (0.1 and 3% w/v, respectively), polyethylene containing nanoscale iron oxide (5% w/v), and ethylene vinyl acetate containing nanoscale titania (2 and 5% w/v) along with their pure thermoplastic matrices were thermally decomposed using the recently developed lab based Integrated Exposure Generation System (INEXS). The life cycle released particulate matter (called LCPM) was monitored using real time instrumentation, size fractionated, sampled, extracted and prepared for toxicological analysis using primary small airway epithelial cells to assess potential toxicological effects. Various cellular assays were used to assess reactive oxygen species and total glutathione as measurements of oxidative stress along with mitochondrial function, cellular viability, and DNA damage. By comparing toxicological profiles of LCPM released from polymer only (control) with nano-enabled LCPM, potential nanofiller effects due to the use of ENMs were determined. We observed associations between NEP properties such as the percent nanofiller loading, host matrix, and nanofiller chemical composition and the physico-chemical properties of released LCPM, which were linked to biological outcomes. More specifically, an increase in percent nanofiller loading promoted a toxicological response independent of increasing LCPM dose. Importantly, differences in host matrix and nanofiller composition were shown to enhance biological activity and toxicity of LCPM. This work highlights the importance of assessing the toxicological properties of LCPM and raises environmental health and safety concerns of nano-enabled products at their end of life during thermal decomposition/incineration.

  2. The influence of health policy and market factors on the hospital safety net.

    PubMed

    Bazzoli, Gloria J; Lindrooth, Richard C; Kang, Ray; Hasnain-Wynia, Romana

    2006-08-01

    To examine how the financial pressures resulting from the Balanced Budget Act (BBA) of 1997 interacted with private sector pressures to affect indigent care provision. American Hospital Association Annual Survey, Area Resource File, InterStudy Health Maintenance Organization files, Current Population Survey, and Bureau of Primary Health Care data. We distinguished core and voluntary safety net hospitals in our analysis. Core safety net hospitals provide a large share of uncompensated care in their markets and have large indigent care patient mix. Voluntary safety net hospitals provide substantial indigent care but less so than core hospitals. We examined the effect of financial pressure in the initial year of the 1997 BBA on uncompensated care for three hospital groups. Data for 1996-2000 were analyzed using approaches that control for hospital and market heterogeneity. All urban U.S. general acute care hospitals with complete data for at least 2 years between 1996 and 2000, which totaled 1,693 institutions. Core safety net hospitals reduced their uncompensated care in response to Medicaid financial pressure. Voluntary safety net hospitals also responded in this way but only when faced with the combined forces of Medicaid and private sector payment pressures. Nonsafety net hospitals did not exhibit similar responses. Our results are consistent with theories of hospital behavior when institutions face reductions in payment. They raise concern given continuing state budget crises plus the focus of recent federal deficit reduction legislation intended to cut Medicaid expenditures.

  3. Community and occupational health concerns in pork production: a review.

    PubMed

    Donham, K J

    2010-04-01

    Public concerns relative to adverse consequences of large-scale livestock production have been increasingly voiced since the late 1960s. Numerous regional, national, and international conferences have been held on the subject since 1994. This paper provides a review of the literature on the community and occupational health concerns of large-scale livestock production with a focus on pork production. The industry has recognized the concerns of the public, and the national and state pork producer groups are including these issues as an important component of their research and policy priorities. One reason large-scale livestock production has raised concern is that a significant component of the industry has separated from traditional family farming and has developed like other industries in management, structure, and concentration. The magnitude of the problem cited by environmental groups has often been criticized by the pork production industry for lack of science-based evidence to document environmental concerns. In addition to general environmental concerns, occupational health of workers has become more relevant because many operations now are employing more than 10 employees, which brings many operations in the United States under the scrutiny of the US Occupational Safety and Health Administration. In this paper, the scientific literature is reviewed relative to the science basis of occupational and environmental impacts on community and worker health. Further, recommendations are made to help promote sustainability of the livestock industry within the context of maintaining good stewardship of our environmental and human capital.

  4. Survey of community pharmacists' perception of electronic cigarettes in London.

    PubMed

    Marques Gomes, Ana C N; Nabhani-Gebara, Shereen; Kayyali, Reem; Buonocore, Federico; Calabrese, Gianpiero

    2016-11-10

    To seek community pharmacists' perception on use, safety and possible effectiveness of e-cigarettes as quit smoking tools, and their future regulation. A survey of a sample of 154 community pharmacies across London, UK. E-cigarettes have exclusively established themselves in the market through consumers-led demand. To date, e-cigarettes still remain unregulated and can be easily purchased in shops, over the internet, but more controversially also in pharmacies in the UK. Pharmacists find themselves with a shortage of information on their safety and efficacy, and may experience an ethical dilemma when consulted by patients/customers. Response rate: 60% (n=92). Independent pharmacies accounted for 90% of the sample. The majority of participants (73%) sell e-cigarettes. A minority of participants (20%) have been presented with adverse effects such as cough and dry mouth. As possible reasons for their use, pharmacists ranked 'aid in stop smoking' as the most important (56%), with 'cheaper alternative' (43%) and 'social/recreational use' (31%) being the least important ones. Safety issues were raised as statements such as 'e-liquid in cartridges may be toxic' were agreed by 52% of respondents. The majority of pharmacists (97%) were supportive of e-cigarettes being regulated, expressing current concerns regarding excipients (42%) and nicotine content (34%). Participants indicated that they would require training in the form of information packs (88%), online tutorials (67%), continuous professional development (CPD) workshops (43%) to cover safety, counselling, dosage instructions, adverse effects and role in the smoking cessation care pathway in the future. Pharmacists expressed concerns about the safety of e-cigarettes, especially regarding the amounts of excipients and nicotine as these still remain unregulated. Currently, there are no guidelines for pharmacists regarding e-cigarettes. Community pharmacists look forward to regulations so to conduct their duties in a more confident and legislated fashion. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  5. Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy.

    PubMed

    Saran, Frank; Chinot, Olivier L; Henriksson, Roger; Mason, Warren; Wick, Wolfgang; Cloughesy, Timothy; Dhar, Sunita; Pozzi, Emanuela; Garcia, Josep; Nishikawa, Ryo

    2016-07-01

    The proposed use of bevacizumab with radiotherapy/temozolomide for newly diagnosed glioblastoma raised potential safety concerns. Bevacizumab has been linked with stroke, bleeding events, and wound-healing complications in other tumor types; these events are of particular concern for glioblastoma (highly vascular tumors that are usually resected). Published data on the interaction of bevacizumab with radiotherapy/temozolomide are also limited. We report safety data from a phase III randomized trial (Avastin in Glioblastoma), focusing on these considerations. Eligible patients received: radiotherapy and temozolomide plus bevacizumab/placebo, 6 cycles; a 4-week treatment break; temozolomide plus bevacizumab/placebo, 6 cycles; and bevacizumab/placebo until progression. Data on adverse events (AEs) were collected throughout. Bevacizumab-treated patients (n = 461) had a longer median safety follow-up time (12.3 vs 8.5 mo), and a higher proportion completed 6 cycles of maintenance temozolomide (64.6% vs 36.9%) versus placebo (n = 450). The incidences of relevant AEs (bevacizumab vs placebo, respectively) were: arterial thromboembolic events (5.9% vs 1.6%); cerebral hemorrhage (3.3% vs 2.0%); wound-healing complications (6.9% vs 4.7%); thrombocytopenia (34.1% vs 27.3%); radiotherapy-associated skin injury (8.2% vs 9.3%); alopecia (39.0% vs 36.0%); gastrointestinal perforation (including gastrointestinal abscesses and fistulae, 1.7% vs 0.4%); and radiotherapy-associated injury (0.4% vs 0.0%). Overall, 15.8% and 23.8% of bevacizumab- and placebo-treated patients had surgery (including biopsy) after progression. Within 30 days of postprogression surgery, AE incidence was 10.9% (bevacizumab) and 23.4% (placebo). The safety profile was consistent with that expected from radiotherapy/temozolomide plus bevacizumab. The increased AE incidence with bevacizumab did not impact patients' ability to receive standard-of-care treatment or to undergo further surgery. © The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Survey of community pharmacists' perception of electronic cigarettes in London

    PubMed Central

    Marques Gomes, Ana C N; Nabhani-Gebara, Shereen; Kayyali, Reem; Buonocore, Federico; Calabrese, Gianpiero

    2016-01-01

    Objectives To seek community pharmacists' perception on use, safety and possible effectiveness of e-cigarettes as quit smoking tools, and their future regulation. Setting A survey of a sample of 154 community pharmacies across London, UK. Context E-cigarettes have exclusively established themselves in the market through consumers-led demand. To date, e-cigarettes still remain unregulated and can be easily purchased in shops, over the internet, but more controversially also in pharmacies in the UK. Pharmacists find themselves with a shortage of information on their safety and efficacy, and may experience an ethical dilemma when consulted by patients/customers. Key findings Response rate: 60% (n=92). Independent pharmacies accounted for 90% of the sample. The majority of participants (73%) sell e-cigarettes. A minority of participants (20%) have been presented with adverse effects such as cough and dry mouth. As possible reasons for their use, pharmacists ranked ‘aid in stop smoking’ as the most important (56%), with ‘cheaper alternative’ (43%) and ‘social/recreational use’ (31%) being the least important ones. Safety issues were raised as statements such as ‘e-liquid in cartridges may be toxic’ were agreed by 52% of respondents. The majority of pharmacists (97%) were supportive of e-cigarettes being regulated, expressing current concerns regarding excipients (42%) and nicotine content (34%). Participants indicated that they would require training in the form of information packs (88%), online tutorials (67%), continuous professional development (CPD) workshops (43%) to cover safety, counselling, dosage instructions, adverse effects and role in the smoking cessation care pathway in the future. Conclusions Pharmacists expressed concerns about the safety of e-cigarettes, especially regarding the amounts of excipients and nicotine as these still remain unregulated. Currently, there are no guidelines for pharmacists regarding e-cigarettes. Community pharmacists look forward to regulations so to conduct their duties in a more confident and legislated fashion. PMID:28186947

  7. Parents' and primary healthcare practitioners' perspectives on the safety of honey and other traditional paediatric healthcare approaches.

    PubMed

    Kumar, Raekha; Lorenc, Ava; Robinson, Nicola; Blair, Mitch

    2011-09-01

    Traditional and complementary healthcare approaches (TCA) are widely used for children, often because of perceived safety. Honey is a traditional remedy for upper respiratory tract symptoms in infants. Health officials currently advise limiting honey use because of the risk of botulism. This paper discusses honey as a traditional healthcare approach for children in a multi-ethnic community, and parents' and primary healthcare practitioners' (PHPs) perceptions of its safety. As part of a larger study exploring beliefs about TCA, this paper focuses on perceived safety and use of honey, using data extracted for detailed analysis. Eleven parent focus groups (n= 92) and 30 interviews with PHPs were conducted. Qualitative data analysis used the Framework approach. London Boroughs of Brent and Harrow TCA, particularly home remedies, dietary and religious approaches were popular for children. Honey was a particularly common TCA, reportedly used by 27 (29%) parents for their children. Honey was believed to be traditional, acceptable, accessible, natural and safe. It was most commonly used for respiratory tract symptoms and administered with hot water and lemon juice. PHPs were more concerned about the safety of TCA than parents. Almost half (40%) of PHPs mentioned the use of honey for children, few perceived it as a 'treatment' or were concerned about botulism. Others were aware of the risks and some reported challenges in communicating risk to parents. TCA are commonly used for children, honey in particular for respiratory tract symptoms. Parents and some PHPs appear unaware of the risk of botulism from honey use in infants. Healthcare practitioners should ask routinely about the use of honey and other TCA, and consider different parental belief systems in ethnically diverse populations. Further research is required on the use and efficacy of honey for infants, to raise awareness of its benefits and risks. © 2010 Blackwell Publishing Ltd.

  8. United Kingdom General Medical Council fails child protection.

    PubMed

    Williams, Catherine

    2007-04-01

    To protect children, pediatricians must be willing to raise the possibility of abuse and not be intimidated by the consequences. We consider that the United Kingdom General Medical Council does not understand child protection matters and has no system for dealing adequately with complaints submitted by parents who claim false allegations of abuse. The actions of the General Medical Council in the recent cases of Drs Roy Meadow and David Southall conflict with current child protection laws and guidance for professionals. By deterring doctors from raising concerns about a child's safety and giving opinions on child deaths, the General Medical Council may be increasing the risk of serious child abuse. Although the rate of registrations by child protection authorities decreased by 28% between 1995 and 2005 (ie, there are fewer multiagency child protection plans), the number of criminal convictions for cruelty to or neglect of a child increased by 247% between 1998 and 2005. It is unacceptable that to date the General Medical Council has refused training in child protection offered by the Royal College of Paediatrics and Child Health.

  9. Beyond the Schoolyard: The Contributions of Parenting Logics, Financial Resources, and Social Institutions to the Social Class Gap in Structured Activity Participation.

    PubMed

    Bennett, Pamela R; Lutz, Amy; Jayaram, Lakshmi

    2012-01-01

    We investigate cultural and structural sources of class differences in youth activity participation with interview, survey, and archival data. We find working- and middle-class parents overlap in parenting logics about participation, though differ in one respect: middle-class parents are concerned with customizing children's involvement in activities, while working-class parents are concerned with achieving safety and social mobility for children through participation. Second, because of financial constraints, working-class families rely on social institutions for participation opportunities, but few are available. Schools act as an equalizing institution by offering low-cost activities, allowing working-class children to resemble middle-class youth in school activities, but they remain disadvantaged in out-of-school activities. School influences are complex, however, as they also contribute to class differences by offering different activities to working- and middle-class youth. Findings raise questions about the extent to which differences in participation reflect class culture rather than the objective realities parents face.

  10. Beyond the Schoolyard: The Contributions of Parenting Logics, Financial Resources, and Social Institutions to the Social Class Gap in Structured Activity Participation

    PubMed Central

    Bennett, Pamela R.; Lutz, Amy; Jayaram, Lakshmi

    2014-01-01

    We investigate cultural and structural sources of class differences in youth activity participation with interview, survey, and archival data. We find working- and middle-class parents overlap in parenting logics about participation, though differ in one respect: middle-class parents are concerned with customizing children’s involvement in activities, while working-class parents are concerned with achieving safety and social mobility for children through participation. Second, because of financial constraints, working-class families rely on social institutions for participation opportunities, but few are available. Schools act as an equalizing institution by offering low-cost activities, allowing working-class children to resemble middle-class youth in school activities, but they remain disadvantaged in out-of-school activities. School influences are complex, however, as they also contribute to class differences by offering different activities to working- and middle-class youth. Findings raise questions about the extent to which differences in participation reflect class culture rather than the objective realities parents face. PMID:25328250

  11. Preconception sex selection for non-medical and intermediate reasons: ethical reflections.

    PubMed

    de Wert, G; Dondorp, W

    2010-01-01

    Sex selection for non-medical reasons is forbidden in many countries. Focusing on preconception sex selection, the authors first observe that it is unclear what should count as a 'medical reason' in this context and argue for the existence of 'intermediate reasons' that do not fit well within the rigid distinction between 'medical'and 'non-medical'. The article further provides a critical review of the arguments for the prohibition of sex selection for non-medical reasons and finds that none of these are conclusive. The authors conclude that the ban should be reconsidered, but also that existing-- societal concerns about possible harmful effects should be taken seriously. Measures to this effect may include limiting the practice to couples who already have at least one child of the sex opposite to that which they now want to select ('family balancing'). Finally, a difficult set of questions is raised by concerns about the reliability and unproven (long-term) safety of the only technology (flow cytometry) proven to work.

  12. Enclomiphene Citrate for the Treatment of Secondary Male Hypogonadism

    PubMed Central

    Rodriguez, Katherine M.; Pastuszak, Alexander W.; Lipshultz, Larry I.

    2016-01-01

    Introduction Hypogonadism is a growing concern in an aging male population. Historically treated using exogenous testosterone, concerns about possible adverse effects of testosterone have led physicians to seek alternative treatment approaches. Areas Covered Enclomiphene citrate is the trans isomer of clomiphene citrate, a non-steroidal estrogen receptor antagonist that is FDA-approved for the treatment of ovarian dysfunction in women. Clomiphene citrate has also been used off-label for many years to treat secondary male hypogonadism, particularly in the setting of male infertility. Here we review the literature examining the efficacy and safety of enclomiphene citrate in the setting of androgen deficiency. Expert Opinion Initial results support the conclusion that enclomiphene citrate increases serum testosterone levels by raising luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels, without negatively impacting semen parameters. The ability to treat testosterone deficiency in men while maintaining fertility supports a role for enclomiphene citrate in the treatment of men in whom testosterone therapy is not a suitable option. PMID:27337642

  13. Biotechnology entrepreneurship and ethics: principles, paradigms, and products.

    PubMed

    Kuszler, Patricia C

    2006-09-01

    Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug or technology, ethical questions arise with respect to protecting human subjects and society from danger and exploitation by researchers. As development gives way to marketing and dissemination of a new product, government regulators are pressed to get drugs and biologics through the regulatory pipeline into the market faster, walking an ethical tightrope between speed and safety. As new biotechnology products enter the market place, doctors and patients traverse yet another tightrope, that between unknown risk and the promise of benefit. And finally, patent protection is increasingly viewed as a unethical culprit in keeping prices high and depriving the global poor from lifesaving drugs and biologics. Bioethics has, to date, been largely a creation of Western research and medicine. As such it is wholly inadequate to respond to the cascade of ethical issues that flow from a vibrant biotechnology industry. And if biotechnology is in its infancy, as most believe, it is crucial that scientists, entrepreneurs and governments engage in dialogue about the ethical and societal questions raised on the road of scientific progress.

  14. Wind tunnel test of Teledyne Geotech model 1564B cup anemometer

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Parker, M.J.; Addis, R.P.

    1991-04-04

    The Department of Energy (DOE) Environment, Safety and Health Compliance Assessment (Tiger Team) of the Savannah River Site (SRS) questioned the method by which wind speed sensors (cup anemometers) are calibrated by the Environmental Technology Section (ETS). The Tiger Team member was concerned that calibration data was generated by running the wind tunnel to only 26 miles per hour (mph) when speeds exceeding 50 mph are readily obtainable. A wind tunnel experiment was conducted and confirmed the validity of the practice. Wind speeds common to SRS (6 mph) were predicted more accurately by 0--25 mph regression equations than 0--50 mphmore » regression equations. Higher wind speeds were slightly overpredicted by the 0--25 mph regression equations when compared to 0--50 mph regression equations. However, the greater benefit of more accurate lower wind speed predictions accuracy outweight the benefit of slightly better high (extreme) wind speed predictions. Therefore, it is concluded that 0--25 mph regression equations should continue to be utilized by ETS at SRS. During the Department of Energy Tiger Team audit, concerns were raised about the calibration of SRS cup anemometers. Wind speed is measured by ETS with Teledyne Geotech model 1564B cup anemometers, which are calibrated in the ETS wind tunnel. Linear regression lines are fitted to data points of tunnel speed versus anemometer output voltages up to 25 mph. The regression coefficients are then implemented into the data acquisition computer software when an instrument is installed in the field. The concern raised was that since the wind tunnel at SRS is able to generate a maximum wind speed higher than 25 mph, errors may be introduced in not using the full range of the wind tunnel.« less

  15. Wind tunnel test of Teledyne Geotech model 1564B cup anemometer

    NASA Astrophysics Data System (ADS)

    Parker, M. J.; Addis, R. P.

    1991-04-01

    The Department of Energy (DOE) Environment, Safety, and Health Compliance Assessment (Tiger Team) of the Savannah River Site (SRS) questioned the method by which wind speed sensors (cup anemometers) are calibrated by the Environmental Technology Section (ETS). The Tiger Team member was concerned that calibration data was generated by running the wind tunnel to only 26 miles per hour (mph) when speeds exceeding 50 mph are readily obtainable. A wind tunnel experiment was conducted and confirmed the validity of the practice. Wind speeds common to SRS (6 mph) were predicted more accurately by 0-25 mph regression equations than 0-50 mph regression equations. Higher wind speeds were slightly overpredicted by the 0-25 mph regression equations when compared to 0-50 mph regression equations. However, the greater benefit of more accurate lower wind speed predictions accuracy outweigh the benefit of slightly better high (extreme) wind speed predictions. Therefore, it is concluded that 0-25 mph regression equations should continue to be utilized by ETS at SRS. During the Department of Energy Tiger Team audit, concerns were raised about the calibration of SRS cup anemometers. Wind speed is measured by ETS with Teledyne Geotech model 1564B cup anemometers, which are calibrated in the ETS wind tunnel. Linear regression lines are fitted to data points of tunnel speed versus anemometer output voltages up to 25 mph. The regression coefficients are then implemented into the data acquisition computer software when an instrument is installed in the field. The concern raised was that since the wind tunnel at SRS is able to generate a maximum wind speed higher than 25 mph, errors may be introduced in not using the full range of the wind tunnel.

  16. Exposure assessment of workers in printed electronics workplace.

    PubMed

    Lee, Ji Hyun; Sohn, Eun Kyung; Ahn, Jin Soo; Ahn, Kangho; Kim, Keun Soo; Lee, Jong Hwan; Lee, Taik Min; Yu, Il Je

    2013-07-01

    Printed electronics uses converging technologies, such as printing, fine mechanics, nanotechnology, electronics and other new technologies. Consequently, printed electronics raises additional health and safety concerns to those experienced in the traditional printing industry. This study investigated two printed electronics workplaces based on a walk-through survey and personal and area sampling. All the printed electronics operations were conducted in a cleanroom. No indication of exposure to excess silver nanoparticles or carbon nanotubes (CNTs) was found. While the organic solvents were lower than current occupational exposure limits, there was a lack of engineering controls, such as local exhaust ventilation, correct enclosure and duct connections. There was also an insufficient quantity of personal protective equipment, and some organic solvents not described in the safety data sheets (SDSs) were detected in the air samples. Plus, the cleaning work, a major emissions operation, was not conducted within a hood, and the cleaning waste was not properly disposed of. Therefore, the present exposure assessment results from two printed electronics workplaces suggest that the printed electronics industry needs to take note of the occupational safety and health risks and hazards already established by the traditional printing industry, along with new risks and hazards originating from converging technologies such as nanotechnology.

  17. Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

    PubMed

    Chrischilles, Elizabeth A; Gagne, Joshua J; Fireman, Bruce; Nelson, Jennifer; Toh, Sengwee; Shoaibi, Azadeh; Reichman, Marsha E; Wang, Shirley; Nguyen, Michael; Zhang, Rongmei; Izem, Rima; Goulding, Margie R; Southworth, Mary Ross; Graham, David J; Fuller, Candace; Katcoff, Hannah; Woodworth, Tiffany; Rogers, Catherine; Saliga, Ryan; Lin, Nancy D; McMahill-Walraven, Cheryl N; Nair, Vinit P; Haynes, Kevin; Carnahan, Ryan M

    2018-03-01

    The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age: <66 HR = 0.88 (0.60, 1.30) and 66+ HR = 1.49 (1.30, 1.71). This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety. Copyright © 2018 John Wiley & Sons, Ltd.

  18. Pharmacokinetics, efficacy and safety of glyburide for treatment of gestational diabetes mellitus.

    PubMed

    Malek, Rana; Davis, Stephen N

    2016-06-01

    Gestational diabetes mellitus (GDM) complicates 10% of all pregnancies and is defined as hyperglycemia first noted during pregnancy. Rates of GDM are rising and untreated GDM results in complications for both mother and fetus. GDM is often managed by diet and exercise but 30-40% of women will require pharmacological intervention. Insulin has traditionally been the treatment of choice but since 2007, glyburide, a second generation sulfonylurea has become the most prescribed medication for GDM. This review will cover the pharmacokinetics, efficacy, and safety of glyburide for the management of GDM. Management of GDM is challenging secondary to the stringent glycemic goals that mimic the lower glucose levels in pregnancy. Glyburide is generally effective in treating hyperglycemia. However, several studies have raised safety concerns showing higher neonatal intensive care unit (NICU) admissions, higher rates of macrosomia, large for gestational age and pre-eclampsia in the mother. For this reason, insulin should be first-line therapy for GDM. In areas of limited resources where the self-monitoring needed for accurate insulin dosing is not possible, where access to refrigeration for insulin storage is not universal, or severe needle phobia then the benefits of glyburide (controlling hyperglycemia) outweighs the harm of NICU admissions and macrosomia.

  19. Indicators of Club Management Practices and Biological Measurements of Patrons’ Drug and Alcohol Use

    PubMed Central

    Byrnes, Hilary F.; Miller, Brenda A.; Johnson, Mark B.; Voas, Robert B.

    2015-01-01

    Background Electronic Music Dance Events in nightclubs attract patrons with heavy alcohol/drug use. Public health concerns are raised from risks related to these behaviors. Practices associated with increased risk in these club settings need to be identified. Objectives The relationship between club management practices and biological measures of patrons’ alcohol/drug use is examined. Methods Observational data from 25 events across 6 urban clubs were integrated with survey data (N=738 patrons, 42.8% female) from patrons exiting these events, 2010–2012. Five indicators of club management practices were examined using mixed model regressions: club security, bar crowding, safety signs, serving intoxicated patrons, and isolation. Results Analyses revealed that serving intoxicated patrons and safety signs were related to less substance use. Specifically, serving intoxicated patrons was related to heavy alcohol and drug use at exit, while safety signs were marginally related to less exit drug use. Conclusions/Importance Findings indicate observable measures in nightclubs provide important indicators for alcohol/drug use, suggesting practices to target. Study strengths include the use of biological measures of substance use on a relatively large scale. Limitations and future directions are discussed. PMID:24832721

  20. Risk of Myocardial Infarction in Patients with Long-Term Non-Vitamin K Antagonist Oral Anticoagulant Treatment.

    PubMed

    Tornyos, Adrienn; Kehl, Dániel; D'Ascenzo, Fabrizio; Komócsi, András

    2016-01-01

    The relative cardiovascular (CV) safety of oral anticoagulants continues to be debated, and in particular concerns for risk of myocardial infarction (MI) have been raised. We analyzed the risk of MI in patients treated long term with oral anticoagulants (vitamin K antagonists [VKA], direct thrombin inhibitors or activated X factor antagonist) for atrial fibrillation, deep vein thrombosis or pulmonary embolism using a network meta-analysis (NMA). Randomized, phase 3 trials comparing novel anticoagulants to VKA were searched. Information on study design and clinical outcomes was extracted. The primary end-point of the analysis was the occurrence of MI or acute coronary syndrome. A Bayesian multiple treatment analysis was performed using fixed-effect and random-effects modeling. Twelve trials including 100,524 randomized patients were analyzed. The odds for MI in NMA were worse with dabigatran when compared to VKA, rivaroxaban, apixaban, and edoxaban (OR: 0.66 CI: 0.49-0.87; OR: 0.56 CI: 0.38-0.82, OR: 0.59 CI 0.40-0.88, and OR: 0.71 CI: 0.50-1.0, respectively).The posterior probability of being the first best choice of treatment was 53.5% for rivaroxaban, 33.8% for apixaban, 9.5% for ximelagatran, 2.0% for edoxaban, 1.2% for VKA, and 0.007% for dabigatran. There is a considerable heterogeneity regarding CV safety among oral anticoagulants. Differences in risk of MI may influence the choice of treatment. Multiple treatment NMA found 29%-44% higher odds of MI with dabigatran supporting the concerns regarding its CV safety. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Japan Flavour and Fragrance Materials Association's (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups.

    PubMed

    Saito, Kenji; Hasegawa-Baba, Yasuko; Sekiya, Fumiko; Hayashi, Shim-Mo; Mirokuji, Yoshiharu; Okamura, Hiroyuki; Maruyama, Shinpei; Ono, Atsushi; Nakajima, Madoka; Degawa, Masakuni; Ozawa, Shogo; Shibutani, Makoto; Maitani, Tamio

    2017-09-01

    We performed a safety evaluation using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the following four flavouring substances that belong to the class of 'aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional oxygenated functional groups' and are uniquely used in Japan: butyl butyrylacetate, ethyl 2-hydroxy-4-methylpentanoate, 3-hydroxyhexanoic acid and methyl hydroxyacetate. Although no genotoxicity study data were found in the published literature, none of the four substances had chemical structural alerts predicting genotoxicity. All four substances were categorised as class I by using Cramer's classification. The estimated daily intake of each of the four substances was determined to be 0.007-2.9 μg/person/day by using the maximised survey-derived intake method and based on the annual production data in Japan in 2001, 2005 and 2010, and was determined to be 0.250-600.0 μg/person/day by using the single-portion exposure technique and based on average-use levels in standard portion sizes of flavoured foods. Both of these estimated daily intake ranges were below the threshold of toxicological concern for class I substances, which is 1800 μg/person/day. Although no information from in vitro and in vivo toxicity studies for the four substances was available, these substances were judged to raise no safety concerns at the current levels of intake.

  2. Military Payloads Hosted on Commercial Satellites: How Can the Space and Missile Systems Center Increase the Number of Commercially Hosted Military Payload Contract Awards

    DTIC Science & Technology

    2015-12-01

    commercial owner-operator’s opportunity to review the preliminary satellite design, raise concerns, and discuss needed modifications—is typically...concerns and raised those concerns through the chain of command. The division chief decided that the executive director of SMC (a two-star general...Indefinite Quantity (ID/ IQ ) contract for CHMPs, referred to as the HoPs (Hosted Payloads) ID/ IQ . The Federal Acquisition Regulation describes an ID

  3. Acceptability of text messages for safety netting patients with low-risk cancer symptoms: a qualitative study.

    PubMed

    Hirst, Yasemin; Lim, Anita Wey Wey

    2018-05-01

    Safety netting is an important diagnostic strategy for patients presenting to primary care with potential (low-risk) cancer symptoms. Typically, this involves asking patients to return if symptoms persist. However, this relies on patients re-appraising their symptoms and making follow-up appointments, which could contribute to delays in diagnosis. Text messaging is increasingly used in primary care to communicate with patients, and could be used to improve safety netting. To explore the acceptability and feasibility of using text messages to safety net patients presenting with low-risk cancer symptoms in GP primary care (txt-netting). Qualitative focus group and interview study with London-based GPs. Participants were identified using convenience sampling methods. Five focus groups and two interviews were conducted with 22 GPs between August and December 2016. Sessions were audiorecorded, transcribed verbatim, and analysed using thematic analysis. GPs were amenable to the concept of using text messages in cancer safety netting, identifying it as an additional tool that could help manage patients and promote symptom awareness. There was wide variation in GP preferences for text message content, and a number of important potential barriers to txt-netting were identified. Concerns were raised about the difficulties of conveying complex safety netting advice within the constraints of a text message, and about confidentiality, widening inequalities, and workload implications. Text messages were perceived to be an acceptable potential strategy for safety netting patients with low-risk cancer symptoms. Further work is needed to ensure it is cost-effective, user friendly, confidential, and acceptable to patients. © British Journal of General Practice 2018.

