77 FR 5023 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-01

... proposed information collection project: ``Medical Office Survey on Patient Safety Culture Comparative... . SUPPLEMENTARY INFORMATION: Proposed Project Medical Office Survey on Patient Safety Culture Comparative Database... AHRQ Medical Office Survey on Patient Safety Culture (Medical Office SOPS) Comparative Database. The...

76 FR 72929 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... proposed information collection project: ``Medical Office Survey on Patient Safety Culture Comparative... Medical Office Survey on Patient Safety Culture Comparative Database. The Agency for Healthcare Research... Patient Safety Culture (Medical Office SOPS) Comparative Database. The Medical Office SOPS Comparative...

16 CFR § 1102.2 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Background and Definitions § 1102.2 Purpose. This... establishment and maintenance of a Publicly Available Consumer Product Safety Information Database (also referred to as the “Database”) on the safety of consumer products and other products or substances...

16 CFR 1102.2 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Background and Definitions § 1102.2... establishment and maintenance of a Publicly Available Consumer Product Safety Information Database (also referred to as the “Database”) on the safety of consumer products and other products or substances...

76 FR 67732 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-02

... proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative... Nursing Home Survey on Patient Safety Culture Comparative Database The Agency for Healthcare Research and... Culture (Nursing Home SOPS) Comparative Database. The Nursing Home SOPS Comparative Database consists of...

16 CFR 1102.26 - Determination of materially inaccurate information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural... reviewing a report of harm or manufacturer comment, either before or after publication in the Database, may... manufacturer comment, be excluded from the Database or corrected by the Commission because it contains...

16 CFR 1102.26 - Determination of materially inaccurate information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural... reviewing a report of harm or manufacturer comment, either before or after publication in the Database, may... manufacturer comment, be excluded from the Database or corrected by the Commission because it contains...

77 FR 4038 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative...: Proposed Project Nursing Home Survey on Patient Safety Culture Comparative Database The Agency for... Nursing Home Survey on Patient Safety Culture (Nursing Home SOPS) Comparative Database. The Nursing Home...

16 CFR 1102.2 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-01-01

... CONSUMER PRODUCT SAFETY INFORMATION DATABASE Background and Definitions § 1102.2 Purpose. This part sets... maintenance of a Publicly Available Consumer Product Safety Information Database (also referred to as the “Database”) on the safety of consumer products and other products or substances regulated by the Commission. ...

16 CFR 1102.2 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-01-01

... CONSUMER PRODUCT SAFETY INFORMATION DATABASE Background and Definitions § 1102.2 Purpose. This part sets... maintenance of a Publicly Available Consumer Product Safety Information Database (also referred to as the “Database”) on the safety of consumer products and other products or substances regulated by the Commission. ...

16 CFR § 1102.26 - Determination of materially inaccurate information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... PRODUCT SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural... reviewing a report of harm or manufacturer comment, either before or after publication in the Database, may... manufacturer comment, be excluded from the Database or corrected by the Commission because it contains...

16 CFR 1102.26 - Determination of materially inaccurate information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10... publication in the Database, may request that the report of harm or manufacturer comment, or portions of such report of harm or manufacturer comment, be excluded from the Database or corrected by the Commission...

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations

PubMed Central

Kim, Seung Won; Kim, Bae-Hwan

2016-01-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials. PMID:27437094

A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations.

PubMed

Kim, Seung Won; Kim, Bae-Hwan

2016-07-01

Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials.

76 FR 1137 - Publicly Available Consumer Product Safety Information Database: Notice of Public Web Conferences

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

...: Notice of Public Web Conferences AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') is announcing two Web conferences... database (``Database''). The Web conferences will be webcast live from the Commission's headquarters in...

[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.

Quality and Safety in Health Care, Part XXVI: The Adult Cardiac Surgery Database.

PubMed

Harolds, Jay A

2017-09-01

The Adult Cardiac Surgery Database of the Society of Thoracic Surgeons has provided highly useful information in quality and safety in general thoracic surgery, including ratings of the surgeons and institutions participating in this type of surgery. The Adult Cardiac Surgery Database information is very helpful for writing guidelines and determining optimal protocols and for many research projects. This article discusses the history and current status of this database.

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version.

PubMed

Salunke, Smita; Brandys, Barbara; Giacoia, George; Tuleu, Catherine

2013-11-30

The screening and careful selection of excipients is a critical step in paediatric formulation development as certain excipients acceptable in adult formulations, may not be appropriate for paediatric use. While there is extensive toxicity data that could help in better understanding and highlighting the gaps in toxicity studies, the data are often scattered around the information sources and saddled with incompatible data types and formats. This paper is the second in a series that presents the update on the Safety and Toxicity of Excipients for Paediatrics ("STEP") database being developed by Eu-US PFIs, and describes the architecture data fields and functions of the database. The STEP database is a user designed resource that compiles the safety and toxicity data of excipients that is scattered over various sources and presents it in one freely accessible source. Currently, in the pilot database data from over 2000 references/10 excipients presenting preclinical, clinical, regulatory information and toxicological reviews, with references and source links. The STEP database allows searching "FOR" excipients and "BY" excipients. This dual nature of the STEP database, in which toxicity and safety information can be searched in both directions, makes it unique from existing sources. If the pilot is successful, the aim is to increase the number of excipients in the existing database so that a database large enough to be of practical research use will be available. It is anticipated that this source will prove to be a useful platform for data management and data exchange of excipient safety information. Copyright © 2013 Elsevier B.V. All rights reserved.

Database for Safety-Oriented Tracking of Chemicals

NASA Technical Reports Server (NTRS)

Stump, Jacob; Carr, Sandra; Plumlee, Debrah; Slater, Andy; Samson, Thomas M.; Holowaty, Toby L.; Skeete, Darren; Haenz, Mary Alice; Hershman, Scot; Raviprakash, Pushpa

2010-01-01

SafetyChem is a computer program that maintains a relational database for tracking chemicals and associated hazards at Johnson Space Center (JSC) by use of a Web-based graphical user interface. The SafetyChem database is accessible to authorized users via a JSC intranet. All new chemicals pass through a safety office, where information on hazards, required personal protective equipment (PPE), fire-protection warnings, and target organ effects (TOEs) is extracted from material safety data sheets (MSDSs) and recorded in the database. The database facilitates real-time management of inventory with attention to such issues as stability, shelf life, reduction of waste through transfer of unused chemicals to laboratories that need them, quantification of chemical wastes, and identification of chemicals for which disposal is required. Upon searching the database for a chemical, the user receives information on physical properties of the chemical, hazard warnings, required PPE, a link to the MSDS, and references to the applicable International Standards Organization (ISO) 9000 standard work instructions and the applicable job hazard analysis. Also, to reduce the labor hours needed to comply with reporting requirements of the Occupational Safety and Health Administration, the data can be directly exported into the JSC hazardous- materials database.

16 CFR 1102.24 - Designation of confidential information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural... allegedly confidential information is not placed in the database, a request for designation of confidential... publication in the Database until it makes a determination regarding confidential treatment. (e) Assistance...

16 CFR 1102.24 - Designation of confidential information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural... allegedly confidential information is not placed in the database, a request for designation of confidential... publication in the Database until it makes a determination regarding confidential treatment. (e) Assistance...

16 CFR § 1102.30 - Publication of manufacturer comments.

Code of Federal Regulations, 2013 CFR

2013-01-01

... SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural....26, the Commission will publish in the Database manufacturer comments submitted in response to a...

78 FR 73540 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

... proposed information collection project: ``Pharmacy Survey on Patient Safety Culture Comparative Database... Project Pharmacy Survey on Patient Safety Culture Comparative Database In 1999, the Institute of Medicine... approval (OMB NO. 0935-0183; Approved 08/12/2011). The survey is designed to enable pharmacies to assess...

Nonbibliographic Databases in a Corporate Health, Safety, and Environment Organization.

ERIC Educational Resources Information Center

Cubillas, Mary M.

1981-01-01

Summarizes the characteristics of TOXIN, CHEMFILE, and the Product Profile Information System (PPIS), nonbibliographic databases used by Shell Oil Company's Health, Safety, and Environment Organization. (FM)

16 CFR 1102.16 - Additional information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest, consistent...

16 CFR 1102.16 - Additional information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest, consistent...

16 CFR 1102.24 - Designation of confidential information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011... allegedly confidential information is not placed in the database, a request for designation of confidential... publication in the Database until it makes a determination regarding confidential treatment. (e) Assistance...

16 CFR § 1102.16 - Additional information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest, consistent...

16 CFR 1102.16 - Additional information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Content Requirements... notices, the CPSC shall include in the Database any additional information it determines to be in the...

Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databases.

PubMed

Egbring, Marco; Kullak-Ublick, Gerd A; Russmann, Stefan

2010-01-01

To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies. We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This system was applied to a dataset from the UK General Practice Research Database (GPRD). Our solution can be setup and customized with limited programming resources, and there is almost no extra cost for software. Access times are short, the displayed information is structured in chronological order and visually attractive, and selected information such as drug exposure can be blinded. External experts can review patient profiles and save evaluations and comments via a common Web browser. Phynx provides a flexible and economical solution for patient-level review of electronic medical information from databases considering the individual clinical context. It can therefore make an important contribution to an efficient validation of outcome assessment in drug safety database studies.

Development of a conceptual integrated traffic safety problem identification database

DOT National Transportation Integrated Search

1999-12-01

The project conceptualized a traffic safety risk management information system and statistical database for improved problem-driver identification, countermeasure development, and resource allocation. The California Department of Motor Vehicles Drive...

FDA toxicity databases and real-time data entry.

PubMed

Arvidson, Kirk B

2008-11-15

Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.

78 FR 28848 - Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the... for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative... SOPS) Comparative Database; OMB NO. 0935- [[Page 28849

16 CFR 1102.44 - Applicability of sections 6(a) and (b) of the CPSA.

Code of Federal Regulations, 2012 CFR

2012-01-01

... PRODUCT SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Notice and...) in the Database. (b) Limitation on construction. Section 1102.44(a) shall not be construed to exempt...

16 CFR 1102.44 - Applicability of sections 6(a) and (b) of the CPSA.

Code of Federal Regulations, 2014 CFR

2014-01-01

... PRODUCT SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Notice and...) in the Database. (b) Limitation on construction. Section 1102.44(a) shall not be construed to exempt...

ToxReporter: viewing the genome through the eyes of a toxicologist.

PubMed

Gosink, Mark

2016-01-01

One of the many roles of a toxicologist is to determine if an observed adverse event (AE) is related to a previously unrecognized function of a given gene/protein. Towards that end, he or she will search a variety of public and propriety databases for information linking that protein to the observed AE. However, these databases tend to present all available information about a protein, which can be overwhelming, limiting the ability to find information about the specific toxicity being investigated. ToxReporter compiles information from a broad selection of resources and limits display of the information to user-selected areas of interest. ToxReporter is a PERL-based web-application which utilizes a MySQL database to streamline this process by categorizing public and proprietary domain-derived information into predefined safety categories according to a customizable lexicon. Users can view gene information that is 'red-flagged' according to the safety issue under investigation. ToxReporter also uses a scoring system based on relative counts of the red-flags to rank all genes for the amount of information pertaining to each safety issue and to display their scored ranking as an easily interpretable 'Tox-At-A-Glance' chart. Although ToxReporter was originally developed to display safety information, its flexible design could easily be adapted to display disease information as well.Database URL: ToxReporter is freely available at https://github.com/mgosink/ToxReporter. © The Author(s) 2016. Published by Oxford University Press.

16 CFR 1102.44 - Applicability of sections 6(a) and (b) of the CPSA.

Code of Federal Regulations, 2011 CFR

2011-01-01

... PRODUCT SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan... publication in § 1102.10(d) in the Database. (b) Limitation on construction. Section 1102.44(a) shall not be...

16 CFR § 1102.44 - Applicability of sections 6(a) and (b) of the CPSA.

Code of Federal Regulations, 2013 CFR

2013-01-01

... CONSUMER PRODUCT SAFETY ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE... § 1102.10(d) in the Database. (b) Limitation on construction. Section 1102.44(a) shall not be construed...

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

FDA toxicity databases and real-time data entry

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

Arvidson, Kirk B.

Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributedmore » in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared.« less

Consumer Product Category Database

EPA Pesticide Factsheets

The Chemical and Product Categories database (CPCat) catalogs the use of over 40,000 chemicals and their presence in different consumer products. The chemical use information is compiled from multiple sources while product information is gathered from publicly available Material Safety Data Sheets (MSDS). EPA researchers are evaluating the possibility of expanding the database with additional product and use information.

Safety Management Information Statistics (SAMIS) - 1995 Annual Report

DOT National Transportation Integrated Search

1997-04-01

The Safety Management Information Statistics 1995 Annual Report is a compilation and analysis of transit accident, casualty and crime statistics reported under the Federal Transit Administration's National Transit Database Reporting by transit system...

From a Viewpoint of Clinical Settings: Pharmacoepidemiology as Reverse Translational Research (rTR).

PubMed

Kawakami, Junichi

2017-01-01

Clinical pharmacology and pharmacoepidemiology research may converge in practise. Pharmacoepidemiology is the study of pharmacotherapy and risk management in patient groups. For many drugs, adverse reaction(s) that were not seen and/or clarified during research and development stages have been reported in the real world. Pharmacoepidemiology can detect and verify adverse drug reactions as reverse translational research. Recently, development and effective use of medical information databases (MID) have been conducted in Japan and elsewhere for the purpose of post-marketing safety of drugs. The Ministry of Health, Labour and Welfare, Japan has been promoting the development of 10-million scale database in 10 hospitals and hospital groups as "the infrastructure project of medical information database (MID-NET)". This project enables estimation of the frequency of adverse reactions, the distinction between drug-induced reactions and basal health-condition changes, and usefulness verification of administrative measures of drug safety. However, because the database information is different from detailed medical records, construction of methodologies for the detection and evaluation of adverse reactions is required. We have been performing database research using medical information system in some hospitals to establish and demonstrate useful methods for post-marketing safety. In this symposium, we aim to discuss the possibility of reverse translational research from clinical settings and provide an introduction to our research.

The new interactive CESAR

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

Fox, P.B.; Yatabe, M.

1987-01-01

In this report the Nuclear Criticality Safety Analytical Methods Resource Center describes a new interactive version of CESAR, a critical experiments storage and retrieval program available on the Nuclear Criticality Information System (NCIS) database at Lawrence Livermore National Laboratory. The original version of CESAR did not include interactive search capabilities. The CESAR database was developed to provide a convenient, readily accessible means of storing and retrieving code input data for the SCALE Criticality Safety Analytical Sequences and the codes comprising those sequences. The database includes data for both cross section preparation and criticality safety calculations. 3 refs., 1 tab.

JDD, Inc. Database

NASA Technical Reports Server (NTRS)

Miller, David A., Jr.

2004-01-01

JDD Inc, is a maintenance and custodial contracting company whose mission is to provide their clients in the private and government sectors "quality construction, construction management and cleaning services in the most efficient and cost effective manners, (JDD, Inc. Mission Statement)." This company provides facilities support for Fort Riley in Fo,rt Riley, Kansas and the NASA John H. Glenn Research Center at Lewis Field here in Cleveland, Ohio. JDD, Inc. is owned and operated by James Vaughn, who started as painter at NASA Glenn and has been working here for the past seventeen years. This summer I worked under Devan Anderson, who is the safety manager for JDD Inc. in the Logistics and Technical Information Division at Glenn Research Center The LTID provides all transportation, secretarial, security needs and contract management of these various services for the center. As a safety manager, my mentor provides Occupational Health and Safety Occupation (OSHA) compliance to all JDD, Inc. employees and handles all other issues (Environmental Protection Agency issues, workers compensation, safety and health training) involving to job safety. My summer assignment was not as considered "groundbreaking research" like many other summer interns have done in the past, but it is just as important and beneficial to JDD, Inc. I initially created a database using a Microsoft Excel program to classify and categorize data pertaining to numerous safety training certification courses instructed by our safety manager during the course of the fiscal year. This early portion of the database consisted of only data (training field index, employees who were present at these training courses and who was absent) from the training certification courses. Once I completed this phase of the database, I decided to expand the database and add as many dimensions to it as possible. Throughout the last seven weeks, I have been compiling more data from day to day operations and been adding the information to the database. It now consists of seven different categories of data (carpet cleaning, forms, NASA Event Schedules, training certifications, wall and vent cleaning, work schedules, and miscellaneous) . I also did some field inspecting with the supervisors around the site and was present at all of the training certification courses that have been scheduled since June 2004. My future outlook for the JDD, Inc. database is to have all of company s information from future contract proposals, weekly inventory, to employee timesheets all in this same database.

16 CFR 1102.28 - Publication of reports of harm.

Code of Federal Regulations, 2011 CFR

2011-01-01

... REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Procedural..., the Commission will publish reports of harm that meet the requirements for publication in the Database...(d) in the Database beyond the 10-business-day time frame set forth in paragraph (a) of this section...

16 CFR 1102.12 - Manufacturer comments.

Code of Federal Regulations, 2012 CFR

2012-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.12 Manufacturer... Database if such manufacturer comment meets the following requirements: (1) Manufacturer comment relates to... publication in the Database. (2) Unique identifier. A manufacturer comment must state the unique identifier...

16 CFR 1102.12 - Manufacturer comments.

Code of Federal Regulations, 2011 CFR

2011-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Content Requirements... private labeler in the Database if such manufacturer comment meets the following requirements: (1... that is submitted for publication in the Database. (2) Unique identifier. A manufacturer comment must...

16 CFR 1102.12 - Manufacturer comments.

Code of Federal Regulations, 2014 CFR

2014-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.12 Manufacturer... Database if such manufacturer comment meets the following requirements: (1) Manufacturer comment relates to... publication in the Database. (2) Unique identifier. A manufacturer comment must state the unique identifier...

16 CFR 1102.30 - Publication of manufacturer comments.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ACT REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011....24, and 1102.26, the Commission will publish in the Database manufacturer comments submitted in...

Traffic safety information systems international scan : strategy implementation white paper

DOT National Transportation Integrated Search

2006-09-01

Safety data provide the key to making sound decisions on the design and operation of roadways, but deficiencies in many States safety databases do not allow for good decisionmaking. The Federal Highway Administration (FHWA), the American Associati...

16 CFR § 1102.12 - Manufacturer comments.

Code of Federal Regulations, 2013 CFR

2013-01-01

... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.12 Manufacturer... Database if such manufacturer comment meets the following requirements: (1) Manufacturer comment relates to... publication in the Database. (2) Unique identifier. A manufacturer comment must state the unique identifier...

Integrating Data Sources for Process Sustainability ...

EPA Pesticide Factsheets

To perform a chemical process sustainability assessment requires significant data about chemicals, process design specifications, and operating conditions. The required information includes the identity of the chemicals used, the quantities of the chemicals within the context of the sustainability assessment, physical properties of these chemicals, equipment inventory, as well as health, environmental, and safety properties of the chemicals. Much of this data are currently available to the process engineer either from the process design in the chemical process simulation software or online through chemical property and environmental, health, and safety databases. Examples of these databases include the U.S. Environmental Protection Agency’s (USEPA’s) Aggregated Computational Toxicology Resource (ACToR), National Institute for Occupational Safety and Health’s (NIOSH’s) Hazardous Substance Database (HSDB), and National Institute of Standards and Technology’s (NIST’s) Chemistry Webbook. This presentation will provide methods and procedures for extracting chemical identity and flow information from process design tools (such as chemical process simulators) and chemical property information from the online databases. The presentation will also demonstrate acquisition and compilation of the data for use in the EPA’s GREENSCOPE process sustainability analysis tool. This presentation discusses acquisition of data for use in rapid LCI development.

Healthcare databases in Europe for studying medicine use and safety during pregnancy.

PubMed

Charlton, Rachel A; Neville, Amanda J; Jordan, Sue; Pierini, Anna; Damase-Michel, Christine; Klungsøyr, Kari; Andersen, Anne-Marie Nybo; Hansen, Anne Vinkel; Gini, Rosa; Bos, Jens H J; Puccini, Aurora; Hurault-Delarue, Caroline; Brooks, Caroline J; de Jong-van den Berg, Lolkje T W; de Vries, Corinne S

2014-06-01

The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. Eight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. This study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

49 CFR 192.949 - How does an operator notify PHMSA?

Code of Federal Regulations, 2013 CFR

2013-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF... Materials Safety Administration, U.S. Department of Transportation, Information Resources Manager, PHP-10... Management Database (IMDB) Web site at http://primis.rspa.dot.gov/gasimp/. [68 FR 69817, Dec. 15, 2003, as...

49 CFR 192.949 - How does an operator notify PHMSA?

Code of Federal Regulations, 2014 CFR

2014-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF... Materials Safety Administration, U.S. Department of Transportation, Information Resources Manager, PHP-10... Management Database (IMDB) Web site at http://primis.rspa.dot.gov/gasimp/. [68 FR 69817, Dec. 15, 2003, as...

49 CFR 192.949 - How does an operator notify PHMSA?

Code of Federal Regulations, 2012 CFR

2012-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF... Materials Safety Administration, U.S. Department of Transportation, Information Resources Manager, PHP-10... Management Database (IMDB) Web site at http://primis.rspa.dot.gov/gasimp/. [68 FR 69817, Dec. 15, 2003, as...

49 CFR 192.949 - How does an operator notify PHMSA?

Code of Federal Regulations, 2011 CFR

2011-10-01

... MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF... Materials Safety Administration, U.S. Department of Transportation, Information Resources Manager, PHP-10... Management Database (IMDB) Web site at http://primis.rspa.dot.gov/gasimp/. [68 FR 69817, Dec. 15, 2003, as...

Creation of a Natural Health Products Database for Assessing Safety for Patients with Chronic Kidney Disease or Renal Transplant.

PubMed

Leung, Sharon; Shalansky, Karen; Vashisht, Puneet; Leung, Marianna; Marin, Judith G

2017-01-01

There is a lack of published safety information on the use of natural health products (NHPs) for patients with chronic kidney disease (CKD) or renal transplant. To create an online database to provide evidence-based safety recommendations for commonly used NHPs, specific to patients with CKD or renal transplant. NHPs used by CKD and transplant patients in British Columbia were identified from the records of the BC Provincial Renal Agency. For each NHP, several databases (MEDLINE, Embase, Lexi-Natural Products, PubMed Dietary Supplement Subset, and Natural Medicines) were searched for any information pertaining to dosage, adverse drug reactions, drug interactions, immunomodulatory effects, and pharmacokinetics in patients with renal disease. Each NHP was given 1 of 4 safety ratings: likely safe, possibly safe, possibly unsafe, and likely unsafe. An NHP was classified as "possibly unsafe" for patients with renal transplant if it had demonstrated in vitro immunomodulatory effects and/or significant interactions with transplant medications due to effects on the cytochrome P450 3A4 isozyme. Of the 19 627 BC-registered patients with renal disease (as of August 2014), 4122 (21%) were using one or more NHPs. The Herbal-CKD website (www.herbalckd.com) was created in 2015 to provide information about 47 commonly used NHPs and 2 known nephrotoxins (aristolochic acid and silver). This website provides a systematic evaluation of safety information for selected NHPs for patients with CKD (both nondialysis and dialysis-dependent) and kidney transplant. The most common NHP safety classification was "possibly safe", reflecting the paucity of studies in renal populations and the availability of safety data for the general population. Limitations of the website include difficulty in interpreting and generalizing the safety literature because most NHP formulations are not standardized, and others are combination products. The website www.herbalckd.com provides an easy-to-use, evidence-based tool for health care professionals to assess the safety of NHPs for CKD and transplant patients.

16 CFR 1102.28 - Publication of reports of harm.

Code of Federal Regulations, 2012 CFR

2012-01-01

... REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural Requirements § 1102.28... publish reports of harm that meet the requirements for publication in the Database. The Commission will... Commission may publish a report of harm that meets the requirements of § 1102.10(d) in the Database beyond...

16 CFR 1102.28 - Publication of reports of harm.

Code of Federal Regulations, 2014 CFR

2014-01-01

... REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural Requirements § 1102.28... publish reports of harm that meet the requirements for publication in the Database. The Commission will... Commission may publish a report of harm that meets the requirements of § 1102.10(d) in the Database beyond...

ARTI refrigerant database

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

Calm, J.M.

1996-07-01

The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern.

ARTI refrigerant database

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

Calm, J.M.

1996-11-15

The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern.

Information systems in food safety management.

PubMed

McMeekin, T A; Baranyi, J; Bowman, J; Dalgaard, P; Kirk, M; Ross, T; Schmid, S; Zwietering, M H

2006-12-01

Information systems are concerned with data capture, storage, analysis and retrieval. In the context of food safety management they are vital to assist decision making in a short time frame, potentially allowing decisions to be made and practices to be actioned in real time. Databases with information on microorganisms pertinent to the identification of foodborne pathogens, response of microbial populations to the environment and characteristics of foods and processing conditions are the cornerstone of food safety management systems. Such databases find application in: Identifying pathogens in food at the genus or species level using applied systematics in automated ways. Identifying pathogens below the species level by molecular subtyping, an approach successfully applied in epidemiological investigations of foodborne disease and the basis for national surveillance programs. Predictive modelling software, such as the Pathogen Modeling Program and Growth Predictor (that took over the main functions of Food Micromodel) the raw data of which were combined as the genesis of an international web based searchable database (ComBase). Expert systems combining databases on microbial characteristics, food composition and processing information with the resulting "pattern match" indicating problems that may arise from changes in product formulation or processing conditions. Computer software packages to aid the practical application of HACCP and risk assessment and decision trees to bring logical sequences to establishing and modifying food safety management practices. In addition there are many other uses of information systems that benefit food safety more globally, including: Rapid dissemination of information on foodborne disease outbreaks via websites or list servers carrying commentary from many sources, including the press and interest groups, on the reasons for and consequences of foodborne disease incidents. Active surveillance networks allowing rapid dissemination of molecular subtyping information between public health agencies to detect foodborne outbreaks and limit the spread of human disease. Traceability of individual animals or crops from (or before) conception or germination to the consumer as an integral part of food supply chain management. Provision of high quality, online educational packages to food industry personnel otherwise precluded from access to such courses.

The construction FACE database - Codifying the NIOSH FACE reports.

PubMed

Dong, Xiuwen Sue; Largay, Julie A; Wang, Xuanwen; Cain, Chris Trahan; Romano, Nancy

2017-09-01

The National Institute for Occupational Safety and Health (NIOSH) has published reports detailing the results of investigations on selected work-related fatalities through the Fatality Assessment and Control Evaluation (FACE) program since 1982. Information from construction-related FACE reports was coded into the Construction FACE Database (CFD). Use of the CFD was illustrated by analyzing major CFD variables. A total of 768 construction fatalities were included in the CFD. Information on decedents, safety training, use of PPE, and FACE recommendations were coded. Analysis shows that one in five decedents in the CFD died within the first two months on the job; 75% and 43% of reports recommended having safety training or installing protection equipment, respectively. Comprehensive research using FACE reports may improve understanding of work-related fatalities and provide much-needed information on injury prevention. The CFD allows researchers to analyze the FACE reports quantitatively and efficiently. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study.

PubMed

Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji

2017-09-01

Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.

16 CFR § 1102.28 - Publication of reports of harm.

Code of Federal Regulations, 2013 CFR

2013-01-01

... REGULATIONS PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Procedural Requirements § 1102.28... publish reports of harm that meet the requirements for publication in the Database. The Commission will... Commission may publish a report of harm that meets the requirements of § 1102.10(d) in the Database beyond...

Michigan urban trunkline segments safety performance functions (SPFs) : final report.

DOT National Transportation Integrated Search

2016-07-01

This study involves the development of safety performance functions (SPFs) for urban and suburban trunkline segments in the : state of Michigan. Extensive databases were developed through the integration of traffic crash information, traffic volumes,...

49 CFR 800.2 - Organization.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Board's information technology infrastructure, including computer systems, networks, databases, and... with information regarding the Safety Board's activities, programs and objectives; supplies the public, the transportation industry and the news media with current, accurate information concerning the work...

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda

2011-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 900,000 reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 5,500 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides de-identified report information through the online ASRS Database at http://asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation \\vill discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda J.

2017-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study

PubMed Central

2014-01-01

Background Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. Methods In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. Results After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. Conclusion In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most of them could be verified and confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety. PMID:25559675

Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study.

PubMed

Yu, Ke; Zhang, Jie; Chen, Minjun; Xu, Xiaowei; Suzuki, Ayako; Ilic, Katarina; Tong, Weida

2014-01-01

Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most of them could be verified and confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety.

THE ART OF DATA MINING THE MINEFIELDS OF TOXICITY ...

EPA Pesticide Factsheets

Toxicity databases have a special role in predictive toxicology, providing ready access to historical information throughout the workflow of discovery, development, and product safety processes in drug development as well as in review by regulatory agencies. To provide accurate information within a hypothesesbuilding environment, the content of the databases needs to be rigorously modeled using standards and controlled vocabulary. The utilitarian purposes of databases widely vary, ranging from a source for (Q)SAR datasets for modelers to a basis for

The use of a computerized database to monitor vaccine safety in Viet Nam.

PubMed Central

Ali, Mohammad; Canh, Gia Do; Clemens, John D.; Park, Jin-Kyung; von Seidlein, Lorenz; Minh, Tan Truong; Thiem, Dinh Vu; Tho, Huu Le; Trach, Duc Dang

2005-01-01

Health information systems to monitor vaccine safety are used in industrialized countries to detect adverse medical events related to vaccinations or to prove the safety of vaccines. There are no such information systems in the developing world, but they are urgently needed. A large linked database for the monitoring of vaccine-related adverse events has been established in Khanh Hoa province, Viet Nam. Data collected during the first 2 years of surveillance, a period which included a mass measles vaccination campaign, were used to evaluate the system. For this purpose the discharge diagnoses of individuals admitted to polyclinics and hospitals were coded according to the International Classification of Diseases (ICD)-10 guidelines and linked in a dynamic population database with vaccination histories. A case-series analysis was applied to the cohort of children vaccinated during the mass measles vaccination campaign. The study recorded 107,022 immunizations in a catchment area with a population of 357,458 and confirmed vaccine coverage of 87% or higher for completed routine childhood vaccinations. The measles vaccination campaign immunized at least 86% of the targeted children aged 9 months to 10 years. No medical event was detected significantly more frequently during the 14 days after measles vaccination than before it. The experience in Viet Nam confirmed the safety of a measles vaccination campaign and shows that it is feasible to establish health information systems such as a large linked database which can provide reliable data in a developing country for a modest increase in use of resources. PMID:16193545

Lessons learned from process incident databases and the process safety incident database (PSID) approach sponsored by the Center for Chemical Process Safety.

PubMed

Sepeda, Adrian L

2006-03-17

Learning from the experiences of others has long been recognized as a valued and relatively painless process. In the world of process safety, this learning method is an essential tool since industry has neither the time and resources nor the willingness to experience an incident before taking corrective or preventative steps. This paper examines the need for and value of process safety incident databases that collect incidents of high learning value and structure them so that needed information can be easily and quickly extracted. It also explores how they might be used to prevent incidents by increasing awareness and by being a tool for conducting PHAs and incident investigations. The paper then discusses how the CCPS PSID meets those requirements, how PSID is structured and managed, and its attributes and features.

[Safe Use of Recent New Drugs-Current Status and Challenges].

PubMed

Ohashi, Yoshiaki

2018-01-01

　In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.

The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

NASA Astrophysics Data System (ADS)

Zhu, Wenmin; Jia, Yuanhua

2018-01-01

Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

75 FR 76831 - Publicly Available Consumer Product Safety Information Database

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-09

..., health care professionals, and public safety entities, will likely lack firsthand knowledge about an...) would state that the definition of ``health care professionals'' includes, but is not limited to, medical examiners, coroners, physicians, nurses, physician's assistants, hospitals, chiropractors, and...

Zebra Crossing Spotter: Automatic Population of Spatial Databases for Increased Safety of Blind Travelers

PubMed Central

Ahmetovic, Dragan; Manduchi, Roberto; Coughlan, James M.; Mascetti, Sergio

2016-01-01

In this paper we propose a computer vision-based technique that mines existing spatial image databases for discovery of zebra crosswalks in urban settings. Knowing the location of crosswalks is critical for a blind person planning a trip that includes street crossing. By augmenting existing spatial databases (such as Google Maps or OpenStreetMap) with this information, a blind traveler may make more informed routing decisions, resulting in greater safety during independent travel. Our algorithm first searches for zebra crosswalks in satellite images; all candidates thus found are validated against spatially registered Google Street View images. This cascaded approach enables fast and reliable discovery and localization of zebra crosswalks in large image datasets. While fully automatic, our algorithm could also be complemented by a final crowdsourcing validation stage for increased accuracy. PMID:26824080

Use of information on disease diagnoses from databases for animal health economic, welfare and food safety purposes: strengths and limitations of recordings.

PubMed

Houe, Hans; Gardner, Ian Andrew; Nielsen, Liza Rosenbaum

2011-01-01

Many animal health, welfare and food safety databases include data on clinical and test-based disease diagnoses. However, the circumstances and constraints for establishing the diagnoses vary considerably among databases. Therefore results based on different databases are difficult to compare and compilation of data in order to perform meta-analysis is almost impossible. Nevertheless, diagnostic information collected either routinely or in research projects is valuable in cross comparisons between databases, but there is a need for improved transparency and documentation of the data and the performance characteristics of tests used to establish diagnoses. The objective of this paper is to outline the circumstances and constraints for recording of disease diagnoses in different types of databases, and to discuss these in the context of disease diagnoses when using them for additional purposes, including research. Finally some limitations and recommendations for use of data and for recording of diagnostic information in the future are given. It is concluded that many research questions have such a specific objective that investigators need to collect their own data. However, there are also examples, where a minimal amount of extra information or continued validation could make sufficient improvement of secondary data to be used for other purposes. Regardless, researchers should always carefully evaluate the opportunities and constraints when they decide to use secondary data. If the data in the existing databases are not sufficiently valid, researchers may have to collect their own data, but improved recording of diagnostic data may improve the usefulness of secondary diagnostic data in the future.

Major accident prevention through applying safety knowledge management approach.

PubMed

Kalatpour, Omid

2016-01-01

Many scattered resources of knowledge are available to use for chemical accident prevention purposes. The common approach to management process safety, including using databases and referring to the available knowledge has some drawbacks. The main goal of this article was to devise a new emerged knowledge base (KB) for the chemical accident prevention domain. The scattered sources of safety knowledge were identified and scanned. Then, the collected knowledge was formalized through a computerized program. The Protégé software was used to formalize and represent the stored safety knowledge. The domain knowledge retrieved as well as data and information. This optimized approach improved safety and health knowledge management (KM) process and resolved some typical problems in the KM process. Upgrading the traditional resources of safety databases into the KBs can improve the interaction between the users and knowledge repository.

Database management systems for process safety.

