Sample records for post authorization safety

  1. Post-authorization safety surveillance of a liquid pentavalent vaccine in Guatemalan children.

    PubMed

    Asturias, Edwin J; Contreras-Roldan, Ingrid L; Ram, Malathi; Garcia-Melgar, Ana J; Morales-Oquendo, Vilma; Hartman, Katharina; Rauscher, Martina; Moulton, Lawrence H; Halsey, Neal A

    2013-12-02

    Combination vaccines have improved the efficiency of delivery of new vaccines in low and middle-income countries. Post-authorization monitoring of adverse events (AEs) after vaccination with a liquid pentavalent DTwP-HepB-Hib combination vaccine was conducted in Guatemalan infants. A prospective observational safety study of the incidence of medical attended events (MAEs) and serious adverse events (SAEs) in children who received pentavalent and oral polio vaccines at 2, 4 and 6 months of age was conducted in two clinics at the Institute of Guatemala. Parents were contacted by telephone after each dose. All outpatient, emergency department visits, and hospitalizations were monitored. A self-controlled analysis was conducted to determine if there was evidence of increased risk of MAEs or SAEs following vaccines as compared to control time windows. Of 3000 recruited infants, 2812 (93.7%) completed the third dose and 2805 (93.5%) completed follow-up. Ten AEs in eight infants, of which four SAEs in four infants, were classified as related to the vaccine. Thirteen deaths were reported due to common illnesses of infancy, and none were judged to be related to the vaccine. The mortality rate (4.4 per 1000) was lower than expected for the population. The incidence-rate-ratio for healthcare visits was lower in post-vaccination time windows than for control windows; after the first vaccine dose, the rate ratios for the risk periods of 0-1, 2-6, and 7-30 days post-vaccination were 0.3, 0.5, and 0.7, respectively (all statistically significantly different from the reference value of 1.0 for the 31-60 day control period). The liquid pentavalent vaccine was associated with lower rates of health care visits and not associated with increases in SAEs or hospitalizations. Systems can be set up in low to middle income countries to capture all health care visits to monitor the safety of new vaccines. Copyright © 2013 Elsevier Ltd. All rights reserved.

  2. School Safety in a Post-Sandy Hook World

    ERIC Educational Resources Information Center

    Trump, Kenneth S.

    2014-01-01

    In this report the author, who is a school safety expert, provides information about school safety in a post-Sandy Hook world. He presents the following: (1) Continuum of Threats and Responses; (2) The role social media plays; (3) Reliable Best Practices; (4) Policy and Funding--Climate and Context; (5) Policy and Funding--Things to Avoid; and (6)…

  3. Post-earthquake building safety inspection: Lessons from the Canterbury, New Zealand, earthquakes

    USGS Publications Warehouse

    Marshall, J.; Jaiswal, Kishor; Gould, N.; Turner, F.; Lizundia, B.; Barnes, J.

    2013-01-01

    The authors discuss some of the unique aspects and lessons of the New Zealand post-earthquake building safety inspection program that was implemented following the Canterbury earthquake sequence of 2010–2011. The post-event safety assessment program was one of the largest and longest programs undertaken in recent times anywhere in the world. The effort engaged hundreds of engineering professionals throughout the country, and also sought expertise from outside, to perform post-earthquake structural safety inspections of more than 100,000 buildings in the city of Christchurch and the surrounding suburbs. While the building safety inspection procedure implemented was analogous to the ATC 20 program in the United States, many modifications were proposed and implemented in order to assess the large number of buildings that were subjected to strong and variable shaking during a period of two years. This note discusses some of the key aspects of the post-earthquake building safety inspection program and summarizes important lessons that can improve future earthquake response.

  4. Training in Post-authorization Pharmacovigilance.

    PubMed

    Ahuja, Vivek; Sharma, Varun

    2010-04-01

    Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.

  5. Training in Post-authorization Pharmacovigilance

    PubMed Central

    Ahuja, Vivek; Sharma, Varun

    2010-01-01

    Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices. PMID:21829787

  6. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational...

  7. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational...

  8. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational...

  9. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational...

  10. 47 CFR 101.215 - Posting of station authorization and transmitter identification cards, plates, or signs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Posting of station authorization and transmitter identification cards, plates, or signs. 101.215 Section 101.215 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Operational...

  11. NASA's post-Challenger safety program - Themes and thrusts

    NASA Technical Reports Server (NTRS)

    Rodney, G. A.

    1988-01-01

    The range of managerial, technical, and procedural initiatives implemented by NASA's post-Challenger safety program is reviewed. The recommendations made by the Rogers Commission, the NASA post-Challenger review of Shuttle design, the Congressional investigation of the accident, the National Research Council, the Aerospace Safety Advisory Panel, and NASA internal advisory panels and studies are summarized. NASA safety initiatives regarding improved organizational accountability for safety, upgraded analytical techniques and methodologies for risk assessment and management, procedural initiatives in problem reporting and corrective-action tracking, ground processing, maintenance documentation, and improved technologies are discussed. Safety issues relevant to the planned Space Station are examined.

  12. [Post-authorization research, registries, and drug development].

    PubMed

    Patarnello, Francesca; Recchia, Giuseppe

    2013-06-01

    In the last decade regulators, payers and health care providers tried to react to three major problems in drug development and drug use in clinical practice: the pharmaceutical R&D productivity crisis, the immaturity of benefit-risk profile for several newly approved drugs and the overall impact on economic sustainability of reimbursing new high cost drugs in their systems. The potentiality of create a continuum between the evidence requirements relevant for registration, for reimbursement and for post authorization research is clear. All different parties involved, like regulators, HTA agencies, scientific communities and manufacturers, are working to improve the knowledge profile of new drugs in order to anticipate the patient access to innovation, limiting or preventing the clinical and economical risks deriving from an incomplete safety and effectiveness profile. The Italian example of "New Drugs AIFA Registries", with or without the application of risk sharing schemes (cost sharing, pay for performance, etc.), introduced a new process and increased the sensitivity on this topic. However this might probably represents only a partial answer to the problem of how to set up the governance of coverage with evidence, drug utilization monitoring, comparative effectiveness research, outcome research programs and may be how to link them to access, pricing and reimbursement. The step change in post authorization research could be to "integrate" different sources and stakeholders in a wider and continuous approach, in a well designed and inclusive "second generation" HTA approach, where all resources (competencies, data, funding) will concur to increase the evidence profile and reduce the risks, and where any "evidence generation approach" is really compliant with the standard and rules of best research practices.

  13. 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.

  14. Social Media Listening for Routine Post-Marketing Safety Surveillance.

    PubMed

    Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

    2016-05-01

    Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

  15. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

  16. New York Metropolitan Transportation Authority safety investigation

    DOT National Transportation Integrated Search

    1993-06-01

    The Federal Transit Administration (FTA) conducted an intensive investigation of passenger and employee safety on the New York Metropolitan Transportation Authority (MTA) and its operating elements. The investigation stressed the system safety concep...

  17. A pre-marketing ALT signal predicts post-marketing liver safety.

    PubMed

    Moylan, Cynthia A; Suzuki, Ayako; Papay, Julie I; Yuen, Nancy A; Ames, Michael; Hunt, Christine M

    2012-08-01

    Drug induced liver injury during drug development is evidenced by a higher incidence of serum alanine aminotransferase (ALT) elevations in treated versus placebo populations and termed an "ALT signal". We sought to quantify whether an ALT signal in pre-marketing clinical trials predicted post-marketing hepatotoxicity. Incidence of ALT elevations (ALT ≥ 3 times upper limits normal [× ULN]) for drug and placebo of new chemical entities and approved drugs associated with hepatotoxicity was calculated using the Food and Drug Administration (FDA) website. Post-marketing liver safety events were identified using the FDA Adverse Event Reporting System (AERS). The association of FDA AERS signal score (EB05 ≥ 2) and excess risk of pre-marketing ALT elevation (difference in incidence of ALT ≥ 3× ULN in treated versus placebo) was examined. An ALT signal of ≥ 1.2% was significantly associated with a post-marketing liver safety signal (p ≤ 0.013) and a 71.4% positive predictive value. An absent ALT signal was associated with a high likelihood of post-marketing liver safety; negative predictive value of 89.7%. Daily drug dose information improved the prediction of post-marketing liver safety. A cut-off of 1.2% increase in ALT ≥ 3× ULN in treated versus placebo groups provides an easily calculated method for predicting post-marketing liver safety. Published by Elsevier Inc.

  18. [Post-marketing drug safety measures for the attainment of safer and more effective use of drug].

    PubMed

    Kurokawa, Tatsuo

    2011-01-01

    In contrast with the 20th century's dramatic improvements in the direct and/or hazardous toxicity of drugs, indirect toxicity and/or long-term safety concerns such as relation of cancer risk and TNF-alpha receptor blockers have caused significant complexity in post-marketing surveillance (PMS) scenery. The post-marketing phase of drugs and their safety measures now appear to be much more complicated and heavier than decades ago. The spontaneous adverse drug reaction (ADR) reporting system which has been one of the main pillars of PMS measures for almost 50 years may have to be reviewed in terms of its effectiveness, and may need augmentation from medical data bases. Only a pharmaco-epidemiological analysis and integration of the output with a conventional spontaneous reporting approach offers a chance to satisfy the current complex safety issues. Today's tendency toward practical saturation at medical/pharmaceutical frontiers, by regulatory authorities and safety divisions of pharmaceutical companies with ever-increasing day-to-day safety information can also be pointed out. Such phenomena may actually reduce the productivity of safety measures and also jeopardize the maintenance of an acceptable risk/benefit drug ratio. To alleviate these potential negative implications, establishment of a consortium to act as a sentinel that would gather up-to-date and essential safety information, including epidemiological data, from all sources and provide it plus recommendations to all stakeholders can be suggested. Through such activities, we could expect significant improvement of drug safety measures in post-marketing phase which would effectively cover not only new drugs but also generic and bio-simulated drugs.

  19. Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.

    PubMed

    Négrier, C; Rothschild, C; Borg, J-Y; Lambert, T; Claeyssens, S; Sanhes, L; Stieltjes, N; Bertrand, A; André, M-H; Sié, P; Gruel, Y; Tellier, Z

    2016-11-01

    A new fibrinogen concentrate Clottafact ® was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France. The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on-demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. Fourteen patients [1-78 years] were included in 7 centres and followed for 1 year. Twenty-one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on-demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable. © 2016 International Society of Blood Transfusion.

  20. [Post-marketing drug safety-risk management plan(RMP)].

    PubMed

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  1. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    PubMed

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

  2. Post-approval safety issues with innovative drugs: a European cohort study.

    PubMed

    Mol, Peter G M; Arnardottir, Arna H; Motola, Domenico; Vrijlandt, Patrick J; Duijnhoven, Ruben G; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Denig, Petra; Straus, Sabine M J M

    2013-11-01

    At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval. We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation. A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation. In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having

  3. Post-Facts: Information Literacy and Authority after the 2016 Election

    ERIC Educational Resources Information Center

    Bluemle, Stefanie R.

    2018-01-01

    This article addresses the challenge that post-truth politics poses to teaching authority in information literacy. First, it isolates an element of the post-truth phenomenon, an element it calls "post-facts", to elucidate why teaching source evaluation is not, by itself, an antidote to fake news or other evidence of Americans' media…

  4. Challenges of post-authorization safety studies: Lessons learned and results of a French study of fentanyl buccal tablet.

    PubMed

    Gavrielov-Yusim, Natalie; Bidollari, Ilda; Kaplan, Sigal; Bartov, Netta

    2018-05-01

    Recruiting and retaining participants in real-world studies that collect primary data are challenging. This article illustrates these challenges using a post-authorization safety study (PASS) to assess adverse events (AEs) experienced with fentanyl buccal tablet (FBT) over 3 months of treatment. This was an observational, prospective, multicenter study in France conducted over 1 year. The study employed primary data collection in FBT-treated patients and their treating physicians via a site qualification questionnaire and patient log completed by physicians and a questionnaire and pain diary completed by patients. Strategies to increase participation included reminders, newsletters, frequent follow-up telephone calls, and reducing the extent of data collected. Of the 1118 physicians contacted who returned the participation form or responded to a telephone call, only 128 expressed willingness to participate. Key reasons for non-participation were lack of interest (69.7%) and FBT not being used in practice by the contacted physician (25.1%). Overall, 224 patients were screened by 31 physicians, and 97 were enrolled. Key reasons for patient non-inclusion were unwillingness or inability to complete the patient AE diary or questionnaire (40.9% [52/127]) and patients' decision (33.9% [43/127]). Despite efforts to increase participation, enrollment in this study was low. Recruitment and retention methods are limited in their capacity to optimally execute a primary data collection in a PASS. For a PASS to provide reliable and valid information on medication use, involvement from health care agencies, regulators, and pharmaceutical companies is needed to establish their importance, drive study participation, and reduce patient withdrawal. Copyright © 2017 John Wiley & Sons, Ltd.

  5. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

  6. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

  7. Evolution of safety-critical requirements post-launch

    NASA Technical Reports Server (NTRS)

    Lutz, R. R.; Mikulski, I. C.

    2001-01-01

    This paper reports the results of a small study of requirements changes to the onboard software of three spacecraft subsequent to launch. Only those requirement changes that resulted from post-launch anoma-lies (i.e., during operations) were of interest here, since the goal was to better understand the relation-ship between critical anomalies during operations and how safety-critical requirements evolve. The results of the study were surprising in that anomaly-driven, post-launch requirements changes were rarely due to previous requirements having been incorrect. Instead, changes involved new requirements (1) for the software to handle rare events or (2) for the software to compensate for hardware failures or limitations. The prevalence of new requirements as a result of post-launch anomalies suggests a need for increased requirements-engineering support of maintenance activities in these systems. The results also confirm both the difficulty and the benefits of pursuing requirements completeness, especially in terms of fault tolerance, during development of critical systems.

  8. Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval.

    PubMed

    Giezen, Thijs J; Mantel-Teeuwisse, Aukje K; Straus, Sabine M J M; Egberts, Toine C G; Blackburn, Stella; Persson, Ingemar; Leufkens, Hubert G M

    2009-01-01

    Since November 2005, an EU Risk Management Plan (EU-RMP) has had to be submitted as part of a marketing application for all new chemical entities in the EU. In the EU-RMP, the safety profile of the medicine has to be described and pharmacovigilance activities should be proposed to study further safety concerns during use of the drug in the real-world setting. These activities include, for example, collection of spontaneously reported adverse events and post-authorization safety studies (PASS). Since the submission of an EU-RMP is a relatively new requirement, there is limited knowledge on the quality and completeness of the study protocols of PASS at the time of approval and there are no data on the influence of certain drug characteristics on the proposed pharmacovigilance activities. To examine the types of proposed pharmacovigilance activities in a sample of EU-RMPs, describe and evaluate the methodology of PASS, identify problems and propose remedies, and compare characteristics between biologicals and small molecules. Eighteen EU-RMPs (nine for biologicals, nine for small molecules) given a positive decision regarding the marketing application by the Committee for Medicinal Products for Human Use between November 2005 and May 2007 were included in this descriptive cohort study. The EU-RMPs were selected over time and different therapeutic areas. Classification of the safety concerns ('important identified risks', 'important potential risks', 'important missing information' within the EU-RMP was studied. For PASS, data source (registry, population-based database, sponsor-owned clinical trial database), source of study population to be included in PASS and comprehensiveness of study protocol (full protocol, limited protocol, study synopsis, short description, commitment without further information) were studied. Compared to small molecules, safety concerns for biologicals were less frequently classified as important identified risks (relative risk [RR] 0.6; 95

  9. [Recommendations for inspections of the French nuclear safety authority].

    PubMed

    Rousse, C; Chauvet, B

    2015-10-01

    The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. Copyright © 2015. Published by Elsevier SAS.

  10. Post-earthquake building safety assessments for the Canterbury Earthquakes

    USGS Publications Warehouse

    Marshall, J.; Barnes, J.; Gould, N.; Jaiswal, K.; Lizundia, B.; Swanson, David A.; Turner, F.

    2012-01-01

    This paper explores the post-earthquake building assessment program that was utilized in Christchurch, New Zealand following the Canterbury Sequence of earthquakes beginning with the Magnitude (Mw.) 7.1 Darfield event in September 2010. The aftershocks or triggered events, two of which exceeded Mw 6.0, continued with events in February and June 2011 causing the greatest amount of damage. More than 70,000 building safety assessments were completed following the February event. The timeline and assessment procedures will be discussed including the use of rapid response teams, selection of indicator buildings to monitor damage following aftershocks, risk assessments for demolition of red-tagged buildings, the use of task forces to address management of the heavily damaged downtown area and the process of demolition. Through the post-event safety assessment program that occurred throughout the Canterbury Sequence of earthquakes, many important lessons can be learned that will benefit future response to natural hazards that have potential to damage structures.

  11. 76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ...-0097] Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits AGENCY: Federal Motor... public comment on data and information concerning the Pre-Authorization Safety Audits (PASAs) for two motor carriers that applied to participate in the Agency's long-haul pilot program to test and...

  12. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    PubMed

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  13. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    PubMed

    Silva, Ivair R

    2018-01-15

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  14. Herpes zoster vaccine live: A 10 year review of post-marketing safety experience

    PubMed Central

    Willis, English D.; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W.; Halsey, Neal A.; Gershon, Anne A.

    2017-01-01

    Background Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. Methods All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. Results A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. Conclusions The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. PMID:29174682

  15. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience.

    PubMed

    Angelo, Maria-Genalin; Zima, Julia; Tavares Da Silva, Fernanda; Baril, Laurence; Arellano, Felix

    2014-05-01

    To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium). We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008-2010). Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain-Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information. Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit-risk profile in adolescent girls and women. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

  16. Study of the post-derailment safety measures on low-speed derailment tests

    NASA Astrophysics Data System (ADS)

    Guo, Lirong; Wang, Kaiyun; Lin, Jianhui; Zhang, Bing; Chen, Zaigang; Song, Xinwu; Du, Gaofeng

    2016-07-01

    Prevention of train from derailment is the most important issue for the railway system. Keeping derailed vehicle close to the track centreline is beneficial to minimise the severe consequences associated with derailments. In this paper, the post-derailment safety measures are studied based on low-speed derailment tests. Post-derailment devices can prevent deviation of the train from the rail by catching the rail, and they are mounted under the axle box. Considering the different structures of vehicles, both trailer and motor vehicles are equipped with the safety device and then separately used in low-speed derailment tests. In derailment tests, two kinds of track, namely the CRTS-I slab ballastless track and the CRTS-II bi-block sleeper ballastless track, are adopted to investigate the effect of the track types on the derailment. In addition, the derailment speed and the weight of the derailed vehicle are also taken into account in derailment tests. The test results indicate that the post-derailment movement of the vehicle includes running and bounce. Reducing the derailment speed and increasing the weight of the head of the train are helpful to reduce the possibility for derailments. For the CRTS-I slab ballastless track, the safety device can prevent trailer vehicles from deviating from the track centreline. The gearbox plays an important role in controlling the lateral displacement of motor vehicle after a derailment while the safety device contributes less to keep derailed motor vehicles on the track centreline. The lateral distance between the safety device and rails should be larger than 181.5 mm for protecting the fasteners system. And for the CRTS-II bi-block sleeper ballastless track, it helps to decrease the post-derailment distance due to the longitudinal impacts with sleepers. It can also restrict the lateral movement of derailed vehicle due to the high shoulders. The results suggest that, CRTS-II bi-block sleeper ballastless track should be widely used

  17. 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...

  18. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    PubMed

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  19. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    PubMed

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  20. 78 FR 28897 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ...] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... CFR 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety... comprised of the following administrative judges: Alex S. Karlin, Chairman, Atomic Safety and Licensing...

  1. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.

  2. Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

    PubMed

    Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

    2017-12-19

    Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (<1%) with 38% occurring in immunocompromised individuals. All reports of disseminated HZ confirmed by PCR as VZV Oka/Merck vaccine-strain were in individuals with immunosuppressive conditions and/or therapy at the time of vaccination. The safety profile of ZVL, following 10 years of post-marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

    PubMed

    Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

    2018-01-01

    Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

  4. General in-situation safety behaviors are uniquely associated with post-event processing.

    PubMed

    Mitchell, Melissa A; Schmidt, Norman B

    2014-06-01

    Research suggests that state anxiety and in-situation safety behaviors are associated with post-event processing (PEP) in social anxiety. Past research has obtained mixed results on whether one or both factors contribute to PEP. The current investigation evaluated state anxiety and in-situation safety behaviors (including subtypes of in-situation safety behaviors) simultaneously to determine their relative contributions to PEP. A prospective study assessed social anxiety, state anxiety, in-situation safety behaviors, PEP, and depression in the context of a speech stressor. Consistent with theory, in-situation safety behaviors were uniquely associated with greater PEP. State anxiety was not uniquely associated with PEP. Furthermore, restricting and active subtypes of in-situation safety behaviors showed specificity to PEP. Limitations of the present study include the use of a nonclinical analog sample and retrospective reporting of PEP. These findings highlight the importance of research on in-situation safety behaviors as a potential contributor to PEP. Published by Elsevier Ltd.

  5. DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

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

    D. A. MC CLURE; C. A. NELSON; R. L. BOUDRIE

    2001-04-01

    This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamosmore » National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety.« less

  6. [Post-operative course in tetraplegics after urological surgers (author's transl)].

    PubMed

    Vigreux, G; Vacant, J; Lepresle, E; Desalle De Hys, C; Debras, C

    1976-06-01

    The authors report their experience with 33 tetraplegics undergoing surgery. The operations were varied, endoscopic (resection of the bladder neck, of the prostate or striate sphincter, lithot-itiasis) or surgical (lombotomies, transintentinal cutaneous ureterostomies). The post-operative course may be dramatic or even fatal (acute hypertension with cerebral haemorrhage). Respiratory insufficiency poses no particular problem and can be controlled. Epidural anaesthesia maintained for several days makes it possible to avoid the more serious problems: -- autonomic hyperreflectivity, -- delayed resolution of ileus and digestive complication. The authors hence use epidural anaesthesia routinely and are satisfied with the technique.

  7. Tensoral for post-processing users and simulation authors

    NASA Technical Reports Server (NTRS)

    Dresselhaus, Eliot

    1993-01-01

    The CTR post-processing effort aims to make turbulence simulations and data more readily and usefully available to the research and industrial communities. The Tensoral language, which provides the foundation for this effort, is introduced here in the form of a user's guide. The Tensoral user's guide is presented in two main sections. Section one acts as a general introduction and guides database users who wish to post-process simulation databases. Section two gives a brief description of how database authors and other advanced users can make simulation codes and/or the databases they generate available to the user community via Tensoral database back ends. The two-part structure of this document conforms to the two-level design structure of the Tensoral language. Tensoral has been designed to be a general computer language for performing tensor calculus and statistics on numerical data. Tensoral's generality allows it to be used for stand-alone native coding of high-level post-processing tasks (as described in section one of this guide). At the same time, Tensoral's specialization to a minute task (namely, to numerical tensor calculus and statistics) allows it to be easily embedded into applications written partly in Tensoral and partly in other computer languages (here, C and Vectoral). Embedded Tensoral, aimed at advanced users for more general coding (e.g. of efficient simulations, for interfacing with pre-existing software, for visualization, etc.), is described in section two of this guide.

  8. Pediatric post-marketing safety systems in North America: assessment of the current status.

    PubMed

    McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

    2015-08-01

    It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

  9. Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars.

    PubMed

    Prager, Welf; Gauglitz, Gerd G

    2018-06-14

    An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12-24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale. A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified. This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  10. Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study

    PubMed Central

    Benea, Otilia Elisabeta; Streinu-Cercel, Adrian; Dorobăţ, Carmen; Rugină, Sorin; Negruţiu, Lucian; Cupşa, Augustin; Duiculescu, Dan; Chiriac, Carmen; Itu, Corina; Prisăcariu, Liviu Jany; Iosif, Ionel

    2014-01-01

    Introduction The aim of the study was to assess the safety and efficacy of darunavir (Prezista®) used in subtype F human immunodeficiency virus – type 1 (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in routine clinical practice. Methods This was a post-authorization, open-label, one-cohort, non-interventional, prospective study conducted at multiple sites in Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) and safety ([serious] adverse events, clinical laboratory evaluation, and vital signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in naturalistic settings. Seventy-eight subjects were recruited by 9 investigational sites and received 600/100 mg DRV/r twice daily. Results Treatment with DRV/r administered with other ARV medications resulted in the expected, statistically relevant improvement of CD4 cell count and viral load in subjects eligible for such treatment. In addition, adherence to treatment was high and the treatment-emergent safety profile observed during this study was consistent with the established safety profile of darunavir. Conclusion DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania. Trial registration NCT01253967 PMID:25276665

  11. Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici).

    PubMed

    Ai, Qinghua; Zhang, Wen; Xie, Yanming; Huang, Wenhua; Liang, Hong; Cao, Hui

    2014-08-01

    To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. This study introduces "get full access" to the flow of information on

  12. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  13. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  14. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  15. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  16. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  17. 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.

  18. Sample size for post-marketing safety studies based on historical controls.

    PubMed

    Wu, Yu-te; Makuch, Robert W

    2010-08-01

    As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

  19. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis.

    PubMed

    le Roux, Carel; Aroda, Vanita; Hemmingsson, Joanna; Cancino, Ana Paula; Christensen, Rune; Pi-Sunyer, Xavier

    2017-01-01

    To investigate whether the efficacy and safety of liraglutide 3.0 mg differed between two subgroups, BMI 27 to <35 and BMI ≥ 35 kg/m², in individuals without and with type 2 diabetes (T2D). A post-hoc analysis of two 56-week, randomized, double-blind, placebo-controlled trials (SCALE Obesity and Prediabetes; SCALE Diabetes). Subgroup differences in treatment effects of liraglutide 3.0 mg were evaluated by testing the interaction between treatment group and baseline BMI subgroup. Significantly greater weight loss (0-56 weeks) was observed with liraglutide 3.0 mg versus placebo in all patient groups while on treatment. There was no evidence that the weight-lowering effect of liraglutide 3.0 mg differed between BMI subgroups (interaction p > 0.05). Similarly, for most secondary endpoints significantly greater improvements were observed with liraglutide 3.0 mg versus placebo, with no indication treatment effects differing between subgroups. The safety profile of liraglutide 3.0 mg was broadly similar across BMI subgroups. This post-hoc analysis did not indicate any differences in the treatment effects, or safety profile, of liraglutide 3.0 mg for individuals with BMI 27 to <35 or ≥35 kg/m². Liraglutide 3.0 mg can therefore be considered for individuals with a BMI of ≥35 as well as for those with a BMI of 27 to <35 kg/m². © 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

  20. Post-licensure rapid immunization safety monitoring program (PRISM) data characterization.

    PubMed

    Baker, Meghan A; Nguyen, Michael; Cole, David V; Lee, Grace M; Lieu, Tracy A

    2013-12-30

    The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of this large claims-based distributed database for vaccine safety surveillance by characterizing the underlying data. We characterized data available on vaccine exposures in PRISM, estimated how much additional data was gained by matching with select state and local immunization registries, and compared vaccination coverage estimates based on PRISM data with other available data sources. We generated rates of computerized codes representing potential health outcomes relevant to vaccine safety monitoring. Standardized algorithms including ICD-9 codes, number of codes required, exclusion criteria and location of the encounter were used to obtain the background rates. The majority of the vaccines routinely administered to infants, children, adolescents and adults were well captured by claims data. Immunization registry data in up to seven states comprised between 5% and 9% of data for all vaccine categories with the exception of 10% for hepatitis B and 3% and 4% for rotavirus and zoster respectively. Vaccination coverage estimates based on PRISM's computerized data were similar to but lower than coverage estimates from the National Immunization Survey and Healthcare Effectiveness Data and Information Set. For the 25 health outcomes of interest studied, the rates of potential outcomes based on ICD-9 codes were generally higher than rates described in the literature, which are typically clinically confirmed cases. PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring. Copyright © 2013 Elsevier Ltd. All rights reserved.

  1. Climate change and landscape development in post-closure safety assessment of solid radioactive waste disposal: Results of an initiative of the IAEA.