  4. Presentation and outcome of clinical poor performance in one health district over a 5-year period: 2002-2007.

    PubMed

    Cox, Stephen J; Holden, John D

    2009-05-01

    The detection, assessment, and management of primary care poor performance raise difficult issues for all those involved. Guidance has largely focused on managing the most serious cases where patient safety is severely compromised. The management of primary care poor performance has become an increasingly important part of primary care trust (PCT) work, but its modes of presentation and prevalence are not well known. To report the prevalence, presentation modes, and management of primary care poor performance cases presenting to one PCT over a 5-year period. A retrospective review of primary care poor performance cases in one district. St Helens PCT administered 35 practices with 130 GPs on the performers list, caring for 190 110 patients in North West England, UK. Cases presenting during 2002-2007 were initially reviewed by the chair of the PCT clinical executive committee. Anonymised data were then jointly reviewed by the assessor and another experienced GP advisor. There were 102 individual presentations (20 per year or one every 2-3 weeks) where clinician performance raised significant cause for concern occurred over the 5-year period. These concerns related to 37 individual clinicians, a range of 1-14 per clinician (mean 2.7). Whistleblowing by professional colleagues on 43 occasions was the most common presentation, of which 26 were from GPs about GPs. Patient complaints (18) were the second most common presentation. Twenty-seven clinicians were GPs, of whom the General Medical Council (GMC) were notified or involved in 13 cases. Clinicians were supported locally, and remedying was exclusively locally managed in 14 cases, and shared with an external organisation (such as the GMC or deanery) in another 12. Professional whistleblowing and patient complaints were the most common sources of presentation. Effective PCT teams are needed to manage clinicians whose performance gives cause for concern. Sufficient resources and both formal and informal ways of reporting concerns are essential.

  5. Practice behaviors of RNs related to hazardous risks within the clinical setting.

    PubMed

    Gordon, G P

    1999-06-01

    A practice behavior survey was distributed to 250 RNs in the Metropolitan Detroit area. Seventy percent of the RNs responded to questions focused on needle-stick and splash injuries, handwashing, gloving, and other available measures that prevent injuries and infection. Respondents reported a larger than expected number of sticks (34.5%) and splashes (40.8%), but most of these instances were handled to the nurses' satisfaction. The nurses reported that while occupationally acquired hepatitis B/C, along with AIDS, are serious concerns, a large majority (75%) had not heard of the Campaign For Health Care Safety. The results of this survey have implications for research, practice, management, and public policy. This exploratory pilot survey raises numerous professional issues.

  6. Design and analysis of surface plasmon resonance (SPR) sensor to check the quality of food from adulteration

    NASA Astrophysics Data System (ADS)

    Kumar, Manish; Raghuwanshi, Sanjeev Kumar

    2018-02-01

    In recent years, food safety issues caused by contamination of chemical substances or microbial species have raised a major area of concern to mankind. The conventional chromatography-based methods for detection of chemical are based on human-observation and slow for real-time monitoring. The surface plasmon resonance (SPR) sensors offers the capability of detection of very low concentrations of adulterated chemical and biological agents for real-time by monitoring. Thus, adulterant agent in food gives change in refractive index of pure food result in corresponding phase change. These changes can be detected at the output and can be related to the concentration of the chemical species present at the point.

  7. Medical regulation of cognitive enhancement devices: some concerns

    PubMed Central

    King, Mike; Gavaghan, Colin; McMillan, John

    2014-01-01

    The authors present a cogent and detailed case for altering the Medical Devices Directive to allow regulation of cognitive enhancement devices (CEDs). Protection against significant risk of harm, especially for the vulnerable, and promotion of benefit through informed use of CEDs are all good features of the proposal. However, the pre-market approval process has limitations, which we explore. We raise the possibility of ‘risk compensation’ in response to the introduction of safety measures, which could alter its effectiveness. The proposal alludes to use of ‘formally trained practitioners,’ which provide a further tier of regulation for CEDs within the proposal. We consider some positive and negative implications of this aspect of the proposal that might warrant further consideration. PMID:27774173

  8. Telecommuting. Factors to consider.

    PubMed

    D'Arruda, K A

    2001-10-01

    1. Telecommuting is a work arrangement in which employees work part time or full time from their homes or smaller telework centers. They communicate with employers via computer. 2. Telecommuting can raise legal issues for companies. Can telecommuting be considered a reasonable accommodation under the Americans With Disabilities Act? When at home, is a worker injured within the course and scope of their employment for purposes of workers' compensation? 3. Occupational and environmental health nurses may need to alter existing programs to meet the distinct needs of telecommuters. Often, there are ergonomic issues and home office safety issues which are not of concern to other employees. Additionally, occupational and environmental health nurses may have to offer programs in new formats (e.g., Internet or Intranet programs) to effectively communicate with teleworkers.

  9. Single molecule Raman spectroscopic assay to detect transgene from GM plants.

    PubMed

    Kadam, Ulhas S; Chavhan, Rahul L; Schulz, Burkhard; Irudayaraj, Joseph

    2017-09-01

    Substantial concerns have been raised for the safety of transgenics on human health and environment. Many organizations, consumer groups, and environmental agencies advocate for stringent regulations to avoid transgene products' contamination in food cycle or in nature. Here we demonstrate a novel approach using surface enhanced Raman spectroscopy (SERS) to detect and quantify transgene from GM plants. We show a highly sensitive and accurate quantification of transgene DNA from multiple transgenic lines of Arabidopsis. The assay allows us to detect and quantify the transgenes as low as 0.10 pg without need for PCR-amplification. This technology is relatively cheap, quick, simple, and suitable for detection at low target concentration. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Prescription drug samples--does this marketing strategy counteract policies for quality use of medicines?

    PubMed

    Groves, K E M; Sketris, I; Tett, S E

    2003-08-01

    Prescription drug samples, as used by the pharmaceutical industry to market their products, are of current interest because of their influence on prescribing, and their potential impact on consumer safety. Very little research has been conducted into the use and misuse of prescription drug samples, and the influence of samples on health policies designed to improve the rational use of medicines. This is a topical issue in the prescription drug debate, with increasing costs and increasing concerns about optimizing use of medicines. This manuscript critically evaluates the research that has been conducted to date about prescription drug samples, discusses the issues raised in the context of traditional marketing theory, and suggests possible alternatives for the future.

  11. Low birth weight: is it related to assisted reproductive technology or underlying infertility?

    PubMed

    Kondapalli, Laxmi A; Perales-Puchalt, Alfredo

    2013-02-01

    Since 1978, we have witnessed a successful evolution of assisted reproductive technology (ART), with improvement of the pregnancy rates and a growing demand. However, in recent years, there has been increasing concern regarding its safety due to the potential health impact on its infants. The raise of the developmental origins of adult disease has positioned low birth weight (LBW) as a significant health issue. Although multiple studies have associated ART with LBW, the etiology of this association remains largely unknown. We review the potential association between different components of ART and infertility with LBW, while acknowledging the limitations of interpretation of the existing literature. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  12. Fire tests to evaluate the potential fire threat and its effects on HEPA filter integrity in cell ventilation at the Oak Ridge National Laboratory, Building 7920

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hasegawa, H.K.; Staggs, K.J.; Doughty, S.M.

    1992-12-01

    As a result of a DOE (Tiger Team) Technical Safety Appraisal (November 1990) of the Radiochemical Engineering Development Center (REDC), ORNL Building 7920, a number of fire protection concerns were identified. The primary concern was the perceived loss of ventilation system containment due to the thermal destruction and/or breaching of the prefilters and/or high-efficiency particulate air filters (HEPA `s) and the resultant radioactive release to the external environment. The following report describes the results of an extensive fire test program performed by the Fire Research Discipline (FRD) of the Special Projects Division of Lawrence Livermore National Lab (LLNL) and fundedmore » by ORNL to address these concerns. Full scale mock-ups of a REDC hot cell tank pit, adjacent cubicle pit, and associated ventilation system were constructed at LLNL and 13 fire experiments were conducted to specifically answer the questions raised by the Tiger Team. Our primary test plan was to characterize the burning of a catastrophic solvent spill (kerosene) of 40 liters and its effect on the containment ventilation system prefilters and HEPA filters. In conjunction with ORNL and Lockwood Greene we developed a test matrix that assessed the fire performance of the prefilters and HEPA filters; evaluated the fire response of the fiber reinforced plastic (FRP) epoxy ventilation duct work; the response and effectiveness of the fire protection system, the effect of fire in a cubicle on the vessel off-gas (VOG) elbow, and other fire safety questions.« less

  13. Types and patterns of safety concerns in home care: client and family caregiver perspectives

    PubMed Central

    Tong, Catherine E.; Sims-Gould, Joanie; Martin-Matthews, Anne

    2016-01-01

    Objective Drawing on interviews with home care clients and their family caregivers, we sought to understand how these individuals conceptualize safety in the provision and receipt of home care, how they promote safety in the home space and how their safety concerns differ from those of home support workers. Design In-depth, semi-structured interviews were conducted with clients and family caregivers. The analysis included topic and analytical coding of participants' verbatim accounts. Setting Interviews were completed in British Columbia, Canada. Participants Totally 82 clients and 55 caregivers participated. Results Clients and family caregivers identified three types of safety concerns: physical, spatial and interpersonal. These concerns are largely multi-dimensional and intersectional. We present a conceptual model of client and caregiver safety concerns. We also examine the factors that intensify and mitigate safety concerns in the home. Conclusions In spite of safety concerns, clients and family caregivers overwhelmingly prefer to receive care in the home setting. Spatial and physical concerns are the most salient. The financial burden of creating a safe care space should not be the client's alone to bear. The conceptualization and promotion of safety in home care must recognize the roles, responsibilities and perspectives of all of the actors involved, including workers, clients and their caregivers. PMID:26832159

  14. Safety huddles to proactively identify and address electronic health record safety

    PubMed Central

    Menon, Shailaja; Singh, Hardeep; Giardina, Traber D; Rayburn, William L; Davis, Brenda P; Russo, Elise M

    2017-01-01

    Objective: Methods to identify and study safety risks of electronic health records (EHRs) are underdeveloped and largely depend on limited end-user reports. “Safety huddles” have been found useful in creating a sense of collective situational awareness that increases an organization’s capacity to respond to safety concerns. We explored the use of safety huddles for identifying and learning about EHR-related safety concerns. Design: Data were obtained from daily safety huddle briefing notes recorded at a single midsized tertiary-care hospital in the United States over 1 year. Huddles were attended by key administrative, clinical, and information technology staff. We conducted a content analysis of huddle notes to identify what EHR-related safety concerns were discussed. We expanded a previously developed EHR-related error taxonomy to categorize types of EHR-related safety concerns recorded in the notes. Results: On review of daily huddle notes spanning 249 days, we identified 245 EHR-related safety concerns. For our analysis, we defined EHR technology to include a specific EHR functionality, an entire clinical software application, or the hardware system. Most concerns (41.6%) involved “EHR technology working incorrectly,” followed by 25.7% involving “EHR technology not working at all.” Concerns related to “EHR technology missing or absent” accounted for 16.7%, whereas 15.9% were linked to “user errors.” Conclusions: Safety huddles promoted discussion of several technology-related issues at the organization level and can serve as a promising technique to identify and address EHR-related safety concerns. Based on our findings, we recommend that health care organizations consider huddles as a strategy to promote understanding and improvement of EHR safety. PMID:28031286

  15. Management of female-to-male transgender persons: medical and surgical management, life expectancy.

    PubMed

    Gooren, Louis J

    2014-06-01

    Hormonal treatment of transgender people is becoming a normal part of medicine, though numbers of subjects remain small because of low prevalence. Information on treatment is scattered and this review brings together the latest information on treatment goals and potential side-effects of androgen treatment of female-to-male transsexual subjects. Androgen treatment of female-to-male transsexuals is usually uneventful, with a good patient compliance. Goals of hormonal treatment are elimination of secondary sex characteristics of the female sex and induction of those of the male sex. Completion takes approximately 2 years. Hormonal treatment is eventually followed by surgical ablation of breasts and removal of uterus and ovaries. Phalloplasty may be considered. Concerns are the sequelae of hypogonadism following surgery, such as loss of bone mass. Contrary to earlier expectations, there is no increase in cardiovascular disease. (Hormone-related) cancers are rare, but vaginal, cervical, endometrial carcinomas have been reported. Cancers of the breasts are of greater concern and have been found in residual mammary tissue after breast ablation. So far, androgen treatment has not raised major safety concerns. Regrets about changing sex have not been reported. Testosterone treatment of female-to-male transsexuals is effective and well tolerated.

  16. [Effects of empathy on fund-raising activities on behalf of victims of the 2011 Great East Japan Earthquake, focusinig on the residents in the South Kanto area].

    PubMed

    Yamamoto, Youichi; Yoo, Seonyoung; Matsui, Yutaka

    2015-02-01

    Fund-raising activities on behalf of victims of the 2011 Great East Japan Earthquake during the year after the earthquake were investigated in residents of the South Kanto area (N = 749), which is adjacent to the disaster area. The percentage of people that raised funds was 67.4%. We investigated the effects of the following on fundraising activities: demographic variables (sex, age, and educational background), trait empathy (empathic concern, perspective taking, and personal distress), former experience with fund-raising activities, effects of similarity to victims (e.g., experienced inconveniences because of the disaster, or had problems returning home), and psychological closeness to victims (e.g, have family members or acquaintances that suffered from the disaster, or that once lived in the disaster area). The results indicated that fund-raising activities were affected by former experience with fund-raising, similarity to victims, psychological closeness to victims, empathic concern, and being female. The relationship between fund-raising activities for victims and empathy are discussed.

  17. Cross-Cultural Counseling Concerns.

    ERIC Educational Resources Information Center

    Ahia, Chikezie Emmanuel

    1984-01-01

    Examines problems and concerns of cross cultural counseling and psychotherapy. Raises specific questions concerning research designs and approaches, differences in cosmology, epistemology, differences in nosology, and problems of evaluation or testing. (JAC)

  18. Teaching Safety: Using Mole Calculations To Teach Aspects of Safety in Post-16 Chemistry.

    ERIC Educational Resources Information Center

    Borrows, Peter; Vincent, Ray; Cochrane, Allen

    1998-01-01

    Recommends beginning certain chemistry courses with revision and consolidation of mole calculations. Argues that by choosing examples related to health and safety, mole calculations can be made less academic while raising student awareness of important issues. (DDR)

  19. Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

    PubMed

    Amarasinghe, Ananda; Black, Steve; Bonhoeffer, Jan; Carvalho, Sandra M Deotti; Dodoo, Alexander; Eskola, Juhani; Larson, Heidi; Shin, Sunheang; Olsson, Sten; Balakrishnan, Madhava Ram; Bellah, Ahmed; Lambach, Philipp; Maure, Christine; Wood, David; Zuber, Patrick; Akanmori, Bartholomew; Bravo, Pamela; Pombo, María; Langar, Houda; Pfeifer, Dina; Guichard, Stéphane; Diorditsa, Sergey; Hossain, Md Shafiqul; Sato, Yoshikuni

    2013-04-18

    Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable delivery of vaccines worldwide. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. Bertolette Selected as EHS Champion of Safety | Poster

    Cancer.gov

    Dan Bertolette has been selected as the most recent NCI at Frederick Champion of Safety, as part of the Champions of Safety Program sponsored by the Environment, Health, and Safety Program (EHS). The goal of the program, which began last year, is to raise awareness and promote a culture of safety by showing NCI at Frederick staff at work in their respective workplaces,

  1. Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

    PubMed

    Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

    2017-11-01

    Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Measurement and standardization of eye safety for optical radiation of LED products

    NASA Astrophysics Data System (ADS)

    Mou, Tongsheng; Peng, Zhenjian

    2013-06-01

    The blue light hazard (BLH) to human eye's retina is now a new issue emerging in applications of artificial light sources. Especially for solid state lighting sources based on the blue chip-LED(GaN), the photons with their energy more than 2.4 eV show photochemical effects on the retina significantly, raising damage both in photoreceptors and retinal pigment epithelium. The photobiological safety of artificial light sources emitting optical radiation has gained more and more attention worldwide and addressed by international standards IEC 62471-2006(CIE S009/E: 2002). Meanwhile, it is involved in IEC safety specifications of LED lighting products and covered by European Directive 2006/25/EC on the minimum health and safety requirements regarding the exposure of the workers to artificial optical radiation. In practical applications of the safety standards, the measuring methods of optical radiation from LED products to eyes are important in establishment of executable methods in the industry. In 2011, a new project to develop the international standard of IEC TR62471-4,that is "Measuring methods of optical radiation related to photobiological safety", was approved and are now under way. This paper presents the concerned methods for the assessment of optical radiation hazards in the standards. Furthermore, a retina radiance meter simulating eye's optical geometry is also described, which is a potential tool for blue light hazard assessment of retinal exposure to optical radiation. The spectroradiometric method integrated with charge-coupled device(CCD) imaging system is introduced to provide more reliable results.

  3. The Influence of Health Policy and Market Factors on the Hospital Safety Net

    PubMed Central

    Bazzoli, Gloria J; Lindrooth, Richard C; Kang, R ay; Hasnain-Wynia, R omana

    2006-01-01

    Objective To examine how the financial pressures resulting from the Balanced Budget Act (BBA) of 1997 interacted with private sector pressures to affect indigent care provision. Data Sources/Study Setting American Hospital Association Annual Survey, Area Resource File, InterStudy Health Maintenance Organization files, Current Population Survey, and Bureau of Primary Health Care data. Study Design We distinguished core and voluntary safety net hospitals in our analysis. Core safety net hospitals provide a large share of uncompensated care in their markets and have large indigent care patient mix. Voluntary safety net hospitals provide substantial indigent care but less so than core hospitals. We examined the effect of financial pressure in the initial year of the 1997 BBA on uncompensated care for three hospital groups. Data for 1996–2000 were analyzed using approaches that control for hospital and market heterogeneity. Data Collection/Extraction Methods All urban U.S. general acute care hospitals with complete data for at least 2 years between 1996 and 2000, which totaled 1,693 institutions. Principal Findings Core safety net hospitals reduced their uncompensated care in response to Medicaid financial pressure. Voluntary safety net hospitals also responded in this way but only when faced with the combined forces of Medicaid and private sector payment pressures. Nonsafety net hospitals did not exhibit similar responses. Conclusions Our results are consistent with theories of hospital behavior when institutions face reductions in payment. They raise concern given continuing state budget crises plus the focus of recent federal deficit reduction legislation intended to cut Medicaid expenditures. PMID:16899001

  4. Finding Funds for Kids.

    ERIC Educational Resources Information Center

    Shorey, Clyde E., Jr.

    Fund raising should be considered a major part of the business of every voluntary organization, even if the organization has relatively small fund raising goals. Voluntary agencies concerned with children should keep in mind the following: (1) public fund raising campaigns can provide a substantial proportion of the funding requirements of many…

  5. Multi-approach model for improving agrochemical safety among rice farmers in Pathumthani, Thailand

    PubMed Central

    Raksanam, Buppha; Taneepanichskul, Surasak; Siriwong, Wattasit; Robson, Mark

    2012-01-01

    The large-scale use of agrochemicals has raised environmental and human health concerns. A comprehensive intervention strategy for improving agrochemical safety among rice farmers in Thailand is lacking. The objective of this study is to develop a model in order to improve farmers’ health and prevent them from being exposed to agrochemical hazards, in addition to evaluating the effectiveness of the intervention in terms of agrochemical safety. This study was conducted between October 2009 and January 2011. It measures changes in the mean scores of agrochemical knowledge, health beliefs, agrochemical use behaviors, and in-home pesticide safety. Knowledge of agrochemical use constitutes a basic knowledge of agrochemicals and agrochemical safety behaviors. Health beliefs constitute perceived susceptibility, severity, benefits, and barriers to using agrochemicals. Agrochemical use behaviors include self-care practices in terms of personal health at specific times including before spraying, while spraying, during storage, transportation, waste management, and health risk management. Fifty rice farmers from Khlong Seven Community (study group) and 51 rice farmers from Bueng Ka Sam community (control group) were randomly recruited with support from community leaders. The participants were involved in a combination of home visits (ie, pesticide safety assessments at home) and community participatory activities regarding agrochemical safety. This study reveals that health risk behaviors regarding agrochemical exposure in the study area are mainly caused by lack of attention to safety precautions and the use of faulty protective gear. After 6 months, the intervention program showed significant improvements in the overall scores on knowledge, beliefs, behaviors, and home pesticide safety in the study group (P < 0.05). Therefore, this intervention model is effective in improving agrochemical safety behaviors among Khlong Seven Community rice farmers. These findings demonstrate that a multi-approach model for improving agrochemical safety behaviors can lead to sustainable prevention of agrochemical hazards for farmers. PMID:22956888

  6. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data.

    PubMed

    D'Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D'Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

    2015-01-01

    Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50 μg, placebo (both delivered via the Breezhaler device), or tiotropium 18 μg (delivered via the HandiHaler device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. The overall safety profile of glycopyrronium was similar to its comparators indicating no increase in the overall risk for any of the investigated safety end points.

  7. 76 FR 38267 - The Federal Motor Carrier Safety Administration's 2011-2016 Strategic Plan: Raising the Safety Bar

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... Federal Docket Management System (FDMS) address: http://www.regulations.gov . Fax: 202-493-2251. Mail: Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room... transport and logistics supply chain in improving CMV safety factors. This is a holistic view of safety that...

  8. Understanding road safety in Kenya: views of matatu drivers.

    PubMed

    Raynor, Nicolas J; Mirzoev, Tolib

    2014-09-01

    Road traffic accidents (RTAs) are estimated to cause 1.3 million deaths and 20-50 million injuries worldwide. Road safety is a challenge in Kenya with causes being multi-factorial. Matatus (minibuses) are involved in a large proportion of accidents. A literature review was completed to identify key issues and refine the scope of the study. The fieldwork included 20 semi-structured interviews with matatu drivers. All participants were male, with driving experience of 1-20 years. Thematic framework was used for analysis. Some unstructured observations on different road users and their behaviours were also recorded. Literature showed that the causes of RTAs in Kenya are multi-factorial, but that human factors play a large part. There is also an evidence gap concerning matatu drivers, who are key stakeholders in road safety. Fieldwork showed that the matatu industry creates financial pressures on drivers and an excessive level of competition, leading to dangerous driving. Corruption of traffic police appears to be a major barrier to improving road safety, as road safety legislation is not enforced, and bribery has become the cultural norm. The general public, including passengers and private vehicles owners, also cause problems by failing to understand their role in road safety and placing the blame on others. The key policy implication for improving road safety in Kenya is seeking measures to ensure responsibility by all road users through awareness raising in the short-term and reforming the matatu industry and addressing the root causes of corruption in the longer term. © The Author 2014. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  9. New graduate registered nurses' knowledge of patient safety and practice: A literature review.

    PubMed

    Murray, Melanie; Sundin, Deborah; Cope, Vicki

    2018-01-01

    To critically appraise available literature and summarise evidence pertaining to the patient safety knowledge and practices of new graduate registered nurses. Responsibility for patient safety should not be limited to the practice of the bedside nurses, rather the responsibility of all in the healthcare system. Previous research identified lapses in safety across the health care, more specifically with new practitioners. Understanding these gaps and what may be employed to counteract them is vital to ensuring patient safety. A focused review of research literature. The review used key terms and Boolean operators across a 5-year time frame in CINAHL, Medline, psycINFO and Google Scholar for research articles pertaining to the area of enquiry. Eighty-four articles met the inclusion criteria, 39 discarded due to irrelevant material and 45 articles were included in the literature review. This review acknowledges that nursing has different stages of knowledge and practice capabilities. A theory-practice gap for new graduate registered nurses exists, and transition to practice is a key learning period setting new nurses on the path to becoming expert practitioners. Within the literature, there was little to no acknowledgement of patient safety knowledge of the newly registered nurse. Issues raised in the 1970s remain a concern for today's new graduate registered nurses. Research has recognised several factors affecting transition from nursing student to new graduate registered nurse. These factors are leaving new practitioners open to potential errors and risking patient safety. Understanding the knowledge of a new graduate registered nurse upon entering clinical practice may assist in organisations providing appropriate clinical and theoretical support to these nurses during their transition. © 2017 John Wiley & Sons Ltd.

  10. Ward round template: enhancing patient safety on ward rounds.

    PubMed

    Gilliland, Niall; Catherwood, Natalie; Chen, Shaouyn; Browne, Peter; Wilson, Jacob; Burden, Helena

    2018-01-01

    Concerns had been raised at clinical governance regarding the safety of our inpatient ward rounds with particular reference to: documentation of clinical observations and National Early Warning Score (NEWS), compliance with Trust guidance for venous thromboembolism (VTE) risk assessment, antibiotic stewardship, palliative care and treatment escalation plans (TEP). This quality improvement project was conceived to ensure these parameters were considered and documented during the ward round, thereby improving patient care and safety. These parameters were based on Trust patient safety guidance and CQUIN targets. The quality improvement technique of plan-do-study-act (PDSA) was used in this project. We retrospectively reviewed ward round entries to record baseline measurements, based on the above described parameters, prior to making any changes. Following this, the change applied was the introduction of a ward round template to include the highlighted important baseline parameters. Monthly PDSA cycles are performed, and baseline measurements are re-examined, then relevant changes were made to the ward round template. Documentation of baseline measurements was poor prior to introduction of the ward round template; this improved significantly following introduction of a standardised ward round template. Following three cycles, documentation of VTE risk assessments increased from 14% to 92%. Antibiotic stewardship documentation went from 0% to 100%. Use of the TEP form went from 29% to 78%. Following introduction of the ward round template, compliance improved significantly in all safety parameters. Important safety measures being discussed on ward rounds will lead to enhanced patient safety and will improve compliance to Trust guidance and comissioning for quality and innovation (CQUIN) targets. Ongoing change implementation will focus on improving compliance with usage of the template on all urology ward rounds.

  11. Exposure ethics: does HIV pre-exposure prophylaxis raise ethical problems for the health care provider and policy maker?

    PubMed

    Venter, Francois; Allais, Lucy; Richter, Marlise

    2014-07-01

    The last few years have seen dramatic progress in the development of HIV pre-exposure prophylaxis (PrEP). These developments have been met by ethical concerns. HIV interventions are often thought to be ethically difficult. In a context which includes disagreements over human rights, controversies over testing policies, and questions about sexual morality and individual responsibility, PrEP has been seen as an ethically complex intervention. We argue that this is mistaken, and that in fact, PrEP does not raise new ethical concerns. Some of the questions posed by PrEP are not specific to HIV prophylaxis, but simply standard public health considerations about resource allocation and striking a balance between individual benefit and public good. We consider sexual disinhibition in the context of private prescriptions, and conclude that only unjustified AIDS-exceptionalism or inappropriate moralism about sex supports thinking that PrEP raises new ethical problems. This negative conclusion is significant in a context where supposed ethical concerns about PrEP have been raised, and in the context of HIV exceptionalism. © 2013 John Wiley & Sons Ltd.

  12. Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France.

    PubMed

    Auffret, Marine; Labreuche, Julien; Duhamel, Alain; Deheul, Sylvie; Cottencin, Olivier; Bordet, Régis; Gautier, Sophie; Rolland, Benjamin

    2017-03-01

    Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the 'Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine' (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence. The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting. The 2012-2013 FPVD notifications associated with baclofen OLP were extracted. The ten most frequent types of ADRs among 'serious' and 'non-serious' reports were listed. The frequency of each type of ADR was compared between CAMTEA and spontaneous reporting, and the magnitudes of the differences were assessed using standardized differences. A total of 428 baclofen reports (1043 ADRs) were identified, among which 221 (51.64%) originated from CAMTEA. The ten most frequent ADRs in 'serious' reports were (1) confusion (17.3%), (2) seizures (11.5%), (3) drowsiness/sedation (11.5%), (4) agitation (10.9%), (5) coma (9.6%), (6) hallucinations (7.7%), (7) falls (7.1%), (8) behavioral disorders (5.8%), (9) withdrawal syndrome (5.1%), and (10) space-time disorientation (5.1%). A standardized difference of <0.2 was identified for six out of the ten most frequent 'serious' ADRs, and eight of the ten 'non-serious' ADRs. A proactive regional pharmacovigilance system could collect a substantial amount of safety data on a specific OLP practice. The profile of the ADRs collected was similar to that seen in the nationwide spontaneous reporting system.

  13. Antibodies, synthetic peptides and related constructs for planetary health based on green chemistry in the Anthropocene.

    PubMed

    Caoili, Salvador Eugenio

    2018-03-01

    The contemporary Anthropocene is characterized by rapidly evolving complex global challenges to planetary health vis-a-vis sustainable development, yet innovation is constrained under the prevailing precautionary regime that regulates technological change. Small-molecule xenobiotic drugs are amenable to efficient large-scale industrial synthesis; but their pharmacokinetics, pharmacodynamics, interactions and ultimate ecological impact are difficult to predict, raising concerns over initial testing and environmental contamination. Antibodies and similar agents can serve as antidotes and drug buffers or vehicles to address patient safety and decrease dosing requirements. More generally, peptidic agents including synthetic peptide-based constructs exemplified by vaccines can be used together with or instead of nonpeptidic xenobiotics, thus enabling advances in planetary health based on principles of green chemistry from manufacturing through final disposition.

  14. Flying vaccinator; a transgenic mosquito delivers a Leishmania vaccine via blood feeding.

    PubMed

    Yamamoto, D S; Nagumo, H; Yoshida, S

    2010-06-01

    'Flying vaccinator' is the concept of using genetically engineered hematophagous insects to deliver vaccines. Here we show the generation of a transgenic anopheline mosquito that expresses the Leishmania vaccine candidate, SP15, fused to monomeric red fluorescent protein (mDsRed) in its salivary glands. Importantly, mice bitten repeatedly by the transgenic mosquitoes raised anti-SP15 antibodies, indicating delivery of SP15 via blood feeding with its immunogenicity intact. Thus, this technology makes possible the generation of transgenic mosquitoes that match the original concept of a 'flying vaccinator'. However, medical safety issues and concerns about informed consent mitigate the use of the 'flying vaccinator' as a method to deliver vaccines. We propose that this expression system could be applied to elucidate saliva-malaria sporozoite interactions.

  15. 76 FR 29335 - Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ...On January 12, 2009, the FAA published a notice of proposed rulemaking on qualification, service, and use of crewmembers and aircraft dispatchers. Because of the complexity of the issues and the concerns raised by commenters, the FAA is issuing this supplemental notice of proposed rulemaking. The FAA proposes to amend the regulations for crewmember and aircraft dispatcher training programs in domestic, flag, and supplemental operations. The proposed regulations enhance traditional training programs by requiring the use of flight simulation training devices for flightcrew members and including additional training and evaluation requirements for all crewmembers and aircraft dispatchers in areas that are critical to safety. The proposal also reorganizes and revises the qualification, training, and evaluation requirements. The proposed changes are intended to contribute significantly to reducing aviation accidents.

  16. Controversies in the use & implementation of drug-eluting stent technology

    PubMed Central

    Itagaki, Brandon K.; Brar, Somjot S.