PubMed

Early, William F

2006-03-17

Several elements of the process safety management regulation (PSM) require tracking and documentation of actions; process hazard analyses, management of change, process safety information, operating procedures, training, contractor safety programs, pre-startup safety reviews, incident investigations, emergency planning, and compliance audits. These elements can result in hundreds of actions annually that require actions. This tracking and documentation commonly is a failing identified in compliance audits, and is difficult to manage through action lists, spreadsheets, or other tools that are comfortably manipulated by plant personnel. This paper discusses the recent implementation of a database management system at a chemical plant and chronicles the improvements accomplished through the introduction of a customized system. The system as implemented modeled the normal plant workflows, and provided simple, recognizable user interfaces for ease of use.

16 CFR § 1102.20 - Transmission of reports of harm to the identified manufacturer or private labeler.

Code of Federal Regulations, 2013 CFR

2013-01-01

... SAFETY INFORMATION DATABASE Procedural Requirements § 1102.20 Transmission of reports of harm to the... of harm, provided such report meets the minimum requirements for publication in the Database, to the... report of harm, or otherwise, then it will not post the report of harm on the Database but will maintain...

THE ART OF DATA MINING THE MINEFIELDS OF TOXICITY DATABASES TO LINK CHEMISTRY TO BIOLOGY

EPA Science Inventory

Toxicity databases have a special role in predictive toxicology, providing ready access to historical information throughout the workflow of discovery, development, and product safety processes in drug development as well as in review by regulatory agencies. To provide accurate i...

ARTI refrigerant database

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

Calm, J.M.

1998-03-15

The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to thermophysical properties, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air conditioning and refrigeration equipment. It also references documents addressing compatibility ofmore » refrigerants and lubricants with other materials.« less

The development of an information system and installation of an Internet web database for the purposes of the occupational health and safety management system.

PubMed

Mavrikakis, I; Mantas, J; Diomidous, M

2007-01-01

This paper is based on the research on the possible structure of an information system for the purposes of occupational health and safety management. We initiated a questionnaire in order to find the possible interest on the part of potential users in the subject of occupational health and safety. The depiction of the potential interest is vital both for the software analysis cycle and development according to previous models. The evaluation of the results tends to create pilot applications among different enterprises. Documentation and process improvements ascertained quality of services, operational support, occupational health and safety advice are the basics of the above applications. Communication and codified information among intersted parts is the other target of the survey regarding health issues. Computer networks can offer such services. The network will consist of certain nodes responsible to inform executives on Occupational Health and Safety. A web database has been installed for inserting and searching documents. The submission of files to a server and the answers to questionnaires through the web help the experts to perform their activities. Based on the requirements of enterprises we have constructed a web file server. We submit files so that users can retrieve the files which they need. The access is limited to authorized users. Digital watermarks authenticate and protect digital objects.

Integrated Functional and Executional Modelling of Software Using Web-Based Databases

NASA Technical Reports Server (NTRS)

Kulkarni, Deepak; Marietta, Roberta

1998-01-01

NASA's software subsystems undergo extensive modification and updates over the operational lifetimes. It is imperative that modified software should satisfy safety goals. This report discusses the difficulties encountered in doing so and discusses a solution based on integrated modelling of software, use of automatic information extraction tools, web technology and databases. To appear in an article of Journal of Database Management.

49 CFR 217.9 - Program of operational tests and inspections; recordkeeping.

Code of Federal Regulations, 2014 CFR

2014-10-01

... controls accessibility to such information retained in its electronic database system and identifies those... inspections required by this section, the Associate Administrator for Safety may, for cause stated, disapprove... disapproval decision. If the Associate Administrator for Safety disapproves the program, (1) The railroad has...

49 CFR 217.9 - Program of operational tests and inspections; recordkeeping.

Code of Federal Regulations, 2010 CFR

2010-10-01

... controls accessibility to such information retained in its electronic database system and identifies those... inspections required by this section, the Associate Administrator for Safety may, for cause stated, disapprove... disapproval decision. If the Associate Administrator for Safety disapproves the program, (1) The railroad has...

49 CFR 217.9 - Program of operational tests and inspections; recordkeeping.

Code of Federal Regulations, 2011 CFR

2011-10-01

... controls accessibility to such information retained in its electronic database system and identifies those... inspections required by this section, the Associate Administrator for Safety may, for cause stated, disapprove... disapproval decision. If the Associate Administrator for Safety disapproves the program, (1) The railroad has...

49 CFR 217.9 - Program of operational tests and inspections; recordkeeping.

Code of Federal Regulations, 2012 CFR

2012-10-01

... controls accessibility to such information retained in its electronic database system and identifies those... inspections required by this section, the Associate Administrator for Safety may, for cause stated, disapprove... disapproval decision. If the Associate Administrator for Safety disapproves the program, (1) The railroad has...

Database Design to Ensure Anonymous Study of Medical Errors: A Report from the ASIPS collaborative

PubMed Central

Pace, Wilson D.; Staton, Elizabeth W.; Higgins, Gregory S.; Main, Deborah S.; West, David R.; Harris, Daniel M.

2003-01-01

Medical error reporting systems are important information sources for designing strategies to improve the safety of health care. Applied Strategies for Improving Patient Safety (ASIPS) is a multi-institutional, practice-based research project that collects and analyzes data on primary care medical errors and develops interventions to reduce error. The voluntary ASIPS Patient Safety Reporting System captures anonymous and confidential reports of medical errors. Confidential reports, which are quickly de-identified, provide better detail than do anonymous reports; however, concerns exist about the confidentiality of those reports should the database be subject to legal discovery or other security breaches. Standard database elements, for example, serial ID numbers, date/time stamps, and backups, could enable an outsider to link an ASIPS report to a specific medical error. The authors present the design and implementation of a database and administrative system that reduce this risk, facilitate research, and maintain near anonymity of the events, practices, and clinicians. PMID:12925548

Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.

PubMed

Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, Shigeru; Yamamoto, Yuji; Fujimoto, Yoko

2018-05-01

Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients. The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan. Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile. Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations. Copyright © 2018. Published by Elsevier Inc.

49 CFR 800.2 - Organization.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Administrator in refusing to issue airman certificates. (e) The Office of Aviation Safety, which conducts... Board's information technology infrastructure, including computer systems, networks, databases, and...

49 CFR 800.2 - Organization.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Administrator in refusing to issue airman certificates. (e) The Office of Aviation Safety, which conducts... Board's information technology infrastructure, including computer systems, networks, databases, and...

49 CFR 800.2 - Organization.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Administrator in refusing to issue airman certificates. (e) The Office of Aviation Safety, which conducts... Board's information technology infrastructure, including computer systems, networks, databases, and...

Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

PubMed

Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David

2017-03-01

The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

PubMed Central

Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

2016-01-01

Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. PMID:27804174

Tox-Database.net: a curated resource for data describing chemical triggered in vitro cardiac ion channels inhibition

PubMed Central

2012-01-01

Background Drugs safety issues are now recognized as being factors generating the most reasons for drug withdrawals at various levels of development and at the post-approval stage. Among them cardiotoxicity remains the main reason, despite the substantial effort put into in vitro and in vivo testing, with the main focus put on hERG channel inhibition as the hypothesized surrogate of drug proarrhythmic potency. The large interest in the IKr current has resulted in the development of predictive tools and informative databases describing a drug's susceptibility to interactions with the hERG channel, although there are no similar, publicly available sets of data describing other ionic currents driven by the human cardiomyocyte ionic channels, which are recognized as an overlooked drug safety target. Discussion The aim of this database development and publication was to provide a scientifically useful, easily usable and clearly verifiable set of information describing not only IKr (hERG), but also other human cardiomyocyte specific ionic channels inhibition data (IKs, INa, ICa). Summary The broad range of data (chemical space and in vitro settings) and the easy to use user interface makes tox-database.net a useful tool for interested scientists. Database URL http://tox-database.net. PMID:22947121

Research on public participant urban infrastructure safety monitoring system using smartphone

NASA Astrophysics Data System (ADS)

Zhao, Xuefeng; Wang, Niannian; Ou, Jinping; Yu, Yan; Li, Mingchu

2017-04-01

Currently more and more people concerned about the safety of major public security. Public participant urban infrastructure safety monitoring and investigation has become a trend in the era of big data. In this paper, public participant urban infrastructure safety protection system based on smart phones is proposed. The system makes it possible to public participant disaster data collection, monitoring and emergency evaluation in the field of disaster prevention and mitigation. Function of the system is to monitor the structural acceleration, angle and other vibration information, and extract structural deformation and implement disaster emergency communications based on smartphone without network. The monitoring data is uploaded to the website to create urban safety information database. Then the system supports big data analysis processing, the structure safety assessment and city safety early warning.

Integrated Functional and Executional Modelling of Software Using Web-Based Databases

NASA Technical Reports Server (NTRS)

Kulkarni, Deepak; Marietta, Roberta

1998-01-01

NASA's software subsystems undergo extensive modification and updates over the operational lifetimes. It is imperative that modified software should satisfy safety goals. This report discusses the difficulties encountered in doing so and discusses a solution based on integrated modelling of software, use of automatic information extraction tools, web technology and databases.

ARTI refrigerant database. Quarterly report, March--May 1997

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

Calm, J.M.

1997-05-01

The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information an older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air-conditioning and refrigeration equipment. The complete documents are not included, though some maymore » be added at a later date.« less

Value of shared preclinical safety studies - The eTOX database.

PubMed

Briggs, Katharine; Barber, Chris; Cases, Montserrat; Marc, Philippe; Steger-Hartmann, Thomas

2015-01-01

A first analysis of a database of shared preclinical safety data for 1214 small molecule drugs and drug candidates extracted from 3970 reports donated by thirteen pharmaceutical companies for the eTOX project (www.etoxproject.eu) is presented. Species, duration of exposure and administration route data were analysed to assess if large enough subsets of homogenous data are available for building in silico predictive models. Prevalence of treatment related effects for the different types of findings recorded were analysed. The eTOX ontology was used to determine the most common treatment-related clinical chemistry and histopathology findings reported in the database. The data were then mined to evaluate sensitivity of established in vivo biomarkers for liver toxicity risk assessment. The value of the database to inform other drug development projects during early drug development is illustrated by a case study.

Preliminary Results Obtained in Integrated Safety Analysis of NASA Aviation Safety Program Technologies

NASA Technical Reports Server (NTRS)

2004-01-01

This is a listing of recent unclassified RTO technical publications processed by the NASA Center for AeroSpace Information from July 1, 2004 through September 30, 2004 available on the NASA Aeronautics and Space Database. Topics covered include: military training; personal active noise reduction; electric combat vehicles.

Dynamic Speed Adaptation for Path Tracking Based on Curvature Information and Speed Limits.

PubMed

Gámez Serna, Citlalli; Ruichek, Yassine

2017-06-14

A critical concern of autonomous vehicles is safety. Different approaches have tried to enhance driving safety to reduce the number of fatal crashes and severe injuries. As an example, Intelligent Speed Adaptation (ISA) systems warn the driver when the vehicle exceeds the recommended speed limit. However, these systems only take into account fixed speed limits without considering factors like road geometry. In this paper, we consider road curvature with speed limits to automatically adjust vehicle's speed with the ideal one through our proposed Dynamic Speed Adaptation (DSA) method. Furthermore, 'curve analysis extraction' and 'speed limits database creation' are also part of our contribution. An algorithm that analyzes GPS information off-line identifies high curvature segments and estimates the speed for each curve. The speed limit database contains information about the different speed limit zones for each traveled path. Our DSA senses speed limits and curves of the road using GPS information and ensures smooth speed transitions between current and ideal speeds. Through experimental simulations with different control algorithms on real and simulated datasets, we prove that our method is able to significantly reduce lateral errors on sharp curves, to respect speed limits and consequently increase safety and comfort for the passenger.

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.

Improving postapproval drug safety surveillance: getting better information sooner.

PubMed

Hennessy, Sean; Strom, Brian L

2015-01-01

Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include the establishment of government-sponsored networks of population databases, the use of data mining approaches, and the formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks and in providing reassurance about the absence of such risks.

Osteoporosis therapies: evidence from health-care databases and observational population studies.

PubMed

Silverman, Stuart L

2010-11-01

Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

Spatial database for intersections.

DOT National Transportation Integrated Search

2015-08-01

Deciding which intersections in the state of Kentucky warrant safety improvements requires a comprehensive inventory : with information on every intersection in the public roadway network. The Kentucky Transportation Cabinet (KYTC) : had previously c...

Dam Removal Information Portal (DRIP)—A map-based resource linking scientific studies and associated geospatial information about dam removals

USGS Publications Warehouse

Duda, Jeffrey J.; Wieferich, Daniel J.; Bristol, R. Sky; Bellmore, J. Ryan; Hutchison, Vivian B.; Vittum, Katherine M.; Craig, Laura; Warrick, Jonathan A.

2016-08-18

The removal of dams has recently increased over historical levels due to aging infrastructure, changing societal needs, and modern safety standards rendering some dams obsolete. Where possibilities for river restoration, or improved safety, exceed the benefits of retaining a dam, removal is more often being considered as a viable option. Yet, as this is a relatively new development in the history of river management, science is just beginning to guide our understanding of the physical and ecological implications of dam removal. Ultimately, the “lessons learned” from previous scientific studies on the outcomes dam removal could inform future scientific understanding of ecosystem outcomes, as well as aid in decision-making by stakeholders. We created a database visualization tool, the Dam Removal Information Portal (DRIP), to display map-based, interactive information about the scientific studies associated with dam removals. Serving both as a bibliographic source as well as a link to other existing databases like the National Hydrography Dataset, the derived National Dam Removal Science Database serves as the foundation for a Web-based application that synthesizes the existing scientific studies associated with dam removals. Thus, using the DRIP application, users can explore information about completed dam removal projects (for example, their location, height, and date removed), as well as discover sources and details of associated of scientific studies. As such, DRIP is intended to be a dynamic collection of scientific information related to dams that have been removed in the United States and elsewhere. This report describes the architecture and concepts of this “metaknowledge” database and the DRIP visualization tool.

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

PubMed

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Aviation Safety Issues Database

NASA Technical Reports Server (NTRS)

Morello, Samuel A.; Ricks, Wendell R.

2009-01-01

The aviation safety issues database was instrumental in the refinement and substantiation of the National Aviation Safety Strategic Plan (NASSP). The issues database is a comprehensive set of issues from an extremely broad base of aviation functions, personnel, and vehicle categories, both nationally and internationally. Several aviation safety stakeholders such as the Commercial Aviation Safety Team (CAST) have already used the database. This broader interest was the genesis to making the database publically accessible and writing this report.

Using Quasi-Horizontal Alignment in the absence of the actual alignment.

PubMed

Banihashemi, Mohamadreza

2016-10-01

Horizontal alignment is a major roadway characteristic used in safety and operational evaluations of many facility types. The Highway Safety Manual (HSM) uses this characteristic in crash prediction models for rural two-lane highways, freeway segments, and freeway ramps/C-D roads. Traffic simulation models use this characteristic in their processes on almost all types of facilities. However, a good portion of roadway databases do not include horizontal alignment data; instead, many contain point coordinate data along the roadways. SHRP 2 Roadway Information Database (RID) is a good example of this type of data. Only about 5% of this geodatabase contains alignment information and for the rest, point data can easily be produced. Even though the point data can be used to extract actual horizontal alignment data but, extracting horizontal alignment is a cumbersome and costly process, especially for a database of miles and miles of highways. This research introduces a so called "Quasi-Horizontal Alignment" that can be produced easily and automatically from point coordinate data and can be used in the safety and operational evaluations of highways. SHRP 2 RID for rural two-lane highways in Washington State is used in this study. This paper presents a process through which Quasi-Horizontal Alignments are produced from point coordinates along highways by using spreadsheet software such as MS EXCEL. It is shown that the safety and operational evaluations of the highways with Quasi-Horizontal Alignments are almost identical to the ones with the actual alignments. In the absence of actual alignment the Quasi-Horizontal Alignment can easily be produced from any type of databases that contain highway coordinates such geodatabases and digital maps. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Research on Zhejiang blood information network and management system].

PubMed

Yan, Li-Xing; Xu, Yan; Meng, Zhong-Hua; Kong, Chang-Hong; Wang, Jian-Min; Jin, Zhen-Liang; Wu, Shi-Ding; Chen, Chang-Shui; Luo, Ling-Fei

2007-02-01

This research was aimed to develop the first level blood information centralized database and real time communication network at a province area in China. Multiple technology like local area network database separate operation, real time data concentration and distribution mechanism, allopatric backup, and optical fiber virtual private network (VPN) were used. As a result, the blood information centralized database and management system were successfully constructed, which covers all the Zhejiang province, and the real time exchange of blood data was realised. In conclusion, its implementation promote volunteer blood donation and ensure the blood safety in Zhejiang, especially strengthen the quick response to public health emergency. This project lays the first stone of centralized test and allotment among blood banks in Zhejiang, and can serve as a reference of contemporary blood bank information systems in China.

The eNanoMapper database for nanomaterial safety information

PubMed Central

Chomenidis, Charalampos; Doganis, Philip; Fadeel, Bengt; Grafström, Roland; Hardy, Barry; Hastings, Janna; Hegi, Markus; Jeliazkov, Vedrin; Kochev, Nikolay; Kohonen, Pekka; Munteanu, Cristian R; Sarimveis, Haralambos; Smeets, Bart; Sopasakis, Pantelis; Tsiliki, Georgia; Vorgrimmler, David; Willighagen, Egon

2015-01-01

Summary Background: The NanoSafety Cluster, a cluster of projects funded by the European Commision, identified the need for a computational infrastructure for toxicological data management of engineered nanomaterials (ENMs). Ontologies, open standards, and interoperable designs were envisioned to empower a harmonized approach to European research in nanotechnology. This setting provides a number of opportunities and challenges in the representation of nanomaterials data and the integration of ENM information originating from diverse systems. Within this cluster, eNanoMapper works towards supporting the collaborative safety assessment for ENMs by creating a modular and extensible infrastructure for data sharing, data analysis, and building computational toxicology models for ENMs. Results: The eNanoMapper database solution builds on the previous experience of the consortium partners in supporting diverse data through flexible data storage, open source components and web services. We have recently described the design of the eNanoMapper prototype database along with a summary of challenges in the representation of ENM data and an extensive review of existing nano-related data models, databases, and nanomaterials-related entries in chemical and toxicogenomic databases. This paper continues with a focus on the database functionality exposed through its application programming interface (API), and its use in visualisation and modelling. Considering the preferred community practice of using spreadsheet templates, we developed a configurable spreadsheet parser facilitating user friendly data preparation and data upload. We further present a web application able to retrieve the experimental data via the API and analyze it with multiple data preprocessing and machine learning algorithms. Conclusion: We demonstrate how the eNanoMapper database is used to import and publish online ENM and assay data from several data sources, how the “representational state transfer” (REST) API enables building user friendly interfaces and graphical summaries of the data, and how these resources facilitate the modelling of reproducible quantitative structure–activity relationships for nanomaterials (NanoQSAR). PMID:26425413

The eNanoMapper database for nanomaterial safety information.

PubMed

Jeliazkova, Nina; Chomenidis, Charalampos; Doganis, Philip; Fadeel, Bengt; Grafström, Roland; Hardy, Barry; Hastings, Janna; Hegi, Markus; Jeliazkov, Vedrin; Kochev, Nikolay; Kohonen, Pekka; Munteanu, Cristian R; Sarimveis, Haralambos; Smeets, Bart; Sopasakis, Pantelis; Tsiliki, Georgia; Vorgrimmler, David; Willighagen, Egon

2015-01-01

The NanoSafety Cluster, a cluster of projects funded by the European Commision, identified the need for a computational infrastructure for toxicological data management of engineered nanomaterials (ENMs). Ontologies, open standards, and interoperable designs were envisioned to empower a harmonized approach to European research in nanotechnology. This setting provides a number of opportunities and challenges in the representation of nanomaterials data and the integration of ENM information originating from diverse systems. Within this cluster, eNanoMapper works towards supporting the collaborative safety assessment for ENMs by creating a modular and extensible infrastructure for data sharing, data analysis, and building computational toxicology models for ENMs. The eNanoMapper database solution builds on the previous experience of the consortium partners in supporting diverse data through flexible data storage, open source components and web services. We have recently described the design of the eNanoMapper prototype database along with a summary of challenges in the representation of ENM data and an extensive review of existing nano-related data models, databases, and nanomaterials-related entries in chemical and toxicogenomic databases. This paper continues with a focus on the database functionality exposed through its application programming interface (API), and its use in visualisation and modelling. Considering the preferred community practice of using spreadsheet templates, we developed a configurable spreadsheet parser facilitating user friendly data preparation and data upload. We further present a web application able to retrieve the experimental data via the API and analyze it with multiple data preprocessing and machine learning algorithms. We demonstrate how the eNanoMapper database is used to import and publish online ENM and assay data from several data sources, how the "representational state transfer" (REST) API enables building user friendly interfaces and graphical summaries of the data, and how these resources facilitate the modelling of reproducible quantitative structure-activity relationships for nanomaterials (NanoQSAR).

HIM-herbal ingredients in-vivo metabolism database.

PubMed

Kang, Hong; Tang, Kailin; Liu, Qi; Sun, Yi; Huang, Qi; Zhu, Ruixin; Gao, Jun; Zhang, Duanfeng; Huang, Chenggang; Cao, Zhiwei

2013-05-31

Herbal medicine has long been viewed as a valuable asset for potential new drug discovery and herbal ingredients' metabolites, especially the in vivo metabolites were often found to gain better pharmacological, pharmacokinetic and even better safety profiles compared to their parent compounds. However, these herbal metabolite information is still scattered and waiting to be collected. HIM database manually collected so far the most comprehensive available in-vivo metabolism information for herbal active ingredients, as well as their corresponding bioactivity, organs and/or tissues distribution, toxicity, ADME and the clinical research profile. Currently HIM contains 361 ingredients and 1104 corresponding in-vivo metabolites from 673 reputable herbs. Tools of structural similarity, substructure search and Lipinski's Rule of Five are also provided. Various links were made to PubChem, PubMed, TCM-ID (Traditional Chinese Medicine Information database) and HIT (Herbal ingredients' targets databases). A curated database HIM is set up for the in vivo metabolites information of the active ingredients for Chinese herbs, together with their corresponding bioactivity, toxicity and ADME profile. HIM is freely accessible to academic researchers at http://www.bioinformatics.org.cn/.

Dynamic Speed Adaptation for Path Tracking Based on Curvature Information and Speed Limits †

PubMed Central

Gámez Serna, Citlalli; Ruichek, Yassine

2017-01-01

A critical concern of autonomous vehicles is safety. Different approaches have tried to enhance driving safety to reduce the number of fatal crashes and severe injuries. As an example, Intelligent Speed Adaptation (ISA) systems warn the driver when the vehicle exceeds the recommended speed limit. However, these systems only take into account fixed speed limits without considering factors like road geometry. In this paper, we consider road curvature with speed limits to automatically adjust vehicle’s speed with the ideal one through our proposed Dynamic Speed Adaptation (DSA) method. Furthermore, ‘curve analysis extraction’ and ‘speed limits database creation’ are also part of our contribution. An algorithm that analyzes GPS information off-line identifies high curvature segments and estimates the speed for each curve. The speed limit database contains information about the different speed limit zones for each traveled path. Our DSA senses speed limits and curves of the road using GPS information and ensures smooth speed transitions between current and ideal speeds. Through experimental simulations with different control algorithms on real and simulated datasets, we prove that our method is able to significantly reduce lateral errors on sharp curves, to respect speed limits and consequently increase safety and comfort for the passenger. PMID:28613251

Adverse drug events and the Freedom of Information Act: an apple in Eden.

PubMed

Stang, P E; Fox, J L

1992-02-01

To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.

Analysis of reference sources used in drug-related Wikipedia articles.

PubMed

Koppen, Laura; Phillips, Jennifer; Papageorgiou, Renee

2015-07-01

References from drug-related Wikipedia articles and a drug information database were compared. Drugs in Food and Drug Administration (FDA) MedWatch alerts from January-July 2013 were searched in Wikipedia and Lexicomp to compare reference types and to assess the time for drug safety information to be incorporated into Wikipedia articles. Wikipedia most commonly cited peer-reviewed journal articles (49.2%) and news articles (12.0%). MedWatch citations were incorporated into Wikipedia on average in 5.9 days. Wikipedia cited various sources but may not be a reliable, up-to-date resource for drug safety information.

Aviation Safety Reporting System: Process and Procedures

NASA Technical Reports Server (NTRS)

Connell, Linda J.

1997-01-01

The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

ARTI refrigerant database

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

Calm, J.M.

1997-02-01

The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alterative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air-conditioning and refrigeration equipment. The complete documents are not included, though some maymore » be added at a later date. The database identifies sources of specific information on various refrigerants. It addresses lubricants including alkylbenzene, polyalkylene glycol, polyolester, and other synthetics as well as mineral oils. It also references documents addressing compatibility of refrigerants and lubricants with metals, plastics, elastomers, motor insulation, and other materials used in refrigerant circuits. Incomplete citations or abstracts are provided for some documents. They are included to accelerate availability of the information and will be completed or replaced in future updates.« less

2017 Joint Annual NDIA/AIA Industrial Security Committee Fall Conference

DTIC Science & Technology

2017-11-15

beyond credit data to offer the insights that government professionals need to make informed decisions and ensure citizen safety, manage compliance...business that provides information technology and professional services. We specialize in managing business processes and systems integration for both... Information Security System ISFD Industrial Security Facilities Database OBMS ODAA Business Management System STEPP Security, Training, Education and

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

Calm, J.M.

The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilities access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern.

Fault displacement hazard assessment for nuclear installations based on IAEA safety standards

NASA Astrophysics Data System (ADS)

Fukushima, Y.

2016-12-01

In the IAEA Safety NS-R-3, surface fault displacement hazard assessment (FDHA) is required for the siting of nuclear installations. If any capable faults exist in the candidate site, IAEA recommends the consideration of alternative sites. However, due to the progress in palaeoseismological investigations, capable faults may be found in existing site. In such a case, IAEA recommends to evaluate the safety using probabilistic FDHA (PFDHA), which is an empirical approach based on still quite limited database. Therefore a basic and crucial improvement is to increase the database. In 2015, IAEA produced a TecDoc-1767 on Palaeoseismology as a reference for the identification of capable faults. Another IAEA Safety Report 85 on ground motion simulation based on fault rupture modelling provides an annex introducing recent PFDHAs and fault displacement simulation methodologies. The IAEA expanded the project of FDHA for the probabilistic approach and the physics based fault rupture modelling. The first approach needs a refinement of the empirical methods by building a world wide database, and the second approach needs to shift from kinematic to the dynamic scheme. Both approaches can complement each other, since simulated displacement can fill the gap of a sparse database and geological observations can be useful to calibrate the simulations. The IAEA already supported a workshop in October 2015 to discuss the existing databases with the aim of creating a common worldwide database. A consensus of a unified database was reached. The next milestone is to fill the database with as many fault rupture data sets as possible. Another IAEA work group had a WS in November 2015 to discuss the state-of-the-art PFDHA as well as simulation methodologies. Two groups jointed a consultancy meeting in February 2016, shared information, identified issues, discussed goals and outputs, and scheduled future meetings. Now we may aim at coordinating activities for the whole FDHA tasks jointly.

Space Station Freedom environmental database system (FEDS) for MSFC testing

NASA Technical Reports Server (NTRS)

Story, Gail S.; Williams, Wendy; Chiu, Charles

1991-01-01

The Water Recovery Test (WRT) at Marshall Space Flight Center (MSFC) is the first demonstration of integrated water recovery systems for potable and hygiene water reuse as envisioned for Space Station Freedom (SSF). In order to satisfy the safety and health requirements placed on the SSF program and facilitate test data assessment, an extensive laboratory analysis database was established to provide a central archive and data retrieval function. The database is required to store analysis results for physical, chemical, and microbial parameters measured from water, air and surface samples collected at various locations throughout the test facility. The Oracle Relational Database Management System (RDBMS) was utilized to implement a secured on-line information system with the ECLSS WRT program as the foundation for this system. The database is supported on a VAX/VMS 8810 series mainframe and is accessible from the Marshall Information Network System (MINS). This paper summarizes the database requirements, system design, interfaces, and future enhancements.

Analysis of questions about use of drugs in breastfeeding to Norwegian drug information centres.

PubMed

Jahnsen, Jan Anker; Widnes, Sofia Frost; Schjøtt, Jan

2018-01-01

Health professionals may advise women to either stop breastfeeding or drug treatment due to restrictive advice in drug monographs. Regional medicines information and pharmacovigilance centres in Norway (RELIS) provide free and industry-independent answers to questions about drugs and breastfeeding documented in a full-text, searchable database (RELIS database). We used the RELIS database to describe which health care practitioners sought information about medication safety in lactation, most common drugs involved, advice provided and which resources were used to provide the advice. A random selection of 100 question-answer pairs (QAPs) from the RELIS database indexed with "BREASTFEEDING" in the period from January 2011 to December 2015 was analysed. Inclusion criteria were queries from health professionals about drugs. Questions about herbal supplements and other exposures not classified as drugs were excluded. The QAPs were manually analysed for compatibility of one or several drugs with breastfeeding, health care profession and workplace of enquirer in addition to advice and search strategy used. In the 100 QAPs there were enquires about 152 drugs. Seventy-four questions concerned a single drug, but the number of drugs evaluated varied between 1 and 16. Fifty-nine questions were from physicians, 34 from nurses or midwives, two from pharmacists and two from other health professionals. Questions from physicians contained 93 drug evaluations (61%), nurses or midwives 47 (31%) and pharmacists seven (5%). The most frequent categories of drugs were antidepressants, antiepileptics and immunosuppressants. The most asked about drugs were lamotrigine, codeine, quetiapine and escitalopram. Fifty-nine percent of the drugs were deemed safe while breastfeeding, 16% if precautions were taken and 12% not recommended. Thirty-nine percent of the drug evaluations used an advanced literature search strategy, and this was significantly ( p  < 0.05) more likely when the enquirer was a physician. This analysis of questions to Norwegian medicines information centres about medicine use in breastfeeding indicates the need for communication about safety of drugs affecting the nervous system, primarily to medical doctors and midwives. In the majority of cases the medicine information centre can reassure about the safety of breastfeeding while taking a drug.

Healthcare Databases in Thailand and Japan: Potential Sources for Health Technology Assessment Research.

PubMed

Saokaew, Surasak; Sugimoto, Takashi; Kamae, Isao; Pratoomsoot, Chayanin; Chaiyakunapruk, Nathorn

2015-01-01

Health technology assessment (HTA) has been continuously used for value-based healthcare decisions over the last decade. Healthcare databases represent an important source of information for HTA, which has seen a surge in use in Western countries. Although HTA agencies have been established in Asia-Pacific region, application and understanding of healthcare databases for HTA is rather limited. Thus, we reviewed existing databases to assess their potential for HTA in Thailand where HTA has been used officially and Japan where HTA is going to be officially introduced. Existing healthcare databases in Thailand and Japan were compiled and reviewed. Databases' characteristics e.g. name of database, host, scope/objective, time/sample size, design, data collection method, population/sample, and variables were described. Databases were assessed for its potential HTA use in terms of safety/efficacy/effectiveness, social/ethical, organization/professional, economic, and epidemiological domains. Request route for each database was also provided. Forty databases- 20 from Thailand and 20 from Japan-were included. These comprised of national censuses, surveys, registries, administrative data, and claimed databases. All databases were potentially used for epidemiological studies. In addition, data on mortality, morbidity, disability, adverse events, quality of life, service/technology utilization, length of stay, and economics were also found in some databases. However, access to patient-level data was limited since information about the databases was not available on public sources. Our findings have shown that existing databases provided valuable information for HTA research with limitation on accessibility. Mutual dialogue on healthcare database development and usage for HTA among Asia-Pacific region is needed.

CSPMS supported by information technology

NASA Astrophysics Data System (ADS)

Zhang, Hudan; Wu, Heng

This paper will propose a whole new viewpoint about building a CSPMS(Coal-mine Safety Production Management System) by means of information technology. This system whose core part is a four-grade automatic triggered warning system achieves the goal that information transmission will be smooth, nondestructive and in time. At the same time, the system provides a comprehensive and collective technology platform for various Public Management Organizations and coal-mine production units to deal with safety management, advance warning, unexpected incidents, preplan implementation, and resource deployment at different levels. The database of this system will support national related industry's resource control, plan, statistics, tax and the construction of laws and regulations effectively.

Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study.

PubMed

Kesselheim, Aaron S; McGraw, Sarah A; Dejene, Sara Z; Rausch, Paula; Dal Pan, Gerald J; Lappin, Brian M; Zhou, Esther H; Avorn, Jerry; Campbell, Eric G

2017-06-01

The US Food and Drug Administration uses drug safety communications (DSCs) to release emerging information regarding post-market safety issues, but it is unclear the extent of awareness by patients and providers of these communications and their specific recommendations. We conducted semi-structured interviews with patients and physicians to evaluate their awareness and understanding of emerging drug safety information related to two sleep aids: zolpidem or eszopiclone. We conducted interviews with 40 patients and ten physicians recruited from a combination of insurer claims databases and online sources. We evaluated (1) sources of drug safety information; (2) discussions between patients and physicians about the two medications; (3) their knowledge of the DSC; and (4) preferences for learning about future drug safety information. Interviews were transcribed and analyzed thematically. Patients cited their physicians, pharmacy inserts, and the Internet as sources of drug safety information. Physicians often referred to medical journals and online medical sources. Most patients reported being aware of information contained in the DSC summaries they were read. Almost all patients and physicians reported discussing side effects during patient-provider conversations, but almost no patients mentioned that physicians had communicated with them key messaging from the DSCs at issue: the risk of next-morning impairment with zolpidem and the lower recommended initial dose for women. Some risks of medications are effectively communicated to patients and physicians; however, there is still a noticeable gap between information issued by the Food and Drug Administration and patient and physician awareness of this knowledge, as well as patients' decisions to act on this information. Disseminators of emerging drug safety information should explore ways of providing user-friendly resources to patients and healthcare professionals that can update them on new risks in a timely manner.

75 FR 11890 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-12

... housed on a secure server and database. The results of the survey shall be used for inpatient quality... of records are necessary to ensure the well-being and safety of patients and that professional...