    PubMed

    Lindborg, T; Thorne, M; Andersson, E; Becker, J; Brandefelt, J; Cabianca, T; Gunia, M; Ikonen, A T K; Johansson, E; Kangasniemi, V; Kautsky, U; Kirchner, G; Klos, R; Kowe, R; Kontula, A; Kupiainen, P; Lahdenperä, A-M; Lord, N S; Lunt, D J; Näslund, J-O; Nordén, M; Norris, S; Pérez-Sánchez, D; Proverbio, A; Riekki, K; Rübel, A; Sweeck, L; Walke, R; Xu, S; Smith, G; Pröhl, G

    2018-03-01

    are projections based on a well-established understanding of the important processes involved and their impacts on different types of landscape. Such projections support the understanding of, and selection of, plausible ranges of scenarios for use in post-closure safety assessments. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  2. Globe rupture with post cataract-surgery safety sunglasses.

    PubMed

    Brooks, Clifford W; Howard, Robert C; Lyons, Robert A; Reilly, Charles D

    2010-07-01

    We report a case of globe rupture associated with the use of post cataract-surgery protective eyewear. The patient had routine cataract surgery 3 months before presentation and had adapted his post cataract-surgery glasses to use on the tennis court. He experienced a large posterior globe rupture after falling directly onto his face during a match. Spectacle torsion is the suspected biomechanical process that led to the rupture. We conclude that although the glasses given to many patients after cataract surgery are protective for most low-impact injuries, patients should be aware they are not designed for activities with a risk for significant impact. Patients should also be counseled to use protective eyewear specifically designed and approved for the sport or activity in which they participate. No author has a financial or proprietary interest in any material or method mentioned. Published by Elsevier Inc.

  3. [Safety monitoring of cell-based medicinal products (CBMPs)].

    PubMed

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  4. Pharmacodynamic analysis of eribulin safety in breast cancer patients using real-world post-marketing surveillance data.

    PubMed

    Kawamura, Takahisa; Kasai, Hidefumi; Fermanelli, Valentina; Takahashi, Toshiaki; Sakata, Yukinori; Matsuoka, Toshiyuki; Ishii, Mika; Tanigawara, Yusuke

    2018-06-22

    Post-marketing surveillance is useful to collect safety data in real-world clinical settings. In this study, we firstly applied the post-marketing real-world data on a mechanistic model analysis for neutropenic profiles of eribulin in patients with recurrent or metastatic breast cancer (RBC/MBC). Demographic and safety data were collected using an active surveillance method from eribulin-treated RBC/MBC patients. Changes in neutrophil counts over time were analyzed using a mechanistic pharmacodynamic model. Pathophysiological factors that may affect the severity of neutropenia were investigated and neutropenic patterns were simulated for different treatment schedules. Clinical and laboratory data were collected from 401 patients (5199 neutrophil count measurements) who had not received granulocyte colony stimulating factor and were eligible for pharmacodynamic analysis. The estimated mean parameters were: mean transit time = 104.5 h, neutrophil proliferation rate constant = 0.0377 h -1 , neutrophil elimination rate constant = 0.0295 h -1 , and linear coefficient of drug effect = 0.0413 mL/ng. Low serum albumin levels and low baseline neutrophil counts were associated with severe neutropenia. The probability of grade ≥3 neutropenia was predicted to be 69%, 27%, and 27% for patients on standard, biweekly, and triweekly treatment scenarios, respectively, based on virtual simulations using the developed pharmacodynamic model. In conclusion, this is the first application of post-marketing surveillance data to a model-based safety analysis. This analysis of safety data reflecting authentic clinical settings will provide useful information on the safe use and potential risk factors of eribulin. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  5. Live-attenuated tetravalent dengue vaccines: The needs and challenges of post-licensure evaluation of vaccine safety and effectiveness.

    PubMed

    Wichmann, Ole; Vannice, Kirsten; Asturias, Edwin J; de Albuquerque Luna, Expedito José; Longini, Ira; Lopez, Anna Lena; Smith, Peter G; Tissera, Hasitha; Yoon, In-Kyu; Hombach, Joachim

    2017-10-09

    Since December 2015, the first dengue vaccine has been licensed in several Asian and Latin American countries for protection against disease from all four dengue virus serotypes. While the vaccine demonstrated an overall good safety and efficacy profile in clinical trials, some key research questions remain which make risk-benefit-assessment for some populations difficult. As for any new vaccine, several questions, such as very rare adverse events following immunization, duration of vaccine-induced protection and effectiveness when used in public health programs, will be addressed by post-licensure studies and by data from national surveillance systems after the vaccine has been introduced. However, the complexity of dengue epidemiology, pathogenesis and population immunity, as well as some characteristics of the currently licensed vaccine, and potentially also future, live-attenuated dengue vaccines, poses a challenge for evaluation through existing monitoring systems, especially in low and middle-income countries. Most notable are the different efficacies of the currently licensed vaccine by dengue serostatus at time of first vaccination and by dengue virus serotype, as well as the increased risk of dengue hospitalization among young vaccinated children observed three years after the start of vaccination in one of the trials. Currently, it is unknown if the last phenomenon is restricted to younger ages or could affect also seronegative individuals aged 9years and older, who are included in the group for whom the vaccine has been licensed. In this paper, we summarize scientific and methodological considerations for public health surveillance and targeted post-licensure studies to address some key research questions related to live-attenuated dengue vaccines. Countries intending to introduce a dengue vaccine should assess their capacities to monitor and evaluate the vaccine's effectiveness and safety and, where appropriate and possible, enhance their surveillance

  6. Pre- and post-exposure safety and efficacy of attenuated rabies virus vaccines are enhanced by their expression of IFNγ

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

    Barkhouse, Darryll A.; Center for Neurovirology 1020 Locust St., Jefferson Alumni Hall, Room 454, Philadelphia, PA 19107; Faber, Milosz

    Consistent with evidence of a strong correlation between interferon gamma (IFNγ) production and rabies virus (RABV) clearance from the CNS, we recently demonstrated that engineering a pathogenic RABV to express IFNγ highly attenuates the virus. Reasoning that IFNγ expression by RABV vaccines would enhance their safety and efficacy, we reverse-engineered two proven vaccine vectors, GAS and GASGAS, to express murine IFNγ. Mortality and morbidity were monitored during suckling mice infection, immunize/challenge experiments and mixed intracranial infections. We demonstrate that GASγ and GASγGAS are significantly attenuated in suckling mice compared to the GASGAS vaccine. GASγ better protects mice from lethal DRV4more » RABV infection in both pre- and post-exposure experiments compared to GASGAS. Finally, GASγGAS reduces post-infection neurological sequelae, compared to control, during mixed intracranial infection with DRV4. These data show IFNγ expression by a vaccine vector can enhance its safety while increasing its efficacy as pre- and post-exposure treatment. - Highlights: • IFNγ expression improves attenuated rabies virus safety and immunogenicity. • IFNγ expression is safer and more immunogenic than doubling glycoprotein expression. • Co-infection with IFNγ-expressing RABV prevents wild-type rabies virus lethality. • Vaccine safety and efficacy is additive for IFNγ and double glycoprotein expression.« less

  7. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    PubMed

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  8. 75 FR 3946 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-438-CP, 50-439-CP; ASLBP No. 10-896-01-CP-BD01] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972, published in the Federal Register, 37 FR 28,710 (1972), and the...

  9. Safety evaluation report on Tennessee Valley Authority: Browns Ferry nuclear performance plan

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

    Not Available

    1989-10-01

    This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Plant and in supporting documents has been prepared by the US Nuclear Regulatory commission staff. The Browns Ferry Nuclear Plant consists of three boiling-water reactors at a site in Limestone County, Alabama. The plan addresses the plant-specific concerns requiring resolution before the startup of Unit 2. The staff will inspect implementation of those TVA programs that address these concerns. Where systems are common to Units 1 and 2 or to Units 2more » and 3, the staff safety evaluations of those systems are included herein. 85 refs.« less

  10. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...; (2) To the contracting officer's knowledge, the Government has not provided advance notice so that... competition without SAFETY Act protections or the subject technology would be sold to the Government only with SAFETY Act protections. (b) Contracting officers shall not authorize offers contingent upon obtaining a...

  11. 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

  12. Ebola and Human Rights: Post-9/11 Public Health and Safety in Epidemics.

    PubMed

    Annas, George J

    2016-05-01

    In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism is often counterproductive to the population's health, and undermines human rights. Using the Ebola epidemic of 2014, this Article suggests how the post-9/11 reframing of public health goals as including disaster preparedness and counterterrorism, and the new military metaphors we have adopted to describe public health, have deformed our public health agencies, and have made them less trusted by the public. In turn, these agencies are therefore less able to prevent and respond to new infectious diseases. The United States' response to Ebola gives us an opportunity to reconsider the merger of public health and public safety domestically and globally. This Article suggests that a deeper commitment to human rights, especially to the right to health, has the theoretical and practical strength to act as a countervailing force and refocus public health on the health of populations rather than on safety and national security.

  13. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    PubMed

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  14. Food safety educational intervention positively influences college students' food safety attitudes, beliefs, knowledge, and self-reported practices.

    PubMed

    Yarrow, Linda; Remig, Valentina M; Higgins, Mary Meck

    2009-01-01

    In this study, the authors evaluated college students' food safety attitudes, beliefs, knowledge, and self-reported practices and explored whether these variables were positively influenced by educational intervention. Students (n=59), were mostly seniors, health or non-health majors, and responsible for meal preparation. Subjects completed a food safety questionnaire (FSQ) prior to educational intervention, which consisted of three interactive modules. Subjects completed module pre-, post-, and post-posttests. The FSQ was also administered after exposure to intervention and five weeks later to determine changes in food safety attitudes, beliefs, knowledge, and self-reported practices. Students' FSQ attitude scores increased from 114 to 122 (p < or = .001); FSQ belief and knowledge scores improved from 86 to 98 (p < or = .001) and from 11 to 13 (p < or = .001), respectively. Food safety knowledge was also measured by module pre- and posttests, and improved significantly after intervention for all students, with health majors having the greatest increase. Intervention resulted in improved food safety self-reported practices for health majors only. The educational intervention appeared effective in improving food safety beliefs and knowledge. For health majors, attitudes and some self-reported practices improved. For all areas, the strongest effects were seen in health majors.

  15. Distress of Routine Activities and Perceived Safety Associated with Post-Traumatic Stress, Depression, and Alcohol Use: 2002 Washington, DC, Sniper Attacks.

    PubMed

    Fullerton, Carol S; Herberman Mash, Holly B; Benevides, K Nikki; Morganstein, Joshua C; Ursano, Robert J

    2015-10-01

    For over 3 weeks in October 2002, a series of sniper attacks in the Washington, DC, area left 10 people dead and 3 wounded. This study examined the relationship of distress associated with routine activities and perceived safety to psychological and behavioral responses. Participants were 1238 residents of the Washington, DC, metropolitan area (aged 18 to 90 years, mean=41.7 years) who completed an Internet survey including the Impact of Event Scale-Revised, Patient Health Questionnaire-9, and items pertaining to distress related to routine activities, perceived safety, and alcohol use. Data were collected at one time point approximately 3 weeks after the first sniper shooting and before apprehension of the suspects. Relationships of distress and perceived safety to post-traumatic stress, depressive symptoms, and increased alcohol use were examined by using linear and logistic regression analyses. Approximately 8% of the participants met the symptom criteria for probable post-traumatic stress disorder, 22% reported mild to severe depression, and 4% reported increased alcohol use during the attacks. Distress related to routine activities and perceived safety were associated with increased post-traumatic stress and depressive symptoms and alcohol use. Distress and perceived safety are associated with specific routine activities and both contribute to psychological and behavioral responses during a terrorist attack. These findings have implications for targeted information dissemination and risk communication by community leaders.

  16. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines.

    PubMed

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-03-24

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. Promoting a Culture of Safety as a Patient Safety Strategy

    PubMed Central

    Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

    2015-01-01

    Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

  18. Patient safety goals for the proposed Federal Health Information Technology Safety Center.

    PubMed

    Sittig, Dean F; Classen, David C; Singh, Hardeep

    2015-03-01

    The Office of the National Coordinator for Health Information Technology is expected to oversee creation of a Health Information Technology (HIT) Safety Center. While its functions are still being defined, the center is envisioned as a public-private entity focusing on promotion of HIT related patient safety. We propose that the HIT Safety Center leverages its unique position to work with key administrative and policy stakeholders, healthcare organizations (HCOs), and HIT vendors to achieve four goals: (1) facilitate creation of a nationwide 'post-marketing' surveillance system to monitor HIT related safety events; (2) develop methods and governance structures to support investigation of major HIT related safety events; (3) create the infrastructure and methods needed to carry out random assessments of HIT related safety in complex HCOs; and (4) advocate for HIT safety with government and private entities. The convening ability of a federally supported HIT Safety Center could be critically important to our transformation to a safe and effective HIT enabled healthcare system. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. Power learning or path dependency? Investigating the roots of the European Food Safety Authority.

    PubMed

    Roederer-Rynning, Christilla; Daugbjerg, Carsten

    2010-01-01

    A key motive for establishing the European Food Safety Authority (EFSA) was restoring public confidence in the wake of multiplying food scares and the BSE crisis. Scholars, however, have paid little attention to the actual political and institutional logics that shaped this new organization. This article explores the dynamics underpinning the making of EFSA. We examine the way in which learning and power shaped its organizational architecture. It is demonstrated that the lessons drawn from the past and other models converged on the need to delegate authority to an external agency, but diverged on its mandate, concretely whether or not EFSA should assume risk management responsibilities. In this situation of competitive learning, power and procedural politics conditioned the mandate granted to EFSA. The European Commission, the European Parliament and the European Council shared a common interest in preventing the delegation of regulatory powers to an independent EU agency in food safety policy.

  20. Creation and preliminary validation of the screening for self-medication safety post-stroke scale (S-5).

    PubMed

    Kaizer, Franceen; Kim, Angela; Van, My Tram; Korner-Bitensky, Nicol

    2010-03-01

    Patients with stroke should be screened for safety prior to starting a self-medication regime. An extensive literature review revealed no standardized self-medication tool tailored to the multi-faceted needs of the stroke population. The aim of this study was to create and validate a condition-specific tool to be used in screening for self-medication safety in individuals with stroke. Items were generated using expert consultation and review of the existing tools. The draft tool was pilot-tested on expert stroke clinicians to receive feedback on content, clarity, optimal cueing and domain omissions. The final version was piloted on patients with stroke using a structured interviewer-administered interview. The tool was progressively refined and validated according to feedback from the 11 expert reviewers. The subsequent version was piloted on patients with stroke. The final version includes 16 questions designed to elicit information on 5 domains: cognition, communication, motor, visual-perception and, judgement/executive function/self-efficacy. The Screening for Safe Self-medication post-Stroke Scale (S-5) has been created and validated for use by health professionals to screen self-medication safety readiness of patients after stroke. Its use should also help to guide clinicians' recommendations and interventions aimed at enhancing self-medication post-stroke.

  1. Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.

    PubMed

    Goda, Maki; Yamakura, Tomoko; Sasaki, Kazuyo; Tajima, Takumi; Ueno, Makoto

    2018-02-01

    To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. The authors conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs, and the changes of laboratory tests as well as efficacy variables. An ADR was reported in 9.09% (125 of 1375 patients) in the safety analysis set. The main ADRs were dehydration, constipation, thirst, pollakiuria, dizziness, cystitis, eczema, pruritus, and rash. The incidence of serious ADRs was 1.02% (14 patients), which included urinary tract infection, dehydration, hypoglycemia, and cerebral infarction (two patients each). ADRs of special interest that had been reported in clinical trials of SGLT2 inhibitors, such as hypoglycemia, volume depletion-related events, genital/urinary tract infection, polyuria/pollakiuria, and ketone body increased were also observed in this PMS. The safety profiles were similar to the results of a previous clinical study of canagliflozin, and new safety concerns were not identified in this survey. The mean change in HbA1c was -0.77% after 12 months of treatment in the efficacy analysis set. In this PMS, the safety and efficacy profiles of canagliflozin in elderly patients with T2DM were obtained in the clinical settings in Japan and the drug was well tolerated and effective in improving glycemic control.

  2. Food Safety Impacts from Post-Harvest Processing Procedures of Molluscan Shellfish.

    PubMed

    Baker, George L

    2016-04-18

    Post-harvest Processing (PHP) methods are viable food processing methods employed to reduce human pathogens in molluscan shellfish that would normally be consumed raw, such as raw oysters on the half-shell. Efficacy of human pathogen reduction associated with PHP varies with respect to time, temperature, salinity, pressure, and process exposure. Regulatory requirements and PHP molluscan shellfish quality implications are major considerations for PHP usage. Food safety impacts associated with PHP of molluscan shellfish vary in their efficacy and may have synergistic outcomes when combined. Further research for many PHP methods are necessary and emerging PHP methods that result in minimal quality loss and effective human pathogen reduction should be explored.

  3. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... the Time of Assignment § 302-9.170 Under what specific conditions may my agency authorize...

  4. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... the Time of Assignment § 302-9.170 Under what specific conditions may my agency authorize...

  5. GPs' compliance with health and safety legislation and their occupational health needs in one London health authority.

    PubMed Central

    Kennedy, Ioanna; Williams, Siân; Reynolds, Anne; Cockcroft, Anne; Solomon, Jack; Farrow, Stephen

    2002-01-01

    This survey assessed general practitioners' (GPs') knowledge of and compliance with, health and safety legislation and occupational health guidance in one London health authority. The response rate was 85%. Although the majority of practices were aware of the most important piece of legislation--The Management of Health and Safety at Work Regulations, 1992--less than one in ten practices had carried out the required systematic risk assessments. Compliance with other health and safety legislation and related employment issues was also poor. The health of GPs and their staff may be at risk and these general practices may be vulnerable to prosecution by the Health and Safety Executive. PMID:12236278

  6. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    PubMed Central

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  7. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

    PubMed

    Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-02-07

     To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the

  8. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... Subsequent to the Time of Assignment § 302-9.170 Under what specific conditions may my agency authorize...

  9. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... Subsequent to the Time of Assignment § 302-9.170 Under what specific conditions may my agency authorize...

  10. 41 CFR 302-9.170 - Under what specific conditions may my agency authorize transportation of a POV to my post of duty...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... conditions may my agency authorize transportation of a POV to my post of duty subsequent to the time of my assignment to that post? 302-9.170 Section 302-9.170 Public Contracts and Property Management Federal Travel... Subsequent to the Time of Assignment § 302-9.170 Under what specific conditions may my agency authorize...

  11. Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs.

    PubMed

    Lu, Zhengwu

    2010-01-01

    To identify key challenges and propose technical considerations in designing electronic case report form (eCRF) for post-marketing studies, the author undertakes a comprehensive literature review of peer reviewed and grey literature to assess the key aspects, processes, standards, recommendations, and best practices in designing eCRFs based on industry experience in designing and supporting electronic data capture (EDC) studies. Literature search using strings on MEDLINE and PUBMED returned few papers directly related to CRF design. Health informatics and general practice journals were searched and results reviewed. Many conference, government commission, health professional and special interests group websites provide relevant information from practical experience - summarization of this information is presented. Further, we presented a list of concrete technical considerations in dealing with EDC technology/system limitations based on literature assessment and industry implementation experience. It is recognized that cross-functional teams be involved in eCRF design process and decision making. To summarize the keys in designing eCRFs to address post-market study safety and pharmacovigilance needs, the first is to identify required data elements from the study protocol supporting data analyses and reporting requirements. Secondly, accepted best practices, CDASH & CDISC guidelines, and company internal or therapeutic unit standard should be considered and applied. Coding (MedDRA & WHODD) mapping should be managed and implemented as well when possible. Finally, we need to be on top of the EDC technologies, challenge the technologies, drive EDC improvement via working with vendors, and utilize the technologies to drive clinical effectiveness. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  12. Safe Physical Activity Environments--To What Extent Are Local Government Authorities Auditing the Safety of Grassed Sporting Grounds?

    ERIC Educational Resources Information Center

    Otago, Leonie; Swan, Peter; Donaldson, Alex; Payne, Warren; Finch, Caroline

    2009-01-01

    Physical activity (PA) participation is influenced by the safety of the settings in which it is undertaken. This study describes the grounds assessment practices of Local Government Authorities (LGAs) in Victoria, Australia to ensure the safety of grassed sporting grounds. It also makes recommendations for improving these practices to maximise the…

  13. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience

    PubMed Central

    Angelo, Maria-Genalin; Zima, Julia; Tavares Da Silva, Fernanda; Baril, Laurence; Arellano, Felix

    2014-01-01

    Purpose To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium). Methods We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008–2010). Results Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain–Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information. Conclusion Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit–risk profile in adolescent girls and women. PMID:24644078

  14. [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

    PubMed

    Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

    2011-10-01

    To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

  15. Post-marketing studies: the work of the Drug Safety Research Unit.

    PubMed

    Mackay, F J

    1998-11-01

    The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general practice is an ideal source of data. PEM studies are general practitioner (community)-based and exposure is based on dispensed prescription data in England. To date, 65 PEM studies have been completed with a mean cohort size of 10 979 patients and the DSRU database has clinical information on over 700000 patients prescribed new drugs. Unlike spontaneous reporting schemes, PEM produces incidence rates for events reported during treatment. Comparative studies can be conducted for drugs in the same class. The DSRU aggregates outcome data for pregnancies exposed to new drugs. Data for children and the elderly can also be specifically examined. PEM data have a number of advantages over data from computerised general practice databases in the UK. PEM is the only technique within the UK capable of monitoring newly marketed drugs in such a comprehensive and systematic way.

  16. Evaluating Post-Earthquake Building Safety Using Economical MEMS Seismometers

    PubMed Central

    Yin, Ren-Cheng

    2018-01-01

    The earthquake early warning (EEW)-research group at National Taiwan University has been developing a microelectromechanical system-based accelerometer called “P-Alert”, designed for issuing EEWs. The main advantage of P-Alert is that it is a relatively economical seismometer. However, because of the expensive nature of commercial hardware for structural health monitoring (SHM) systems, the application of SHM to buildings remains limited. To determine the performance of P-Alert for evaluating post-earthquake building safety, we conducted a series of steel-frame shaking table tests with incremental damage. We used the fragility curves of different damage levels and the interstory drift ratios (calculated by the measured acceleration of each story using double integration and a filter) to gauge the potential damage levels. We concluded that the acceptable detection of damage for an entire building is possible. With improvements to the synchronization of the P-Alert sensors, we also anticipate a damage localization feature for the stories of a building. PMID:29734736

  17. Evaluating Post-Earthquake Building Safety Using Economical MEMS Seismometers.

    PubMed

    Hsu, Ting-Yu; Yin, Ren-Cheng; Wu, Yih-Min

    2018-05-05

    The earthquake early warning (EEW)-research group at National Taiwan University has been developing a microelectromechanical system-based accelerometer called “P-Alert”, designed for issuing EEWs. The main advantage of P-Alert is that it is a relatively economical seismometer. However, because of the expensive nature of commercial hardware for structural health monitoring (SHM) systems, the application of SHM to buildings remains limited. To determine the performance of P-Alert for evaluating post-earthquake building safety, we conducted a series of steel-frame shaking table tests with incremental damage. We used the fragility curves of different damage levels and the interstory drift ratios (calculated by the measured acceleration of each story using double integration and a filter) to gauge the potential damage levels. We concluded that the acceptable detection of damage for an entire building is possible. With improvements to the synchronization of the P-Alert sensors, we also anticipate a damage localization feature for the stories of a building.

  18. [Explore method about post-marketing safety re-evaluation of Chinese patent medicines based on HIS database in real world].

    PubMed

    Yang, Wei; Xie, Yanming; Zhuang, Yan

    2011-10-01

    There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals. Chinese patent medicine's safety problems are the most concerned by patients and physicians. At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China. However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems. HIS database in real world is a good resource with rich information to research medicine safety. This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures. This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database. A clear protocol has been completed as for the first step for the whole study. The protocol is as follows. First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database. Secondly, select some related laboratory tests indexes as the safety evaluating outcomes, such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests. Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines. Finally, judge the relationship between those abnormal changing and Chinese patent medicine. We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.

  19. [The problem of post-marketing surveillance planning on drugs for infectious disease].

    PubMed

    Sato, J

    2001-12-01

    In principle, a new drug is approved via the assessments of safety and efficacy by the Ministry of Health, Labor and Welfare (MHLW). After approval, conduct of post-marketing surveillance is requested by law in order to assess the safety and efficacy of the drug in a large number of patients. Before initiating a surveillance, submission to MHLW of a document on the plan of survey is necessary in the purpose of inspection if it includes any ethical or regulatory problem or not. Through the inspections of the plans submitted during the period of April 1998 and March 2000, many problems have been pointed out. In this report, the author introduces some of the concrete problems noted in the plans on drugs for infectious diseases and shows some of the guidance made by the authority how to improve them. It is expected that such practical analyses of cases may be useful for future planning of post-marketing surveillance on drugs for infectious diseases.

  20. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  1. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  2. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  3. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  4. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

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

    PubMed

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

    2013-06-01

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

  6. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

    PubMed

    Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

    2015-09-01

    Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

  7. Perioperative Lidocaine Infusions for the Prevention of Chronic Post-Surgical Pain: A Systematic Review and Meta-Analysis of Efficacy and Safety.

    PubMed

    Bailey, Martin; Corcoran, Tomas; Schug, Stephan; Toner, Andrew

    2018-05-11

    Chronic post-surgical pain (CPSP) occurs in 12% of surgical populations and is a high priority for perioperative research. Systemic lidocaine may modulate several of the pathophysiological processes linked to CPSP. This systematic review aims to identify and synthesize the evidence linking lidocaine infusions and CPSP.The authors conducted a systematic literature search of the major medical databases from inception until October 2017. Trials that randomized adults without baseline pain to perioperative lidocaine infusion or placebo were included if they reported on CPSP. The primary outcome was the presence of procedure-related pain at three months or longer after surgery. The secondary outcomes of pain intensity, adverse safety events and local anesthetic toxicity were also assessed.Six trials from four countries (n=420) were identified. CPSP incidence was consistent with existing epidemiological data. Perioperative lidocaine infusions significantly reduced the primary outcome (odds ratio, 0.29; 95% CI, 0.18 to 0.48), although the difference in intensity of CPSP assessed by the short form McGill pain questionnaire (four trials) was not statistically significant (weighted mean difference, -1.55; 95% CI, -3.16 to 0.06). Publication and other bias were highly apparent, as were limitations in trial design. Each study included a statement reporting no adverse events attributable to lidocaine, but systematic safety surveillance strategies were absent.Current limited clinical trial data and biological plausibility support lidocaine infusions use to reduce the development of CPSP without full assurances as to its safety. This hypothesis should be addressed in future definitive clinical trials with comprehensive safety assessment and reporting.

  8. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Posting. 34.53 Section 34.53 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.53 Posting. All areas in which industrial radiography is being...

  9. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Posting. 34.53 Section 34.53 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.53 Posting. All areas in which industrial radiography is being...

  10. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Posting. 34.53 Section 34.53 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.53 Posting. All areas in which industrial radiography is being...

  11. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Posting. 34.53 Section 34.53 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.53 Posting. All areas in which industrial radiography is being...

  12. 10 CFR 34.53 - Posting.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Posting. 34.53 Section 34.53 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.53 Posting. All areas in which industrial radiography is being...

  13. Post-disaster housing reconstruction: Perspectives of the NGO and local authorities on delay issues

    NASA Astrophysics Data System (ADS)

    Khalid, Khairin Norhashidah; Nifa, Faizatul Akmar Abdul; Ismail, Risyawati Mohamed; Lin, Chong Khai

    2016-08-01

    Post disaster reconstruction is complex, dynamic and chaotic in nature and as such represents many challenges because it is unlike normal construction. However, the time scale of reconstruction is shorter than the normal construction, but it often deals with uncertainties and the scale of the construction activities required is relatively high. After a disaster impacts a country, many governments, institutions and aid organizations cooperate and involved with the reconstruction process. This is seen as a tool for applying policies and programs designed to remedy the weakness in developmental policies, infrastructure and institutional arrangements. This paper reports a part of an on-going research on post-disaster housing reconstruction in Malaysia. An extensive literature review and pilot interviews were undertaken to establish the factors that contribute to the delay in post-disaster reconstruction project. Accordingly, this paper takes the perspective of recovery from non-government organization (NGO) and local authorities which act as providers of social services, builders of infrastructure, regulators of economic activity and managers of the natural environment. As a result, it is important on how those decisions are made, who is involved in the decision-making, and what are the consequences of this decision.