    2012-01-01

    The introduction of drug eluting stents has resulted in dramatic reductions in the rates of restenosis and the need for repeat revascularization. In the last several years, concern has been raised regarding the long-term safety of this technology, particularly in the area of late restenosis and stent thrombosis. The development of newer anti-restenotic drug coatings, biodegradable polymers and even completely bioabsorbable stents offer the potential to address these limitations. Additional questions that have recently come to the forefront include the optimal duration of dual antiplatelet therapy, the use of platelet reactivity assays and genetic testing and drug eluting stent use in the treatment of acute myocardial infarction. This article will attempt to address these and other areas of controversy in the use and implementation of drug eluting stents. PMID:23391788

  17. Before the experts arrive.

    PubMed

    Chandley, M

    2001-06-01

    This article addresses the rare event of the hostage situation in a forensic psychiatric nursing setting. It has a specific focus on the initial response and the accompanying issues for nurses at the clinical interface as the situation emerges. The intention of this article is to both offer guidance and raise the profile of this unique management issue because little attention is drawn to early-stage hostage situations at an organizational level. When a hostage situation occurs, inadequate preparation can mean the difference between life and death for the hostage, negotiator, or hostage taker. This article provides an overview of the relevant literature and offers guidance about the actions required when a nurse suddenly becomes responsible for managing the early stages of such a traumatic event. Responses, safety, and communication factors concerning the hostage taker are covered.

  18. Aloe vera: A review of toxicity and adverse clinical effects.

    PubMed

    Guo, Xiaoqing; Mei, Nan

    2016-04-02

    The Aloe plant is employed as a dietary supplement in a variety of foods and as an ingredient in cosmetic products. The widespread human exposure and its potential toxic and carcinogenic activities raise safety concerns. Chemical analysis reveals that the Aloe plant contains various polysaccharides and phenolic chemicals, notably anthraquinones. Ingestion of Aloe preparations is associated with diarrhea, hypokalemia, pseudomelanosis coli, kidney failure, as well as phototoxicity and hypersensitive reactions. Recently, Aloe vera whole leaf extract showed clear evidence of carcinogenic activity in rats, and was classified by the International Agency for Research on Cancer as a possible human carcinogen (Group 2B). This review presents updated information on the toxicological effects, including the cytotoxicity, genotoxicity, carcinogenicity, and adverse clinical effects of Aloe vera whole leaf extract, gel, and latex.

  19. Deep Sequencing of Plant and Animal DNA Contained within Traditional Chinese Medicines Reveals Legality Issues and Health Safety Concerns

    PubMed Central

    Coghlan, Megan L.; Haile, James; Houston, Jayne; Murray, Dáithí C.; White, Nicole E.; Moolhuijzen, Paula; Bellgard, Matthew I.; Bunce, Michael

    2012-01-01

    Traditional Chinese medicine (TCM) has been practiced for thousands of years, but only within the last few decades has its use become more widespread outside of Asia. Concerns continue to be raised about the efficacy, legality, and safety of many popular complementary alternative medicines, including TCMs. Ingredients of some TCMs are known to include derivatives of endangered, trade-restricted species of plants and animals, and therefore contravene the Convention on International Trade in Endangered Species (CITES) legislation. Chromatographic studies have detected the presence of heavy metals and plant toxins within some TCMs, and there are numerous cases of adverse reactions. It is in the interests of both biodiversity conservation and public safety that techniques are developed to screen medicinals like TCMs. Targeting both the p-loop region of the plastid trnL gene and the mitochondrial 16S ribosomal RNA gene, over 49,000 amplicon sequence reads were generated from 15 TCM samples presented in the form of powders, tablets, capsules, bile flakes, and herbal teas. Here we show that second-generation, high-throughput sequencing (HTS) of DNA represents an effective means to genetically audit organic ingredients within complex TCMs. Comparison of DNA sequence data to reference databases revealed the presence of 68 different plant families and included genera, such as Ephedra and Asarum, that are potentially toxic. Similarly, animal families were identified that include genera that are classified as vulnerable, endangered, or critically endangered, including Asiatic black bear (Ursus thibetanus) and Saiga antelope (Saiga tatarica). Bovidae, Cervidae, and Bufonidae DNA were also detected in many of the TCM samples and were rarely declared on the product packaging. This study demonstrates that deep sequencing via HTS is an efficient and cost-effective way to audit highly processed TCM products and will assist in monitoring their legality and safety especially when plant reference databases become better established. PMID:22511890

  20. Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age.

    PubMed

    Gorse, Geoffrey J; Falsey, Ann R; Johnson, Carol M; Morrison, Dennis; Fried, David L; Ervin, John E; Greenberg, David P; Ozol-Godfrey, Ayca; Landolfi, Victoria; Tsang, Peter H

    2013-12-05

    This clinical trial examined the safety and immunogenicity of annual revaccination with Fluzone(®) Intradermal (Sanofi Pasteur, Swiftwater, PA) vaccine compared to a standard intramuscular (IM) split-virion trivalent influenza vaccine (Fluzone(®), Sanofi Pasteur). This phase II, active-controlled, multi-centre, open-label trial was conducted in 2009 and 2010, and enrolled 1250 adults 18-64 years of age who were randomly selected from participants in a phase III influenza vaccine trial the previous year (NCT00772109). Subjects who had previously received the ID vaccine were randomized 2:1 to be revaccinated with the ID or IM vaccine and those who previously received the IM vaccine were randomized 1:1. Solicited reactions were recorded on the day of vaccination and continuing for the next 7 days, non-serious adverse events for 28 days, and serious adverse events for 6 months after vaccination. Hemagglutination inhibition antibody titres were assessed pre-vaccination and at day 28. Reactions were well-tolerated and resolved in the first 7 days, but erythema, induration, swelling, pruritus and ecchymosis were reported by more subjects receiving the ID vaccine than the IM vaccine. Compared to receipt of IM vaccine in the previous year, ID vaccine in the previous year led to statistically higher rates of erythema, swelling and induration after IM vaccine in the second year. Injection-site pain and systemic reactions did not differ between ID and IM vaccines. No treatment-related serious adverse events were reported. Geometric mean antibody titres, seroprotection rates, and seroconversion rates were non-inferior for the ID and IM vaccines for all three viral strains. The ID vaccine was as immunogenic as the IM vaccine, and raised no safety concerns. It can be used interchangeably with the IM vaccine for annual revaccination in adults 18-64 years of age in consecutive years without safety concerns. Copyright © 2013 Elsevier Ltd. All rights reserved.

  1. Ethylcellulose-coated polyolefin separators for lithium-ion batteries with improved safety performance.

    PubMed

    Xiong, Ming; Tang, Haolin; Wang, Yadong; Pan, Mu

    2014-01-30

    With the widely use in portable electronic devices and electric vehicles, the safety of lithium-ion battery has raised serious concerns, in which the thermal stability of separator plays an essential role in preventing thermal runaway reactions. The novelty of this work is to coat commercialized polyethylene (PE) separator and trilayer polypropylene/polyethylene/polypropylene (PP/PE/PP) separator with ethylcellulose (EC), a thermally stable and renewable biomass. The formation of the EC layer with high porosity is through a simple dipping and extracting process. The effects of the EC layer on thermal shrinkage, electrolyte wettability and cell performance are investigated. After coating, the thermal shrinkage of PE separator at shutdown and meltdown point is reduced from 20% to 9% and 42% to 23% respectively, while the drop of OCV under increasing temperature is also postponed from 130°C to 160°C. The electrolyte wettability of pristine trilayer PP/PE/PP separator is greatly improved, leading to increased capacity retention from 28% to 99% of the cell. Copyright © 2013 Elsevier Ltd. All rights reserved.

  2. New perspectives on understanding cultural diversity in nurse–patient communication.

    PubMed

    Crawford, Tonia; Candlin, Sally; Roger, Peter

    Effective communication is essential in developing rapport with patients, and many nursing roles such as patient assessment, education, and counselling consist only of dialogue. With increasing cultural diversity among nurses and patients in Australia, there are growing concerns relating to the potential for miscommunication, as differences in language and culture can cause misunderstandings which can have serious impacts on health outcomes and patient safety (Hamilton & Woodward-Kron, 2010). According to Grant and Luxford (2011)) there is little research into the way health professionals approach working with cultural difference or how this impacts on their everyday practice. Furthermore, there has been minimal examination of intercultural nurse–patient communication from a linguistic perspective. Applying linguistic frameworks to nursing practice can help nurses understand what is happening in their communication with patients, particularly where people from different cultures are interacting. This paper discusses intercultural nurse–patient communication and refers to theoretical frameworks from applied linguistics to explain how miscommunication may occur. It illustrates how such approaches will help to raise awareness of underlying causes and potentially lead to more effective communication skills, therapeutic relationships and therefore patient satisfaction and safety.

  3. Condom use and high-risk sexual acts in adult films: a comparison of heterosexual and homosexual films.

    PubMed

    Grudzen, Corita R; Elliott, Marc N; Kerndt, Peter R; Schuster, Mark A; Brook, Robert H; Gelberg, Lillian

    2009-04-01

    We compared the prevalence of condom use during a variety of sexual acts portrayed in adult films produced for heterosexual and homosexual audiences to assess compliance with state Occupational Health and Safety Administration regulations. We analyzed 50 heterosexual and 50 male homosexual films released between August 1, 2005, and July 31, 2006, randomly selected from the distributor of 85% of the heterosexual adult films released each year in the United States. Penile-vaginal intercourse was protected with condoms in 3% of heterosexual scenes. Penile-anal intercourse, common in both heterosexual (42%) and homosexual (80%) scenes, was much less likely to be protected with condoms in heterosexual than in homosexual scenes (10% vs 78%; P < .001). No penile-oral acts were protected with condoms in any of the selected films. Heterosexual films were much less likely than were homosexual films to portray condom use, raising concerns about transmission of HIV and other sexually transmitted diseases, especially among performers in heterosexual adult films. In addition, the adult film industry, especially the heterosexual industry, is not adhering to state occupational safety regulations.

  4. Recent Advances in Drug Eluting Stents

    PubMed Central

    Puranik, Amey S.; Dawson, Eileen R.; Peppas, Nicholas A.

    2013-01-01

    One of the most common medical interventions to reopen an occluded vessel is the implantation of a coronary stent. While this method of treatment is effective initially, restenosis, or the re-narrowing of the artery frequently occurs largely due to neointimal hyperplasia of smooth muscle cells. Drug eluting stents were developed in order to provide local, site-specific, controlled release of drugs that can inhibit neointima formation. By implementing a controlled release delivery system it may be possible to control the time release of the pharmacological factors and thus be able to bypass some of the critical events associated with stent hyperplasia and prevent the need for subsequent intervention. However, since the advent of first-generation drug eluting stents, long-term adverse effects have raised concerns regarding their safety. These limitations in safety and efficacy have triggered considerable research in developing biodegradable stents and more potent drug delivery systems. In this review, we shed light on the current state-of-the-art in drug eluting stents, problems related to them and highlight some of the ongoing research in this area. PMID:23117022

  5. Economics of gynecologic morcellation.

    PubMed

    Bortoletto, Pietro; Friedman, Jaclyn; Milad, Magdy P

    2018-02-01

    As the Food and Drug Administration raised concern over the power morcellator in 2014, the field has seen significant change, with patients and physicians questioning which procedure is safest and most cost-effective. The economic impact of these decisions is poorly understood. Multiple new technologies have been developed to allow surgeons to continue to afford patients the many benefits of minimally invasive surgery while minimizing the risks of power morcellation. At the same time, researchers have focused on the true benefits of the power morcellator from a safety and cost perspective, and consistently found that with careful patient selection, by preventing laparotomies, it can be a cost-effective tool. Changes since 2014 have resulted in new techniques and technologies to allow these minimally invasive procedures to continue to be offered in a safe manner. With this rapid change, physicians are altering their practice and patients are attempting to educate themselves to decide what is best for them. This evolution has allowed us to refocus on the cost implications of new developments, allowing stakeholders the opportunity to maximize patient safety and surgical outcomes while minimizing cost.

  6. Dynamic oversight: implementation gaps and challenges

    NASA Astrophysics Data System (ADS)

    Howard, John

    2011-04-01

    Nanotechnology is touted as a transformative technology in that it is predicted to improve many aspects of human life. There are hundreds of products in the market that utilize nanostructures in their design, such as composite materials made out of carbon or metal oxides. Potential risks to consumers, to the environment, and to workers from the most common passive nanomaterial—carbon nanotubes—are emerging through scientific research. Newer more active nanostructures—such as cancer therapies and targeted drug systems—are also increasing in use and are raising similar risk concerns. Governing the risks to workers is the subject of this commentary. The Occupational Safety and Health Act of 1970 grants the Occupational Safety and Health Administration the legal authority to set occupational health standards to insure that no worker suffers material impairment of health from work. However, setting a standard to protect workers from nanotechnology risks may occur some time in the future because the risks to workers have not been well characterized scientifically. Alternative risk governances—such as dynamic oversight through stakeholder partnerships, "soft law" approaches, and national adoption of international consensus standards—are evaluated in this article.

  7. Preparing a Community Hospital to Manage Work-related Exposures to Infectious Agents in BioSafety Level 3 and 4 Laboratories

    PubMed Central

    Bloom, Marshall E.; Hoe, Nancy P.; Arminio, Thomas; Carlson, Paul; Powers, Tamara; Feldmann, Heinz; Wilson, Deborah

    2010-01-01

    Construction of new BioSafety Level (BSL) 3 and 4 laboratories has raised concerns regarding provision of care to exposed workers because of healthcare worker (HCW) unfamiliarity with precautions required. When the National Institutes of Health began construction of a new BSL-4 laboratory in Hamilton, Montana, USA, in 2005, they contracted with St. Patrick Hospital in Missoula, Montana, for care of those exposed. A care and isolation unit is described. We developed a training program for HCWs that emphasized the optimal use of barrier precautions and used pathogen-specific modules and simulations with mannequins and fluorescent liquids that represented infectious body fluids. The facility and training led to increased willingness among HCWs to care for patients with all types of communicable diseases. This model may be useful for other hospitals, whether they support a BSL-4 facility, are in the proximity of a BSL-3 facility, or are interested in upgrading their facilities to prepare for exotic and novel infectious diseases. PMID:20202409

  8. Mutagenicity and Acute Oral Toxicity Test for Herbal Poultry Feed Supplements.

    PubMed

    Srinivasa Rao, Boddapati; Chandrasekaran, C V; Srikanth, H S; Sasikumar, Murugan; Edwin Jothie, R; Haseena, Begum; Bharathi, Bethapudi; Selvam, Ramasamy; Prashanth, D'Souza

    2018-01-01

    Herbal products are being used and trusted globally for thousands of years for their health benefits and limited side effects. Globally, a general belief amongst the consumers is that herbal supplements are always safe because they are "natural." But later, research reveals that they may not be safe. This raises concern on their safety and implications for their use as feed supplement or medicine. Toxicity testing can reveal some of the risks that may be associated with use of herbs, therefore avoiding potential harmful effects. The present study was designed to investigate five poultry feed supplements (PFS), EGMAX® (to revitalize ovarian activity), FEED-X ™ (feed efficiency enhancer), KOLIN PLUS ™ (natural replacer of synthetic choline chloride), PHYTOCEE® (natural defence enhancer), and STODI® (to prevent and control loose droppings), for their possible mutagenicity and toxicity. Bacterial reverse mutation (BRMT) and acute oral toxicity tests were employed to assess the PFS for their possible mutagenicity and toxicity. Results indicated that the PFS were devoid of mutagenic effects in BRMT and showed higher safety profile in rodent acute oral toxicity test.

  9. Good manufacturing practice and viral safety.

    PubMed

    Kerner, B

    1995-07-01

    The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

  10. Electronic nicotine delivery systems: regulatory and safety challenges: Singapore perspective.

    PubMed

    Cheah, Nuan Ping; Chong, Norman Wee Lin; Tan, Jing; Morsed, Faridatul Akmam; Yee, Shen Kuan

    2014-03-01

    Many electronic nicotine delivery systems (ENDS) are marketed as safer tobacco alternative products or effective cessation therapies. ENDS samples were evaluated for design features, including nicotine and glycols content. This could be useful in developing a legal framework to handle ENDS. Identification of the nicotine, glycerol and propylene glycol (PPG) contents was conducted using gas chromatography mass spectrometry with quantification performed using flame ionisation techniques. Varying nicotine amounts were found in ENDS cartridges which were labelled with the same concentration. Chemicals such as PPG and glycerol were found to be present in the nicotine-containing liquid of the cartridges. ENDS varied in their contents and packaging information. Limited information was available on the contents of nicotine and other chemicals present in a variety of ENDS sampled. Based on samples tested in this study, many contain misleading information on product ingredients. The results show poor consistency between actual nicotine content analysed on ENDS cartridges and the amount labelled. These findings raise safety and efficacy concerns for current and would-be recreational users or those trying to quit smoking.

  11. The challenge of comorbidity in clinical trials for multiple sclerosis.

    PubMed

    Marrie, Ruth Ann; Miller, Aaron; Sormani, Maria Pia; Thompson, Alan; Waubant, Emmanuelle; Trojano, Maria; O'Connor, Paul; Reingold, Stephen; Cohen, Jeffrey A

    2016-04-12

    We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS). We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS. We recommend establishing age- and sex-specific incidence estimates for comorbidities in the MS population, including those that commonly raise concern in clinical trials of immunomodulatory agents; shifting phase III clinical trials of new therapies from explanatory to more pragmatic trials; describing comorbidity status of the enrolled population in publications reporting clinical trials; evaluating treatment response, tolerability, and safety in clinical trials according to comorbidity status; and considering comorbidity status in the design of pharmacovigilance strategies. Our recommendations will help address knowledge gaps regarding comorbidity that interfere with the ability to interpret safety in monitored trials and will enhance the generalizability of findings from clinical trials to "real world" settings where the MS population commonly has comorbid conditions. © 2016 American Academy of Neurology.

  12. The challenge of comorbidity in clinical trials for multiple sclerosis

    PubMed Central

    Miller, Aaron; Sormani, Maria Pia; Thompson, Alan; Waubant, Emmanuelle; Trojano, Maria; O'Connor, Paul; Reingold, Stephen; Cohen, Jeffrey A.

    2016-01-01

    Objective: We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS). Methods: We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS. Results: We recommend establishing age- and sex-specific incidence estimates for comorbidities in the MS population, including those that commonly raise concern in clinical trials of immunomodulatory agents; shifting phase III clinical trials of new therapies from explanatory to more pragmatic trials; describing comorbidity status of the enrolled population in publications reporting clinical trials; evaluating treatment response, tolerability, and safety in clinical trials according to comorbidity status; and considering comorbidity status in the design of pharmacovigilance strategies. Conclusion: Our recommendations will help address knowledge gaps regarding comorbidity that interfere with the ability to interpret safety in monitored trials and will enhance the generalizability of findings from clinical trials to “real world” settings where the MS population commonly has comorbid conditions. PMID:26888986

  13. Contrasting patterns of care for musculoskeletal disorders and injuries of the upper extremity and knee through workers' compensation and private health care insurance among union carpenters in Washington State, 1989 to 2008.

    PubMed

    Lipscomb, Hester J; Schoenfisch, Ashley L; Cameron, Wilfrid; Kucera, Kristen L; Adams, Darrin; Silverstein, Barbara A

    2015-09-01

    Musculoskeletal symptoms and disorders (MSDIs) are common reasons for visits to medical providers in the general population and they are common work-related complaints. Prior reports raise concerns as to whether declines in workers' compensation (WC) rates represent true improvement in occupational health and safety or shifting of care to other payment systems. By linking administrative records, we compared patterns of WC claims and private health care utilization for disorders of the upper extremity (UE) and knee among a large cohort of union carpenters over a 20-year period. As WC claim rates declined, private health care utilization increased. The increase was muted somewhat but sustained when adjusting for other patterns of health care utilization. Findings suggest the decline of WC claim rates do not solely represent improved occupational safety in this population, but also a considerable shifting of care to their private insurance coverage over time. © 2015 Wiley Periodicals, Inc.

  14. What treatment for a child with tall stature?

    PubMed

    Edouard, Thomas

    2017-06-01

    Tall stature is statistically defined as a height standard deviation score (SDS) above 2 for a given age, sex and population group. The most common cause of tall stature is constitutional (often familial) tall stature. However, underlying endocrine or genetic disorders must be considered as some of them may require specific treatment or management. In constitutional tall stature, healthy children are referred to discuss treatment aiming at reducing adult height. The indications of treatment are rare and usually discussed in girls with extremely tall stature (height SDS>4, corresponding to 185cm in girls). The treatment options for tall children are limited and concerns have been raised about their long-term safety. Indeed, recent studies have suggested that high-dose estrogens in adolescent girls may be associated with an increased risk of infertility, as well as increased risk of cancer. Surgical epiphysiodesis has also been reported to reduce adult height but this invasive procedure in healthy children can be questionable and further data on its safety profile are required. Copyright © 2017. Published by Elsevier Masson SAS.

  15. Ethical concerns and dilemmas of Finnish and Dutch health professionals.

    PubMed

    Hopia, Hanna; Lottes, Ilsa; Kanne, Mariël

    2016-09-01

    Healthcare professionals encounter ethical dilemmas and concerns in their practice. More research is needed to understand these ethical problems and to know how to educate professionals to respond to them. To describe ethical dilemmas and concerns at work from the perspectives of Finnish and Dutch healthcare professionals studying at the master's level. Exploratory, qualitative study that used the text of student online discussions of ethical dilemmas at work as data. Participants' online discussions were analyzed using inductive content analysis. The sample consisted of 49 students at master's level enrolled in professional ethics courses at universities in Finland and the Netherlands. Permission for conducting the study was granted from both universities of applied sciences. All students provided their informed consent for the use of their assignments as research data. Participants described 51 problematic work situations. Among these, 16 were found to be ethical dilemmas, and the remaining were work issues with an ethical concern and did not meet criteria of a dilemma. The most common problems resulted from concerns about quality care, safety of healthcare professionals, patients' rights, and working with too few staff and inadequate resources. The results indicated that participants were concerned about providing quality of care and raised numerous questions about how to provide it in challenging situations. The results show that it was difficult for students to differentiate ethical dilemmas from other ethical work concerns. Online discussions among healthcare providers give them an opportunity to relate ethical principles to real ethical dilemmas and problems in their work as well as to critically analyze ethical issues. We found that discussions with descriptions of ethical dilemmas and concerns by health professionals provide important information and recommendations not only for education and practice but also for health policy. © The Author(s) 2015.

  16. How can nanobiotechnology oversight advance science and industry: examples from environmental, health, and safety studies of nanoparticles (nano-EHS)

    NASA Astrophysics Data System (ADS)

    Wang, Jing; Asbach, Christof; Fissan, Heinz; Hülser, Tim; Kuhlbusch, Thomas A. J.; Thompson, Drew; Pui, David Y. H.

    2011-04-01

    Nanotechnology has great potential to transform science and industry in the fields of energy, material, environment, and medicine. At the same time, more concerns are being raised about the occupational health and safety of nanomaterials in the workplace and the implications of nanotechnology on the environment and living systems. Studies on environmental, health, and safety (EHS) issues of nanomaterials have a strong influence on public acceptance of nanotechnology and, eventually, affect its sustainability. Oversight and regulation by government agencies and non-governmental organizations (NGOs) play significant roles in ensuring responsible and environmentally friendly development of nanotechnology. The EHS studies of nanomaterials can provide data and information to help the development of regulations and guidelines. We present research results on three aspects of EHS studies: physico-chemical characterization and measurement of nanomaterials; emission, exposure, and toxicity of nanomaterials; and control and abatement of nanomaterial releases using filtration technology. Measurement of nanoparticle agglomerates using a newly developed instrument, the Universal NanoParticle Analyzer (UNPA), is discussed. Exposure measurement results for silicon nanoparticles in a pilot scale production plant are presented, as well as exposure measurement and toxicity study of carbon nanotubes (CNTs). Filtration studies of nanoparticle agglomerates are also presented as an example of emission control methods.

  17. Recent trends of modern bacterial insecticides for pest control practice in integrated crop management system.

    PubMed

    Chattopadhyay, Pritam; Banerjee, Goutam; Mukherjee, Sayantan

    2017-05-01

    Food security and safety are the major concern in ever expanding human population on the planet earth. Each and every year insect pests cause a serious damage in agricultural field that cost billions of dollars annually to farmers. The loss in term of productivity and high cost of chemical pesticides enhance the production cost. Irrespective use of chemical pesticides (such as Benzene hexachloride, Endosulfan, Aldicarb, and Fenobucarb) in agricultural field raised several types of environmental issues. Furthermore, continuous use of chemical pesticides creates a selective pressure which helps in emerging of resistance pest. These excess chemical pesticide residues also contaminate the environment including the soil and water. Therefore, the biological control of insect pest in the agricultural field gains more importance due to food safety and environment friendly nature. In this regard, bacterial insecticides offer better alternative to chemical pesticides. It not only helps to establish food security through fighting against insect pests but also ensure the food safety. In this review, we have categorized insect pests and the corresponding bacterial insecticides, and critically analyzed the importance and mode of action of bacterial pesticides. We also have summarized the use of biopesticides in integrated pest management system. We have tried to focus the future research area in this field for the upcoming scientists.

  18. A single immunization with a recombinant canine adenovirus expressing the rabies virus G protein confers protective immunity against rabies in mice

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Li Jianwei; Faber, Milosz; Papaneri, Amy

    2006-12-20

    Rabies vaccines based on live attenuated rabies viruses or recombinant pox viruses expressing the rabies virus (RV) glycoprotein (G) hold the greatest promise of safety and efficacy, particularly for oral immunization of wildlife. However, while these vaccines induce protective immunity in foxes, they are less effective in other animals, and safety concerns have been raised for some of these vaccines. Because canine adenovirus 2 (CAV2) is licensed for use as a live vaccine for dogs and has an excellent efficacy and safety record, we used this virus as an expression vector for the RVG. The recombinant CAV2-RV G produces virusmore » titers similar to those produced by wild-type CAV2, indicating that the RVG gene does not affect virus replication. Comparison of RVG expressed by CAV2-RV G with that of vaccinia-RV G recombinant virus (V-RG) revealed similar amounts of RV G on the cell surface. A single intramuscular or intranasal immunization of mice with CAV2-RVG induced protective immunity in a dose-dependent manner, with no clinical signs or discomfort from the virus infection regardless of the route of administration or the amount of virus.« less

  19. Modeling work zone crash frequency by quantifying measurement errors in work zone length.

    PubMed

    Yang, Hong; Ozbay, Kaan; Ozturk, Ozgur; Yildirimoglu, Mehmet

    2013-06-01

    Work zones are temporary traffic control zones that can potentially cause safety problems. Maintaining safety, while implementing necessary changes on roadways, is an important challenge traffic engineers and researchers have to confront. In this study, the risk factors in work zone safety evaluation were identified through the estimation of a crash frequency (CF) model. Measurement errors in explanatory variables of a CF model can lead to unreliable estimates of certain parameters. Among these, work zone length raises a major concern in this analysis because it may change as the construction schedule progresses generally without being properly documented. This paper proposes an improved modeling and estimation approach that involves the use of a measurement error (ME) model integrated with the traditional negative binomial (NB) model. The proposed approach was compared with the traditional NB approach. Both models were estimated using a large dataset that consists of 60 work zones in New Jersey. Results showed that the proposed improved approach outperformed the traditional approach in terms of goodness-of-fit statistics. Moreover it is shown that the use of the traditional NB approach in this context can lead to the overestimation of the effect of work zone length on the crash occurrence. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. Thermal decomposition of nano-enabled thermoplastics: Possible environmental health and safety implications

    PubMed Central

    Sotiriou, Georgios A.; Singh, Dilpreet; Zhang, Fang; Chalbot, Marie-Cecile G.; Spielman-Sun, Eleanor; Hoering, Lutz; Kavouras, Ilias G.; Lowry, Gregory V.; Wohlleben, Wendel; Demokritou, Philip

    2015-01-01

    Nano-enabled products (NEPs) are currently part of our life prompting for detailed investigation of potential nano-release across their life-cycle. Particularly interesting is their end-of-life thermal decomposition scenario. Here, we examine the thermal decomposition of a widely used NEP, namely thermoplastic nanocomposites, and assess the properties of the byproducts (released aerosol and residual ash) and possible environmental health and safety implications. We focus on establishing a fundamental understanding on the effect of thermal decomposition parameters, such as polymer matrix, nanofiller properties, decomposition temperature, on the properties of byproducts using a recently-developed lab-based experimental integrated platform. Our results indicate that thermoplastic polymer matrix strongly influences size and morphology of released aerosol, while there was minimal but detectable nano-release, especially when inorganic nanofillers were used. The chemical composition of the released aerosol was found not to be strongly influenced by the presence of nanofiller at least for the low, industry-relevant loadings assessed here. Furthermore, the morphology and composition of residual ash was found to be strongly influenced by the presence of nanofiller. The findings presented here on thermal decomposition/incineration of NEPs raise important questions and concerns regarding the potential fate and transport of released engineered nanomaterials in environmental media and potential environmental health and safety implications. PMID:26642449

  1. Eating out: consumer perceptions of food safety.

    PubMed

    Worsfold, Denise

    2006-06-01

    The purpose of this investigation was to improve the understanding of the public's perception of hygiene standards in eating places and their knowledge of the inspection system. A telephone survey found that despite many claiming experience of food poisoning, and a widely held belief that using eating places may result in illness, people continue to eat out or purchase takeaways regularly. Nearly all respondents claimed that the standard of food hygiene was important to them when deciding where to eat out. Assessments of hygiene standards were mainly based on aesthetics. A minority had concerns/complaints about the hygiene standards of eating places they had used. People do not appear to be well informed about the role of the local authorities in protecting food safety and how the food safety laws are enforced. They believe that they have the right to know the result of a hygiene inspection. Half of them thought that it was difficult to find information on the hygiene standards of eating places. If access to information was easier, some consumers would eat out more often. The public will need to be educated on the inspection and enforcement process if 'scores on doors' is adopted as the main method of raising the confidence of the public in the standards of the food industry.

  2. The importance of imaging strategies for pre-clinical and clinical in vivo distribution of oncolytic viruses

    PubMed Central

    Pelin, Adrian; Wang, Jiahu; Bell, John; Le Boeuf, Fabrice

    2017-01-01

    Oncolytic viruses (OVs) are an emergent and unique therapy for cancer patients. Similar to chemo- and radiation therapy, OV can lyse (kill) cancer cell directly. In general, the advantages of OVs over other treatments are primarily: a higher safety profile (as shown by less adverse effects), ability to replicate, transgene(s) delivery, and stimulation of a host’s immune system against cancer. The latter has prompted successful use of OVs with other immunotherapeutic strategies in a synergistic manner. In spite of extended testing in pre-clinical and clinical setting, using biologically derived therapeutics like virus always raises potential concerns about safety (replication at non-intended locations) and bio-availability of the product. Recent advent in in vivo imaging techniques dramatically improves the convenience of use, quality of pictures, and amount of information acquired. Easy assessing of safety/localization of the biotherapeutics like OVs became a new potential weapon in the physician’s arsenal to improve treatment outcome. Given that OVs are typically replicating, in vivo imaging can also track virus replication and persistence as well as precisely mapping tumor tissues presence. This review discusses the importance of imaging in vivo in evaluating OV efficacy, as well as currently available tools and techniques. PMID:29637059

  3. No meaningful association between suicidal behavior and the use of IL-17A-neutralizing or IL-17RA-blocking agents.

    PubMed

    Chiricozzi, Andrea; Romanelli, Marco; Saraceno, Rosita; Torres, Tiago

    2016-12-01

    An emerging class of agents blocking IL-17 signaling represents a very promising therapeutic approach. One of these agents, brodalumab, has been associated with an increased risk of suicide behavior. Areas covered: This review sought to provide an overview strictly focused on suicide behavior signals related to the use of IL-17 agents. Data collection regarding this peculiar safety aspect was primarily based on: (i) a revision of safety outcomes belonging to phase II and phase III trials; (ii) a systematic search using the Pubmed Medline database; and (iii) collecting recent data issued as posters or communications in eminent international meetings. Expert opinion: Whilst secukinumab and ixekizumab were not associated with increased signal of suicidal behavior, being recently approved for the treatment of psoriasis by EMA and FDA, brodalumab raised concern because of suicide behavior cases that led to pause momentarily its development program during pre-marketing stage before obtaining the positive recommendation by an FDA advisory panel for its approval. Indeed, a careful re-evaluation of brodalumab safety profile is being performed and no evidence clarified a significant association or a pathogenic mechanism linking brodalumab treatment to the risk of suicidal behavior, suggesting that cases of suicidal behavior accidentally occurred during brodalumab trials.