The Dangers of Dental Devices as reported in the FDA MAUDE Database

PubMed Central

Hebballi, Nutan B; Ramoni, Rachel; Kalenderian, Elsbeth; Delattre, Veronique F.; Stewart, Denice C.L.; Kent, Karla; White, Joel M; Vaderhobli, Ram; Walji, Muhammad F

2014-01-01

Objectives To determine the frequency and type of adverse events (AEs) associated with dental devices reported to Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods We downloaded and thoroughly reviewed the dental device-related AEs reported to MAUDE from January 01, 1996 – December 31, 2011. Results MAUDE received a total of 1,978,056 reports between January 01, 1996 and December 31, 2011. Among these reports, 28,046 (1.4 percent) AEs reports were associated with dental devices. Within the dental AE reports that had event type information, 17,261 reported injuries, 7,777 reported device malfunctions, and 66 reported deaths. Among the 66 entries classified as death reports, 52 actually reported a death in the description; the remaining were either misclassified or lacked sufficient information in the report to determine whether a death had occurred. 53.5 percent of the dental device associated AEs pertained to endosseous implants. Conclusion There is a plethora of devices used in dental care, and to achieve Element 1 of AHRQ’s Patient Safety Initiative, we must be able to monitor the safety of dental devices. While MAUDE is essentially the single source of this valuable information, our investigations led us to conclude that it currently has major limitations that prevent it from being the broad-based patient safety sentinel the profession requires. Practical Implications As potential contributors to MAUDE, dental care teams play a key role in improving the profession’s access to information about the safety of dental devices. PMID:25637208

A Unique Digital Electrocardiographic Repository for the Development of Quantitative Electrocardiography and Cardiac Safety: The Telemetric and Holter ECG Warehouse (THEW)

PubMed Central

Couderc, Jean-Philippe

2010-01-01

The sharing of scientific data reinforces open scientific inquiry; it encourages diversity of analysis and opinion while promoting new research and facilitating the education of next generations of scientists. In this article, we present an initiative for the development of a repository containing continuous electrocardiographic information and their associated clinical information. This information is shared with the worldwide scientific community in order to improve quantitative electrocardiology and cardiac safety. First, we present the objectives of the initiative and its mission. Then, we describe the resources available in this initiative following three components: data, expertise and tools. The Data available in the Telemetric and Holter ECG Warehouse (THEW) includes continuous ECG signals and associated clinical information. The initiative attracted various academic and private partners whom expertise covers a large list of research arenas related to quantitative electrocardiography; their contribution to the THEW promotes cross-fertilization of scientific knowledge, resources, and ideas that will advance the field of quantitative electrocardiography. Finally, the tools of the THEW include software and servers to access and review the data available in the repository. To conclude, the THEW is an initiative developed to benefit the scientific community and to advance the field of quantitative electrocardiography and cardiac safety. It is a new repository designed to complement the existing ones such as Physionet, the AHA-BIH Arrhythmia Database, and the CSE database. The THEW hosts unique datasets from clinical trials and drug safety studies that, so far, were not available to the worldwide scientific community. PMID:20863512

Toxic substances registry system: Index of material safety data sheets

NASA Technical Reports Server (NTRS)

1991-01-01

The Material Safety Data Sheets (MSDSs) listed in this index reflect product inventories and associated MSDSs which have been submitted to the Toxic Substance Registry database maintained by the Base Operations Contractor at the Kennedy Space Center. The purpose of this index is to provide a means to access information on the hazards associated with the toxic and otherwise hazardous chemicals stored and used at the Kennedy Space Center.

The Impact of Environment and Occupation on the Health and Safety of Active Duty Air Force Members: Database Development and De-Identification.

PubMed

Erich, Roger; Eaton, Melinda; Mayes, Ryan; Pierce, Lamar; Knight, Andrew; Genovesi, Paul; Escobar, James; Mychalczuk, George; Selent, Monica

2016-08-01

Preparing data for medical research can be challenging, detail oriented, and time consuming. Transcription errors, missing or nonsensical data, and records not applicable to the study population may hamper progress and, if unaddressed, can lead to erroneous conclusions. In addition, study data may be housed in multiple disparate databases and complex formats. Merging methods may be incomplete to obtain temporally synchronized data elements. We created a comprehensive database to explore the general hypothesis that environmental and occupational factors influence health outcomes and risk-taking behavior among active duty Air Force personnel. Several databases containing demographics, medical records, health survey responses, and safety incident reports were cleaned, validated, and linked to form a comprehensive, relational database. The final step involved removing and transforming personally identifiable information to form a Health Insurance Portability and Accountability Act compliant limited database. Initial data consisted of over 62.8 million records containing 221 variables. When completed, approximately 23.9 million clean and valid records with 214 variables remained. With a clean, robust database, future analysis aims to identify high-risk career fields for targeted interventions or uncover potential protective factors in low-risk career fields. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

Healthcare Databases in Thailand and Japan: Potential Sources for Health Technology Assessment Research

PubMed Central

Saokaew, Surasak; Sugimoto, Takashi; Kamae, Isao; Pratoomsoot, Chayanin; Chaiyakunapruk, Nathorn

2015-01-01

Background Health technology assessment (HTA) has been continuously used for value-based healthcare decisions over the last decade. Healthcare databases represent an important source of information for HTA, which has seen a surge in use in Western countries. Although HTA agencies have been established in Asia-Pacific region, application and understanding of healthcare databases for HTA is rather limited. Thus, we reviewed existing databases to assess their potential for HTA in Thailand where HTA has been used officially and Japan where HTA is going to be officially introduced. Method Existing healthcare databases in Thailand and Japan were compiled and reviewed. Databases’ characteristics e.g. name of database, host, scope/objective, time/sample size, design, data collection method, population/sample, and variables were described. Databases were assessed for its potential HTA use in terms of safety/efficacy/effectiveness, social/ethical, organization/professional, economic, and epidemiological domains. Request route for each database was also provided. Results Forty databases– 20 from Thailand and 20 from Japan—were included. These comprised of national censuses, surveys, registries, administrative data, and claimed databases. All databases were potentially used for epidemiological studies. In addition, data on mortality, morbidity, disability, adverse events, quality of life, service/technology utilization, length of stay, and economics were also found in some databases. However, access to patient-level data was limited since information about the databases was not available on public sources. Conclusion Our findings have shown that existing databases provided valuable information for HTA research with limitation on accessibility. Mutual dialogue on healthcare database development and usage for HTA among Asia-Pacific region is needed. PMID:26560127

Semantic Annotation of Complex Text Structures in Problem Reports

NASA Technical Reports Server (NTRS)

Malin, Jane T.; Throop, David R.; Fleming, Land D.

2011-01-01

Text analysis is important for effective information retrieval from databases where the critical information is embedded in text fields. Aerospace safety depends on effective retrieval of relevant and related problem reports for the purpose of trend analysis. The complex text syntax in problem descriptions has limited statistical text mining of problem reports. The presentation describes an intelligent tagging approach that applies syntactic and then semantic analysis to overcome this problem. The tags identify types of problems and equipment that are embedded in the text descriptions. The power of these tags is illustrated in a faceted searching and browsing interface for problem report trending that combines automatically generated tags with database code fields and temporal information.

Summary Report: Uniform Traffic Control And Warning Messages For Portable Changeable Message Signs

DOT National Transportation Integrated Search

2000-03-01

The California database incorporated in the Highway Safety Information System (HSIS) is derived from the California TASAS (Traffic Accident Surveillance and Analysis System). The system, maintained by the Traffic Operations Office of Caltrans, is a m...

Safety first: Instrumentality for reaching safety determines attention allocation under threat.

PubMed

Vogt, Julia; Koster, Ernst H W; De Houwer, Jan

2017-04-01

Theories of attention to emotional information suggest that attentional processes prioritize threatening information. In this article, we suggest that attention will prioritize the events that are most instrumental to a goal in any given context, which in threatening situations is typically reaching safety. To test our hypotheses, we used an attentional cueing paradigm that contained cues signaling imminent threat (i.e., aversive noises) as well as cues that allowed participants to avoid threat (instrumental safety signals). Correct reactions to instrumental safety signals seemingly allowed participants to lower the presentation rate of the threat. Experiment 1 demonstrates that attention prioritizes instrumental safety signals over threat signals. Experiment 2 replicates this finding and additionally compares instrumental safety signals to other action-relevant signals controlling for action relevance as cause of the effects. Experiment 3 demonstrates that when actions toward threat signals permit to avoid threat, attention prioritizes threat signals. Taken together, these results support the view that instrumentality for reaching safety determines the allocation of attention under threat. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Pharmacovigilance in Israel - tools, processes, and actions.

PubMed

Schwartzberg, Eyal; Berkovitch, Matitiahu; Dil Nahlieli, Dorit; Nathan, Joseph; Gorelik, Einat

2017-08-01

Due to the limited safety data available at the time that a new medication is first marketed, it is essential to continue the collection and monitoring of safety data about adverse drug reactions (ADRs) during the medication's life cycle. This activity, known as pharmacovigilance (PV), is performed worldwide by the pharmaceutical industry as well as by regulatory agencies. In 2012, the Israeli Ministry of Health (MOH) established a Pharmacovigilance and Drug Information Department. The Department is tasked with identifying, monitoring, and initiating activities aimed at minimizing risks associated with medication utilization. To enable this, the MOH has devised procedures for PV and promoted extensive legislation in this area that require marketing authorization holders (MAHs) and medical institutions in Israel to report ADRs and new safety information to the MOH. A computerized database was created to support the reporting process. The objective of this article is to characterize the PV tools and activities implemented in Israel. Since September 2014, The Israeli Pharmacovigilance and Drug Information Department receives ICSRs at a central computerized database developed for this purpose. The data were analyzed by Department personnel and ICSRs were characterized according to their seriousness, source, categories of drugs involved, and the reporting format. Additionally, the Department reviewed signals detected from ADR reports and from other sources and assessed the resulting regulatory actions. An analysis of the Individual Case Safety Reports (ICSRs) submitted to the MOH's ADRs central database reveals that during the review period, a total of 16,409 ICSRs were received by the Department and 850 signals were identified, resulting in the following PV activities: inquiry and enhanced follow-up (430, 50.6%), prescriber's and patient's leaflets updates (204, 24%), recall of products/batches (6, 0.7%), alerts for health care professionals (63, 7.4%). Eighty five (10%) of the signals required a comprehensive investigation involving external specialist and 1 (0.1%) resulted in initiation of epidemiologic study. Additionally, in 2015 the Department incorporated comprehensive framework for risk minimization of marketed medicinal products, also known as risk management plans (RMPs). As practiced by other health authorities, the Israeli MOH effectively implemented various PV tools to ensure the safety of the Israeli health consumer.

Aerospace Medicine and Biology: A Continuing Bibliography. Supplement 474

NASA Technical Reports Server (NTRS)

1998-01-01

This bibliography lists reports, articles and other documents recently introduced into the NASA scientific and technical information database. Subject coverage includes: Aerospace medicine and psychology, life support systems and controlled environments, safety equipment, exobiology and extraterrestrial life and flightcrew behavior and performance.

International Guide To Highway Transportation Information: Volume 4 - Bibliographic And Non-Bibliographic Database Producers

DOT National Transportation Integrated Search

2014-01-01

Connected vehicle wireless data communications can enable safety applications that may reduce injuries and fatalities suffered on our roads and highways, as well as enabling reductions in traffic congestion and impacts on the environment. As a critic...

Seat belt, DWI, and other traffic violations among recent immigrants in Florida and Tennessee.

DOT National Transportation Integrated Search

2013-05-01

Phase I of this project identified two States, Florida and Tennessee, that maintain information on drivers traffic violations and residency status. : Phase II analyzed State databases to examine seat belt nonuse, DWI, and other traffic safety viol...

49 CFR 390.101 - Scope.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 5 2012-10-01 2012-10-01 false Scope. 390.101 Section 390.101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Registry Program is the registry itself, which is a national database of names and contact information for...

49 CFR 390.101 - Scope.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 5 2013-10-01 2013-10-01 false Scope. 390.101 Section 390.101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Registry Program is the registry itself, which is a national database of names and contact information for...

49 CFR 390.101 - Scope.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false Scope. 390.101 Section 390.101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION... Registry Program is the registry itself, which is a national database of names and contact information for...

Complying with Executive Order 13148 using the Enterprise Environmental Safety And Occupational Health Management Information System.

PubMed

McFarland, Michael J; Nelson, Tim M; Rasmussen, Steve L; Palmer, Glenn R; Olivas, Arthur C

2005-03-01

All U.S. Department of Defense (DoD) facilities are required under Executive Order (EO) 13148, "Greening the Government through Leadership in Environmental Management," to establish quality-based environmental management systems (EMSs) that support environmental decision-making and verification of continuous environmental improvement by December 31, 2005. Compliance with EO 13148 as well as other federal, state, and local environmental regulations places a significant information management burden on DoD facilities. Cost-effective management of environmental data compels DoD facilities to establish robust database systems that not only address the complex and multifaceted environmental monitoring, record-keeping, and reporting requirements demanded by these rules but enable environmental management decision-makers to gauge improvements in environmental performance. The Enterprise Environmental Safety and Occupational Health Management Information System (EESOH-MIS) is a new electronic database developed by the U.S. Air Force to manage both the data needs associated with regulatory compliance programs across its facilities as well as the non-regulatory environmental information that supports installation business practices. The U.S. Air Force, which has adopted the Plan-Do-Check-Act methodology as the EMS standard that it will employ to address EO 13148 requirements.

SFCOMPO-2.0: An OECD NEA database of spent nuclear fuel isotopic assays, reactor design specifications, and operating data

DOE PAGES

Michel-Sendis, F.; Gauld, I.; Martinez, J. S.; ...

2017-08-02

SFCOMPO-2.0 is the new release of the Organisation for Economic Co-operation and Development (OECD) Nuclear Energy Agency (NEA) database of experimental assay measurements. These measurements are isotopic concentrations from destructive radiochemical analyses of spent nuclear fuel (SNF) samples. We supplement the measurements with design information for the fuel assembly and fuel rod from which each sample was taken, as well as with relevant information on operating conditions and characteristics of the host reactors. These data are necessary for modeling and simulation of the isotopic evolution of the fuel during irradiation. SFCOMPO-2.0 has been developed and is maintained by the OECDmore » NEA under the guidance of the Expert Group on Assay Data of Spent Nuclear Fuel (EGADSNF), which is part of the NEA Working Party on Nuclear Criticality Safety (WPNCS). Significant efforts aimed at establishing a thorough, reliable, publicly available resource for code validation and safety applications have led to the capture and standardization of experimental data from 750 SNF samples from more than 40 reactors. These efforts have resulted in the creation of the SFCOMPO-2.0 database, which is publicly available from the NEA Data Bank. Our paper describes the new database, and applications of SFCOMPO-2.0 for computer code validation, integral nuclear data benchmarking, and uncertainty analysis in nuclear waste package analysis are briefly illustrated.« less

SFCOMPO-2.0: An OECD NEA database of spent nuclear fuel isotopic assays, reactor design specifications, and operating data

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

Michel-Sendis, F.; Gauld, I.; Martinez, J. S.

SFCOMPO-2.0 is the new release of the Organisation for Economic Co-operation and Development (OECD) Nuclear Energy Agency (NEA) database of experimental assay measurements. These measurements are isotopic concentrations from destructive radiochemical analyses of spent nuclear fuel (SNF) samples. We supplement the measurements with design information for the fuel assembly and fuel rod from which each sample was taken, as well as with relevant information on operating conditions and characteristics of the host reactors. These data are necessary for modeling and simulation of the isotopic evolution of the fuel during irradiation. SFCOMPO-2.0 has been developed and is maintained by the OECDmore » NEA under the guidance of the Expert Group on Assay Data of Spent Nuclear Fuel (EGADSNF), which is part of the NEA Working Party on Nuclear Criticality Safety (WPNCS). Significant efforts aimed at establishing a thorough, reliable, publicly available resource for code validation and safety applications have led to the capture and standardization of experimental data from 750 SNF samples from more than 40 reactors. These efforts have resulted in the creation of the SFCOMPO-2.0 database, which is publicly available from the NEA Data Bank. Our paper describes the new database, and applications of SFCOMPO-2.0 for computer code validation, integral nuclear data benchmarking, and uncertainty analysis in nuclear waste package analysis are briefly illustrated.« less

Tocilizumab use in pregnancy: Analysis of a global safety database including data from clinical trials and post-marketing data.

PubMed

Hoeltzenbein, Maria; Beck, Evelin; Rajwanshi, Richa; Gøtestam Skorpen, Carina; Berber, Erhan; Schaefer, Christof; Østensen, Monika

2016-10-01

Analyze the cumulative evidence for pregnancy outcomes after maternal exposure to tocilizumab, an anti-interleukin-6-receptor monoclonal antibody used for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. At present, published experience on tocilizumab use during pregnancy is very limited. We have analyzed all pregnancy-related reports documented in the Roche Global Safety Database until December 31, 2014 (n = 501). After exclusion of ongoing pregnancies, duplicates, and cases retrieved from the literature, 399 women were found to have been exposed to tocilizumab shortly before or during pregnancy, with pregnancy outcomes being reported in 288 pregnancies (72.2%). Of these 288 pregnancies, 180 were prospectively reported resulting in 109 live births (60.6%), 39 spontaneous abortions (21.7%), 31 elective terminations of pregnancy (17.2%), and 1 stillbirth. The rate of malformations was 4.5%. Co-medications included methotrexate in 21.1% of the prospectively ascertained cases. Compared to the general population, an increased rate of preterm birth (31.2%) was observed. Retrospectively reported pregnancies (n = 108) resulted in 55 live births (50.9%), 31 spontaneous abortions (28.7%), and 22 elective terminations (20.4%). Three infants/fetuses with congenital anomalies were reported in this group. No increased risks for adverse pregnancy outcomes were observed after paternal exposure in 13 pregnancies with known outcome. No indication for a substantially increased malformation risk was observed. Considering the limitations of global safety databases, the data do not yet prove safety, but provide information for physicians and patients to make informed decisions. This is particularly important after inadvertent exposure to tocilizumab, shortly before or during early pregnancy. Copyright © 2016 Elsevier Inc. All rights reserved.

Databases on biotechnology and biosafety of GMOs.

PubMed

Degrassi, Giuliano; Alexandrova, Nevena; Ripandelli, Decio

2003-01-01

Due to the involvement of scientific, industrial, commercial and public sectors of society, the complexity of the issues concerning the safety of genetically modified organisms (GMOs) for the environment, agriculture, and human and animal health calls for a wide coverage of information. Accordingly, development of the field of biotechnology, along with concerns related to the fate of released GMOs, has led to a rapid development of tools for disseminating such information. As a result, there is a growing number of databases aimed at collecting and storing information related to GMOs. Most of the sites deal with information on environmental releases, field trials, transgenes and related sequences, regulations and legislation, risk assessment documents, and literature. Databases are mainly established and managed by scientific, national or international authorities, and are addressed towards scientists, government officials, policy makers, consumers, farmers, environmental groups and civil society representatives. This complexity can lead to an overlapping of information. The purpose of the present review is to analyse the relevant databases currently available on the web, providing comments on their vastly different information and on the structure of the sites pertaining to different users. A preliminary overview on the development of these sites during the last decade, at both the national and international level, is also provided.

RTECS database (on the internet). Online data

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

NONE

The Registry of Toxic Effects of Chemical Substances (RTECS (trademark)) is a database of toxicological information compiled, maintained, and updated by the National Institute for Occupational Safety and Health. The program is mandated by the Occupational Safety and Health Act of 1970. The original edition, known as the `Toxic Substances List,` was published on June 28, 1971, and included toxicologic data for approximately 5,000 chemicals. Since that time, the list has continuously grown and been updated, and its name changed to the current title, `Registry of Toxic Effects of Chemical Substances.` RTECS (trademark) now contains over 133,000 chemicals as NIOSHmore » strives to fulfill the mandate to list `all known toxic substances...and the concentrations at which...toxicity is known to occur.` This database is now available for searching through the Gov. Research-Center (GRC) service. GRC is a single online web-based search service to well known Government databases. Featuring powerful search and retrieval software, GRC is an important research tool. The GRC web site is at http://grc.ntis.gov.« less

Effectiveness and safety of moxibustion treatment for non-specific lower back pain: protocol for a systematic review.

PubMed

Leem, Jungtae; Lee, Seunghoon; Park, Yeoncheol; Seo, Byung-Kwan; Cho, Yeeun; Kang, Jung Won; Lee, Yoon Jae; Ha, In-Hyuk; Lee, Hyun-Jong; Kim, Eun-Jung; Lee, Sanghoon; Nam, Dongwoo

2017-06-23

Many patients experience acute lower back pain that becomes chronic pain. The proportion of patients using complementary and alternative medicine to treat lower back is increasing. Even though several moxibustion clinical trials for lower back pain have been conducted, the effectiveness and safety of moxibustion intervention is controversial. The purpose of this study protocol for a systematic review is to evaluate the effectiveness and safety of moxibustion treatment for non-specific lower back pain patients. We will conduct an electronic search of several databases from their inception to May 2017, including Embase, PubMed, Cochrane Central Register of Controlled Trial, Allied and Complementary Medicine Database, Wanfang Database, Chongqing VIP Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure Database, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Oriental Medicine Advanced Searching Integrated System, the Korea Institute of Science and Technology, and KoreaMed. Randomised controlled trials investigating any type of moxibustion treatment will be included. The primary outcome will be pain intensity and functional status/disability due to lower back pain. The secondary outcome will be a global measurement of recovery or improvement, work-related outcomes, radiographic improvement of structure, quality of life, and adverse events (presence or absence). Risk ratio or mean differences with a 95% confidence interval will be used to show the effect of moxibustion therapy when it is possible to conduct a meta-analysis. This review will be published in a peer-reviewed journal and will be presented at an international academic conference for dissemination. Our results will provide current evidence of the effectiveness and safety of moxibustion treatment in non-specific lower back pain patients, and thus will be beneficial to patients, practitioners, and policymakers. CRD42016047468 in PROSPERO 2016. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Vulnerability of Occupational Health and Safety to Deregulation: The Weakening of Information Regulations during the Economic Crisis in Korea.

PubMed

Jhang, Won Gi

2018-05-01

This study was conducted to investigate the causes and consequences of the vulnerability of occupational health and safety (OHS) regulations to deregulation during a period of economic crisis in the Republic of Korea. Analysis of Korea's national regulation database revealed that the vulnerability of OHS regulations to deregulation was related to the fact that OHS policy included many regulations without direct deregulatory impacts on workers. The most affected victim of this characteristic was information regulation that provided a legal basis for government's monitoring and inspection of OHS activities. The massive relaxation of information regulation has the potential to weaken government oversight and to tempt businesses to hide industrial accidents. Since changes in regulations without direct deregulatory impacts are not easily identifiable by workers, careful monitoring of deregulation is necessary to prevent policy impacts harmful to workers' health and safety.

Immunization against social fear learning.

PubMed

Golkar, Armita; Olsson, Andreas

2016-06-01

Social fear learning offers an efficient way to transmit information about potential threats; little is known, however, about the learning processes that counteract the social transmission of fear. In three separate experiments, we found that safety information transmitted from another individual (i.e., demonstrator) during preexposure prevented subsequent observational fear learning (Experiments 1-3), and this effect was maintained in a new context involving direct threat confrontation (Experiment 3). This protection from observational fear learning was specific to conditions in which information about both safety and danger was transmitted from the same demonstrator (Experiments 2-3) and was unaffected by increasing the number of the safety demonstrators (Experiment 3). Collectively, these findings demonstrate that observational preexposure can limit social transmission of fear. Future research is needed to better understand the conditions under which such effects generalize across individual demonstrators. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Cost effective nuclear commercial grade dedication

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

Maletz, J.J.; Marston, M.J.

1991-01-01

This paper describes a new computerized database method to create/edit/view specification technical data sheets (mini-specifications) for procurement of spare parts for nuclear facility maintenance and to develop information that could support possible future facility life extension efforts. This method may reduce cost when compared with current manual methods. The use of standardized technical data sheets (mini-specifications) for items of the same category improves efficiency. This method can be used for a variety of tasks, including: Nuclear safety-related procurement; Non-safety related procurement; Commercial grade item procurement/dedication; Evaluation of replacement items. This program will assist the nuclear facility in upgrading its procurementmore » activities consistent with the recent NUMARC Procurement Initiative. Proper utilization of the program will assist the user in assuring that the procured items are correct for the applications, provide data to assist in detecting fraudulent materials, minimize human error in withdrawing database information, improve data retrievability, improve traceability, and reduce long-term procurement costs.« less

Comparison of two drug safety signals in a pharmacovigilance data mining framework.

PubMed

Tubert-Bitter, Pascale; Bégaud, Bernard; Ahmed, Ismaïl

2016-04-01

Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database. © The Author(s) 2012.

Preliminary Results Obtained in Integrated Safety Analysis of NASA Aviation Safety Program Technologies

NASA Technical Reports Server (NTRS)

2005-01-01

This is a listing of recent unclassified RTO technical publications for January 1, 2005 through March 31, 2005 processed by the NASA Center for AeroSpace Center available on the NASA Aeronautics and Space Database. Contents include 1) Electronic Information Management; 2) Decision Support to Combined Joint Task Force and Component Commanders; 3) RTO Technical Publications : A Quarterly Listing (December 2004); 4) The Role of Humans in Intelligent and Automated Systems.

The development and application of electronic information system for safety administration of newborns in the rooming-in care.

PubMed

Wang, Fang; Dong, Jian-Cheng; Chen, Jian-Rong; Wu, Hui-Qun; Liu, Man-Hua; Xue, Li-Ly; Zhu, Xiang-Hua; Wang, Jian

2015-01-01

To independently research and develop an electronic information system for safety administration of newborns in the rooming-in care, and to investigate the effects of its clinical application. By VS 2010 SQL SERVER 2005 database and adopting Microsoft visual programming tool, an interactive mobile information system was established, with integrating data, information and knowledge with using information structures, information processes and information technology. From July 2011 to July 2012, totally 210 newborns from the rooming-in care of the Obstetrics Department of the Second Affiliated Hospital of Nantong University were chosen and randomly divided into two groups: the information system monitoring group (110 cases) and the regular monitoring group (100 cases). Incidence of abnormal events and degree of satisfaction were recorded and calculated. ① The wireless electronic information system has four main functions including risk scaling display, identity recognition display, nursing round notes board and health education board; ② statistically significant differences were found between the two groups both on the active or passive discovery rate of abnormal events occurred in the newborns (P<0.05) and the satisfaction degree of the mothers and their families (P<0.05); ③ the system was sensitive and reliable, and the wireless transmission of information was correct and safety. The system is with high practicability in the clinic and can ensure the safety for the newborns with improved satisfactions.

Generating PubMed Chemical Queries for Consumer Health Literature

PubMed Central

Loo, Jeffery; Chang, Hua Florence; Hochstein, Colette; Sun, Ying

2005-01-01

Two popular NLM resources that provide information for consumers about chemicals and their safety are the Household Products Database and Haz-Map. Search queries to PubMed via web links were generated from these databases. The query retrieves consumer health-oriented literature about adverse effects of chemicals. The retrieval was limited to a manageable set of 20 to 60 citations, achieved by successively applying increasing limits to the search until the desired number of references was reached. PMID:16779322

Are automatic systems the future of motorcycle safety? A novel methodology to prioritize potential safety solutions based on their projected effectiveness.

PubMed

Gil, Gustavo; Savino, Giovanni; Piantini, Simone; Baldanzini, Niccolò; Happee, Riender; Pierini, Marco

2017-11-17

Motorcycle riders are involved in significantly more crashes per kilometer driven than passenger car drivers. Nonetheless, the development and implementation of motorcycle safety systems lags far behind that of passenger cars. This research addresses the identification of the most effective motorcycle safety solutions in the context of different countries. A knowledge-based system of motorcycle safety (KBMS) was developed to assess the potential for various safety solutions to mitigate or avoid motorcycle crashes. First, a set of 26 common crash scenarios was identified from the analysis of multiple crash databases. Second, the relative effectiveness of 10 safety solutions was assessed for the 26 crash scenarios by a panel of experts. Third, relevant information about crashes was used to weigh the importance of each crash scenario in the region studied. The KBMS method was applied with an Italian database, with a total of more than 1 million motorcycle crashes in the period 2000-2012. When applied to the Italian context, the KBMS suggested that automatic systems designed to compensate for riders' or drivers' errors of commission or omission are the potentially most effective safety solution. The KBMS method showed an effective way to compare the potential of various safety solutions, through a scored list with the expected effectiveness of each safety solution for the region to which the crash data belong. A comparison of our results with a previous study that attempted a systematic prioritization of safety systems for motorcycles (PISa project) showed an encouraging agreement. Current results revealed that automatic systems have the greatest potential to improve motorcycle safety. Accumulating and encoding expertise in crash analysis from a range of disciplines into a scalable and reusable analytical tool, as proposed with the use of KBMS, has the potential to guide research and development of effective safety systems. As the expert assessment of the crash scenarios is decoupled from the regional crash database, the expert assessment may be reutilized, thereby allowing rapid reanalysis when new crash data become available. In addition, the KBMS methodology has potential application to injury forecasting, driver/rider training strategies, and redesign of existing road infrastructure.

Road Risk Modeling and Cloud-Aided Safety-Based Route Planning.

PubMed

Li, Zhaojian; Kolmanovsky, Ilya; Atkins, Ella; Lu, Jianbo; Filev, Dimitar P; Michelini, John

2016-11-01

This paper presents a safety-based route planner that exploits vehicle-to-cloud-to-vehicle (V2C2V) connectivity. Time and road risk index (RRI) are considered as metrics to be balanced based on user preference. To evaluate road segment risk, a road and accident database from the highway safety information system is mined with a hybrid neural network model to predict RRI. Real-time factors such as time of day, day of the week, and weather are included as correction factors to the static RRI prediction. With real-time RRI and expected travel time, route planning is formulated as a multiobjective network flow problem and further reduced to a mixed-integer programming problem. A V2C2V implementation of our safety-based route planning approach is proposed to facilitate access to real-time information and computing resources. A real-world case study, route planning through the city of Columbus, Ohio, is presented. Several scenarios illustrate how the "best" route can be adjusted to favor time versus safety metrics.

Environment/Health/Safety (EHS): Databases

Science.gov Websites

Hazard Documents Database Biosafety Authorization System CATS (Corrective Action Tracking System) (for findings 12/2005 to present) Chemical Management System Electrical Safety Ergonomics Database (for new Learned / Best Practices REMS - Radiation Exposure Monitoring System SJHA Database - Subcontractor Job

From ontology selection and semantic web to an integrated information system for food-borne diseases and food safety.

PubMed

Yan, Xianghe; Peng, Yun; Meng, Jianghong; Ruzante, Juliana; Fratamico, Pina M; Huang, Lihan; Juneja, Vijay; Needleman, David S

2011-01-01

Several factors have hindered effective use of information and resources related to food safety due to inconsistency among semantically heterogeneous data resources, lack of knowledge on profiling of food-borne pathogens, and knowledge gaps among research communities, government risk assessors/managers, and end-users of the information. This paper discusses technical aspects in the establishment of a comprehensive food safety information system consisting of the following steps: (a) computational collection and compiling publicly available information, including published pathogen genomic, proteomic, and metabolomic data; (b) development of ontology libraries on food-borne pathogens and design automatic algorithms with formal inference and fuzzy and probabilistic reasoning to address the consistency and accuracy of distributed information resources (e.g., PulseNet, FoodNet, OutbreakNet, PubMed, NCBI, EMBL, and other online genetic databases and information); (c) integration of collected pathogen profiling data, Foodrisk.org ( http://www.foodrisk.org ), PMP, Combase, and other relevant information into a user-friendly, searchable, "homogeneous" information system available to scientists in academia, the food industry, and government agencies; and (d) development of a computational model in semantic web for greater adaptability and robustness.

Construction of a database for published phase II/III drug intervention clinical trials for the period 2009-2014 comprising 2,326 records, 90 disease categories, and 939 drug entities.

PubMed

Jeong, Sohyun; Han, Nayoung; Choi, Boyoon; Sohn, Minji; Song, Yun-Kyoung; Chung, Myeon-Woo; Na, Han-Sung; Ji, Eunhee; Kim, Hyunah; Rhew, Ki Yon; Kim, Therasa; Kim, In-Wha; Oh, Jung Mi

2016-06-01

To construct a database of published clinical drug trials suitable for use 1) as a research tool in accessing clinical trial information and 2) in evidence-based decision-making by regulatory professionals, clinical research investigators, and medical practitioners. Comprehensive information obtained from a search of design elements and results of clinical trials in peer reviewed journals using PubMed (http://www.ncbi.nlm.ih.gov/pubmed). The methodology to develop a structured database was devised by a panel composed of experts in medical, pharmaceutical, information technology, and members of Ministry of Food and Drug Safety (MFDS) using a step by step approach. A double-sided system consisting of user mode and manager mode served as the framework for the database; elements of interest from each trial were entered via secure manager mode enabling the input information to be accessed in a user-friendly manner (user mode). Information regarding methodology used and results of drug treatment were extracted as detail elements of each data set and then inputted into the web-based database system. Comprehensive information comprising 2,326 clinical trial records, 90 disease states, and 939 drugs entities and concerning study objectives, background, methods used, results, and conclusion could be extracted from published information on phase II/III drug intervention clinical trials appearing in SCI journals within the last 10 years. The extracted data was successfully assembled into a clinical drug trial database with easy access suitable for use as a research tool. The clinically most important therapeutic categories, i.e., cancer, cardiovascular, respiratory, neurological, metabolic, urogenital, gastrointestinal, psychological, and infectious diseases were covered by the database. Names of test and control drugs, details on primary and secondary outcomes and indexed keywords could also be retrieved and built into the database. The construction used in the database enables the user to sort and download targeted information as a Microsoft Excel spreadsheet. Because of the comprehensive and standardized nature of the clinical drug trial database and its ease of access it should serve as valuable information repository and research tool for accessing clinical trial information and making evidence-based decisions by regulatory professionals, clinical research investigators, and medical practitioners.

Patient handover in orthopaedics, improving safety using Information Technology.

PubMed

Pearkes, Tim

2015-01-01

Good inpatient handover ensures patient safety and continuity of care. An adjunct to this is the patient list which is routinely managed by junior doctors. These lists are routinely created and managed within Microsoft Excel or Word. Following the merger of two orthopaedic departments into a single service in a new hospital, it was felt that a number of safety issues within the handover process needed to be addressed. This quality improvement project addressed these issues through the creation and implementation of a new patient database which spanned the department, allowing trouble free, safe, and comprehensive handover. Feedback demonstrated an improved user experience, greater reliability, continuity within the lists and a subsequent improvement in patient safety.

Sandia National Laboratories/New Mexico Environmental Information Document - Volume 1

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

BAYLISS, LINDA S.; GUERRERO, JOSEPH V.; JOHNS, WILLIAM H.

This Sandia National Laboratories/New Mexico Environmental Information Document (EID) compiles information on the existing environment, or environmental baseline, for SNUNM. Much of the information is drawn from existing reports and databases supplemented by new research and data. The SNL/NM EID, together with the Sandia National Laboratories/New Mexico Facilities and Safety Information Document, provide a basis for assessing the environment, safety, and health aspects of operating selected facilities at SNL/NM. The environmental baseline provides a record of the existing physical, biological, and socioeconomic environment at SNL/NLM prior to being altered (beneficially or adversely) by proposed programs or projects. More specifically, themore » EID provides information on the following topics: Geology; Land Use; Hydrology and Water Resources; Air Quality and Meteorology; Ecology; Noise and Vibration; Cultural Resources; Visual Resources; Socioeconomic and Community Services; Transportation; Material Management; Waste Management; and Regulatory Requirements.« less

The National Map - Orthoimagery Layer

USGS Publications Warehouse

,

2007-01-01

Many Federal, State, and local agencies use a common set of framework geographic information databases as a tool for economic and community development, land and natural resource management, and health and safety services. Emergency management and homeland security applications rely on this information. Private industry, nongovernmental organizations, and individual citizens use the same geographic data. Geographic information underpins an increasingly large part of the Nation's economy. The U.S. Geological Survey (USGS) is developing The National Map to be a seamless, continually maintained, and nationally consistent set of online, public domain, framework geographic information databases. The National Map will serve as a foundation for integrating, sharing, and using data easily and consistently. The data will be the source of revised paper topographic maps. The National Map includes digital orthorectified imagery; elevation data; vector data for hydrography, transportation, boundary, and structure features; geographic names; and land cover information.