  14. Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies.

    PubMed

    Coloma, Preciosa M; Becker, Benedikt; Sturkenboom, Miriam C J M; van Mulligen, Erik M; Kors, Jan A

    2015-10-01

    There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. The aim of this study was to evaluate the potential contribution of mining social media networks for medicines safety surveillance using the following associations as case studies: (1) rosiglitazone and cardiovascular events (i.e. stroke and myocardial infarction); and (2) human papilloma virus (HPV) vaccine and infertility. We collected publicly accessible, English-language posts on Facebook, Google+, and Twitter until September 2014. Data were queried for co-occurrence of keywords related to the drug/vaccine and event of interest within a post. Messages were analysed with respect to geographical distribution, context, linking to other web content, and author's assertion regarding the supposed association. A total of 2537 posts related to rosiglitazone/cardiovascular events and 2236 posts related to HPV vaccine/infertility were retrieved, with the majority of posts representing data from Twitter (98 and 85%, respectively) and originating from users in the US. Approximately 21% of rosiglitazone-related posts and 84% of HPV vaccine-related posts referenced other web pages, mostly news items, law firms' websites, or blogs. Assertion analysis predominantly showed affirmation of the association of rosiglitazone/cardiovascular events (72%; n = 1821) and of HPV vaccine/infertility (79%; n = 1758). Only ten posts described personal accounts of rosiglitazone/cardiovascular adverse event experiences, and nine posts described HPV vaccine problems related to infertility. Publicly available data from the considered social media networks were sparse and largely untrackable for the purpose of providing early clues of safety concerns regarding the prespecified case studies. Further research investigating other case studies and exploring other social media platforms are necessary to further characterise

  15. Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

    PubMed

    Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

    2017-05-01

    Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

  16. Safety evaluation report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan

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

    Not Available

    1991-01-01

    This safety evaluation report (SER) was prepared by the US Nuclear Regulatory Commission (NRC) staff and represents the second and last supplement (SSER 2) to the staff's original SER published as Volume 3 of NUREG-1232 in April 1989. Supplement 1 of Volume 3 of NUREG-1232 (SSER 1) was published in October 1989. Like its predecessors, SSER 2 is composed of numerous safety evaluations by the staff regarding specific elements contained in the Browns Ferry Nuclear Performance Plan (BFNPP), Volume 3 (up to and including Revision 2), submitted by the Tennessee Valley Authority (TVA) for the Browns Ferry Nuclear Plant (BFN).more » The Browns Ferry Nuclear Plant consists of three boiling-water reactors (BWRs) at a site in Limestone County, Alabama. The BFNPP describes the corrective action plans and commitments made by TVA to resolve deficiencies with its nuclear programs before the startup of Unit 2. The staff has inspected and will continue to inspect TVA's implementation of these BFNPP corrective action plans that address staff concerns about TVA's nuclear program. SSER 2 documents the NRC staff's safety evaluations and conclusions for those elements of the BFNPP that were not previously addressed by the staff or that remained open as a result of unresolved issues identified by the staff in previous SERs and inspections.« less

  17. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    PubMed

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  18. The new structure and contents of employers' juridical responsibility for workers' health and safety in the post-industrial system.

    PubMed

    Ichino, P

    2006-01-01

    1. The enlargement of the labour law application area in the post-industrial system. 2. The enormous growth of differences in productivity between workers and its consequences on the employer's safety obligation. 3. Depressive disorders as a typical professional risk in the post-industrial system and the employer's prevention responsibility. 4. Harassment in the work-place as a typical pathologic consequence of the de-standardization of jobs. The specific employer's prevention responsibility in this field. 5. A conclusive remark.

  19. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  20. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  1. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  2. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  3. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  4. Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author, Volume 18 (1) through Volume 22 (6)

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

    Cottrell, W.B.; Passiakos, M.

    This index to Nuclear Safety covers articles published in Nuclear Safety, Volume 18, Number 1 (January-February 1977) through Volume 22, Number 6 (November-December 1981). The index is divided into three section: a chronological list of articles (including abstracts), a permuted-title (KWIC) index, and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. Over 300 technical articles published in Nuclear Safety in the last 5 years are listed in this index.

  5. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

    PubMed

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

  6. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study

    PubMed Central

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    Purpose The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. Materials and methods The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4) in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. Main outcome measure(s) An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. Main results The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Conclusion Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce

  7. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

    PubMed Central

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-01-01

    Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

  8. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

    PubMed

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-10-01

    Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

  9. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines

    PubMed Central

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-01-01

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes. PMID:25444788

  10. Attitudes and beliefs on the establishment of a national food safety authority in Cyprus. A population-based survey.

    PubMed

    Hadjigeorgiou, Andreas; Talias, Michael A; Soteriades, Elpidoforos S; Philalithis, Anastasios; Psaroulaki, Anna; Gikas, Achilleas; Tselentis, Yiannis

    2014-04-01

    Cyprus does not have a National Food Safety Authority (NFSA), but a multi-level, fragmented system with responsibilities divided among different ministries and governmental agencies, frequently impeding efforts to effectively manage food risks by duplication and overlapping of responsibilities. A population-based survey was carried out to determine the beliefs and attitudes of interested parties concerning the establishment of a NFSA in Cyprus. Information was collected using a random stratified sampling design and a structured questionnaire. A total of 868 questionnaires were collected (704 from regular consumers, 154 from food businesses' representatives, and 10 from public services' directors or acting head officers). About 11% of food businesses' representatives and 45% of consumers reported that they did not know which public authorities are responsible for food control. Moreover, 2 out of 10 (17%) of responders from public agencies, 70% from food businesses and 91% from consumers, although not aware of ongoing efforts to establish a food safety authority in Cyprus (currently under consideration), were supportive of the idea [8 out of 10 (83%) of responders from public services, 93% from food businesses, and 89% of consumers]. Finally, 7 out of 10 (67%) from the public agencies and 84% of representatives from food businesses agreed with the separation of risk assessment from risk management activities. Public opinion in Cyprus as well as public agencies and food businesses' representatives support the establishment of a single independent national food safety authority in Cyprus based on the European paradigm including the division of risk activities. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Results of European post-marketing surveillance of bosentan in pulmonary hypertension.

    PubMed

    Humbert, M; Segal, E S; Kiely, D G; Carlsen, J; Schwierin, B; Hoeper, M M

    2007-08-01

    After the approval of bosentan for the treatment of pulmonary arterial hypertension (PAH), European authorities required the introduction of a post-marketing surveillance system (PMS) to obtain further data on its safety profile. A novel, prospective, internet-based PMS was designed, which solicited reports on elevated aminotransferases, medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation. Data captured included demographics, PAH aetiology, baseline functional status and concomitant PAH-specific medications. Safety signals captured included death, hospitalisation, serious adverse events, unexpected adverse events and elevated aminotransferases. Within 30 months, 4,994 patients were included, representing 79% of patients receiving bosentan in Europe. In total, 4,623 patients were naïve to treatment; of these, 352 had elevated aminotransferases, corresponding to a crude incidence of 7.6% and an annual rate of 10.1%. Bosentan was discontinued due to elevated aminotransferases in 150 (3.2%) bosentan-naïve patients. Safety results were consistent across subgroups and aetiologies. The novel post-marketing surveillance captured targeted safety data ("potential safety signals") from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials. These data complement those from randomised controlled clinical trials and provide important additional information on the safety profile of bosentan.

  12. Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1--Vol. 17, No. 6

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

    Cottrell, W.B.; Klein, A.

    1977-02-23

    This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970), through Vol. 17, No. 6 (Nov.-Dec. 1976). The index includes a chronological list of articles (including abstract) followed by KWIC and Author Indexes. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 350 technical articles in the last six years of publication.

  13. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    PubMed

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  14. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children.

    PubMed

    Hansen, J; Zhang, L; Eaton, A; Baxter, R; Robertson, C A; Decker, M D; Greenberg, D P; Bassily, E; Klein, N P

    2018-04-12

    Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55 years of age, in 2007 for children 2-10 years of age, and in 2011 for infants/toddlers 9-23 months of age. We conducted two studies at Kaiser Permanente Northern California (KPNC), an integrated health care organization, to assess the safety of MenACWY-D in 2-10-year-olds and 9-23-month-olds receiving the vaccine during routine clinical care. We conducted observational, retrospective studies of MenACWY-D in 2-10-year-olds (October 2007-October 2010) and in 9-23-month-olds (June 2011-June 2014). We monitored all subjects for non-elective hospitalizations, emergency department visits, and selected outpatient outcomes (specified neurological conditions, hypersensitivity reactions and new-onset autoimmune diseases) up to 6 months after vaccination, depending on the study. Using a self-control risk-interval design, we calculated incidence rate ratios (IRRs) comparing outcomes during the post-vaccination risk interval (0-30 days) with those during more remote post-vaccination comparison intervals (31-60 and 31-180 days [children] or 31-75 days [infants/toddlers]). There were 1421 children aged 2-10 years and 116 infants/toddlers aged 9-23 months who received MenACWY-D. Approximately 30% of the 2-10-year-olds and 67% of the 9-23-month-olds were considered at increased risk of meningococcal disease. Among 2-10-year-olds, there was 1 hospitalization on post-vaccination day 5 for fever, which was considered possibly related to vaccination. The only significantly elevated outcome among 2-10-year-olds was cellulitis/abscess (2 cases occurred during the risk interval versus 0 during comparison interval; IRR not evaluable [NE], 95% CI: 1.42, NE). After medical record review, the 2 cases were considered unrelated to vaccination. Among 9-23-month-olds, no outcomes were significantly elevated after vaccination and there were no hospitalizations. There were no deaths observed

  15. The European post-marketing observational sertindole study: an investigation of the safety of antipsychotic drug treatment.

    PubMed

    Kasper, Siegfried; Möller, Hans-Jürgen; Hale, Anthony

    2010-02-01

    The objective of the European Post-marketing Observational Serdolect((R)) (EPOS) Study was to compare the safety of treatment with Serdolect (sertindole) with that of usual treatment in patients with schizophrenia, in normal European clinical practice. The EPOS was a multicentre, multinational, referenced, cohort study. Patients were enrolled at 226 centres in ten European countries. The study was prematurely terminated in 1998 as a result of the temporary market suspension of sertindole. Termination of the study reduced the number of patients recruited from the planned 12,000 to 2,321. While the power of the study was weakened, it did provide useful mortality information, which may be useful for future long-term studies. Crude mortality in the sertindole and non-sertindole groups was 1.45 (95% confidence interval, CI 0.53-3.16) and 1.50 (CI 0.72-2.76) deaths/100 patient-years exposed, respectively. There were no more cardiac deaths in the sertindole group than in the non-sertindole group. QT interval prolongation did not translate into an increased risk of death. Sertindole was well tolerated and caused few extrapyramidal symptoms. Although CIs remained large, this post-marketing study does not provide any evidence against the use of sertindole under normal conditions. Sertindole was well tolerated and posed no significant safety problems.

  16. Safety Evaluation Report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan: Browns Ferry Unit 2 restart

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

    Not Available

    1989-04-01

    This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Power Station and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of Unit 2. The staff will inspect implementation of those programs. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 3 refs.

  17. Cardiovascular safety of vildagliptin in patients with type 2 diabetes: A European multi-database, non-interventional post-authorization safety study.

    PubMed

    Williams, Rachael; de Vries, Frank; Kothny, Wolfgang; Serban, Carmen; Lopez-Leon, Sandra; Chu, Changan; Schlienger, Raymond

    2017-10-01

    The aim of this non-interventional, multi-database, analytical cohort study was to assess the cardiovascular (CV) safety of vildagliptin vs other non-insulin antidiabetic drugs (NIADs) using real-world data from 5 European electronic healthcare databases. Patients with type 2 diabetes aged ≥18 years on NIAD treatment were enrolled. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) for the outcomes of interest (myocardial infarction [MI], acute coronary syndrome [ACS], stroke, congestive heart failure [CHF], individually and as a composite) were estimated using negative binomial regression. Approximately 2.8% of the enrolled patients (n = 738 054) used vildagliptin at any time during the study, with an average follow-up time of 1.4 years, resulting in a cumulative current vildagliptin exposure of 28 330 person-years. The adjusted IRRs (vildagliptin [±other NIADs] vs other NIADs) were in the range of 0.61 to 0.97 (MI), 0.55 to 1.60 (ACS), 0.02 to 0.77 (stroke), 0.49 to 1.03 (CHF), and 0.22 to 1.02 (composite CV outcomes). The IRRs and their 95% CIs were close to 1, demonstrating no increased risk of adverse CV events, including the risk of CHF, with vildagliptin vs other NIADs in real-world conditions. © 2017 Crown copyright. Diabetes, Obesity and Metabolism © 2017 John Wiley & Sons Ltd.

  18. Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view.

    PubMed

    Cohet, Catherine; Rosillon, Dominique; Willame, Corinne; Haguinet, Francois; Marenne, Marie-Noëlle; Fontaine, Sandrine; Buyse, Hubert; Bauchau, Vincent; Baril, Laurence

    2017-05-25

    Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence. Copyright © 2017 GSK Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

  19. Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

    PubMed Central

    Chambers, Christina D; Tutuncu, Zuhre N; Johnson, Diana; Jones, Kenneth L

    2006-01-01

    For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described. PMID:16774693

  20. [Efficacy, safety and comfort of compression therapy models in the immediate post-operative period after a greater saphenectomy. A prospective randomised study].

    PubMed

    Collazo Chao, Eliseo; Luque, María Antonia; González-Ripoll, Carmen

    2010-10-01

    There is still controversy on the best compression therapy after performing a greater saphenectomy. The purpose of this study is to establish whether the use of a controlled compression stocking has the same level of safety and efficacy as a compression bandage in the immediate post-operative period after a greater saphenectomy. A prospective, randomised, open-labelled study, comparing three groups: a) a conventional compression bandage for one week, b) a conventional compression bandage replaced by a controlled tubular compression stocking at 5h of its putting in place, c) immediate direct use of the controlled tubular compression stocking, was conducted on fifty-five consecutive outpatients with a greater saphenectomy in one of their legs, and who fulfilled the inclusion criteria. The working hypothesis was that the controlled tubular compression stocking could replace, in terms of efficacy, safety and comfort, the usual controlled compression in the immediate post-operative period after saphenous vein stripping. The analysis variables were pain, control of bleeding, analgesics in the post-operative period, bruising, incapacity during the first week after the operation and comfort level. There were no statistically significant differences found between the three types of compressions studied as regards, safety, efficacy, comfort level, pain and analgesic consumption, but there was as regards the level of convenience in favour of the use of the stocking. The controlled tubular compression stocking can replace the compression bandage with more advantages after greater saphenous vein stripping in outpatients, having the same safety and efficacy. Copyright © 2009 AEC. Published by Elsevier Espana. All rights reserved.

  1. Scientific Method and the Regulation of Health and Nutritional Claims by the European Food Safety Authority

    ERIC Educational Resources Information Center

    Hoad, Darren

    2011-01-01

    The protection of European consumers from the false or misleading scientific and nutritional claims of food manufacturers took a step forward with the recent opinions of the European Food Safety Authority (EFSA). As a risk assessment agency, the EFSA recently assessed and rejected a vast number of food claim forcing the withdrawal of many claims…

  2. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    PubMed

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  3. Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

    PubMed

    Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

    2012-08-01

    Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

  4. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

    PubMed

    Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

    2017-12-01

    Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

  5. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

  6. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

  7. Authorization basis supporting documentation for plutonium finishing plant

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

    King, J.P., Fluor Daniel Hanford

    1997-03-05

    The identification and definition of the authorization basis for the Plutonium Finishing Plant (PFP) facility and operations are essential for compliance to DOE Order 5480.21, Unreviewed Safety Questions. The authorization basis, as defined in the Order, consists of those aspects of the facility design basis, i.e., the structures, systems and components (SSCS) and the operational requirements that are considered to be important to the safety of operations and are relied upon by DOE to authorize operation of the facility. These facility design features and their function in various accident scenarios are described in WHC-SD-CP-SAR-021, Plutonium Finishing Plant Final Safety Analysismore » Report (FSAR), Chapter 9, `Accident Analysis.` Figure 1 depicts the relationship of the Authorization Basis to its components and other information contained in safety documentation supporting the Authorization Basis. The PFP SSCs that are important to safety, collectively referred to as the `Safety Envelope` are discussed in various chapters of the FSAR and in WHC-SD-CP-OSR-010, Plutonium Finishing Plant Operational Safety Requirements. Other documents such as Criticality Safety Evaluation Reports (CSERS) address and support some portions of the Authorization Basis and Safety Envelope.« less

  8. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  9. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  10. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  11. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  12. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  13. [Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

    PubMed

    Xie, Yanming; Wei, Xu

    2011-10-01

    Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

  14. Full Bayesian evaluation of the safety effects of reducing the posted speed limit in urban residential area.

    PubMed

    Islam, Md Tazul; El-Basyouny, Karim

    2015-07-01

    Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. Drug packaging in 2014: authorities should direct more efforts towards medication safety.

    PubMed

    2015-05-01

    In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

  16. Post-marketing monitoring of intussusception after rotavirus vaccination in Japan.

    PubMed

    Bauchau, Vincent; Van Holle, Lionel; Mahaux, Olivia; Holl, Katsiaryna; Sugiyama, Keiji; Buyse, Hubert

    2015-07-01

    Rotarix(TM) was launched in November 2011 in Japan to prevent rotavirus gastroenteritis. Some studies suggest that Rotarix(TM) may have a temporal association with a risk of intussusception (IS). We assessed a possible association between IS and Rotarix(TM) vaccination in Japan. All IS cases spontaneously reported post-vaccination (Brighton collaboration levels 1, 2, and 3) were extracted from the GlaxoSmithKline spontaneous report database on the 11th of January 2013. Expected numbers of IS cases were estimated using the number of vaccine doses distributed and the Japanese incidence rate of IS stratified by month of age. The observed versus expected analysis considered the IS cases for each risk period (7 and 30 days post-vaccination) and for each vaccine dose (two doses). Before January 2013, approximately 601 000 Rotarix(TM) doses were distributed in Japan. For a risk period of 7 days post-dose 1 and post-dose 2, 10 and five IS cases were observed, whereas 3.4 and 7.6 were expected, providing an observed-to-expected ratio of 2.96 (95% confidence interval [CI]: 1.42; 5.45) and 0.66 (95% CI: 0.21; 1.53), respectively. For a risk period of 30 days post-dose 1 and post-dose 2, 14 and eight cases were observed, whereas 14.5 and 32.7 were expected, providing an observed-to-expected ratio of 0.97 (95% CI: 0.53; 1.62) and 0.24 (95% CI: 0.11; 0.48), respectively. A statistically significant excess of IS cases was observed within 7 days post-dose 1, but not post-dose 2. These results are consistent with previous observations in large post-marketing safety studies in other world regions. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

  17. Safe Schools Survey: Post-Secondary Survey Results.

    ERIC Educational Resources Information Center

    Mowery, Andrea

    This report provides the results of a survey of safety and security at colleges and universities in Minnesota, along with policy recommendations to improve safety and security at Minnesota post-secondary institutions. It is based on campus security reports voluntarily submitted by 60 of the 110 Minnesota post-secondary institutions, personal…

  18. Laboratory safety and the WHO World Alliance for Patient Safety.

    PubMed

    McCay, Layla; Lemer, Claire; Wu, Albert W

    2009-06-01

    Laboratory medicine has been a pioneer in the field of patient safety; indeed, the College of American Pathology first called attention to the issue in 1946. Delivering reliable laboratory results has long been considered a priority, as the data produced in laboratory medicine have the potential to critically influence individual patients' diagnosis and management. Until recently, most attention on laboratory safety has focused on the analytic stage of laboratory medicine. Addressing this stage has led to significant and impressive improvements in the areas over which laboratories have direct control. However, recent data demonstrate that pre- and post-analytical phases are at least as vulnerable to errors; to further improve patient safety in laboratory medicine, attention must now be focused on the pre- and post-analytic phases, and the concept of patient safety as a multi-disciplinary, multi-stage and multi-system concept better understood. The World Alliance for Patient Safety (WAPS) supports improvement of patient safety globally and provides a potential framework for considering the total testing process.

  19. Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.

    PubMed

    Miller, Elaine R; Moro, Pedro L; Cano, Maria; Lewis, Paige; Bryant-Genevier, Marthe; Shimabukuro, Tom T

    2016-05-27

    23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. Published by Elsevier Ltd.

  20. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Post-launch and post-flight-attempt hazard controls. 417.415 Section 417.415 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... evidence; and (4) Ensuring public safety from hazardous debris, such as plans for recovery and salvage of...

  1. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Post-launch and post-flight-attempt hazard controls. 417.415 Section 417.415 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... evidence; and (4) Ensuring public safety from hazardous debris, such as plans for recovery and salvage of...

  2. 14 CFR 417.415 - Post-launch and post-flight-attempt hazard controls.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Post-launch and post-flight-attempt hazard controls. 417.415 Section 417.415 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... evidence; and (4) Ensuring public safety from hazardous debris, such as plans for recovery and salvage of...

  3. 41 CFR 302-9.204 - What is the “authorized point of origin” when I transport my POV from my post of duty?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... point of originâ when I transport my POV from my post of duty? 302-9.204 Section 302-9.204 Public Contracts and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... Return Transportation of a POV From a Post of Duty § 302-9.204 What is the “authorized point of origin...

  4. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

    PubMed

    de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

    2018-03-21

    A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  5. A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion.

    PubMed

    Barbanti Brodano, G; Griffoni, C; Zanotti, B; Gasbarrini, A; Bandiera, S; Ghermandi, R; Boriani, S

    2015-10-01

    Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion, because of its known osteoinductive and osteoconductive properties. Considering its autogenous origin, the use of ICBG has not been associated to an increase of intraoperative or postoperative complications directly related to the surgery. However, complications related to the harvesting procedure and to the donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. The family of ceramic-based bone grafts has been widely used and studied during the last years for spine surgical procedures in order to reduce the need for iliac crest bone grafting and the consequent morbidity associated to the harvesting procedures. We report here the results of a post-market surveillance analysis performed on four independent cohorts of patients (115 patients) to evaluate the safety of three different formulations of hydroxyapatite-derived products used as bone graft extenders/substitutes for lumbar arthrodesis. No intraoperative or post-operative complications related to the use of hydroxyapatite-derived products were detected, during medium and long follow up period (minimum 12 months-maximum 5 years). This post-market surveillance analysis evidenced the safety of ceramic products as bone graft extenders or substitutes for spine fusion. Moreover, the evidence of the safety of hydroxyapatite-derived products allows to perform clinical studies aimed at evaluating the fusion rates and the clinical outcomes of these materials as bone graft extenders/substitutes, in order to support their use as an alternative to ICBG for spine fusion.

  6. Highway Safety Program Manual: Volume 14: Pedestrian Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 14 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on pedestrian safety. The purpose and objectives of a pedestrian safety program are outlined. Federal authority in the area of pedestrian safety and policies regarding a safety program…

  7. Monitoring biomedical literature for post-market safety purposes by analyzing networks of text-based coded information.

    PubMed

    Botsis, Taxiarchis; Foster, Matthew; Kreimeyer, Kory; Pandey, Abhishek; Forshee, Richard

    2017-01-01

    Literature review is critical but time-consuming in the post-market surveillance of medical products. We focused on the safety signal of intussusception after the vaccination of infants with the Rotashield Vaccine in 1999 and retrieved all PubMed abstracts for rotavirus vaccines published after January 1, 1998. We used the Event-based Text-mining of Health Electronic Records system, the MetaMap tool, and the National Center for Biomedical Ontologies Annotator to process the abstracts and generate coded terms stamped with the date of publication. Data were analyzed in the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment to evaluate the intussusception-related findings before and after the release of the new rotavirus vaccines in 2006. The tight connection of intussusception with the historical signal in the first period and the absence of any safety concern for the new vaccines in the second period were verified. We demonstrated the feasibility for semi-automated solutions that may assist medical reviewers in monitoring biomedical literature.

  8. Revealing and Resolving Patient Safety Defects: The Impact of Leadership WalkRounds on Frontline Caregiver Assessments of Patient Safety

    PubMed Central

    Frankel, Allan; Grillo, Sarah Pratt; Pittman, Mary; Thomas, Eric J; Horowitz, Lisa; Page, Martha; Sexton, Bryan

    2008-01-01

    Objective To evaluate the impact of rigorous WalkRounds on frontline caregiver assessments of safety climate, and to clarify the steps and implementation of rigorous WalkRounds. Data Sources/Study Setting Primary outcome variables were baseline and post WalkRounds safety climate scores from the Safety Attitudes Questionnaire (SAQ). Secondary outcomes were safety issues elicited through WalkRounds. Study period was August 2002 to April 2005; seven hospitals in Massachusetts agreed to participate; and the project was implemented in all patient care areas. Study Design Prospective study of the impact of rigorously applied WalkRounds on frontline caregivers assessments of safety climate in their patient care area. WalkRounds were conducted weekly and according to the seven-step WalkRounds Guide. The SAQ was administered at baseline and approximately 18 months post-WalkRounds implementation to all caregivers in patient care areas. Results Two of seven hospitals complied with the rigorous WalkRounds approach; hospital A was an academic teaching center and hospital B a community teaching hospital. Of 21 patient care areas, SAQ surveys were received from 62 percent of respondents at baseline and 60 percent post WalkRounds. At baseline, 10 of 21 care areas (48 percent) had safety climate scores below 60 percent, whereas post-WalkRounds three care areas (14 percent) had safety climate scores below 60 percent without improving by 10 points or more. Safety climate scale scores in hospital A were 62 percent at baseline and 77 percent post-WalkRounds (t=2.67, p=.03), and in hospital B were 46 percent at baseline and 56 percent post WalkRounds (t=2.06, p=.06). Main safety issues by category were equipment/facility (A [26 percent] and B [33 percent]) and communication (A [24 percent] and B [18 percent]). Conclusions WalkRounds implementation requires significant organizational will; sustainability requires outstanding project management and leadership engagement. In the patient

  9. Incentivizing primary care providers to innovate: building medical homes in the post-Katrina New Orleans safety net.

    PubMed

    Rittenhouse, Diane R; Schmidt, Laura A; Wu, Kevin J; Wiley, James

    2014-02-01

    To evaluate safety-net clinics' responses to a novel community-wide Patient-Centered Medical Home (PCMH) financial incentive program in post-Katrina New Orleans. Between June 2008 and June 2010, we studied 50 primary care clinics in New Orleans receiving federal funds to expand services and improve care delivery. Multiwave, longitudinal, observational study of a local safety-net primary care system. Clinic-level data from a semiannual survey of clinic leaders (89.3 percent response rate), augmented by administrative records. Overall, 62 percent of the clinics responded to financial incentives by achieving PCMH recognition from the National Committee on Quality Assurance (NCQA). Higher patient volume, higher baseline PCMH scores, and type of ownership were significant predictors of achieving NCQA recognition. The steepest increase in adoption of PCMH processes occurred among clinics achieving the highest, Level 3, NCQA recognition. Following NCQA recognition, 88.9 percent stabilized or increased their use of PCMH processes, although several specific PCMH processes had very low rates of adoption overall. Findings demonstrate that widespread PCMH implementation is possible in a safety-net environment when external financial incentives are aligned with the goal of practice innovation. © Health Research and Educational Trust.

  10. Social media for arthritis-related comparative effectiveness and safety research and the impact of direct-to-consumer advertising.