  4. Accounting for actions and omissions: a discourse analysis of student nurse accounts of responding to instances of poor care.

    PubMed

    Ion, Robin; Smith, Kate; Moir, Jim; Nimmo, Sheila

    2016-05-01

    To explore how nursing students account for decisions to report or not report poor care witnessed on placement and to examine the implications of findings for educators. Concern has been raised about the extent to which cases of poor care go unreported. Failure to report cases may have serious consequences for patient safety. Semistructured interviews were conducted with 13 undergraduate students at a UK university during 2013. They were asked to consider their response to episodes of poor practice witnessed on placement. Data were transcribed verbatim and categorized according to whether or not students reported concerns. Cases were analysed in accordance with Potter and Wetherall's version of discourse analysis to identify the discursive strategies used to account for decisions to report or not report poor practice. Participants took care to present themselves in a positive light regardless of whether or not they had reported an episode of concern. Those who had reported tended to attribute their actions to internal factors such as moral strength and a commitment to a professional code. Those who had not or would not report concerns provided accounts which referred to external influences that prevented them from doing so or made reporting pointless. This study provides information about how students account for their actions and omissions in relation to the reporting of poor care. Findings suggest ways educators might increase reporting of concerns. © 2016 John Wiley & Sons Ltd.

  5. 29 CFR 1955.5 - Petitions for withdrawal of approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... petition for public comment; (ii) Holding informal discussion on the issues raised by the petition with the... future action on those issues or any other issues raised regarding a State plan. ...

  6. Perceived Influences on Farmers' Market Use among Urban, WIC-enrolled Women.

    PubMed

    Di Noia, Jennifer; Monica, Dorothy; Cullen, Karen Weber; Thompson, Debbe

    2017-09-01

    We identified perceived barriers and facilitators to purchasing fruits and vegetables (FV) at farmers' markets, FV shopping practices, and reactions to a planned online lesson to promote farmers' market use among urban, inner-city WIC-enrolled women. Thirteen focus groups were conducted with 3-5 participants each (N = 54). Common barriers were structural (transportation issues) and informational (not knowing the locations of markets). Improving access (by increasing the number of area markets, expanding market hours and locations, and increasing transportation options to markets) and raising awareness of the importance of eating healthfully were common facilitators. Information was sought on the locations of farmers who accept FV vouchers provided by WIC, FV sold at farmers' markets, reasons to eat locally grown FV, and FV food safety and preparation skills. Questions were raised about the accessibility of an online lesson; providing information via inperson seminars and handouts also was recommended. Although purchasing FV at supermarkets and corner stores and bodegas was common, concerns were expressed about the freshness, cost, quality, and variety of produce sold at these venues. Findings aid understanding of factors to consider in designing interventions to promote farmers' market use in this population.

  7. Safety-Related Concerns of Parents for Children with Disabilities and Chronic Conditions.

    PubMed

    Olsen, Lise L; Kruse, Sami; Miller, Anton R; Brussoni, Mariana

    2016-01-01

    The aim of this study was to explore the safety-related concerns of parents of children with a variety of disabilities and chronic conditions. We sought to examine concerns common to parents as they related to their children's delayed development, behavioral difficulties, and chronic conditions. A qualitative approach guided by grounded theory was used. Participants included parents of children between 1 and 5 years with a disability or chronic condition who resided in British Columbia, Canada. Data were collected using in-depth in-person interviews and analysis conducted using constant comparative methods. Three themes were identified that reflected parental safety concerns. These included concerns about: (1) Child's level of understanding about danger; (2) Child interactions with physical environment (concerns about child movement, concerns about ingestions); (3) Child interactions with social environment. Difficult-to-manage behaviors and cognitive limitations exacerbated parents' safety concerns. Parents were found to share safety concerns about movement and ingestions across a range of types of child health conditions. For themes of child movement and child ingestions, findings supported the utility of a noncategorical approach for the design of injury prevention strategies for these types of concerns. Parent concerns about child lack of understanding about risk and social safety concerns were linked to a smaller number of conditions and supported a more tailored approach. Flexible approaches may be needed that can offer both generic and specific information and to meet the needs of parents and clinicians.

  8. Mothers' Concerns for Personal Safety and Privacy While Breastfeeding: An Unexplored Phenomenon.

    PubMed

    Rosen-Carole, Casey; Allen, Katherine; Fagnano, Maria; Dozier, Ann; Halterman, Jill

    2018-04-01

    Preliminary qualitative research in upstate NY shows new mothers are worried about safety while breastfeeding. Little is known regarding prevalence of these concerns and their effect on breastfeeding outcomes. (1) Determine frequency of breastfeeding safety and privacy concerns; (2) Explore their association with breastfeeding outcomes. Mothers were surveyed immediately and 1-month postpartum about breastfeeding goals; both surveys addressed privacy and safety concerns at home, work, and in public. Outcome data included breastfeeding intent, exclusivity, and duration. Breastfeeding/non-breastfeeding mothers were compared using Chi-square and multivariate analyses. A total of 279 women enrolled. Of these 82.8% initiated breastfeeding; at 1-month 72% provided any breast milk, and 44% were exclusively breastfeeding. About 99% felt safe breastfeeding at home; 25% reported privacy concerns; and 5% felt "vulnerable or unsafe" while breastfeeding. At 1-month, 49% agreed there was a safe place to breastfeed/express milk at work (20% unsure). Non-breastfeeding mothers expressed more safety concerns outside home/at work: 18% breastfeeding versus 28% non-breastfeeding outside home; 27% breastfeeding versus 40% non-breastfeeding at work. Nearly 54% who reported feeling vulnerable/unsafe with breastfeeding initiated breastfeeding, compared with 86% not reporting this concern (p = 0.008). Fewer women initiating breastfeeding reported vulnerability/safety (3% breastfeeding versus 14% non-breastfeeding, p = 0.008) or privacy (22% breastfeeding versus 40% non-breastfeeding, p = 0.19) concerns. Associations held after controlling for age, race, parity, insurance, geography, and marital-status. Significant associations between initiation, privacy, and safety concerns did not extend to duration or exclusivity. Many breastfeeding women reported safety and privacy concerns, especially outside the home and at work, which may influence breastfeeding initiation. Further study may identify methods to address these issues, potentially increasing breastfeeding rates.

  9. 77 FR 53164 - Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway Workers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-31

    ...-0059, Notice No. 6] RIN 2130-AC37 Railroad Workplace Safety; Adjacent-Track On-Track Safety for Roadway... complex issues raised in both the petitions for reconsideration of the final rule published November 30... issues. One of the Petitions included a request for a delay in the effective date of the final rule until...

  10. Use of New Communication Technologies to Change NASA Safety Culture: Incorporating the Use of Blogs as a Fundamental Communications Tool

    NASA Technical Reports Server (NTRS)

    Huls, Dale thomas

    2005-01-01

    The purpose of this paper is to explore an innovative approach to culture change at NASA that goes beyond reorganizations, management training, and a renewed emphasis on safety. Over the last five years, a technological social revolution has been emerging from the internet. Blogs (aka web logs) are transforming traditional communication and information sharing outlets away from established information sources such as the media. The Blogosphere has grown from zero blogs in 1999 to approximately 4.5 million as of November 2004 and is expected to double in 2005. Blogs have demonstrated incredible effectiveness and efficiency with regards to affecting major military and political events. Consequently, NASA should embrace the new information paradigm presented by blogging. NASA can derive exceptional benefits from the new technology as follows: 1) Personal blogs can overcome the silent safety culture by giving voice to concerns or questions that are not well understood or seemingly inconsequential to the NASA community at-large without the pressure of formally raising a potential false alarm. Since blogs can be open to Agency-wide participation, an incredible amount of resources from an extensive pool of experience can focus on a single issue, concern, or problem and quickly vetted, discussed and assessed for feasibility, significance, and criticality. The speed for which this could be obtained cannot be matched through any other process or procedure currently in use. 2) Through official NASA established blogs, lessons learned can be a real-time two way process that is formed and implemented from the ground level. Data mining of official NASA blogs and personal blogs of NASA personnel can identify hot button issues and concerns to senior management. 3) NASA blogs could function as a natural ombudsman for the NASA community. Through the recognition of issues being voiced by the community and taking a proactive stance on those issues, credibility within NASA Management can be restored. For NASA to harness the capabilities of blogs, NASA must develop an Agency-wide policy on blogging to encourage use and provide guidance. This policy should describe basic rules of conduct and content as well as a policy of non-retribution and/or anonymity. The Agency must provide sever space within their firewalls, provide appropriate software tools, and promote blogs in newsletters and official websites. By embracing the use of blogs, a potential pool of 19,000 experts could be available to address each posted safety issue, concern, problem, or question. Blogs could result in real NASA culture change.

  11. Factors influencing African-American mothers' concerns about immunization safety: a summary of focus group findings.

    PubMed Central

    Shui, Irene; Kennedy, Allison; Wooten, Karen; Schwartz, Benjamin; Gust, Deborah

    2005-01-01

    OBJECTIVE: To examine the vaccine safety concerns of African-American mothers who, despite concerns, have their children immunized. METHODS: Six focus groups of Atlanta-area African-American mothers who were very concerned about vaccine safety but whose children were fully vaccinated were conducted. RESULTS: Major factors influencing participants' concerns about immunizations included: lack of information and mistrust of the medical community and government. Factors that convinced parents to have their child immunized despite their concerns included social norms and/or laws supporting immunization and fear of the consequences of not immunizing. Suggestions given to reduce concerns included improving available information that addressed their concerns and provider-patient communication. CONCLUSIONS: Addressing mothers' concerns about immunization is important both from an ethical perspective, in assuring that they are fully informed of the risks and benefits of immunizations, as well as from a practical one, in reducing the possibility that they will decide not to immunize their child. Changes in the childhood immunization process should be made to reduce parental concern about vaccine safety. Some changes that may be considered include improved provider communication about immunizations and additional tailored information about the necessity and safety of vaccines. PMID:15926642

  12. Parental Support and Youth Occupational Attainment: Help or Hindrance?

    PubMed

    Manzoni, Anna

    2018-05-02

    Although several concerns surround the transition to adulthood and youth increasingly rely on parental support, our knowledge about the implications of parental support for youth development and transition to adulthood is limited. This study fills this gap by conceptualizing development within a life course perspective that links social inequality and early life course transitions. It draws on a subsample of youth observed between age 18 and 28 from the Transition to Adulthood supplement of the Panel Study of Income Dynamics 2005-2015 (N = 7,542; 53% female, 51.3% white). Mixed-effects models reveal that the more direct financial transfers youth receive, the higher their occupational status. Yet, indirect financial support parents offer through co-residence shows the opposite pattern. Among youth receiving monetary transfers, college graduates have particularly high occupational status; however, among youth living with their parents, college graduates have the lowest occupational status. Although different types of parental support may equally act as safety nets, their divergent implications for youths' occupational attainment raise concerns about the reproduction and possible intensification of inequality during this developmental stage.

  13. Preconception sex selection for non-medical and intermediate reasons: ethical reflections

    PubMed Central

    de Wert, G.; Dondorp, W.

    2010-01-01

    Sex selection for non-medical reasons is forbidden in many countries. Focusing on preconception sex selection, the authors first observe that it is unclear what should count as a ‘medical reason’ in this context and argue for the existence of ‘intermediate reasons’ that do not fit well within the rigid distinction between ‘medical’and ‘non-medical’. The article further provides a critical review of the arguments for the prohibition of sex selection for non-medical reasons and finds that none of these are conclusive. The authors conclude that the ban should be reconsidered, but also that existing societal concerns about possible harmful effects should be taken seriously. Measures to this effect may include limiting the practice to couples who already have at least one child of the sex opposite to that which they now want to select (‘family balancing’). Finally, a difficult set of questions is raised by concerns about the reliability and unproven (long-term) safety of the only technology (flow cytometry) proven to work. PMID:25009714

  14. The development and implementation of cockpit resource management in UAL recurrent training

    NASA Technical Reports Server (NTRS)

    Shroyer, David H.

    1987-01-01

    Line Oriented Flight Training (LOFT) for United Airlines started in 1976. At that time it was basically no more than a line-simulated training function conducted in a full-mission simulator with no attention or stress on its human factor content. Very soon after the implementation of the LOFT program concerns were voiced about certain crew behavioral situations they were observing in the flight crew's execution of cockpit duties. These duties involved emergency procedures as well as irregular and normal procedures and situations. It was evident that new information was surfacing concerning crew interaction, or its lack thereof, in the cockpit and its effect on satisfactory performance. These observations naturally raised the question of how this information translated into the safety of aircraft operations. A training system had to be repetitive, the crew interactive, and the training had to be conducted under the crew concept. The foundation had to have two other factors: (1) it was necessary to have adequate human factor content, and (2) an advanced state-of-the-art simulator and appropriate electronic devices were required. These concepts are further discussed.

  15. Modeling and analyzing traffic safety perceptions: An application to the speed limit reduction pilot project in Edmonton, Alberta.

    PubMed

    El-Basyouny, Karim; El-Bassiouni, Mohamed Yahia

    2013-03-01

    To address the speeding problem in residential areas, the City of Edmonton initiated a pilot project to reduce the posted speed limit from 50km/h to 40km/h within six residential communities. This paper investigates the community perceptions of traffic safety within the six pilot communities in two phases: prior to project initiation (pre-pilot) and following the end of the project (post-pilot). This objective was accomplished by analyzing the results of two random dialing telephone surveys comprising 300 residents each. A preliminary analysis showed compatible demographic configurations for the two samples and confirmed that the residents were aware of both the posted speed limits and the adopted speed management controls. For the confirmatory factor analysis (CFA), a two-group (pre-pilot and post-pilot) three-factor model was used to assess the residents' perceptions of the speeding behavior (Speeding), their concerns about traffic safety issues (Concerns), and their perceptions of traffic safety (Safety). Comparing the CFA results of the post-pilot survey versus those of the pre-pilot survey, it was evident that there was a significant decrease in Speeding and Concerns accompanied by a significant increase in Safety. A structural equations model (SEM) was also fitted to the data in order to assess the impact of Speeding and Concerns on Safety. The results showed that Concerns increase significantly with Speeding, and that both factors have significant negative impacts on Safety. However, while the impact of Concerns on Safety was direct, that of Speeding on Safety was largely indirect (i.e., mediated through Concerns). Overall, the multivariate analysis has demonstrated that the pilot project was successful in improving the residents' perceptions of traffic safety in their community. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  16. Understanding dengue pathogenesis: implications for vaccine design.

    PubMed Central

    Stephenson, John R.

    2005-01-01

    In the second half of the twentieth century dengue spread throughout the tropics, threatening the health of a third of the world's population. Dengue viruses cause 50-100 million cases of acute febrile disease every year, including more than 500,000 reported cases of the severe forms of the disease--dengue haemorrhagic fever and dengue shock syndrome. Attempts to create conventional vaccines have been hampered by the lack of suitable experimental models, the need to provide protection against all four serotypes simultaneously and the possible involvement of virus-specific immune responses in severe disease. The current understanding of dengue pathogenesis is outlined in this review, with special emphasis on the role of the immune response. The suspected involvement of the immune system in increased disease severity and vascular damage has raised concerns about every vaccine design strategy proposed so far. Clearly more research is needed on understanding the correlates of protection and mechanisms of pathogenesis. There is, however, an urgent need to provide a solution to the escalating global public health problems caused by dengue infections. Better disease management, vector control and improved public health measures will help reduce the current disease burden, but a safe and effective vaccine is probably the only long-term solution. Although concerns have been raised about the possible safety and efficacy of both conventional and novel vaccine technologies, the situation is now so acute that it is not possible to wait for the perfect vaccine. Consequently the careful and thorough evaluation of several of the current candidate vaccines may be the best approach to halting the spread of disease. PMID:15868023

  17. Development of a method to remove raised-pavement markers (RPMs) from road surfaces : final report.

    DOT National Transportation Integrated Search

    2012-06-01

    The Georgia Department of Transportation (GDOT) uses raised pavement markers (RPMs) widely on roads : throughout the State to increase road safety. Each of the approximate 3 million RPMs in Georgia was placed : manually. Unfortunately, RPMs do not la...

  18. Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature.

    PubMed

    Beijers, Lian; Jeronimus, Bertus F; Turner, Erick H; de Jonge, Peter; Roest, Annelieke M

    2017-03-29

    This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as 'non-FDA' concerns. Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  19. An analysis of electronic health record-related patient safety concerns

    PubMed Central

    Meeks, Derek W; Smith, Michael W; Taylor, Lesley; Sittig, Dean F; Scott, Jean M; Singh, Hardeep

    2014-01-01

    Objective A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system. Methods The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports. Results We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or ‘hidden dependencies’ within the EHR. Discussion EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. Conclusions Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them. PMID:24951796

  20. Influence of raised plastic floors compared with pine shaving litter on environment and Pekin duck condition.

    PubMed

    Karcher, D M; Makagon, M M; Fraley, G S; Fraley, S M; Lilburn, M S

    2013-03-01

    Commercial poultry production management practices have been under increased public scrutiny driven by concerns for food safety and animal welfare. Within the United States, wood shavings and raised plastic floors are common flooring systems used in duck production. It is intuitive that each flooring type would present different management challenges influencing physical characteristics of growing ducks. This study evaluated the relationship between flooring type and duck condition during the winter. Random samples of 20 ducks from 5 predetermined areas (n = 100) were examined in commercial duck houses (n = 9, litter; n = 11, raised plastic slats). Ducks were assessed at 7, 21, and 32 d of age for eye, nostril, and feather cleanliness, feather and foot pad quality, and gait. The data were analyzed to determine the proportion of ducks with a given score. In both housing types, the proportion of 0 scores for foot pad quality improved during the production cycle (P < 0.0001). Feather hygiene declined with age in ducks reared on litter flooring, whereas ducks reared on slatted flooring had cleaner feathers at d 32 (P < 0.011). With the exception of foot pad scores, the majority of ducks had no detectable problems for any single trait. The only main effect due to flooring pertained to feather quality with the proportion of ducks having a 0 or 1 score greater in litter flooring systems than slats (P < 0.05). Overall, the condition of ducks reared, regardless of flooring system, was considered to be good.

  1. 78 FR 31415 - Safety Zone; USA Triathlon; Milwaukee Harbor, Milwaukee, WI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-24

    ... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone... from the activation of this safety zone. 2. Impact on Small Entities Under the Regulatory Flexibility... on a substantial number of small entities. The term ``small entities'' comprises small businesses...

  2. Whistleblowing: it's time to overcome the negative image.

    PubMed

    Shah, Fatima

    2005-06-01

    The media perpetuates the stereotype of the whistleblower forced to go outside his or her organization and risk his or her career to bring wrongdoing to public awareness. In fact, NHS trusts should all have a whistleblowing policy in place which encourages people to raise genuine concerns about wrongdoing, and offer protection to those who do this. This article aims to help health workers understand the whistleblowing process and so assist them in raising concerns within their organization.

  3. Lost in Translation? Challenges and Opportunities for Raising Health and Safety Awareness among a Multinational Workforce in the United Arab Emirates

    PubMed Central

    Cooling, Robert Fletcher; Aw, Tar-Ching

    2012-01-01

    The United Arab Emirates (UAE) has experienced tremendous economic and industrial growth in the petroleum, airline, maritime and construction sectors, especially since the discovery of oil reserves. Mass recruitment of low skilled or unskilled laborers from less-developed countries has been utilized to satisfy the manpower demands of these fast paced industrial developments. Such workforce recruitment has created an unusual populace demographic, with the total UAE population estimated at 8.3 million, composed of 950,000 Emiratis, with the remainder being multinational expatriate workers, with varying educational qualifications, work experience, religious beliefs, cultural practices, and native languages. These unique characteristics pose a challenge for health and safety professionals tasked with ensuring the UAE workforce adheres to specific occupational health and safety procedures. The paper discusses two case studies that employ a novel multimedia approach to raising health and safety awareness among a multinational workforce. PMID:23251846

  4. Risk perception, risk management and safety assessment: what can governments do to increase public confidence in their vaccine system?

    PubMed

    MacDonald, Noni E; Smith, Jennifer; Appleton, Mary

    2012-09-01

    For decades vaccine program managers and governments have devoted many resources to addressing public vaccine concerns, vaccine risk perception, risk management and safety assessment. Despite ever growing evidence that vaccines are safe and effective, public concerns continue. Education and evidence based scientific messages have not ended concerns. How can governments and programs more effectively address the public's vaccine concerns and increase confidence in the vaccine safety system? Vaccination hesitation has been attributed to concerns about vaccine safety, perceptions of high vaccine risks and low disease risk and consequences. Even when the public believes vaccines are important for protection many still have concerns about vaccine safety. This overview explores how heuristics affect public perception of vaccines and vaccine safety, how the public finds and uses vaccine information, and then proposes strategies for changes in the approach to vaccine safety communications. Facts and evidence confirming the safety of vaccines are not enough. Vaccine beliefs and behaviours must be shaped. This will require a shift in the what, when, how and why of vaccine risk and benefit communication content and practice. A change to a behavioural change strategy such as the WHO COMBI program that has been applied to disease eradication efforts is suggested. Copyright © 2011. Published by Elsevier Ltd.. All rights reserved.

  5. Parental safety concerns and active school commute: correlates across multiple domains in the home-to-school journey

    PubMed Central

    2014-01-01

    Background Empirical evidence of the relationship between safety concerns and walking to school (WTS) is growing. However, current research offers limited understanding of the multiple domains of parental safety concerns and the specific mechanisms through which parents articulate safety concerns about WTS. A more detailed understanding is needed to inform environmental and policy interventions. This study examined the relationships between both traffic safety and personal safety concerns and WTS in the U.S. Methods This cross-sectional analysis examined data from the Texas Childhood Obesity Prevention Policy Evaluation (T-COPPE) project, an evaluation of state-wide obesity prevention policy interventions. All study data were from the survey (n = 830) of parents with 4th grade students attending 81 elementary schools across Texas, and living within two miles from their children's schools. Traffic safety and personal safety concerns were captured for the home neighborhood, en-route to school, and school environments. Binary logistic regression analysis was used to assess the odds of WTS controlling for significant covariates. Results Overall, 18% of parents reported that their child walked to school on most days of the week. For traffic safety, students were more likely to walk to school if their parent reported favorable perceptions about the following items in the home neighborhood environment: higher sidewalk availability, well maintained sidewalks and safe road crossings. For the route to school, the odds of WTS were higher for those who reported "no problem" with each one of the following: traffic speed, amount of traffic, sidewalks/pathways, intersection/crossing safety, and crossing guards, when compared to those that reported "always a problem". For personal safety in the en-route to school environment, the odds of WTS were lower when parents reported concerns about: stray or dangerous animals and availability of others with whom to walk. Conclusions Findings offered insights into the specific issues that drive safety concerns for elementary school children’s WTS behaviors. The observed associations between more favorable perceptions of safety and WTS provide further justification for practical intervention strategies to reduce WTS barriers that can potentially bring long-term physical activity and health benefits to school-aged children. PMID:24602213

  6. Impact of extended duty hours on medical trainees

    PubMed Central

    Weiss, Pnina; Kryger, Meir; Knauert, Melissa

    2018-01-01

    Many studies on resident physicians have demonstrated that extended work hours are associated with a negative impact on well-being, education, and patient care. However, the relationship between the work schedule and the degree of impairment remains unclear. In recent years, because of concerns for patient safety, national minimum standards for duty hours have been instituted (2003) and revised (2011). These changes were based on studies of the effects of sleep deprivation on human performance and specifically on the effect of extended shifts on resident performance. These requirements necessitated significant restructuring of resident schedules. Concerns were raised that these changes have impaired continuity of care, resident education and supervision, and patient safety. We review the studies on the effect of extended work hours on resident well-being, education, and patient care as well as those assessing the effect of work hour restrictions. Although many studies support the adverse effects of extended shifts, there are some conflicting results due to factors such as heterogeneity of protocols, schedules, subjects, and environments. Assessment of the effect of work hour restrictions has been even more difficult. Recent data demonstrating that work hour limitations have not been associated with improvement in patient outcomes or resident education and well-being have been interpreted as support for lifting restrictions in some specialties. However, these studies have significant limitations and should be interpreted with caution. Until future research clarifies duty hours that optimize patient outcomes, resident education, and well-being, it is recommended that current regulations be followed. PMID:29073389

  7. Geochemistry and mercury contamination in receiving environments of artisanal mining wastes and identified concerns for food safety.

    PubMed

    Reichelt-Brushett, Amanda J; Stone, Jane; Howe, Pelli; Thomas, Bernard; Clark, Malcolm; Male, Yusthinus; Nanlohy, Albert; Butcher, Paul

    2017-01-01

    Artisanal small-scale gold mining (ASGM) using mercury (Hg) amalgamation has been occurring on Buru Island, Indonesia since early 2012, and has caused rapid accumulation of high Hg concentrations in river, estuary and marine sediments. In this study, sediment samples were collected from several sites downstream of the Mount Botak ASGM site, as well as in the vicinity of the more recently established site at Gogrea where no sampling had previously been completed. All sediment samples had total Hg (THg) concentrations exceeding Indonesian sediment quality guidelines and were up to 82 times this limit at one estuary site. The geochemistry of sediments in receiving environments indicates the potential for Hg-methylation to form highly bioavailable Hg species. To assess the current contamination threat from consumption of local seafood, samples of fish, molluscs and crustaceans were collected from the Namlea fish market and analysed for THg concentrations. The majority of edible tissue samples had elevated THg concentrations, which raises concerns for food safety. This study shows that river, estuary and marine ecosystems downstream of ASGM operations on Buru Island are exposed to dangerously high Hg concentrations, which are impacting aquatic food chains, and fisheries resources. Considering the high dietary dependence on marine protein in the associated community and across the Mollucas Province, and the short time period since ASGM operations commenced in this region, the results warrant urgent further investigation, risk mitigation, and community education. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

    PubMed

    Sugimoto, Takashi; Shinozaki, Tomohiro; Naruse, Takashi; Miyamoto, Yuki

    2014-01-01

    Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. Many people were at least occasionally concerned about radiation (53.5%), food safety (47.3%), and about natural disaster (69.5%). Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06), food safety (1.70; 1.38-2.10), and natural disasters (1.74; 1.39-2.19). Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77), food safety (1.38; 1.20-1.59), and natural disasters (1.30; 1.12-1.52). Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74) and food safety (1.30; 1.07-1.59), which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety). Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

  9. Who Was Concerned about Radiation, Food Safety, and Natural Disasters after the Great East Japan Earthquake and Fukushima Catastrophe? A Nationwide Cross-Sectional Survey in 2012

    PubMed Central

    Sugimoto, Takashi; Shinozaki, Tomohiro; Naruse, Takashi; Miyamoto, Yuki

    2014-01-01

    Background Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. Methods The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. Results Many people were at least occasionally concerned about radiation (53.5%), food safety (47.3%), and about natural disaster (69.5%). Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35–2.06), food safety (1.70; 1.38–2.10), and natural disasters (1.74; 1.39–2.19). Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33–1.77), food safety (1.38; 1.20–1.59), and natural disasters (1.30; 1.12–1.52). Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58–2.74) and food safety (1.30; 1.07–1.59), which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25–5.01 about radiation, 1.49; 1.08–2.06 about food safety). Conclusions Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively. PMID:25181292

  10. [Weighing use and safety of therapeutic agents and feed additives (author's transl)].

    PubMed

    van der Wal, P

    1982-02-01

    (1) The pros and cons of using feed additives and therapeutic agents may be successfully weighed in the light of carefully considered consumer requirements. (2) The socio-economic interests of the producer and the welfare of the animal will also determine the response of the production apparatus to consumer requirements. (3) Consumption of the current amounts of products of animal origin and maintenance of price and quality will only be feasible in the event of rational large-scale production in which constituents used in nutrition, prophylaxis and therapeutics are highly important factors. (4) Using these ingredients should be preceded by accurate evaluation of their use and safety. Testing facilities, conduct of studies and reporting should be such as to make the results nationally and internationally acceptable to all those concerned. (5) In deciding whether feed constituents are acceptable in view of the established use and safety, compliance will have to be sought with those standards which are accepted in other fields of society. Measures which result in raising the price of food without actually helping to reduce the risks to the safety of man, animals and environment, are likely to be rejected by any well-informed consumer who is aware of the facts. (6) For accurate weighing of use and safety at a national level, possibilities are hardly adequate in Europe. Decisions reached within the framework of the European Community, also tuned to U.S.A.- conditions are rightly encouraged. A centrally managed professionally staffed and equipped test system in the European Community would appear to be indispensable.