Incident reporting in one UK accident and emergency department.

PubMed

Tighe, Catherine M; Woloshynowych, Maria; Brown, Ruth; Wears, Bob; Vincent, Charles

2006-01-01

Greater focus is needed on improving patient safety in modern healthcare systems and the first step to achieving this is to reliably identify the safety issues arising in healthcare. Research has shown the accident and emergency (A&E) department to be a particularly problematic environment where safety is a concern due to various factors, such as the range, nature and urgency of presenting conditions and the high turnover of patients. As in all healthcare environments clinical incident reporting in A&E is an important tool for detecting safety issues which can result in identifying solutions, learning from error and enhancing patient safety. This tool must be responsive and flexible to the local circumstances and work for the department to support the clinical governance agenda. In this paper, we describe the local processes for reporting and reviewing clinical incidents in one A&E department in a London teaching hospital and report recent changes to the system within the department. We used the historical data recorded on the Trust incident database as a representation of the information that would be available to the department in order to identify the high risk areas. In this paper, we evaluate the internal processes, the information available on the database and make recommendations to assist the emergency department in their internal processes. These will strengthen the internal review and staff feedback system so that the department can learn from incidents in a consistent manner. The process was reviewed by detailed examination of the centrally held electronic record (Datix database) of all incidents reported in a one year period. The nature of the incident and the level and accuracy of information provided in the incident reports was evaluated. There were positive aspects to the established system including evidence of positive changes made as a result of the reporting process, new initiatives to feedback to staff, and evolution of the programme for reporting and discussing the incidents internally. There appeared to be a mismatch between the recorded events and the category allocated to the incident in the historical record. In addition the database did not contain complete information for every incident, contributory factors were rarely recorded and relatively large numbers of incidents were recorded as "other" in the type of incident. There was also observed difficulty in updating the system as there is at least a months time lag between reporting or an incident and discussion/resolution of issues at the local departmental clinical risk management committee meetings. We used Leape's model for assessing the reporting system as a whole and found the system in the department to be relatively safe, fairly easy to use and moderately effective. Recommendations as a result of this study include the introduction of an electronic reporting system, limiting the number of staff who categorise the incidents--using clear definitions for classifications including a structured framework for contributory factors, and a process that allows incidents to be updated on the database locally after the discussion. This research may have implications for the incident reporting process in other specialities as well as in other hospitals.

Food traceability systems in China: The current status of and future perspectives on food supply chain databases, legal support, and technological research and support for food safety regulation.

PubMed

Tang, Qi; Li, Jiajia; Sun, Mei; Lv, Jun; Gai, Ruoyan; Mei, Lin; Xu, Lingzhong

2015-02-01

Over the past few decades, the field of food security has witnessed numerous problems and incidents that have garnered public attention. Given this serious situation, the food traceability system (FTS) has become part of the expanding food safety continuum to reduce the risk of food safety problems. This article reviews a great deal of the related literature and results from previous studies of FTS to corroborate this contention. This article describes the development and benefits of FTS in developed countries like the United States of America (USA), Japan, and some European countries. Problems with existing FTS in China are noted, including a lack of a complete database, inadequate laws and regulations, and lagging technological research into FTS. This article puts forward several suggestions for the future, including improvement of information websites, clarification of regulatory responsibilities, and promotion of technological research.

Text mining to decipher free-response consumer complaints: insights from the NHTSA vehicle owner's complaint database.

PubMed

Ghazizadeh, Mahtab; McDonald, Anthony D; Lee, John D

2014-09-01

This study applies text mining to extract clusters of vehicle problems and associated trends from free-response data in the National Highway Traffic Safety Administration's vehicle owner's complaint database. As the automotive industry adopts new technologies, it is important to systematically assess the effect of these changes on traffic safety. Driving simulators, naturalistic driving data, and crash databases all contribute to a better understanding of how drivers respond to changing vehicle technology, but other approaches, such as automated analysis of incident reports, are needed. Free-response data from incidents representing two severity levels (fatal incidents and incidents involving injury) were analyzed using a text mining approach: latent semantic analysis (LSA). LSA and hierarchical clustering identified clusters of complaints for each severity level, which were compared and analyzed across time. Cluster analysis identified eight clusters of fatal incidents and six clusters of incidents involving injury. Comparisons showed that although the airbag clusters across the two severity levels have the same most frequent terms, the circumstances around the incidents differ. The time trends show clear increases in complaints surrounding the Ford/Firestone tire recall and the Toyota unintended acceleration recall. Increases in complaints may be partially driven by these recall announcements and the associated media attention. Text mining can reveal useful information from free-response databases that would otherwise be prohibitively time-consuming and difficult to summarize manually. Text mining can extend human analysis capabilities for large free-response databases to support earlier detection of problems and more timely safety interventions.

SaferProducts.gov

MedlinePlus

... Register & Respond Search Recalls & Reports About Questions Welcome Consumers Report your unsafe product on SaferProducts.gov. Tell CPSC. ... Unsafe Product Business Sign In Search Recalls/Repairs & Reports Advanced Search Most ... does not guarantee the accuracy, completeness, or adequacy of the contents of the Publicly Available Consumer Product Safety Information Database on SaferProducts.gov, particularly ...

49 CFR 236.1023 - Errors and malfunctions.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., the railroad shall maintain a database of all safety-relevant hazards as set forth in the PTCSP and... next business day; (2) Be transmitted in a manner and form acceptable to the Associate Administrator... information shall be forwarded to the Associate Administrator as soon as practicable in supplemental reports...

49 CFR 236.1023 - Errors and malfunctions.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., the railroad shall maintain a database of all safety-relevant hazards as set forth in the PTCSP and... next business day; (2) Be transmitted in a manner and form acceptable to the Associate Administrator... information shall be forwarded to the Associate Administrator as soon as practicable in supplemental reports...

49 CFR 236.1023 - Errors and malfunctions.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., the railroad shall maintain a database of all safety-relevant hazards as set forth in the PTCSP and... next business day; (2) Be transmitted in a manner and form acceptable to the Associate Administrator... information shall be forwarded to the Associate Administrator as soon as practicable in supplemental reports...

49 CFR 236.1023 - Errors and malfunctions.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., the railroad shall maintain a database of all safety-relevant hazards as set forth in the PTCSP and... next business day; (2) Be transmitted in a manner and form acceptable to the Associate Administrator... information shall be forwarded to the Associate Administrator as soon as practicable in supplemental reports...

49 CFR 236.1023 - Errors and malfunctions.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., the railroad shall maintain a database of all safety-relevant hazards as set forth in the PTCSP and... next business day; (2) Be transmitted in a manner and form acceptable to the Associate Administrator... information shall be forwarded to the Associate Administrator as soon as practicable in supplemental reports...

Identifying and Synchronizing Health Information Technology (HIT) Events from FDA Medical Device Reports.

PubMed

Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang

2017-01-01

Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.

Leader humility and team creativity: The role of team information sharing, psychological safety, and power distance.

PubMed

Hu, Jia; Erdogan, Berrin; Jiang, Kaifeng; Bauer, Talya N; Liu, Songbo

2018-03-01

In this study, we identify leader humility, characterized by being open to admitting one's limitations, shortcomings, and mistakes, and showing appreciation and giving credit to followers, as a critical leader characteristic relevant for team creativity. Integrating the literatures on creativity and leadership, we explore the relationship between leader humility and team creativity, treating team psychological safety and team information sharing as mediators. Further, we hypothesize and examine team power distance as a moderator of the relationship. We tested our hypotheses using data gathered from 72 work teams and 354 individual members from 11 information and technology firms in China using a multiple-source, time-lagged research design. We found that the positive relationship between leader humility and team information sharing was significant and positive only within teams with a low power distance value. In addition, leader humility was negatively related to team psychological safety in teams with a high power distance value, whereas the relationship was positive yet nonsignificant in teams with low power distance. Furthermore, team information sharing and psychological safety were both significantly related to team creativity. We discuss theoretical and practical implications for leadership and work teams. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Who knows the risk? A multilevel study of systematic variations in work-related safety knowledge in the European workforce.

PubMed

Dragano, Nico; Lunau, Thorsten; Eikemo, Terje A; Toch-Marquardt, Marlen; van der Wel, Kjetil A; Bambra, Clare

2015-08-01

Health and safety instructions are important components of occupational prevention. Albeit instruction is mandatory in most countries, research suggests that safety knowledge varies among the workforce. We analysed a large European sample to explore if all subgroups of employees are equally reached. In a comparative perspective, we also investigated if country-level determinants influence the variance of safety knowledge between countries. We used data on 24,534 employees from 27 countries who participated in the 2010 European Working Conditions Survey. Safety knowledge was measured as self-assessed quality of safety information. Country-level determinants were added from Eurostat databases (gross domestic product) and the European Survey of Enterprises on New and Emerging Risks (ESENER) study (% companies with A: safety plan or B: a labour inspectorate visit). Associations between knowledge, sociodemographic, occupational characteristics and macrodeterminants were studied with hierarchical regression models. In our sample, 10.1% reported a low degree of health and safety knowledge. Across all countries, younger workers, lower educated workers, production workers, private sector employees, those with less job experience or a temporary contract, or those who work in small businesses were more likely to report low levels of information. Moreover, low information prevalence varied by country. Countries with a high proportion of companies with a safety plan and recent labour inspectorate on-site visits had higher proportions of informed workers. A vast majority reported to be well informed about safety risks but systematic inequalities in the degree of knowledge between subgroups were evident. Further efforts on the workplace, the organisational and the political level are needed to universally implement existing occupational safety regulations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

Calm, J.M.

The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufactures and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air-conditioning and refrigeration equipment. The complete documents are not included, though some maymore » be added at a later date. The database identifies sources of specific information on many refrigerants including propane, ammonia, water, carbon dioxide, propylene, ethers, and others as well as azeotropic and zeotropic blends of these fluids. It addresses lubricants including alkylbenzene, polyalkylene glycol, polyolester, and other synthetics as well as mineral oils. It also references documents addressing compatibility of refrigerants and lubricants with metals, plastics, elastomers, motor insulation, and other materials used in refrigerant circuits. Incomplete citations or abstracts are provided for some documents. They are included to accelerate availability of the information and will be completed or replaced in future updates.« less

Agricultural Safety and Health: A Resource Guide. Rural Information Center Publication Series, No. 40. Revised Edition.

ERIC Educational Resources Information Center

Zimmerman, Joy, Comp.

This guide lists resource materials that address agricultural occupational injuries and diseases and their prevention. Many of the entries were derived from the AGRICOLA database produced by the National Agricultural Library and include journal articles, books, government reports, training materials, and audiovisual materials. The first section…

[Registry of the Italian Institute for Occupational Prevention and Safety of local productive units: methodology and structure].

PubMed

Scarselli, A; Leva, A; Campo, G; Marconi, M; Nesti, M; Erba, P

2005-01-01

The Italian Institute for Occupational Prevention and Safety (ISPESL) carried out a register of enterprises operating in industry, services and agriculture sector to provide information on their location, economical activity and occupational data. This database has been built merging administrative files from the National Institute of Social Security (INPS) and the Computer Science Society of Italian Chambers of Commerce (InfoCamere). Enterprises have been classified by economic sector - in accordance with ISTAT (National Statistics Institute) "Ateco91" classification--and by accuracy level of the record linkage. In details, three different subsystems have been set up: (A) enterprises satisfying linkage; (B) enterprises in InfoCamere file not linked with INPS file; (C) enterprises in INPS file not linked with InfoCamere file. In the whole, 6.026.676 factories have been collected, of which 1.188.784 in group A, 4.543.091 in group B and 294.801 in group C. Establishing a database of information on industries may be useful to improve preventive programs and to plan health care surveillance systems.

Validating crash locations for quantitative spatial analysis: a GIS-based approach.

PubMed

Loo, Becky P Y

2006-09-01

In this paper, the spatial variables of the crash database in Hong Kong from 1993 to 2004 are validated. The proposed spatial data validation system makes use of three databases (the crash, road network and district board databases) and relies on GIS to carry out most of the validation steps so that the human resource required for manually checking the accuracy of the spatial data can be enormously reduced. With the GIS-based spatial data validation system, it was found that about 65-80% of the police crash records from 1993 to 2004 had correct road names and district board information. In 2004, the police crash database contained about 12.7% mistakes for road names and 9.7% mistakes for district boards. The situation was broadly comparable to the United Kingdom. However, the results also suggest that safety researchers should carefully validate spatial data in the crash database before scientific analysis.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

PubMed

Lu, Zhengwu

2009-01-01

Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

Stent thrombosis with bioabsorbable polymer drug-eluting stents: insights from the Food and Drug Administration database.

PubMed

Khan, Abdur R; Tripathi, Avnish; Farid, Talha A; Abaid, Bilal; Bhatt, Deepak L; Resar, Jon R; Flaherty, Michael P

2017-11-01

SYNERGY, a bioabsorbable polymer-based, everolimus-eluting stent (BP-DES), recently received regulatory approval in the USA for use in percutaneous coronary interventions. Yet, information on the safety of BP-DES in routine clinical practice is limited. Our aim was to compare the safety of the recently approved BP-DES with current durable polymer drug-eluting stents (DP-DES) by analyzing adverse events, namely, stent thrombosis (ST), reported to the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database requires nationwide mandatory notification for adverse events on devices approved for clinical use. This database was searched for adverse events reported between 1 October 2015 and 25 December 2016, encountered after the placement of either BP-DES or DP-DES. Only those adverse events were included where the exposure period to the stents was comparable after the index procedure. Of all the adverse events reported, the event of interest was ST. A total of 951 adverse events were reported. ST occurred in 48/951 of all events, 31/309 and 17/642 when BP-DES or DP-DES were used, respectively (P=0.00001). Of the 31 ST events with BP-DES, 68% (21/31) occurred within less than or equal to 24 h of the index procedure and 52% (16/31) occurred within less than or equal to 2 h. Our results raise the possibility of an increased risk of ST, particularly early ST (within 24 h), with the recently approved BP-DES. However, because of the inherent limitations of reporting within the MAUDE database, these data merely highlight a potential need for additional surveillance and randomized trials to assess further the safety of the bioabsorbable platform.

The Impact of Environment and Occupation on the Health and Safety of Active Duty Air Force Members - Database Development and De-Identification

DTIC Science & Technology

2015-04-01

et al. Work , obesity , and occupational safety and health . Am J Public Health . 2007; 97(3):428-436. 7. Grunberg L, Moore S, Anderson-Connolly R...AFRL-SA-WP-SR-2015-0005 The Impact of Environment and Occupation on the Health and Safety of Active Duty Air Force Members – Database...TITLE AND SUBTITLE The Impact of Environment and Occupation on the Health and Safety of Active Duty Air Force Members – Database Development and De

Oral administration of herbal medicines for radiation pneumonitis in lung cancer patients: A systematic review and meta-analysis

PubMed Central

Baek, Hyunjung; Kim, Jae-Hyo; Lee, Beom-Joon

2018-01-01

Background Radiation pneumonitis is a common and serious complication of radiotherapy. Many published randomized controlled studies (RCTs) reveal a growing trend of using herbal medicines as adjuvant therapy to prevent radiation pneumonitis; however, their efficacy and safety remain unexplored. Objective The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines as adjunctive therapy for the prevention of radiation pneumonitis in patients with lung cancer who undergo radiotherapy. Methods We searched the following 11 databases: three English medical databases [MEDLINE (PubMed), EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL)], five Korean medical databases (Korean Studies Information, Research information Service System, KoreaMed, DBPIA, National Digital Science Library), and three Chinese medical databases [the China National Knowledge Database (CNKI), Journal Integration Platform (VIP), and WanFang Database]. The primary outcome was the incidence of radiation pneumonitis. The risk of bias was assessed using the Cochrane risk-of-bias tool. Results Twenty-two RCTs involving 1819 participants were included. The methodological quality was poor for most of the studies. Meta-analysis showed that herbal medicines combined with radiotherapy significantly reduced the incidence of radiation pneumonitis (n = 1819; RR 0.53, 95% CI 0.45–0.63, I2 = 8%) and the incidence of severe radiation pneumonitis (n = 903; RR 0.22, 95% CI 0.11–0.41, I2 = 0%). Combined therapy also improved the Karnofsky performance score (n = 420; WMD 4.62, 95% CI 1.05–8.18, I2 = 82%). Conclusion There is some encouraging evidence that oral administration of herbal medicines combined with radiotherapy may benefit patients with lung cancer by preventing or minimizing radiation pneumonitis. However, due to the poor methodological quality of the identified studies, definitive conclusion could not be drawn. To confirm the merits of this approach, further rigorously designed large scale trials are warranted. PMID:29847598

The Microbial Rosetta Stone Database: A compilation of global and emerging infectious microorganisms and bioterrorist threat agents

PubMed Central

Ecker, David J; Sampath, Rangarajan; Willett, Paul; Wyatt, Jacqueline R; Samant, Vivek; Massire, Christian; Hall, Thomas A; Hari, Kumar; McNeil, John A; Büchen-Osmond, Cornelia; Budowle, Bruce

2005-01-01

Background Thousands of different microorganisms affect the health, safety, and economic stability of populations. Many different medical and governmental organizations have created lists of the pathogenic microorganisms relevant to their missions; however, the nomenclature for biological agents on these lists and pathogens described in the literature is inexact. This ambiguity can be a significant block to effective communication among the diverse communities that must deal with epidemics or bioterrorist attacks. Results We have developed a database known as the Microbial Rosetta Stone. The database relates microorganism names, taxonomic classifications, diseases, specific detection and treatment protocols, and relevant literature. The database structure facilitates linkage to public genomic databases. This paper focuses on the information in the database for pathogens that impact global public health, emerging infectious organisms, and bioterrorist threat agents. Conclusion The Microbial Rosetta Stone is available at . The database provides public access to up-to-date taxonomic classifications of organisms that cause human diseases, improves the consistency of nomenclature in disease reporting, and provides useful links between different public genomic and public health databases. PMID:15850481

Health information technology and hospital patient safety: a conceptual model to guide research.

PubMed

Paez, Kathryn; Roper, Rebecca A; Andrews, Roxanne M

2013-09-01

The literature indicates that health information technology (IT) use may lead to some gains in the quality and safety of care in some situations but provides little insight into this variability in the results that has been found. The inconsistent findings point to the need for a conceptual model that will guide research in sorting out the complex relationships between health IT and the quality and safety of care. A conceptual model was developed that describes how specific health IT functions could affect different types of inpatient safety errors and that include contextual factors that influence successful health IT implementation. The model was applied to a readily available patient safety measure and nationwide data (2009 AHA Annual Survey Information Technology Supplement and 2009 Healthcare Cost and Utilization Project State Inpatient Databases). The model was difficult to operationalize because (1) available health IT adoption data did not characterize health IT features and extent of usage, and (2) patient safety measures did not elucidate the process failures leading to safety-related outcomes. The sample patient safety measure--Postoperative Physiologic and Metabolic Derangement Rate--was not significantly related to self-reported health IT capabilities when adjusted for hospital structural characteristics. These findings illustrate the critical need for collecting data that are germane to health IT and the possible mechanisms by which health IT may affect inpatient safety. Well-defined and sufficiently granular measures of provider's correct use of health IT functions, the contextual factors surrounding health IT use, and patient safety errors leading to health care-associated conditions are needed to illuminate the impact of health IT on patient safety.

Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

PubMed

Liedert, B; Bassus, S; Schneider, C K; Kalinke, U; Löwer, J

2007-01-01

This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

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.

Database and Management Information Support for the U.S. Army SBIR program

DTIC Science & Technology

1994-06-10

milestones under the new process. BRTRC also supported preparations for a video teleconference between Mr. George Singley, the Deputy Assistant...Bob Wrenn, the in the sotware package. It should go smoothly; however, DoD SBIR Program Manager, and the in the interest of safety, please do not...144,206 autostereoscopic video ...................................................... 139 beam processing

Driver acceptance of commercial vehicle operations (CVO) technology in the motor carrier environment. Executive summary, Critical issues relating to acceptance of technology by interstate truck and bus drivers

DOT National Transportation Integrated Search

2000-05-01

The California database incorporated in the Highway Safety Information System (HSIS) is derived from the California TASAS (Traffic Accident Surveillance and Analysis System). The system, maintained by the Traffic Operations Office of Caltrans, is a m...

Quality and Safety in Health Care, Part XXIX: The Transcatheter Valve Therapy Registry.

PubMed

Harolds, Jay A

2017-11-01

The American College of Cardiology, the Society of Thoracic Surgeons, and other organizations cooperated to form the Transcatheter Valve Therapy Registry. This registry studies information on the outcome of valve therapy device placement with a transcatheter approach. The companies that manufacture these devices can use the registry to meet the post-product sale surveillance requirements of the US Food and Drug Administration. There will also be linkage to the registry information from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, which has information on open cardiac valve surgery.

Certifiable database generation for SVS

NASA Astrophysics Data System (ADS)

Schiefele, Jens; Damjanovic, Dejan; Kubbat, Wolfgang

2000-06-01

In future aircraft cockpits SVS will be used to display 3D physical and virtual information to pilots. A review of prototype and production Synthetic Vision Displays (SVD) from Euro Telematic, UPS Advanced Technologies, Universal Avionics, VDO-Luftfahrtgeratewerk, and NASA, are discussed. As data sources terrain, obstacle, navigation, and airport data is needed, Jeppesen-Sanderson, Inc. and Darmstadt Univ. of Technology currently develop certifiable methods for acquisition, validation, and processing methods for terrain, obstacle, and airport databases. The acquired data will be integrated into a High-Quality Database (HQ-DB). This database is the master repository. It contains all information relevant for all types of aviation applications. From the HQ-DB SVS relevant data is retried, converted, decimated, and adapted into a SVS Real-Time Onboard Database (RTO-DB). The process of data acquisition, verification, and data processing will be defined in a way that allows certication within DO-200a and new RTCA/EUROCAE standards for airport and terrain data. The open formats proposed will be established and evaluated for industrial usability. Finally, a NASA-industry cooperation to develop industrial SVS products under the umbrella of the NASA Aviation Safety Program (ASP) is introduced. A key element of the SVS NASA-ASP is the Jeppesen lead task to develop methods for world-wide database generation and certification. Jeppesen will build three airport databases that will be used in flight trials with NASA aircraft.

Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

PubMed

Johansson, Saga; Wallander, Mari-Ann; de Abajo, Francisco J; García Rodríguez, Luis Alberto

2010-03-01

Post-launch drug safety monitoring is essential for the detection of adverse drug signals that may be missed during preclinical trials. Traditional methods of postmarketing surveillance such as spontaneous reporting have intrinsic limitations, many of which can be overcome by the additional application of structured pharmacoepidemiological approaches. However, further improvement in drug safety monitoring requires a shift towards more proactive pharmacoepidemiological methods that can detect adverse drug signals as they occur in the population. To assess the feasibility of using proactive monitoring of an electronic medical record system, in combination with an independent endpoint adjudication committee, to detect adverse events among users of selected drugs. UK General Practice Research Database (GPRD) information was used to detect acute liver disorder associated with the use of amoxicillin/clavulanic acid (hepatotoxic) or low-dose aspirin (acetylsalicylic acid [non-hepatotoxic]). Individuals newly prescribed these drugs between 1 October 2005 and 31 March 2006 were identified. Acute liver disorder cases were assessed using GPRD computer records in combination with case validation by an independent endpoint adjudication committee. Signal generation thresholds were based on the background rate of acute liver disorder in the general population. Over a 6-month period, 8148 patients newly prescribed amoxicillin/clavulanic acid and 5577 patients newly prescribed low-dose aspirin were identified. Within this cohort, searches identified 11 potential liver disorder cases from computerized records: six for amoxicillin/clavulanic acid and five for low-dose aspirin. The independent endpoint adjudication committee refined this to four potential acute liver disorder cases for whom paper-based information was requested for final case assessment. Final case assessments confirmed no cases of acute liver disorder. The time taken for this study was 18 months (6 months for recruitment and 12 months for data management and case validation). To reach the estimated target exposure necessary to raise or rule out a signal of concern to public health, we determined that a recruitment period 2-3 times longer than that used in this study would be required. Based on the real market uptake of six commonly used medicinal products launched between 2001 and 2006 in the UK (budesonide/eformoterol [fixed-dose combination], duloxetine, ezetimibe, metformin/rosiglitazone [fixed-dose combination], tiotropium bromide and tadalafil) the target exposure would not have been reached until the fifth year of marketing using a single database. It is feasible to set up a system that actively monitors drug safety using a healthcare database and an independent endpoint adjudication committee. However, future successful implementation will require multiple databases to be queried so that larger study populations are included. This requires further development and harmonization of international healthcare databases.

eBASIS (Bioactive Substances in Food Information Systems) and Bioactive Intakes: Major Updates of the Bioactive Compound Composition and Beneficial Bioeffects Database and the Development of a Probabilistic Model to Assess Intakes in Europe.

PubMed

Plumb, Jenny; Pigat, Sandrine; Bompola, Foteini; Cushen, Maeve; Pinchen, Hannah; Nørby, Eric; Astley, Siân; Lyons, Jacqueline; Kiely, Mairead; Finglas, Paul

2017-03-23

eBASIS (Bioactive Substances in Food Information Systems), a web-based database that contains compositional and biological effects data for bioactive compounds of plant origin, has been updated with new data on fruits and vegetables, wheat and, due to some evidence of potential beneficial effects, extended to include meat bioactives. eBASIS remains one of only a handful of comprehensive and searchable databases, with up-to-date coherent and validated scientific information on the composition of food bioactives and their putative health benefits. The database has a user-friendly, efficient, and flexible interface facilitating use by both the scientific community and food industry. Overall, eBASIS contains data for 267 foods, covering the composition of 794 bioactive compounds, from 1147 quality-evaluated peer-reviewed publications, together with information from 567 publications describing beneficial bioeffect studies carried out in humans. This paper highlights recent updates and expansion of eBASIS and the newly-developed link to a probabilistic intake model, allowing exposure assessment of dietary bioactive compounds to be estimated and modelled in human populations when used in conjunction with national food consumption data. This new tool could assist small- and medium-sized enterprises (SMEs) in the development of food product health claim dossiers for submission to the European Food Safety Authority (EFSA).

A comprehensive global genotype-phenotype database for rare diseases.

PubMed

Trujillano, Daniel; Oprea, Gabriela-Elena; Schmitz, Yvonne; Bertoli-Avella, Aida M; Abou Jamra, Rami; Rolfs, Arndt

2017-01-01

The ability to discover genetic variants in a patient runs far ahead of the ability to interpret them. Databases with accurate descriptions of the causal relationship between the variants and the phenotype are valuable since these are critical tools in clinical genetic diagnostics. Here, we introduce a comprehensive and global genotype-phenotype database focusing on rare diseases. This database (CentoMD ® ) is a browser-based tool that enables access to a comprehensive, independently curated system utilizing stringent high-quality criteria and a quickly growing repository of genetic and human phenotype ontology (HPO)-based clinical information. Its main goals are to aid the evaluation of genetic variants, to enhance the validity of the genetic analytical workflow, to increase the quality of genetic diagnoses, and to improve evaluation of treatment options for patients with hereditary diseases. The database software correlates clinical information from consented patients and probands of different geographical backgrounds with a large dataset of genetic variants and, when available, biomarker information. An automated follow-up tool is incorporated that informs all users whenever a variant classification has changed. These unique features fully embedded in a CLIA/CAP-accredited quality management system allow appropriate data quality and enhanced patient safety. More than 100,000 genetically screened individuals are documented in the database, resulting in more than 470 million variant detections. Approximately, 57% of the clinically relevant and uncertain variants in the database are novel. Notably, 3% of the genetic variants identified and previously reported in the literature as being associated with a particular rare disease were reclassified, based on internal evidence, as clinically irrelevant. The database offers a comprehensive summary of the clinical validity and causality of detected gene variants with their associated phenotypes, and is a valuable tool for identifying new disease genes through the correlation of novel genetic variants with specific, well-defined phenotypes.

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

The design and implementation of hydrographical information management system (HIMS)

NASA Astrophysics Data System (ADS)

Sui, Haigang; Hua, Li; Wang, Qi; Zhang, Anming

2005-10-01

With the development of hydrographical work and information techniques, the large variety of hydrographical information including electronic charts, documents and other materials are widely used, and the traditional management mode and techniques are unsuitable for the development of the Chinese Marine Safety Administration Bureau (CMSAB). How to manage all kinds of hydrographical information has become an important and urgent problem. A lot of advanced techniques including GIS, RS, spatial database management and VR techniques are introduced for solving these problems. Some design principles and key techniques of the HIMS including the mixed mode base on B/S, C/S and stand-alone computer mode, multi-source & multi-scale data organization and management, multi-source data integration and diverse visualization of digital chart, efficient security control strategies are illustrated in detail. Based on the above ideas and strategies, an integrated system named Hydrographical Information Management System (HIMS) was developed. And the HIMS has been applied in the Shanghai Marine Safety Administration Bureau and obtained good evaluation.

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.

Classification of antecedents towards safety use of health information technology: A systematic review.

PubMed

Salahuddin, Lizawati; Ismail, Zuraini

2015-11-01

This paper provides a systematic review of safety use of health information technology (IT). The first objective is to identify the antecedents towards safety use of health IT by conducting systematic literature review (SLR). The second objective is to classify the identified antecedents based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model and an extension of DeLone and McLean (D&M) information system (IS) success model. A systematic literature review (SLR) was conducted from peer-reviewed scholarly publications between January 2000 and July 2014. SLR was carried out and reported based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The related articles were identified by searching the articles published in Science Direct, Medline, EMBASE, and CINAHL databases. Data extracted from the resultant studies included are to be analysed based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model, and also from the extended DeLone and McLean (D&M) information system (IS) success model. 55 articles delineated to be antecedents that influenced the safety use of health IT were included for review. Antecedents were identified and then classified into five key categories. The categories are (1) person, (2) technology, (3) tasks, (4) organization, and (5) environment. Specifically, person is attributed by competence while technology is associated to system quality, information quality, and service quality. Tasks are attributed by task-related stressor. Organisation is related to training, organisation resources, and teamwork. Lastly, environment is attributed by physical layout, and noise. This review provides evidence that the antecedents for safety use of health IT originated from both social and technical aspects. However, inappropriate health IT usage potentially increases the incidence of errors and produces new safety risks. The review cautions future implementation and adoption of health IT to carefully consider the complex interactions between social and technical elements propound in healthcare settings. Copyright © 2015. Published by Elsevier Ireland Ltd.

Composite Structures Damage Tolerance Analysis Methodologies

NASA Technical Reports Server (NTRS)

Chang, James B.; Goyal, Vinay K.; Klug, John C.; Rome, Jacob I.

2012-01-01

This report presents the results of a literature review as part of the development of composite hardware fracture control guidelines funded by NASA Engineering and Safety Center (NESC) under contract NNL04AA09B. The objectives of the overall development tasks are to provide a broad information and database to the designers, analysts, and testing personnel who are engaged in space flight hardware production.

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

PubMed

Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

2016-10-01

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

Analysis of the accuracy and readability of herbal supplement information on Wikipedia.

PubMed

Phillips, Jennifer; Lam, Connie; Palmisano, Lisa

2014-01-01

To determine the completeness and readability of information found in Wikipedia for leading dietary supplements and assess the accuracy of this information with regard to safety (including use during pregnancy/lactation), contraindications, drug interactions, therapeutic uses, and dosing. Cross-sectional analysis of Wikipedia articles. The contents of Wikipedia articles for the 19 top-selling herbal supplements were retrieved on July 24, 2012, and evaluated for organization, content, accuracy (as compared with information in two leading dietary supplement references) and readability. Accuracy of Wikipedia articles. No consistency was noted in how much information was included in each Wikipedia article, how the information was organized, what major categories were used, and where safety and therapeutic information was located in the article. All articles in Wikipedia contained information on therapeutic uses and adverse effects but several lacked information on drug interactions, pregnancy, and contraindications. Wikipedia articles had 26%-75% of therapeutic uses and 76%-100% of adverse effects listed in the Natural Medicines Comprehensive Database and/or Natural Standard. Overall, articles were written at a 13.5-grade level, and all were at a ninth-grade level or above. Articles in Wikipedia in mid-2012 for the 19 top-selling herbal supplements were frequently incomplete, of variable quality, and sometimes inconsistent with reputable sources of information on these products. Safety information was particularly inconsistent among the articles. Patients and health professionals should not rely solely on Wikipedia for information on these herbal supplements when treatment decisions are being made.

[Survey of Literature on the Development of an Evidence Database for Hospital-prepared Drugs in Japan].

PubMed

Momo, Kenji

2018-01-01

　Hospital-prepared drugs (HP), known as In'Naiseizai in Japan, are custom-prepared formulations which offer medical professionals an alternative administration pathway by changing the formulation of existing drugs according to a patients' needs. Preparing the HP is one of several roles of pharmacists in providing personalized medicine at hospitals in Japan. In 2012, the Japanese Society of Hospital Pharmacists provided guidelines for the appropriate use of "Hospital-prepared drugs". The following information was included in this guide: 1) documentation of the proper procedures, materials, prescription practices, etc., 2) required approval from the institutional review board of each HP on the risk-based classifications, and 3) to assess the stability, efficacy, and safety of each HP. However, several problems persist for pharmacists trying to prepare or use HP appropriately; the most common is insufficient manpower to both assess and prepare these drugs during routine hospital work. To resolve this problem, we are developing an evidence database for HP based on surveys of the current literature. This database has been developed for 109 drugs to date. Data-driven assessment of the stability of HP showed that 52 out of 109 drugs examined (47.7%). Notably, only 6 of the 109 HP (5.5%) in the database had all three characteristics of "stability", "safety", and "efficacy". In conclusion, the application of this database will save manpower hours for hospital pharmacists in the preparation of HP. In the near future, we will make this database available to the wider medical community via the web or through literature.

A Solution on Identification and Rearing Files Insmallhold Pig Farming

NASA Astrophysics Data System (ADS)

Xiong, Benhai; Fu, Runting; Lin, Zhaohui; Luo, Qingyao; Yang, Liang

In order to meet government supervision of pork production safety as well as consumeŕs right to know what they buy, this study adopts animal identification, mobile PDA reader, GPRS and other information technologies, and put forward a data collection method to set up rearing files of pig in smallhold pig farming, and designs related metadata structures and its mobile database, and develops a mobile PDA embedded system to collect individual information of pig and uploading into the remote central database, and finally realizes mobile links to the a specific website. The embedded PDA can identify both a special pig bar ear tag appointed by the Ministry of Agricultural and a general data matrix bar ear tag designed by this study by mobile reader, and can record all kinds of inputs data including bacterins, feed additives, animal drugs and even some forbidden medicines and submitted them to the center database through GPRS. At the same time, the remote center database can be maintained by mobile PDA and GPRS, and finally reached pork tracking from its origin to consumption and its tracing through turn-over direction. This study has suggested a feasible technology solution how to set up network pig electronic rearing files involved smallhold pig farming based on farmer and the solution is proved practical through its application in the Tianjińs pork quality traceability system construction. Although some individual techniques have some adverse effects on the system running such as GPRS transmitting speed now, these will be resolved with the development of communication technology. The full implementation of the solution around China will supply technical supports in guaranteeing the quality and safety of pork production supervision and meet consumer demand.