    PubMed

    Curtis, Jeffrey R; Chen, Lang; Higginbotham, Phillip; Nowell, W Benjamin; Gal-Levy, Ronit; Willig, James; Safford, Monika; Coe, Joseph; O'Hara, Kaitlin; Sa'adon, Roee

    2017-03-07

    Social media may complement traditional data sources to answer comparative effectiveness/safety questions after medication licensure. The Treato platform was used to analyze all publicly available social media data including Facebook, blogs, and discussion boards for posts mentioning inflammatory arthritis (e.g. rheumatoid, psoriatic). Safety events were self-reported by patients and mapped to medical ontologies, resolving synonyms. Disease and symptom-related treatment indications were manually redacted. The units of analysis were unique terms in posts. Pre-specified conditions (e.g. herpes zoster (HZ)) were selected based upon safety signals from clinical trials and reported as pairwise odds ratios (ORs); drugs were compared with Fisher's exact test. Empirically identified events were analyzed using disproportionality analysis and reported as relative reporting ratios (RRRs). The accuracy of a natural language processing (NLP) classifier to identify cases of shingles associated with arthritis medications was assessed. As of October 2015, there were 785,656 arthritis-related posts. Posts were predominantly US posts (75%) from patient authors (87%) under 40 years of age (61%). For HZ posts (n = 1815), ORs were significantly increased with tofacitinib versus other rheumatoid arthritis therapies. ORs for mentions of perforated bowel (n = 13) were higher with tocilizumab versus other therapies. RRRs associated with tofacitinib were highest in conditions related to baldness and hair regrowth, infections and cancer. The NLP classifier had a positive predictive value of 91% to identify HZ. There was a threefold increase in posts following television direct-to-consumer advertisement (p = 0.04); posts expressing medication safety concerns were significantly more frequent than favorable posts. Social media is a challenging yet promising data source that may complement traditional approaches for comparative effectiveness research for new medications.

  11. Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.

    PubMed

    Wang, Yali; Dong, Duo; Cheng, Gang; Zuo, Shuyan; Liu, Dawei; Du, Xiaoxi

    2014-10-07

    Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Highway Safety Program Manual: Volume 3: Motorcycle Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

  13. Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

    PubMed

    Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

    2017-12-01

    Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

  14. Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

    PubMed

    Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

    2018-06-01

    Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

  15. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.544 Post hearing briefs. The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief... 42 Public Health 1 2010-10-01 2010-10-01 false Post hearing briefs. 3.544 Section 3.544 Public...

  16. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.544 Post hearing briefs. The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief... 42 Public Health 1 2014-10-01 2014-10-01 false Post hearing briefs. 3.544 Section 3.544 Public...

  17. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.544 Post hearing briefs. The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief... 42 Public Health 1 2012-10-01 2012-10-01 false Post hearing briefs. 3.544 Section 3.544 Public...

  18. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.544 Post hearing briefs. The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief... 42 Public Health 1 2011-10-01 2011-10-01 false Post hearing briefs. 3.544 Section 3.544 Public...

  19. 42 CFR 3.544 - Post hearing briefs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.544 Post hearing briefs. The ALJ may require the parties to file post-hearing briefs. In any event, any party may file a post-hearing brief... 42 Public Health 1 2013-10-01 2013-10-01 false Post hearing briefs. 3.544 Section 3.544 Public...

  20. Non-ablative fractional resurfacing of surgical and post-traumatic scars.

    PubMed

    Vasily, David B; Cerino, Mary E; Ziselman, Ethel M; Zeina, S Tannous

    2009-11-01

    Non-ablative, fractional lasers generate microscopic columns of coagulated tissue through the epidermis and dermis to evoke a wound healing response. In this study, the authors examined the efficacy and safety of the non-ablative 1540 nm erbium:glass fractional laser in the treatment of surgical and post-traumatic scars. Clinical studies were conducted on a range of surgical and post-traumatic scars with a 1540 nm erbium:glass fractional laser varying energy, pulse widths, treatment passes, and number of treatments. A histological study was conducted on a postsurgical scar to follow the time course of healing post-treatment and the impact of the fractional treatment on normalization of scar tissue, as compared to baseline histology of the scar. Histologic findings demonstrated rapid re-epithelialization of the epidermis within 72 hours of treatment. Remodeling of scar tissue with renewal and reorganization of collagen fibers in the dermis was noted two weeks post-treatment. Clinical subjects, with Fitzpatrick skin types II-V, received three to seven treatments with microbeam energies up to 60 mJ/pb and five passes. Relative to baseline, 73% of treated scars improved 50% or more and 43% improved 75% or more. Side effects included mild swelling (95% of subjects), erythema (94%) and purpura (5%), which all resolved within two to three days. Downtime was minimal-to-none for all subjects. These data illustrate the safety and efficacy of the 1540 nm erbium:glass fractional laser in the treatment of surgical and post-traumatic scars. Practitioners can vary energy and microbeam density in order to tailor the treatment to reflect the individual scar characteristics.

  1. Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

    PubMed

    Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

    2017-09-01

    Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

  2. How does patient safety culture in the operating room and post-anesthesia care unit compare to the rest of the hospital?

    PubMed

    Kaafarani, Haytham M A; Itani, Kamal M F; Rosen, Amy K; Zhao, Shibei; Hartmann, Christine W; Gaba, David M

    2009-07-01

    A strong patient safety culture in the operating room (OR) and post-anesthesia care unit (PACU) is essential to promote safe care. The Patient Safety Climate in Healthcare Organizations (PSCHO) survey was administered to employees at 30 Veterans Affairs (VA) hospitals. The survey consisted of 42 close-ended items representing 12 different dimensions of safety. We measured percent problematic response (PPR); higher PPR values reflect weaker safety culture. The "OR/PACU" and the "Other Work Areas" groups' item-specific, dimension-specific, and overall problematic responses were compared. The overall and dimension-specific PPRs were similar between the OR/PACU and the Other Work Areas group (overall: 20.2% and 18.1%, respectively; P = .41). When the 2 groups were compared on an item-by-item level, the OR/PACU staff reported more frequent witnessing of unsafe patient care (PPR 55.1% vs 43.2%; P = .01), and perceived less understanding by senior leadership of clinical care (PPR 28.3% vs 17.1%; P = .01) and less hospital interest in quality of care (PPR 20.4% vs 12.5%; P = .03). Specific areas of safety culture in the OR/PACU were found that should be targeted for improvement.

  3. The safety significance of aircraft accident post mortem findings.

    DOT National Transportation Integrated Search

    1969-10-01

    A review of post mortem examinations obtained in 1968 of pilot victims of general aviation aircraft accidents reveals that 51 percent of the pilot victims were studied by pathologists. The post mortem examination population above was taken from 687 p...

  4. 75 FR 41531 - Brookwood-Sago Mine Safety Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... stated goals and current reporting period. objectives for improving safety. Conduct and report pre-test and post- test results of trainees. Course evaluations of trainer and training materials. The extent... pre-test and post- and improves safety. educational materials test results of the training materials...

  5. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement, however...

  6. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement, however...

  7. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement, however...

  8. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement, however...

  9. 41 CFR 302-9.171 - If circumstances warrant an authorization to transport a POV to my post of duty after my...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... Transportation Subsequent to the Time of Assignment § 302-9.171 If circumstances warrant an authorization to... signed at the time of your assignment to the post of duty. Violation of that service agreement, however...

  10. A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

    PubMed

    Hay, C R; Lee, C A; Savidge, G

    1996-01-01

    The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

  11. 16 CFR 1500.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1500.2 Section 1500.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS § 1500.2 Authority. Authority under the...

  12. Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

    PubMed

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

    2017-05-01

    To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

  13. Communicating vaccine safety during the development and introduction of vaccines.

    PubMed

    Kochhar, Sonali

    2015-01-01

    Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.

  14. Safety culture and the 5 steps to safer surgery: an intervention study.

    PubMed

    Hill, M R; Roberts, M J; Alderson, M L; Gale, T C E

    2015-06-01

    Improvements in safety culture have been postulated as one of the mechanisms underlying the association between the introduction of the World Health Organisation (WHO) Surgical Safety Checklist with perioperative briefings and debriefings, and enhanced patient outcomes. The 5 Steps to Safer Surgery (5SSS) incorporates pre-list briefings, the three steps of the WHO Surgical Safety Checklist (SSC) and post-list debriefings in one framework. We aimed to identify any changes in safety culture associated with the introduction of the 5SSS in orthopaedic operating theatres. We assessed the safety culture in the elective orthopaedic theatres of a large UK teaching hospital before and after introduction of the 5SSS using a modified version of the Safety Attitude Questionnaire - Operating Room (SAQ-OR). Primary outcome measures were pre-post intervention changes in the six safety culture domains of the SAQ-OR. We also analysed changes in responses to two items regarding perioperative briefings. The SAQ-OR survey response rate was 80% (60/75) at baseline and 74% (53/72) one yr later. There were significant improvements in both the reported frequency (P<0.001) and perceived importance (P=0.018) of briefings, and in five of the six safety culture domain scores (Working Conditions, Perceptions of Management, Job Satisfaction, Safety Climate and Teamwork Climate) of the SAQ-OR (P<0.001 in all cases). Scores in the sixth domain (Stress Recognition) decreased significantly (P=0.028). Implementation of the 5SSS was associated with a significant improvement in the safety culture of elective orthopaedic operating theatres. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  15. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  16. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  17. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  18. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  19. Dams and Levees: Safety Risks

    NASA Astrophysics Data System (ADS)

    Carter, N. T.

    2017-12-01

    The nation's flood risk is increasing. The condition of U.S. dams and levees contributes to that risk. Dams and levee owners are responsible for the safety, maintenance, and rehabilitation of their facilities. Dams-Of the more than 90,000 dams in the United States, about 4% are federally owned and operated; 96% are owned by state and local governments, public utilities, or private companies. States regulate dams that are not federally owned. The number of high-hazard dams (i.e., dams whose failure would likely result in the loss of human life) has increased in the past decade. Roughly 1,780 state-regulated, high-hazard facilities with structural ratings of poor or unsatisfactory need rehabilitation. Levees-There are approximately 100,000 miles of levees in the nation; most levees are owned and maintained by municipalities and agricultural districts. Few states have levee safety programs. The U.S. Army Corps of Engineers (Corps) inspects 15,000 miles of levees, including levees that it owns and local levees participating in a federal program to assist with certain post-flood repairs. Information is limited on how regularly other levees are inspected. The consequence of a breach or failure is another aspect of risk. State and local governments have significant authority over land use and development, which can shape the social and economic impacts of a breach or failure; they also lead on emergency planning and related outreach. To date, federal dam and levee safety efforts have consisted primarily of (1) support for state dam safety standards and programs, (2) investments at federally owned dams and levees, and (3) since 2007, creation of a national levee database and enhanced efforts and procedures for Corps levee inspections and assessments. In Public Law 113-121, enacted in 2014, Congress (1) directed the Corps to develop voluntary guidelines for levee safety and an associated hazard potential classification system for levees, and (2) authorized support for the

  20. Pregnant woman and road safety: experimental crash test with post mortem human subject.

    PubMed

    Delotte, Jerome; Behr, Michel; Thollon, Lionel; Arnoux, Pierre-Jean; Baque, Patrick; Bongain, Andre; Brunet, Christian

    2008-05-01

    Trauma affect between 3 and 7% of all pregnancies in industrialized countries, and the leading cause of these traumas is car crashes. The difficulty to appreciate physiologic and anatomic changes occurring during pregnancy explain that majority of studies were not based on anatomical data. We present a protocol to create a realistic anatomical model of pregnant woman using a post mortem human subject (PMHS). We inserted a physical model of the gravid uterus into the pelvis of a PMHS. 3D acceleration sensors were placed on the subject to measure the acceleration on different body segments. We simulated three frontal impact situations at 20 km/h between two average European cars. Two main kinematics events were identified as possible causes of injuries: lap belt loading and backrest impact. Cadaver experiments provide one interesting complementary approach to study injury mechanisms related to road accidents involving pregnant women. This anatomical accuracy makes it possible to progress in the field of safety devices.

  1. 30 CFR 44.9 - Posting of petition.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting of petition. 44.9 Section 44.9 Mineral... REQUIREMENTS RULES OF PRACTICE FOR PETITIONS FOR MODIFICATION OF MANDATORY SAFETY STANDARDS General § 44.9 Posting of petition. An operator of a mine for which there is no representative of miners shall post a...

  2. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

  3. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

  4. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

  5. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

  6. 14 CFR 417.25 - Post launch report.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

  7. 49 CFR Appendix to Subpart H of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North America-Domiciled...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Evaluation Criteria for Non-North America-Domiciled Motor Carriers Appendix to Subpart H of Part 385... Special Rules for New Entrant Non-North America-Domiciled Carriers Pt. 385, Subpt. H, App. Appendix to Subpart H of Part 385—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North...

  8. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

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

    Mladineo, Stephen V.; Frazar, Sarah L.; Kurzrok, Andrew J.

    This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation with either a newcomer State, or to a State with a fully developed SRA.

  9. 49 CFR 190.239 - Safety orders.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... pipeline integrity risk to public safety, property, or the environment, the Associate Administrator may... existence of a condition that poses a pipeline integrity risk to public safety, property, or the environment... public safety, property, or the environment. (5) Post-hearing action. Following a hearing under this...

  10. 29 CFR 1926.1083 - Post-dive procedures.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures § 1926.1083 Post-dive procedures. Note: The requirements applicable to construction work under this section are...

  11. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and...

  12. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and...

  13. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... Transportation Pov Transportation Subsequent to the Time of Assignment § 302-9.175 When I am authorized to...

  14. 41 CFR 302-9.175 - When I am authorized to transport a POV, including a replacement POV, to my post of duty...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... transport a POV, including a replacement POV, to my post of duty subsequent to the time of my assignment to... and Property Management Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND... Transportation Pov Transportation Subsequent to the Time of Assignment § 302-9.175 When I am authorized to...

  15. 30 CFR 77.1402-1 - Maximum load; posting.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ....1402-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL... number of men permitted to ride on each hoist or elevator at one time; this limit shall be posted on each...

  16. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

    PubMed

    Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

    2014-01-01

    A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

  17. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  18. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  19. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  20. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  1. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  2. Microbial safety of fresh produce

    USDA-ARS?s Scientific Manuscript database

    The book entitled “Microbial Safety of Fresh Produce” with 23 chapters is divided into following six sections: Microbial contamination of fresh produce, Pre-harvest strategies, post-harvest interventions, Produce safety during processing and handling, Public, legal, and economic Perspectives, and Re...

  3. Enhanced clinical outcome with manual massage following cryolipolysis treatment: a 4-month study of safety and efficacy.

    PubMed

    Boey, Gerald E; Wasilenchuk, Jennifer L

    2014-01-01

    Cryolipolysis procedures have been shown to safely and effectively reduce the thickness of fat in a treated region. This study was conducted to determine whether the addition of post-treatment manual massage would improve efficacy while maintaining the safety profile of the original cryolipolysis treatment protocol. The study population consisted of an efficacy group (n = 10) and a safety group (n = 7). Study subjects were treated on each side of the lower abdomen with a Cooling Intensity Factor of 42 (-72.9 mW/cm(2) ) for 60 minutes. One side of the abdomen was massaged post-treatment and the other side served as the control. Immediately post-treatment, the massage side was treated for 1 minute using a vigorous kneading motion followed by 1 minute of circular massage using the pads of the fingers. For the efficacy group, photos and ultrasound measurements were taken at baseline, 2 months, and 4 months post-treatment. For the safety group, histological analysis was completed at 0, 3, 8, 14, 30, 60, and 120 days post-treatment to examine the effects of massage on subcutaneous tissue over time. Post-treatment manual massage resulted in a consistent and discernible increase in efficacy over the non-massaged side. At 2 months post-treatment, mean fat layer reduction was 68% greater in the massage side than in the non-massage side as measured by ultrasound. By 4 months, mean fat layer reduction was 44% greater in the massage side. Histological results showed no evidence of necrosis or fibrosis resulting from the massage. Post-treatment manual massage is a safe and effective technique to enhance the clinical outcome from a cryolipolysis procedure. © 2013 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

  4. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable in...

  5. Rutosides for prevention of post-thrombotic syndrome.

    PubMed

    Morling, Joanne R; Yeoh, Su Ern; Kolbach, Dinanda N

    2015-09-16

    Post-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. The current standard care for the prevention of PTS following DVT is elastic compression stockings. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the prevention of post-thrombotic syndrome. This is an update of the review first published in 2013. To determine the effectiveness and safety of rutosides for prevention of PTS in patients with DVT, compared to placebo, no intervention, or reference medication. For this update the Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched September 2015) and the Cochrane Register of Studies (CRS) ((CENTRAL) 2015, Issue 8). Clinical trials databases were searched for details of ongoing and unpublished studies. We planned to include trials of rutosides versus any alternative (placebo, no intervention, or reference medication) in the prevention of PTS in patients with DVT. Two review authors independently assessed studies for inclusion and intended to extract information from the trials. No studies were identified comparing rutosides versus any alternative in the prevention of PTS. As there were no studies identified in this review there is currently insufficient evidence to determine the effectiveness and safety of rutosides for prevention of PTS in patients with DVT. Some studies suggest that rutosides may provide short-term relief of PTS symptoms. However, there is nothing published on their use as a preventative therapy for PTS. High quality randomised controlled trials of rutoside versus any alternative are required to

  6. Post-marketing surveillance of sertindole.

    PubMed

    Toumi, Mondher

    2002-01-01

    The atypical antipsychotic drug, sertindole, like several other drugs, causes QT interval prolongation. Prolongation of the QT interval on the electrocardiogram has been associated with an increased risk of ventricular arrhythmia, including the more serious form, torsades de pointes, and is thus a safety concern for the authorities. In the case of sertindole, however, the available pharmacoepidemiological studies gathering data from about 10 000 patients documented the lack of increased risk associated to sertindole in comparison to other atypical antipsychotics. On the basis of these data, as well as non-clinical and clinical safety data, the CPMP expert group concluded that, although sertindole has the potential to prolong the QT interval, ¤ ¤ QT interval prolongation does not seem to be a reliable proxy for the risk of severe cardiac arrhythmias'', and there are no clinical data suggesting that sertindole is more arrhythmogenic than are other atypical antipsychotics. To further substantiate this conclusion, two post-marketing surveillance studies have been initiated. One is a randomized comparison of sertindole and risperidone under normal conditions of use. Randomization minimizes selection bias and the intention is that allocation to the two treatment arms will yield comparable treatment groups. While the two drugs will be given in an open-label fashion, all safety data will be blinded and reviewed by an independent safety committee. The other study is an observational study that includes all patients prescribed sertindole who, for whatever reason, will not be included in the randomized study. In all, 10 000 patients are expected to take part in the studies, which will run for at least 1 year.

  7. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  8. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  9. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  10. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  11. Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

    ERIC Educational Resources Information Center

    Renfrew, Malcolm M., Ed.; Palladino, George F.

    1980-01-01

    Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

  12. 77 FR 28451 - Unsatisfactory Safety Rating; Revocation of Operating Authority Registration; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ... carrier for failure to comply with safety fitness requirements; if the Agency determines that a motor carrier is ``Unfit'' based on its Safety Fitness Determination procedures, the Agency must revoke the... failure to comply with safety fitness requirements. See 49 U.S.C. 13905(f)(1)(B) and (3). The implementing...

  13. 77 FR 10666 - Pipeline Safety: Post Accident Drug and Alcohol Testing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... operators of Liquefied Natural Gas (LNG) facilities to conduct post- accident drug and alcohol tests of... reviewed, along with other applicable sections of Part 199: Under Sec. 199.105, post-accident drug tests of... administering the test. Covered employees must remain available for post-accident testing, but emergency...

  14. The role of the military in post-conflict situations.

    PubMed

    Court, Bruce V

    2004-11-01

    This article considers the possible role of the military in relation to 'post-conflict situations' and helping to improve the health of affected civilian populations. The opinions expressed are personal reflections which draw upon the author's recent military medical experience in southern Iraq in 2004. The perspective of humanitarian aid agencies that have strong reservations about any involvement with the military is recognised, as they seek to maintain neutrality and the safety of their staff. The environment itself, however, may represent an unacceptable level of threat to humanitarian aid agencies, if their personnel are at risk of serious intimidation, e.g. kidnap or murder. Where terrorist and insurgent para-military groups emerge in a post-war fighting phase, it may be that the military is best placed to help co-ordinate efforts to ensure public health and health care provision until a satisfactory level of security is attained and humanitarian aid agencies are able to operate with confidence.

  15. Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

    PubMed

    Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

    2018-05-01

    We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  16. Sex differences in discriminating between cues predicting threat and safety.

    PubMed

    Day, Harriet L L; Reed, Molly M; Stevenson, Carl W

    2016-09-01

    Post-traumatic stress disorder (PTSD) is more prevalent in women than men. PTSD is characterized by overgeneralization of fear to innocuous stimuli and involves impaired inhibition of learned fear by cues that predict safety. While evidence indicates that learned fear inhibition through extinction differs in males and females, less is known about sex differences in fear discrimination and safety learning. Here we examined auditory fear discrimination in male and female rats. In Experiment 1A, rats underwent 1-3days of discrimination training consisting of one tone predicting threat (CS+; presented with footshock) and another tone predicting safety (CS-; presented alone). Females, but not males, discriminated between the CS+ and CS- after one day of training. After 2-3days of training, however, males discriminated whereas females generalized between the CS+ and CS-. In Experiment 1B, females showed enhanced anxiety-like behaviour and locomotor activity in the open field, although these results were unlikely to explain the sex differences in fear discrimination. In Experiment 2, we found no differences in shock sensitivity between males and females. In Experiment 3, males and females again discriminated and generalized, respectively, after three days of training. Moreover, fear generalization in females resulted from impaired safety learning, as shown by a retardation test. Whereas subsequent fear conditioning to the previous CS- retarded learning in males, females showed no such retardation. These results suggest that, while females show fear discrimination with limited training, they show fear generalization with extended training due to impaired safety learning. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  17. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    PubMed

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

  18. Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.

    PubMed

    Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

    2017-06-01

    The construction industry has hit a plateau in terms of safety performance. Safety climate is regarded as a leading indicator of safety performance; however, relatively little safety climate research has been done in the Canadian construction industry. Safety climate may be geographically sensitive, thus it is necessary to examine how the construct of safety climate is defined and used to improve safety performance in different regions. On the other hand, more and more attention has been paid to job related stress in the construction industry. Previous research proposed that individual resilience may be associated with a better safety performance and may help employees manage stress. Unfortunately, few empirical research studies have examined this hypothesis. This paper aims to examine the role of safety climate and individual resilience in safety performance and job stress in the Canadian construction industry. The research was based on 837 surveys collected in Ontario between June 2015 and June 2016. Structural equation modeling (SEM) techniques were used to explore the impact of individual resilience and safety climate on physical safety outcomes and on psychological stress among construction workers. The results show that safety climate not only affected construction workers' safety performance but also indirectly affected their psychological stress. In addition, it was found that individual resilience had a direct negative impact on psychological stress but had no impact on physical safety outcomes. These findings highlight the roles of both organizational and individual factors in individual safety performance and in psychological well-being. Construction organizations need to not only monitor employees' safety performance, but also to assess their employees' psychological well-being. Promoting a positive safety climate together with developing training programs focusing on improving employees' psychological health - especially post-trauma psychological

  19. The Strategy for Safety: Preventing Crises through Safety Audits

    ERIC Educational Resources Information Center

    Schwartz, Sara Goldsmith

    2013-01-01

    In this article the author demonstrates the importance of school safety audits and describes what schools should focus on in a safety audit. Ultimately, each school should determine its own safety audit strategy based on its unique circumstances, including the type of community within which it is located, the age of the students it serves, and the…

  20. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... Authority. The Administrator shall perform, for and under the supervision of the Secretary, such duties as...

  1. 16 CFR § 1700.2 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Authority. § 1700.2 Section § 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of...

  2. 2016 Traffic Safety Culture Index

    MedlinePlus

    ... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ...

  3. EFFECT OF A ROAD SAFETY EDUCATION INTERVENTION ON ROAD SAFETY KNOWLEDGE OF UNIVERSITY DRIVERS IN IBADAN, NIGERIA.

    PubMed

    Olumide, A O; Owoaje, E T

    2016-06-01

    It is essential for drivers employed in the formal sector to have good knowledge of road safety in order to safeguard their lives and those of the staff they are employed to drive. The study was conducted to determine the effect of a road safety education intervention on road safety knowledge of drivers employed in the University of Ibadan, Nigeria. A quasi-experimental study of 98 intervention and 78 control drivers selected using a cluster sampling technique was conducted. The intervention comprised a two-day training on road safety and first aid. The drivers' knowledge of road safety was measured at baseline, immediately and 4-months post-intervention. Aggregate scores of road safety knowledge were computed giving minimum and maximum obtainable scores of 0 and 16 respectively. Change in mean scores over the three measurement periods was assessed using Repeated Measures Analysis of Variance (ANOVA). Independent t-test was used to compare the scores between intervention and control drivers at each of the assessment periods. Twenty-nine drivers did not complete the study (attrition rate = 16.5%). At baseline, mean road safety knowledge scores for the intervention and control drivers were 12.7±2.2 and 12.9± 2.3 (p = 0.510) respectively. Immediately and four months post intervention, the scores of the intervention drivers were 13.8±1.9 and 12.8±1.6; while scores for the controls were 13.3±2.0 and 13.2±1.8. Repeated measures ANOVA revealed that the increase in knowledge over the three assessment periods was not statistically significant. The intervention resulted in an initial increase in road safety knowledge of the intervention drivers. However, this was not sustained to the forth month post-intervention. This finding suggests periodic refresher trainings to sustain the knowledge acquired.

  4. [Do residents and nurses communicate safety relevant concerns? : simulation study on the influence of the authority gradient].

    PubMed

    St Pierre, M; Scholler, A; Strembski, D; Breuer, G

    2012-10-01

    Due to the negative impact on decision-making too steep authority gradients in teams represent a risk factor for patient safety. As residents and nursing staff may fear sanctions they may be reluctant to forward critical information to or challenge planned actions of attending physicians. In the setting of a simulation course it was investigated whether and to what extent team members would challenge decisions of familiar attending physicians. In each case where participants did not voice an opinion the underlying motives for the behavior were investigated. A total of 59 physicians and 18 nursing staff participated in the scenario. During a rapid sequence induction they were confronted with 7 critical situations created by the attending physician who had been instructed by the simulation team. Recommendations of the German Society of Anaesthesiology were ignored as well as clinical standard operating procedures (SOPs) and two potentially fatal drug administrations were ordered. An attempt was made to determine whether team members were aware of the safety threat at all and if so how they would solve the resulting conflicts. The level of verbal challenge was scored. During debriefing participants were asked to verbalize the motives which they thought might account for their silence or level of challenge. In situations where non-verbal conflict resolution was possible 65% of the participants pursued that strategy whereas 35% voiced an opinion. Situations necessitating verbal intervention were identified in 66% but 72% of the participants chose to remain silent. Team members decided to challenge the attending physician in only 28% of the situations. In 35% their statement was oblique, in 25% the problem was addressed but not further pursued and only in 40% did participants show crisp advocacy and assertiveness and initiated discussion. Asked why they had refrained from challenging the attending physician 37% had no answer, in 35% of situations participants observed a

  5. 30 CFR 57.19108 - Posting warning signs during shaft work.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting warning signs during shaft work. 57.19108 Section 57.19108 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL...

  6. Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.

    PubMed

    Fox, Bethany

    2012-01-01

    While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.

  7. French policy for managing the post-accident phase of a nuclear accident.

    PubMed

    Gallay, F; Godet, J L; Niel, J C

    2015-06-01

    In 2005, at the request of the French Government, the Nuclear Safety Authority (ASN) established a Steering Committee for the Management of the Post-Accident Phase of a Nuclear Accident or a Radiological Emergency, with the objective of establishing a policy framework. Under the supervision of ASN, this Committee, involving several tens of experts from different backgrounds (e.g. relevant ministerial offices, expert agencies, local information commissions around nuclear installations, non-governmental organisations, elected officials, licensees, and international experts), developed a number of recommendations over a 7-year period. First published in November 2012, these recommendations cover the immediate post-emergency situation, and the transition and longer-term periods of the post-accident phase in the case of medium-scale nuclear accidents causing short-term radioactive release (less than 24 h) that might occur at French nuclear facilities. They also apply to actions to be undertaken in the event of accidents during the transportation of radioactive materials. These recommendations are an important first step in preparation for the management of a post-accident situation in France in the case of a nuclear accident. © The Chartered Institution of Building Services Engineers 2014.