  11. Pharmacokinetics, pharmacodynamics, metabolism, toxicology and residues of phenylbutazone in humans and horses.

    PubMed

    Lees, Peter; Toutain, Pierre-Louis

    2013-06-01

    The presence of horse meat in food products destined for human consumption and labelled as beef has raised several concerns of public interest. This review deals solely with one aspect of these concerns; samples of equine tissue from horses destined for the human food chain have tested positive for the non-steroidal anti-inflammatory drug, phenylbutazone. The safety of some or all such foods for human consumers is a major concern, because it was shown many years ago that phenylbutazone therapy in humans can be associated with life threatening blood dyscrasias. As an initial basis for assessing the potential toxicity of foods containing phenylbutazone and its metabolites, this article reviews (1) the pharmacokinetic, pharmacodynamic, metabolic and toxicological profiles of phenylbutazone, with particular reference to horses and humans; (2) toxicity data in laboratory animals; (3) phenylbutazone residues in food producing species, and (4) as a preliminary assessment, the potential hazard associated with the consumption of horse meat containing phenylbutazone and its metabolites. Since phenylbutazone cannot be classified as a carcinogenic substance in humans, and noting that blood dyscrasias in humans are likely to be dose and treatment duration-dependent, the illegal and erratic presence of trace amount residues of phenylbutazone in horse meat is not a public health issue. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

    PubMed Central

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

    2012-01-01

    Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

  13. A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

    PubMed

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

    2012-11-01

    Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

  14. Lung Function Measurements in Rodents in Safety Pharmacology Studies

    PubMed Central

    Hoymann, Heinz Gerd

    2012-01-01

    The ICH guideline S7A requires safety pharmacology tests including measurements of pulmonary function. In the first step – as part of the “core battery” – lung function tests in conscious animals are requested. If potential adverse effects raise concern for human safety, these should be explored in a second step as a “follow-up study”. For these two stages of safety pharmacology testing, both non-invasive and invasive techniques are needed which should be as precise and reliable as possible. A short overview of typical in vivo measurement techniques is given, their advantages and disadvantages are discussed and out of these the non-invasive head-out body plethysmography and the invasive but repeatable body plethysmography in orotracheally intubated rodents are presented in detail. For validation purposes the changes in the respective parameters such as tidal midexpiratory flow (EF50) or lung resistance have been recorded in the same animals in typical bronchoconstriction models and compared. In addition, the technique of head-out body plethysmography has been shown to be useful to measure lung function in juvenile rats starting from day two of age. This allows safety pharmacology testing and toxicological studies in juvenile animals as a model for the young developing organism as requested by the regulatory authorities (e.g., EMEA Guideline 1/2008). It is concluded that both invasive and non-invasive pulmonary function tests are capable of detecting effects and alterations on the respiratory system with different selectivity and area of operation. The use of both techniques in a large number of studies in mice and rats in the last years have demonstrated that they provide useful and reliable information on pulmonary mechanics in safety pharmacology and toxicology testing, in investigations of respiratory disorders, and in pharmacological efficacy studies. PMID:22973226

  15. Developing Natural Solutions to Reducing Food Safety Pathogens in Organically Raised Poultry

    USDA-ARS?s Scientific Manuscript database

    Organic poultry production is one of the fastest growing segments of organic agriculture with a 20% increase/yr since the establishment of the National Organic Program (NOP). Restrictions on prophylactic antibiotics used for conventional poultry production raise unique challenges for organic produce...

  16. Measuring and improving patient safety through health information technology: The Health IT Safety Framework

    PubMed Central

    Singh, Hardeep

    2016-01-01

    Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety benefits of health IT in real-world clinical settings. PMID:26369894

  17. Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists.

    PubMed

    Kirschenbaum, Bonnie E

    2009-12-15

    To discuss the role of restricted drug distribution systems in the implementation of risk evaluation and mitigation strategies (REMS), health-system pharmacists' concerns associated with the use of specialty pharmacies and other restricted drug distribution systems, reimbursement policies for high-cost specialty drugs, supply chain models for traditional and specialty drugs, and emerging trends in the management of and reimbursement for specialty pharmaceuticals. Restricted drug distribution systems established by pharmaceutical manufacturers, specialty pharmacies, or other specialty suppliers may be a component of REMS, which are required by the Food and Drug Administration for the management of known or potential serious risks from certain drugs. Concerns of health-system pharmacists using specialty suppliers include access to pharmaceuticals, operational challenges, product integrity, financial implications, continuity of care, and patient safety. An ambulatory care patient taking a specialty drug product from home to a hospital outpatient clinic or inpatient setting for administration, a practice known as "brown bagging," raises concerns about product integrity and institutional liability. An institution's finances, tolerance for liability, and ability to skillfully manage the processes involved often determine its choice between an approach that prohibits brown bagging but is costly and one that permits the practice under certain conditions and is less costly. The recent shift from a traditional supply chain model to a specialty pharmacy supply chain model for high-cost pharmaceuticals has the potential to increase pharmaceutical costs for health systems. A dialogue is needed between health-system pharmacists and group purchasing organizations to address the latter's role in mitigating the financial implications of this change and to help clarify the safety issues. Some health plans have shifted part of the cost of expensive drugs to patients by establishing a fourth tier of drugs with a large copayment based on a substantial percentage of the cost of the drug. The number and cost of specialty drugs are expected to increase in the future. New approaches and reimbursement models are emerging to manage the high cost of new pharmaceuticals. Health-system pharmacists can improve drug safety and manage costs by collaborating with group purchasing organizations, establishing policies for brown bagging, and making efforts to reconcile drug therapy provided in different settings through traditional drug channels and specialty pharmacies or other restricted drug distribution systems.

  18. 77 FR 35844 - Safety Zone; Olde Ellison Bay Days Fireworks Display, Ellison Bay, WI

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... of Proposed Rulemaking A. Regulatory History and Information The Coast Guard is issuing this... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone...

  19. Management of chronic spontaneous urticaria in the elderly.

    PubMed

    Ventura, Maria Teresa; Cassano, Nicoletta; Romita, Paolo; Vestita, Michelangelo; Foti, Caterina; Vena, Gino Antonio

    2015-04-01

    The guidelines for the management of urticaria in adults and children have been revised and updated recently. However, there are few data in the literature concerning several aspects of this disease in the elderly (e.g., epidemiology, etiopathogenesis, clinical aspects, association with co-morbidities, efficacy and safety profiles of treatments, and management strategies). This is an obvious deficiency in the data, as this disease causes a deterioration in quality of life, affecting the quality of sleep, everyday life habits and activities, and inducing severe disability. Chronic spontaneous urticaria (CSU) can also be associated with internal, infectious, autoimmune, or neoplastic diseases. It is therefore necessary to pay particular attention to these clinical issues through appropriate clinical examinations. At the same time, the specific features of medications used to treat CSU in the elderly should be carefully evaluated, as its pharmacological treatment raises a number of problems related both to the clinical condition of the patient and to concomitant diseases, as well as to the polypharmacotherapy, which is common in older subjects and may cause safety problems because of the drug interactions. Non-sedating new-generation antihistamines are the mainstay treatment of CSU for the elderly. The efficacy and safety of alternative treatment options have not been assessed in the geriatric population with CSU; corticosteroids and cyclosporine (ciclosporin) should be used by this population with extreme caution. Similarly, there are no data regarding the actual safety profile of the new-generation antihistamines at higher doses than those recommended in elderly patients.

  20. Fund Raising in California School Districts. A Discussion Paper.

    ERIC Educational Resources Information Center

    Allen, Thomas W.; Hughes, K. Scott

    The results of a 1982 survey of California school districts concerning their efforts at private fundraising are presented here. It was found that 123 (or 61 percent) of responding districts either have programs or are planning programs. Although six districts raised more than $100,000 in 1981-82, the majority raised less that $20,000. Of the 66…

  1. Raising the topic of weight in general practice: perspectives of GPs and primary care nurses.

    PubMed

    Blackburn, Maxine; Stathi, Afroditi; Keogh, Edmund; Eccleston, Christopher

    2015-08-07

    To explore general practitioners' (GPs) and primary care nurses' perceived barriers to raising the topic of weight in general practice. A qualitative study using the Theoretical Domains Framework (TDF). 34 semistructured interviews were conducted to explore views, opinions and experiences of initiating a discussion about weight. Content and thematic analyses were used to analyse the interview transcripts. General practices located in one primary care trust in the South West of England. 17 GPs and 17 nurses aged between 32 and 66 years. The modal age range for GPs was 30-39 years and for nurses, 40-49 years. Barriers were synthesised into three main themes: (1) limited understanding about obesity care, (2) concern about negative consequences, and (3) having time and resources to raise a sensitive topic. Most barriers were related to raising the topic in more routine settings, rather than when dealing with an associated medical condition. GPs were particularly worried about damaging their relationship with patients and emphasised the need to follow their patient's agenda. Uncertainty about obesity, concerns about alienating patients and feeling unable to raise the topic within the constraints of a 10 min consultation, is adding to the reluctance of GPs and nurses to broach the topic of weight. Addressing these concerns through training or by providing evidence of effective interventions that are feasible to deliver within consultations may lead to greater practitioner engagement and willingness to raise the topic. 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.

  2. Are Australians concerned about nanoparticles? A comparative analysis with established and emerging environmental health issues.

    PubMed

    Capon, Adam; Rolfe, Margaret; Gillespie, James; Smith, Wayne

    2015-02-01

    Introducing new technologies into society raises considerable public concern. We determine the public concern about nanoparticles, and compare this concern to other environmental health issues such as wind farms and coal seam gas production. A repeat cross sectional survey examining views on environmental health issues, risk, chemicals and trust was undertaken in more than 1,300 Australian residents in 2000 and 2013. Logistic regression and principal component analysis was used to investigate predictors of nanoparticle concern and identify a component structure for environmental health issues that could explain a trend of future nanoparticle concern. Australians have a relatively low level of concern about the risks of nanoparticles to health when compared to their concerns about other environmental health issues. Items associated with concern included gender, a general wish to avoid chemicals and possibly trust in politicians. Concern over nanoparticles clustered with similar views on technological risks. Current public concern over the risks of nanoparticles is low. However, a reframing of the issue towards 'chemicals' is likely to have a negative effect on risk perceptions. This paper raises questions about appropriate channels for the effective communication of risk. © 2015 Public Health Association of Australia.

  3. Presentation and outcome of clinical poor performance in one health district over a 5-year period: 2002–2007

    PubMed Central

    Cox, Stephen J; Holden, John D

    2009-01-01

    Background The detection, assessment, and management of primary care poor performance raise difficult issues for all those involved. Guidance has largely focused on managing the most serious cases where patient safety is severely compromised. The management of primary care poor performance has become an increasingly important part of primary care trust (PCT) work, but its modes of presentation and prevalence are not well known. Aim To report the prevalence, presentation modes, and management of primary care poor performance cases presenting to one PCT over a 5-year period. Design of study A retrospective review of primary care poor performance cases in one district. Setting St Helens PCT administered 35 practices with 130 GPs on the performers list, caring for 190 110 patients in North West England, UK. Method Cases presenting during 2002–2007 were initially reviewed by the chair of the PCT clinical executive committee. Anonymised data were then jointly reviewed by the assessor and another experienced GP advisor. Results There were 102 individual presentations (20 per year or one every 2–3 weeks) where clinician performance raised significant cause for concern occurred over the 5-year period. These concerns related to 37 individual clinicians, a range of 1–14 per clinician (mean 2.7). Whistleblowing by professional colleagues on 43 occasions was the most common presentation, of which 26 were from GPs about GPs. Patient complaints (18) were the second most common presentation. Twenty-seven clinicians were GPs, of whom the General Medical Council (GMC) were notified or involved in 13 cases. Clinicians were supported locally, and remedying was exclusively locally managed in 14 cases, and shared with an external organisation (such as the GMC or deanery) in another 12. Conclusion Professional whistleblowing and patient complaints were the most common sources of presentation. Effective PCT teams are needed to manage clinicians whose performance gives cause for concern. Sufficient resources and both formal and informal ways of reporting concerns are essential. PMID:19401017

  4. We Never See Children in Parks: A Qualitative Examination of the Role of Safety Concerns on Physical Activity Among Children.

    PubMed

    Rader, Nicole E; Byrd, Sylvia H; Fountain, Brent J; Bounds, Christopher W; Gray, Virginia; Frugé, Andrew Dandridge

    2015-07-01

    Previous literature indicates physical activity and obesity are interrelated problems, especially among children in disorganized environments. Qualitative focus groups were conducted with parents of elementary school children located within the Mississippi Delta to answer one overarching research question: "What influence do safety concerns have on physical activity for children in the Mississippi Delta?" There were 2 large themes; first was that recreational areas were criminal and the second was that safety concerns were a barrier to physical activity. Safety concerns as a barrier to physical activity rendered 3 sub-themes, including 1) Parental fear of crime inhibited the use of public recreational spaces, 2) Parental perceptions of police as ineffective and untrustworthy reduced the use of public spaces where children might play, and 3) Parents often expressed safety-induced intense supervision requirements that limited the physical activity of their children. Our study provides valuable insights into the mechanisms by which safety concerns limit physical activity of children in the Mississippi Delta.

  5. 76 FR 34869 - Safety Zone; Truman-Hobbs Alteration of the Elgin Joliet & Eastern Railroad Drawbridge; Illinois...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... raise any novel legal or policy issues. The safety zone around the bridge project will be relatively... through the safety zone when permitted by the Captain of the Port. Small Entities Under the Regulatory... impact on a substantial number of small entities. The term ``small entities'' comprises small businesses...

  6. 77 FR 39408 - Safety Zone; Buffalo July 4th Fireworks, Lake Erie, Buffalo, NY

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone... through the safety zone when permitted by the Captain of the Port. 2. Impact on Small Entities The... the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies...

  7. 77 FR 39406 - Safety Zone; Tom Graves Memorial Fireworks, Port Bay, Wolcott, NY

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone... through the safety zone when permitted by the Captain of the Port. 2. Impact on Small Entities The... the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies...

  8. Management of preterm labor: atosiban or nifedipine?

    PubMed

    de Heus, Roel; Mulder, Eduard J H; Visser, Gerard H A

    2010-08-09

    Preterm birth is strongly associated with neonatal death and long-term neurological morbidity. The purpose of tocolytic drug administration is to postpone threatening preterm delivery for 48 hours to allow maximal effect of antenatal corticosteroids and maternal transportation to a center with specialized neonatal care facilities. There is uncertainty about the value of atosiban (oxytocin receptor antagonist) and nifedipine (calcium channel blocker) as first-line tocolytic drugs in the management of preterm labor. For nifedipine, concerns have been raised about unproven safety, lack of placebo-controlled trials, and its off-label use. The tocolytic efficacy of atosiban has also been questioned because of a lack of reduction in neonatal morbidity. This review discusses the available evidence, the pros and cons of either drug and aims to provide information to support a balanced choice of first-line tocolytic drug: atosiban or nifedipine?

  9. Plume interference with space shuttle range safety signals

    NASA Technical Reports Server (NTRS)

    Boynton, F. P.; Rajaseknar, P. S.

    1979-01-01

    The computational procedure for signal propagation in the presence of an exhaust plume is presented. Comparisons with well-known analytic diffraction solutions indicate that accuracy suffers when mesh spacing is inadequate to resolve the first unobstructed Fresnel zone at the plume edge. Revisions to the procedure to improve its accuracy without requiring very large arrays are discussed. Comparisons to field measurements during a shuttle solid rocket motor (SRM) test firing suggest that the plume is sharper edged than one would expect on the basis of time averaged electron density calculations. The effects, both of revisions to the computational procedure and of allowing for a sharper plume edge, are to raise the signal level near tail aspect. The attenuation levels then predicted are still high enough to be of concern near SRM burnout for northerly launches of the space shuttle.

  10. Nanoparticles can cause DNA damage across a cellular barrier

    NASA Astrophysics Data System (ADS)

    Bhabra, Gevdeep; Sood, Aman; Fisher, Brenton; Cartwright, Laura; Saunders, Margaret; Evans, William Howard; Surprenant, Annmarie; Lopez-Castejon, Gloria; Mann, Stephen; Davis, Sean A.; Hails, Lauren A.; Ingham, Eileen; Verkade, Paul; Lane, Jon; Heesom, Kate; Newson, Roger; Case, Charles Patrick

    2009-12-01

    The increasing use of nanoparticles in medicine has raised concerns over their ability to gain access to privileged sites in the body. Here, we show that cobalt-chromium nanoparticles (29.5 +/- 6.3 nm in diameter) can damage human fibroblast cells across an intact cellular barrier without having to cross the barrier. The damage is mediated by a novel mechanism involving transmission of purine nucleotides (such as ATP) and intercellular signalling within the barrier through connexin gap junctions or hemichannels and pannexin channels. The outcome, which includes DNA damage without significant cell death, is different from that observed in cells subjected to direct exposure to nanoparticles. Our results suggest the importance of indirect effects when evaluating the safety of nanoparticles. The potential damage to tissues located behind cellular barriers needs to be considered when using nanoparticles for targeting diseased states.

  11. Toxic Effects of Di-2-ethylhexyl Phthalate: An Overview

    PubMed Central

    2018-01-01

    Di-2-ethylhexyl phthalate (DEHP) is extensively used as a plasticizer in many products, especially medical devices, furniture materials, cosmetics, and personal care products. DEHP is noncovalently bound to plastics, and therefore, it will leach out of these products after repeated use, heating, and/or cleaning of the products. Due to the overuse of DEHP in many products, it enters and pollutes the environment through release from industrial settings and plastic waste disposal sites. DEHP can enter the body through inhalation, ingestion, and dermal contact on a daily basis, which has raised some concerns about its safety and its potential effects on human health. The main aim of this review is to give an overview of the endocrine, testicular, ovarian, neural, hepatotoxic, and cardiotoxic effects of DEHP on animal models and humans in vitro and in vivo. PMID:29682520

  12. Hypersensitivity reactions to vaccine constituents: a case series and review of the literature.

    PubMed

    Leventhal, Jonathan S; Berger, Emily M; Brauer, Jeremy A; Cohen, David E

    2012-01-01

    Vaccines are composed of immunogens, preservatives, adjuvants, antibiotics, and manufacturing by-products. Components of vaccines may rarely elicit adverse reactions in susceptible individuals, thus raising concerns regarding vaccine safety. In this report, we add to the medical literature 3 cases of cutaneous delayed-type hypersensitivity to the vaccine preservative aluminum. We provide a review of major constituents in vaccines that have elicited immediate-type or delayed-type hypersensitivity reactions and describe their clinical manifestations. We include a table of the Food and Drug Administration-approved vaccines, which lists the quantities of major components including ovalbumin (egg protein), gelatin, aluminum, neomycin, 2-phenoxyethanol, thimerosal, and formaldehyde. Our goals were to inform physicians on the variety of hypersensitivity reactions to common vaccines and to provide information on the choice of vaccines in patients with suspected hypersensitivity.

  13. Inhibition of melanin content by Punicalagins in the super fruit pomegranate (Punica granatum).

    PubMed

    Rana, Jatinder; Diwakar, Ganesh; Saito, Lisa; Scholten, Jeffrey D; Mulder, Timothy

    2013-01-01

    Current efforts to develop effective skin lightening products through the inhibition of melanin production have focused on compounds that inhibit the function and activity of tyrosinase, the rate-limiting enzyme in the melanin biosynthesis pathway. Synthetic tyrosinase inhibitors, such as hydroquinone, kojic acid, and arbutin, have been reported to cause skin irritation or acute dermatitis, raising concerns about the safety of these compounds. As a result, there is a need for safe natural ingredients that show effective skin lightening. In this report, we have identified a natural ingredient, pomegranate fruit extract, that inhibits melanin production in melanocytes and shows potential for use as a cosmetic skin lightening agent. In addition, we have identified a polyphenolic compound, punicalagins, as the active melanin inhibitor in pomegranate fruit extract based on its capacity to directly inhibit melanin production.

  14. 'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.

    PubMed

    Martinez, William; Etchegaray, Jason M; Thomas, Eric J; Hickson, Gerald B; Lehmann, Lisa Soleymani; Schleyer, Anneliese M; Best, Jennifer A; Shelburne, Julia T; May, Natalie B; Bell, Sigall K

    2015-11-01

    To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour. Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns. Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (r<0.85 for all correlations), a measure of discriminant validity. The SUC-Safe and SUC-Prof scales were associated with participants' self-reported speaking up behaviour about safety and professionalism concerns (r=0.21, p<0.001 and r=0.22, p<0.001, respectively), a measure of concurrent validity, while teamwork and safety climate scales were not. We created and provided evidence for the reliability and validity of two measures (SUC-Safe and SUC-Prof scales) associated with self-reported speaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics. 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.

  15. The Fundamentals of Community College Fund Raising.

    ERIC Educational Resources Information Center

    Brumbach, Mary A.; Bumphus, Walter G.

    1993-01-01

    Presents a guide for community college fund raising. Discusses organizational principles and structural models; operational concerns such as stewardship of funds, information dissemination, and donor research; and the importance of presidential support, institutional reputation and environment, and experienced grants managers. Includes practical…

  16. Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

    PubMed

    Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

    2018-05-15

    Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

  17. Fears, Uncertainties, and Hopes: Patient-Initiated Actions and Doctors’ Responses During Oncology Interviews*

    PubMed Central

    Beach, Wayne A.; Dozier, David M.

    2015-01-01

    New cancer patients frequently raise concerns about fears, uncertainties, and hopes during oncology interviews. This study sought to understand when and how patients raise their concerns, how doctors responded to these patient-initiated actions, and implications for communication satisfaction. A sub-sampling of video recorded and transcribed encounters was investigated involving 44 new patients and 14 oncologists. Patients completed pre-post self-report measures about fears, uncertainties, and hopes as well as post-evaluations of interview satisfaction. Conversation Analysis (CA) was employed to initially identify pairs of patient-initiated and doctor-responsive actions. A coding scheme was subsequently developed, and two independent coding teams, comprised of two coders each, reliably identified patient-initiated and doctor-responsive social actions. Interactional findings reveal that new cancer patients initiate actions much more frequently than previous research had identified, concerns are usually raised indirectly, and with minimal emotion. Doctors tend to respond to these concerns immediately, but with even less affect, and rarely partner with patients. From pre-post results it was determined that the higher patients’ reported fears, the higher their post-visit fears and lower their satisfaction. Patients with high uncertainty were highly proactive (e.g., asked more questions), yet reported even greater uncertainties following encounters. Hopeful patients also exited interviews with high hopes. Overall, new patients were very satisfied: Oncology interviews significantly decreased patients’ fears and uncertainties, while increasing hopes. Discussion raises key issues for improving communication and managing quality cancer care. PMID:26134261

  18. Adolescents' attitudes towards e-cigarette ingredients, safety, addictive properties, social norms, and regulation.

    PubMed

    Gorukanti, Anuradha; Delucchi, Kevin; Ling, Pamela; Fisher-Travis, Raymond; Halpern-Felsher, Bonnie

    2017-01-01

    E-cigarette use has dramatically increased. While studies have examined adolescents' attitudes towards smoking, few have extended this research to adolescents' attitudes towards e-cigarettes. The goal of this study was to examine adolescents' attitudes regarding e-cigarette ingredients, safety, addictive properties, social norms, accessibility, price, and regulation; and determine whether attitudes differ by past cigarette/e-cigarette use. Participants were 786 9th and 12th graders from California (63.21% females; mean age=16.10years [SD=1.6]; 26.61% White, 21.98% Asian/Pacific Islander, 29.82% Hispanic, and 21.59% other). Results indicated that 19.05% of participants believed smoke from e-cigarettes is water; 23.03% believed e-cigarettes aren't a tobacco product; 40.36% considered e-cigarettes to be for cessation, and 43.13% felt they were safer than cigarettes. Participants felt it was more acceptable to use e-cigarettes indoors and outdoors compared to cigarettes (p<0.0001), 23.13% felt raising e-cigarette taxes is a bad idea, 63.95% thought e-cigarettes were easier to get than cigarettes, 54.42% felt e-cigarettes cost too much, 64.33% felt the age for buying e-cigarettes should be raised, and 64.37% favored e-cigarette regulation. Adolescents who used e-cigarettes and/or cigarettes had significantly more favorable e-cigarette attitudes than non-users. This study indicates that adolescents are aware of some of the risks of e-cigarettes, although many harbor misperceptions and hold more favorable attitudes towards e-cigarettes than cigarettes. Of concern is the relationship between favorable e-cigarette attitudes and use. Findings suggest the need to provide adolescents with correct information about e-cigarette ingredients, risks, and the insufficient evidence of their role in cigarette cessation. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Adolescents' Attitudes towards E-cigarette Ingredients, Safety, Addictive Properties, Social Norms, and Regulation

    PubMed Central

    Gorukanti, Anuradha; Delucchi, Kevin; Ling, Pamela; Fisher-Travis, Raymond; Halpern-Felsher, Bonnie

    2017-01-01

    E-cigarette use has dramatically increased. While studies have examined adolescents’ attitudes towards smoking, few have extended this research to adolescents’ attitudes towards e-cigarettes. The goal of this study was to examine adolescents' attitudes regarding e-cigarette ingredients, safety, addictive properties, social norms, accessibility, price, and regulation; and determine whether attitudes differ by past cigarette/e-cigarette use. Participants were 786 9th and 12th graders from California (63.21% females; mean age = 16.10 years [SD = 1.6]; 26.61% White, 21.98% Asian/Pacific Islander, 29.82% Hispanic, and 21.59% other). Results indicated that 19.05% of participants believed smoke from e-cigarettes is water; 23.03% believed e-cigarettes aren't a tobacco product; 40.36% considered e-cigarettes to be for cessation, and 43.13% felt they were safer than cigarettes. Participants felt it was more acceptable to use e-cigarettes indoors and outdoors compared to cigarettes (p < .0001), 23.13% felt raising e-cigarette taxes is a bad idea, 63.95% thought e-cigarettes were easier to get than cigarettes, 54.42% felt e-cigarettes cost too much, 64.33% felt the age for buying e-cigarettes should be raised, and 64.37% favored e-cigarette regulation. Adolescents who used e-cigarettes and/or cigarettes had significantly more favorable e-cigarette attitudes than non-users. This study indicates that adolescents are aware of some of the risks of e-cigarettes, although many harbor misperceptions and hold more favorable attitudes towards e-cigarettes than cigarettes. Of concern is the relationship between favorable e-cigarette attitudes and use. Findings suggest the need to provide adolescents with correct information about e-cigarette ingredients, risks, and the insufficient evidence of their role in cigarette cessation. PMID:27773711

  20. Mechanized Off-Road Equipment Safety. Module SH-17. Safety and Health.

    ERIC Educational Resources Information Center

    Center for Occupational Research and Development, Inc., Waco, TX.

    This student module on mechanized off-road equipment safety is one of 50 modules concerned with job safety and health. This module aims to encourage the development of a positive approach to safety as it concerns the heavy equipment industry. Following the introduction, 15 objectives (each keyed to a page in the text) the student is expected to…

  1. 77 FR 38495 - Safety Zone; Village of Sodus Point Fireworks Display, Sodus Bay, Sodus Point, NY

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-28

    .... Regulatory History and Information The Coast Guard is issuing this temporary final rule without prior notice... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone...

  2. Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

    PubMed

    Singh, Hardeep; Sittig, Dean F

    2016-04-01

    Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety benefits of health IT in real-world clinical settings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. 78 FR 36429 - Safety Zone; Private Party Fireworks; Lake Michigan, Chicago, IL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... not raise any novel legal or policy issues. The safety zone created by this rule will be small and... the safety zone when permitted by the Captain of the Port. 2. Impact on Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities...

  4. 78 FR 34582 - Safety Zone; Rochester Yacht Club Fireworks, Genesee River, Rochester, NY

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-10

    ... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone... through the safety zone when permitted by the Captain of the Port. 2. Impact on Small Entities Under the... entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule will not have a...

  5. 78 FR 34575 - Safety Zone; Bay Swim VI, Presque Isle Bay, Erie, PA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-10

    ... of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone... through the safety zone when permitted by the Captain of the Port. 2. Impact on Small Entities Under the... entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule will not have a...

  6. 76 FR 41693 - Safety Zone; Truman-Hobbs Alteration of the Elgin Joliet & Eastern Railroad Drawbridge; Illinois...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... or e-mail BM1 Adam Kraft, U.S. Coast Guard Sector Lake Michigan, at 414-747-7148 or Adam[email protected] project of the Elgin Joliet & Eastern Railroad Drawbridge poses significant risks to public safety and... not raise any novel legal or policy issues. The safety zone around the bridge project will be...

  7. The 'over-researched community': An ethics analysis of stakeholder views at two South African HIV prevention research sites.

    PubMed

    Koen, Jennifer; Wassenaar, Douglas; Mamotte, Nicole

    2017-12-01

    Health research in resource-limited, multi-cultural contexts raises complex ethical concerns. The term 'over-researched community' (ORC) has been raised as an ethical concern and potential barrier to community participation in research. However, the term lacks conceptual clarity and is absent from established ethics guidelines and academic literature. In light of the concern being raised in relation to research in low- and middle-income countries (LMICs), a critical and empirical exploration of the meaning of ORC was undertaken. Guided by Emanuel et al.'s (2004) eight principles for ethically sound research in LMICs, this study examines the relevance and meaning of the terms 'over-research' and 'over-researched community' through an analysis of key stakeholder perspectives at two South African research sites. Data were collected between August 2007 and October 2008. 'Over-research' was found to represent a conglomeration of ethical concerns often used as a proxy for standard research ethics concepts. 'Over-research' seemed fundamentally linked to disparate positions and perspectives between different stakeholders in the research interaction, arising from challenges in inter-stakeholder relationships. 'Over-research' might be interpreted to mean exploitation. However, exploitation itself could mean different things. Using the term may lead to obscured understanding of real or perceived ethical concerns, making it difficult to identify and address the underlying concerns. It is recommended that the term be carefully and critically interrogated for clarity when used in research ethics discourse. Because it represents other legitimate concerns, it should not be dismissed without careful exploration. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Fire safety

    Treesearch

    Robert H. White; Mark A. Dietenberger

    1999-01-01

    Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Since basic data on fire behavior of wood products...

  9. Aviation safety : FAA and DOD response to similar safety concerns

    DOT National Transportation Integrated Search

    2002-01-01

    Report to the Honorable Norman Y. Mineta, Secretary of Transportation, and the Honorable Donald H. Rumsfeld, Secretary of Defense. : Safety of aircraft is a paramount concern in both civilian and military aviation. The Federal Aviation Administration...

  10. FRAMEWORK FOR EVALUATION OF PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR USE IN SAFETY OR RISK ASSESSMENT

    EPA Science Inventory

    ABSTRACT

    Proposed applications of increasingly sophisticated biologically-based computational models, such as physiologically-based pharmacokinetic (PBPK) models, raise the issue of how to evaluate whether the models are adequate for proposed uses including safety or risk ...

  11. JPRS Report China

    DTIC Science & Technology

    1988-03-01

    of Laser Radiation on Blood Enzymes of Sheep 66 Outbreak of Pox in Mature Hogs Reported 66 Study of Peanut Viruses Summarized 66 Polymorphus...As far as peasants are concerned, raising 1 pig is not better than raising 10 chickens , and therefore their enthusiasm is dampened. We will raise...1988 30 ECONOMIC on bank credit. If necessary, we can draw on the experi- ence of the Philippines, Brazil, Mexico , France, and other countries and

  12. Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine.