Analysis of workplace compliance measurements of asbestos by the U.S. Occupational Safety and Health Administration (1984-2011).

PubMed

Cowan, Dallas M; Cheng, Thales J; Ground, Matthew; Sahmel, Jennifer; Varughese, Allysha; Madl, Amy K

2015-08-01

The United States Occupational Safety and Health Administration (OSHA) maintains the Chemical Exposure Health Data (CEHD) and the Integrated Management Information System (IMIS) databases, which contain quantitative and qualitative data resulting from compliance inspections conducted from 1984 to 2011. This analysis aimed to evaluate trends in workplace asbestos concentrations over time and across industries by combining the samples from these two databases. From 1984 to 2011, personal air samples ranged from 0.001 to 175 f/cc. Asbestos compliance sampling data associated with the construction, automotive repair, manufacturing, and chemical/petroleum/rubber industries included measurements in excess of 10 f/cc, and were above the permissible exposure limit from 2001 to 2011. The utility of combining the databases was limited by the completeness and accuracy of the data recorded. In this analysis, 40% of the data overlapped between the two databases. Other limitations included sampling bias associated with compliance sampling and errors occurring from user-entered data. A clear decreasing trend in both airborne fiber concentrations and the numbers of asbestos samples collected parallels historically decreasing trends in the consumption of asbestos, and declining mesothelioma incidence rates. Although air sampling data indicated that airborne fiber exposure potential was high (>10 f/cc for short and long-term samples) in some industries (e.g., construction, manufacturing), airborne concentrations have significantly declined over the past 30 years. Recommendations for improving the existing exposure OSHA databases are provided. Copyright © 2015. Published by Elsevier Inc.

Acupuncture for treating sciatica: a systematic review protocol

PubMed Central

Qin, Zongshi; Liu, Xiaoxu; Yao, Qin; Zhai, Yanbing; Liu, Zhishun

2015-01-01

Introduction This systematic review aims to assess the effectiveness and safety of acupuncture for treating sciatica. Methods The following nine databases will be searched from their inception to 30 October 2014: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Chinese Biomedical Literature Database (CBM), the Chinese Medical Current Content (CMCC), the Chinese Scientific Journal Database (VIP database), the Wan-Fang Database, the China National Knowledge Infrastructure (CNKI) and Citation Information by National Institute of Informatics (CiNii). Randomised controlled trials (RCTs) of acupuncture for sciatica in English, Chinese or Japanese without restriction of publication status will be included. Two researchers will independently undertake study selection, extraction of data and assessment of study quality. Meta-analysis will be conducted after screening of studies. Data will be analysed using risk ratio for dichotomous data, and standardised mean difference or weighted mean difference for continuous data. Dissemination This systematic review will be disseminated electronically through a peer-reviewed publication or conference presentations. Trial registration number PROSPERO CRD42014015001. PMID:25922105

[Benefits of large healthcare databases for drug risk research].

PubMed

Garbe, Edeltraut; Pigeot, Iris

2015-08-01

Large electronic healthcare databases have become an important worldwide data resource for drug safety research after approval. Signal generation methods and drug safety studies based on these data facilitate the prospective monitoring of drug safety after approval, as has been recently required by EU law and the German Medicines Act. Despite its large size, a single healthcare database may include insufficient patients for the study of a very small number of drug-exposed patients or the investigation of very rare drug risks. For that reason, in the United States, efforts have been made to work on models that provide the linkage of data from different electronic healthcare databases for monitoring the safety of medicines after authorization in (i) the Sentinel Initiative and (ii) the Observational Medical Outcomes Partnership (OMOP). In July 2014, the pilot project Mini-Sentinel included a total of 178 million people from 18 different US databases. The merging of the data is based on a distributed data network with a common data model. In the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) there has been no comparable merging of data from different databases; however, first experiences have been gained in various EU drug safety projects. In Germany, the data of the statutory health insurance providers constitute the most important resource for establishing a large healthcare database. Their use for this purpose has so far been severely restricted by the Code of Social Law (Section 75, Book 10). Therefore, a reform of this section is absolutely necessary.

The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA.

PubMed Central

Chen, R. T.; DeStefano, F.; Davis, R. L.; Jackson, L. A.; Thompson, R. S.; Mullooly, J. P.; Black, S. B.; Shinefield, H. R.; Vadheim, C. M.; Ward, J. I.; Marcy, S. M.

2000-01-01

The Vaccine Safety Datalink is a collaborative project involving the National Immunization Program of the Centers for Disease Control and Prevention and several large health maintenance organizations in the USA. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. outpatient visits, emergency room visits, hospitalizations, and deaths) and covariates (e.g. birth certificates, census data) are prospectively collected and linked under joint protocol at multiple health maintenance organizations for analysis. Approximately 6 million persons (2% of the population of the USA) are now members of health maintenance organizations participating in the Vaccine Safety Datalink, which has proved to be a valuable resource providing important information on a number of vaccine safety issues. The databases and infrastructure created for the Vaccine Safety Datalink have also provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field. PMID:10743283

49 CFR 384.209 - Notification of traffic violations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS STATE... that conviction to the Federal Convictions and Withdrawal Database. (b) Required notification with... Convictions and Withdrawal Database. [78 FR 60232, Oct. 1, 2013] ...

49 CFR 384.209 - Notification of traffic violations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS STATE... that conviction to the Federal Convictions and Withdrawal Database. (b) Required notification with... Convictions and Withdrawal Database. [78 FR 60232, Oct. 1, 2013] ...

Biological agents database in the armed forces.

PubMed

Niemcewicz, Marcin; Kocik, Janusz; Bielecka, Anna; Wierciński, Michał

2014-10-01

Rapid detection and identification of the biological agent during both, natural or deliberate outbreak is crucial for implementation of appropriate control measures and procedures in order to mitigate the spread of disease. Determination of pathogen etiology may not only support epidemiological investigation and safety of human beings, but also enhance forensic efforts in pathogen tracing, collection of evidences and correct inference. The article presents objectives of the Biological Agents Database, which was developed for the purpose of the Ministry of National Defense of the Republic of Poland under the European Defence Agency frame. The Biological Agents Database is an electronic catalogue of genetic markers of highly dangerous pathogens and biological agents of weapon of mass destruction concern, which provides full identification of biological threats emerging in Poland and in locations of activity of Polish troops. The Biological Agents Database is a supportive tool used for tracing biological agents' origin as well as rapid identification of agent causing the disease of unknown etiology. It also provides support in diagnosis, analysis, response and exchange of information between institutions that use information contained in it. Therefore, it can be used not only for military purposes, but also in a civilian environment.

Exploring inattention and distraction in the SafetyNet Accident Causation Database.

PubMed

Talbot, Rachel; Fagerlind, Helen; Morris, Andrew

2013-11-01

Distraction and inattention are considered to be very important and prevalent factors in the causation of road accidents. There have been many recent research studies which have attempted to understand the circumstances under which a driver becomes distracted or inattentive and how distraction/inattention can be prevented. Both factors are thought to have become more important in recent times partly due to the evolution of in-vehicle information and communication technology. This study describes a methodology that was developed to understand when factors such as distraction and inattention may have been contributors to crashes and also describes some of the consequences of distraction and inattention in terms of subsequent driver actions. The study uses data relating to distraction and inattention from the SafetyNet Accident Causation Database. This database was formulated as part of the SafetyNet project to address the lack of representative in-depth accident causation data within the European Union. Data were collected in 6 European countries using 'on-scene' and 'nearly on-scene' crash investigation methodologies. 32% of crashes recorded in the database, involved at least one driver, rider or pedestrian, who was determined to be 'Inattentive' or 'Distracted'. 212 of the drivers were assigned 'Distraction' and 140 drivers were given the code 'Inattention'. It was found that both distraction and inattention often lead to missed observations within the driving task and consequently 'Timing' or 'Direction' become critical events in the aetiology of crashes. In addition, the crash types and outcomes may differ according to the type and nature of the distraction and inattention as determined by the in-depth investigations. The development of accident coding methodology is described in this study as is its evolution into the Driver Reliability and Error Analysis Model (DREAM) version 3.0. Copyright © 2012 Elsevier Ltd. All rights reserved.

Pharmacodynamic and pharmacokinetic evaluation of buprenorphine + samidorphan for the treatment of major depressive disorder.

PubMed

Ragguett, Renee-Marie; Rong, Carola; Rosenblat, Joshua D; Ho, Roger C; McIntyre, Roger S

2018-04-01

Treatment resistant depression (TRD) represents approximately 20% of all individuals receiving care for major depressive disorder. The opioidergic system is identified as a novel target which hitherto has not been sufficiently investigated in adults with TRD. The combination product buprenorphine + samidorphan is an opioid modulatory agent which has demonstrated replicated evidence of efficacy in TRD without abuse liability. Areas covered: Databases Pubmed, Google Scholar and clinicaltrials.gov were searched from inception through December 2017 for clinical trial information, pharmacokinetics, and pharmacodynamics of buprenorphine + samidorphan. Herein we provide a summary of the available information. Eight clinical trials were identified for inclusion, of the eight trials, five trials had available results and are included in detail in our review. Expert opinion: Buprenorphine + samidorphan has demonstrated efficacy in TRD. Extant evidence surrounding the safety and tolerability profile of buprenorphine + samidorphan does not identify any significant safety concerns. Additional studies are needed in order to assess the long-term safety and efficacy of this product.

Nanomaterials for environmental remediation: investigating the role of nanoinformatics in support of environmental, health, and safety oversight of nanotechnologies at the local level.

PubMed

Massawe, Ephraim

2013-01-01

Nanotechnology is the science and practice of manipulating matter at or near atomic scale to create new materials of unique and novel properties for specific applications. Nanomaterials, including engineered nanoparticles (ENPs), have been used successfully for remediation since they are superior in technical performance and cost-effectiveness than traditional remedial technologies. Evidence indicates, however, that exposure to nanomaterials may lead to significant safety and health impacts. To protect human health against undesired risks from nanomaterials requires that safe and sustainable development of nanotechnology is in tandem with the availability of relevant information. State agencies responsible for the environment, safety, and public health were surveyed to understand their current and future information needs and capabilities to regulate nanomaterials. Because significant data gaps still exist on the toxicity and ecological impacts of nanomaterials, precautionary measures should be taken. Research to develop techniques for exposure assessments, surveillance and monitoring, databases, and characteristics of workplaces where ENPs are used is encouraged.

The STEP database through the end-users eyes--USABILITY STUDY.

PubMed

Salunke, Smita; Tuleu, Catherine

2015-08-15

The user-designed database of Safety and Toxicity of Excipients for Paediatrics ("STEP") is created to address the shared need of drug development community to access the relevant information of excipients effortlessly. Usability testing was performed to validate if the database satisfies the need of the end-users. Evaluation framework was developed to assess the usability. The participants performed scenario based tasks and provided feedback and post-session usability ratings. Failure Mode Effect Analysis (FMEA) was performed to prioritize the problems and improvements to the STEP database design and functionalities. The study revealed several design vulnerabilities. Tasks such as limiting the results, running complex queries, location of data and registering to access the database were challenging. The three critical attributes identified to have impact on the usability of the STEP database included (1) content and presentation (2) the navigation and search features (3) potential end-users. Evaluation framework proved to be an effective method for evaluating database effectiveness and user satisfaction. This study provides strong initial support for the usability of the STEP database. Recommendations would be incorporated into the refinement of the database to improve its usability and increase user participation towards the advancement of the database. Copyright © 2015 Elsevier B.V. All rights reserved.

A Real-Time Construction Safety Monitoring System for Hazardous Gas Integrating Wireless Sensor Network and Building Information Modeling Technologies.

PubMed

Cheung, Weng-Fong; Lin, Tzu-Hsuan; Lin, Yu-Cheng

2018-02-02

In recent years, many studies have focused on the application of advanced technology as a way to improve management of construction safety management. A Wireless Sensor Network (WSN), one of the key technologies in Internet of Things (IoT) development, enables objects and devices to sense and communicate environmental conditions; Building Information Modeling (BIM), a revolutionary technology in construction, integrates database and geometry into a digital model which provides a visualized way in all construction lifecycle management. This paper integrates BIM and WSN into a unique system which enables the construction site to visually monitor the safety status via a spatial, colored interface and remove any hazardous gas automatically. Many wireless sensor nodes were placed on an underground construction site and to collect hazardous gas level and environmental condition (temperature and humidity) data, and in any region where an abnormal status is detected, the BIM model will alert the region and an alarm and ventilator on site will start automatically for warning and removing the hazard. The proposed system can greatly enhance the efficiency in construction safety management and provide an important reference information in rescue tasks. Finally, a case study demonstrates the applicability of the proposed system and the practical benefits, limitations, conclusions, and suggestions are summarized for further applications.

eBASIS (Bioactive Substances in Food Information Systems) and Bioactive Intakes: Major Updates of the Bioactive Compound Composition and Beneficial Bioeffects Database and the Development of a Probabilistic Model to Assess Intakes in Europe

PubMed Central

Plumb, Jenny; Pigat, Sandrine; Bompola, Foteini; Cushen, Maeve; Pinchen, Hannah; Nørby, Eric; Astley, Siân; Lyons, Jacqueline; Kiely, Mairead; Finglas, Paul

2017-01-01

eBASIS (Bioactive Substances in Food Information Systems), a web-based database that contains compositional and biological effects data for bioactive compounds of plant origin, has been updated with new data on fruits and vegetables, wheat and, due to some evidence of potential beneficial effects, extended to include meat bioactives. eBASIS remains one of only a handful of comprehensive and searchable databases, with up-to-date coherent and validated scientific information on the composition of food bioactives and their putative health benefits. The database has a user-friendly, efficient, and flexible interface facilitating use by both the scientific community and food industry. Overall, eBASIS contains data for 267 foods, covering the composition of 794 bioactive compounds, from 1147 quality-evaluated peer-reviewed publications, together with information from 567 publications describing beneficial bioeffect studies carried out in humans. This paper highlights recent updates and expansion of eBASIS and the newly-developed link to a probabilistic intake model, allowing exposure assessment of dietary bioactive compounds to be estimated and modelled in human populations when used in conjunction with national food consumption data. This new tool could assist small- and medium-sized enterprises (SMEs) in the development of food product health claim dossiers for submission to the European Food Safety Authority (EFSA). PMID:28333085

A unique database for gathering data from a mobile app and medical prescription software: a useful data source to collect and analyse patient-reported outcomes of depression and anxiety symptoms.

PubMed

Watanabe, Yoshinori; Hirano, Yoko; Asami, Yuko; Okada, Maki; Fujita, Kazuya

2017-11-01

A unique database named 'AN-SAPO' was developed by Iwato Corp. and Japan Brain Corp. in collaboration with the psychiatric clinics run by Himorogi Group in Japan. The AN-SAPO database includes patients' depression/anxiety score data from a mobile app named AN-SAPO and medical records from medical prescription software named 'ORCA'. On the mobile app, depression/anxiety severity can be evaluated by answering 20 brief questions and the scores are transferred to the AN-SAPO database together with the patients' medical records on ORCA. Currently, this database is used at the Himorogi Group's psychiatric clinics and has over 2000 patients' records accumulated since November 2013. Since the database covers patients' demographic data, prescribed drugs, and the efficacy and safety information, it could be a useful supporting tool for decision-making in clinical practice. We expect it to be utilised in wider areas of medical fields and for future pharmacovigilance and pharmacoepidemiological studies.

Potential use of an arthropod database to support the non-target risk assessment and monitoring of transgenic plants.

PubMed

Romeis, Jörg; Meissle, Michael; Alvarez-Alfageme, Fernando; Bigler, Franz; Bohan, David A; Devos, Yann; Malone, Louise A; Pons, Xavier; Rauschen, Stefan

2014-12-01

Worldwide, plants obtained through genetic modification are subject to a risk analysis and regulatory approval before they can enter the market. An area of concern addressed in environmental risk assessments is the potential of genetically modified (GM) plants to adversely affect non-target arthropods and the valued ecosystem services they provide. Environmental risk assessments are conducted case-by-case for each GM plant taking into account the plant species, its trait(s), the receiving environments into which the GM plant is to be released and its intended uses, and the combination of these characteristics. To facilitate the non-target risk assessment of GM plants, information on arthropods found in relevant agro-ecosystems in Europe has been compiled in a publicly available database of bio-ecological information during a project commissioned by the European Food Safety Authority (EFSA). Using different hypothetical GM maize case studies, we demonstrate how the information contained in the database can assist in identifying valued species that may be at risk and in selecting suitable species for laboratory testing, higher-tier studies, as well as post-market environmental monitoring.

Vision based flight procedure stereo display system

NASA Astrophysics Data System (ADS)

Shen, Xiaoyun; Wan, Di; Ma, Lan; He, Yuncheng

2008-03-01

A virtual reality flight procedure vision system is introduced in this paper. The digital flight map database is established based on the Geographic Information System (GIS) and high definitions satellite remote sensing photos. The flight approaching area database is established through computer 3D modeling system and GIS. The area texture is generated from the remote sensing photos and aerial photographs in various level of detail. According to the flight approaching procedure, the flight navigation information is linked to the database. The flight approaching area vision can be dynamic displayed according to the designed flight procedure. The flight approaching area images are rendered in 2 channels, one for left eye images and the others for right eye images. Through the polarized stereoscopic projection system, the pilots and aircrew can get the vivid 3D vision of the flight destination approaching area. Take the use of this system in pilots preflight preparation procedure, the aircrew can get more vivid information along the flight destination approaching area. This system can improve the aviator's self-confidence before he carries out the flight mission, accordingly, the flight safety is improved. This system is also useful in validate the visual flight procedure design, and it helps to the flight procedure design.

A systematic review of the evidence on clitoral reconstruction after female genital mutilation/cutting.

PubMed

Abdulcadir, Jasmine; Rodriguez, Maria I; Say, Lale

2015-05-01

Clitoral reconstruction is a new surgical technique for women who have undergone female genital mutilation/cutting (FGM/C). To review evidence on the safety and efficacy of clitoral reconstruction. PubMed and Cochrane databases were searched for articles published in any language from database inception until May 2014. Search terms related to FGM/C and clitoral reconstruction were used in various combinations. Studies of any design that reported on safety or clinical outcomes (e.g. appearance, pain, sexual response, or patient satisfaction) associated with clitoral reconstruction after FGM/C were included. Evidence was summarized and systematically assessed via a standard data abstraction form. Four of 269 identified articles were included. They were fair to poor in quality. Summary measures could not be computed owing to heterogeneity. The studies reported on immediate surgical complications, clitoral appearance, dyspareunia or chronic pain, and clitoral function postoperatively via non-standardized scales. Women who request clitoral reconstruction should be informed about the scarcity of evidence available. Additional research is needed on the safety and efficacy of the procedure to identify both long-term outcomes and which women might benefit. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Toward an integrated knowledge environment to support modern oncology.

PubMed

Blake, Patrick M; Decker, David A; Glennon, Timothy M; Liang, Yong Michael; Losko, Sascha; Navin, Nicholas; Suh, K Stephen

2011-01-01

Around the world, teams of researchers continue to develop a wide range of systems to capture, store, and analyze data including treatment, patient outcomes, tumor registries, next-generation sequencing, single-nucleotide polymorphism, copy number, gene expression, drug chemistry, drug safety, and toxicity. Scientists mine, curate, and manually annotate growing mountains of data to produce high-quality databases, while clinical information is aggregated in distant systems. Databases are currently scattered, and relationships between variables coded in disparate datasets are frequently invisible. The challenge is to evolve oncology informatics from a "systems" orientation of standalone platforms and silos into an "integrated knowledge environments" that will connect "knowable" research data with patient clinical information. The aim of this article is to review progress toward an integrated knowledge environment to support modern oncology with a focus on supporting scientific discovery and improving cancer care.

Flight deck party line issues : an Aviation Safety Reporting System analysis

DOT National Transportation Integrated Search

1995-06-01

This document describes an analysis of the Aviation Safety Reporting System : (ASRS) database with regards to human factors aspects concerning the : implementation of Data Link into the flightdeck. The ASRS database contains : thousands of reports co...

Patient Safety Leadership WalkRounds.

PubMed

Frankel, Allan; Graydon-Baker, Erin; Neppl, Camilla; Simmonds, Terri; Gustafson, Michael; Gandhi, Tejal K

2003-01-01

In the WalkRounds concept, a core group, which includes the senior executives and/or vice presidents, conducts weekly visits to different areas of the hospital. The group, joined by one or two nurses in the area and other available staff, asks specific questions about adverse events or near misses and about the factors or systems issues that led to these events. ANALYSIS OF EVENTS: Events in the Walkrounds are entered into a database and classified according to the contributing factors. The data are aggregated by contributing factors and priority scores to highlight the root issues. The priority scores are used to determine QI pilots and make best use of limited resources. Executives are surveyed quarterly about actions they have taken as a direct result of WalkRounds and are asked what they have learned from the rounds. As of September 2002, 47 Patient Safety Leadership WalkRounds visited a total of 48 different areas of the hospital, with 432 individual comments. The WalkRounds require not only knowledgeable and invested senior leadership but also a well-organized support structure. Quality and safety personnel are needed to collect data and maintain a database of confidential information, evaluate the data from a systems approach, and delineate systems-based actions to improve care delivery. Comments of frontline clinicians and executives suggested that WalkRounds helps educate leadership and frontline staff in patient safety concepts and will lead to cultural changes, as manifested in more open discussion of adverse events and an improved rate of safety-based changes.

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

PubMed

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

2016-05-01

In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of events reported in each database were related to the purpose of the database and the source of the reports, resulting in significant differences in reported event categories across the 3 systems, and (3) a public-private collaboration for investigating ventilator-related adverse events under the P5S model is feasible. Copyright © 2016 by Daedalus Enterprises.

Development of a Comprehensive Database System for Safety Analyst

PubMed Central

Paz, Alexander; Veeramisti, Naveen; Khanal, Indira; Baker, Justin

2015-01-01

This study addressed barriers associated with the use of Safety Analyst, a state-of-the-art tool that has been developed to assist during the entire Traffic Safety Management process but that is not widely used due to a number of challenges as described in this paper. As part of this study, a comprehensive database system and tools to provide data to multiple traffic safety applications, with a focus on Safety Analyst, were developed. A number of data management tools were developed to extract, collect, transform, integrate, and load the data. The system includes consistency-checking capabilities to ensure the adequate insertion and update of data into the database. This system focused on data from roadways, ramps, intersections, and traffic characteristics for Safety Analyst. To test the proposed system and tools, data from Clark County, which is the largest county in Nevada and includes the cities of Las Vegas, Henderson, Boulder City, and North Las Vegas, was used. The database and Safety Analyst together help identify the sites with the potential for safety improvements. Specifically, this study examined the results from two case studies. The first case study, which identified sites having a potential for safety improvements with respect to fatal and all injury crashes, included all roadway elements and used default and calibrated Safety Performance Functions (SPFs). The second case study identified sites having a potential for safety improvements with respect to fatal and all injury crashes, specifically regarding intersections; it used default and calibrated SPFs as well. Conclusions were developed for the calibration of safety performance functions and the classification of site subtypes. Guidelines were provided about the selection of a particular network screening type or performance measure for network screening. PMID:26167531

t4 Workshop Report

PubMed Central

Silbergeld, Ellen K.; Contreras, Elizabeth Q.; Hartung, Thomas; Hirsch, Cordula; Hogberg, Helena; Jachak, Ashish C.; Jordan, William; Landsiedel, Robert; Morris, Jeffery; Patri, Anil; Pounds, Joel G.; de Vizcaya Ruiz, Andrea; Shvedova, Anna; Tanguay, Robert; Tatarazako, Norihasa; van Vliet, Erwin; Walker, Nigel J.; Wiesner, Mark; Wilcox, Neil; Zurlo, Joanne

2014-01-01

Summary In October 2010, a group of experts met as part of the transatlantic think tank for toxicology (t4) to exchange ideas about the current status and future of safety testing of nanomaterials. At present, there is no widely accepted path forward to assure appropriate and effective hazard identification for engineered nanomaterials. The group discussed needs for characterization of nanomaterials and identified testing protocols that incorporate the use of innovative alternative whole models such as zebrafish or C. elegans, as well as in vitro or alternative methods to examine specific functional pathways and modes of action. The group proposed elements of a potential testing scheme for nanomaterials that works towards an integrated testing strategy, incorporating the goals of the NRC report Toxicity Testing in the 21st Century: A Vision and a Strategy by focusing on pathways of toxic response, and utilizing an evidence-based strategy for developing the knowledge base for safety assessment. Finally, the group recommended that a reliable, open, curated database be developed that interfaces with existing databases to enable sharing of information. PMID:21993959

Use of patient safety culture instruments in operating rooms: A systematic literature review.

PubMed

Zhao, Pujng; Li, Yaqin; Li, Zhi; Jia, Pengli; Zhang, Longhao; Zhang, Mingming

2017-05-01

To identify and qualitatively describe, in a literature review, how the instruments were used to evaluate patient safety culture in the operating rooms of published studies. Systematic searches of the literature were conducted using the major database including MEDLINE, EMbase, The Cochrane Library, and four Chinese databases including Chinese Biomedical Literature Database (CBM), Wanfang Data, Chinese Scientific Journal Database (VIP), and Chinese Journals Full-text Database (CNKI) for studies published up to March 2016. We summarized and analyzed the country scope, the instrument utilized in the study, the year when the instrument was used, and fields of operating rooms. Study populations, study settings, and the time span between baseline and follow-up phase were evaluated according to the study design. We identified 1025 references, of which 99 were obtained for full-text assessment; 47 of these studies were deemed relevant and included in the literature review. Most of the studies were from the USA. The most commonly used patient safety culture instrument was Safety Attitude Questionnaire. All identified instruments were used after 2002 and across many fields. Most included studies on patient safety culture were conducted in teaching hospitals or university hospitals. The study population in the cross-sectional studies was much more than that in the before-after studies. The time span between baseline and follow-up phase of before-after studies were almost over three months. Although patient safety culture is considered important in health care and patient safety, the number of studies in which patient safety culture has been estimated using the instruments in operating rooms, is fairly small. © 2017 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Development and evaluation of a web-based software for crash data collection, processing and analysis.

PubMed

Montella, Alfonso; Chiaradonna, Salvatore; Criscuolo, Giorgio; De Martino, Salvatore

2017-02-05

First step of the development of an effective safety management system is to create reliable crash databases since the quality of decision making in road safety depends on the quality of the data on which decisions are based. Improving crash data is a worldwide priority, as highlighted in the Global Plan for the Decade of Action for Road Safety adopted by the United Nations, which recognizes that the overall goal of the plan will be attained improving the quality of data collection at the national, regional and global levels. Crash databases provide the basic information for effective highway safety efforts at any level of government, but lack of uniformity among countries and among the different jurisdictions in the same country is observed. Several existing databases show significant drawbacks which hinder their effective use for safety analysis and improvement. Furthermore, modern technologies offer great potential for significant improvements of existing methods and procedures for crash data collection, processing and analysis. To address these issues, in this paper we present the development and evaluation of a web-based platform-independent software for crash data collection, processing and analysis. The software is designed for mobile and desktop electronic devices and enables a guided and automated drafting of the crash report, assisting police officers both on-site and in the office. The software development was based both on the detailed critical review of existing Australasian, EU, and U.S. crash databases and software as well as on the continuous consultation with the stakeholders. The evaluation was carried out comparing the completeness, timeliness, and accuracy of crash data before and after the use of the software in the city of Vico Equense, in south of Italy showing significant advantages. The amount of collected information increased from 82 variables to 268 variables, i.e., a 227% increase. The time saving was more than one hour per crash, i.e., a 36% reduction. The on-site data collection did not produce time saving, however this is a temporary weakness that will be annihilated very soon in the future after officers are more acquainted with the software. The phase of evaluation, processing and analysis carried out in the office was dramatically shortened, i.e., a 69% reduction. Another benefit was the standardization which allowed fast and consistent data analysis and evaluation. Even if all these benefits are remarkable, the most valuable benefit of the new procedure was the reduction of the police officers mistakes during the manual operations of survey and data evaluation. Because of these benefits, the satisfaction questionnaires administrated to the police officers after the testing phase showed very good acceptance of the procedure. Copyright © 2017 Elsevier Ltd. All rights reserved.

IDAAPM: integrated database of ADMET and adverse effects of predictive modeling based on FDA approved drug data.

PubMed

Legehar, Ashenafi; Xhaard, Henri; Ghemtio, Leo

2016-01-01

The disposition of a pharmaceutical compound within an organism, i.e. its Absorption, Distribution, Metabolism, Excretion, Toxicity (ADMET) properties and adverse effects, critically affects late stage failure of drug candidates and has led to the withdrawal of approved drugs. Computational methods are effective approaches to reduce the number of safety issues by analyzing possible links between chemical structures and ADMET or adverse effects, but this is limited by the size, quality, and heterogeneity of the data available from individual sources. Thus, large, clean and integrated databases of approved drug data, associated with fast and efficient predictive tools are desirable early in the drug discovery process. We have built a relational database (IDAAPM) to integrate available approved drug data such as drug approval information, ADMET and adverse effects, chemical structures and molecular descriptors, targets, bioactivity and related references. The database has been coupled with a searchable web interface and modern data analytics platform (KNIME) to allow data access, data transformation, initial analysis and further predictive modeling. Data were extracted from FDA resources and supplemented from other publicly available databases. Currently, the database contains information regarding about 19,226 FDA approval applications for 31,815 products (small molecules and biologics) with their approval history, 2505 active ingredients, together with as many ADMET properties, 1629 molecular structures, 2.5 million adverse effects and 36,963 experimental drug-target bioactivity data. IDAAPM is a unique resource that, in a single relational database, provides detailed information on FDA approved drugs including their ADMET properties and adverse effects, the corresponding targets with bioactivity data, coupled with a data analytics platform. It can be used to perform basic to complex drug-target ADMET or adverse effects analysis and predictive modeling. IDAAPM is freely accessible at http://idaapm.helsinki.fi and can be exploited through a KNIME workflow connected to the database.Graphical abstractFDA approved drug data integration for predictive modeling.

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% CI 0.3, 1.0) and more frequently as important missing information (RR 1.6; 95% CI 1.0, 2.7). Forty-seven PASS were proposed; 31 for biologicals and 16 for small molecules. Compared with studies proposed in population-based databases (4 for biologicals, 8 for small molecules), studies in registries (18 for biologicals, 4 for small molecules) were more frequently proposed for biologicals than for small molecules (RR 2.5; 95% CI 1.1, 5.7). About 60% of the proposed PASS will include EU inhabitants. No full study protocols were submitted; 26% involved a limited study protocol, 33% a study synopsis, 37% a short description and 4% a commitment without further information. Approximately 40% of the study proposals for PASS were classified as a short description or a commitment to perform a study without further information, precluding an adequate scientific assessment. Studying non-EU populations may give rise to difficulties with generalizability of the results to the EU due to differences in patient characteristics, differences in the indication for the medicine and different healthcare systems. This study emphasizes the need for more complete study proposals to be submitted earlier on in the evaluation period and for the inclusion of EU inhabitants in PASS. In addition, differences in the characteristics between biologicals and small molecules, e.g. in the data source proposed, support the need for individualized tailored PASS depending on the type of drug.

Prediction of Safety Stock Using Fuzzy Time Series (FTS) and Technology of Radio Frequency Identification (RFID) for Stock Control at Vendor Managed Inventory (VMI)

NASA Astrophysics Data System (ADS)

Mashuri, Chamdan; Suryono; Suseno, Jatmiko Endro

2018-02-01

This research was conducted by prediction of safety stock using Fuzzy Time Series (FTS) and technology of Radio Frequency Identification (RFID) for stock control at Vendor Managed Inventory (VMI). Well-controlled stock influenced company revenue and minimized cost. It discussed about information system of safety stock prediction developed through programming language of PHP. Input data consisted of demand got from automatic, online and real time acquisition using technology of RFID, then, sent to server and stored at online database. Furthermore, data of acquisition result was predicted by using algorithm of FTS applying universe of discourse defining and fuzzy sets determination. Fuzzy set result was continued to division process of universe of discourse in order to be to final step. Prediction result was displayed at information system dashboard developed. By using 60 data from demand data, prediction score was 450.331 and safety stock was 135.535. Prediction result was done by error deviation validation using Mean Square Percent Error of 15%. It proved that FTS was good enough in predicting demand and safety stock for stock control. For deeper analysis, researchers used data of demand and universe of discourse U varying at FTS to get various result based on test data used.

Data Analysis Approaches for the Risk-Informed Safety Margins Characterization Toolkit

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

Mandelli, Diego; Alfonsi, Andrea; Maljovec, Daniel P.

2016-09-01

In the past decades, several numerical simulation codes have been employed to simulate accident dynamics (e.g., RELAP5-3D, RELAP-7, MELCOR, MAAP). In order to evaluate the impact of uncertainties into accident dynamics, several stochastic methodologies have been coupled with these codes. These stochastic methods range from classical Monte-Carlo and Latin Hypercube sampling to stochastic polynomial methods. Similar approaches have been introduced into the risk and safety community where stochastic methods (such as RAVEN, ADAPT, MCDET, ADS) have been coupled with safety analysis codes in order to evaluate the safety impact of timing and sequencing of events. These approaches are usually calledmore » Dynamic PRA or simulation-based PRA methods. These uncertainties and safety methods usually generate a large number of simulation runs (database storage may be on the order of gigabytes or higher). The scope of this paper is to present a broad overview of methods and algorithms that can be used to analyze and extract information from large data sets containing time dependent data. In this context, “extracting information” means constructing input-output correlations, finding commonalities, and identifying outliers. Some of the algorithms presented here have been developed or are under development within the RAVEN statistical framework.« less

All-terrain vehicles and associated spinal injuries.

PubMed

Sanfilippo, James A; Winegar, Corbett D; Harrop, James S; Albert, Todd J; Vaccaro, Alexander R

2008-08-15

Case cohort. To illuminate factors associated with all-terrain vehicle (ATV) injuries and injury morphology. Traditionally thought of as safe, injuries associated with ATVs can be severe and life threatening. In 2005 alone, the US Consumer Product Safety Commission estimated 136,100 injuries and 767 deaths associated with ATVs use and misuse. A database of all spine related consults from one institution was reviewed and all patients with spine or spinal cord injuries associated with ATV use were identified. All pertinent demographic, clinical, and radiographic information were collected and analyzed. Thirty-six patients were identified from the spinal cord injury database. The male:female ratio was 11:1 of the ATV injured patient. This is statistically different from the general database population, with a males representing 70% of patients (P < 0.002). The average ATV injured patient was 13.7 years younger than the average database patient (P < 0.001). The incidence of an axial compression or burst type fracture morphology was significantly higher in the ATV injured patient population (50%) compared with the database population as a whole (12%). Factors predisposing patients to injury on ATVs include excessive speed, use of alcohol or controlled substances, use of machinery after dark, and inexperience. All-terrain vehicles (ATVs) are currently experiencing enormous popularity in the United States. These recreational vehicles are associated with a higher incidence of axial compression and burst-type fracture morphologies. In general, all-terrain vehicles although highly dangerous leading to death or serious injury can be fun, enjoyable, and safe if proper regulations and safety precautions are implemented and followed.