  8. Development of alternative wood-post MGS approach guardrail transition.

    DOT National Transportation Integrated Search

    2011-11-28

    The objective of this study was to develop a wood-post MGS approach transition system that is equivalent to the : simplified steel-post, MGS stiffness transition recently developed at the Midwest Roadside Safety Facility. An extensive : literature re...

  9. 23 CFR 1350.7 - Post-award requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 23 Highways 1 2012-04-01 2012-04-01 false Post-award requirements. 1350.7 Section 1350.7 Highways... MOTORCYCLIST SAFETY PROGRAM § 1350.7 Post-award requirements. (a) Within 30 days after notification of award but in no event later than September 12 of each year, a State must submit electronically to the agency...

  10. 23 CFR 1350.7 - Post-award requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Post-award requirements. 1350.7 Section 1350.7 Highways... MOTORCYCLIST SAFETY PROGRAM § 1350.7 Post-award requirements. (a) Within 30 days after notification of award but in no event later than September 12 of each year, a State must submit electronically to the agency...

  11. 23 CFR 1350.7 - Post-award requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 23 Highways 1 2011-04-01 2011-04-01 false Post-award requirements. 1350.7 Section 1350.7 Highways... MOTORCYCLIST SAFETY PROGRAM § 1350.7 Post-award requirements. (a) Within 30 days after notification of award but in no event later than September 12 of each year, a State must submit electronically to the agency...

  12. Safety evaluation of phytosterol-esters. Part 9: Results of a European post-launch monitoring programme.

    PubMed

    Lea, L J; Hepburn, P A

    2006-08-01

    Phytosterol-esters were developed by Unilever as a cholesterol lowering novel food ingredient for use initially in vegetable oil spreads. In addition to an extensive package of safety studies and clinical studies a programme of post-launch monitoring (PLM) was developed. PLM was used to address the following questions: (a) Is the product use as predicted/recommended? (b) Are the known effects as predicted? (c) Does the product cause unexpected health effects? The overall conclusions from the PLM programme were: the product is being bought by the target population but intakes are less than the original assumptions made in the risk assessment; long-term use of phytosterol-ester enriched spreads results in a reduction in the serum levels of the most lipophilic carotenoids but at current levels of intake this is unlikely to result in reductions in carotenoids that are of biological significance; evaluation of health related consumer complaints have not indicated any unexpected health effects associated with the use of the product in the marketplace. As part of the European approval under Regulation (EC) No. 258/97 on Novel Foods and Food Ingredients the results of the PLM programme had to be submitted to the European Commission (EC) and reviewed by the Scientific Committee on Food (SCF). They concluded that the study provided valuable information, which complemented the pre-market safety evaluation studies, and that the EC mandatory requirement had been met.

  13. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.

    PubMed

    Bravo, Lulu; Chitraka, Amarjeet; Liu, Aixue; Choudhury, Jaydeep; Kumar, Kishore; Berezo, Lennie; Cimafranca, Leonard; Chatterjee, Pallab; Garg, Pankaj; Siriwardene, Prasanna; Bernardo, Rommel; Mehta, Shailesh; Balasubramanian, Sundaram; Karkada, Naveen; Htay Han, Htay

    2014-01-01

    Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.

  14. 75 FR 63774 - Pipeline Safety: Safety of On-Shore Hazardous Liquid Pipelines

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Pipelines AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of... Gas Pipeline Safety Act of 1968, Public Law 90-481, delegated to DOT the authority to develop...

  15. State safety oversight program : audit of the tri-state oversight committee and the Washington metropolitan area transit authority, final audit report, March 4, 2010.

    DOT National Transportation Integrated Search

    2010-03-04

    The Federal Transit Administration (FTA) conducted an on-site audit of the safety program implemented by the Washington Metropolitan Area Transit Authority (WMATA) and overseen by the Tri-State Oversight Committee (TOC) between December 14 and 17, 20...

  16. Comparison of Efficacy and Safety of Intramuscular Piroxicam and Tramadol for Post-operative Pain in Patients Undergoing Caesarean Delivery.

    PubMed

    Thippeswamy, Tejashree; Krishnaswamy, Bhuvana; Bengalorkar, Girish M; Mariyappa, Narayanaswamy

    2016-11-01

    Post-caesarean section pain can be both stressful and unfavourable. Effective and rapid reduction of pain facilitates early ambulation and care of the new born. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and opioids are used for pain relief but they are associated with adverse effects both in the mother and the child. To evaluate efficacy and safety of piroxicam and tramadol in post-caesarean section pain. Primigravidae who underwent elective caesarean section received either piroxicam 20mg or tramadol 100mg intra-muscularly, following recovery from anaesthesia. Severity of pain was assessed using Visual Analogue Scale (VAS) and side-effects to study drugs were noted. Rescue analgesic butorphanol 2mg was administered if VAS score was more than four. Patient's satisfaction score was assessed at 12 hours post-operatively. Mean age in piroxicam and tramadol groups were 23.32±3.43 and 22.03±2.0 years respectively. Significant reduction in pain was observed at 2, 4, 8, 12 and 24 hours in both groups (p<0.001). Pain relief was significant at 2, 4 and 8 hours in piroxicam group compared to tramadol. Twenty-one and 12 patients in tramadol and piroxicam groups received rescue analgesic respectively. Sedation and nausea was significantly higher in tramadol group (p<0.001), 46.66% of patients graded their satisfaction score as good and 15% as excellent in piroxicam group. Intra-muscular piroxicam was effective in reducing post-caesarean section pain for 24 hours with minimal side-effects compared to tramadol.

  17. MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

    DTIC Science & Technology

    More than a thousand articles on biological safety in infectious disease laboratories are listed for the use of supervisors responsible for the safety of laboratory personnel. An author index is included.

  18. Preliminary safety analysis of the Baita Bihor radioactive waste repository, Romania

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

    Little, Richard; Bond, Alex; Watson, Sarah

    2007-07-01

    A project funded under the European Commission's Phare Programme 2002 has undertaken an in-depth analysis of the operational and post-closure safety of the Baita Bihor repository. The repository has accepted low- and some intermediate-level radioactive waste from industry, medical establishments and research activities since 1985 and the current estimate is that disposals might continue for around another 20 to 35 years. The analysis of the operational and post-closure safety of the Baita Bihor repository was carried out in two iterations, with the second iteration resulting in reduced uncertainties, largely as a result taking into account new information on the hydrologymore » and hydrogeology of the area, collected as part of the project. Impacts were evaluated for the maximum potential inventory that might be available for disposal to Baita Bihor for a number of operational and postclosure scenarios and associated conceptual models. The results showed that calculated impacts were below the relevant regulatory criteria. In light of the assessment, a number of recommendations relating to repository operation, optimisation of repository engineering and waste disposals, and environmental monitoring were made. (authors)« less

  19. The moderating role of safety-specific trust on the relation between safety-specific leadership and safety citizenship behaviors.

    PubMed

    Conchie, Stacey M; Donald, Ian J

    2009-04-01

    The authors examined whether safety-specific trust moderates or mediates the relationship between safety-specific transformational leadership and subordinates' safety citizenship behavior. Data from 139 subordinate-supervisor dyads were collected from the United Kingdom construction industry and analyzed using hierarchical regression models. Results showed that safety-specific trust moderated rather than mediated the effects of safety-specific transformational leaders on subordinates' behavior. Specifically, in conditions of high and moderate safety-specific trust, leaders had a significant effect on subordinates' safety citizenship behavior. However, in conditions of low safety-specific trust, leaders did not significantly influence subordinates' safety citizenship behavior. The implications of these findings for general safety theory and practice are discussed.

  20. 47 CFR 95.1107 - Authorized locations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1107 Authorized locations. The operation of a wireless medical telemetry transmitter under this part is authorized anywhere within a health...

  1. 47 CFR 95.1107 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1107 Section 95.1107 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1107 Authorized locations. The...

  2. 47 CFR 95.1203 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1203 Section 95.1203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Medical Device Radiocommunication Service (MedRadio) § 95.1203 Authorized locations. MedRadio...

  3. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  4. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  5. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  6. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  7. 49 CFR 392.9a - Operating authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Operating authority. 392.9a Section 392.9a Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS DRIVING OF COMMERCIAL MOTOR...

  8. 32 CFR 643.120 - Post offices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Post offices. 643.120 Section 643.120 National... Additional Authority of Commanders § 643.120 Post offices. Title 10 U.S.C. 4779b, provides that the SA shall assign suitable space for post office purposes at military posts where post offices have been established...

  9. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    PubMed

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  10. 33 CFR 147.5 - Delegation of authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Delegation of authority. 147.5 Section 147.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OUTER CONTINENTAL SHELF ACTIVITIES SAFETY ZONES § 147.5 Delegation of authority. The authority to...

  11. 33 CFR 147.5 - Delegation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Delegation of authority. 147.5 Section 147.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OUTER CONTINENTAL SHELF ACTIVITIES SAFETY ZONES § 147.5 Delegation of authority. The authority to...

  12. Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

    PubMed

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Fujii, Shoko; Kakiuchi, Seigo; Fujiwara, Hisataka; Kameda, Hiroyuki; Tamura, Masahiro; Kaku, Kohei

    2017-11-01

    Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively. The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  13. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES... for Ship Stations § 80.1103 Equipment authorization. (a) All equipment specified in § 80.1101 must be...

  14. 47 CFR 95.1505 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1505 Section 95.1505 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... locations. Operation of DSRCS On-Board Units is authorized anywhere CB station operation is permitted under...

  15. 40 CFR 158.1050 - Post-application exposure-general requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) PESTICIDE PROGRAMS DATA REQUIREMENTS FOR PESTICIDES Human Exposure § 158.1050 Post-application exposure... by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants...

  16. 40 CFR 158.1050 - Post-application exposure-general requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) PESTICIDE PROGRAMS DATA REQUIREMENTS FOR PESTICIDES Human Exposure § 158.1050 Post-application exposure... by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants...

  17. 40 CFR 158.1050 - Post-application exposure-general requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) PESTICIDE PROGRAMS DATA REQUIREMENTS FOR PESTICIDES Human Exposure § 158.1050 Post-application exposure... by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants...

  18. 40 CFR 158.1050 - Post-application exposure-general requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) PESTICIDE PROGRAMS DATA REQUIREMENTS FOR PESTICIDES Human Exposure § 158.1050 Post-application exposure... by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants...

  19. 40 CFR 158.1050 - Post-application exposure-general requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) PESTICIDE PROGRAMS DATA REQUIREMENTS FOR PESTICIDES Human Exposure § 158.1050 Post-application exposure... by the Occupational Safety and Health Administration, provide adequate protection for a particular pesticide use pattern, post-application exposure data may not be required for that use pattern. Applicants...

  20. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects.

    PubMed

    Shi, Nianmin; Zhang, Yibin; Zheng, Huizhen; Zhu, Zhenggang; Wang, Dingming; Li, Sihai; Li, Yuhua; Yang, Liqing; Zhang, Junnan; Bai, Yunhua; Lu, Qiang; Zhang, Zheng; Luo, Fengji; Yu, Chun; Li, Li

    2017-06-03

    To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.

  1. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects

    PubMed Central

    Shi, Nianmin; Zhang, Yibin; Zheng, Huizhen; Zhu, Zhenggang; Wang, Dingming; Li, Sihai; Li, Yuhua; Yang, Liqing; Zhang, Junnan; Bai, Yunhua; Lu, Qiang; Zhang, Zheng; Luo, Fengji; Yu, Chun; Li, Li

    2017-01-01

    ABSTRACT Aim: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. Methods: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). Results: No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. Conclusions: Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China. PMID:28121231

  2. NASA Post-Columbia Safety & Mission Assurance, Review and Assessment Initiatives

    NASA Astrophysics Data System (ADS)

    Newman, J. Steven; Wander, Stephen M.; Vecellio, Don; Miller, Andrew J.

    2005-12-01

    On February 1, 2003, NASA again experienced a tragic accident as the Space Shuttle Columbia broke apart upon reentry, resulting in the loss of seven astronauts. Several of the findings and observations of the Columbia Accident Investigation Board addressed the need to strengthen the safety and mission assurance function at NASA. This paper highlights key steps undertaken by the NASA Office of Safety and Mission Assurance (OSMA) to establish a stronger and more- robust safety and mission assurance function for NASA programs, projects, facilities and operations. This paper provides an overview of the interlocking OSMA Review and Assessment Division (RAD) institutional and programmatic processes designed to 1) educate, inform, and prepare for audits, 2) verify requirements flow-down, 3) verify process capability, 4) verify compliance with requirements, 5) support risk management decision making, 6) facilitate secure web- based collaboration, and 7) foster continual improvement and the use of lessons learned.

  3. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY § 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when...

  4. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY § 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when...

  5. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  6. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  7. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  8. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  9. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis

    PubMed Central

    le Roux, Carel; Aroda, Vanita; Hemmingsson, Joanna; Cancino, Ana Paula; Christensen, Rune; Pi-Sunyer, Xavier

    2018-01-01

    Objective To investigate whether the efficacy and safety of liraglutide 3.0 mg differed between two subgroups, BMI 27 to <35 and BMI ≥ 35 kg/m², in individuals without and with type 2 diabetes (T2D). Methods A post-hoc analysis of two 56-week, randomized, double-blind, placebo-controlled trials (SCALE Obesity and Prediabetes; SCALE Diabetes). Subgroup differences in treatment effects of liraglutide 3.0 mg were evaluated by testing the interaction between treatment group and baseline BMI subgroup. Results Significantly greater weight loss (0–56 weeks) was observed with liraglutide 3.0 mg versus placebo in all patient groups while on treatment. There was no evidence that the weight-lowering effect of liraglutide 3.0 mg differed between BMI subgroups (interaction p > 0.05). Similarly, for most secondary endpoints significantly greater improvements were observed with liraglutide 3.0 mg versus placebo, with no indication treatment effects differing between subgroups. The safety profile of liraglutide 3.0 mg was broadly similar across BMI subgroups. Conclusion This post-hoc analysis did not indicate any differences in the treatment effects, or safety profile, of liraglutide 3.0 mg for individuals with BMI 27 to <35 or ≥35 kg/m². Liraglutide 3.0 mg can therefore be considered for individuals with a BMI of ≥35 as well as for those with a BMI of 27 to <35 kg/m². PMID:29145215

  10. Post earthquake investigation field manual for the state of Kentucky.

    DOT National Transportation Integrated Search

    2006-09-01

    The rapid assessment of a bridge structure's safety and functionality is an essential component to restoring vital lifeline routes after a major earthquake. Appropriate posting categories are used to assure the safety of the travelling public. The ob...

  11. [Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception].

    PubMed

    Pérez-Vilar, S; Díez-Domingo, J; Gomar-Fayos, J; Pastor-Villalba, E; Sastre-Cantón, M; Puig-Barberà, J

    2014-08-01

    The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry. The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%. Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  12. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  13. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  14. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  15. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  16. Liquefied natural gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1977-01-01

    Bibliography, assembled from computer search of NASA Aerospace Safety Data Bank, including title of report, author, abstract, source, description of figures, key references, and key words or subject terms. Publication is indexed by key subjects and by authors. Items are relevant to design engineers and safety specialists.

  17. 48 CFR 605.502 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PLANNING PUBLICIZING CONTRACT ACTIONS Paid Advertisements 605.502 Authority. (a) For paid advertisements in... the purposes of FAR 5.502(a). For acquisitions by overseas posts necessitating paid advertisements in...

  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. [Topics from "Overseas Drug Safety Information" in the past five years].

    PubMed

    Amanuma, Kimiko

    2013-01-01

    The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled "Overseas Drug Safety Information" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the "Overseas Drug Safety Information" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.

  20. Teaching safety at a summer camp: evaluation of a fire safety curriculum in an urban community setting.

    PubMed

    Chavez, Audrie A; Duzinski, Sarah V; Wheeler, Tareka C; Lawson, Karla A

    2014-09-01

    To evaluate the effectiveness of the Danger Rangers Fire Safety Curriculum in increasing the fire safety knowledge of low-income, minority children in an urban community setting. Data was collected from child participants via teacher/researcher administered pre-, post-, and retention tests. A self-administered questionnaire was collected from parents pre- and post-intervention to assess fire/burn prevention practices. Paired t-tests were conducted to compare pre-, post-, and retention test mean scores by grade group. McNemar's test was used to determine if there was a change in parent-reported prevention practices following the intervention. The first/second grade group and the third grade group scored significantly higher on the post- and retention test as compared to the pre-test (p<0.0001 for all comparisons). There was no significant change in scores for the pre-k/k group after the intervention. There was a significant increase in 2 of 4 parent-reported fire/burn-related prevention practices after the intervention. Fire safety knowledge improved among first to third grade children, but not among pre-kinder and kindergarten children who participated in the intervention. This study also showed that a program targeted towards children and delivered in a classroom setting has the potential to influence familial prevention practices by proxy. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  1. The effects of acute nicotine on contextual safety discrimination.

    PubMed

    Kutlu, Munir G; Oliver, Chicora; Gould, Thomas J

    2014-11-01

    Anxiety disorders, such as post-traumatic stress disorder (PTSD), may be related to an inability to distinguish safe versus threatening environments and to extinguish fear memories. Given the high rate of cigarette smoking in patients with PTSD, as well as the recent finding that an acute dose of nicotine impairs extinction of contextual fear memory, we conducted a series of experiments to investigate the effect of acute nicotine in an animal model of contextual safety discrimination. Following saline or nicotine (at 0.0275, 0.045, 0.09 and 0.18 mg/kg) administration, C57BL/6J mice were trained in a contextual discrimination paradigm, in which the subjects received presentations of conditioned stimuli (CS) that co-terminated with a foot-shock in one context (context A (CXA)) and only CS presentations without foot-shock in a different context (context B (CXB)). Therefore, CXA was designated as the 'dangerous context', whereas CXB was designated as the 'safe context'. Our results suggested that saline-treated animals showed a strong discrimination between dangerous and safe contexts, while acute nicotine dose-dependently impaired contextual safety discrimination (Experiment 1). Furthermore, our results demonstrate that nicotine-induced impairment of contextual safety discrimination learning was not a result of increased generalized freezing (Experiment 2) or contingent on the common CS presentations in both contexts (Experiment 3). Finally, our results show that increasing the temporal gap between CXA and CXB during training abolished the impairing effects of nicotine (Experiment 4). The findings of this study may help link nicotine exposure to the safety learning deficits seen in anxiety disorder and PTSD patients. © The Author(s) 2014.

  2. 16 CFR 1101.71 - Delegation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Delegation of authority. 1101.71 Section... INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Delegation of Authority to Information Group § 1101.71 Delegation of authority. (a) Delegation. Pursuant to section 27(b)(9) of the CPSA...

  3. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. 41 U.S.C. chapter 81, Drug-Free Workplace. [79 FR 24208, Apr...

  4. Safety in the Elementary Science Classroom.

    ERIC Educational Resources Information Center

    Dean, Robert A.; And Others

    This safety guide for elementary school science teachers who plan science activities or laboratories for their students, presents information in the form of a flip chart that can be posted in the classroom and referred to in an emergency. Space is provided for emergency telephone numbers. A safety checklist is given for the teacher. Topics…

  5. Formal testing and utilization of streaming media to improve flight crew safety knowledge.

    PubMed

    Bellazzini, Marc A; Rankin, Peter M; Quisling, Jason; Gangnon, Ronald; Kohrs, Mike

    2008-01-01

    Increased concerns over the safety of air medical transport have prompted development of novel ways to increase safety. The objective of our study was to determine if an Internet streaming media safety video increased crew safety knowledge. 23 out of 40 crew members took an online safety pre-test, watched a safety video specific to our program and completed immediate and long-term post-testing 6 months later. Mean pre-test, post-test and 6 month follow up test scores were 84.9%, 92.3% and 88.4% respectively. There was a statistically significant difference in all scores (p safety training in our study.

  6. Safety in Riding Programs: A Director's Guide.

    ERIC Educational Resources Information Center

    Kpachavi, Teresa

    1996-01-01

    Camp riding programs should be examined regularly for liability and risk management issues. Elements of a basic safety assessment include requiring proper safety apparel, removing obstructions from riding rings, ensuring doors and gates are closed, requiring use of lead ropes, securing equine medications, banning smoking, posting written…

  7. Effectiveness of a school-based nutrition and food safety education program among primary and junior high school students in Chongqing, China.

    PubMed

    Zhou, Wen-Jie; Xu, Xiang-Long; Li, Ge; Sharma, Manoj; Qie, Ya-Ling; Zhao, Yong

    2016-03-01

    Health behavioral patterns, especially eating patterns, established in childhood often carry over into adulthood, and some of the unhealthy ones are later associated with adult morbidity and mortality. Recently, a few nutrition and food safety education programs have been implemented in primary and junior high schools in China. This study aims to examine the effectiveness of a school-based nutrition and food safety education program among primary and junior high school students in China. A mixed study design incorporating an intervention study and a quantitative survey was conducted for this research. With stratified cluster sampling, students from the 5(th) and 6(th) grade in one primary school and the 7(th) and 8(th) grade in one junior high school in Chongqing, China, were all selected and separated randomly into an intervention group (n = 501) and a control group (n = 522). Effectiveness evaluation investigations were performed at the initial time and nine-month follow-up (n = 472), respectively. Effectiveness of pre-/post-intervention and nine-month follow-up changes in scores of nutrition knowledge and food safety was assessed using a two-tailed t-test and analysis of variance. Nutrition knowledge scores for the intervention group were mean 9.03, SD±2.75 at the baseline, and 14.70±3.28 after intervention. There was a significant improvement (t = 29.78, p < 0.01). The nine-month follow-up knowledge scores of the intervention group were 12.35±2.89, which were lower than the immediately after the intervention group (t = 12.40, p<0.01), but higher than those of the baseline level (t = 18.04, p < 0.01). Food safety scores of the post-intervention were higher (p < 0.01) than that of the control group in both pre-intervention and nine-month follow-up. The control group had no significant change in the pre-post intervention. It is feasible and effective to improve nutrition and food safety knowledge among primary and junior high school students through school

  8. Safety assessment of adjuvanted vaccines: Methodological considerations

    PubMed Central

    Da Silva, Fernanda Tavares; Di Pasquale, Alberta; Yarzabal, Juan P; Garçon, Nathalie

    2015-01-01

    Adjuvants mainly interact with the innate immune response and are used to enhance the quantity and quality of the downstream adaptive immune response to vaccine antigens. Establishing the safety of a new adjuvant-antigen combination is achieved through rigorous evaluation that begins in the laboratory, and that continues throughout the vaccine life-cycle. The strategy for the evaluation of safety pre-licensure is guided by the disease profile, vaccine indication, and target population, and it is also influenced by available regulatory guidelines. In order to allow meaningful interpretation of clinical data, clinical program methodology should be optimized and standardized, making best use of all available data sources. Post-licensure safety activities are directed by field experience accumulated pre- and post-licensure clinical trial data and spontaneous adverse event reports. Continued evolution of safety evaluation processes that keep pace with advances in vaccine technology and updated communication of the benefit-risk profile is necessary to maintain public confidence in vaccines. PMID:26029975

  9. Risk Management Plans: are they a tool for improving drug safety?

    PubMed

    Frau, Serena; Font Pous, Maria; Luppino, Maria Rosa; Conforti, Anita

    2010-08-01

    In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.

  10. Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance.

    PubMed

    Kameda, Hideto; Nishida, Keiichiro; Nannki, Toshihiro; Watanabe, Akira; Oshima, Yukiya; Momohara, Shigaki

    2017-01-01

    Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were -1.29 ± 1.46 and -1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

  11. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  12. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  13. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  14. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  15. 78 FR 25916 - Authorization of Radiofrequency Equipment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-03

    ...] Authorization of Radiofrequency Equipment AGENCY: Federal Communications Commission. ACTION: Proposed rule. SUMMARY: This document proposes certain changes to the Commission's equipment authorization processes to... TCBs in certifying RF equipment and post-market surveillance, as well as the Commission's role in...

  16. 30 CFR 71.403 - Waiver of surface facilities requirements; posting of waiver.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Occupational Safety and Health, may, upon written application by the operator, and after consideration of any...; posting of waiver. 71.403 Section 71.403 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-SURFACE COAL MINES AND SURFACE...

  17. 47 CFR 87.147 - Authorization of equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorization of equipment. 87.147 Section 87.147 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Technical Requirements § 87.147 Authorization of equipment. (a) Certification may be...

  18. 47 CFR 95.1109 - Equipment authorization requirement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment authorization requirement. 95.1109 Section 95.1109 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... be authorized under the certification procedure prior to marketing or use in accordance with the...

  19. 47 CFR 95.1109 - Equipment authorization requirement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Equipment authorization requirement. 95.1109 Section 95.1109 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... be authorized under the certification procedure prior to marketing or use in accordance with the...

  20. Statistical issues in the design, conduct and analysis of two large safety studies.

    PubMed

    Gaffney, Michael

    2016-10-01

    The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

  1. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.105 Exemption authority. (a) The head of an...

  2. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.105 Exemption authority. (a) The head of an...

  3. Transsexualism and Flight Safety

    DTIC Science & Technology

    1987-05-08

    Security Classification) Transsexualism and Flight Safety 12. PERSONAL AUTHOR(S) Clements, Thomas I. and Wicks, Roland E. 13a. TYPE OF REPORT 13b. TIME... transsexual pilot with questionable judgment affecting flight safety is reported. The definition, etiology, and presenting symptoms are discussed. Three...involve all the phases of therapy and can be significant. Though the transsexual tends to have more episodes of anxiety and depression than the norm

  4. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management. (b...

  5. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management. (b...

  6. [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.

  7. 29 CFR 1926.1418 - Authority to stop operation.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 8 2011-07-01 2011-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Cranes and Derricks in...

  8. Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea.

    PubMed

    Kim, Tae Heon; Lee, Sang Eun; Lee, Hahn-Ey; Lee, Kyu-Sung

    2016-08-01

    The aim of this study was to evaluate the safety and efficacy of fesoterodine fumarate (fesoterodine; Toviaz ) in Korean patients with overactive bladder (OAB) in routine clinical practice. This was an open-label, non-interventional, prospective, post-marketing surveillance study submitted to the Korean Ministry of Food and Drug Safety. A total of 3109 patients aged ≥18 years with OAB symptoms were prescribed flexible doses of fesoterodine at the investigator's discretion. Safety was assessed based upon the reporting of adverse events (AEs). Efficacy was evaluated on the basis of patient self-assessment using a bladder diary as well as on the basis of investigator assessment in terms of overall clinical efficacy. A final analysis was performed on 3107 (99.9%) and 2978 (95.8%) patients for safety and efficacy analysis, respectively. The mean treatment duration of fesoterodine was 83.2 days. The incidence of AEs was 8.5% (265/3107). Common AEs that accounted for more than 1.0% of the total AE incidence included dry mouth (5.4%, 168/3107), constipation (1.5%, 48/3107) and micturition disorder (1.1%, 35/3107). Mean episodes of urinary frequency, urgency, and urgency urinary incontinence (UUI) per 24 hours decreased by 4.0, 2.4, and 0.8, respectively (all p < 0.001). At the final follow-up visit, the investigators found improvement in clinical efficacy for the majority of patients (90.1%, 2684/2978). Limitations of this study include the observational study design and the relatively short treatment duration. These results suggest that fesoterodine is a well tolerated and effective treatment for Korean patients with OAB in routine clinical practice.