    PubMed

    Gould, A Lawrence; Wang, William B

    2017-01-15

    The development of drugs and biologicals whose mechanisms of action may extend beyond their target indications has led to a need to identify unexpected potential toxicities promptly even while blinded clinical trials are under way. One component of recently issued FDA rules regarding safety reporting requirements raises the possibility of breaking the blind for pre-identified serious adverse events that are not the clinical endpoints of a blinded study. Concern has been expressed that unblinding individual cases of frequently occurring adverse events could compromise the overall validity of the study. However, if external information is available about adverse event rates among patients not receiving the test product in populations similar to the study population, then it may be possible to address the potential for elevated risk without unblinding the trial. This article describes a Bayesian approach for determining the likelihood of elevated risk suitable binomial or Poisson likelihoods that applies regardless of the metric used to express the difference. The method appears to be particularly appropriate for routine monitoring of safety information for project development programs that include large blinded trials. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  13. NIOSH comments to DOL on MSHA's advance notice of proposed rulemaking (ANPR) metal and nonmetal mine safety and health, radiation standards by J. D. Millar, March 18, 1985

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1985-03-18

    The testimony presents the views of NIOSH with regard to specific issues raised by MSHA in a proposed rulemaking affecting metal and nonmetal mine safety and health, radiation standards. Results are included from epidemiological studies in which the relationship between lung cancer and exposure to radon daughters was examined. A quantitative risk assessment is also noted which will be considered in the development of a NIOSH recommended exposure limit for radon daughters. Specific issues addressed include risk assessment, particularly the relationship and the associated uncertainty between cumulative lifetime radon daughters exposure at or below 120 working level months and themore » lifetime risk of lung cancer or other biological response, and themethodology used to arrive at the risk relationship. The use of a nonthreshold model extrapolating from elevated exposure levels is considered along with modification of the risk relationship to account for cell repair or other factors. Questions concerning the latency period, cigarette smoking, exposure to thoron daughters, exposure to gamma radiation, and exposure to ore dusts are also addressed.« less

  14. Condom Use and High-Risk Sexual Acts in Adult Films: A Comparison of Heterosexual and Homosexual Films

    PubMed Central

    Elliott, Marc N.; Kerndt, Peter R.; Schuster, Mark A.; Brook, Robert H.; Gelberg, Lillian

    2009-01-01

    Objectives. We compared the prevalence of condom use during a variety of sexual acts portrayed in adult films produced for heterosexual and homosexual audiences to assess compliance with state Occupational Health and Safety Administration regulations. Methods. We analyzed 50 heterosexual and 50 male homosexual films released between August 1, 2005, and July 31, 2006, randomly selected from the distributor of 85% of the heterosexual adult films released each year in the United States. Results. Penile–vaginal intercourse was protected with condoms in 3% of heterosexual scenes. Penile–anal intercourse, common in both heterosexual (42%) and homosexual (80%) scenes, was much less likely to be protected with condoms in heterosexual than in homosexual scenes (10% vs 78%; P < .001). No penile–oral acts were protected with condoms in any of the selected films. Conclusions. Heterosexual films were much less likely than were homosexual films to portray condom use, raising concerns about transmission of HIV and other sexually transmitted diseases, especially among performers in heterosexual adult films. In addition, the adult film industry, especially the heterosexual industry, is not adhering to state occupational safety regulations. PMID:19218178

  15. Results of EUREKA project STILMED: transfer to standards

    NASA Astrophysics Data System (ADS)

    Woellmer, Wolfgang

    1996-12-01

    The final results of the German part of the joint project STILMED 'Safety Technology in Laser Medicine' are available and being prepared for publication. The question is raised, if parts of these results may be subject to international standards. An overview is given for the structure and procedure of national, European and international standardization. Existing standards are considered concerning their relationship to STILMED, which dealt with the chemical, particulate and microbiological composition and possible hazards of laser plume, as well as protection means, like plume evacuators, including the development of nozzles and instruments with integrated evacuation channels, and face masks. Results of basic research and experiences with medical treatment modalities are not matter for standardization. On the other hand, plume evacuators and their technical data should be submitted to standards, which define test procedures for their performance and safety. Also, surgical face masks, for which no international standards exists, could be well suited for standardization, although the multitude of application conditions would make it an excessive task. At least, products that claim 'for laser use' or 'laserproof' or similar should fulfill standardized requirements, and the respective wording needs protection by standard definition.

  16. Drug-Drug Interactions, Effectiveness, and Safety of Hormonal Contraceptives in Women Living with HIV.

    PubMed

    Scarsi, Kimberly K; Darin, Kristin M; Chappell, Catherine A; Nitz, Stephanie M; Lamorde, Mohammed

    2016-11-01

    Family planning options, including hormonal contraceptives, are essential for improving reproductive health among the more than 17 million women living with HIV worldwide. For these women, prevention of unintended pregnancy decreases maternal and child mortality, as well as reduces the risk of perinatal HIV transmission. Similarly, treatment of HIV with antiretroviral therapy (ART) is essential for reducing morbidity and mortality among HIV-positive individuals, as well as preventing HIV transmission between sexual partners or from mother to child. Importantly, despite the benefits of hormonal contraceptives, barriers to effective family planning methods exist for HIV-positive women. Specifically, drug-drug interactions can occur between some antiretroviral medications and some hormonal contraceptives, which may influence both contraceptive efficacy and tolerability. In addition, safety concerns have been raised about the impact of hormonal contraceptives on HIV disease progression, tolerability, and the risk of female-to-male HIV transmission. This review article summarizes the potential for drug-drug interactions, tolerability, and contraceptive effectiveness when hormonal contraceptives are combined with ART. In addition, the evidence surrounding the influence of hormonal contraceptives on HIV transmission and HIV disease progression in women living with HIV are summarized.

  17. Soy protein for infant feeding: what do we know?

    PubMed

    Turck, Dominique

    2007-05-01

    This review discusses the safety, nutritional adequacy and recommendations for use of soy protein formulae, based mainly on the most relevant reports published during 2005 and 2006. Concerns have recently been raised regarding potential risks with soy protein formulae, in particular regarding their high phytoestrogenic isoflavone content. Recent data are insufficient to draw definitive conclusions on safety, but authorities and paediatric societies from several countries recently advised health professionals to use soy protein formulae only in certain cases. Indications for use of soy protein formulae, mainly for prevention and management of food allergy, have also been better defined. Soy protein formulae ensure normal growth and development in healthy term infants but they have no nutritional advantages over cow's milk protein formulae. Main indications include severe lactose intolerance, galactosaemia and need to avoid foods of animal origin. Soy protein formulae have no role in preventing allergy or in management of nonspecific gastrointestinal symptoms (e.g. infantile colic and regurgitation). They should not be used in preterm infants or infants with food allergy before age 6 months. After 6 months, soy protein formulae may be considered if tolerance to soy protein is established.

  18. Lasers and intense pulsed light (IPL) association with cancerous lesions.

    PubMed

    Ash, Caerwyn; Town, Godfrey; Whittall, Rebecca; Tooze, Louise; Phillips, Jaymie

    2017-11-01

    The development and use of light and lasers for medical and cosmetic procedures has increased exponentially over the past decade. This review article focuses on the incidence of reported cases of skin cancer post laser or IPL treatment. The existing evidence base of over 25 years of laser and IPL use to date has not raised any concerns regarding its long-term safety with only a few anecdotal cases of melanoma post treatment over two decades of use; therefore, there is no evidence to suggest that there is a credible cancer risk. Although laser and IPL technology has not been known to cause skin cancer, this does not mean that laser and IPL therapies are without long-term risks. Light therapies and lasers to treat existing lesions and CO 2 laser resurfacing can be a preventative measure against BCC and SCC tumour formation by removing photo-damaged keratinocytes and encouraged re-epithelisation from stem cells located deeper in the epidermis. A review of the relevant literature has been performed to address the issue of long-term IPL safety, focussing on DNA damage, oxidative stress induction and the impact of adverse events.

  19. Policies to protect persons with dementia in assisted living: déjà vu all over again?

    PubMed

    Kaskie, Brian P; Nattinger, Matthew; Potter, Andrew

    2015-04-01

    Continued growth in the number of individuals with dementia residing in assisted living (AL) raises concerns about their safety and protection. In this Forum, we review current AL practices relevant to residents with dementia and present a rationale for examining the government role in protecting these individuals within this context. Since public oversight of AL is currently a state prerogative, we assess states' regulatory activity across 3 domains closely related to safety and protection of persons with dementia: environmental features, staffing, and use of chemical restraints. We then step back to consider the state policymaking environment and assess the feasibility of developing a minimum standard of regulations from one state to the next. This Forum concludes with a historical comparison between the contemporary AL market and the nursing home care market prior to the Nursing Home Reform Act of 1987, and we discuss how an increased amount of federal interest could improve existing state efforts to protect persons with dementia residing in AL. © The Author 2015. 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.

  20. Nanotechnology in cosmetics: Opportunities and challenges

    PubMed Central

    Raj, Silpa; Jose, Shoma; Sumod, U. S.; Sabitha, M.

    2012-01-01

    Nanotechnology is the science of manipulating atoms and molecules in the nanoscale - 80,000 times smaller than the width of a human hair. The world market for products that contain nanomaterials is expected to reach $2.6 trillion by 2015. The use of nanotechnology has stretched across various streams of science, from electronics to medicine and has now found applications in the field of cosmetics by taking the name of nanocosmetics. This widespread influence of nanotechnology in the cosmetic industries is due to the enhanced properties attained by the particles at the nano level including color, transparency, solubility etc. The different types of nanomaterials employed in cosmetics include nanosomes, liposomes, fullerenes, solid lipid nanoparticles etc. Recently, concerns over the safety of such nanocosmetics are raised and have forced the cosmetic industries to limit the use of nanotechnology in cosmetics and for enforcing laws to undergo a full-fledged safety assessment before they enter into the market. In this review, emphasis is made on the types of nanomaterials used in cosmetics by the various cosmetic brands, the potential risks caused by them both to human life and also to the environment and what all regulations have been undertaken or can be taken to overcome them. PMID:22923959

  1. Pharmacovigilance in Asia

    PubMed Central

    Biswas, Pipasha

    2013-01-01

    An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in Asia. It has been a constant challenge to standardize pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geaographical, cultural and medical practices in these regioon. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries, though several attempts have been taken. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance. For this to happen, the mind set of people working in regulatory agencies, the Pharmaceutical companies, prescribers and patients/consumers need to change. PMID:24347987

  2. Surgical management of benign and indeterminate hepatic lesions in the era of laparoscopic liver surgery.

    PubMed

    Abu Hilal, Mohammed; Di Fabio, Francesco; Teng, Mabel Joey; Godfrey, Dean Anthony; Primrose, John Neil; Pearce, Neil William

    2011-01-01

    The expansion of the laparoscopic approach for the management of benign liver lesions has raised concerns regarding the risk of widening surgical indications and compromising safety. Large single-centre series focusing on laparoscopic management of benign liver lesions are sporadic. We reviewed a prospectively collected database of patients undergoing pure laparoscopic liver resection (LLR) for benign liver lesions. All cases were individually discussed at a multidisciplinary team meeting. Forty-six patients underwent 50 LLRs for benign disease. Indications for surgery were: symptomatic lesions, preoperative diagnosis of adenoma or cystadenoma, and lesions with an indeterminate diagnosis. The preoperative diagnosis was uncertain in 11 cases. Of these, histological diagnosis was hepatocellular carcinoma in one (9%) and benign lesion in 10 patients (91%). Thirteen patients (28%) required major hepatectomy. Three patients (7%) developed postoperative complications. Mortality was nil. The median postoperative hospital stay following major and minor hepatectomy was 4 and 3 days, respectively. The laparoscopic approach represents a safe option for the management of benign and indeterminate liver lesions, even when major hepatectomy is required. LLR should be only performed in specialized centres to ensure safety and strict adherence to orthodox surgical indication. Copyright © 2011 S. Karger AG, Basel.

  3. The challenges posed by radiation and radionuclide releases to the environment.

    PubMed

    Wenning, Richard J; Apitz, Sabine E; Backhaus, Thomas; Barnthouse, Lawrence; Batley, Graeme; Brooks, Bryan; Chapman, Peter M; Griffin, Michael; Kapustka, Lawrence; Landis, Wayne; Leung, Kenneth M Y; Linkov, Igor; Seager, Thomas P; Suter, Glenn; Tannenbaum, Lawrence

    2011-07-01

    The recent accident at the Fukushima I nuclear power plant in Japan (also known as Fukushima Daiichi) captured the world's attention and re-invigorated concerns about the safety of nuclear power technology. The Editors of Integrated Environmental Assessment and Management invited experts in the field to describe the primary issues associated with the control and release of radioactive materials to the environment, particularly those that are of importance to the health of the human populations and the ecological systems that populate our planet. This collection of invited short commentaries aims to inform on the safety of nuclear power plants damaged by natural disasters and provide a primer on the potential environmental impacts. The intent of these invited commentaries is not to fuel the excitement and fears about the Fukushima Daiichi incident; rather, it is to collect views and comments from some of the world's experts on the broad science and policy challenges raised by this event, and to provide high-level views on the science issues that surround this situation in order to improve our collective ability to avoid or at least minimize the consequences of future events. Copyright © 2011 SETAC.

  4. Current and prospective safety issues at the HFBR

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Tichler, P.R.

    The Brookhaven High Flux Beam Reactor (HFBR) was designed primarily to produce external neutron beams for experimental research. It is cooled, moderated and reflected by heavy water and uses MTR-ETR type fuel elements containing enriched uranium. The reactor power when operation began in 19965 was 40 MW, was raised to 60 MW in 1982 after a number of plant modifications, and operated at that level until 1989. Since that time safety questions have been raised which resulted in extended shutdowns and a reduction in operating power to 30 MW. This paper will discuss the principle safety issues, plans for theirmore » resolution and return to 60 MW operation. In addition, radiation embrittlement of the reactor vessel and thermal shield and its affect on the life of the facility will be briefly discussed.« less

  5. Current and prospective safety issues at the HFBR

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Tichler, P.R.

    The Brookhaven high-flux beam reactor (HFBR) was designed primarily to produce external neutron beams for experimental research. It is cooled, moderated, and reflected by heavy water and uses materials test reactor and engineering test reactor type of fuel elements containing enriched uranium. The reactor power when operation began in 1965 was 40 MW, was raised to 60 MW in 1982 after a number of plant modifications, and operated at that level until 1989. Since that time, safety questions have been raised that resulted in extended shutdowns and a reduction in operating power to 30 MW. This paper discusses the principalmore » safety issues and plans for their resolution and return to 60-MW operation. In addition, radiation embrittlement of the reactor vessel and thermal shield and its effect on the life of the facility are briefly discussed.« less

  6. Aspartame: should individuals with Type II Diabetes be taking it?

    PubMed

    Choudhary, Arbind Kumar

    2017-05-31

    Individuals with type II diabetes (T2D) have to manage blood glucose levels to sustain health and longevity. Artificial sweeteners (including aspartame) are suggested sugar alternatives for these individuals. The safety of aspartame in particular, has long been the centre of debate. Although it is such a controversial product, many clinicians recommend its use to T2D patients, during a controlled diet and as part of an intervention strategy. Aspartame is 200 times sweeter than sugar and has a negligible effect on blood glucose levels, and it is suggested for use so that T2D can control carbohydrate intake and blood glucose levels. However, research suggests that aspartame intake may lead to an increased risk of weight gain rather than weight loss, and cause impaired blood glucose tolerance in T2D. This review consolidates knowledge gained from studies that link aspartame consumption to the various mechanisms associated with T2D. We review literature that provides evidence that raise concerns that aspartame may exacerbate T2D and add to the global burden of disease. Aspartame may act as a chemical stressor by increasing cortisol levels, and may induce systemic oxidative stress by producing excess free radicals, and it may also alter gut microbial activity and interfere with the N-methyl D-aspartate (NMDA) receptor, resulting in insulin deficiency or resistance. Aspartame and its metabolites are safe for T2D is still debatable due to a lack of consistent data. More research is required that provides evidence and raise concerns that aspartame may exacerbate prevalence of pathological physiology in the already stressed physiology of T2D. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  7. Ethics and Epistemology in Big Data Research.

    PubMed

    Lipworth, Wendy; Mason, Paul H; Kerridge, Ian; Ioannidis, John P A

    2017-12-01

    Biomedical innovation and translation are increasingly emphasizing research using "big data." The hope is that big data methods will both speed up research and make its results more applicable to "real-world" patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethical, organizational, and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, and data analysis techniques. While such advances will likely go some way towards resolving technical and methodological issues, we believe that the epistemological issues raised by big data research have important ethical implications and raise questions about the very possibility of big data research achieving its goals.

  8. Communication and general concern criterion prior to activation of the rapid response team: a grounded theory.

    PubMed

    Martland, Jarrad; Chamberlain, Diane; Hutton, Alison; Smigielski, Michael

    2016-11-01

    Objective Patients commonly show signs and symptoms of deterioration for hours or days before cardiorespiratory arrest. Rapid response teams (RRT) were created to improve recognition and response to patient deterioration in these situations. Activation criteria include vital signs or 'general concern' by a clinician or family member. The general concern criterion for RRT activation accounts for nearly one-third of all RRT activity, and although it is well established that communication deficits between staff can contribute to poorer outcomes for patients, there is little evidence pertaining to communication and its effects on the general concern RRT activation. Thus, the aim of the present study was to develop a substantive grounded theory related to the communication process between clinicians that preceded the activation of an RRT when general concern criterion was used. Methods Qualitative grounded theory involved collection of three types of data details namely personal notes from participants in focus groups with white board notes from discussions and audio recordings of the focus groups sessions. Focus groups were conducted with participants exploring issues associated with clinician communication and how it related to the activation of an RRT using the general concern criterion. Results The three main phases of coding (i.e. open, axial and selective coding) analysis identified 322 separate open codes. The strongest theme contributed to a theory of ineffective communication and decreased psychological safety, namely that 'In the absence of effective communication there is a subsequent increase in anxiety, fear or concern that can be directly attributed to the activation of an RRT using the 'general concern' criterion'. The RRT filled cultural and process deficiencies in the compliance with an escalation protocol. Issues such as 'not for resuscitation documentation' and 'inability to establish communication with and between medical or nursing personnel' rated highly and contributed to the debate. Conclusions This study highlighted that in the surveillance and management of the deteriorating patient and in the absence of effective communication there is a subsequent increase in anxiety, fear or concern that can be directly attributed to the activation of an RRT for the 'general concern' calling criteria. What is known about the topic? Deficiencies in collaboration and communication between healthcare professionals (HCPs) increase the stress and anxiety of healthcare staff and correspond to poorer outcomes for patients. The RRT can be activated as a 'general concern RRT' without observation of physiological derangements if staff are concerned about a patient's condition, allowing for assistance from a skilled critical care team at the patient's bedside. There are limited data on how poor communication affects the frequency of activation of general concern RRTs. What does this paper add? This study shows that poor communication between health professionals increases staff levels of anxiety and concern. In addition, the RRT system is being used to fill deficiencies in many other hospital processes, including end-of-life discussions. The deficiencies in hospital processes contribute to poor communication and increased levels of concern with this study demonstrating a direct link between a clinician's level of anxiety/concern and the 'general concern' activation category for the RRT system. What are the implications for practitioners? The present study highlights the importance of effective communication strategies between HCPs to improve patient safety and quality of care. The study also highlights the expanding role of the RRT in hospitals, which has implications for hospital policy makers with regard to future funding and resource allocation. Finally, many of the concerns raised in the present study by the focus groups have been addressed by recent measures introduced through the Australian Commission on Safety and Quality in Health Care (e.g. rapid detection and response observation charts and Introduction, Situation, Background, Assessment and Recommendation [ISBAR] style of communication) with these measures supported by the findings of the present study.

  9. Raising the Bar for Reproducible Science at the US Environmental Protection Agency Office of Research and Development

    EPA Science Inventory

    Considerable concern has been raised regarding research reproducibility both within and outside the scientific community. Several factors possibly contribute to a lack of reproducibility, including a failure to adequately employ statistical considerations during study design, bia...

  10. Educational Choice: Practical Policy Questions. Occasional Paper Series No. 7.

    ERIC Educational Resources Information Center

    First, Patricia F.

    The consideration of school choice plans raises policy questions for school administrators. This paper addresses pragmatic concerns about definitions and policy questions related to educational finance. Interdistrict choice, emphasizing families' right to choose among existing public schools, raises questions regarding transportation and…

  11. Bond Issues.

    ERIC Educational Resources Information Center

    Pollack, Rachel H.

    2000-01-01

    Notes trends toward increased borrowing by colleges and universities and offers guidelines for institutions that are considering issuing bonds to raise money for capital projects. Discussion covers advantages of using bond financing, how use of bonds impacts on traditional fund raising, other cautions and concerns, and some troubling aspects of…

  12. Evaluation of the patient safety Leadership Walkabout programme of a hospital in Singapore.

    PubMed

    Lim, Raymond Boon Tar; Ng, Benjamin Boon Lui; Ng, Kok Mun

    2014-02-01

    The Patient Safety Leadership Walkabout (PSLWA) programme is a commonly employed tool in the West, in which senior leaders visit sites within the hospital that are involved in patient care to talk to healthcare staff about patient safety issues. As there is a lack of perspective regarding PSLWA in Asia, we carried out an evaluation of its effectiveness in improving the patient safety culture in Tan Tock Seng Hospital, Singapore. A mixed methods analysis approach was used to review and evaluate all documents, protocols, meeting minutes, post-walkabout surveys, action plans and verbal feedback pertaining to the walkabouts conducted from January 2005 to October 2012. A total of 321 patient safety issues were identified during the study period. Of these, 308 (96.0%) issues were resolved as of November 2012. Among the various categories of issues raised, issues related to work environment were the most common (45.2%). Of all the issues raised during the walkabouts, 72.9% were not identified through other conventional methods of error detection. With respect to the hospital's patient safety culture, 94.8% of the participants reported an increased awareness in patient safety and 90.2% expressed comfort in openly and honestly discussing patient safety issues. PSLWA serves as a good tool to uncover latent errors before actual harm reaches the patient. If properly implemented, it is an effective method for engaging leadership, identifying patient safety issues, and supporting a culture of patient safety in the hospital setting.

  13. Dark Skies Awareness Programs for the International Year of Astronomy: Involvement, Outcomes and Sustainability

    NASA Astrophysics Data System (ADS)

    Walker, Constance E.

    2010-01-01

    The preservation of dark skies is a growing global concern, yet it is one of the easiest environmental problems people can address on local levels. For this reason, the goal of the IYA Dark Skies Awareness Cornerstone Project is to raise public awareness of the impact of artificial lighting on local environments by getting people worldwide involved in a variety of programs. These programs provide resources on light pollution for new technologies like a presence in Second Life and podcasts, for local thematic events at national parks and observatory open houses, for international thematic events like International Dark Skies Week and Earth Hour, for a program in the arts like an international photo contest, for global citizen-science programs that measure night sky brightness worldwide, and for educational materials like a kit with a light shielding demonstration. These programs have been successfully used around the world during IYA to raise awareness of the effects of light pollution on public health, economic issues, ecological consequences, energy conservation, safety and security, and astronomy. The presentation will provide an update, take a look ahead at the project's sustainability, and describe how people can be involved in the future. Information about the programs is at www.darkskiesawareness.org.

  14. Promoting Dark Skies Awareness Programs Beyond the International Year of Astronomy 2009

    NASA Astrophysics Data System (ADS)

    Walker, Constance E.; Dark Skies Working Group

    2010-01-01

    The preservation of dark skies is a growing global concern, yet it is one of the easiest environmental problems people can address on local levels. For this reason, the goal of the International Year of Astronomy 2009 (IYA2009) Dark Skies Awareness Cornerstone Project is to raise public awareness of the impact of artificial lighting on local environments by getting people worldwide involved in a variety of programs. These programs provide resources on light pollution for new technologies like a presence in Second Life and podcasts, for local thematic events at national parks and observatory open houses, for international thematic events like International Dark Skies Week and Earth Hour, for a program in the arts like an international photo contest, for global citizen-science programs that measure night sky brightness worldwide, and for educational materials like a kit with a light shielding demonstration. These programs have been successfully used around the world during IYA2009 to raise awareness of the effects of light pollution on public health, economic issues, ecological consequences, energy conservation, safety and security, and astronomy. The poster will provide an update, take a look ahead at the project's sustainability, and describe how people can be involved in the future. Information about the programs is at www.darkskiesawareness.org.

  15. Ethical practice in internet research involving vulnerable people: lessons from a self-harm discussion forum study (SharpTalk).

    PubMed

    Sharkey, Siobhan; Jones, Ray; Smithson, Janet; Hewis, Elaine; Emmens, Tobit; Ford, Tamsin; Owens, Christabel

    2011-12-01

    The internet is widely used for health information and support, often by vulnerable people. Internet-based research raises both familiar and new ethical problems for researchers and ethics committees. While guidelines for internet-based research are available, it is unclear to what extent ethics committees use these. Experience of gaining research ethics approval for a UK study (SharpTalk), involving internet-based discussion groups with young people who self-harm and health professionals is described. During ethical review, unsurprisingly, concerns were raised about the vulnerability of potential participants. These were dominated by the issue of anonymity, which also affected participant safety and consent. These ethical problems are discussed, and our solutions, which included: participant usernames specific to the study, a closed website, private messaging facilities, a direct contact email to researchers, information about forum rules displayed on the website, a 'report' button for participants, links to online support, and a discussion room for forum moderators. This experience with SharpTalk suggests that an approach to ethics, which recognises the relational aspects of research with vulnerable people, is particularly useful for internet-based health research. The solutions presented here can act as guidance for researchers developing proposals and for ethics committees reviewing them.

  16. Potential Effects of Pomegranate Polyphenols in Cancer Prevention and Therapy

    PubMed Central

    Turrini, Eleonora; Ferruzzi, Lorenzo

    2015-01-01

    Cancer is the second leading cause of death and is becoming the leading one in old age. Vegetable and fruit consumption is inversely associated with cancer incidence and mortality. Currently, interest in a number of fruits high in polyphenols has been raised due to their reported chemopreventive and/or chemotherapeutic potential. Pomegranate has been shown to exert anticancer activity, which is generally attributed to its high content of polyphenols. This review provides a comprehensive analysis of known targets and mechanisms along with a critical evaluation of pomegranate polyphenols as future anticancer agents. Pomegranate evokes antiproliferative, anti-invasive, and antimetastatic effects, induces apoptosis through the modulation of Bcl-2 proteins, upregulates p21 and p27, and downregulates cyclin-cdk network. Furthermore, pomegranate blocks the activation of inflammatory pathways including, but not limited to, the NF-κB pathway. The strongest evidence for its anticancer activity comes from studies on prostate cancer. Accordingly, some exploratory clinical studies investigating pomegranate found a trend of efficacy in increasing prostate-specific antigen doubling time in patients with prostate cancer. However, the genotoxicity reported for pomegranate raised certain concerns over its safety and an accurate assessment of the risk/benefit should be performed before suggesting the use of pomegranate or its polyphenols for cancer-related therapeutic purposes. PMID:26180600

  17. Potential Effects of Pomegranate Polyphenols in Cancer Prevention and Therapy.

    PubMed

    Turrini, Eleonora; Ferruzzi, Lorenzo; Fimognari, Carmela

    2015-01-01

    Cancer is the second leading cause of death and is becoming the leading one in old age. Vegetable and fruit consumption is inversely associated with cancer incidence and mortality. Currently, interest in a number of fruits high in polyphenols has been raised due to their reported chemopreventive and/or chemotherapeutic potential. Pomegranate has been shown to exert anticancer activity, which is generally attributed to its high content of polyphenols. This review provides a comprehensive analysis of known targets and mechanisms along with a critical evaluation of pomegranate polyphenols as future anticancer agents. Pomegranate evokes antiproliferative, anti-invasive, and antimetastatic effects, induces apoptosis through the modulation of Bcl-2 proteins, upregulates p21 and p27, and downregulates cyclin-cdk network. Furthermore, pomegranate blocks the activation of inflammatory pathways including, but not limited to, the NF-κB pathway. The strongest evidence for its anticancer activity comes from studies on prostate cancer. Accordingly, some exploratory clinical studies investigating pomegranate found a trend of efficacy in increasing prostate-specific antigen doubling time in patients with prostate cancer. However, the genotoxicity reported for pomegranate raised certain concerns over its safety and an accurate assessment of the risk/benefit should be performed before suggesting the use of pomegranate or its polyphenols for cancer-related therapeutic purposes.

  18. Issues and Concerns of Assessment for English Language Learners with Learning Disabilities

    ERIC Educational Resources Information Center

    Pichardo, Blanca

    2014-01-01

    Limited research has been accomplished within the past few years regarding issues and concerns of assessment for English Language Learners (ELL) with Learning Disabilities (LD). The increasing number of this unique population throughout schools has raised many concerns for professionals in education. English Language Learners with Learning…

  19. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Wang, Kejian, E-mail: kejian.wang.bio@gmail.com; Weng, Zuquan; Sun, Liya

    Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. Inmore » the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.« less

  20. Implementing electronic handover: interventions to improve efficiency, safety and sustainability.

    PubMed

    Alhamid, Sharifah Munirah; Lee, Desmond Xue-Yuan; Wong, Hei Man; Chuah, Matthew Bingfeng; Wong, Yu Jun; Narasimhalu, Kaavya; Tan, Thuan Tong; Low, Su Ying

    2016-10-01

    Effective handovers are critical for patient care and safety. Electronic handover tools are increasingly used today to provide an effective and standardized platform for information exchange. The implementation of an electronic handover system in tertiary hospitals can be a major challenge. Previous efforts in implementing an electronic handover tool failed due to poor compliance and buy-in from end-users. A new electronic handover tool was developed and incorporated into the existing electronic medical records (EMRs) for medical patients in Singapore General Hospital (SGH). There was poor compliance by on-call doctors in acknowledging electronic handovers, and lack of adherence to safety rules, raising concerns about the safety and efficiency of the electronic handover tool. Urgent measures were needed to ensure its safe and sustained use. A quality improvement group comprising stakeholders, including end-users, developed multi-faceted interventions using rapid PDSA (P-Plan, D-Do, S-Study, A-Act ) cycles to address these issues. Innovative solutions using media and online software provided cost-efficient measures to improve compliance. The percentage of unacknowledged handovers per day was used as the main outcome measure throughout all PDSA cycles. Doctors were also assessed for improvement in their knowledge of safety rules and their perception of the electronic handover tool. An electronic handover tool complementing daily clinical practice can be successfully implemented using solutions devised through close collaboration with end-users supported by the senior leadership. A combined 'bottom-up' and 'top-down' approach with regular process evaluations is crucial for its long-term sustainability. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  1. Do we know what foundation year doctors think about patient safety incident reporting? Development of a Web based tool to assess attitude and knowledge.

    PubMed

    Robson, Jean; de Wet, Carl; McKay, John; Bowie, Paul

    2011-11-01

    Making healthcare safer is an international priority. Patient safety modules are now taught in medical schools, and methods to assess related student knowledge and attitudes have been developed. However, little is known about the attitudes and knowledge which foundation doctors are developing to patient safety and incident reporting in the healthcare workplace, since a specific assessment tool appears to be lacking. To develop, content validate and pilot test an online questionnaire survey to elicit foundation doctors' knowledge and experience of patient safety and incident reporting, and assess related attitudes and behaviours. Questionnaire content validity was facilitated through: a steering group; literature review; feedback from foundation year doctors and consultant staff; a modified Delphi group; and completion of a content validity index by experts. In 2010 a cross-sectional online survey of 110 foundation year 1 and 2 doctors was then undertaken in three Scottish NHS board areas, utilising the developed 25 item questionnaire. The questionnaire was validated, and piloted among 69 foundation year doctors who responded to the questionnaire. The pilot has provided valuable insights into trainee attitudes and experience. For example, 32 (48%) believed that most safety incidents were due to things that they could not do anything about; and 31 (43%) admitted to being involved in medication errors which were not formally reported. The pilot study was successful in taking the first steps to developing a validated survey questionnaire for a key staff group, foundation year doctors, in a priority area. However, the findings raise concerns about trainee experience of and attitudes to reporting, and the frequency with which incidents go unreported.