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

Carr, F. Jr.; Mahaffey, J.A.

The purpose of the DOE/OHER Chernobyl Database project is to create and maintain an information system to provide usable information for research studies related to the nuclear accident. The system is the official United States repository for information about the Chernobyl accident and its consequences, and currently includes an extensive bibliography and diverse radiological measurements with supporting information. PNL has established two resources: original (not summarized) measurement data, currently about 80,000 measurements, with ancillary information; and about 2,200 bibliographic citations, some including abstracts. Major organizations that have contributed radiological measurement data include the Washington State Department of Social and Healthmore » Services; United States Environmental Protection Agency (domestic and foreign data); United States Nuclear Regulatory Commission; Stone Webster; Brookhaven National Laboratory; Commissariat A L'energie Atomique in France; Ministry of Agriculture, Fisheries, and Food in the United Kingdom; Japan National Institute of Radiological Sciences; and the Finnish Centre For Radiation and Nuclear Safety (STUK). Scientists in Australia, Austria, Belgium, Canada, China, Denmark, England, Federal Republic of Germany, Finland, France, Ireland, Italy, Japan, the Netherlands, Romania, Scotland, Spain, Sweden, Switzerland, United States, Wales, and Yugoslavia have made contributions. Bibliographic materials have been obtained from scientists in the above countries that have replied to requests. In addition, literature searches have been conducted, including a search of the DOE Energy Database. The last search was conducted in January, 1989. This document lists the bibliographic information in the DOE/OHER Chernobyl Database at the current time.« less

Database search for safety information on cosmetic ingredients.

PubMed

Pauwels, Marleen; Rogiers, Vera

2007-12-01

Ethical considerations with respect to experimental animal use and regulatory testing are worldwide under heavy discussion and are, in certain cases, taken up in legislative measures. The most explicit example is the European cosmetic legislation, establishing a testing ban on finished cosmetic products since 11 September 2004 and enforcing that the safety of a cosmetic product is assessed by taking into consideration "the general toxicological profile of the ingredients, their chemical structure and their level of exposure" (OJ L151, 32-37, 23 June 1993; OJ L066, 26-35, 11 March 2003). Therefore the availability of referenced and reliable information on cosmetic ingredients becomes a dire necessity. Given the high-speed progress of the World Wide Web services and the concurrent drastic increase in free access to information, identification of relevant data sources and evaluation of the scientific value and quality of the retrieved data, are crucial. Based upon own practical experience, a survey is put together of freely and commercially available data sources with their individual description, field of application, benefits and drawbacks. It should be mentioned that the search strategies described are equally useful as a starting point for any quest for safety data on chemicals or chemical-related substances in general.

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

Region and database management for HANDI 2000 business management system

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

Wilson, D.

The Data Integration 2000 Project will result in an integrated and comprehensive set of functional applications containing core information necessary to support the Project Hanford Management Contract. It is based on the Commercial-Off-The-Shelf product solution with commercially proven business processes. The COTS product solution set, of PassPort and People Soft software, supports finance, supply and chemical management/Material Safety Data Sheet, human resources.

Environmental contaminants of emerging concern in seafood--European database on contaminant levels.

PubMed

Vandermeersch, Griet; Lourenço, Helena Maria; Alvarez-Muñoz, Diana; Cunha, Sara; Diogène, Jorge; Cano-Sancho, German; Sloth, Jens J; Kwadijk, Christiaan; Barcelo, Damia; Allegaert, Wim; Bekaert, Karen; Fernandes, José Oliveira; Marques, Antonio; Robbens, Johan

2015-11-01

Marine pollution gives rise to concern not only about the environment itself but also about the impact on food safety and consequently on public health. European authorities and consumers have therefore become increasingly worried about the transfer of contaminants from the marine environment to seafood. So-called "contaminants of emerging concern" are chemical substances for which no maximum levels have been laid down in EU legislation, or substances for which maximum levels have been provided but which require revision. Adequate information on their presence in seafood is often lacking and thus potential risks cannot be excluded. Assessment of food safety issues related to these contaminants has thus become urgent and imperative. A database (www.ecsafeseafooddbase.eu), containing available information on the levels of contaminants of emerging concern in seafood and providing the most recent data to scientists and regulatory authorities, was developed. The present paper reviews a selection of contaminants of emerging concern in seafood including toxic elements, endocrine disruptors, brominated flame retardants, pharmaceuticals and personal care products, polycyclic aromatic hydrocarbons and derivatives, microplastics and marine toxins. Current status on the knowledge of human exposure, toxicity and legislation are briefly presented and the outcome from scientific publications reporting on the levels of these compounds in seafood is presented and discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

Computer-aided diagnosis workstation and database system for chest diagnosis based on multi-helical CT images

NASA Astrophysics Data System (ADS)

Satoh, Hitoshi; Niki, Noboru; Mori, Kiyoshi; Eguchi, Kenji; Kaneko, Masahiro; Kakinuma, Ryutarou; Moriyama, Noriyuki; Ohmatsu, Hironobu; Masuda, Hideo; Machida, Suguru; Sasagawa, Michizou

2006-03-01

Multi-helical CT scanner advanced remarkably at the speed at which the chest CT images were acquired for mass screening. Mass screening based on multi-helical CT images requires a considerable number of images to be read. It is this time-consuming step that makes the use of helical CT for mass screening impractical at present. To overcome this problem, we have provided diagnostic assistance methods to medical screening specialists by developing a lung cancer screening algorithm that automatically detects suspected lung cancers in helical CT images and a coronary artery calcification screening algorithm that automatically detects suspected coronary artery calcification. We also have developed electronic medical recording system and prototype internet system for the community health in two or more regions by using the Virtual Private Network router and Biometric fingerprint authentication system and Biometric face authentication system for safety of medical information. Based on these diagnostic assistance methods, we have now developed a new computer-aided workstation and database that can display suspected lesions three-dimensionally in a short time. This paper describes basic studies that have been conducted to evaluate this new system. The results of this study indicate that our computer-aided diagnosis workstation and network system can increase diagnostic speed, diagnostic accuracy and safety of medical information.

A statistical analysis of the impact of advertising signs on road safety.

PubMed

Yannis, George; Papadimitriou, Eleonora; Papantoniou, Panagiotis; Voulgari, Chrisoula

2013-01-01

This research aims to investigate the impact of advertising signs on road safety. An exhaustive review of international literature was carried out on the effect of advertising signs on driver behaviour and safety. Moreover, a before-and-after statistical analysis with control groups was applied on several road sites with different characteristics in the Athens metropolitan area, in Greece, in order to investigate the correlation between the placement or removal of advertising signs and the related occurrence of road accidents. Road accident data for the 'before' and 'after' periods on the test sites and the control sites were extracted from the database of the Hellenic Statistical Authority, and the selected 'before' and 'after' periods vary from 2.5 to 6 years. The statistical analysis shows no statistical correlation between road accidents and advertising signs in none of the nine sites examined, as the confidence intervals of the estimated safety effects are non-significant at 95% confidence level. This can be explained by the fact that, in the examined road sites, drivers are overloaded with information (traffic signs, directions signs, labels of shops, pedestrians and other vehicles, etc.) so that the additional information load from advertising signs may not further distract them.

Environmental contaminants of emerging concern in seafood – European database on contaminant levels

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

Vandermeersch, Griet, E-mail: griet.vandermeersch@ilvo.vlaanderen.be; Lourenço, Helena Maria; Alvarez-Muñoz, Diana

Marine pollution gives rise to concern not only about the environment itself but also about the impact on food safety and consequently on public health. European authorities and consumers have therefore become increasingly worried about the transfer of contaminants from the marine environment to seafood. So-called “contaminants of emerging concern” are chemical substances for which no maximum levels have been laid down in EU legislation, or substances for which maximum levels have been provided but which require revision. Adequate information on their presence in seafood is often lacking and thus potential risks cannot be excluded. Assessment of food safety issuesmore » related to these contaminants has thus become urgent and imperative. A database ( (www.ecsafeseafooddbase.eu)), containing available information on the levels of contaminants of emerging concern in seafood and providing the most recent data to scientists and regulatory authorities, was developed. The present paper reviews a selection of contaminants of emerging concern in seafood including toxic elements, endocrine disruptors, brominated flame retardants, pharmaceuticals and personal care products, polycyclic aromatic hydrocarbons and derivatives, microplastics and marine toxins. Current status on the knowledge of human exposure, toxicity and legislation are briefly presented and the outcome from scientific publications reporting on the levels of these compounds in seafood is presented and discussed. - Highlights: • Development of a European database regarding contaminants of emerging concern. • Current status on knowledge of human exposure, toxicity and legislation. • Review on the occurrence of contaminants of emerging concern in seafood.« less

Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

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

Jordan, Scott A., E-mail: scott.jordan@hc-sc.gc.c; Cunningham, David G.; Marles, Robin J.

Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantitymore » and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.« less

POPSCAN: A CNES Geo-Information Study for Re-Entry Risk Assessment

NASA Astrophysics Data System (ADS)

Fuentes, N.; Tholey, N.; Battiston, S.; Montabord, M.; Studer, M.

2013-09-01

Within the framework of the FSOA, French Space Operations Act (referred to as the "Loi relative aux Opérations Spatiales" or LOS in French), including in particular the monitoring of safety requirements for people and property, one major parameter to consider is Geographic Information (GI) on population distribution, human activity, and land occupation.This article gives an overview of the set of geographic and demographic data examined for CNES control offices, outlining the advantages and limits of each one : coverage, precision, update frequency, availability, distribution, ...It focuses on the two major available global population databases: GPW-GRUMP from CIESIN of COLUMBIA University and LandScan from ORNL. The work engaged on POPSCAN integrates digital analysis about these two world population grids and also comparisons on other databases such as GLOBAL- INSIGHT, VMAP0, ESRI, DMSP-ISA, GLOBCOVER, OpenFlights, ... for urban areas, communication networks, sensitive human activities and land use.

Identification of Crew-Systems Interactions and Decision Related Trends

NASA Technical Reports Server (NTRS)

Jones, Sharon Monica; Evans, Joni K.; Reveley, Mary S.; Withrow, Colleen A.; Ancel, Ersin; Barr, Lawrence

2013-01-01

NASA Vehicle System Safety Technology (VSST) project management uses systems analysis to identify key issues and maintain a portfolio of research leading to potential solutions to its three identified technical challenges. Statistical data and published safety priority lists from academic, industry and other government agencies were reviewed and analyzed by NASA Aviation Safety Program (AvSP) systems analysis personnel to identify issues and future research needs related to one of VSST's technical challenges, Crew Decision Making (CDM). The data examined in the study were obtained from the National Transportation Safety Board (NTSB) Aviation Accident and Incident Data System, Federal Aviation Administration (FAA) Accident/Incident Data System and the NASA Aviation Safety Reporting System (ASRS). In addition, this report contains the results of a review of safety priority lists, information databases and other documented references pertaining to aviation crew systems issues and future research needs. The specific sources examined were: Commercial Aviation Safety Team (CAST) Safety Enhancements Reserved for Future Implementation (SERFIs), Flight Deck Automation Issues (FDAI) and NTSB Most Wanted List and Open Recommendations. Various automation issues taxonomies and priority lists pertaining to human factors, automation and flight design were combined to create a list of automation issues related to CDM.

Mass media health information: quantitative and qualitative analysis of daily press coverage and its relation with public perceptions.

PubMed

Carducci, Annalaura; Alfani, Simona; Sassi, Manuela; Cinini, Alessandra; Calamusa, Andrea

2011-03-01

This paper describes the methods followed by the Pisa University OCS for collecting, storing and analyzing all health-related articles and database contents. Moreover, an example population survey on the topic of food safety based on such analysis is shown. Articles published each day since 1999 in Italy's three most popular newspapers are collected and stored in a Data Base Text; on these articles quantitative and qualitative analyses were conducted. On the basis of these results as well as of epidemiological data, a questionnaire survey was carried out about sources of information, knowledge and risk perception of citizens regarding food safety. On a total of 24,434 articles on all health topics, 18% regarded food related hazards: their evolution over time showed peaks on BSE, avian flu and dioxin. A large proportion of the people surveyed declared having changed their food habits, at least temporarily, as a consequence of media information. Most get their information on food safety mainly from television. Most respondents remembered having previously heard news on BSE, avian flu and dioxin, but did not recall having heard of listeriosis, brucellosis or typhoid fever. Newspapers articles facing food related hazards tend to be alarming thus affecting the citizens risk perception. On the other hand people often ignore how to manage their own food safety in a practical way. Analysis of media messages can help to evaluate and correct the negative effects that may result in wrong information. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Automatic summary generating technology of vegetable traceability for information sharing

NASA Astrophysics Data System (ADS)

Zhenxuan, Zhang; Minjing, Peng

2017-06-01

In order to solve problems of excessive data entries and consequent high costs for data collection in vegetable traceablility for farmers in traceability applications, the automatic summary generating technology of vegetable traceability for information sharing was proposed. The proposed technology is an effective way for farmers to share real-time vegetable planting information in social networking platforms to enhance their brands and obtain more customers. In this research, the influencing factors in the vegetable traceablility for customers were analyzed to establish the sub-indicators and target indicators and propose a computing model based on the collected parameter values of the planted vegetables and standard legal systems on food safety. The proposed standard parameter model involves five steps: accessing database, establishing target indicators, establishing sub-indicators, establishing standard reference model and computing scores of indicators. On the basis of establishing and optimizing the standards of food safety and traceability system, this proposed technology could be accepted by more and more farmers and customers.

Twenty-fifth water reactor safety information meeting: Proceedings. Volume 2: Human reliability analysis and human performance evaluation; Technical issues related to rulemakings; Risk-informed, performance-based initiatives; High burn-up fuel research

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

Monteleone, S.

1998-03-01

This three-volume report contains papers presented at the conference. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Japan, Norway, and Russia. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. This volume contains the following: (1) human reliability analysis and human performance evaluation; (2) technical issues relatedmore » to rulemakings; (3) risk-informed, performance-based initiatives; and (4) high burn-up fuel research. Selected papers have been indexed separately for inclusion in the Energy Science and Technology Database.« less

Toxic substances registry system: Index of material safety data sheets

NASA Technical Reports Server (NTRS)

1993-01-01

The Material Safety Data Sheets (MSDS's) listed in this index reflect product inventories and associated MSDS's which were submitted to the Toxic Substances Registry database maintained by the Base Operations Contractor at the Kennedy Space Center. The purpose of this index is to provide KSC government, contractor, and tenant organizations a means to access information on the hazards associated with these chemicals. The Toxic Substance Registry Service (TSRS) was established to manage information dealing with the storage and use of toxic and otherwise hazardous materials at KSC. As a part of this service, the BOC Environmental Health Services maintains a central repository of MSDS's which were provided to TSRS. The data on the TSRS are obtained from NASA, contractor, and tenant organizations who use or store hazardous materials at KSC. It is the responsibility of these organizations to conduct inventories, obtain MSDS's, distribute Hazard Communication information to their employees, and otherwise implement compliance with appropriate Federal, State, and NASA Hazard Communication and Worker Right-to-Know regulations and policies.

SU-G-TeP4-06: An Integrated Application for Radiation Therapy Treatment Plan Directives, Management, and Reporting

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

Matuszak, M; Anderson, C; Lee, C

Purpose: With electronic medical records, patient information for the treatment planning process has become disseminated across multiple applications with limited quality control and many associated failure modes. We present the development of a single application with a centralized database to manage the planning process. Methods: The system was designed to replace current functionalities of (i) static directives representing the physician intent for the prescription and planning goals, localization information for delivery, and other information, (ii) planning objective reports, (iii) localization and image guidance documents and (iv) the official radiation therapy prescription in the medical record. Using the Eclipse Scripting Applicationmore » Programming Interface, a plug-in script with an associated domain-specific SQL Server database was created to manage the information in (i)–(iv). The system’s user interface and database were designed by a team of physicians, clinical physicists, database experts, and software engineers to ensure usability and robustness for clinical use. Results: The resulting system has been fully integrated within the TPS via a custom script and database. Planning scenario templates, version control, approvals, and logic-based quality control allow this system to fully track and document the planning process as well as physician approval of tradeoffs while improving the consistency of the data. Multiple plans and prescriptions are supported along with non-traditional dose objectives and evaluation such as biologically corrected models, composite dose limits, and management of localization goals. User-specific custom views were developed for the attending physician review, physicist plan checks, treating therapists, and peer review in chart rounds. Conclusion: A method was developed to maintain cohesive information throughout the planning process within one integrated system by using a custom treatment planning management application that interfaces directly with the TPS. Future work includes quantifying the improvements in quality, safety and efficiency that are possible with the routine clinical use of this system. Supported in part by NIH-P01-CA-059827.« less

FDA MAUDE data on complications with lasers, light sources, and energy-based devices.

PubMed

Tremaine, Anne Marie; Avram, Mathew M

2015-02-01

It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety. © 2015 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Effectiveness of adverse effects search filters: drugs versus medical devices.

PubMed

Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

2016-07-01

The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%-87%) than for drugs (88%-93%) in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%-81%) than in MEDLINE (67%-87%) for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

A Real-Time Construction Safety Monitoring System for Hazardous Gas Integrating Wireless Sensor Network and Building Information Modeling Technologies

PubMed Central

Cheung, Weng-Fong; Lin, Tzu-Hsuan; Lin, Yu-Cheng

2018-01-01

In recent years, many studies have focused on the application of advanced technology as a way to improve management of construction safety management. A Wireless Sensor Network (WSN), one of the key technologies in Internet of Things (IoT) development, enables objects and devices to sense and communicate environmental conditions; Building Information Modeling (BIM), a revolutionary technology in construction, integrates database and geometry into a digital model which provides a visualized way in all construction lifecycle management. This paper integrates BIM and WSN into a unique system which enables the construction site to visually monitor the safety status via a spatial, colored interface and remove any hazardous gas automatically. Many wireless sensor nodes were placed on an underground construction site and to collect hazardous gas level and environmental condition (temperature and humidity) data, and in any region where an abnormal status is detected, the BIM model will alert the region and an alarm and ventilator on site will start automatically for warning and removing the hazard. The proposed system can greatly enhance the efficiency in construction safety management and provide an important reference information in rescue tasks. Finally, a case study demonstrates the applicability of the proposed system and the practical benefits, limitations, conclusions, and suggestions are summarized for further applications. PMID:29393887

Surgical checklists: a systematic review of impacts and implementation

PubMed Central

Treadwell, Jonathan R; Lucas, Scott; Tsou, Amy Y

2014-01-01

Background Surgical complications represent a significant cause of morbidity and mortality with the rate of major complications after inpatient surgery estimated at 3–17% in industrialised countries. The purpose of this review was to summarise experience with surgical checklist use and efficacy for improving patient safety. Methods A search of four databases (MEDLINE, CINAHL, EMBASE and the Cochrane Database of Controlled Trials) was conducted from 1 January 2000 to 26 October 2012. Articles describing actual use of the WHO checklist, the Surgical Patient Safety System (SURPASS) checklist, a wrong-site surgery checklist or an anaesthesia equipment checklist were eligible for inclusion (this manuscript summarises all but the anaesthesia equipment checklists, which are described in the Agency for Healthcare Research and Quality publication). Results We included a total of 33 studies. We report a variety of outcomes including avoidance of adverse events, facilitators and barriers to implementation. Checklists have been adopted in a wide variety of settings and represent a promising strategy for improving the culture of patient safety and perioperative care in a wide variety of settings. Surgical checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating staff. Strategies for successful checklist implementation included enlisting institutional leaders as local champions, incorporating staff feedback for checklist adaptation and avoiding redundancies with existing systems for collecting information. Conclusions Surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide. Further studies are needed to evaluate to what degree checklists improve clinical outcomes and whether improvements may be more pronounced in particular settings. PMID:23922403

49 CFR 375.103 - What are the definitions of terms used in this part?

Code of Federal Regulations, 2011 CFR

2011-10-01

...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY... household goods transportation service. This includes written or electronic database listings of your name, address, and telephone number in an on-line database. This excludes listings of your name, address, and...

49 CFR 375.103 - What are the definitions of terms used in this part?

Code of Federal Regulations, 2010 CFR

2010-10-01

...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY... household goods transportation service. This includes written or electronic database listings of your name, address, and telephone number in an on-line database. This excludes listings of your name, address, and...

Kaiser Permanente Northern California pregnancy database: Description and proof of concept study.

PubMed

Zerbo, Ousseny; Chan, Berwick; Goddard, Kristin; Lewis, Ned; Bok, Karin; Klein, Nicola P; Baxter, Roger

2016-11-04

We describe the establishment of a dynamic database linking mothers to newborns with the goal of studying vaccine safety in both pregnant women and their children and provide results of a study utilizing this database as a proof of concept. All Kaiser Permanente Northern California (KPNC) live births and their mothers were eligible for inclusion in the pregnancy database. We used the medical record number (MRN), a unique identifier, to retrieve information about events that occurred during the pregnancy and at delivery and linked this same MRN to newborns for post-partum follow up. We conducted a retrospective cohort study to evaluate the association between receipt of tetanus, diphtheria and acellular pertussis (Tdap) vaccine during pregnancy and fever 0-3days after the first dose of diphtheria tetanus and acellular pertussis (DTaP) vaccine in the infant. The study included infants who were born at ⩾37weeks gestation from January 1, 2009 - October 1, 2015 and who received their first DTaP vaccine between 6 and 10weeks of age. We utilized diagnostic codes from inpatient, emergency department, outpatient clinics, and telephone calls. We identified fever using ICD 9 code 780.6, recorded temperature ⩾101 degree Fahrenheit, or parental report. The database contained the starting and ending date of each pregnancy and basic demographic characteristics of mothers and infants. There were 859,699 women and 873,753 children in the database as of January 2016. The proof of concept study included 148,699 infants. In a multivariable logistic regression analysis, Tdap vaccination during pregnancy was not associated with infant fever 0-3daysafter first dose of DTaP (adjusted odds ratio=0.92, 95% CI 0.82-1.04). The KPNC pregnancy database can be used for studies investigating exposure during pregnancy and outcomes in mothers and/or infants, particularly monitoring vaccine safety and effectiveness. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of the Effects of Receiving Trauma-Informed Practices on Domestic Violence Shelter Residents.

PubMed

Sullivan, Cris M; Goodman, Lisa A; Virden, Tyler; Strom, Jennifer; Ramirez, Rachel

2017-08-17

Domestic violence is a potentially traumatizing experience that has devastating psychological and physical consequences. In response, domestic violence shelter programs have focused increasing attention on helping adult and child survivors understand and heal from this trauma. What have come to be called trauma-informed practices include (a) reflecting an understanding of trauma and its many effects on health and behavior, (b) addressing both physical and psychological safety concerns, (c) using a culturally informed strengths-based approach, (d) helping to illuminate the nature and effects of abuse on survivors' everyday experience; and (e) providing opportunities for clients to regain control over their lives. Despite the proliferation of these practices, little is known about their effects on survivors. In response, the current study explored the extent to which trauma-informed practices, as experienced by shelter residents, related to changes in their levels of self-efficacy, safety-related empowerment, and depressive symptoms over the course of approximately 30 days in shelter. Fifty-seven shelter residents from 4 programs in Ohio completed surveys shortly after arriving in shelter and again before exit. Their perception of the degree to which they received trauma-informed services was associated with significant improvement in their self-efficacy and safety-related empowerment, but had no impact on depressive symptoms. Depressive symptoms decreased over time, regardless of receipt of trauma-informed practice. Implications for policy and practice are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Composite Overwrapped Pressure Vessels: Database Extension Task 3.0 and Impact Damage Effects Control Task 8.0

NASA Technical Reports Server (NTRS)

Beeson, Harold D.; Davis, Dennis D.; Ross, William L., Sr.; Tapphorn, Ralph M.

2002-01-01

This document represents efforts accomplished at the NASA Johnson Space Center White Sands Test Facility (WSTF) in support of the Enhanced Technology for Composite Overwrapped Pressure Vessels (COPV) Program, a joint research and technology effort among the U.S. Air Force, NASA, and the Aerospace Corporation. WSTF performed testing for several facets of the program. Testing that contributed to the Task 3.0 COPV database extension objective included baseline structural strength, failure mode and safe-life, impact damage tolerance, sustained load/impact effect, and materials compatibility. WSTF was also responsible for establishing impact protection and control requirements under Task 8.0 of the program. This included developing a methodology for establishing an impact control plan. Seven test reports detail the work done at WSTF. As such, this document contributes to the database of information regarding COPV behavior that will ensure performance benefits and safety are maintained throughout vessel service life.

The Toxic Exposure Surveillance System (TESS): Risk assessment and real-time toxicovigilance across United States poison centers

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

Watson, William A.; Litovitz, Toby L.; Belson, Martin G.

2005-09-01

The Toxic Exposure Surveillance System (TESS) is a uniform data set of US poison centers cases. Categories of information include the patient, the caller, the exposure, the substance(s), clinical toxicity, treatment, and medical outcome. The TESS database was initiated in 1985, and provides a baseline of more than 36.2 million cases through 2003. The database has been utilized for a number of safety evaluations. Consideration of the strengths and limitations of TESS data must be incorporated into data interpretation. Real-time toxicovigilance was initiated in 2003 with continuous uploading of new cases from all poison centers to a central database. Real-timemore » toxicovigilance utilizing general and specific approaches is systematically run against TESS, further increasing the potential utility of poison center experiences as a means of early identification of potential public health threats.« less

Current status of cardiovascular surgery in Japan, 2013 and 2014: A report based on the Japan Cardiovascular Surgery Database (JCVSD). 1: Mission and history of JCVSD.

PubMed

Takamoto, Shinichi; Motomura, Noboru; Miyata, Hiroaki; Tsukihara, Hiroyuki

2018-01-01

The Japan Cardiovascular Surgery Database (JCVSD) was created in 2000 with the support of the Society of Thoracic Surgeons (STS). The STS database content was translated to Japanese using the same disease criteria and in 2001, data entry for adult cardiac surgeries was initiated online using the University Hospital Medical Information Network (UMIN). In 2008, data entry for congenital heart surgeries was initiated in the congenital section of JCVSD and preoperative expected mortality (JapanSCORE) in adult cardiovascular surgeries was first calculated using the risk model of JCVSD. The Japan Surgical Board system merged with JCVSD in 2011, and all cardiovascular surgical data were registered in the JCVSD from 2012 onward. The reports resulting from the data analyses of the JCVSD will encourage further improvements in the quality of cardiovascular surgeries, patient safety, and medical care in Japan.

Preliminary Results Obtained in Integrated Safety Analysis of NASA Aviation Safety Program Technologies

NASA Technical Reports Server (NTRS)

2001-01-01

This is a listing of recent unclassified RTO technical publications processed by the NASA Center for AeroSpace Information from January 1, 2001 through March 31, 2001 available on the NASA Aeronautics and Space Database. Contents include 1) Cognitive Task Analysis; 2) RTO Educational Notes; 3) The Capability of Virtual Reality to Meet Military Requirements; 4) Aging Engines, Avionics, Subsystems and Helicopters; 5) RTO Meeting Proceedings; 6) RTO Technical Reports; 7) Low Grazing Angle Clutter...; 8) Verification and Validation Data for Computational Unsteady Aerodynamics; 9) Space Observation Technology; 10) The Human Factor in System Reliability...; 11) Flight Control Design...; 12) Commercial Off-the-Shelf Products in Defense Applications.

Exploitation of molecular profiling techniques for GM food safety assessment.

PubMed

Kuiper, Harry A; Kok, Esther J; Engel, Karl-Heinz

2003-04-01

Several strategies have been developed to identify unintended alterations in the composition of genetically modified (GM) food crops that may occur as a result of the genetic modification process. These include comparative chemical analysis of single compounds in GM food crops and their conventional non-GM counterparts, and profiling methods such as DNA/RNA microarray technologies, proteomics and metabolite profiling. The potential of profiling methods is obvious, but further exploration of specificity, sensitivity and validation is needed. Moreover, the successful application of profiling techniques to the safety evaluation of GM foods will require linked databases to be built that contain information on variations in profiles associated with differences in developmental stages and environmental conditions.

A safety app to respond to dating violence for college women and their friends: the MyPlan study randomized controlled trial protocol.

PubMed

Glass, Nancy; Clough, Amber; Case, James; Hanson, Ginger; Barnes-Hoyt, Jamie; Waterbury, Amy; Alhusen, Jeanne; Ehrensaft, Miriam; Grace, Karen Trister; Perrin, Nancy

2015-09-08

Research demonstrates high rates of physical and sexual victimization of women by intimate partners on college campuses (Black et al. 2001). College women in abusive relationships must weigh complex factors (health, academics, economics, and social stigma) during critical decision-making regarding the relationship. Rather than access formal support systems (e.g., campus security, administrators, counselors), research indicates abused college women most often turn to informal networks; specifically friends (Perspect Psychiatr Care 41:162-171, 2005), who often lack the knowledge or resources to provide effective support (Nurs Res 54(4):235-242, 2005). Decision aids have been shown to assist with health-related decisions by improving knowledge, creating realistic expectations, and resolving decisional conflict (Cochrane Database Syst Rev 1:1-332, 2014). This study is a randomized controlled trial testing the effectiveness of an interactive safety decision aid web-based and smartphone application (App) for abused college women and their friends. Three hundred female college students experiencing abuse and three hundred friends of female college students experiencing abuse will be recruited in Maryland and Oregon and randomized to either the intervention safety decision aid, accessible by website or smartphone App, or a usual safety planning control website/App. The intervention App allows users to enter information on: a) relationship health; b) safety priorities; and c) severity of violence/danger in relationship. The App uses this information to provide personalized safety planning information and resources. Self-reported outcome measures for abused college women on safety seeking behaviors, decisional conflict, IPV exposure and mental health will be collected at baseline, six, and 12-months post-baseline via the study App/website. Outcomes measured for friends are IPV awareness, confidence to intervene, supportive behaviors and decisional conflict. Protocols for safely recruiting, retaining and collecting data from abused women via web/App are discussed. This trial may provide important information on the impact of an App and web-based safety planning tool on college women's decisional conflict and safety behavior use when making difficult safety decisions. This study is the first, to our knowledge, to test an intervention that engages friends of abused college women. The trial may also inform researchers on the feasibility of safely conducting research with abused women using online recruitment and enrollment methods and collecting data via an App or website. Clinicaltrials.gov ID: NCT02236663.

Mass and Reliability System (MaRS)

NASA Technical Reports Server (NTRS)

Barnes, Sarah

2016-01-01

The Safety and Mission Assurance (S&MA) Directorate is responsible for mitigating risk, providing system safety, and lowering risk for space programs from ground to space. The S&MA is divided into 4 divisions: The Space Exploration Division (NC), the International Space Station Division (NE), the Safety & Test Operations Division (NS), and the Quality and Flight Equipment Division (NT). The interns, myself and Arun Aruljothi, will be working with the Risk & Reliability Analysis Branch under the NC Division's. The mission of this division is to identify, characterize, diminish, and communicate risk by implementing an efficient and effective assurance model. The team utilizes Reliability and Maintainability (R&M) and Probabilistic Risk Assessment (PRA) to ensure decisions concerning risks are informed, vehicles are safe and reliable, and program/project requirements are realistic and realized. This project pertains to the Orion mission, so it is geared toward a long duration Human Space Flight Program(s). For space missions, payload is a critical concept; balancing what hardware can be replaced by components verse by Orbital Replacement Units (ORU) or subassemblies is key. For this effort a database was created that combines mass and reliability data, called Mass and Reliability System or MaRS. The U.S. International Space Station (ISS) components are used as reference parts in the MaRS database. Using ISS components as a platform is beneficial because of the historical context and the environment similarities to a space flight mission. MaRS uses a combination of systems: International Space Station PART for failure data, Vehicle Master Database (VMDB) for ORU & components, Maintenance & Analysis Data Set (MADS) for operation hours and other pertinent data, & Hardware History Retrieval System (HHRS) for unit weights. MaRS is populated using a Visual Basic Application. Once populated, the excel spreadsheet is comprised of information on ISS components including: operation hours, random/nonrandom failures, software/hardware failures, quantity, orbital replaceable units (ORU), date of placement, unit weight, frequency of part, etc. The motivation for creating such a database will be the development of a mass/reliability parametric model to estimate mass required for replacement parts. Once complete, engineers working on future space flight missions will have access a mean time to failures and on parts along with their mass, this will be used to make proper decisions for long duration space flight missions

The relationship between labor unions and safety in US airlines: Is there a "union effect?"

NASA Astrophysics Data System (ADS)

Zapf, Renee Catherine

Every airline union claims to work for safety and presents anecdotes where greater airline safety has been achieved through union efforts. The effect unionization has on safety outcomes in U.S. commercial airlines, however, wasn't found to be previously tested. Studies have shown that in industries such as coal mining, retail, and construction, unionization does lead to an increase in safety. This study evaluated the safety rates of 15 major US commercial airlines to compare the difference between unionized and non-unionized airlines. These safety rates were compared based on if and how long each airline's pilots and flight attendants have been unionized, to determine if unionization had an effect on safety outcomes. The 15 airlines included in the study identified as operating most of the years between 1990 and 2013, with annual departures averaging over 130,000, available through the Bureau of Transportation Statistics. Accident and Incident information was acquired through the National Transportation Safety Board database. The number of accident and incidents divided by the total departures at each airline was used as the safety rate. Union websites provided information on unionization at the airlines. Due to the complex nature of the aviation industry, a number of confounding factors could have affected the tests, including mergers, route structures, and legislation. To help control for these confounding factors, this study was limited to airlines with a stable presence in the industry over time, which limited the number of airlines included. No significant difference was found between unionized and non-unionized airlines in this study, though the mean safety rate of unionized airlines was found be better than non-unionized airlines. This study did not take into account safety improvements that were union-backed and eventually required at all airlines, regardless of unionization. Due to the large sample size of the small population the difference in safety rate means could be indicative of greater safety in unionized airlines.

[Validation of interaction databases in psychopharmacotherapy].

PubMed

Hahn, M; Roll, S C

2018-03-01

Drug-drug interaction databases are an important tool to increase drug safety in polypharmacy. There are several drug interaction databases available but it is unclear which one shows the best results and therefore increases safety for the user of the databases and the patients. So far, there has been no validation of German drug interaction databases. Validation of German drug interaction databases regarding the number of hits, mechanisms of drug interaction, references, clinical advice, and severity of the interaction. A total of 36 drug interactions which were published in the last 3-5 years were checked in 5 different databases. Besides the number of hits, it was also documented if the mechanism was correct, clinical advice was given, primary literature was cited, and the severity level of the drug-drug interaction was given. All databases showed weaknesses regarding the hit rate of the tested drug interactions, with a maximum of 67.7% hits. The highest score in this validation was achieved by MediQ with 104 out of 180 points. PsiacOnline achieved 83 points, arznei-telegramm® 58, ifap index® 54 and the ABDA-database 49 points. Based on this validation MediQ seems to be the most suitable databank for the field of psychopharmacotherapy. The best results in this comparison were achieved by MediQ but this database also needs improvement with respect to the hit rate so that the users can rely on the results and therefore increase drug therapy safety.