  9. Hysterosalpingo-foam sonography (HyFoSy): Tolerability, safety and the occurrence of pregnancy post-procedure.

    PubMed

    Tanaka, Keisuke; Chua, Jackie; Cincotta, Robert; Ballard, Emma L; Duncombe, Gregory

    2018-02-01

    Fallopian tube patency testing is an essential part of infertility evaluation. Hysterosalpingo-contrast sonography (HyCoSy) has been described as reliable, well tolerated and safe compared to other modalities such as laparoscopy and a dye test or hysterosalpingography. Limited availability of the previously used contrast has led to the introduction of a foam contrast agent as an alternative. To assess the tolerability, safety and occurrence of pregnancy post-procedure of hysterosalpingo-foam sonography (HyFoSy). A retrospective cohort study of women who had a HyFoSy at Queensland Ultrasound for Women from March 2013 to February 2015. A questionnaire was sent to their referring doctor to identify any complications or subsequent pregnancies with or without artificial reproductive technology (ART) within six months of the HyFoSy. Of 200 women, four cases were abandoned due to difficulty introducing the intracervical catheter, severe discomfort or a vasovagal episode. Response from referring doctors for 155 women reported no post-procedural complication. One hundred and eleven women were followed up for at least six months. Twenty-four out of 59 women (40.7%) who had ART and 24 out of 52 women (46.2%) who did not have ART conceived. Fifty percent of women who were nulligravida at the time of investigation, found to have at least one patent fallopian tube, whose partner had a normal semen analysis, spontaneously conceived within the time of follow up. HyFoSy is well tolerated and safe. A preponderance of pregnancies in the first month after HyFoSy suggests that a therapeutic effect may exist. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  10. Improved Inspection Techniques for Steel Prestressing/Post-tensioning Strand : Volume I

    DOT National Transportation Integrated Search

    2012-06-01

    Post-tensioned bridges require a detailed inspection of their post-tensioning systems since damage in these : systems is not evident and can result in costly repairs/replacements, loss of integrity and reduction in safety : of the bridge. Different n...

  11. 14 CFR 437.27 - Pre-flight and post-flight operations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Pre-flight and post-flight operations. 437.27 Section 437.27 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... Experimental Permit Operational Safety Documentation § 437.27 Pre-flight and post-flight operations. An...

  12. 14 CFR 437.27 - Pre-flight and post-flight operations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Pre-flight and post-flight operations. 437.27 Section 437.27 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... Experimental Permit Operational Safety Documentation § 437.27 Pre-flight and post-flight operations. An...

  13. 14 CFR 437.27 - Pre-flight and post-flight operations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Pre-flight and post-flight operations. 437.27 Section 437.27 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... Experimental Permit Operational Safety Documentation § 437.27 Pre-flight and post-flight operations. An...

  14. 14 CFR 437.27 - Pre-flight and post-flight operations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Pre-flight and post-flight operations. 437.27 Section 437.27 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... Experimental Permit Operational Safety Documentation § 437.27 Pre-flight and post-flight operations. An...

  15. 22 CFR 710.15 - Delegation of authority.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Delegation of authority. 710.15 Section 710.15 Foreign Relations OVERSEAS PRIVATE INVESTMENT CORPORATION ADMINISTRATIVE PROVISIONS ADMINISTRATIVE ENFORCEMENT PROCEDURES OF POST-EMPLOYMENT RESTRICTIONS § 710.15 Delegation of authority. The functions of the...

  16. Tasseography: Reading Post-Racial Resistance to Teaching

    ERIC Educational Resources Information Center

    Houston, Akil

    2011-01-01

    This article focuses on developing a progressive philosophy of praxis that challenges, what the author argues is, a post-racial resistance to teaching about racial injustice. Post-racial resistance to teaching can lead to forms of enlightened racism and sexism in the classroom. In this essay, the author develops and extends the use of the metaphor…

  17. 76 FR 47262 - Brookwood-Sago Mine Safety Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... industry during the current reporting period. Pre-test and post- test results of trainees. Course... funding ends. 2. Agency creates training Increase number of Pre-test and post- materials and improves quality educational test results of the safety. materials developed. training materials. Provide quality...

  18. Safety, efficacy and immunogenicity evaluation of the SAG2 oral rabies vaccine in Formosan ferret badgers.

    PubMed

    Hsu, Ai-Ping; Tseng, Chun-Hsien; Barrat, Jacques; Lee, Shu-Hwae; Shih, Yu-Hua; Wasniewski, Marine; Mähl, Philippe; Chang, Chia-Chia; Lin, Chun-Ta; Chen, Re-Shang; Tu, Wen-Jane; Cliquet, Florence; Tsai, Hsiang-Jung

    2017-01-01

    Since 2013, rabies cases have been reported among Formosan ferret badgers in Taiwan, and they have been shown to be the major reservoirs for Taiwanese enzootics. To control and eradicate rabies, the authorities plan to implement a vaccination programme. Before distributing live vaccines in the field, this study assessed the safety, efficacy, and immunogenicity of SAG2 vaccine on ferret badgers by direct oral instillation. After application of 109 TCID50/dose, no virus was excreted into the oral cavity 1-7 days post-application, and safety was also satisfactorily verified over a 266-day period. Moreover, despite the low level of rabies virus neutralising antibodies induced after vaccination of a 108 TCID50/dose, the efficacy assessment revealed a 100% survival rate (15/15) of vaccinees and an 87.5% fatality rate (7/8) in control animals after a challenge on the 198th day post-vaccination. The immunisation and protection rates obtained more than 6 months after a single vaccination dose demonstrated that SAG2 is an ideal vaccine candidate to protect Formosan ferret badgers against rabies in Taiwan.

  19. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    PubMed

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  20. Foremen's intervention to prevent falls and increase safety communication at residential construction sites.

    PubMed

    Kaskutas, Vicki; Buckner-Petty, Skye; Dale, Ann Marie; Gaal, John; Evanoff, Bradley A

    2016-10-01

    This research aimed to improve residential construction foremen's communication skills and safety behaviors of their crewmembers when working at heights. Eighty-four residential construction foremen participated in the 8-hr fall prevention and safety communication training. We compared pre- and post-intervention surveys from foremen and their crewmembers to measure the effect of training. Foremen and crewmembers' ratings showed improvements in fall prevention knowledge, behaviors, and safety communication and were sustained 6-months post-training, with emphasized areas demonstrating larger increases. Ratings were similar between foremen and crewmembers, suggesting that the foremen effectively taught their crew and assigned accurate ratings. Based upon associations between safety behaviors and reported falls observed in prior research, we would expect a 16.6% decrease in the one year cumulative incidence of self-reported falls post-intervention. This intervention improved safety knowledge and behaviors of a large number of workers by training construction foremen in fall prevention and safety communication skills. Am. J. Ind. Med. 59:823-831, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  1. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005, Public...

  2. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005, Public...

  3. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... July 31, 2001, Energy Efficient Standby Power Devices. (f) Executive Order 13423 of January 24, 2007... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities...

  4. A Clinical Audit of Escorts' Awareness And Patients' Safety Following Intravenous Sedation In Adult Oral Surgery.

    PubMed

    Licheri, Luca; Erriu, Matteo; Bryant, Vincenzo; Piras, Vincenzo

    2016-01-01

    To evaluate current level of safety under the care of an escort following intravenous sedation, post-sedation arrangements and to identify potential risk levels. Information and post-sedation arrangements are important to patients'safety following surgery but although there is a general consensus over what is recommended for patients and their escorts, there is little, if any, literature on the escorts' awareness of sedation and accordance to post-sedation arrangement and recommendations. Escorts of 113 consecutive patients treated in oral surgery under sedation (midazolam) completed a questionnaire composed of 27 questions divided into seven sections including demographics, awareness of sedation, source of information and post-operative arrangement. From the data collected, two scores were calculated representative of the escorts' Safety and Reliability. Data were then analysed by ANOVA. Safety scores were statistically correlated with instruction source while Reliability correlated to a wider variety of parameters including gender, age as well as information source. Provision of clear written information to escorts is recommended as likely to improve patients' safety. Assessment of escorts' Safety and Reliability could provide a means for improving quality and safety of sedation service.

  5. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

    PubMed

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-10-02

    According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

  6. Creating Safe Environments for Children with Post-Traumatic Stress Disorder.

    ERIC Educational Resources Information Center

    Demaree, Mary Ann

    1995-01-01

    Discusses development of Post-Traumatic Stress Disorder (PTSD) in children living in violent homes and communities. Discusses the role of teachers in creating classrooms that feel safe. Notes the importance of relearning safety to children who have PTSD. Describes strategies to create feeling of safety in the children. (BAC)

  7. Biomarkers of Risk for Post-traumatic Stress Disorder (PTSD)

    DTIC Science & Technology

    2009-05-01

    Post - traumatic Stress Disorder ( PTSD ) PRINCIPAL INVESTIGATOR: Audrey R. Tyrka, MD, PhD... Post - traumatic Stress Disorder ( PTSD ) 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-07-1-0269 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S...1,087,938. 11. United States Department of Defense, “Biomarkers of risk for post - traumatic stress disorder ( PTSD ),” Principal Investigator,

  8. 30 CFR 57.19108 - Posting warning signs during shaft work.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Posting warning signs during shaft work. 57.19108 Section 57.19108 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... MINES Personnel Hoisting Shafts § 57.19108 Posting warning signs during shaft work. When persons are...

  9. 30 CFR 57.19108 - Posting warning signs during shaft work.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Posting warning signs during shaft work. 57.19108 Section 57.19108 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... MINES Personnel Hoisting Shafts § 57.19108 Posting warning signs during shaft work. When persons are...

  10. Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin.

    PubMed

    Del Prato, Stefano; Rosenstock, Julio; Garcia-Sanchez, Ricardo; Iqbal, Nayyar; Hansen, Lars; Johnsson, Eva; Chen, Hungta; Mathieu, Chantal

    2018-06-01

    The safety of triple oral therapy with dapagliflozin plus saxagliptin plus metformin versus dual therapy with dapagliflozin or saxagliptin plus metformin was compared in a post-hoc analysis of 3 randomized trials of sequential or concomitant add-on of dapagliflozin and saxagliptin to metformin. In the concomitant add-on trial, patients with type 2 diabetes on stable metformin received dapagliflozin 10 mg/d plus saxagliptin 5 mg/d. In sequential add-on trials, patients on metformin plus either saxagliptin 5 mg/d or dapagliflozin 10 mg/d received dapagliflozin 10 mg/d or saxagliptin 5 mg/d, respectively, as add-on therapy. After 24 weeks, incidences of adverse events and serious adverse events were similar between triple and dual therapy and between concomitant and sequential add-on regimens. Urinary tract infections were more common with sequential than with concomitant add-on therapy; genital infections were reported only with sequential add-on of dapagliflozin to saxagliptin plus metformin. Hypoglycaemia incidence was <2.0% across all analysis groups. In conclusion, the safety and tolerability of triple therapy with dapagliflozin, saxagliptin and metformin, as either concomitant or sequential add-on, were similar to dual therapy with either agent added to metformin. © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  11. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... exclusive authority to settle any issue or case without the consent of the ALJ. ...

  12. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... exclusive authority to settle any issue or case without the consent of the ALJ. ...

  13. Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union.

    PubMed

    Bolognesi, Claudia; Castoldi, Anna F; Crebelli, Riccardo; Barthélémy, Eric; Maurici, Daniela; Wölfle, Detlef; Volk, Katharina; Castle, Laurence

    2017-06-01

    Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European "Union list" of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety "in use". If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating "non standard" food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  14. Trinity cable safety system.

    DOT National Transportation Integrated Search

    2007-01-31

    Cab1eSafety System (CASS).is being tested by the Oklahoma Department of Transportation (ODOT) along I-35 in McClain County. CASS will be compare with two other system approve by ODOT. Using C-shaped post tensioned cables, CASS is designed to...

  15. Safety and regulation of yeasts used for biocontrol or biopreservation in the food or feed chain.

    PubMed

    Sundh, Ingvar; Melin, Petter

    2011-01-01

    Yeasts have been important components of spontaneous fermentations in food and beverage processing for millennia. More recently, the potential of utilising antagonistic yeasts, e.g. Pichia anomala and Candida spp., for post-harvest biological control of spoilage fungi during storage of plant-derived produce ('biopreservation') has been clearly demonstrated. Although some yeast species are among the safest microorganisms known, several have been reported in opportunistic infections in humans, including P. anomala and bakers' yeast, Saccharomyces cerevisiae. More research is needed about the dominant pathogenicity and virulence factors in opportunistic yeasts, and whether increased utilisation of biopreservative yeasts in general could contribute to an increased prevalence of yeast infections. The regulatory situation for yeasts used in post-harvest biocontrol is complex and the few products that have reached the market are mainly registered as biological pesticides. The qualified presumption of safety (QPS) approach to safety assessments of microorganisms intentionally added to food or feed, recently launched by the European Food Safety Authority, can lead to more efficient evaluations of new products containing microbial species with a sufficient body of knowledge or long-term experience on their safety. P. anomala is one of several yeast species that have been given QPS status, although the status is restricted to use of this yeast for enzyme and metabolite production purposes. With regard to authorisation of new biopreservative yeasts, we recommend that the possibility to regulate microorganisms for food biopreservation as food additives be considered.

  16. 78 FR 72666 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... Network Authority Board Meeting AGENCY: National Telecommunications and Information Administration, U.S... Authority. SUMMARY: The Board of the First Responder Network Authority (FirstNet) will convene open public... single nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for...

  17. 48 CFR 923.7001 - Nuclear safety.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Nuclear safety. 923.7001... Efficiency, Renewable Energy Technologies, and Occupational Safety Programs 923.7001 Nuclear safety. The DOE regulates the nuclear safety of its major facilities under its own statutory authority derived from the...

  18. Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England.

    PubMed

    de Lusignan, Simon; Dos Santos, Gaël; Correa, Ana; Haguinet, François; Yonova, Ivelina; Lair, Florence; Byford, Rachel; Ferreira, Filipa; Stuttard, Karen; Chan, Tom

    2017-05-17

    To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season's vaccine. A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data. This study builds on a feasibility study carried out at the start of the 2015/2016 influenza season. We will report influenza vaccine exposure and any AEIs reported via ADR card or recorded directly into the EHR, from the commencement of influenza vaccination and ends as specified by EMA (30 November 2016). Ten volunteer English general practices, primarily using the GSK influenza vaccines. They had selected this vaccine in advance of the study. People who receive a seasonal influenza vaccine, in each age group defined in EMA interim guidance: 6 months to 5 years, 6-12 years, 13-17 years, 18-65 years and >65 years. The primary outcome measure is the rate of AEIs occurring within 7 days postvaccination, using passive surveillance of general practitioner (GP) EHR systems enhanced by a card-based ADR reporting system. Extracted data will be presented overall by brand (Fluarix Tetra vs others), by age strata and risk groups. The secondary outcome measure is the vaccine uptake among the subjects registered in the enrolled general practices. Ethical approval was granted by the Proportionate Review Sub-committee of the North East-Newcastle & North Tyneside 2 on 5 August 2016. The study received approval from the Health Research Authority on 1 September 2016. We will produce an interim analysis within 8 weeks, and an end-of-study report, which will be submitted to peer-reviewed journals. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  19. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009, Federal...

  20. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National Energy...

  1. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009, Federal...

  2. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National Energy...

  3. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National Energy...

  4. Unstoppable The Gap Between Public Safety and Traffic Safety in the Age of Driverless Cars

    DTIC Science & Technology

    2017-03-01

    themselves, what will the increase in traffic safety cost society in terms of public safety? • What can public safety and homeland security...industry. Safer products are more marketable products, and companies that work with law enforcement for the benefit of public safety may have an...secondary public safety benefit of crime suppression. Reasonable suspicion to stop a vehicle would be an infrequent occurrence, and the legal authority

  5. Tolerability and safety of the intravenous immunoglobulin octagam® 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials.

    PubMed

    Wietek, Stefan; Svorc, Daniel; Debes, Anette; Svae, Tor-Einar

    2018-05-01

    To provide detailed data on the tolerability and safety of octagam ® 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of patients with immune thrombocytopenia (ITP) involved in an integrated analysis of post-authorisation safety surveillance (PASS) studies. A subgroup analysis was conducted using data collected from two non-interventional studies that included patients with ITP treated with octagam ® 10%. Patients were observed and monitored for possible adverse drug reactions (ADRs) during or after administration of octagam ® 10%, with a particular focus on thromboembolic events (TEEs). ADRs were analysed at the case and event level. In this analysis of 112 patients receiving octagam ® 10% (mean dose 0.4 g/kg/infusion), there were five cases with at least one adverse drug reaction (ADR) associated with 626 infusions of octagam ® 10% (case incidence of 0.8% per infusion). ADRs were of mild or moderate severity. There were a total of 10 events, most commonly back pain (n = 3) and headache (n = 2). Nausea, dizziness and a sensation of heaviness were also reported. The remaining two events involved drug exposure during pregnancy. There were no TEEs or other serious ADRs. In this subgroup analysis of patients who received octagam ® 10% (manufactured using an amended process) in two PASS studies, the overall ADR rate was low, with ADRs occurring in only 0.8% of all infusions. No TEEs or other serious ADRs were reported. Routine clinical use of octagam ® 10% was safe and well tolerated, with no unexpected safety issues, in patients with ITP. The two studies from which data were taken are registered with the International Standard Randomised Controlled Trial Number Registry, numbers ISRCTN58800347 and ISRCTN02245668.

  6. 30 CFR 56.19108 - Posting warning signs during shaft work.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Posting warning signs during shaft work. 56.19108 Section 56.19108 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Personnel Hoisting Shafts § 56.19108 Posting warning signs during shaft work. When persons are working in a...

  7. 30 CFR 56.19108 - Posting warning signs during shaft work.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Posting warning signs during shaft work. 56.19108 Section 56.19108 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Personnel Hoisting Shafts § 56.19108 Posting warning signs during shaft work. When persons are working in a...

  8. 30 CFR 56.19108 - Posting warning signs during shaft work.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Posting warning signs during shaft work. 56.19108 Section 56.19108 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Personnel Hoisting Shafts § 56.19108 Posting warning signs during shaft work. When persons are working in a...

  9. 30 CFR 56.19108 - Posting warning signs during shaft work.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Posting warning signs during shaft work. 56.19108 Section 56.19108 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Personnel Hoisting Shafts § 56.19108 Posting warning signs during shaft work. When persons are working in a...

  10. A Canadian Journey: Post-Secondary Education Since 1945

    ERIC Educational Resources Information Center

    Bruneau, William

    2004-01-01

    In this article, the author traces the history of Canadian post-secondary education. The author observes how the development of the country's post-secondary education reflects the changes of its socioeconomic priorities. Two relatively calm beginnings characterized by the construction of the first universities, the period of expansion of the…

  11. Safety climate and attitude toward medication error reporting after hospital accreditation in South Korea.

    PubMed

    Lee, Eunjoo

    2016-09-01

    This study compared registered nurses' perceptions of safety climate and attitude toward medication error reporting before and after completing a hospital accreditation program. Medication errors are the most prevalent adverse events threatening patient safety; reducing underreporting of medication errors significantly improves patient safety. Safety climate in hospitals may affect medication error reporting. This study employed a longitudinal, descriptive design. Data were collected using questionnaires. A tertiary acute hospital in South Korea undergoing a hospital accreditation program. Nurses, pre- and post-accreditation (217 and 373); response rate: 58% and 87%, respectively. Hospital accreditation program. Perceived safety climate and attitude toward medication error reporting. The level of safety climate and attitude toward medication error reporting increased significantly following accreditation; however, measures of institutional leadership and management did not improve significantly. Participants' perception of safety climate was positively correlated with their attitude toward medication error reporting; this correlation strengthened following completion of the program. Improving hospitals' safety climate increased nurses' medication error reporting; interventions that help hospital administration and managers to provide more supportive leadership may facilitate safety climate improvement. Hospitals and their units should develop more friendly and intimate working environments that remove nurses' fear of penalties. Administration and managers should support nurses who report their own errors. © 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.

  12. Public Employee Unions and the Post Commander.

    DTIC Science & Technology

    1982-04-01

    sector employees joining unions was addressed in June, 1981 while the author was a student in a graduate degree program . Then, as now, my bias was anti...AD-A116 168 ARMY WAR COLL CARLISLE BARRACKS PA F/6 5/1 PUBLIC EMPLOYEE UNIONS AND THE POST COMMANDER. (U) APR 82 E L DANIEL UNCLASSIFIED u mm um(u pp...COVERED Public Employee Unions and the Post Commander Student Essay 6. PERFORMING ORG. REPORT NUMBER 7. AUTHOR(s) 8. CONTRACT OR GRANT NUMBER(S) LTC

  13. Impact of the World Health Organization's Surgical Safety Checklist on safety culture in the operating theatre: a controlled intervention study

    PubMed Central

    Haugen, A. S.; Søfteland, E.; Eide, G. E.; Sevdalis, N.; Vincent, C. A.; Nortvedt, M. W.; Harthug, S.

    2013-01-01

    Background Positive changes in safety culture have been hypothesized to be one of the mechanisms behind the reduction in mortality and morbidity after the introduction of the World Health Organization's Surgical Safety Checklist (SSC). We aimed to study the checklist effects on safety culture perceptions in operating theatre personnel using a prospective controlled intervention design at a single Norwegian university hospital. Methods We conducted a study with pre- and post-intervention surveys using the intervention and control groups. The primary outcome was the effects of the Norwegian version of the SSC on safety culture perceptions. Safety culture was measured using the validated Norwegian version of the Hospital Survey on Patient Safety Culture. Descriptive characteristics of operating theatre personnel and checklist compliance data were also recorded. A mixed linear regression model was used to assess changes in safety culture. Results The response rate was 61% (349/575) at baseline and 51% (292/569) post-intervention. Checklist compliance ranged from 77% to 85%. We found significant positive changes in the checklist intervention group for the culture factors ‘frequency of events reported’ and ‘adequate staffing’ with regression coefficients at −0.25 [95% confidence interval (CI), −0.47 to −0.07] and 0.21 (95% CI, 0.07–0.35), respectively. Overall, the intervention group reported significantly more positive culture scores—including at baseline. Conclusions Implementation of the SSC had rather limited impact on the safety culture within this hospital. PMID:23404986

  14. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... subpart limits the authority of the Secretary to settle any issue or case or to compromise any penalty. ...

  15. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... subpart limits the authority of the Secretary to settle any issue or case or to compromise any penalty. ...

  16. The dental safety net in Connecticut.

    PubMed

    Beazoglou, Tryfon; Heffley, Dennis; Lepowsky, Steven; Douglass, Joanna; Lopez, Monica; Bailit, Howard

    2005-10-01

    Many poor, medically disabled and geographically isolated populations have difficulty accessing private-sector dental care and are considered underserved. To address this problem, public- and voluntary-sector organizations have established clinics and provide care to the underserved. Collectively, these clinics are known as "the dental safety net." The authors describe the dental safety net in Connecticut and examine the capacity and efficiency of this system to provide care to the noninstitutionalized underserved population of the state. The authors describe Connecticut's dental safety net in terms of dentists, allied health staff members, operatories, patient visits and patients treated per dentist per year. The authors compare the productivity of safety-net dentists with that of private practitioners. They also estimate the capacity of the safety net to treat people enrolled in Medicaid and the State Children's Health Insurance Program. The safety net is made up of dental clinics in community health centers, hospitals, the dental school and public schools. One hundred eleven dentists, 38 hygienists and 95 dental assistants staff the clinics. Safety-net dentists have fewer patient visits and patients than do private practitioners. The Connecticut safety-net system has the capacity to treat about 28.2 percent of publicly insured patients. The dental safety net is an important community resource, and greater use of allied dental personnel could substantially improve the capacity of the system to care for the poor and other underserved populations.

  17. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  18. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  19. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  20. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  1. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  2. Institutional Response to Ohio's Campus Safety Initiatives: A Post-Virginia Tech Analysis

    ERIC Educational Resources Information Center

    Jackson, Natalie Jo

    2009-01-01

    The purpose of this study was to examine how institutions of higher education were responding to unprecedented state involvement in campus safety planning and policymaking in the aftermath of the Virginia Tech tragedy. Focused on Ohio, a state in which a state-level task force was convened and charged to promulgate campus safety recommendations…

  3. Embedding Fonts in MetaPost Output

    DTIC Science & Technology

    2016-04-19

    by John Hobby ) based on Donald Knuth’s META- FONT [4] with high quality PostScript output. An outstanding feature of MetaPost is that typeset fonts in...output, the graphics are perfectly scalable to any arbitrary res- olution. John Hobby , its author, writes: “[MetaPost] is really a programming lan- guage...for generating graphics, especially fig- ures for TEX [5] and troff documents.” This quote by Hobby indicates that MetaPost figures are not only

  4. 78 FR 48029 - Improving Chemical Facility Safety and Security

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... responding to risks in chemical facilities (including during pre-inspection, inspection execution, post.... Sec. 2. Establishment of the Chemical Facility Safety and Security Working Group. (a) There is established a Chemical Facility Safety and Security Working Group (Working Group) co-chaired by the Secretary...

  5. Laboratory Safety in the Biology Lab.

    ERIC Educational Resources Information Center

    Ritch, Donna; Rank, Jane

    2001-01-01

    Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

  6. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea.

    PubMed

    Park, Sang Hyoung; Kim, Young-Ho; Lee, Ji Hyun; Kwon, Hyeok Jin; Lee, Suck-Ho; Park, Dong Il; Kim, Hyung Kil; Cheon, Jae Hee; Im, Jong Pil; Kim, You Sun; Lee, Sung Young; Lee, Sang Joon

    2015-01-01

    To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea. This post-marketing study included patients with active moderate-to-severe Crohn's disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission. No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not. CT-P13 was well tolerated and efficacious in patients with IBD.

  7. Safety assurance and compliance program (SACP) : accomplishments for CY 2001

    DOT National Transportation Integrated Search

    2002-08-01

    This recent research report by the Federal Railroad Administration (FRA), posted online, provides ease of access to information on the Safety Assurance and Compliance Program. The FRA promotes and helps ensure the safety of the nation's railroad indu...

  8. Monitoring food safety violation reports from internet forums.

    PubMed

    Kate, Kiran; Negi, Sumit; Kalagnanam, Jayant

    2014-01-01

    Food-borne illness is a growing public health concern in the world. Government bodies, which regulate and monitor the state of food safety, solicit citizen feedback about food hygiene practices followed by food establishments. They use traditional channels like call center, e-mail for such feedback collection. With the growing popularity of Web 2.0 and social media, citizens often post such feedback on internet forums, message boards etc. The system proposed in this paper applies text mining techniques to identify and mine such food safety complaints posted by citizens on web data sources thereby enabling the government agencies to gather more information about the state of food safety. In this paper, we discuss the architecture of our system and the text mining methods used. We also present results which demonstrate the effectiveness of this system in a real-world deployment.

  9. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  10. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  11. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  12. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  13. Post-arrest therapeutic hypothermia in pediatric patients with congenital heart disease.

    PubMed

    Cheng, Henry H; Rajagopal, Satish K; Sansevere, Arnold J; McDavitt, Erica; Wigmore, Daniel; Mecklosky, Jessica; Andren, Kristofer; Williams, Kathryn A; Danehy, Amy; Soul, Janet S

    2018-05-01

    While therapeutic hypothermia (TH) is an effective neuroprotective therapy for neonatal hypoxic-ischemic encephalopathy, TH has not been demonstrated to improve outcome in other pediatric populations. Patients with acquired or congenital heart disease (CHD) are at high risk of both cardiac arrest and neurodevelopmental impairments, and therapies are needed to improve neurologic outcome. The primary goal of our study was to compare safety/efficacy outcomes in post-arrest CHD patients treated with TH versus controls not treated with TH. Patients with CHD treated during the first 18 months after initiation of a post-arrest TH protocol (temperature goal: 33.5 °C) were compared to historical and contemporary post-arrest controls not treated with TH. Post-arrest data, including temperature, safety measures (e.g. arrhythmia, bleeding), neurodiagnostic data (EEG, neuroimaging), and survival were compared. Thirty arrest episodes treated with TH and 51 control arrest episodes were included. The groups did not differ in age, duration of arrest, post-arrest lactate, or use of ECMO-CPR. The TH group's post-arrest temperature was significantly lower than control's (33.6 ± 0.2 °C vs 34.7 ± 0.5 °C, p < 0.001). There was no difference between the groups in safety/efficacy measures, including arrhythmia, infections, chest-tube output, or neuroimaging abnormalities, nor in hospital survival (TH 61.5% vs control 59.1%, p = NS). Significantly more controls had seizures than TH patients (26.1% vs. 4.0%, p = 0.04). Almost all seizures were subclinical and occurred more than 24 h post-arrest. Our data show that pediatric CHD patients who suffer cardiac arrest can be treated effectively and safely with TH, which may decrease the incidence of seizures. Copyright © 2018 Elsevier B.V. All rights reserved.