  2. Is safety of childhood growth hormone therapy related to dose? Data from a large observational study.

    PubMed

    Sävendahl, Lars; Pournara, Effie; Pedersen, Birgitte Tønnes; Blankenstein, Oliver

    2016-05-01

    Concerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice. NordiNet(®) International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin(®) (somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark). Long-term safety data (1998-2013) were collected on 13 834 growth hormone treated pediatric patients with short stature. Incidence rates (IRs) of adverse events (AEs) defined as adverse drug reactions (ADRs), serious ADRs (SADRs), and serious AEs (SAEs) were calculated by mortality risk group (low/intermediate/high). The effect of growth hormone dose on IRs and the occurrence of cerebrovascular AEs were investigated by the risk group. We found that 61.0% of patients were classified as low-risk, 33.9% intermediate-risk, and 5.1% high-risk. Three hundred and two AEs were reported in 261 (1.9%) patients during a mean (s.d.) treatment duration of 3.9 (2.8) years. IRs were significantly higher in the high- vs the low-risk group (high risk vs low risk-ADR: 9.11 vs 3.14; SAE: 13.66 vs 1.85; SADR: 4.97 vs 0.73 events/1000 patient-years of exposure; P < 0.0001 for all). Except for SAEs in the intermediate-risk group (P = 0.0486) in which an inverse relationship was observed, no association between IRs and growth hormone dose was found. No cerebrovascular events were reported. We conclude that safety data from NordiNet(®) IOS do not reveal any new safety signals and confirm a favorable overall safety profile in accordance with other pediatric observational studies. No association between growth hormone dose and the incidence of AEs during growth hormone treatment in childhood was found. © 2016 European Society of Endocrinology.

  3. Fire safety of wood construction

    Treesearch

    Robert H. White; Mark A. Dietenberger

    2010-01-01

    Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements and related fire performance data are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Because basic data...

  4. Machine and Woodworking Tool Safety. Module SH-24. Safety and Health.

    ERIC Educational Resources Information Center

    Center for Occupational Research and Development, Inc., Waco, TX.

    This student module on machine and woodworking tool safety is one of 50 modules concerned with job safety and health. This module discusses specific practices and precautions concerned with the efficient operation and use of most machine and woodworking tools in use today. Following the introduction, 13 objectives (each keyed to a page in the…

  5. The Impact of Terrorism on School Safety Planning.

    ERIC Educational Resources Information Center

    Trump, Kenneth S.

    2002-01-01

    Discusses why history and "thinking outside of the box" should encourage schools to acknowledge that they are potentially vulnerable targets of terrorism. Presents new safety and security issues raised by the threat of terrorism, including anthrax scares, cell phone use, and field trips. Describes "heightened security"…

  6. 76 FR 35861 - Safety Culture at the Waste Treatment and Immobilization Plant

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ... high. This unhealthy tension has rendered the WTP project's formal processes to resolve safety issues... Board's investigative record demonstrates that both DOE and contractor project management behaviors... allegations raised by Dr. Tamosaitis, a contractor employee removed from his position at WTP, a construction...

  7. Students' Perceptions of Patient Safety during the Transition from Undergraduate to Postgraduate Training: An Activity Theory Analysis

    ERIC Educational Resources Information Center

    de Feijter, Jeantine M.; de Grave, Willem S.; Dornan, Tim; Koopmans, Richard P.; Scherpbier, Albert J. J. A.

    2011-01-01

    Evidence that medical error can cause harm to patients has raised the attention of the health care community towards patient safety and influenced how and what medical students learn about it. Patient safety is best taught when students are participating in clinical practice where they actually encounter patients at risk. This type of learning is…

  8. From Barnyard to Food Table: the Omnipresence of Hepatitis E virus and Risk for Zoonotic Infection and Food Safety

    PubMed Central

    Meng, Xiang-Jin

    2011-01-01

    Hepatitis E virus (HEV) is an important but extremely understudied pathogen. The mechanisms of HEV replication and pathogenesis are poorly understood, and a vaccine against HEV is not yet available. HEV is classified in the family Hepeviridae consisting of at least four recognized major genotypes. Genotypes 1 and 2 HEV are restricted to humans and associated with epidemics in developing countries, whereas genotypes 3 and 4 HEV are zoonotic and responsible for sporadic cases worldwide. The identification and characterization of a number of animal strains of HEV from pigs, chickens, rabbits, rats, mongoose, deer, and possibly cattle and sheep have significantly broadened the host range and diversity of HEV. The demonstrated ability of cross-species infection by some animal strains of HEV raises public health concerns for zoonotic HEV infection. Pigs are a recognized reservoir for HEV, and pig handlers are at increased risk of zoonotic HEV infection. Sporadic cases of hepatitis E have been definitively linked to the consumption of raw or undercooked animal meats such as pig livers, sausages, and deer meats. In addition, since large amounts of viruses excreted in feces, animal manure land application and runoffs can contaminate irrigation and drinking water with concomitant contamination of produce or shellfish. HEV RNA of swine origin has been detected in swine manure, sewage water and oysters, and consumption of contaminated shellfish has also been implicated in sporadic cases of hepatitis E. Therefore, the animal strains of HEV pose not only a zoonotic risk but also food and environmental safety concerns. PMID:21316404

  9. Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

    PubMed

    Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

    2017-04-01

    To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

  10. Affordability of and Access to Information About Health Insurance Among Immigrant and Non-immigrant Residents After Massachusetts Health Reform.

    PubMed

    Kang, Ye Jin; McCormick, Danny; Zallman, Leah

    2017-08-01

    Immigrants' perceptions of affordability of insurance and knowledge of insurance after health reform are unknown. We conducted face-to-face surveys with a convenience sample of 1124 patients in three Massachusetts safety net Emergency Departments after the Massachusetts health reform (August 2013-January 2014), comparing immigrants and non-immigrants. Immigrants, as compared to non-immigrants, reported more concern about paying premiums (30 vs. 11 %, p = 0.0003) and about affording the current ED visit (38 vs. 22 %, p < 0.0001). Immigrants were also less likely to report having unpaid medical bills (24 vs. 32 %, p = 0.0079), however this difference was not present among those with any hospitalization in the past year. Insured immigrants were less likely to know copayment amounts (57 vs. 71 %, p = 0.0018). Immigrants were more likely to report that signing up for insurance would be easier with fewer plans (53 vs. 34 %, p = 0.0443) and to lack information about insurance in their primary language (31 vs. 1 %, p < 0.0001) when applying for insurance. Immigrants who sought insurance information via websites or helplines were more likely to find that information useful than non-immigrants (100 vs. 92 %, p = 0.0339). Immigrants seeking care in safety net emergency departments had mixed experiences with affordability of and knowledge about insurance after Massachusetts health reform, raising concern about potential disparities under the Affordable Care Act that is based on the MA reform.

  11. Food safety in Thailand 1: it is safe to eat watermelon and durian in Thailand.

    PubMed

    Wanwimolruk, Sompon; Kanchanamayoon, Onnicha; Boonpangrak, Somchai; Prachayasittikul, Virapong

    2015-05-01

    The wide use of pesticides raises serious concerns regarding food safety and environmental impacts. There is increasing public concern about the potential health risks linked with exposure to pesticides. Regulation of maximum residue limits (MRL) of pesticide residues in food commodities has been established in many developed countries. For developing countries, like Thailand, this regulation often exists in law, but is not completely enforced in practice. Thus, pesticide residue levels in vegetables and fruits have not been thoroughly monitored. The present study aimed to examine potential health risks associated with pesticide exposure by determining the pesticide residues in two commonly consumed fruits, watermelon and durian. The fruit samples were purchased from markets in central provinces of Thailand and assayed for the content of 28 pesticides. Analysis of pesticides was performed by multiresidue extraction and followed by GC-MS/MS detection. Of 28 pesticides investigated, 5 were detected in 90.7% of the watermelon samples (n = 75) and 3 in 90% of durian samples (n = 30). Carbofuran, chlorpyrifos, diazinon, dimethoate and metalaxyl were found in watermelons, whereas dichlorvos, dimethoate and metalaxyl were detected in durians. However, their levels were much lower than the recommended MRL values. These pesticide levels detected in the fruits are unlikely to harm the consumers; therefore it is safe to eat watermelon and durian in Thailand. While our results found negligible risk associated with pesticide exposure from consuming these common tropical fruits, special precautions should be considered to decrease total exposure to these harmful pesticides from various foods.

  12. [Determining health policy for sensible mobile phone use--current world status].

    PubMed

    Sagi, Omer Itzhak; Sadetzki, Siegal

    2011-03-01

    Mobile phones have become the leading communication system, with more than 4.5 billions users around the world. The sharp increase in the number of users, and its penetration to all populations, including children, has raised concern about possible adverse health effects, particularly cancer This article reviews the public health policies introduced in Israel and several other countries regarding mobile phone use in view of the lack of clarity concerning the safety of this new technology. The data show that most countries have adopted the precautionary principle as the leading guideline, recommending the use of simple and low-cost safety measures which could substantially reduce exposure to the brain and other body organs from mobile phones. These include the use of text messages, hands-free kits, and/or the loud-speaker mode of the phone. Accordingly, recommendations, guidelines, standards, and legislation aimed at the general population, drivers, state institutions and the industry have been formulated. For children, who are considered to be more susceptible to cancer development following exposure to carcinogens, there is widespread consensus for a stricter approach. In some countries, measures such as banning use of mobile phones in schools, prohibiting sales/advertisements targeted at young age groups, expanding warnings on phones/ packages, and encouraging educational campaigns have been adopted for this population. Regulations regarding phone use while driving have been instituted in most countries. In conclusion, many public health practitioners have moved from the theoretical level (adoption of the precautionary principle) to an active phase of introducing regulations, with specific emphasis to various populations.

  13. Home Visitations for Delivering an Early Childhood Obesity Intervention in Denver: Parent and Patient Navigator Perspectives.

    PubMed

    Knierim, Shanna Doucette; Moore, Susan L; Raghunath, Silvia Gutiérrez; Yun, Lourdes; Boles, Richard E; Davidson, Arthur J

    2018-06-23

    Objective This qualitative study explored parent and patient navigator perspectives of home visitation as part of a childhood obesity program in a low-income, largely Latino population. Methods Three patient navigators and 25 parents who participated in a home-based, childhood obesity program participated in focus groups or interviews. Emergent themes were identified through content analysis of qualitative data. Results Three overall themes were identified. Patient navigators and parents perceived: (1) enabling characteristics of home-based program delivery which facilitated family participation and/or behavior change (i.e., convenience, increased accountability, inclusion of household members, delivery in a familiar, intimate setting, and individualized pace and content); (2) logistic and cultural challenges to home-based delivery which reduced family participation and program reach (i.e., difficulties scheduling visits, discomfort with visitors in the home, and confusion about the patient navigator's role); and (3) remediable home-based delivery challenges which could be ameliorated by additional study staff (e.g., supervision of children, safety concerns) or through organized group sessions. Both patient navigators and participating parents discussed an interest in group classes with separate, supervised child-targeted programming and opportunities to engage with other families for social support. Conclusions for Practice A home visitation program delivering a pediatric obesity prevention curriculum in Denver was convenient and held families accountable, but posed scheduling difficulties and raised safety concerns. Conducting home visits in pairs, adding obesity prevention curriculum to existing home visiting programs, or pairing the convenience of home visits with group classes may be future strategies to explore.

  14. Cell-Based Therapies for Joint Disease in Veterinary Medicine: What We Have Learned and What We Need to Know

    PubMed Central

    Bogers, Sophie Helen

    2018-01-01

    Biological cell-based therapies for the treatment of joint disease in veterinary patients include autologous-conditioned serum, platelet-rich plasma, and expanded or non-expanded mesenchymal stem cell products. This narrative review outlines the processing and known mechanism of action of these therapies and reviews current preclinical and clinical efficacy in joint disease in the context of the processing type and study design. The significance of variation for biological activity and consequently regulatory approval is also discussed. There is significant variation in study outcomes for canine and equine cell-based products derived from whole blood or stem cell sources such as adipose and bone marrow. Variation can be attributed to altering bio-composition due to factors including preparation technique and source. In addition, study design factors like selection of cases with early vs. late stage osteoarthritis (OA), or with intra-articular soft tissue injury, influence outcome variation. In this under-regulated field, variation raises concerns for product safety, consistency, and efficacy. Cell-based therapies used for OA meet the Food and Drug Administration’s (FDA’s) definition of a drug; however, researchers must consider their approach to veterinary cell-based research to meet future regulatory demands. This review explains the USA’s FDA guidelines as an example pathway for cell-based therapies to demonstrate safety, effectiveness, and manufacturing consistency. An understanding of the variation in production consistency, effectiveness, and regulatory concerns is essential for practitioners and researchers to determine what products are indicated for the treatment of joint disease and tactics to improve the quality of future research. PMID:29713634

  15. The SunWise School Program Guide: A School Program that Radiates Good Ideas

    ERIC Educational Resources Information Center

    US Environmental Protection Agency, 2003

    2003-01-01

    To help educators raise sun safety awareness, the U.S. Environmental Protection Agency (EPA) has developed the SunWise School Program, a national education program for children in grades K through 8. SunWise Partner Schools sponsor classroom and schoolwide activities that raise children's awareness of stratospheric ozone depletion, UV radiation,…

  16. Aerospace Safety Advisory Panel Annual Report for 1999

    NASA Technical Reports Server (NTRS)

    Blomberg, Richard D.

    2000-01-01

    This report covers the activities of the Aerospace Safety Advisory Panel (ASAP) for the calendar year 1999.This was a year of notable achievements and significant frustrations. Both the Space Shuttle and International Space Station (ISS) programs were delayed.The Space Shuttle prudently postponed launches after the occurrence of a wiring short during ascent of the STS-93 mission. The ISS construction schedule slipped as a result of the Space Shuttle delays and problems the Russians experienced in readying the Service Module and its launch vehicle. Each of these setbacks was dealt with in a constructive way. The STS-93 short circuit led to detailed wiring inspections and repairs on all four orbiters as well as analysis of other key subsystems for similar types of hidden damage. The ISS launch delays afforded time for further testing, training, development, and contingency planning. The safety consciousness of the NASA and contractor workforces, from hands-on labor to top management, continues high. Nevertheless, workforce issues remain among the most serious safety concerns of the Panel. Cutbacks and reorganizations over the past several years have resulted in problems related to workforce size, critical skills, and the extent of on-the-job experience. These problems have the potential to impact safety as the Space Shuttle launch rate increases to meet the demands of the ISS and its other customers. As with last year's report, these work- force-related issues were considered of sufficient import to place them first in the material that follows. Some of the same issues of concern for the Space Shuttle and ISS arose in a review of the launch vehicle for the Terra mission that the Panel was asked by NASA to undertake. Other areas the Panel was requested to assess included the readiness of the Inertial Upper Stage for the deployment of the Chandra X-ray Observatory and the possible safety impact of electromagnetic effects on the Space Shuttle. The findings and recommendations in this report do not highlight any major, immediate issues that might compromise the safe pursuit of the various NASA programs. They do, however, cover concerns that the Panel believes should be addressed in the interest of maintaining NASA's excellent safety record.The Panel is pleased to note that remedial efforts for some of the findings raised are underway. Given appropriate funding and cooperative efforts among the Administration, the Congress and the various contractors, the Panel is convinced that safety problems can be avoided or solved resulting in lower risk for NASA's human space and aeronautics programs. Section II of this report contains specific findings and recommendations generated by Panel activities during the calendar year 1999. Section III presents more detailed information in support of these findings and recommendations. A current roster of Panel members, consultants, and staff is included as Appendix A. Appendix B contains NASA's response to the findings and recommendations from the 1998 annual report. It has been augmented this year to include brief explanations of why the Panel classified the NASA response as " open,""continuing," or "closed." Appendix C lists the fact-finding activities of the Panel in 1999.

  17. Temperature changes associated with radiofrequency exposure near authentic metallic implants in the head phantom--a near field simulation study with 900, 1800 and 2450 MHz dipole.

    PubMed

    Matikka Virtanen, H; Keshvari, J; Lappalainen, R

    2010-10-07

    Along with increased use of wireless communication devices operating in the radiofrequency (RF) range, concern has been raised about the related possible health risks. Among other concerns, the interaction of medical implants and RF devices has been studied in order to assure the safety of implant carriers under various exposure conditions. In the RF range, the main established quantitative effect of electromagnetic (EM) fields on biological tissues is heating due to vibrational movements of water molecules. The temperature changes induced in tissues also constitute the basis for the setting of RF exposure limits and recommendations. In this study, temperature changes induced by electromagnetic field enhancements near passive metallic implants have been simulated in the head region. Furthermore, the effect of the implant material on the induced temperature change was evaluated using clinically used metals with the highest and the lowest thermal conductivities. In some cases, remarkable increases in maximum temperatures of tissues (as much as 8 °C) were seen in the near field with 1 W power level whereas at lower power levels significant temperature increases were not observed.

  18. Hydrogen permeation in FeCrAl alloys for LWR cladding application

    NASA Astrophysics Data System (ADS)

    Hu, Xunxiang; Terrani, Kurt A.; Wirth, Brian D.; Snead, Lance L.

    2015-06-01

    FeCrAl, an advanced oxidation-resistant iron-based alloy class, is a highly prevalent candidate as an accident-tolerant fuel cladding material. Compared with traditional zirconium alloy fuel cladding, increased tritium permeation through FeCrAl fuel cladding to the primary coolant is expected, raising potential safety concerns. In this study, the hydrogen permeability of several FeCrAl alloys was obtained using a static permeation test station, which was calibrated and validated using 304 stainless steel. The high hydrogen permeability of FeCrAl alloys leads to concerns with respect to potentially significant tritium release when used for fuel cladding in LWRs. The total tritium inventory inside the primary coolant of a light water reactor was quantified by applying a 1-dimensional steady state tritium diffusion model to demonstrate the dependence of tritium inventory on fuel cladding type. Furthermore, potential mitigation strategies for tritium release from FeCrAl fuel cladding were discussed and indicate the potential for application of an alumina layer on the inner clad surface to serve as a tritium barrier. More effort is required to develop a robust, economical mitigation strategy for tritium permeation in reactors using FeCrAl clad fuel assemblies.

  19. Toxicological relevance of emerging contaminants for drinking water quality.

    PubMed

    Schriks, Merijn; Heringa, Minne B; van der Kooi, Margaretha M E; de Voogt, Pim; van Wezel, Annemarie P

    2010-01-01

    The detection of many new compounds in surface water, groundwater and drinking water raises considerable public concern, especially when human health based guideline values are not available it is questioned if detected concentrations affect human health. In an attempt to address this question, we derived provisional drinking water guideline values for a selection of 50 emerging contaminants relevant for drinking water and the water cycle. For only 10 contaminants, statutory guideline values were available. Provisional drinking water guideline values were based upon toxicological literature data. The maximum concentration levels reported in surface waters, groundwater and/or drinking water were compared to the (provisional) guideline values of the contaminants thus obtained, and expressed as Benchmark Quotient (BQ) values. We focused on occurrence data in the downstream parts of the Rhine and Meuse river basins. The results show that for the majority of compounds a substantial margin of safety exists between the maximum concentration in surface water, groundwater and/or drinking water and the (provisional) guideline value. The present assessment therefore supports the conclusion that the majority of the compounds evaluated pose individually no appreciable concern to human health. (c) 2009 Elsevier Ltd. All rights reserved.

  20. Controlling off-label medication use.

    PubMed

    Gillick, Muriel R

    2009-03-03

    Off-label prescribing may lead to innovative new uses of old medications, is essential in such fields as pediatrics, and avoids the lengthy and expensive process of modifying U.S. Food and Drug Administration (FDA) drug labeling. Using medications for unapproved indications, however, raises concerns about patient safety when the drugs have a high potential for toxicity and generates economic concerns when their cost is high. A possible means of controlling the use of off-label drugs is to focus on medications used off-label that are both expensive and potentially risky. These are principally biotechnology drugs, such as recombinant enzymes, cytokines, and monoclonal antibodies. This article suggests a 2-step process for controlling use of such drugs, analogous to that used for devices. Once a drug is FDA approved, it would undergo scrutiny using the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination method if its cost exceeds a specified benchmark-for example, $12 000, which is the average cost of a pacemaker. The CMS would pay only for off-label uses for which there is adequate evidence in its National Coverage Determination process. Other insurance companies would probably adopt the recommendations of CMS.

  1. Temperature changes associated with radiofrequency exposure near authentic metallic implants in the head phantom—a near field simulation study with 900, 1800 and 2450 MHz dipole

    NASA Astrophysics Data System (ADS)

    Matikka (formerly Virtanen, H.; Keshvari, J.; Lappalainen, R.

    2010-10-01

    Along with increased use of wireless communication devices operating in the radiofrequency (RF) range, concern has been raised about the related possible health risks. Among other concerns, the interaction of medical implants and RF devices has been studied in order to assure the safety of implant carriers under various exposure conditions. In the RF range, the main established quantitative effect of electromagnetic (EM) fields on biological tissues is heating due to vibrational movements of water molecules. The temperature changes induced in tissues also constitute the basis for the setting of RF exposure limits and recommendations. In this study, temperature changes induced by electromagnetic field enhancements near passive metallic implants have been simulated in the head region. Furthermore, the effect of the implant material on the induced temperature change was evaluated using clinically used metals with the highest and the lowest thermal conductivities. In some cases, remarkable increases in maximum temperatures of tissues (as much as 8 °C) were seen in the near field with 1 W power level whereas at lower power levels significant temperature increases were not observed.

  2. Use of Electronic Medication Administration Records to Reduce Perceived Stress and Risk of Medication Errors in Nursing Homes.

    PubMed

    Alenius, Malin; Graf, Peter

    2016-07-01

    Concerns have been raised about the effects of current medication administration processes on the safety of many of the aspects of medication administration. Keeping electronic medication administration records could decrease many of these problems. Unfortunately, there has not been much research on this topic, especially in nursing homes. A prospective case-control survey was consequently performed at two nursing homes; the electronic record system was introduced in one, whereas the other continued to use paper records. The personnel were asked to fill in a questionnaire of their perceptions of stress and risk of medication errors at baseline (n = 66) and 20 weeks after the intervention group had started recording medication administration electronically (n = 59). There were statistically significant decreases in the perceived risk of omitting a medication, of medication errors occurring because of communication problems, and of medication errors occurring because of inaccurate medication administration records in the intervention group (all P < .01 vs the control group). The perceived overall daily stress levels were also reduced in the intervention group (P < .05). These results indicate that the utilization of electronic medication administration records will reduce many of the concerns regarding the medication administration process.

  3. Tyrosine kinase inhibitors in pulmonary arterial hypertension: a double-edge sword?

    PubMed

    Godinas, Laurent; Guignabert, Christophe; Seferian, Andrei; Perros, Frederic; Bergot, Emmanuel; Sibille, Yves; Humbert, Marc; Montani, David

    2013-10-01

    New treatments for pulmonary arterial hypertension (PAH) are a crucial need. The increased proliferation, migration, and survival of pulmonary vascular cells within the pulmonary artery wall in PAH have allowed successful transposition of pathophysiological elements from oncologic researches. Next steps will require translation of these biological advances in PAH therapeutic arsenal and guidelines. This review synthesizes recent data concerning the role of receptor tyrosine kinases and their inhibitors in PAH, with implications in animal models and humans. Results of clinical trials are now accumulating to establish beneficial role of tyrosine kinase inhibitors (TKIs) in PAH and further findings are expected in the near future. Beside this curative approach, evidences of a possible TKI-induced cardiotoxicity are emerging. These safety issues raise concern about a potential amplified harmful effect in PAH, a pathology characterized by an underlying cardiac dysfunction. In addition, analyses of PAH registries shed light on a selective pulmonary vascular toxicity triggered by TKIs, especially dasatinib. These possible dual effects of the TKIs in PAH need to be taken in account for future pharmacological development of this therapeutic class in PAH. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  4. Implications of bilateral free trade agreements on access to medicines.

    PubMed Central

    Correa, Carlos María

    2006-01-01

    The TRIPS Agreement of the World Trade Organization (WTO) mandated the introduction of protection of intellectual property rights, notably patents, for pharmaceutical products. While the implications for the access to medicines contained in the terms of this Agreement raised significant concerns, a recent new wave of free trade agreements, negotiated outside the WTO, requires even higher levels of intellectual property protection for medicines than those mandated by that Agreement. The measures involved include the extension of the patent term beyond 20 years; prohibition of use of test data on drug efficacy and safety for certain periods for the approval of generic products; the linkage between drug registration and patent protection; in some cases, limitations to the grounds for granting compulsory licences. This article reviews some of these measures that further limit the competition of generic products and discusses their possible implication for access to medicines. PMID:16710551

  5. Investigations of Shuttle Main Landing Gear Door Environmental Seals

    NASA Technical Reports Server (NTRS)

    Finkbeiner, Joshua; Dunlap, Pat; Steinetz, Bruce; DeMango, Jeff; Newswander, Daniel

    2005-01-01

    The environmental seals for the main landing gear doors of the Shuttle Orbiters were raised by the Columbia Accident Investigation Board as a potential safety concern. Inspections of seals installed on the Shuttle Discovery revealed that they were permanently deformed and no longer met certified seal compression requirements. Replacement of the seals led to the inability to fully close the main landing gear doors. Johnson Space Center requested that Glenn Research Center conduct tests on the main landing gear door environmental seals to assist in installing the seals in a manner to allow the main landing gear doors to fully close. Further testing was conducted to fill out the seal performance database. Results from the testing indicated that the method of bonding the seals was important in reducing seal loads on the main landing gear doors. Also, the replacement seals installed in Shuttle Discovery were found to have leakage performance sufficient to meet the certification requirements.

  6. Transdifferentiation and reprogramming: Overview of the processes, their similarities and differences.

    PubMed

    Cieślar-Pobuda, Artur; Knoflach, Viktoria; Ringh, Mikael V; Stark, Joachim; Likus, Wirginia; Siemianowicz, Krzysztof; Ghavami, Saeid; Hudecki, Andrzej; Green, Jason L; Łos, Marek J

    2017-07-01

    Reprogramming, or generation of induced pluripotent stem (iPS) cells (functionally similar to embryonic stem cells or ES cells) by the use of transcription factors (typically: Oct3/4, Sox2, c-Myc, Klf4) called "Yamanaka factors" (OSKM), has revolutionized regenerative medicine. However, factors used to induce stemness are also overexpressed in cancer. Both, ES cells and iPS cells cause teratoma formation when injected to tissues. This raises a safety concern for therapies based on iPS derivates. Transdifferentiation (lineage reprogramming, or -conversion), is a process in which one mature, specialized cell type changes into another without entering a pluripotent state. This process involves an ectopic expression of transcription factors and/or other stimuli. Unlike in the case of reprogramming, tissues obtained by this method do not carry the risk of subsequent teratomagenesis. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. The flaws and human harms of animal experimentation.

    PubMed

    Akhtar, Aysha

    2015-10-01

    Nonhuman animal ("animal") experimentation is typically defended by arguments that it is reliable, that animals provide sufficiently good models of human biology and diseases to yield relevant information, and that, consequently, its use provides major human health benefits. I demonstrate that a growing body of scientific literature critically assessing the validity of animal experimentation generally (and animal modeling specifically) raises important concerns about its reliability and predictive value for human outcomes and for understanding human physiology. The unreliability of animal experimentation across a wide range of areas undermines scientific arguments in favor of the practice. Additionally, I show how animal experimentation often significantly harms humans through misleading safety studies, potential abandonment of effective therapeutics, and direction of resources away from more effective testing methods. The resulting evidence suggests that the collective harms and costs to humans from animal experimentation outweigh potential benefits and that resources would be better invested in developing human-based testing methods.

  8. Assisted living nursing practice: medication management: part 2 supervision and monitoring of medication administration by unlicensed assistive personnel.

    PubMed

    Mitty, Ethel; Flores, Sandi

    2007-01-01

    More than half the states permit assistance with or administration of medications by unlicensed assistive personnel or med techs. Authorization of this nursing activity (or task) is more likely because of state assisted living regulation than by support and approval of the state Board of Nursing. In many states, the definition of "assistance with" reads exactly like "administration of" thereby raising concern with regard to delegation, accountability, and liability for practice. It is, as well, a hazardous path for the assisted living nurse who must monitor and evaluate the performance of the individual performing this nursing task. This article, the second in a series on medication management, addresses delegation, standards of practice of medication administration, types of medication errors, the components of a performance evaluation tool, and a culture of safety. Maintaining professional standards of assisted living nursing practice courses throughout the suggested recommendations.

  9. Case cluster of pneumoconiosis at a coal slag processing facility.

    PubMed

    Fagan, Kathleen M; Cropsey, Erin B; Armstrong, Jenna L

    2015-05-01

    During an inspection by the Occupational Safety and Health Administration (OSHA) of a small coal slag processing plant with 12 current workers, four cases of pneumoconiosis were identified among former workers. The OSHA investigation consisted of industrial hygiene sampling, a review of medical records, and case interviews. Some personal sampling measurements exceeded the OSHA Permissible Exposure Limit (PEL) for total dust exposures of 15 mg/m(3), and the measured respirable silica exposure of 0.043 mg/m(3), although below OSHA's current PEL for respirable dust containing silica, was above the American Conference of Governmental Industrial Hygienists' Threshold Limit Value (TLV). Chest x-rays for all four workers identified small opacities consistent with pneumoconiosis. This is the first known report of lung disease in workers processing coal slag and raises concerns for workers exposed to coal slag dust. © 2015 Wiley Periodicals, Inc.

  10. In Vitro Adsorption and in Vivo Pharmacokinetic Interaction between Doxycycline and Frequently Used Mycotoxin Binders in Broiler Chickens.

    PubMed

    De Mil, Thomas; Devreese, Mathias; Broekaert, Nathan; Fraeyman, Sophie; De Backer, Patrick; Croubels, Siska

    2015-05-06

    Mycotoxin binders are readily mixed in feeds to prevent uptake of mycotoxins by the animal. Concerns were raised for nonspecific binding with orally administered veterinary drugs by the European Food Safety Authority in 2010. This paper describes the screening for in vitro adsorption of doxycycline-a broad-spectrum tetracycline antibiotic-to six different binders that were able to bind >75% of the doxycycline. Next, an in vivo pharmacokinetic interaction study of doxycycline with two of the binders, which demonstrated significant in vitro binding, was performed in broiler chickens using an oral bolus model. It was shown that two montmorillonite-based binders were able to lower the area under the plasma concentration-time curve of doxycycline by >60% compared to the control group. These results may indicate a possible risk for reduced efficacy of doxycycline when used concomitantly with montmorillonite-based mycotoxin binders.

  11. [Analytical quality in biological monitoring of workers exposed to chemicals: experience of the Prevention and Safety at the Workplace Service in Modena].

    PubMed

    Alpaca, R I Paredes; Migliore, A; Di Rico, R; Canali, Claudia; Rota, Cristina; Trenti, T; Cariani, Elisabetta

    2010-01-01

    The quality of laboratory data is one of the main factors in guaranteeing efficacy of biological monitoring. To analyze the quality of laboratory data used for biological monitoring of exposed workers. A survey involving 18 companies employing 945 workers in the area of Modena, Italy, was carried out in 2008. Most of the 9 private laboratories receiving biological samples did not perform directly part or all of the laboratory assessments requested, but this was not indicated in the final report. Major problems were observed in the application of internal quality control, and only one laboratory participated in external quality assessment for blood lead measurements. Our results raise major concerns on the traceability and reliability of laboratory assessments performed for biomonitoring of exposed workers. Systematic evaluation of the quality of analytical data would be highly recommendable.