Keeping patients safe in healthcare organizations: a structuration theory of safety culture.

PubMed

Groves, Patricia S; Meisenbach, Rebecca J; Scott-Cawiezell, Jill

2011-08-01

This paper presents a discussion of the use of structuration theory to facilitate understanding and improvement of safety culture in healthcare organizations. Patient safety in healthcare organizations is an important problem worldwide. Safety culture has been proposed as a means to keep patients safe. However, lack of appropriate theory limits understanding and improvement of safety culture. The proposed structuration theory of safety culture was based on a critique of available English-language literature, resulting in literature published from 1983 to mid-2009. CINAHL, Communication and Mass Media Complete, ABI/Inform and Google Scholar databases were searched using the following terms: nursing, safety, organizational culture and safety culture. When viewed through the lens of structuration theory, safety culture is a system involving both individual actions and organizational structures. Healthcare organization members, particularly nurses, share these values through communication and enact them in practice, (re)producing an organizational safety culture system that reciprocally constrains and enables the actions of the members in terms of patient safety. This structurational viewpoint illuminates multiple opportunities for safety culture improvement. Nurse leaders should be cognizant of competing value-based culture systems in the organization and attend to nursing agency and all forms of communication when attempting to create or strengthen a safety culture. Applying structuration theory to the concept of safety culture reveals a dynamic system of individual action and organizational structure constraining and enabling safety practice. Nurses are central to the (re)production of this safety culture system. © 2011 Blackwell Publishing Ltd.

An Online Resource for Flight Test Safety Planning

NASA Technical Reports Server (NTRS)

Lewis, Greg

2007-01-01

A viewgraph presentation describing an online database for flight test safety techniques is shown. The topics include: 1) Goal; 2) Test Hazard Analyses; 3) Online Database Background; 4) Data Gathering; 5) NTPS Role; 6) Organizations; 7) Hazard Titles; 8) FAR Paragraphs; 9) Maneuver Name; 10) Identified Hazard; 11) Matured Hazard Titles; 12) Loss of Control Causes; 13) Mitigations; 14) Database Now Open to the Public; 15) FAR Reference Search; 16) Record Field Search; 17) Keyword Search; and 18) Results of FAR Reference Search.

Design considerations, architecture, and use of the Mini-Sentinel distributed data system.

PubMed

Curtis, Lesley H; Weiner, Mark G; Boudreau, Denise M; Cooper, William O; Daniel, Gregory W; Nair, Vinit P; Raebel, Marsha A; Beaulieu, Nicolas U; Rosofsky, Robert; Woodworth, Tiffany S; Brown, Jeffrey S

2012-01-01

We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA. A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners. A review of existing common data models informed the process. Each participating organization designed a process to extract, transform, and load its source data, applying the common data model to create the Mini-Sentinel Distributed Database. Transformed data were characterized and evaluated using a series of programs developed centrally and executed locally by participating organizations. A secure communications portal was designed to facilitate queries of the Mini-Sentinel Distributed Database and transfer of confidential data, analytic tools were developed to facilitate rapid response to common questions, and distributed querying software was implemented to facilitate rapid querying of summary data. As of July 2011, information on 99,260,976 health plan members was included in the Mini-Sentinel Distributed Database. The database includes 316,009,067 person-years of observation time, with members contributing, on average, 27.0 months of observation time. All data partners have successfully executed distributed code and returned findings to the Mini-Sentinel Operations Center. This work demonstrates the feasibility of building a large, multiorganizational distributed data system in which organizations retain possession of their data that are used in an active surveillance system. Copyright © 2012 John Wiley & Sons, Ltd.

Similarity-based modeling in large-scale prediction of drug-drug interactions.

PubMed

Vilar, Santiago; Uriarte, Eugenio; Santana, Lourdes; Lorberbaum, Tal; Hripcsak, George; Friedman, Carol; Tatonetti, Nicholas P

2014-09-01

Drug-drug interactions (DDIs) are a major cause of adverse drug effects and a public health concern, as they increase hospital care expenses and reduce patients' quality of life. DDI detection is, therefore, an important objective in patient safety, one whose pursuit affects drug development and pharmacovigilance. In this article, we describe a protocol applicable on a large scale to predict novel DDIs based on similarity of drug interaction candidates to drugs involved in established DDIs. The method integrates a reference standard database of known DDIs with drug similarity information extracted from different sources, such as 2D and 3D molecular structure, interaction profile, target and side-effect similarities. The method is interpretable in that it generates drug interaction candidates that are traceable to pharmacological or clinical effects. We describe a protocol with applications in patient safety and preclinical toxicity screening. The time frame to implement this protocol is 5-7 h, with additional time potentially necessary, depending on the complexity of the reference standard DDI database and the similarity measures implemented.

Review of Safety Reports Involving Electronic Flight Bags.

DOT National Transportation Integrated Search

2010-04-01

Safety events in which Electronic Flight Bags (EFBs) were a factor are reviewed. Relevant reports were obtained from the public Aviation Safety Reporting System (ASRS) database and the National Transportation Safety Board (NTSB) accident report datab...

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance.

PubMed

Izem, Rima; Sanchez-Kam, Matilde; Ma, Haijun; Zink, Richard; Zhao, Yueqin

2018-03-01

Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. This paper discusses data sources and analysis considerations for safety signal detection after a medical product is approved for marketing. This manuscript is the second in a series of papers from the American Statistical Association Biopharmaceutical Section Safety Working Group. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from passive postmarketing surveillance systems compared to other sources. Signal detection has traditionally relied on spontaneous reporting databases that have been available worldwide for decades. However, current regulatory guidelines and ease of reporting have increased the size of these databases exponentially over the last few years. With such large databases, data-mining tools using disproportionality analysis and helpful graphics are often used to detect potential signals. Although the data sources have many limitations, analyses of these data have been successful at identifying safety signals postmarketing. Experience analyzing these dynamic data is useful in understanding the potential and limitations of analyses with new data sources such as social media, claims, or electronic medical records data.

Design and implementation of an identification system in construction site safety for proactive accident prevention.

PubMed

Yang, Huanjia; Chew, David A S; Wu, Weiwei; Zhou, Zhipeng; Li, Qiming

2012-09-01

Identifying accident precursors using real-time identity information has great potential to improve safety performance in construction industry, which is still suffering from day to day records of accident fatality and injury. Based on the requirements analysis for identifying precursor and the discussion of enabling technology solutions for acquiring and sharing real-time automatic identification information on construction site, this paper proposes an identification system design for proactive accident prevention to improve construction site safety. Firstly, a case study is conducted to analyze the automatic identification requirements for identifying accident precursors in construction site. Results show that it mainly consists of three aspects, namely access control, training and inspection information and operation authority. The system is then designed to fulfill these requirements based on ZigBee enabled wireless sensor network (WSN), radio frequency identification (RFID) technology and an integrated ZigBee RFID sensor network structure. At the same time, an information database is also designed and implemented, which includes 15 tables, 54 queries and several reports and forms. In the end, a demonstration system based on the proposed system design is developed as a proof of concept prototype. The contributions of this study include the requirement analysis and technical design of a real-time identity information tracking solution for proactive accident prevention on construction sites. The technical solution proposed in this paper has a significant importance in improving safety performance on construction sites. Moreover, this study can serve as a reference design for future system integrations where more functions, such as environment monitoring and location tracking, can be added. Copyright © 2011 Elsevier Ltd. All rights reserved.

Development of a functional, internet-accessible department of surgery outcomes database.

PubMed

Newcomb, William L; Lincourt, Amy E; Gersin, Keith; Kercher, Kent; Iannitti, David; Kuwada, Tim; Lyons, Cynthia; Sing, Ronald F; Hadzikadic, Mirsad; Heniford, B Todd; Rucho, Susan

2008-06-01

The need for surgical outcomes data is increasing due to pressure from insurance companies, patients, and the need for surgeons to keep their own "report card". Current data management systems are limited by inability to stratify outcomes based on patients, surgeons, and differences in surgical technique. Surgeons along with research and informatics personnel from an academic, hospital-based Department of Surgery and a state university's Department of Information Technology formed a partnership to develop a dynamic, internet-based, clinical data warehouse. A five-component model was used: data dictionary development, web application creation, participating center education and management, statistics applications, and data interpretation. A data dictionary was developed from a list of data elements to address needs of research, quality assurance, industry, and centers of excellence. A user-friendly web interface was developed with menu-driven check boxes, multiple electronic data entry points, direct downloads from hospital billing information, and web-based patient portals. Data were collected on a Health Insurance Portability and Accountability Act-compliant server with a secure firewall. Protected health information was de-identified. Data management strategies included automated auditing, on-site training, a trouble-shooting hotline, and Institutional Review Board oversight. Real-time, daily, monthly, and quarterly data reports were generated. Fifty-eight publications and 109 abstracts have been generated from the database during its development and implementation. Seven national academic departments now use the database to track patient outcomes. The development of a robust surgical outcomes database requires a combination of clinical, informatics, and research expertise. Benefits of surgeon involvement in outcomes research include: tracking individual performance, patient safety, surgical research, legal defense, and the ability to provide accurate information to patient and payers.

Evolution of a Structure-Searchable Database into a Prototype for a High-Fidelity SmartPhone App for 62 Common Pesticides Used in Delaware.

PubMed

D'Souza, Malcolm J; Barile, Benjamin; Givens, Aaron F

2015-05-01

Synthetic pesticides are widely used in the modern world for human benefit. They are usually classified according to their intended pest target. In Delaware (DE), approximately 42 percent of the arable land is used for agriculture. In order to manage insectivorous and herbaceous pests (such as insects, weeds, nematodes, and rodents), pesticides are used profusely to biologically control the normal pest's life stage. In this undergraduate project, we first created a usable relational database containing 62 agricultural pesticides that are common in Delaware. Chemically pertinent quantitative and qualitative information was first stored in Bio-Rad's KnowItAll® Informatics System. Next, we extracted the data out of the KnowItAll® system and created additional sections on a Microsoft® Excel spreadsheet detailing pesticide use(s) and safety and handling information. Finally, in an effort to promote good agricultural practices, to increase efficiency in business decisions, and to make pesticide data globally accessible, we developed a mobile application for smartphones that displayed the pesticide database using Appery.io™; a cloud-based HyperText Markup Language (HTML5), jQuery Mobile and Hybrid Mobile app builder.

DICOM index tracker enterprise: advanced system for enterprise-wide quality assurance and patient safety monitoring

NASA Astrophysics Data System (ADS)

Zhang, Min; Pavlicek, William; Panda, Anshuman; Langer, Steve G.; Morin, Richard; Fetterly, Kenneth A.; Paden, Robert; Hanson, James; Wu, Lin-Wei; Wu, Teresa

2015-03-01

DICOM Index Tracker (DIT) is an integrated platform to harvest rich information available from Digital Imaging and Communications in Medicine (DICOM) to improve quality assurance in radiology practices. It is designed to capture and maintain longitudinal patient-specific exam indices of interests for all diagnostic and procedural uses of imaging modalities. Thus, it effectively serves as a quality assurance and patient safety monitoring tool. The foundation of DIT is an intelligent database system which stores the information accepted and parsed via a DICOM receiver and parser. The database system enables the basic dosimetry analysis. The success of DIT implementation at Mayo Clinic Arizona calls for the DIT deployment at the enterprise level which requires significant improvements. First, for geographically distributed multi-site implementation, the first bottleneck is the communication (network) delay; the second is the scalability of the DICOM parser to handle the large volume of exams from different sites. To address this issue, DICOM receiver and parser are separated and decentralized by site. To facilitate the enterprise wide Quality Assurance (QA), a notable challenge is the great diversities of manufacturers, modalities and software versions, as the solution DIT Enterprise provides the standardization tool for device naming, protocol naming, physician naming across sites. Thirdly, advanced analytic engines are implemented online which support the proactive QA in DIT Enterprise.

Validation of a common data model for active safety surveillance research

PubMed Central

Ryan, Patrick B; Reich, Christian G; Hartzema, Abraham G; Stang, Paul E

2011-01-01

Objective Systematic analysis of observational medical databases for active safety surveillance is hindered by the variation in data models and coding systems. Data analysts often find robust clinical data models difficult to understand and ill suited to support their analytic approaches. Further, some models do not facilitate the computations required for systematic analysis across many interventions and outcomes for large datasets. Translating the data from these idiosyncratic data models to a common data model (CDM) could facilitate both the analysts' understanding and the suitability for large-scale systematic analysis. In addition to facilitating analysis, a suitable CDM has to faithfully represent the source observational database. Before beginning to use the Observational Medical Outcomes Partnership (OMOP) CDM and a related dictionary of standardized terminologies for a study of large-scale systematic active safety surveillance, the authors validated the model's suitability for this use by example. Validation by example To validate the OMOP CDM, the model was instantiated into a relational database, data from 10 different observational healthcare databases were loaded into separate instances, a comprehensive array of analytic methods that operate on the data model was created, and these methods were executed against the databases to measure performance. Conclusion There was acceptable representation of the data from 10 observational databases in the OMOP CDM using the standardized terminologies selected, and a range of analytic methods was developed and executed with sufficient performance to be useful for active safety surveillance. PMID:22037893

49 CFR 365.507 - FMCSA action on the application.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS RULES... databases of the governments of Mexico and the United States. (c) Pre-authorization safety audit. Every...

49 CFR 365.507 - FMCSA action on the application.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS RULES... databases of the governments of Mexico and the United States. (c) Pre-authorization safety audit. Every...

IFKIS a basis for organizational measures in avalanche risk management

NASA Astrophysics Data System (ADS)

Bründl, M.; Etter, H.-J.; Klingler, Ch.; Steiniger, M.; Rhyner, J.; Ammann, W.

2003-04-01

The avalanche winter 1999 in Switzerland showed that the combination of protection measures like avalanche barriers, hazard zone mapping, artificial avalanche release and organisational measures (closure of roads, evacuation etc.) proved to perform well. However, education as well as information and communication between the involved organizations proved to be a weak link in the crisis management. In the first part of the project IFKIS we developed a modular education and training course program for security responsibles of settlements and roads. In the second part an information system was developed which improves on the one hand the information fluxes between the national center for avalanche forecasting, the Swiss Federal Institute for Snow and Avalanche Research SLF, and the local forecasters. On the other hand the communication between the avalanche security services in the communities can be enhanced. During the last two years an information system based on Internet technology has been developed for this purpose. This system allows the transmission of measured data and observations to a central database at SLF and visualization of the data for different users. It also provides the possibility to exchange information on organizational measures like closure of roads, artificial avalanche release etc. on a local and regional scale. This improves the information fluxes and the coordination of safety-measures because all users, although at different places, are on the same information level. Inconsistent safety-measures can be avoided and information and communication concerning avalanche safety becomes much more transparent for all persons involved in hazard management. The training program as well the concept for the information-system are important basics for an efficient avalanche risk management but also for other natural processes and catastrophes.

Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration.

PubMed

Drozda, Joseph P; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E

2018-02-01

The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture. Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors. The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model. The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Building Collaboration: A Scoping Review of Cultural Competency and Safety Education and Training for Healthcare Students and Professionals in Canada.

PubMed

Guerra, Olivia; Kurtz, Donna

2017-01-01

Phenomenon: This scoping literature review summarizes current Canadian health science education and training aimed to lessen health gaps between Aboriginal and non-Aboriginal peoples. Keyword searches of peer-reviewed and gray literature databases, websites, and resources recommended by local Aboriginal community members identified 1,754 resources. Using specific inclusion and exclusion criteria, 26 resources relevant to education and training of healthcare professionals and students in Canada were selected. Information included self-assessment for cultural competency/safety skills, advocacy within Canadian healthcare, and descriptions of current programs and training approaches. In spite of increasing awareness and use of cultural competency and safety concepts, few programs have been successfully implemented. Insights: A concerted effort among health science education and training bodies to develop integrated and effective programs could result in comprehensive processes that hasten the Canadian culturally safe healthcare provision, thus reducing the gaps among populations.

A New Cure for Medical Errors

NASA Technical Reports Server (NTRS)

2002-01-01

In May 2000, senior officials of the U.S. Department of Veterans Affairs (VA) and NASA signed an agreement that would commit the two agencies to create the Patient Safety Reporting System (PSRS) to report: events or situations that could have resulted in accident, injury, or illness, but did not, either by chance or through timely intervention (close-calls); unexpected serious occurrences that involved a patient or employee's death, physical injury, or psychological injury; lessens learned; and safety ideas. The VA provided NASA with funding for the initial development of the new system, which automatically removes all personal names, facility names and locations, and other potentially identifying information before entering reports into its database. Designed to complement the VA's current internal reporting systems, the PSRS is modeled after NASA's Aviation Safety Reporting System, which was established in 1975 under a Memorandum of Agreement between the Federal Aviation Administration and NASA and began operation in 1976.

A CTD–Pfizer collaboration: manual curation of 88 000 scientific articles text mined for drug–disease and drug–phenotype interactions

PubMed Central

Davis, Allan Peter; Wiegers, Thomas C.; Roberts, Phoebe M.; King, Benjamin L.; Lay, Jean M.; Lennon-Hopkins, Kelley; Sciaky, Daniela; Johnson, Robin; Keating, Heather; Greene, Nigel; Hernandez, Robert; McConnell, Kevin J.; Enayetallah, Ahmed E.; Mattingly, Carolyn J.

2013-01-01

Improving the prediction of chemical toxicity is a goal common to both environmental health research and pharmaceutical drug development. To improve safety detection assays, it is critical to have a reference set of molecules with well-defined toxicity annotations for training and validation purposes. Here, we describe a collaboration between safety researchers at Pfizer and the research team at the Comparative Toxicogenomics Database (CTD) to text mine and manually review a collection of 88 629 articles relating over 1 200 pharmaceutical drugs to their potential involvement in cardiovascular, neurological, renal and hepatic toxicity. In 1 year, CTD biocurators curated 2 54 173 toxicogenomic interactions (1 52 173 chemical–disease, 58 572 chemical–gene, 5 345 gene–disease and 38 083 phenotype interactions). All chemical–gene–disease interactions are fully integrated with public CTD, and phenotype interactions can be downloaded. We describe Pfizer’s text-mining process to collate the articles, and CTD’s curation strategy, performance metrics, enhanced data content and new module to curate phenotype information. As well, we show how data integration can connect phenotypes to diseases. This curation can be leveraged for information about toxic endpoints important to drug safety and help develop testable hypotheses for drug–disease events. The availability of these detailed, contextualized, high-quality annotations curated from seven decades’ worth of the scientific literature should help facilitate new mechanistic screening assays for pharmaceutical compound survival. This unique partnership demonstrates the importance of resource sharing and collaboration between public and private entities and underscores the complementary needs of the environmental health science and pharmaceutical communities. Database URL: http://ctdbase.org/ PMID:24288140

A CTD-Pfizer collaboration: manual curation of 88,000 scientific articles text mined for drug-disease and drug-phenotype interactions.

PubMed

Davis, Allan Peter; Wiegers, Thomas C; Roberts, Phoebe M; King, Benjamin L; Lay, Jean M; Lennon-Hopkins, Kelley; Sciaky, Daniela; Johnson, Robin; Keating, Heather; Greene, Nigel; Hernandez, Robert; McConnell, Kevin J; Enayetallah, Ahmed E; Mattingly, Carolyn J

2013-01-01

Improving the prediction of chemical toxicity is a goal common to both environmental health research and pharmaceutical drug development. To improve safety detection assays, it is critical to have a reference set of molecules with well-defined toxicity annotations for training and validation purposes. Here, we describe a collaboration between safety researchers at Pfizer and the research team at the Comparative Toxicogenomics Database (CTD) to text mine and manually review a collection of 88,629 articles relating over 1,200 pharmaceutical drugs to their potential involvement in cardiovascular, neurological, renal and hepatic toxicity. In 1 year, CTD biocurators curated 254,173 toxicogenomic interactions (152,173 chemical-disease, 58,572 chemical-gene, 5,345 gene-disease and 38,083 phenotype interactions). All chemical-gene-disease interactions are fully integrated with public CTD, and phenotype interactions can be downloaded. We describe Pfizer's text-mining process to collate the articles, and CTD's curation strategy, performance metrics, enhanced data content and new module to curate phenotype information. As well, we show how data integration can connect phenotypes to diseases. This curation can be leveraged for information about toxic endpoints important to drug safety and help develop testable hypotheses for drug-disease events. The availability of these detailed, contextualized, high-quality annotations curated from seven decades' worth of the scientific literature should help facilitate new mechanistic screening assays for pharmaceutical compound survival. This unique partnership demonstrates the importance of resource sharing and collaboration between public and private entities and underscores the complementary needs of the environmental health science and pharmaceutical communities. Database URL: http://ctdbase.org/

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.

49 CFR 385.607 - FMCSA action on the application.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY... maintained in databases of the governments of the country where the carrier's principal place of business is...

49 CFR 385.607 - FMCSA action on the application.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY... maintained in databases of the governments of the country where the carrier's principal place of business is...

Development of a consumer product ingredient database for chemical exposure screening and prioritization.

PubMed

Goldsmith, M-R; Grulke, C M; Brooks, R D; Transue, T R; Tan, Y M; Frame, A; Egeghy, P P; Edwards, R; Chang, D T; Tornero-Velez, R; Isaacs, K; Wang, A; Johnson, J; Holm, K; Reich, M; Mitchell, J; Vallero, D A; Phillips, L; Phillips, M; Wambaugh, J F; Judson, R S; Buckley, T J; Dary, C C

2014-03-01

Consumer products are a primary source of chemical exposures, yet little structured information is available on the chemical ingredients of these products and the concentrations at which ingredients are present. To address this data gap, we created a database of chemicals in consumer products using product Material Safety Data Sheets (MSDSs) publicly provided by a large retailer. The resulting database represents 1797 unique chemicals mapped to 8921 consumer products and a hierarchy of 353 consumer product "use categories" within a total of 15 top-level categories. We examine the utility of this database and discuss ways in which it will support (i) exposure screening and prioritization, (ii) generic or framework formulations for several indoor/consumer product exposure modeling initiatives, (iii) candidate chemical selection for monitoring near field exposure from proximal sources, and (iv) as activity tracers or ubiquitous exposure sources using "chemical space" map analyses. Chemicals present at high concentrations and across multiple consumer products and use categories that hold high exposure potential are identified. Our database is publicly available to serve regulators, retailers, manufacturers, and the public for predictive screening of chemicals in new and existing consumer products on the basis of exposure and risk. Published by Elsevier Ltd.

Use of large healthcare databases for rheumatology clinical research.

PubMed

Desai, Rishi J; Solomon, Daniel H

2017-03-01

Large healthcare databases, which contain data collected during routinely delivered healthcare to patients, can serve as a valuable resource for generating actionable evidence to assist medical and healthcare policy decision-making. In this review, we summarize use of large healthcare databases in rheumatology clinical research. Large healthcare data are critical to evaluate medication safety and effectiveness in patients with rheumatologic conditions. Three major sources of large healthcare data are: first, electronic medical records, second, health insurance claims, and third, patient registries. Each of these sources offers unique advantages, but also has some inherent limitations. To address some of these limitations and maximize the utility of these data sources for evidence generation, recent efforts have focused on linking different data sources. Innovations such as randomized registry trials, which aim to facilitate design of low-cost randomized controlled trials built on existing infrastructure provided by large healthcare databases, are likely to make clinical research more efficient in coming years. Harnessing the power of information contained in large healthcare databases, while paying close attention to their inherent limitations, is critical to generate a rigorous evidence-base for medical decision-making and ultimately enhancing patient care.

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

PubMed

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical preparations. Copyright © 2017 John Wiley & Sons, Ltd.

New active substances authorized in the United Kingdom between 1972 and 1994

PubMed Central

Jefferys, David B; Leakey, Diane; Lewis, John A; Payne, Sandra; Rawlins, Michael D

1998-01-01

Aims The study was undertaken to assemble a list of all new active medicinal substances authorised in the United Kingdom between 1972 and 1994; to assess whether the pattern of introductions had changed; and to examine withdrawal rates and the reasons for withdrawal. Methods The identities of those new active substances whose manufacturers had obtained Product Licences between 1972 and 1994 were sought from the Medicines Control Agency's product data-base. For each substance relevant information was retrieved including the year of granting the Product Licence, its therapeutic class, whether currently authorised (and, if not, reason for withdrawal), and its nature (chemical, biological etc.). Results The Medicines Control Agency's data-base was cross-checked against two other data-bases for completeness. A total of 583 new active substances (in 579 products) were found to have been authorised over the study period. The annual rates of authorisation varied widely (9 to 40 per year). Whilst there was no evidence for any overall change in the annual rates of authorising new chemical entities, there has been a trend for increasing numbers of new products of biological origin to be authorised in recent years. Fifty-nine of the 583 new active substances have been withdrawn (1 each for quality and efficacy, 22 for safety, and 35 for commercial reasons). Conclusions For reasons that are unclear there is marked heterogeneity in the annual rates of authorisation of new active substances. Their 10 year survival is approximately 88% with withdrawals being, predominantly, for commercial or safety reasons. This confirms the provisional nature of assessments about safety at the time when a new active substance is introduced into routine clinical practice, and emphasises the importance of pharmacovigilance. PMID:9491828

A web-based, relational database for studying glaciers in the Italian Alps

NASA Astrophysics Data System (ADS)

Nigrelli, G.; Chiarle, M.; Nuzzi, A.; Perotti, L.; Torta, G.; Giardino, M.

2013-02-01

Glaciers are among the best terrestrial indicators of climate change and thus glacier inventories have attracted a growing, worldwide interest in recent years. In Italy, the first official glacier inventory was completed in 1925 and 774 glacial bodies were identified. As the amount of data continues to increase, and new techniques become available, there is a growing demand for computer tools that can efficiently manage the collected data. The Research Institute for Geo-hydrological Protection of the National Research Council, in cooperation with the Departments of Computer Science and Earth Sciences of the University of Turin, created a database that provides a modern tool for storing, processing and sharing glaciological data. The database was developed according to the need of storing heterogeneous information, which can be retrieved through a set of web search queries. The database's architecture is server-side, and was designed by means of an open source software. The website interface, simple and intuitive, was intended to meet the needs of a distributed public: through this interface, any type of glaciological data can be managed, specific queries can be performed, and the results can be exported in a standard format. The use of a relational database to store and organize a large variety of information about Italian glaciers collected over the last hundred years constitutes a significant step forward in ensuring the safety and accessibility of such data. Moreover, the same benefits also apply to the enhanced operability for handling information in the future, including new and emerging types of data formats, such as geographic and multimedia files. Future developments include the integration of cartographic data, such as base maps, satellite images and vector data. The relational database described in this paper will be the heart of a new geographic system that will merge data, data attributes and maps, leading to a complete description of Italian glacial environments.

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.

A Global Survey of Deep Underground Facilities; Examples of Geotechnical and Engineering Capabilities, Achievements, Challenges (Mines, Shafts, Tunnels, Boreholes, Sites and Underground Facilities for Nuclear Waste and Physics R&D): A Guide to Interactive Global Map Layers, Table Database, References and Notes

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

Tynan, Mark C.; Russell, Glenn P.; Perry, Frank V.

These associated tables, references, notes, and report present a synthesis of some notable geotechnical and engineering information used to create four interactive layer maps for selected: 1) deep mines and shafts; 2) existing, considered or planned radioactive waste management deep underground studies or disposal facilities 3) deep large diameter boreholes, and 4) physics underground laboratories and facilities from around the world. These data are intended to facilitate user access to basic information and references regarding “deep underground” facilities, history, activities, and plans. In general, the interactive maps and database provide each facility’s approximate site location, geology, and engineered features (e.g.:more » access, geometry, depth, diameter, year of operations, groundwater, lithology, host unit name and age, basin; operator, management organization, geographic data, nearby cultural features, other). Although the survey is not comprehensive, it is representative of many of the significant existing and historical underground facilities discussed in the literature addressing radioactive waste management and deep mined geologic disposal safety systems. The global survey is intended to support and to inform: 1) interested parties and decision makers; 2) radioactive waste disposal and siting option evaluations, and 3) safety case development applicable to any mined geologic disposal facility as a demonstration of historical and current engineering and geotechnical capabilities available for use in deep underground facility siting, planning, construction, operations and monitoring.« less

Impact of data base structure in a successful in vitro-in vivo correlation for pharmaceutical products.

PubMed

Roudier, B; Davit, B; Schütz, H; Cardot, J-M

2015-01-01

The in vitro-in vivo correlation (IVIVC) (Food and Drug Administration 1997) aims to predict performances in vivo of a pharmaceutical formulation based on its in vitro characteristics. It is a complex process that (i) incorporates in a gradual and incremental way a large amount of information and (ii) requires information from different properties (formulation, analytical, clinical) and associated dedicated treatments (statistics, modeling, simulation). These results in many studies that are initiated and integrated into the specifications (quality target product profile, QTPP). This latter defines the appropriate experimental designs (quality by design, QbD) (Food and Drug Administration 2011, 2012) whose main objectives are determination (i) of key factors of development and manufacturing (critical process parameters, CPPs) and (ii) of critical points of physicochemical nature relating to active ingredients (API) and critical quality attribute (CQA) which may have implications in terms of efficiency, safety, and inoffensiveness for the patient, due to their non-inclusion. These processes generate a very large amount of data that is necessary to structure. In this context, the storage of information in a database (DB) and the management of this database (database management system, DBMS) become an important issue for the management of projects and IVIVC and more generally for development of new pharmaceutical forms. This article describes the implementation of a prototype object-oriented database (OODB) considered as a tool, which is helpful for decision taking, responding in a structured and consistent way to the issues of project management of IVIVC (including bioequivalence and bioavailability) (Food and Drug Administration 2003) necessary for the implementation of QTPP.

Development of Database for Accident Analysis in Indian Mines

NASA Astrophysics Data System (ADS)

Tripathy, Debi Prasad; Guru Raghavendra Reddy, K.

2016-10-01

Mining is a hazardous industry and high accident rates associated with underground mining is a cause of deep concern. Technological developments notwithstanding, rate of fatal accidents and reportable incidents have not shown corresponding levels of decline. This paper argues that adoption of appropriate safety standards by both mine management and the government may result in appreciable reduction in accident frequency. This can be achieved by using the technology in improving the working conditions, sensitising workers and managers about causes and prevention of accidents. Inputs required for a detailed analysis of an accident include information on location, time, type, cost of accident, victim, nature of injury, personal and environmental factors etc. Such information can be generated from data available in the standard coded accident report form. This paper presents a web based application for accident analysis in Indian mines during 2001-2013. An accident database (SafeStat) prototype based on Intranet of the TCP/IP agreement, as developed by the authors, is also discussed.

75 FR 61553 - National Transit Database: Amendments to the Urbanized Area Annual Reporting Manual and to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... Transit Database: Amendments to the Urbanized Area Annual Reporting Manual and to the Safety and Security... the 2011 National Transit Database Urbanized Area Annual Reporting Manual and Announcement of... Transit Administration's (FTA) National Transit Database (NTD) reporting requirements, including...

Concept analysis of safety climate in healthcare providers.

PubMed

Lin, Ying-Siou; Lin, Yen-Chun; Lou, Meei-Fang

2017-06-01

To report an analysis of the concept of safety climate in healthcare providers. Compliance with safe work practices is essential to patient safety and care outcomes. Analysing the concept of safety climate from the perspective of healthcare providers could improve understanding of the correlations between safety climate and healthcare provider compliance with safe work practices, thus enhancing quality of patient care. Concept analysis. The electronic databases of CINAHL, MEDLINE, PubMed and Web of Science were searched for literature published between 1995-2015. Searches used the keywords 'safety climate' or 'safety culture' with 'hospital' or 'healthcare'. The concept analysis method of Walker and Avant analysed safety climate from the perspective of healthcare providers. Three attributes defined how healthcare providers define safety climate: (1) creation of safe working environment by senior management in healthcare organisations; (2) shared perception of healthcare providers about safety of their work environment; and (3) the effective dissemination of safety information. Antecedents included the characteristics of healthcare providers and healthcare organisations as a whole, and the types of work in which they are engaged. Consequences consisted of safety performance and safety outcomes. Most studies developed and assessed the survey tools of safety climate or safety culture, with a minority consisting of interventional measures for improving safety climate. More prospective studies are needed to create interventional measures for improving safety climate of healthcare providers. This study is provided as a reference for use in developing multidimensional safety climate assessment tools and interventional measures. The values healthcare teams emphasise with regard to safety can serve to improve safety performance. Having an understanding of the concept of and interventional measures for safety climate allows healthcare providers to ensure the safety of their operations and their patients. © 2016 John Wiley & Sons Ltd.

The design of the automated control system for warehouse equipment under radio-electronic manufacturing

NASA Astrophysics Data System (ADS)

Kapulin, D. V.; Chemidov, I. V.; Kazantsev, M. A.

2017-01-01

In the paper, the aspects of design, development and implementation of the automated control system for warehousing under the manufacturing process of the radio-electronic enterprise JSC «Radiosvyaz» are discussed. The architecture of the automated control system for warehousing proposed in the paper consists of a server which is connected to the physically separated information networks: the network with a database server, which stores information about the orders for picking, and the network with the automated storage and retrieval system. This principle allows implementing the requirements for differentiation of access, ensuring the information safety and security requirements. Also, the efficiency of the developed automated solutions in terms of optimizing the warehouse’s logistic characteristics is researched.

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-marketing boxed warning. Although drugs approved with a boxed warning or priority review are more likely to experience serious post-marketing safety events, other information provided during the FDA drug review that is easy to quantify is generally not associated with post-marketing safety events. It appears that these post-marketing events are not discernible during a pre-marketing review and therefore might not be avoidable using current review data.

Effects of health information technology on patient outcomes: a systematic review.

PubMed

Brenner, Samantha K; Kaushal, Rainu; Grinspan, Zachary; Joyce, Christine; Kim, Inho; Allard, Rhonda J; Delgado, Diana; Abramson, Erika L

2016-09-01

To systematically review studies assessing the effects of health information technology (health IT) on patient safety outcomes. The authors employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement methods. MEDLINE, Cumulative Index to Nursing Allied Health (CINAHL), EMBASE, and Cochrane Library databases, from 2001 to June 2012, were searched. Descriptive and comparative studies were included that involved use of health IT in a clinical setting and measured effects on patient safety outcomes. Data on setting, subjects, information technology implemented, and type of patient safety outcomes were all abstracted. The quality of the studies was evaluated by 2 independent reviewers (scored from 0 to 10). A total of 69 studies met inclusion criteria. Quality scores ranged from 1 to 9. There were 25 (36%) studies that found benefit of health IT on direct patient safety outcomes for the primary outcome measured, 43 (62%) studies that either had non-significant or mixed findings, and 1 (1%) study for which health IT had a detrimental effect. Neither the quality of the studies nor the rate of randomized control trials performed changed over time. Most studies that demonstrated a positive benefit of health IT on direct patient safety outcomes were inpatient, single-center, and either cohort or observational trials studying clinical decision support or computerized provider order entry. Many areas of health IT application remain understudied and the majority of studies have non-significant or mixed findings. Our study suggests that larger, higher quality studies need to be conducted, particularly in the long-term care and ambulatory care settings. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Screening Electronic Health Record-Related Patient Safety Reports Using Machine Learning.