  14. An assessment of drinking-water quality post-Haiyan.

    PubMed

    Magtibay, Bonifacio; Anarna, Maria Sonabel; Fernando, Arturo

    2015-01-01

    Access to safe drinking-water is one of the most important public health concerns in an emergency setting. This descriptive study reports on an assessment of water quality in drinking-water supply systems in areas affected by Typhoon Haiyan immediately following and 10 months after the typhoon. Water quality testing and risk assessments of the drinking-water systems were conducted three weeks and 10 months post-Haiyan. Portable test kits were used to determine the presence of Escherichia coli and the level of residual chlorine in water samples. The level of risk was fed back to the water operators for their action. Of the 121 water samples collected three weeks post-Haiyan, 44% were contaminated, while 65% (244/373) of samples were found positive for E. coli 10 months post-Haiyan. For the three components of drinking-water systems - source, storage and distribution - the proportions of contaminated systems were 70%, 67% and 57%, respectively, 10 months after Haiyan. Vulnerability to faecal contamination was attributed to weak water safety programmes in the drinking-water supply systems. Poor water quality can be prevented or reduced by developing and implementing a water safety plan for the systems. This, in turn, will help prevent waterborne disease outbreaks caused by contaminated water post-disaster.

  15. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  16. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 7 2014-10-01 2014-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  17. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 7 2013-10-01 2013-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  18. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  19. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority... 49 Transportation 7 2010-10-01 2010-10-01 false Delegation to the Directors of Office of Aviation...

  20. Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

    PubMed

    Furlan, Giovanni

    2012-08-01

    Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

  1. Procedure-Authoring Tool Improves Safety on Oil Rigs

    NASA Technical Reports Server (NTRS)

    2014-01-01

    Dark, cold, and dangerous environments are plentiful in space and on Earth. To ensure safe operations in difficult surroundings, NASA relies heavily on procedures written well ahead of time. Houston-based TRACLabs Inc. worked with Ames Research Center through the SBIR program to create an electronic procedure authoring tool, now used by NASA and companies in the oil and gas industry.

  2. ASAP Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    2004-01-01

    This is the First Quarterly Report for the newly reconstituted Aerospace Safety Advisory Panel (ASAP). The NASA Administrator rechartered the Panel on November 18,2003, to provide an independent, vigilant, and long-term oversight of NASA's safety policies and programs well beyond Return to Flight of the Space Shuttle. The charter was revised to be consistent with the original intent of Congress in enacting the statute establishing ASAP in 1967 to focus on NASA's safety and quality systems, including industrial and systems safety, risk-management and trend analysis, and the management of these activities.The charter also was revised to provide more timely feedback to NASA by requiring quarterly rather than annual reports, and by requiring ASAP to perform special assessments with immediate feedback to NASA. ASAP was positioned to help institutionalize the safety culture of NASA in the post- Stafford-Covey Return to Flight environment.

  3. 47 CFR 95.101 - What the license authorizes.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false What the license authorizes. 95.101 Section 95.101 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES General Mobile Radio Service (GMRS) § 95.101 What the license authorizes. (a) A...

  4. 47 CFR 95.101 - What the license authorizes.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false What the license authorizes. 95.101 Section 95.101 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES General Mobile Radio Service (GMRS) § 95.101 What the license authorizes. (a) A...

  5. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  6. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  7. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  8. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  9. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  10. Post-PharmD Industry Fellowship Opportunities and Proposed Guidelines for Uniformity

    PubMed Central

    Larochelle, Paul A.; Giang, Dan K.; Silva, Matthew A.; Kcomt, Marisol; Malloy, Michael J.; Kay, Stephen

    2009-01-01

    The focus of this paper is to examine the surge in the development of post-PharmD industry fellowships (ie, pharmacy fellowship programs sponsored by the biopharmaceutical or pharmaceutical industry). These post-PharmD training programs do not fit the currently accepted definition of a pharmacy fellowship; therefore, the authors propose a new and distinct definition to encompass these fellowships. The authors provide program examples to showcase the establishment of the post-PharmD industry fellowship institutional centers. Finally, the authors provide recommendations to create uniformity in the programs of this relatively new category of post-PharmD training. PMID:19513158

  11. Safety analysis of long-term budesonide nasal irrigations in patients with chronic rhinosinusitis post endoscopic sinus surgery.

    PubMed

    Soudry, Ethan; Wang, Jane; Vaezeafshar, Reza; Katznelson, Laurence; Hwang, Peter H

    2016-06-01

    Although the safety of topical nasal steroids is well established for nasal spray forms, data regarding the safety of steroid irrigations is limited. We studied the effect of long-term budesonide nasal irrigations (>6 months) on hypothalamic-pituitary-adrenal axis (HPAA) function and intraocular pressure (IOP) in patients post-endoscopic sinus surgery. This was retrospective case series. Adrenal function was assessed by using the high-dose cosyntropin stimulation test. A total of 48 patients were assessed, with a mean duration of budesonide irrigations of 22 months. Stimulated cortisol levels were abnormally low in 11 patients (23%). None reported to have symptoms of adrenal suppression. Three of 4 patients who repeated the study being off budesonide for at least 1 month returned to near normal levels. Logistic regression analysis revealed that concomitant use of both nasal steroid sprays and pulmonary steroid inhalers was significantly associated with HPAA suppression (p = 0.024). Patients with low stimulated cortisol levels were able to continue budesonide irrigations under the supervision of an endocrinologist without frank clinical manifestations of adrenal insufficiency. IOP was within normal limits in all patients. Long-term use of budesonide nasal irrigations is generally safe, but asymptomatic HPAA suppression may occur in selected patients. Concomitant use of both nasal steroid sprays and pulmonary steroid inhalers while using daily budesonide nasal irrigations is associated with an increased risk. Rhinologists should be alerted to the potential risks of long-term use of budesonide nasal irrigations, and monitoring for HPAA suppression may be warranted in patients receiving long-term budesonide irrigation therapy. © 2016 ARS-AAOA, LLC.

  12. Multimodal impairment-based physical therapy for the treatment of patients with post-concussion syndrome: A retrospective analysis on safety and feasibility.

    PubMed

    Grabowski, Patrick; Wilson, John; Walker, Alyssa; Enz, Dan; Wang, Sijian

    2017-01-01

    Demonstrate implementation, safety and feasibility of multimodal, impairment-based physical therapy (PT) combining vestibular/oculomotor and cervical rehabilitation with sub-symptom threshold exercise for the treatment of patients with post-concussion syndrome (PCS). University hospital outpatient sports medicine facility. Twenty-five patients (12-20 years old) meeting World Health Organization criteria for PCS following sport-related concussion referred for supervised PT consisting of sub-symptom cardiovascular exercise, vestibular/oculomotor and cervical spine rehabilitation. Retrospective cohort. Post-Concussion Symptom Scale (PCSS) total score, maximum symptom-free heart rate (SFHR) during graded exercise testing (GXT), GXT duration, balance error scoring system (BESS) score, and number of adverse events. Patients demonstrated a statistically significant decreasing trend (p < 0.01) for total PCSS scores (pre-PT M = 18.2 (SD = 14.2), post-PT M = 9.1 (SD = 10.8), n = 25). Maximum SFHR achieved on GXT increased 23% (p < 0.01, n = 14), and BESS errors decreased 52% (p < 0.01, n = 13). Two patients reported mild symptom exacerbation with aerobic exercise at home, attenuated by adjustment of the home exercise program. Multimodal, impairment-based PT is safe and associated with diminishing PCS symptoms. This establishes feasibility for future clinical trials to determine viable treatment approaches to reduce symptoms and improve function while avoiding negative repercussions of physical inactivity and premature return to full activity. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. 12 CFR 1777.2 - Preservation of other authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Preservation of other authority. 1777.2 Section 1777.2 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE OVERSIGHT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS PROMPT CORRECTIVE ACTION § 1777.2 Preservation of other authority...

  14. Comparison of amateur boxing before and after the 2013 rules change and the impact on boxers' safety.

    PubMed

    Davis, Philip; Waldock, Robert; Connorton, Andrew; Driver, Sonny; Anderson, Sean

    2018-06-01

    The effect of the rules change in 2013 on amateur boxing strategy, technique and safety in comparison with pre-2013 is unknown. Pre-2013 and post-2013 3×3 min elite level amateur boxing was compared from video footage of 29 Olympic (pre-2013) and 50 World Championship bouts (post-2013) totalling 99 male boxers (mean±SD) age: 24.3±3.2 years, height: 177.3±11.3 cm and body mass: 70.7±16.4 kg. Many techniques that were dominant pre-2013 were used less post-2013, including: total punches thrown, rear hand punches, hook rear hand, punches landed, uppercut punches, total punches to the body (all <0.05), while movement around the ring and defensive movements were higher post-2013 (both p<0.004). Post-2013 boxers have increased their foot movement by 20% to move in and then away from their opponent, combined with long-range punches and deliberate defensive movements. The percentage of rounds where standing counts were issued changed from 9% to 3% pre-2013 to post-2013. However, pre-2013, 1.7% of bouts did not last the full duration due to referee stoppage, while post-2013, this increased to 4.2% as a result of two knockouts and eight technical knockouts. Boxers should be aware of the large changes in technical demands of boxing. An increased risk of concussive or traumatic brain injury post-2013 is equivocal. However, an increase in skin splits and technical knockouts is apparent. It is likely that boxers believe head guard removal has made them more prone to knockouts. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

    MedlinePlus

    ... Information and Adverse Event Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share ... use. [Posted 06/01/2018] More What's New FDA Approved Safety Information DailyMed (National Library of Medicine) ...

  16. 48 CFR 752.7029 - Post privileges.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... (JUL 1993) (a) Routine health room services may be available, subject to post policy, to U.S. citizen contractors and their authorized dependents (regardless of citizenship) at the post of duty. These services do not include hospitalization, or predeparture or end of tour medical examinations. The services...

  17. 48 CFR 752.7029 - Post privileges.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (JUL 1993) (a) Routine health room services may be available, subject to post policy, to U.S. citizen contractors and their authorized dependents (regardless of citizenship) at the post of duty. These services do not include hospitalization, or predeparture or end of tour medical examinations. The services...

  18. 48 CFR 752.7029 - Post privileges.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (JUL 1993) (a) Routine health room services may be available, subject to post policy, to U.S. citizen contractors and their authorized dependents (regardless of citizenship) at the post of duty. These services do not include hospitalization, or predeparture or end of tour medical examinations. The services...

  19. 48 CFR 752.7029 - Post privileges.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... (JUL 1993) (a) Routine health room services may be available, subject to post policy, to U.S. citizen contractors and their authorized dependents (regardless of citizenship) at the post of duty. These services do not include hospitalization, or predeparture or end of tour medical examinations. The services...

  20. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND...

  1. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND...

  2. The effects of organizational commitment and structural empowerment on patient safety culture.

    PubMed

    Horwitz, Sujin K; Horwitz, Irwin B

    2017-03-20

    Purpose The purpose of this paper is to investigate the relationship between patient safety culture and two attitudinal constructs: affective organizational commitment and structural empowerment. In doing so, the main and interaction effects of the two constructs on the perception of patient safety culture were assessed using a cohort of physicians. Design/methodology/approach Affective commitment was measured with the Organizational Commitment Questionnaire, whereas structural empowerment was assessed with the Conditions of Work Effectiveness Questionnaire-II. The abbreviated versions of these surveys were administered to a cohort of 71 post-doctoral medical residents. For the data analysis, hierarchical regression analyses were performed for the main and interaction effects of affective commitment and structural empowerment on the perception of patient safety culture. Findings A total of 63 surveys were analyzed. The results revealed that both affective commitment and structural empowerment were positively related to patient safety culture. A potential interaction effect of the two attitudinal constructs on patient safety culture was tested but no such effect was detected. Research limitations/implications This study suggests that there are potential benefits of promoting affective commitment and structural empowerment for patient safety culture in health care organizations. By identifying the positive associations between the two constructs and patient safety culture, this study provides additional empirical support for Kanter's theoretical tenet that structural and organizational support together helps to shape the perceptions of patient safety culture. Originality/value Despite the wide recognition of employee empowerment and commitment in organizational research, there has still been a paucity of empirical studies specifically assessing their effects on patient safety culture in health care organizations. To the authors' knowledge, this study is the first

  3. Safety, efficacy and immunogenicity evaluation of the SAG2 oral rabies vaccine in Formosan ferret badgers

    PubMed Central

    Hsu, Ai-Ping; Tseng, Chun-Hsien; Barrat, Jacques; Lee, Shu-Hwae; Shih, Yu-Hua; Wasniewski, Marine; Mähl, Philippe; Chang, Chia-Chia; Lin, Chun-Ta; Chen, Re-Shang; Tu, Wen-Jane; Cliquet, Florence

    2017-01-01

    Since 2013, rabies cases have been reported among Formosan ferret badgers in Taiwan, and they have been shown to be the major reservoirs for Taiwanese enzootics. To control and eradicate rabies, the authorities plan to implement a vaccination programme. Before distributing live vaccines in the field, this study assessed the safety, efficacy, and immunogenicity of SAG2 vaccine on ferret badgers by direct oral instillation. After application of 109 TCID50/dose, no virus was excreted into the oral cavity 1–7 days post-application, and safety was also satisfactorily verified over a 266-day period. Moreover, despite the low level of rabies virus neutralising antibodies induced after vaccination of a 108 TCID50/dose, the efficacy assessment revealed a 100% survival rate (15/15) of vaccinees and an 87.5% fatality rate (7/8) in control animals after a challenge on the 198th day post-vaccination. The immunisation and protection rates obtained more than 6 months after a single vaccination dose demonstrated that SAG2 is an ideal vaccine candidate to protect Formosan ferret badgers against rabies in Taiwan. PMID:28977009

  4. Post-event debriefings during neonatal care: why are we not doing them, and how can we start?

    PubMed

    Sawyer, T; Loren, D; Halamek, L P

    2016-06-01

    Post-event debriefings are a foundational behavior of high performing teams. Despite the inherent value of post-event debriefings, the frequency with which they are used in neonatal care is extremely low. If post-event debriefings are so beneficial, why aren't they conducted more frequently? The reasons are many, but solutions are available. In this report, we provide practical advice on conducting post-event debriefing in neonatal care. In addition, we examine the perceived barriers to conducting post-event debriefings, and offer strategies to overcome them. Finally, we consider opportunities to foster a culture change within neonatal care which integrates debriefing as standard daily work. By establishing a safety culture in neonatal care that encourages and facilitates effective post-event debriefings, patient safety can be enhanced and clinical outcomes can be improved.

  5. Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

    PubMed Central

    Terao, Takeshi; Ishida, Atsuko; Kimura, Toshifumi; Yoshida, Mitsuhiro; Hara, Terufumi

    2017-01-01

    Background A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). Patients and methods Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation. Results A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment. Conclusion The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. PMID:28652744

  6. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of the...

  7. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of the...

  8. Measurement and monitoring of safety: impact and challenges of putting a conceptual framework into practice.

    PubMed

    Chatburn, Eleanor; Macrae, Carl; Carthey, Jane; Vincent, Charles

    2018-03-06

    The Measurement and Monitoring of Safety Framework provides a conceptual model to guide organisations in assessing safety. The Health Foundation funded a large-scale programme to assess the value and impact of applying the Framework in regional and frontline care settings. We explored the experiences and reflections of key participants in the programme. The study was conducted in the nine healthcare organisations in England and Scotland testing the Framework (three regional improvement bodies, six frontline settings). Post hoc interviews with clinical and managerial staff were analysed using template analysis. Participants reported that the Framework promoted a substantial shift in their thinking about how safety is actively managed in their environment. It provided a common language, facilitated a more inquisitive approach and encouraged a more holistic view of the components of safety. These changes in conceptual understanding, however, did not always translate into broader changes in practice, with many sites only addressing some aspects of the Framework. One of the three regions did embrace the Framework in its entirety and achieved wider impact with a range of interventions. This region had committed leaders who took time to fully understand the concepts, who maintained a flexible approach to exploring the utility of the Framework and who worked with frontline staff to translate the concepts for local settings. The Measuring and Monitoring of Safety Framework has the potential to support a broader and richer approach to organisational safety. Such a conceptually based initiative requires both committed leaders who themselves understand the concepts and more time to establish understanding and aims than might be needed in a standard improvement programme. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  9. Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons.

    PubMed

    Li, Rongxia; Stewart, Brock; McNeil, Michael M; Duffy, Jonathan; Nelson, Jennifer; Kawai, Alison Tse; Baxter, Roger; Belongia, Edward A; Weintraub, Eric

    2016-08-01

    The changes in each year in influenza vaccine antigenic components as well as vaccine administration patterns may pose new risks of adverse events following immunization (AEs). To evaluate the safety of influenza vaccines annually administered to people ≥ 6 months, we conducted weekly post licensure surveillance for seven pre-specified adverse events following receipt of influenza vaccines during the 2013-2014 and 2014-2015 seasons in the Vaccine Safety Datalink (VSD). We used both a historically-controlled cohort design with the Poisson-based maximized sequential probability ratio test (maxSPRT) and a self-controlled risk interval (SCRI) design with the binomial-based maxSPRT. For each adverse event outcome, we defined the risk interval on the basis of biologic plausibility and prior literature. For the historical cohort design, numbers of expected adverse events were calculated from the prior seven seasons, adjusted for age and site. For the SCRI design, a comparison window was defined either before vaccination or after vaccination, depending on each specific outcome. An elevated risk of febrile seizures 0-1 days following trivalent inactivated influenza vaccine (IIV3) was identified in children aged 6-23 months during the 2014-2015 season using the SCRI design. We found the relative risk (RR) of febrile seizures following concomitant administration of IIV3 and PCV13 was 5.3 with a 95% CI 1.87-14.75. Without concomitant PCV 13 administration, the estimated risk decreased and was no longer statistically significant (RR: 1.4; CI: 0.54 - 3.61). No increased risks, other than for febrile seizures, were identified in influenza vaccine safety surveillance during 2013-2014 and 2014-2015 seasons in the VSD. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  10. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

    PubMed

    Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi

    2018-03-01

    Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with

  11. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination.

    PubMed

    Díez-Domingo, Javier; Baldó, José-María; Planelles-Catarino, Maria Victoria; Garcés-Sánchez, María; Ubeda, Isabel; Jubert-Rosich, Angels; Marès, Josep; Garcia-Corbeira, Pilar; Moris, Philippe; Teko, Maurice; Vanden Abeele, Carline; Gillard, Paul

    2015-03-01

    An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3-9 years. In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3-9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03A or AS03B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4(+) T cells with a TH 1 profile were observed. Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination. © 2014 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

  12. [Research progress in post-fire debris flow].

    PubMed

    Di, Xue-ying; Tao, Yu-zhu

    2013-08-01

    The occurrence of the secondary disasters of forest fire has significant impacts on the environment quality and human health and safety. Post-fire debris flow is one of the most hazardous secondary disasters of forest fire. To understand the occurrence conditions of post-fire debris flow and to master its occurrence situation are the critical elements in post-fire hazard assessment. From the viewpoints of vegetation, precipitation threshold and debris flow material sources, this paper elaborated the impacts of forest fire on the debris flow, analyzed the geologic and geomorphic conditions, precipitation and slope condition that caused the post-fire debris flow as well as the primary mechanisms of debris-flow initiation caused by shallow landslide or surface runoff, and reviewed the research progress in the prediction and forecast of post-fire debris flow and the related control measures. In the future research, four aspects to be focused on were proposed, i. e., the quantification of the relationships between the fire behaviors and environmental factors and the post-fire debris flow, the quantitative research on the post-fire debris flow initiation and movement processes, the mechanistic model of post-fire debris flow, and the rapid and efficient control countermeasures of post-fire debris flow.

  13. Safety and health concerns in forestry operations

    Treesearch

    Robert B. Rummer

    1997-01-01

    The author discusses several safety models, including the "Three E?s": engineering, education, and enforcement; the Heinrich-Lateiner model; the organizational model; and the behavioral safety model. Rummer encourages approaching safety from a broader perspective, enabling the industry to track changes in all aspects and to keep leading the safety target....

  14. Post market surveillance in the german medical device sector - current state and future perspectives.

    PubMed

    Zippel, Claus; Bohnet-Joschko, Sabine

    2017-08-01

    Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. 77 FR 67342 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... Network Authority Board Meeting AGENCY: National Telecommunications and Information Administration, U.S... Responder Network Authority (FirstNet). DATES: The meetings will be held on December 11, 2012; April 23... safety broadband network. The FirstNet Board is responsible for making strategic decisions regarding...

  16. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials.

    PubMed

    Schoenfeld, P; Pimentel, M; Chang, L; Lembo, A; Chey, W D; Yu, J; Paterson, C; Bortey, E; Forbes, W P

    2014-05-01

    The efficacy of rifaximin, a nonsystemic, gut-targeted antibiotic for reducing non-constipation-predominant irritable bowel syndrome (non-C IBS) symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, double-blind, placebo-controlled trials, but detailed data about rifaximin safety and tolerability during treatment and subsequent follow-up periods are lacking. To assess and determine the frequency of rifaximin and placebo adverse events (AEs) in phase 2b and phase 3 non-C IBS trials. A post hoc pooled safety analysis of the phase 2b (rifaximin 275, 550, and 1100 mg twice daily for 2 weeks; 550 mg twice daily for 4 weeks) and phase 3 (rifaximin 550 mg three times daily for 2 weeks) studies was performed. Data on treatment and post-treatment AEs were collected. Patients were followed up for 12 weeks and 10 weeks post-treatment in the phase 2b and phase 3 trials, respectively. Patients receiving rifaximin (n = 1103) and placebo (n = 829) had a similar incidence of drug-related AEs (12.1% vs. 10.7%), serious AEs (1.5% vs. 2.2%), drug-related AEs resulting in study discontinuation (0.8% vs. 0.8%), gastrointestinal-associated AEs (12.2% vs. 12.2%) and infection-associated AEs (8.5% vs. 9.5%). There were no cases of Clostridium difficile colitis or deaths. The safety and tolerability profile of rifaximin during treatment and post-treatment was comparable to placebo. Future research should define the safety and tolerability profile, including risk of C. difficile colitis and microbial antibiotic resistance, with repeated courses of rifaximin in patients with non-constipation-predominant irritable bowel syndrome (ClinicalTrials.gov: NCT00269412, NCT00731679, and NCT00724126). © 2014 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

  17. 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.

  18. An assessment of drinking-water quality post-Haiyan

    PubMed Central

    Anarna, Maria Sonabel; Fernando, Arturo

    2015-01-01

    Introduction Access to safe drinking-water is one of the most important public health concerns in an emergency setting. This descriptive study reports on an assessment of water quality in drinking-water supply systems in areas affected by Typhoon Haiyan immediately following and 10 months after the typhoon. Methods Water quality testing and risk assessments of the drinking-water systems were conducted three weeks and 10 months post-Haiyan. Portable test kits were used to determine the presence of Escherichia coli and the level of residual chlorine in water samples. The level of risk was fed back to the water operators for their action. Results Of the 121 water samples collected three weeks post-Haiyan, 44% were contaminated, while 65% (244/373) of samples were found positive for E. coli 10 months post-Haiyan. For the three components of drinking-water systems – source, storage and distribution – the proportions of contaminated systems were 70%, 67% and 57%, respectively, 10 months after Haiyan. Discussion Vulnerability to faecal contamination was attributed to weak water safety programmes in the drinking-water supply systems. Poor water quality can be prevented or reduced by developing and implementing a water safety plan for the systems. This, in turn, will help prevent waterborne disease outbreaks caused by contaminated water post-disaster. PMID:26767136

  19. 14 CFR 431.33 - Safety organization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety organization. 431.33 Section 431.33... Launch and Reentry of a Reusable Launch Vehicle § 431.33 Safety organization. (a) An applicant shall maintain a safety organization and document it by identifying lines of communication and approval authority...

  20. Effect of safety education on knowledge of and compliance with road safety signs among commercial motorcyclists in Uyo, Southern Nigeria.

    PubMed

    Johnson, O E; Adebayo, A M

    2011-09-01

    Compliance with road safety signs is important in the reduction of motorcycle accidents. The aim of this study was to implement health education intervention and assess its impact on the knowledge of and compliance with road safety signs among commercial motorcyclists in Uyo, Southern Nigeria. This was an intervention study among motorcyclists in Uyo, Southern Nigeria, with a control group from a similar town. The instrument of data collection was a semi-structured interviewer administered questionnaire. Subjects were selected through multistage sampling method. Baseline data on compliance to road safety signs was collected from both groups. Motorcyclists in the intervention group were given education on the importance of compliance to road safety signs. Data was subsequently collected from both groups 3 months post intervention and analysed using the Statistical Package for the Social Sciences version 11. A total of 200 respondents participated in the study, 100 from each group. Following intervention, respondents with good knowledge score increased from 21% at baseline to 82% at 3 months post intervention in the intervention group (p<0.05) and from 19% to 21% in the control group. Compliance score in the intervention group increased from 15% to 70% (p<0.05) and from 12% to 18% in the control group. A significant increase in compliance to road safety signs was recorded among motorcyclists in the intervention group after safety education. All motorcyclists should therefore be given education on road safety signs as this will improve compliance and lead to safer road use among them.

  1. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  2. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  3. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  4. Post-marketing safety surveillance conducted in Korea (2008–2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™)

    PubMed Central

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-01-01

    ABSTRACT Purpose: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). Methods: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. Results: A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. Conclusions: We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice. PMID:27494163

  5. [Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

    PubMed

    Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings.

  6. 47 CFR 80.407 - Operator authorization.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... rules pertinent to the application for and posting of radio operator authorizations. Rules applicable to... commercial radio operators are contained in part 13 of this chapter. (a) Application. Detailed information about application forms, filing procedures, and places to file applications for radio operator...

  7. Efficacy and Safety of Roflumilast in Korean Patients with COPD

    PubMed Central

    Lee, Jae Seung; Hong, Yoon Ki; Park, Tae Sun; Lee, Sei Won; Oh, Yeon-Mok

    2016-01-01

    Purpose Roflumilast is the only oral phosphodiesterase 4 inhibitor approved to treat chronic obstructive pulmonary disease (COPD) patients [post-bronchodilator forced expiratory volume in 1 second (FEV1) <50% predicted] with chronic bronchitis and a history of frequent exacerbations. This study evaluated the efficacy and safety of roflumilast in Korean patients with COPD and compared the efficacy based on the severity of airflow limitation. Materials and Methods A post-hoc subgroup analysis was performed in Korean COPD patients participating in JADE, a 12-week, double-blinded, placebo-controlled, parallel-group, phase III trial in Asia. The primary efficacy endpoint was the mean [least-squares mean adjusted for covariates (LSMean)] change in post-bronchodilator FEV1 from baseline to each post-randomization visit. Safety endpoints included adverse events (AEs) and changes in laboratory values, vital signs, and electrocardiograms. Results A total of 260 Korean COPD patients were recruited, of which 207 were randomized to roflumilast (n=102) or placebo (n=105) treatment. After 12 weeks, LSMean post-bronchodilator FEV1 increased by 43 mL for patients receiving roflumilast and decreased by 60 mL for those taking placebo. Adverse events were more common in the roflumilast group than in the placebo group; however, the types and frequency of AEs were comparable to those reported in previous studies. Conclusion Roflumilast significantly improved lung function with a tolerable safety profile in Korean COPD patients irrespective of the severity of airflow limitation. PMID:27189287

  8. 47 CFR 95.1303 - Authorized locations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized locations. 95.1303 Section 95.1303 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... efforts in order to resolve or mitigate any potential interference problem with the Arecibo Observatory...

  9. 47 CFR 95.1303 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1303 Section 95.1303 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... efforts in order to resolve or mitigate any potential interference problem with the Arecibo Observatory...

  10. 47 CFR 95.1003 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1003 Section 95.1003 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... reasonable efforts in order to resolve or mitigate any potential interference problem with the Arecibo...

  11. 47 CFR 95.1003 - Authorized locations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized locations. 95.1003 Section 95.1003 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... reasonable efforts in order to resolve or mitigate any potential interference problem with the Arecibo...