  12. Influence of ICRF heating on the stability of TAEs

    NASA Astrophysics Data System (ADS)

    Sears, J.; Burke, W.; Parker, R. R.; Snipes, J. A.; Wolfe, S.

    2007-11-01

    Unstable toroidicity-induced Alfv'en eigenmodes (TAEs) can appear spontaneously due to resonant interaction with fast particles such as fusion alphas, raising concern that TAEs may threaten ITER performance. This work investigates the progression of stable TAE damping rates toward instability during a scan of ICRF heating power up to 3.1 MW. Stable eigenmodes are identified in Alcator C-Mod by the Active MHD diagnostic. Unstable TAEs are observed to appear spontaneously in C-Mod limited L-mode plasmas at sufficient tail energies generated by >3 MW of ICRF heating. However preliminary analysis of experiments with moderate ICRF heating power show that TAE stability may not simply degrade with overall fast particle content. There are hints that the stability of some TAEs may be enhanced in the presence of fast particle distribution tails. Furthermore, the radial profile of the energetic particle distribution relative to the safety factor profile affects the ICRF power influence on TAE stability.

  13. DNA based identification of medicinal materials in Chinese patent medicines

    NASA Astrophysics Data System (ADS)

    Chen, Rong; Dong, Juan; Cui, Xin; Wang, Wei; Yasmeen, Afshan; Deng, Yun; Zeng, Xiaomao; Tang, Zhuo

    2012-12-01

    Chinese patent medicines (CPM) are highly processed and easy to use Traditional Chinese Medicine (TCM). The market for CPM in China alone is tens of billions US dollars annually and some of the CPM are also used as dietary supplements for health augmentation in the western countries. But concerns continue to be raised about the legality, safety and efficacy of many popular CPM. Here we report a pioneer work of applying molecular biotechnology to the identification of CPM, particularly well refined oral liquids and injections. What's more, this PCR based method can also be developed to an easy to use and cost-effective visual chip by taking advantage of G-quadruplex based Hybridization Chain Reaction. This study demonstrates that DNA identification of specific Medicinal materials is an efficient and cost-effective way to audit highly processed CPM and will assist in monitoring their quality and legality.

  14. HPV vaccine: immersed in controversy.

    PubMed

    Ohri, Linda K

    2007-11-01

    There has been substantial media coverage of the quadrivalent human papillomavirus (HPV) vaccine since the Food and Drug Administration approved Gardasil (Merck & Co., Inc.) on June 8, 2006. The most vocal complaints maintain that its use will promote promiscuity among teenagers, and condemn proposed mandated use for school entry. Some also question evidence for the vaccine's safety. There have been concerns raised by both providers and patients regarding financial barriers to access. Still others argue that additional populations could benefit who have not been included in current recommendations. Clarification of these issues is essential to advance optimal use of this important new vaccine. There is strong evidence to support HPV vaccine as an effective, safe, and efficient public health measure. School mandates are valuable tools to reduce disparities in availability of immunizations. The time has come to consider universal funding as a means to improve access to all recommended vaccines.

  15. Social and ethical issues in mitochondrial donation.

    PubMed

    Dimond, Rebecca

    2015-09-01

    The UK is at the forefront of mitochondrial science and is currently the only country in the world to legalize germ-line technologies involving mitochondrial donation. However, concerns have been raised about genetic modification and the 'slippery slope' to designer babies. This review uses academic articles, newspaper reports and public documents. Mitochondrial donation offers women with mitochondrial disease an opportunity to have healthy, genetically related children. Key areas of disagreement include safety, the creation of three-parent babies, impact on identity, implications for society, definitions of genetic modification and reproductive choice. The UK government legalized the techniques in March 2015. Scientific and medical communities across the world followed the developments with interest. It is expected that the first cohort of 'three parent' babies will be born in the UK in 2016. Their health and progress will be closely monitored. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. The paradoxical effect of bevacizumab in the therapy of malignant gliomas

    PubMed Central

    Thompson, Eric M.; Frenkel, Eugene P.

    2011-01-01

    One rationale behind the use of agents that inhibit vascular endothelial growth factor in the therapy of primary CNS malignancies is based upon the concept that normalization of tumor vasculature with a decrease in tumor interstitial pressure will improve access of cytoreductive drugs and improve radiotherapy efficacy due to increased oxygen delivery. However, several studies have raised the concern that these agents may both rapidly restore the low permeability characteristics of the blood–brain barrier and counteract the beneficial effect of pseudoprogression. The result may be decreased therapeutic efficacy while increasing infiltration by co-opting normal vessels. In this discussion, we examine both histologic and radiographic tumor progression in the context of antiangiogenic agents. Issues dealing with the safety of bevacizumab (Avastin®, Genentech, South San Francisco, CA) and its potential to decrease efficacy of standard radiochemotherapy when used to treat patients with newly diagnosed malignant glioma are emphasized. PMID:21205697

  17. Disaster policy and nuclear liability: Insights from post-Chernobyl agriculture in the United Kingdom

    NASA Astrophysics Data System (ADS)

    Kerr, William A.; Kwaczek, Adrienne S.; Mooney, Sian

    1989-09-01

    The recent events at Chernobyl have again brought the issues of nuclear safety to the forefront of the nuclear power debate. Fortunately, our experience with such incidents has been very limited, but it is important to learn as much as possible from such events so as to minimize the cost and effect of any other nuclear incidents, be they small or large. Much of the discussion about the possible effects of nuclear incidents has centered around the human cost in terms of health. While this is undoubtedly of paramount concern, the effect of the release of radiation from Chernobyl on the agricultural resource base in Europe can provide valuable insights on how to reduce the costs associated with the contamination of agricultural areas. This article outlines some of the lessons that can be learned using the livestock-raising industry in northern Wales as an example.

  18. Sterile-Insect Methods for Control of Mosquito-Borne Diseases: An Analysis

    PubMed Central

    Benedict, Mark; Bellini, Romeo; Clark, Gary G.; Dame, David A.; Service, Mike W.; Dobson, Stephen L.

    2010-01-01

    Abstract Effective vector control, and more specifically mosquito control, is a complex and difficult problem, as illustrated by the continuing prevalence (and spread) of mosquito-transmitted diseases. The sterile insect technique and similar methods control certain agricultural insect pest populations in a species-specific, environmentally sound, and effective manner; there is increased interest in applying this approach to vector control. Such an approach, like all others in use and development, is not a one-size-fits-all solution, and will be more appropriate in some situations than others. In addition, the proposed release of pest insects, and more so genetically modified pest insects, is bound to raise questions in the general public and the scientific community as to such a method's efficacy, safety, and sustainability. This article attempts to address these concerns and indicate where sterile-insect methods are likely to be useful for vector control. PMID:19725763

  19. Is conflict of interest becoming a challenge for institution-based institutional review boards?

    PubMed

    Freedman, Ralph S; McKinney, Ross

    2013-08-01

    Expansion of business relationships between academic institutions and their leaders and industry have become a reality, whereas media attention regarding conflict of interest (COI) at academic institutions has raised concerns about possible erosion of public trust. The Institutional Review Board (IRB) should collaborate with institutional COI committees to ensure that research with human subjects is in compliance with various applicable federal regulations. The IRB and COI committee should take additional independent action as necessary under their separate mandates to protect the welfare, safety, and rights of human subjects and to include limits on protocols affected by significant financial interests of the institution or its decision makers. If unable to review research due to an intrainstitutional conflict, the local IRB should consider transferring the study review and oversight to an external unaffiliated institutional or central IRB. A process for involvement of an executive institutional IRB is proposed. ©2013 AACR.

  20. Environmental pollution and shipping feasibility of the Nicaragua Canal.

    PubMed

    Chen, Jihong; Zeng, Xin; Deng, Yibing

    2016-12-15

    In recent years, the Nicaraguan government's renewed interest in constructing this interoceanic canal has once again aroused widespread concern, particularly in the global shipping industry. The project's immense ecological risks, coupled with the recent expansions of both the Panama Canal and the Suez Canal, have raised questions among scientists and experts about its viability. Whether the Nicaragua Canal is really feasible for international shipping, given its high marine pollution risks, requires the further study. This paper discusses and analyses the feasibility of the Nicaragua Canal in the context of its environmental impact and value as a shipping service. This paper aims to provide an important information reference to inform strategic decision-making among policymakers and stakeholders. Our research results indicate that the environmental complexity, economic costs and safety risks of building a new transoceanic canal are simply too high to justify the project. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. [Genetically modified organisms in food--production, detection and risks].

    PubMed

    Zeljezić, Davor

    2004-11-01

    The first genetically modified plant (GMP) was a tobacco resistant to antibiotics in 1983. In 1996, the first genetically altered crop, a delayed-ripening tomato was commercially released. In the year 2003, the estimated global area of GM crops for was 67.7 million hectares. To produce such a plant a gene of interest has to be isolated from the donor. Together with a promoter, terminator sequence and marker gene it has to be introduced into the plant cell which is then stimulated to generate a whole GMP expressing new characteristics (herbicide/insect resistance, delayed ripening). The last few months have seen a strong public debate over genetically modified organisms which has raised scientific, economic, political, and ethical issues. Some questions concerning the safety of GMPs are still to be answered, and decisions about their future should be based on scientifically validated information.

  2. Hydroxocobalamin treatment of acute cyanide poisoning from apricot kernels.

    PubMed

    Cigolini, Davide; Ricci, Giogio; Zannoni, Massimo; Codogni, Rosalia; De Luca, Manuela; Perfetti, Paola; Rocca, Giampaolo

    2011-05-24

    Clinical experience with hydroxocobalamin in acute cyanide poisoning via ingestion remains limited. This case concerns a 35-year-old mentally ill woman who consumed more than 20 apricot kernels. Published literature suggests each kernel would have contained cyanide concentrations ranging from 0.122 to 4.09 mg/g (average 2.92 mg/g). On arrival, the woman appeared asymptomatic with a raised pulse rate and slight metabolic acidosis. Forty minutes after admission (approximately 70 min postingestion), the patient experienced headache, nausea and dyspnoea, and was hypotensive, hypoxic and tachypnoeic. Following treatment with amyl nitrite and sodium thiosulphate, her methaemoglobin level was 10%. This prompted the administration of oxygen, which evoked a slight improvement in her vital signs. Hydroxocobalamin was then administered. After 24 h, she was completely asymptomatic with normalised blood pressure and other haemodynamic parameters. This case reinforces the safety and effectiveness of hydroxocobalamin in acute cyanide poisoning by ingestion.

  3. Hydroxocobalamin treatment of acute cyanide poisoning from apricot kernels.

    PubMed

    Cigolini, Davide; Ricci, Giogio; Zannoni, Massimo; Codogni, Rosalia; De Luca, Manuela; Perfetti, Paola; Rocca, Giampaolo

    2011-09-01

    Clinical experience with hydroxocobalamin in acute cyanide poisoning via ingestion remains limited. This case concerns a 35-year-old mentally ill woman who consumed more than 20 apricot kernels. Published literature suggests each kernel would have contained cyanide concentrations ranging from 0.122 to 4.09 mg/g (average 2.92 mg/g). On arrival, the woman appeared asymptomatic with a raised pulse rate and slight metabolic acidosis. Forty minutes after admission (approximately 70 min postingestion), the patient experienced headache, nausea and dyspnoea, and was hypotensive, hypoxic and tachypnoeic. Following treatment with amyl nitrite and sodium thiosulphate, her methaemoglobin level was 10%. This prompted the administration of oxygen, which evoked a slight improvement in her vital signs. Hydroxocobalamin was then administered. After 24 h, she was completely asymptomatic with normalised blood pressure and other haemodynamic parameters. This case reinforces the safety and effectiveness of hydroxocobalamin in acute cyanide poisoning by ingestion.

  4. The utility of conductive plastic electrodes in prolonged ICU EEG monitoring.

    PubMed

    Das, Rohit R; Lucey, Brendan P; Chou, Sherry H-Y; Espinosa, Patricio S; Zamani, Amir A; Dworetzky, Barbara A; Bromfield, Edward B; Lee, Jong Woo

    2009-01-01

    We investigated the feasibility and utilization of conductive plastic electrodes (CPEs) in patients undergoing continuous video-electroencephalographic (EEG) monitoring in the intensive care unit (ICU), and assessed the quality of brain magnetic resonance imaging (MRI) and computed tomography (CT) images obtained during this period. A total of 54 patients were monitored. Seizures were recorded in 16 patients. Twenty-five patients had neuroimaging performed with electrodes in place; 15 MRI and 23 CT scans were performed. All patients had excellent quality anatomical images without clinically significant artifacts, and without any signs or symptoms that raised safety concerns. Recording quality of the EEG was indistinguishable to that achieved with standard gold electrodes. The use of CPEs allowed for uninterrupted EEG recording of patients who required urgent neuroimaging, and decreased the amount of time spent by the technologists required to remove and reattach leads.

  5. The Potential of Adaptive Design in Animal Studies.

    PubMed

    Majid, Arshad; Bae, Ok-Nam; Redgrave, Jessica; Teare, Dawn; Ali, Ali; Zemke, Daniel

    2015-10-12

    Clinical trials are the backbone of medical research, and are often the last step in the development of new therapies for use in patients. Prior to human testing, however, preclinical studies using animal subjects are usually performed in order to provide initial data on the safety and effectiveness of prospective treatments. These studies can be costly and time consuming, and may also raise concerns about the ethical treatment of animals when potentially harmful procedures are involved. Adaptive design is a process by which the methods used in a study may be altered while it is being conducted in response to preliminary data or other new information. Adaptive design has been shown to be useful in reducing the time and costs associated with clinical trials, and may provide similar benefits in preclinical animal studies. The purpose of this review is to summarize various aspects of adaptive design and evaluate its potential for use in preclinical research.

  6. The Potential of Adaptive Design in Animal Studies

    PubMed Central

    Majid, Arshad; Bae, Ok-Nam; Redgrave, Jessica; Teare, Dawn; Ali, Ali; Zemke, Daniel

    2015-01-01

    Clinical trials are the backbone of medical research, and are often the last step in the development of new therapies for use in patients. Prior to human testing, however, preclinical studies using animal subjects are usually performed in order to provide initial data on the safety and effectiveness of prospective treatments. These studies can be costly and time consuming, and may also raise concerns about the ethical treatment of animals when potentially harmful procedures are involved. Adaptive design is a process by which the methods used in a study may be altered while it is being conducted in response to preliminary data or other new information. Adaptive design has been shown to be useful in reducing the time and costs associated with clinical trials, and may provide similar benefits in preclinical animal studies. The purpose of this review is to summarize various aspects of adaptive design and evaluate its potential for use in preclinical research. PMID:26473839

  7. Germ line genome editing in clinics: the approaches, objectives and global society

    PubMed Central

    2017-01-01

    Genome editing allows for the versatile genetic modification of somatic cells, germ cells and embryos. In particular, CRISPR/Cas9 is worldwide used in biomedical research. Although the first report on Cas9-mediated gene modification in human embryos focused on the prevention of a genetic disease in offspring, it raised profound ethical and social concerns over the safety of subsequent generations and the potential misuse of genome editing for human enhancement. The present article considers germ line genome editing approaches from various clinical and ethical viewpoints and explores its objectives. The risks and benefits of the following three likely objectives are assessed: the prevention of monogenic diseases, personalized assisted reproductive technology (ART) and genetic enhancement. Although genetic enhancement should be avoided, the international regulatory landscape suggests the inevitability of this misuse at ART centers. Under these circumstances, possible regulatory responses and the potential roles of public dialogue are discussed. PMID:26615180

  8. Positive inotropes in heart failure: a review article

    PubMed Central

    Amin, Ahmad; Maleki, Majid

    2012-01-01

    Increasing myocardial contractility has long been considered a big help for patients with systolic heart failure, conferring an augmented haemodynamic profile in terms of higher cardiac output, lower cardiac filling pressure and better organ perfusion. Though concerns have been raised over the safety issues regarding the clinical trials of different inotropes in hearts with systolic dysfunction, they still stand as a main therapeutic strategy in many centres dealing with such patients. They must be used as short in duration, low in dose and stopped as early as possible. Evidence-based guidelines have provided clinicians with valuable data for better applying inotropes in heart failure patients. In this paper, the authors address clinical trials with different agents used for increasing cardiac contractility in heart failure patients. Furthermore, the authors focus on recent guidelines on making the most out of inotropes in heart failure patients. PMID:27326019

  9. The subcutaneous implantable cardioverter-defibrillator.

    PubMed

    Grace, Andrew

    2014-01-01

    To consider the case of need that underpinned the development of the subcutaneous implantable cardioverter-defibrillator (SICD), the preclinical and clinical data obtained so far, its current role and likely future. The data from prospective clinical evaluation of the device demonstrated safety and efficacy leading to Food and Drug Administration approval. This superseded earlier reports from Europe that raised some clinical concerns, previously anticipated through the introduction of new technology. Recent estimates indicate maybe 55% of patients in routine clinical practice needing an ICD are potentially suitable for a subcutaneous device. The SICD provides a useful alternative for high-energy (ICD) therapy in those deemed at risk and who need defibrillation and in whom there are no indications for cardiac resynchronization, bradycardia support or antitachycardia pacing. There is the possibility of both higher specificity and the avoidance of myo-cellular damage with shock delivery, and if these two aspects play out subcutaneous defibrillation could become an option of choice in many settings.

  10. Radiology corner. Answer to last month's radiology case and image: gun shot wound to the chest of a military working dog.

    PubMed

    Galer, Meghan; Magid, Donna; Folio, Les

    2009-06-01

    This Military Working Dog (MWD) was shot in the chest during combat operations in Iraq. Military Working Dogs are critical to the safety and well-being of deployed troops in combat operations and, as such, they are triaged and treated in our combat hospitals just like any other soldier; their speciation is not a factor in their triage status. This case familiarizes military physicians with the basic canine anatomy, positioning, and radiological technique they should be aware of before deploying. We also strive to raise awareness of the vital roles that these MWDs play for our forces, counterany concerns that may arise over the issue of treating these dogs in human facilities, and leave the reader feeling better prepared to handle the situation should they ever find themselves poised to save one of our four-legged warriors.

  11. Minimum dV for Targeted Spacecraft Disposal

    NASA Technical Reports Server (NTRS)

    Bacon, John B.

    2017-01-01

    The study analyzes the minimum capability required to dispose safely of a space object. The study considers 3- sigma environmental uncertainties, as well as spacecraft-specific constraints such as the available thrust, total impulse, the achievable increase or decrease in commandable frontal area under stable attitude (or stable tumble), and the final controllable altitude at which any such dV may be imparted. The study addresses the definition of the length and location of a 'safe' disposal area, which is a statistical manifestation of uncertainty in this process. Some general legal concerns are raised that are unique to this prospect of low dV disposals. Future work is summarized. The goal of such research is to improve public safety by creating optimally safe disposal strategies (and potentially, applicable regulations) for low-dV and/or low-thrust spacecraft that under more traditional strategies would need to be abandoned to fully-random decay with its inherent higher risk of human casualty.

  12. Biotechnology and the American agricultural industry. Council on Scientific Affairs, American Medical Association.

    PubMed

    1991-03-20

    To meet the needs of a rapidly growing population and minimize the toxic influences of traditional farming practices on the environment, the American agricultural industry has applied molecular technology to the development of food crops and livestock. By placing genes specific for highly desirable phenotypes into the DNA of plants, animals, and bacteria, farmers have increased crop and livestock survival, enhanced the nutritional quality of foods, increased industry productivity, and reduced the need for toxic pesticides and herbicides. However, introduction of genetically modified foods into the marketplace has raised a spectrum of public health issues. Physicians, as the most proximal scientific resource for most individuals, are uniquely positioned to address patient concerns regarding the safety of genetically altered foods. This report provides an overview of the inherent risks and benefits of "agrogenetics" and offers a series of recommendations designed to promote the education of the medical community and dispel public misconception regarding genetic manipulation.

  13. Conflicts of interest in approvals of additives to food determined to be generally recognized as safe: out of balance.

    PubMed

    Neltner, Thomas G; Alger, Heather M; O'Reilly, James T; Krimsky, Sheldon; Bero, Lisa A; Maffini, Maricel V

    Food and Drug Administration (FDA) guidance allows food manufacturers to determine whether additives to food are "generally recognized as safe" (GRAS). Manufacturers are not required to notify the FDA of a GRAS determination, although in some instances they notify the agency. The individuals that companies select to make these determinations may have financial conflicts of interest. To determine the extent to which individuals selected by manufacturers to make GRAS determinations have conflicts of interest between their obligations to ensure that the use of the additive is safe and their financial relationships to the company. DESIGN Using conflict of interest criteria developed by a committee of the Institute of Medicine, we analyzed 451 GRAS notifications that were voluntarily submitted to the FDA between 1997 and 2012. Number of GRAS notices submitted to the FDA; frequency of various types of relationships between decision maker and additive manufacturer; frequency of participation on GRAS panels by individuals; and number of GRAS safety determinations identified by the FDA that were not submitted to the agency. For the 451 GRAS notifications, 22.4% of the safety assessments were made by an employee of an additive manufacturer, 13.3% by an employee of a consulting firm selected by the manufacturer, and 64.3% by an expert panel selected by either a consulting firm or the manufacturer. A standing expert panel selected by a third party made none of these safety assessments. The 290 panels that made GRAS determinations had an average of 3.5 members, with a maximum of 7. Ten individuals served on 27 or more panels; 1 individual served on 128 panels (44.1%). At least 1 of the 10 individuals with the most frequent service was a member of 225 panels (77.6%). Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.

  14. Post Fukushima tsunami simulations for Malaysian coasts

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Koh, Hock Lye, E-mail: kohhl@ucsiuniversity.edu.my; Teh, Su Yean, E-mail: syteh@usm.my; Abas, Mohd Rosaidi Che

    The recent recurrences of mega tsunamis in the Asian region have rekindled concern regarding potential tsunamis that could inflict severe damage to affected coastal facilities and communities. The 11 March 2011 Fukushima tsunami that crippled nuclear power plants in Northern Japan has further raised the level of caution. The recent discovery of petroleum reserves in the coastal water surrounding Malaysia further ignites the concern regarding tsunami hazards to petroleum facilities located along affected coasts. Working in a group, federal government agencies seek to understand the dynamics of tsunami and their impacts under the coordination of the Malaysian National Centre formore » Tsunami Research, Malaysian Meteorological Department. Knowledge regarding the generation, propagation and runup of tsunami would provide the scientific basis to address safety issues. An in-house tsunami simulation models known as TUNA has been developed by the authors to assess tsunami hazards along affected beaches so that mitigation measures could be put in place. Capacity building on tsunami simulation plays a critical role in the development of tsunami resilience. This paper aims to first provide a simple introduction to tsunami simulation towards the achievement of tsunami simulation capacity building. The paper will also present several scenarios of tsunami dangers along affected Malaysia coastal regions via TUNA simulations to highlight tsunami threats. The choice of tsunami generation parameters reflects the concern following the Fukushima tsunami.« less

  15. Using e-cigarettes in the home to reduce smoking and secondhand smoke: disadvantaged parents' accounts.

    PubMed

    Rowa-Dewar, Neneh; Rooke, Catriona; Amos, Amanda

    2017-02-01

    Electronic cigarettes (e-cigarettes) are subject to considerable public health debate. Most public health experts agree that for smokers who find it particularly challenging to quit, e-cigarettes may reduce harm. E-cigarette use in the home may also reduce children's secondhand smoke (SHS) exposure, although e-cigarette vapour may pose risks. This is the first qualitative study to explore disadvantaged parents' views and experiences of e-cigarettes in relation to reducing SHS exposure in the home. Interviews with 25 disadvantaged parents from Edinburgh who smoked and had children aged 1-3 were conducted in 2013, with 17 re-interviewed in 2014. Accounts of e-cigarette perceptions and use were analysed thematically. E-cigarettes were seen by some as potentially valuable in helping quitting or reducing smoking in difficult circumstances, and protecting children from SHS when smoking outside is constrained. However, parents raised concerns about safety issues and continuing their nicotine addiction. In relation to children, concerns included possible health effects of the vapour, children playing with them and role-modelling e-cigarette use. While significant concerns remain about e-cigarettes, for some parents who find it challenging to quit or safely leave their children to smoke outside, e-cigarettes may offer potential for reducing the harm to them and their children. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  16. Drivers’ attitudes and behaviors toward bicyclists : intermodal interactions and implications for road safety.

    DOT National Transportation Integrated Search

    2017-06-01

    Road safety concerns are a legitimate concern when promoting increased bicycle use. Currently, bicyclist traffic fatalities and injuries present both a public health concern and a disincentive to people taking up or continuing to bicycle for transpor...

  17. Attention-deficit hyperactivity disorder medication use: factors involved in prescribing, safety aspects and outcomes.

    PubMed

    Martinez-Raga, Jose; Ferreros, Amparo; Knecht, Carlos; de Alvaro, Raquel; Carabal, Eloisa

    2017-03-01

    While treatment of patients with attention-deficit hyperactivity disorder (ADHD) is based on a multimodal approach that combines medication with specific psychological interventions, pharmacotherapy alone is generally considered an essential and cost-effective element. This paper aims to comprehensively and critically review factors involved in prescribing and medication use in individuals diagnosed with ADHD, focusing on the difficulties facing patients with ADHD seeking treatment, as well as the safety and tolerability aspects of ADHD pharmacotherapies, with particular attention on the cardiovascular adverse events and the potential risk of misuse or diversion of ADHD medications. A comprehensive and systematic literature search of PubMed/MEDLINE database was conducted to identify studies published in peer-reviewed journals until 1 August 2016. Children, adolescents and adults often encounter significant difficulties in the process of accessing specialist assessment and treatment for ADHD as a consequence of disparities in service organization and available treatment provision. Despite the well-established efficacy and overall safety profile, ADHD medications are not exempt from adverse events. The cardiovascular safety of pharmacotherapies used for treating individuals with ADHD has raised particular concerns; however there is little evidence of serious cardiovascular adverse events, including no serious corrected QT (QTc) abnormalities associated with stimulants, atomoxetine or α2-adrenergic receptor agonists. Although the abuse of prescription stimulant drugs, particularly, short-acting stimulants is a prevalent and growing problem, nonmedical use of prescription stimulants within the clinical context is very limited. In addition, nonstimulant ADHD medications lack any reinforcing effects and consequently any abuse potential.

  18. Clinical risk management in mental health: a qualitative study of main risks and related organizational management practices.

    PubMed

    Briner, Matthias; Manser, Tanja

    2013-02-04

    A scientific understanding of clinical risk management (CRM) in mental health care is essential for building safer health systems and for improving patient safety. While evidence on patient safety and CRM in physical health care has increased, there is limited research on these issues in mental health care. This qualitative study provides an overview of the most important clinical risks in mental health and related organizational management practices. We conducted in-depth expert interviews with professionals responsible for CRM in psychiatric hospitals. Interviews were transcribed and analyzed applying qualitative content analysis to thematically sort the identified risks. The main concerns for CRM in mental health are a) violence and self-destructive behavior (i.e. protecting patients and staff from other patients, and patients from themselves), b) treatment errors, especially in the process of therapy, and c) risks associated with mental illnesses (e.g. psychosis or depression). This study identified critical differences to CRM in hospitals for physical disorder and challenges specific to CRM in mental health. Firstly, many psychiatric patients do not believe that they are ill and are therefore in hospital against their will. Secondly, staff safety is a much more prominent theme for CRM in mental health care as it is directly related to the specifics of mental illnesses. The current study contributes to the understanding of patient safety and raises awareness for CRM in mental health. The mental health specific overview of central risks and related organizational management practices offers a valuable basis for CRM development in mental health and an addition to CRM in general.

  19. Private-public sector co-operation to improve pesticide safety standards in developing countries.

    PubMed

    Ellis, W W

    1998-01-01

    This paper draws on the author's experiences of the pilot phase of the Safe Use Project (SUP) in Thailand; this project is a part of a major GIFAP initiative carried out in some developing countries. The SUP's objectives were; i) to raise awareness and compliance in the safe handling and storage of pesticides within the industry, the medical profession and the end-users; ii) to reduce the incidence of pesticide poisoning; iii) to protect the environment; iiii) to help relevant government agencies with resources, expertise and training. To achieve those objectives, the SUP used local-language training resources, provided basic training, lobbied for changes in governmental policies and regulations, and acted as a focal point for pesticide safety-related information. The SUP targeted the whole distribution chain, from importer/formulator, through to the endusers. Also medical profession, teachers and school students were targeted. On the base of independent audit and surveys, a general improvement in awareness has been shown within targeted groups; a longer time frame is required to detect meaningful changes in farmer practice. The SUP key programmes have been: I) training of trainers, retailers and farmers; II) schools programme; III) medical training; IV) protective clothing; V) industry standards; VI) model farm. The main conclusions of the pilot phase were: i) pesticide safety needs to be addressed by all concerned agencies in a joint effort; ii) a rural development perspective must be adopted in improving pesticide safety; iii) integrated pest management training programmes must include precautionary advice for proper handling, use and disposal of pesticides, wherever these are necessary.

  20. Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine

    PubMed Central

    Grupping, Katrijn; Campora, Laura; Douha, Martine; Heineman, Thomas C; Klein, Nicola P; Lal, Himal; Peterson, James; Vastiau, Ilse; Oostvogels, Lidia

    2017-01-01

    Abstract Background Protection against herpes zoster (HZ) induced by the live attenuated zoster vaccine Zostavax (ZVL) wanes within 3–7 years. Revaccination may renew protection. We assessed whether (re)vaccination with the adjuvanted HZ subunit vaccine candidate (HZ/su) induced comparable immune responses in previous ZVL recipients and ZVL-naive individuals (HZ-NonVac). Methods In an open-label, multicenter study, adults ≥65 years of age, vaccinated with ZVL ≥5 years previously (HZ-PreVac), were matched to ZVL-naive adults (HZ-NonVac). Participants received 2 doses of HZ/su 2 months apart. The primary objective of noninferiority of the humoral immune response 1 month post–dose 2 was considered demonstrated if the upper limit of the 95% confidence interval (CI) of the adjusted anti–glycoprotein E geometric mean concentration (GMC) ratio of HZ-NonVac over HZ-PreVac was <1.5. HZ/su cellular immunogenicity, reactogenicity, and safety were also assessed. Results In 430 participants, humoral immune response to HZ/su was noninferior in HZ-PreVac compared with HZ-NonVac (adjusted GMC ratio, 1.04 [95% CI, .92–1.17]). Cellular immunogenicity, reactogenicity, and safety appeared to be comparable between groups. HZ/su was well-tolerated, with no safety concerns raised within 1 month post–dose 2. Conclusions HZ/su induces a strong immune response irrespective of prior vaccination with ZVL, and may be an attractive option to revaccinate prior ZVL recipients. Clinical Trials Registration NCT02581410. PMID:29029122

Some links on this page may take you to non-federal websites. Their policies may differ from this site.
Top