  12. Safety Education--An Essential Element of Technical Training

    ERIC Educational Resources Information Center

    Glazener, Everett R.; Comstock, Thomas W.

    1978-01-01

    After tracing the background of the safety movement, provisions of recent safety legislation, and the ecological and environmental impact of industrial processes, the author stresses the need for safety education in technical education programs to prepare future employees for industrial safety requirements. (MF)

  13. Feasibility of Virtual Reality Augmented Cycling for Health Promotion of People Post-Stroke

    PubMed Central

    Deutsch, Judith E; Myslinski, Mary Jane; Kafri, Michal; Ranky, Richard; Sivak, Mark; Mavroidis, Constantinos; Lewis, Jeffrey A

    2013-01-01

    Background and Purpose A virtual reality (VR) augmented cycling kit (VRACK) was developed to address motor control and fitness deficits of individuals with chronic stroke. In this paper we report on the safety, feasibility and efficacy of using the VRACK to train cardio-respiratory (CR) fitness of individuals in the chronic phase poststroke. Methods Four individuals with chronic stroke (47–65 years old and three or more years post-stroke), with residual lower extremity impairments (Fugl Meyer 24–26/34) who were limited community ambulators (gait speed range 0.56 to 1.1 m/s) participated in this study. Safety was defined as the absence of adverse events. Feasibility was measured using attendance, total exercise time, and “involvement” measured with the Presence Questionnaire (PQ). Efficacy of CR fitness was evaluated using a sub-maximal bicycle ergometer test before and after an 8-week training program. Results The intervention was safe and feasible with participants having 1 adverse event, 100% adherence, achieving between 90 and 125 minutes of cycling each week and a mean PQ score of 39 (SD 3.3). There was a statistically significant 13% (p = 0.035) improvement in peak VO2 with a range of 6–24.5 %. Discussion and Conclusion For these individuals post-stroke, VR augmented cycling, using their heart rate to set their avatar’s speed, fostered training of sufficient duration and intensity to promote CR fitness. In addition, there was a transfer of training from the bicycle to walking endurance. VR augmented cycling may be an addition to the therapist’s tools for concurrent training of mobility and health promotion of individuals post-stroke. Video Abstract available (see Video, Supplemental Digital Content 1) for more insights from the authors. PMID:23863828

  14. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  15. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  16. Commonwealth of Virginia, Department of Transportation Safety, transportation safety plan for the period July 1, 1981-June 30, 1982.

    DOT National Transportation Integrated Search

    1981-01-01

    Senate Bill 85, passed by the General Assembly in 1978, renamed the Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to participate in the evaluation of current safety measures in all modes of trans...

  17. School Bus Fleet Safety: Planning and Development.

    ERIC Educational Resources Information Center

    Bieber, Robert M.

    1984-01-01

    To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

  18. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...— (i) For offers contingent upon SAFETY Act designation, a pre-qualification designation notice or a block designation; or (ii) For offers contingent upon SAFETY Act certification, a block certification... contingent upon SAFETY Act designation or certification before contract award. 50.205-3 Section 50.205-3...

  19. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants.

    PubMed

    Narang, Anil; Bose, Anuradha; Pandit, Anand Nilkanth; Dutta, Phalguni; Kang, Gagandeep; Bhattacharya, Sujit Kumar; Datta, Sanjoy Kumar; Suryakiran, P V; Delem, Andrée; Han, Htay Htay; Bock, Hans Ludwig

    2009-06-01

    This study was undertaken to assess the immunogenicity, reactogenicity and safety of two doses of an oral live-attenuated human rotavirus vaccine, strain RIX4414 (Rotarix()) in an Indian setting. The seroconversion rate observed one month post-dose 2 in the RIX4414 group 58.3% [95% CI: 48.7; 67.4] was significantly higher when compared to the placebo group 6.3%; [95% CI: 2.5; 12.5]. The reactogenicity and safety profile was similar for both groups. Healthy infants (N = 363), approximately eight weeks of age were enrolled to receive two doses of RIX4414 vaccine (n = 182) or placebo (n = 181) separated by one month. To assess the immune response, blood samples were taken before vaccination and one month post-dose 2 of RIX4414/placebo. Solicited symptoms were collected for eight-days post each dose and safety data was collected throughout the study. Two doses of RIX4414 (Rotarix()) were immunogenic, had a good safety profile and were well-tolerated when administered to healthy Indian infants. ClinicalTrials.gov; NCT00289172; eTrack 103792.

  20. 29 CFR 2201.3 - Delegation of authority and responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Section 2201.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION REGULATIONS IMPLEMENTING THE FREEDOM OF INFORMATION ACT § 2201.3 Delegation of authority and responsibilities. (a) The Chairman delegates to the Chief FOIA Officer the authority to act upon all requests for...

  1. 47 CFR 90.515 - Change or cancellation of authorization without hearing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... hearing. 90.515 Section 90.515 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND... cancellation of authorization without hearing. Every application for authority to engage in developmental... authorization issued pursuant thereto will be accepted with the express understanding of the applicant that it...

  2. Why the European Food Safety Authority was right to reject health claims for probiotics.

    PubMed

    Katan, M B

    2012-06-01

    Probiotics are microbes that are claimed to promote health and well-being when added to foods. However, the European Food Safety Authority (EFSA) has so far advised negatively about health claims for probiotics. Companies and scientists have protested against these rejections, sometimes in vigorous language. I argue that EFSA could not have acted differently, given EU regulations and the lack of convincing evidence for some of the claimed effects of probiotics on human health and well-being. One EU regulation that makes it hard to demonstrate the benefits of probiotics is the prohibition of medical claims, i.e. claims that a food prevents or cures a disease. If this prohibition did not exist, manufacturers of nutritional treatments might circumvent the costly procedures required for drugs, and market their products to ill people without thorough proof that they are effective and safe. However, the prohibition is also a legal fiction, because promotion of health and prevention of disease is largely the same thing. EFSA has recently indicated that it will allow health claims based on the ability of probiotics to reduce infections. To a certain extent, this abolishes the distinction between health claims and medical claims. It remains to be seen if probiotics producers can convince EFSA that their products prevent or cure infections and other diseases in humans.

  3. Breast milk sharing via the internet: the practice and health and safety considerations.

    PubMed

    Keim, Sarah A; McNamara, Kelly A; Jayadeva, Chenali M; Braun, Ashlea C; Dillon, Chelsea E; Geraghty, Sheela R

    2014-08-01

    To characterize the practice of breast milk sharing via the internet in the US and examine factors associated with participants' communication regarding potential health and safety risks. This cross-sectional study examined all original postings (n = 254) placed during 1 week in 2011 on four websites to facilitate the sharing of breast milk. Postings were characterized for intent and health and safety topics (i.e., selling vs. donating milk, hygiene/handling practices, infectious disease screening, diet/exercise habits, substance and pharmaceutical use, milk quality claims, price) communicated between milk providers and recipients. Approximately 69% of postings were providing milk and 31% were seeking milk; 47% included identifiers. Few provider postings reflected measures to potentially reduce risks to recipients: 20% mentioned using a healthy handling/hygiene practice, 11% offered specifics about infectious disease screening, 51% mentioned limiting/abstaining from 1+ substances. The presence of indications about handling/hygiene, diet/exercise, and abstaining from substances were strongly positively associated with each other (ORs 7.42-13.80), with the odds of selling (ORs 6.03-∞), and with making quality claims (ORs 3.14-13.54), but not with disease screening. One-fifth of recipients sought milk for a child with a medical condition or poor birth outcome. Most recipients (90%) did not specify any health and safety practices of a provider in their posting. Health behaviors and screening for diseases that may affect milk safety are not prominent topics in postings seeking to share milk. This lack of communication may exacerbate the health risks to recipient infants, especially infants at increased risk due to pre-existing health conditions.

  4. 41 CFR 302-9.206 - What should I do if there is no port or terminal at my authorized point of origin or authorized...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... there is no port or terminal at my authorized point of origin or authorized destination when I transport... Federal Travel Regulation System RELOCATION ALLOWANCES TRANSPORTATION AND STORAGE OF PROPERTY 9-ALLOWANCES... From a Post of Duty § 302-9.206 What should I do if there is no port or terminal at my authorized point...

  5. Midwest guardrail system (MGS) with an omitted post.

    DOT National Transportation Integrated Search

    2016-02-22

    The objective of this research study was to evaluate the MGS (31 tall W-beam guardrail) with an omitted post according to the safety performance criteria provided in MASH. A single full-scale crash test was conducted with the 2270P pickup truck in...

  6. 7 CFR 1717.304 - State regulatory authority rate jurisdiction.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND....304 State regulatory authority rate jurisdiction. (a) In the event that rate revisions required by the... subpart. (c) In the event that the state regulatory authority shall fail to act favorably upon the...

  7. 7 CFR 1717.304 - State regulatory authority rate jurisdiction.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND....304 State regulatory authority rate jurisdiction. (a) In the event that rate revisions required by the... subpart. (c) In the event that the state regulatory authority shall fail to act favorably upon the...

  8. 7 CFR 1717.304 - State regulatory authority rate jurisdiction.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE POST-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND....304 State regulatory authority rate jurisdiction. (a) In the event that rate revisions required by the... subpart. (c) In the event that the state regulatory authority shall fail to act favorably upon the...

  9. 29 CFR 1954.3 - Exercise of Federal discretionary authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Exercise of Federal discretionary authority. 1954.3 Section 1954.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... § 1954.3 Exercise of Federal discretionary authority. (a)(1) When a State plan is approved under section...

  10. Rutosides for prevention of post-thrombotic syndrome.

    PubMed

    Morling, Joanne R; Yeoh, Su Ern; Kolbach, Dinanda N

    2013-04-30

    Post-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. The current standard care for the prevention of PTS following DVT is elastic compression stockings. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the prevention of post-thrombotic syndrome. To determine the effectiveness and safety of rutosides for prevention of PTS in patients with DVT, compared to placebo, no intervention, or reference medication. The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched October 2012) and CENTRAL (2012, Issue 9). Clinical trials databases were searched for details of ongoing and unpublished studies. We planned to include trials of rutosides versus any alternative (placebo, no intervention, or reference medication) in the prevention of PTS in patients with DVT. Two authors independently assessed studies for inclusion and intended to extract information from the trials. No studies were identified comparing rutosides versus any alternative in the prevention of PTS. As there were no studies identified in this review it is not possible to support the use of rutosides in the prevention of PTS. Some studies suggest that rutosides may provide short-term relief of PTS symptoms. However, there is nothing published on their use as a preventative therapy for PTS. High quality randomised controlled trials of rutoside versus any alternative are required to build the evidence base in this area.

  11. Post-Disaster Safety Net: Instituting Leadership, Economic and Technological Arrangements

    ERIC Educational Resources Information Center

    Akaiso, Darlington

    2013-01-01

    This dissertation will present the findings of an in-depth study conducted on flood victims in Bangkok, Thailand. The objective of this study is to explore the feasibility of using modern technologies as a post-crisis remediation strategy to reconnect displaced families in the aftermath of a disaster. This will include investigating which modern…

  12. [Results of a post-marketing surveillance of meropenem for febrile neutropenia].

    PubMed

    Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

    2015-08-01

    The post-marketing surveillance of meropenem (Meropen) for febrile neutropenia (FN) was conducted between July 2010 and June 2012 to evaluate safety and efficacy under actual clinical use. There were 1191 and 1124 evaluable cases for safety and efficacy respectively, of 1207 case cards collected from 180 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 15.7% (187/1191 cases), and the main ADRs were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic function abnormal, and liver disorder, which were similar to these observed in the clinical study for FN or post marketing surveillances of meropenem conducted before. In efficacy analysis, the overall efficacy was 81.8% (919/1124 cases). Also, it was 79.2% (708/894 cases) for hematological malignancy and 91.8% (213/232 cases) for solid cancer. These results confirmed meropenem (Meropen) is one of the well-tolerated and potent antimicrobial agents for febrile neutropenia.

  13. 47 CFR 95.1109 - Equipment authorization requirement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Section 95.1109 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1109 Equipment authorization requirement. (a) Wireless medical telemetry devices operating under this part must...

  14. Enhancing vaccine safety capacity globally: a lifecycle perspective

    PubMed Central

    Chen, Robert T.; Shimabukuro, Tom T.; Martin, David B.; Zuber, Patrick L.F.; Weibel, Daniel M.; Sturkenboom, Miriam

    2015-01-01

    Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th Century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved in the future to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a “lifecycle” approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle- income countries. PMID:26433922

  15. Improving construction site safety through leader-based verbal safety communication.

    PubMed

    Kines, Pete; Andersen, Lars P S; Spangenberg, Soren; Mikkelsen, Kim L; Dyreborg, Johnny; Zohar, Dov

    2010-10-01

    The construction industry is one of the most injury-prone industries, in which production is usually prioritized over safety in daily on-site communication. Workers have an informal and oral culture of risk, in which safety is rarely openly expressed. This paper tests the effect of increasing leader-based on-site verbal safety communication on the level of safety and safety climate at construction sites. A pre-post intervention-control design with five construction work gangs is carried out. Foremen in two intervention groups are coached and given bi-weekly feedback about their daily verbal safety communications with their workers. Foremen-worker verbal safety exchanges (experience sampling method, n=1,693 interviews), construction site safety level (correct vs. incorrect, n=22,077 single observations), and safety climate (seven dimensions, n=105 questionnaires) are measured over a period of up to 42 weeks. Baseline measurements in the two intervention and three control groups reveal that foremen speak with their workers several times a day. Workers perceive safety as part of their verbal communication with their foremen in only 6-16% of exchanges, and the levels of safety at the sites range from 70-87% (correct observations). Measurements from baseline to follow-up in the two intervention groups reveal that safety communication between foremen and workers increases significantly in one of the groups (factor 7.1 increase), and a significant yet smaller increase is found when the two intervention groups are combined (factor 4.6). Significant increases in the level of safety are seen in both intervention groups (7% and 12% increases, respectively), particularly in regards to 'access ways' and 'railings and coverings' (39% and 84% increases, respectively). Increases in safety climate are seen in only one of the intervention groups with respect to their 'attention to safety.' No significant trend changes are seen in the three control groups on any of the three measures

  16. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    PubMed

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  17. [Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

    PubMed

    Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

    2011-10-01

    As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

  18. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

    PubMed

    Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2018-03-12

    We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P < 0.0001) than at baseline, and levels of the bone turnover markers BAP and TRACP-5b were reduced (-14.64%; P = 0.0009, and - 29.51%; P < 0.0001, respectively). In conclusion, the safety and effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

  19. 78 FR 55064 - First Responder Network Authority Board Special Review Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... Network Authority Board Special Review Committee Meeting AGENCY: National Telecommunications and... Responder Network Authority Special Review Committee. SUMMARY: The First Responder Network Authority (First... nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for making...

  20. A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: results of over 3200 consecutive cases in post-marketing all-patient surveillance.

    PubMed

    Akaza, Hideyuki; Oya, Mototsugu; Iijima, Masafumi; Hyodo, Ichinosuke; Gemma, Akihiko; Itoh, Hiroshi; Adachi, Masatoshi; Okayama, Yutaka; Sunaya, Toshiyuki; Inuyama, Lyo

    2015-10-01

    Real-life safety and efficacy of sorafenib in advanced renal cell carcinoma in a nationwide patient population were evaluated by post-marketing all-patient surveillance. All patients with unresectable or metastatic renal cell carcinoma in Japan who started sorafenib therapy from February 2008 to September 2009 were registered and followed for up to 12 months. Baseline characteristics, treatment status, tumor response, survival and safety data were recorded by the prescribing physicians. Safety and efficacy were evaluated in 3255 and 3171 patients, respectively. The initial daily dose was 800 mg in 78.2% of patients. Median duration of treatment was 6.7 months and the mean relative dose intensity was 68.4%. Overall, 2227 patients (68.4%) discontinued the treatment by 12 months, half of which (52.0% of discontinued patients) were due to adverse events. The most common adverse drug reactions were hand-foot skin reaction (59%), hypertension (36%), rash (25%) and increase in lipase/amylase (23%). The median progression-free survival was 7.3 months (95% confidence intervals: 6.7-8.1), and the overall survival rate at 1 year was 75.4% (73.5-77.1). Prognostic factors for overall survival were mostly consistent with those in previous clinical trials in the univariate analysis and largely similar to those for progression-free survival and duration of treatment in the multivariate analysis. Sorafenib for the treatment of advanced renal cell carcinoma under the labeled dose was feasible in daily medical practice, for its acceptable toxicity profile and favorable clinical benefit that were consistent with those in clinical trials. © The Author 2015. Published by Oxford University Press.

  1. Safety of remifentanil in transsphenoidal surgery: A single-center analysis of 540 patients.

    PubMed

    Cote, David J; Burke, William T; Castlen, Joseph P; King, Chih H; Zaidi, Hasan A; Smith, Timothy R; Laws, Edward R; Aglio, Linda S

    2017-04-01

    Although some studies have examined the efficacy and safety of remifentanil in patients undergoing neurosurgical procedures, none has examined its safety in transsphenoidal operations specifically. In this study, all transsphenoidal operations performed by a single author from 2008 to 2015 were retrospectively reviewed to evaluate the safety of remifentanil in a consecutive series of patients. During the study period, 540 transsphenoidal operations were identified. Of these, 443 (82.0%) patients received remifentanil intra-operatively; 97 (18.0%) did not. The two groups were well-matched with regard to demographic categories, comorbidities, and pre-operative medications (p>0.05), except pre-operative tobacco use (p=0.021). Patients were also well-matched with regard to radiographic features and surgical techniques. Patients who received remifentanil were more likely to harbor a macroadenoma (78.1% vs. 67.0%, p=0.025), and had slightly longer anesthesia time on average (269.2minvs. 239.4min, p=0.024). All pathologic diagnoses were well-matched between the two groups, except that patients receiving remifentanil were more likely to harbor a non-functioning adenoma (46.5% vs. 26.8%, p<0.001). Analysis of post-operative complications showed no significant difference between patients who received remifentanil and those who did not, and length of stay and prevalence of ICU stay did not differ between the two groups. In a well-matched series of 540 patients undergoing transsphenoidal surgery, remifentanil was found to be a safe anesthetic adjunct. There were no significant differences in post-operative hospital course or complications in patients who did and did not receive intra-operative remifentanil. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Another Approach to Enhance Airline Safety: Using Management Safety Tools

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

    2006-01-01

    The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

  3. Thyroidectomy: post-operative care and common complications.

    PubMed

    Furtado, L

    Any surgical procedure involves risks. Thyroid surgery can cause potentially fatal complications during the early post-operative phase. It is essential that nurses have the knowledge and skills to detect early signs and symptoms of potential complications and take appropriate action. Early detection and rapid response are key to maintaining patient safety and minimising harm.

  4. Foremen’s Intervention to Prevent Falls and Increase Safety Communication at Residential Construction Sites

    PubMed Central

    Kaskutas, Vicki; Buckner-Petty, Skye; Dale, Ann Marie; Gaal, John; Evanoff, Bradley A.

    2017-01-01

    Background This research aimed to improve residential construction foremen’s communication skills and safety behaviors of their crewmembers when working at heights. Methods Eighty-four residential construction foremen participated in the 8-hour fall prevention and safety communication training. We compared pre-intervention surveys from foremen and their crewmembers to measure the effect of training. Results Foremen and crewmembers’ ratings showed improvements in fall prevention knowledge, behaviors, and safety communication and were sustained 6-months post-training, with emphasized areas demonstrating larger increases. Ratings were similar between foremen and crewmembers, suggesting that the foremen effectively taught their crew and assigned accurate ratings. Based upon associations between safety behaviors and reported falls observed in prior research, we would expect a 16.6% decrease in the one year cumulative incidence of self-reported falls post-intervention. Conclusions This intervention improved safety knowledge and behaviors of a large number of workers by training construction foremen in fall prevention and safety communication skills. PMID:27345465

  5. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

    PubMed

    Endrikat, J; Schwenke, C; Prince, M R

    2015-07-01

    To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

  6. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.

    PubMed

    Wang, Can; Shi, Qing-Ping; Ding, Feng; Jiang, Xiao-Dong; Tang, Wei; Yu, Mei-Ling; Zhu, Jian-Hua

    2018-01-01

    To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening. This study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening. The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use. Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology

  7. 77 FR 27442 - Recruitment of First Responder Network Authority Board of Directors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... First Responder Network Authority Board of Directors AGENCY: National Telecommunications and Information... First Responder Network Authority (FirstNet). The Act created FirstNet as an independent authority within NTIA that will establish a single nationwide, interoperable public safety broadband network. The...

  8. Validation of a physically based catchment model for application in post-closure radiological safety assessments of deep geological repositories for solid radioactive wastes.

    PubMed

    Thorne, M C; Degnan, P; Ewen, J; Parkin, G

    2000-12-01

    The physically based river catchment modelling system SHETRAN incorporates components representing water flow, sediment transport and radionuclide transport both in solution and bound to sediments. The system has been applied to simulate hypothetical future catchments in the context of post-closure radiological safety assessments of a potential site for a deep geological disposal facility for intermediate and certain low-level radioactive wastes at Sellafield, west Cumbria. In order to have confidence in the application of SHETRAN for this purpose, various blind validation studies have been undertaken. In earlier studies, the validation was undertaken against uncertainty bounds in model output predictions set by the modelling team on the basis of how well they expected the model to perform. However, validation can also be carried out with bounds set on the basis of how well the model is required to perform in order to constitute a useful assessment tool. Herein, such an assessment-based validation exercise is reported. This exercise related to a field plot experiment conducted at Calder Hollow, west Cumbria, in which the migration of strontium and lanthanum in subsurface Quaternary deposits was studied on a length scale of a few metres. Blind predictions of tracer migration were compared with experimental results using bounds set by a small group of assessment experts independent of the modelling team. Overall, the SHETRAN system performed well, failing only two out of seven of the imposed tests. Furthermore, of the five tests that were not failed, three were positively passed even when a pessimistic view was taken as to how measurement errors should be taken into account. It is concluded that the SHETRAN system, which is still being developed further, is a powerful tool for application in post-closure radiological safety assessments.

  9. Post opioid overdose outreach by public health and public safety agencies: Exploration of emerging programs in Massachusetts.

    PubMed

    Formica, Scott W; Apsler, Robert; Wilkins, Lindsay; Ruiz, Sarah; Reilly, Brittni; Walley, Alexander Y

    2018-04-01

    Opioid overdose is a significant public health problem. Collaborative programs between local public health and public safety agencies have emerged to connect overdose survivors and their personal networks with harm reduction and addiction treatment services following a non-fatal overdose event. This study explored the prevalence of these programs in Massachusetts and the different ways they have been structured and function. We sent an online screening questionnaire to police and fire departments in all 351 communities in Massachusetts to find instances in which they collaborated with a community-based public health agency to implement a post-overdose outreach and support program. We conducted telephone interviews with communities that implemented this type of program and categorized programs based on their structure, outreach approach, and other key characteristics. Police and fire personnel from 110 of the 351 communities in Massachusetts (31% response rate) completed the screening survey. Among respondents, 21% (23/110) had implemented a collaborative, community-based, post-overdose program with a well-defined process to connect overdose survivors and their personal networks with support services or addiction treatment services. Using data from the interviews, we identified four types of programs: (1) Multi-Disciplinary Team Visit, (2) Police Visit with Referrals, (3) Clinician Outreach, and (4) Location-Based Outreach. This study represents the first attempt to systematically document an emerging approach intended to connect opioid overdose survivors and their personal networks with harm reduction and addiction treatment services soon after a non-fatal overdose event. These programs have the potential to increase engagement with the social service and addiction treatment systems by those who are at elevated risk for experiencing a fatal opioid overdose. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. Post-marketing surveillance of thrombomodulin alfa, a novel treatment of disseminated intravascular coagulation - safety and efficacy in 1,032 patients with hematologic malignancy.

    PubMed

    Asakura, Hidesaku; Takahashi, Hoyu; Tsuji, Hajime; Matsushita, Tadashi; Ninomiya, Hideyuki; Honda, Goichi; Mimuro, Jun; Eguchi, Yutaka; Kitajima, Isao; Sakata, Yoichi

    2014-03-01

    Post-marketing surveillance of thrombomodulin alfa (TM-α) was performed to evaluate safety and efficacy in patients with disseminated intravascular coagulation (DIC) with hematologic malignancy. All patients treated with TM-α from May 2008 to April 2010 in Japan were included. Information about baseline characteristics, safety, and efficacy were collected. The DIC resolution rate, survival rate on Day 28 after the last TM-α administration, and changes in DIC score and coagulation tests were evaluated. The underlying diseases associated with DIC were acute myeloid leukemia (except for acute promyelocytic leukemia, n=350), lymphoma (n=199), acute promyelocytic leukemia (n=172), acute lymphoblastic leukemia (n=156), myelodysplastic syndromes (n=61), and other (n=94). The incidence rates of bleeding-related adverse events and adverse drug reactions were 17.8% and 4.6%, respectively. In subjects with bleeding symptoms at baseline, 55.0% were assessed as disappeared or improved based on symptoms after TM-α treatment. The DIC resolution and survival rates were 55.9% and 70.7%, respectively. The DIC score and coagulation tests including thrombin-antithrombin complex (TAT) were significantly improved. Coagulation tests were significantly improved after TM-α treatment even in subjects whose clinical course of underlying disease was assessed as unchanged or exacerbated. This surveillance confirmed the safety and efficacy of TM-α in clinical practice, thus TM-α may be an ideal treatment for patients with DIC based upon hematologic malignancy. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. 47 CFR 87.103 - Posting station license.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... records. (b) Aircraft radio stations. The license must be either posted in the aircraft or kept with the aircraft registration certificate. If a single authorization covers a fleet of aircraft, a copy of the license must be either posted in each aircraft or kept with each aircraft registration certificate. (c...

  12. 47 CFR 87.103 - Posting station license.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... records. (b) Aircraft radio stations. The license must be either posted in the aircraft or kept with the aircraft registration certificate. If a single authorization covers a fleet of aircraft, a copy of the license must be either posted in each aircraft or kept with each aircraft registration certificate. (c...

  13. 47 CFR 87.103 - Posting station license.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... records. (b) Aircraft radio stations. The license must be either posted in the aircraft or kept with the aircraft registration certificate. If a single authorization covers a fleet of aircraft, a copy of the license must be either posted in each aircraft or kept with each aircraft registration certificate. (c...

  14. 47 CFR 87.103 - Posting station license.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... records. (b) Aircraft radio stations. The license must be either posted in the aircraft or kept with the aircraft registration certificate. If a single authorization covers a fleet of aircraft, a copy of the license must be either posted in each aircraft or kept with each aircraft registration certificate. (c...

  15. 47 CFR 87.103 - Posting station license.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... records. (b) Aircraft radio stations. The license must be either posted in the aircraft or kept with the aircraft registration certificate. If a single authorization covers a fleet of aircraft, a copy of the license must be either posted in each aircraft or kept with each aircraft registration certificate. (c...

  16. Safety climate in OHSAS 18001-certified organisations: antecedents and consequences of safety behaviour.

    PubMed

    Fernández-Muñiz, Beatriz; Montes-Peón, José Manuel; Vázquez-Ordás, Camilo José

    2012-03-01

    The occupational health and safety standard OHSAS 18001 has gained considerable acceptance worldwide, and firms from diverse sectors and of varying sizes have implemented it. Despite this, very few studies have analysed safety management or the safety climate in OHSAS 18001-certified organisations. The current work aims to analyse the safety climate in these organisations, identify its dimensions, and propose and test a structural equation model that will help determine the antecedents and consequences of employees' safety behaviour. For this purpose, the authors carry out an empirical study using a sample of 131 OHSAS 18001-certified organisations located in Spain. The results show that management's commitment, and particularly communication, have an effect on safety behaviour and on safety performance, employee satisfaction, and firm competitiveness. These findings are particularly important for management since they provide evidence about the factors that should be encouraged to reduce risks and improve performance in this type of organisation. Copyright © 2011 Elsevier Ltd. All rights reserved.

  17. Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer-updated results.

    PubMed

    Kimura, Go; Ueda, Takeshi

    2017-03-01

    A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28-1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18-0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. © The Author 2016. Published by Oxford University Press.

  18. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  19. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  20. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

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