PubMed

Marella, William M; Sparnon, Erin; Finley, Edward

2017-03-01

The objective of this study was to develop a semiautomated approach to screening cases that describe hazards associated with the electronic health record (EHR) from a mandatory, population-based patient safety reporting system. Potentially relevant cases were identified through a query of the Pennsylvania Patient Safety Reporting System. A random sample of cases were manually screened for relevance and divided into training, testing, and validation data sets to develop a machine learning model. This model was used to automate screening of remaining potentially relevant cases. Of the 4 algorithms tested, a naive Bayes kernel performed best, with an area under the receiver operating characteristic curve of 0.927 ± 0.023, accuracy of 0.855 ± 0.033, and F score of 0.877 ± 0.027. The machine learning model and text mining approach described here are useful tools for identifying and analyzing adverse event and near-miss reports. Although reporting systems are beginning to incorporate structured fields on health information technology and the EHR, these methods can identify related events that reporters classify in other ways. These methods can facilitate analysis of legacy safety reports by retrieving health information technology-related and EHR-related events from databases without fields and controlled values focused on this subject and distinguishing them from reports in which the EHR is mentioned only in passing. Machine learning and text mining are useful additions to the patient safety toolkit and can be used to semiautomate screening and analysis of unstructured text in safety reports from frontline staff.

Developing tools for the safety specification in risk management plans: lessons learned from a pilot project.

PubMed

Cooper, Andrew J P; Lettis, Sally; Chapman, Charlotte L; Evans, Stephen J W; Waller, Patrick C; Shakir, Saad; Payvandi, Nassrin; Murray, Alison B

2008-05-01

Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience and identifying limitations in safety information are now required for marketing authorisation applications (MAA). A collaborative research project was conducted to gain experience with tools for presenting and evaluating data in the safety specification. This paper presents those tools found to be useful and the lessons learned from their use. Archive data from a successful MAA were utilised. Methods were assessed for demonstrating the extent of clinical safety experience, evaluating the sensitivity of the clinical trial data to detect treatment differences and identifying safety signals from adverse event and laboratory data to define the extent of safety knowledge with the drug. The extent of clinical safety experience was demonstrated by plots of patient exposure over time. Adverse event data were presented using dot plots, which display the percentages of patients with the events of interest, the odds ratio, and 95% confidence interval. Power and confidence interval plots were utilised for evaluating the sensitivity of the clinical database to detect treatment differences. Box and whisker plots were used to display laboratory data. This project enabled us to identify new evidence-based methods for presenting and evaluating clinical safety data. These methods represent an advance in the way safety data from clinical trials can be analysed and presented. This project emphasises the importance of early and comprehensive planning of the safety package, including evaluation of the use of epidemiology data.

Chemical hazards database and detection system for Microgravity and Materials Processing Facility (MMPF)

NASA Technical Reports Server (NTRS)

Steele, Jimmy; Smith, Robert E.

1991-01-01

The ability to identify contaminants associated with experiments and facilities is directly related to the safety of the Space Station. A means of identifying these contaminants has been developed through this contracting effort. The delivered system provides a listing of the materials and/or chemicals associated with each facility, information as to the contaminant's physical state, a list of the quantity and/or volume of each suspected contaminant, a database of the toxicological hazards associated with each contaminant, a recommended means of rapid identification of the contaminants under operational conditions, a method of identifying possible failure modes and effects analysis associated with each facility, and a fault tree-type analysis that will provide a means of identifying potential hazardous conditions related to future planned missions.

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.

Implications of electronic health record downtime: an analysis of patient safety event reports.

PubMed

Larsen, Ethan; Fong, Allan; Wernz, Christian; Ratwani, Raj M

2018-02-01

We sought to understand the types of clinical processes, such as image and medication ordering, that are disrupted during electronic health record (EHR) downtime periods by analyzing the narratives of patient safety event report data. From a database of 80 381 event reports, 76 reports were identified as explicitly describing a safety event associated with an EHR downtime period. These reports were analyzed and categorized based on a developed code book to identify the clinical processes that were impacted by downtime. We also examined whether downtime procedures were in place and followed. The reports were coded into categories related to their reported clinical process: Laboratory, Medication, Imaging, Registration, Patient Handoff, Documentation, History Viewing, Delay of Procedure, and General. A majority of reports (48.7%, n = 37) were associated with lab orders and results, followed by medication ordering and administration (14.5%, n = 11). Incidents commonly involved patient identification and communication of clinical information. A majority of reports (46%, n = 35) indicated that downtime procedures either were not followed or were not in place. Only 27.6% of incidents (n = 21) indicated that downtime procedures were successfully executed. Patient safety report data offer a lens into EHR downtime-related safety hazards. Important areas of risk during EHR downtime periods were patient identification and communication of clinical information; these should be a focus of downtime procedure planning to reduce safety hazards. EHR downtime events pose patient safety hazards, and we highlight critical areas for downtime procedure improvement. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Bias in benefit-risk appraisal in older products: the case of buflomedil for intermittent claudication.

PubMed

De Backer, Tine L M; Vander Stichele, Robert H; Van Bortel, Luc M

2009-01-01

Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards were not in place at the time these products were registered. This issue of bias in benefit-risk assessment of older products is illustrated here with an example: buflomedil in intermittent claudication. Data on efficacy were retrieved from a Cochrane systematic review. Data on safety were obtained by comparing the number of reports of serious adverse events and fatalities published in the literature with those reported in postmarketing surveillance databases. In the case of efficacy, the slim basis of evidence for the benefit of buflomedil is undermined by documented publication bias. In the case of safety, bias in reporting to international safety databases is illustrated by the discrepancy between the number of drug-related deaths published in the literature (20), the potentially drug-related deaths in the WHO database (20) and deaths attributed to buflomedil in the database of the international marketing authorization holder (11). In older products, efficacy cannot be evaluated without a thorough search for publication bias. For safety, case reporting of drug-related serious events and deaths in the literature remains a necessary instrument for risk appraisal of older medicines, despite the existence of postmarketing safety databases. The enforcement of efficient communication between healthcare workers, drug companies, national centres of pharmacovigilance, national poison centers and the WHO is necessary to ensure the validity of postmarketing surveillance reporting systems. Drugs considered obsolete because of unfavourable benefit-risk assessment should not be allowed to stay on the market.

A Pilot Study of Website Information Regarding Aromatase Inhibitors: Dietary Supplement Interactions

PubMed Central

McDermott, Cara L.; Hsieh, Angela A.; Sweet, Erin S.; Tippens, Kimberly M.

2011-01-01

Abstract Objectives Patients who have hormone receptor–positive breast cancer and who are taking aromatase inhibitors (AIs) should understand the benefits and risks of concomitant dietary supplement (DS) use. The International Society for Integrative Oncology (SIO) encourages patients to discuss DS use with their health care practitioners. The objective was to conduct a pilot study rating Internet websites from the perspective of health care practitioners for information about AI–DS interactions. Design Five (5) Internet websites suggested by SIO were evaluated using the DISCERN instrument rating tool. The available AI–DS information on these websites was rated by 4 evaluators: 2 naturopathic doctors, 1 oncology pharmacy resident, and a pharmacy student. Results The overall rankings ranged from 1.6 to 3.9, with considerable variability in the type of information available from the websites. The interevaluator rankings of the websites ranged from 0.44 to 0.89. The evaluators consistently found the most reliable, unbiased, and comprehensive information on AI–DS interactions at the Natural Medicines Comprehensive Database and Memorial Sloan-Kettering Cancer Center websites. However, more than one database was needed for provision of optimal patient information on AI–DS interactions. Conclusions In order to effectively advise patients regarding AI–DS interactions, more than one website should be evaluated to assess the potential efficacy and safety of DS in women whose breast cancer is being treated with an AI. PMID:22087614

A systematic review of the safety climate intervention literature: Past trends and future directions.

PubMed

Lee, Jin; Huang, Yueng-Hsiang; Cheung, Janelle H; Chen, Zhuo; Shaw, William S

2018-04-26

Safety climate represents the meaningfulness of safety and how safety is valued in an organization. The contributions of safety climate to organizational safety have been well documented. There is a dearth of empirical research, however, on specific safety climate interventions and their effectiveness. The present study aims at examining the trend of safety climate interventions and offering compiled information for designing and implementing evidence-based safety climate interventions. Our literature search yielded 384 titles that were inspected by three examiners. Using a stepwise process that allowed for assessment of interobserver agreement, 19 full articles were selected and reviewed. Results showed that 10 out of the 19 articles (52.6%) were based on a quasi-experimental pre- and postintervention design, whereas 42.1% (n = 8) studies were based on a mixed-design approach (including both between- and within-subject design). All interventions in these 19 studies involved either safety-/health-related communication or education/training. Improvement of safety leadership was also a common component of safety climate interventions. According to the socio-technical systems classification of intervention strategies, all studies were categorized as interventions focusing on improving organizational and managerial structure as well as the personnel subsystem; four of them also aimed at improving technological aspects of work, and five of them aimed at improving the physical work subsystem. In general, a vast majority of the studies (89.5%, n = 17) showed a statistically significant improvement in safety climate across their organizations postintervention. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

What is lost when searching only one literature database for articles relevant to injury prevention and safety promotion?

PubMed

Lawrence, D W

2008-12-01

To assess what is lost if only one literature database is searched for articles relevant to injury prevention and safety promotion (IPSP) topics. Serial textword (keyword, free-text) searches using multiple synonym terms for five key IPSP topics (bicycle-related brain injuries, ethanol-impaired driving, house fires, road rage, and suicidal behaviors among adolescents) were conducted in four of the bibliographic databases that are most used by IPSP professionals: EMBASE, MEDLINE, PsycINFO, and Web of Science. Through a systematic procedure, an inventory of articles on each topic in each database was conducted to identify the total unduplicated count of all articles on each topic, the number of articles unique to each database, and the articles available if only one database is searched. No single database included all of the relevant articles on any topic, and the database with the broadest coverage differed by topic. A search of only one literature database will return 16.7-81.5% (median 43.4%) of the available articles on any of five key IPSP topics. Each database contributed unique articles to the total bibliography for each topic. A literature search performed in only one database will, on average, lead to a loss of more than half of the available literature on a topic.

Statewide crash analysis and forecasting.

DOT National Transportation Integrated Search

2008-11-20

There is a need for the development of safety analysis tools to allow Penn DOT to better assess the safety performance of road : segments in the Commonwealth. The project utilized a safety management system database at Penn DOT that integrates crash,...

Vaxjo: a web-based vaccine adjuvant database and its application for analysis of vaccine adjuvants and their uses in vaccine development.

PubMed

Sayers, Samantha; Ulysse, Guerlain; Xiang, Zuoshuang; He, Yongqun

2012-01-01

Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO) in the Web Ontology Language (OWL) format.

Methods and means used in programming intelligent searches of technical documents

NASA Technical Reports Server (NTRS)

Gross, David L.

1993-01-01

In order to meet the data research requirements of the Safety, Reliability & Quality Assurance activities at Kennedy Space Center (KSC), a new computer search method for technical data documents was developed. By their very nature, technical documents are partially encrypted because of the author's use of acronyms, abbreviations, and shortcut notations. This problem of computerized searching is compounded at KSC by the volume of documentation that is produced during normal Space Shuttle operations. The Centralized Document Database (CDD) is designed to solve this problem. It provides a common interface to an unlimited number of files of various sizes, with the capability to perform any diversified types and levels of data searches. The heart of the CDD is the nature and capability of its search algorithms. The most complex form of search that the program uses is with the use of a domain-specific database of acronyms, abbreviations, synonyms, and word frequency tables. This database, along with basic sentence parsing, is used to convert a request for information into a relational network. This network is used as a filter on the original document file to determine the most likely locations for the data requested. This type of search will locate information that traditional techniques, (i.e., Boolean structured key-word searching), would not find.

A privacy preserving protocol for tracking participants in phase I clinical trials.

PubMed

El Emam, Khaled; Farah, Hanna; Samet, Saeed; Essex, Aleksander; Jonker, Elizabeth; Kantarcioglu, Murat; Earle, Craig C

2015-10-01

Some phase 1 clinical trials offer strong financial incentives for healthy individuals to participate in their studies. There is evidence that some individuals enroll in multiple trials concurrently. This creates safety risks and introduces data quality problems into the trials. Our objective was to construct a privacy preserving protocol to track phase 1 participants to detect concurrent enrollment. A protocol using secure probabilistic querying against a database of trial participants that allows for screening during telephone interviews and on-site enrollment was developed. The match variables consisted of demographic information. The accuracy (sensitivity, precision, and negative predictive value) of the matching and its computational performance in seconds were measured under simulated environments. Accuracy was also compared to non-secure matching methods. The protocol performance scales linearly with the database size. At the largest database size of 20,000 participants, a query takes under 20s on a 64 cores machine. Sensitivity, precision, and negative predictive value of the queries were consistently at or above 0.9, and were very similar to non-secure versions of the protocol. The protocol provides a reasonable solution to the concurrent enrollment problems in phase 1 clinical trials, and is able to ensure that personal information about participants is kept secure. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Vaxjo: A Web-Based Vaccine Adjuvant Database and Its Application for Analysis of Vaccine Adjuvants and Their Uses in Vaccine Development

PubMed Central

Sayers, Samantha; Ulysse, Guerlain; Xiang, Zuoshuang; He, Yongqun

2012-01-01

Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO) in the Web Ontology Language (OWL) format. PMID:22505817

Disaster Response and Preparedness Application: Emergency Environmental Response Tool (EERT)

NASA Technical Reports Server (NTRS)

Smoot, James; Carr, Hugh; Jester, Keith

2003-01-01

In 2000, the National Aeronautics and Space Administration (NASA) Environmental Office at the John C. Stennis Space Center (SSC) developed an Environmental Geographic Information Systems (EGIS) database. NASA had previously developed a GIS database at SSC to assist in the NASA Environmental Office's management of the Center. This GIS became the basis for the NASA-wide EGIS project, which was proposed after the applicability of the SSC database was demonstrated. Since its completion, the SSC EGIS has aided the Environmental Office with noise pollution modeling, land cover assessment, wetlands delineation, environmental hazards mapping, and critical habitat delineation for protected species. At SSC, facility management and safety officers are responsible for ensuring the physical security of the facilities, staff, and equipment as well as for responding to environmental emergencies, such as accidental releases of hazardous materials. All phases of emergency management (planning, mitigation, preparedness, and response) depend on data reliability and system interoperability from a variety of sources to determine the size and scope of the emergency operation. Because geospatial data are now available for all NASA facilities, it was suggested that this data could be incorporated into a computerized management information program to assist facility managers. The idea was that the information system could improve both the effectiveness and the efficiency of managing and controlling actions associated with disaster, homeland security, and other activities. It was decided to use SSC as a pilot site to demonstrate the efficacy of having a baseline, computerized management information system that ultimately was referred to as the Emergency Environmental Response Tool (EERT).

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial.

PubMed

Rawson, Nigel S B; D'Arcy, Carl

2018-04-30

Administrative healthcare utilization databases are frequently used either individually or as a component of aggregated data for evaluating drug safety issues without taking into account their known deficiencies. All too often insufficient evidence is provided about their validity for the purposes for which they are used. The assessment of data validity is a key constituent that should be included in drug safety research studies and should take a broad multifaceted approach that encompasses both diagnostic and drug exposure data. Drug safety researchers need to continue advancing their knowledge of the data resources they use and to ensure that they and the users of their research understand the limitations of the data that are the foundation on which their research is built. Fundamental issues regarding data validity should be addressed in each use of administrative data for drug safety research.

Analyzing partially missing confounder information in comparative effectiveness and safety research of therapeutics.

PubMed

Toh, Sengwee; García Rodríguez, Luis A; Hernán, Miguel A

2012-05-01

Electronic healthcare databases are commonly used in comparative effectiveness and safety research of therapeutics. Many databases now include additional confounder information in a subset of the study population through data linkage or data collection. We described and compared existing methods for analyzing such datasets. Using data from The Health Improvement Network and the relation between non-steroidal anti-inflammatory drugs and upper gastrointestinal bleeding as an example, we employed several methods to handle partially missing confounder information. The crude odds ratio (OR) of upper gastrointestinal bleeding was 1.50 (95% confidence interval: 0.98, 2.28) among selective cyclo-oxygenase-2 inhibitor initiators (n = 43 569) compared with traditional non-steroidal anti-inflammatory drug initiators (n = 411 616). The OR dropped to 0.81 (0.52, 1.27) upon adjustment for confounders recorded for all patients. When further considering three additional variables missing in 22% of the study population (smoking, alcohol consumption, body mass index), the OR was between 0.80 and 0.83 for the missing-category approach, the missing-indicator approach, single imputation by the most common category, multiple imputation by chained equations, and propensity score calibration. The OR was 0.65 (0.39, 1.09) and 0.67 (0.38, 1.16) for the unweighted and the inverse probability weighted complete-case analysis, respectively. Existing methods for handling partially missing confounder data require different assumptions and may produce different results. The unweighted complete-case analysis, the missing-category/indicator approach, and single imputation require often unrealistic assumptions and should be avoided. In this study, differences across methods were not substantial, likely due to relatively low proportion of missingness and weak confounding effect by the three additional variables upon adjustment for other variables. Copyright © 2012 John Wiley & Sons, Ltd.

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

2017-01-01

Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal population. PMID:28804696

The National Hip Fracture Database (NHFD) - Using a national clinical audit to raise standards of nursing care.

PubMed

Johansen, Antony; Boulton, Christopher; Hertz, Karen; Ellis, Michael; Burgon, Vivienne; Rai, Sunil; Wakeman, Rob

2017-08-01

The National Hip Fracture Database (NHFD) is a key clinical governance programme for staff working in trauma wards across England, Wales and Northern Ireland. It uses prospectively collected information about the 65,000 people who present with hip fracture each year, and links these with information about the quality of care and outcome for each individual. The NHFD can, therefore, provide a picture of the care offered to frail older people with this injury - people who, between them, occupy nearly half of inpatient trauma beds. The NHFD uses its website (www.nhfd.co.uk) to feed back live information to each of the countries' 180 trauma units - allowing them to bench mark their performance against national standards, and against that in other hospitals. This helps to develop a consensus over the best care for frail older people in areas where national guidance is not yet available. This article shows how the NHFD is contributing to four key aspects of patient safety and nursing care: the prevention of pressure ulcers and post-operative delirium, the monitoring of falls incidence across hospitals and nutritional assessment of patients with hip fracture. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development of a Consumer Product Ingredient Database for ...

EPA Pesticide Factsheets

Consumer products are a primary source of chemical exposures, yet little structured information is available on the chemical ingredients of these products and the concentrations at which ingredients are present. To address this data gap, we created a database of chemicals in consumer products using product Material Safety Data Sheets (MSDSs) publicly provided by a large retailer. The resulting database represents 1797 unique chemicals mapped to 8921 consumer products and a hierarchy of 353 consumer product “use categories” within a total of 15 top-level categories. We examine the utility of this database and discuss ways in which it will support (i) exposure screening and prioritization, (ii) generic or framework formulations for several indoor/consumer product exposure modeling initiatives, (iii) candidate chemical selection for monitoring near field exposure from proximal sources, and (iv) as activity tracers or ubiquitous exposure sources using “chemical space” map analyses. Chemicals present at high concentrations and across multiple consumer products and use categories that hold high exposure potential are identified. Our database is publicly available to serve regulators, retailers, manufacturers, and the public for predictive screening of chemicals in new and existing consumer products on the basis of exposure and risk. The National Exposure Research Laboratory’s (NERL’s) Human Exposure and Atmospheric Sciences Division (HEASD) conducts resear

Review of safety reports involving electronic flight bags

DOT National Transportation Integrated Search

2009-04-27

Electronic Flight Bags (EFBs) are a relatively new device used by pilots. Even so, 37 safety-related events involving EFBs were identified from the public online Aviation Safety Reporting System (ASRS) database as of June 2008. In addition, two accid...

Critical roles of orthopaedic surgeon leadership in healthcare systems to improve orthopaedic surgical patient safety.

PubMed

Kuo, Calvin C; Robb, William J

2013-06-01

The prevention of medical and surgical harm remains an important public health problem despite increased awareness and implementation of safety programs. Successful introduction and maintenance of surgical safety programs require both surgeon leadership and collaborative surgeon-hospital alignment. Documentation of success of such surgical safety programs in orthopaedic practice is limited. We describe the scope of orthopaedic surgical patient safety issues, define critical elements of orthopaedic surgical safety, and outline leadership roles for orthopaedic surgeons needed to establish and sustain a culture of safety in contemporary healthcare systems. We identified the most common causes of preventable surgical harm based on adverse and sentinel surgical events reported to The Joint Commission. A comprehensive literature review through a MEDLINE(®) database search (January 1982 through April 2012) to identify pertinent orthopaedic surgical safety articles found 14 articles. Where gaps in orthopaedic literature were identified, the review was supplemented by 22 nonorthopaedic surgical references. Our final review included 36 articles. Six important surgical safety program elements needed to eliminate preventable surgical harm were identified: (1) effective surgical team communication, (2) proper informed consent, (3) implementation and regular use of surgical checklists, (4) proper surgical site/procedure identification, (5) reduction of surgical team distractions, and (6) routine surgical data collection and analysis to improve the safety and quality of surgical patient care. Successful surgical safety programs require a culture of safety supported by all six key surgical safety program elements, active surgeon champions, and collaborative hospital and/or administrative support designed to enhance surgical safety and improve surgical patient outcomes. Further research measuring improvements from such surgical safety systems in orthopaedic care is needed.

Tasimelteon (Hetlioz™): A New Melatonin Receptor Agonist for the Treatment of Non-24-Hour Sleep-Wake Disorder.

PubMed

Bonacci, Janene M; Venci, Jineane V; Gandhi, Mona A

2015-10-01

In January 2014, the US Food and Drug Administration approved tasimelteon (Hetlioz™), a melatonin-receptor agonist for the treatment of non-24-hour sleep-wake disorder. This article provides an overview of the mechanism of action, pharmacokinetic properties, as well as the clinical efficacy, safety, and tolerability of tasimelteon. Relevant information was identified through a comprehensive literature search of several databases using the key words tasimelteon, Non-24-hour Sleep-Wake disorder, Non-24, and melatonin. Further information was obtained from the tasimelteon package insert, fda.gov, clinicaltrials.gov, briefing materials provided by Vanda Pharmaceuticals, and posters from scientific meetings. © The Author(s) 2014.

Radiation Embrittlement Archive Project

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

Klasky, Hilda B; Bass, Bennett Richard; Williams, Paul T

2013-01-01

The Radiation Embrittlement Archive Project (REAP), which is being conducted by the Probabilistic Integrity Safety Assessment (PISA) Program at Oak Ridge National Laboratory under funding from the U.S. Nuclear Regulatory Commission s (NRC) Office of Nuclear Regulatory Research, aims to provide an archival source of information about the effect of neutron radiation on the properties of reactor pressure vessel (RPV) steels. Specifically, this project is an effort to create an Internet-accessible RPV steel embrittlement database. The project s website, https://reap.ornl.gov, provides information in two forms: (1) a document archive with surveillance capsule(s) reports and related technical reports, in PDF format,more » for the 104 commercial nuclear power plants (NPPs) in the United States, with similar reports from other countries; and (2) a relational database archive with detailed information extracted from the reports. The REAP project focuses on data collected from surveillance capsule programs for light-water moderated, nuclear power reactor vessels operated in the United States, including data on Charpy V-notch energy testing results, tensile properties, composition, exposure temperatures, neutron flux (rate of irradiation damage), and fluence, (Fast Neutron Fluence a cumulative measure of irradiation for E>1 MeV). Additionally, REAP contains data from surveillance programs conducted in other countries. REAP is presently being extended to focus on embrittlement data analysis, as well. This paper summarizes the current status of the REAP database and highlights opportunities to access the data and to participate in the project.« less

Cutaneous drug reaction case reports: from the world literature.

PubMed

2003-01-01

Skin disorders are the most common adverse reactions attributed to drugs. Any skin disorder can be imitated, induced or aggravated by drugs. To help you keep up-to-date with the very latest skin reactions occurring with both new and established drugs, this section of the journal brings you information selected from the adverse drug reaction alerting service Reactions Weekly. Reactions Weekly is the complete drug safety alerting service and summarizes information selected from over 1600 biomedical journals. This newsletter is produced by Adis International and is available in a variety of formats. Please contact your nearest Adis office for subscription details. The use of tradenames, identified by ['~'] or the use of a registered ((R)) or trade mark ( trade mark ), is for product identification purposes only and does not imply endorsement. The following case reports are selected from the very latest to be published in the world dermatology literature. Any claim of a first report has been verified by a search of AdisBase (a proprietary database of Adis International) and Medline. In addition, the World Health Organization (WHO) Adverse Drug Reactions database is also searched. This database, maintained by the Uppsala Monitoring Centre in Sweden, is the largest and most comprehensive adverse drug reaction source in the world, with information obtained from National Centers of 65 affiliate countries. Each case report is assessed for seriousness using the FDA MedWatch definition of serious (patient outcome is: death; life-threatening; hospitalization; disability; congenital anomaly; or requires intervention to prevent permanent impairment or damage).

Attitudes and Opinions of Doctors of Chiropractic Specializing in Pediatric Care Toward Patient Safety: A Cross-sectional Survey.

PubMed

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

2016-09-01

The purpose of this cross-sectional survey was to evaluate attitudes and opinions of doctors of chiropractic (DCs) specializing in pediatric care toward patient safety. The Medical Office Survey on Patient Safety Culture of the Agency for Healthcare Research and Quality was adapted for providers who use spinal manipulation therapy and sent out to 2 US chiropractic organizations' pediatric council members (n = 400) between February and April 2014. The survey measured 12 patient safety dimensions and included questions on patient safety items and quality issues, information exchange, and overall clinic ratings. Data analyses included a percent composite average and a nonrespondent analysis. The response rate was 29.5% (n = 118). Almost one- third of respondents' patients were pediatric (≤17 years of age). DCs with a pediatric certification were 3 times more likely to respond (P < .001), but little qualitative differences were found in responses. The patient safety dimensions with the highest positive composite percentages were Organizational Learning (both administration and clinical) and Teamwork (>90%). Patient Care Tracking/Follow-up and Work Pressure and Pace were patient safety dimensions that had the lowest positive composite scores (<85%). The responses also indicated that there was concern regarding information exchange with insurance/third-party payors. Two quality issues identified for improvement were (1) updating a patient's medication list and (2) following up on critically abnormal results from a laboratory or imaging test within 1 day. The average overall patient safety rating score indicated that 83% of respondents rated themselves as "very good" or "excellent." Compared with 2014 Agency for Healthcare Research and Quality physician referent data from medical offices, pediatric DCs appear to have more positive patient safety attitudes and opinions. Future patient safety studies need to prospectively evaluate safety performance with direct feedback from patients and compare results with these self-assessed safety attitudes, as well as make further use of this survey to develop a comparable database for spinal manipulation providers. Copyright © 2016. Published by Elsevier Inc.

Differences in emergency colorectal surgery in Medicaid and uninsured patients by hospital safety net status.

PubMed

Bradley, Cathy J; Dahman, Bassam; Sabik, Lindsay M

2015-02-01

We examined whether safety net hospitals reduce the likelihood of emergency colorectal cancer (CRC) surgery in uninsured and Medicaid-insured patients. If these patients have better access to care through safety net providers, they should be less likely to undergo emergency resection relative to similar patients at non- safety net hospitals. Using population-based data, we estimated the relationship between safety net hospitals, patient insurance status, and emergency CRC surgery. We extracted inpatient admission data from the Virginia Health Information discharge database and matched them to the Virginia Cancer Registry for patients aged 21 to 64 years who underwent a CRC resection between January 1, 1999, and December 31, 2005 (n = 5488). We differentiated between medically defined emergencies and those that originated in the emergency department (ED). For each definition of emergency surgery, we estimated the linear probability models of the effects of being treated at a safety net hospital on the probability of having an emergency resection. Safety net hospitals reduce emergency surgeries among uninsured and Medicaid CRC patients. When defining an emergency resection as those that involved an ED visit, these patients were 15 to 20 percentage points less likely to have an emergency resection when treated in a safety net hospital. Our results suggest that these hospitals provide a benefit, most likely through the access they afford to timely and appropriate care, to uninsured and Medicaid-insured patients relative to hospitals without a safety net mission.

Massive parallelization of serial inference algorithms for a complex generalized linear model

PubMed Central

Suchard, Marc A.; Simpson, Shawn E.; Zorych, Ivan; Ryan, Patrick; Madigan, David

2014-01-01

Following a series of high-profile drug safety disasters in recent years, many countries are redoubling their efforts to ensure the safety of licensed medical products. Large-scale observational databases such as claims databases or electronic health record systems are attracting particular attention in this regard, but present significant methodological and computational concerns. In this paper we show how high-performance statistical computation, including graphics processing units, relatively inexpensive highly parallel computing devices, can enable complex methods in large databases. We focus on optimization and massive parallelization of cyclic coordinate descent approaches to fit a conditioned generalized linear model involving tens of millions of observations and thousands of predictors in a Bayesian context. We find orders-of-magnitude improvement in overall run-time. Coordinate descent approaches are ubiquitous in high-dimensional statistics and the algorithms we propose open up exciting new methodological possibilities with the potential to significantly improve drug safety. PMID:25328363

Toxicological database of soil and derived products (BDT).

PubMed

Uricchio, Vito Felice

2008-01-01

The Toxicological database of soil and derived products is a project firstly proposed by the Regional Environmental Authority of Apulia. Such a project aims to provide comprehensive and updated information on the regional environmental characteristics, on the pollution state of the regional soil, on the main pollutants and on the reclaim techniques to be used in case of both non-point (agricultural activities) and point (industrial activities) sources of pollution. The project's focus is on the soil pollution because of the fundamental role played by the soil in supporting the biological cycle. Furthermore, the reasons for the project are related both to the reduction of human health risks due to toxic substances ingestion (these substances are present in some ring of the eating chain), and to the recognition of the importance of the groundwater quality safety (primary source of fresh water in many Mediterranean Regions). The essential requirements of a data entry are the following: speed and simplicity of the data entry; reliability and stability of the database structures; speed, easiness and pliability of the queries. Free consultation of the database represents one of the most remarkable advantages coming from the use of an "open" system.

49 CFR 368.6 - FMCSA action on the application.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS APPLICATION... action on the application. (a) The Federal Motor Carrier Safety Administration will review the... in the application against data maintained in databases of the governments of Mexico and the United...

49 CFR 368.6 - FMCSA action on the application.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS APPLICATION... action on the application. (a) The Federal Motor Carrier Safety Administration will review the... in the application against data maintained in databases of the governments of Mexico and the United...

49 CFR 368.6 - FMCSA action on the application.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS APPLICATION... action on the application. (a) The Federal Motor Carrier Safety Administration will review the... in the application against data maintained in databases of the governments of Mexico and the United...

49 CFR 368.6 - FMCSA action on the application.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS APPLICATION... action on the application. (a) The Federal Motor Carrier Safety Administration will review the... in the application against data maintained in databases of the governments of Mexico and the United...

49 CFR 368.6 - FMCSA action on the application.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS APPLICATION... action on the application. (a) The Federal Motor Carrier Safety Administration will review the... in the application against data maintained in databases of the governments of Mexico and the United...

Safety and performance benefits of arginine supplements for military personnel: a systematic review.

PubMed

Brooks, James R; Oketch-Rabah, Hellen; Low Dog, Tieraona; Gorecki, Dennis K J; Barrett, Marilyn L; Cantilena, Louis; Chung, Mei; Costello, Rebecca B; Dwyer, Johanna; Hardy, Mary L; Jordan, Scott A; Maughan, Ronald J; Marles, Robin J; Osterberg, Robert E; Rodda, Bruce E; Wolfe, Robert R; Zuniga, Jorge M; Valerio, Luis G; Jones, Donnamaria; Deuster, Patricia; Giancaspro, Gabriel I; Sarma, Nandakumara D

2016-11-01

Dietary supplements are widely used by military personnel and civilians for promotion of health. The objective of this evidence-based review was to examine whether supplementation with l-arginine, in combination with caffeine and/or creatine, is safe and whether it enhances athletic performance or improves recovery from exhaustion for military personnel. Information from clinical trials and adverse event reports were collected from 17 databases and 5 adverse event report portals. Studies and reports were included if they evaluated the safety and the putative outcomes of enhanced performance or improved recovery from exhaustion associated with the intake of arginine alone or in combination with caffeine and/or creatine in healthy adults aged 19 to 50 years. Information related to population, intervention, comparator, and outcomes was abstracted. Of the 2687 articles screened, 62 articles meeting the inclusion criteria were analyzed. Strength of evidence was assessed in terms of risk of bias, consistency, directness, and precision. Most studies had few participants and suggested risk of bias that could negatively affect the results. l-Arginine supplementation provided little enhancement of athletic performance or improvements in recovery. Short-term supplementation with arginine may result in adverse gastrointestinal and cardiovascular effects. No information about the effects of arginine on the performance of military personnel was available. The available information does not support the use of l-arginine, either alone or in combination with caffeine, creatine, or both, to enhance athletic performance or improve recovery from exhaustion. Given the information gaps, an evidence-based review to assess the safety or effectiveness of multi-ingredient dietary supplements was not feasible, and therefore the development of a computational model-based approach to predict the safety of multi-ingredient dietary supplements is recommended. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Investigation of criticality safety control infraction data at a nuclear facility

DOE PAGES

Cournoyer, Michael E.; Merhege, James F.; Costa, David A.; ...

2014-10-27

Chemical and metallurgical operations involving plutonium and other nuclear materials account for most activities performed at the LANL's Plutonium Facility (PF-4). The presence of large quantities of fissile materials in numerous forms at PF-4 makes it necessary to maintain an active criticality safety program. The LANL Nuclear Criticality Safety (NCS) Program provides guidance to enable efficient operations while ensuring prevention of criticality accidents in the handling, storing, processing and transportation of fissionable material at PF-4. In order to achieve and sustain lower criticality safety control infraction (CSCI) rates, PF-4 operations are continuously improved, through the use of Lean Manufacturing andmore » Six Sigma (LSS) business practices. Employing LSS, statistically significant variations (trends) can be identified in PF-4 CSCI reports. In this study, trends have been identified in the NCS Program using the NCS Database. An output metric has been developed that measures ADPSM Management progress toward meeting its NCS objectives and goals. Using a Pareto Chart, the primary CSCI attributes have been determined in order of those requiring the most management support. Data generated from analysis of CSCI data help identify and reduce number of corresponding attributes. In-field monitoring of CSCI's contribute to an organization's scientific and technological excellence by providing information that can be used to improve criticality safety operation safety. This increases technical knowledge and augments operational safety.« less

75 FR 49869 - Changes to Standard Numbering System, Vessel Identification System, and Boating Accident Report...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... Boating Accident Report Database AGENCY: Coast Guard, DHS. ACTION: Reopening of public comment period... Boating Accident Report Database. DATES: Comments and related material must either be submitted to our... Database that, collectively, are intended to improve recreational boating safety efforts, enhance law...

77 FR 16434 - Revocation of Multiple Domestic, Alaskan, and Hawaiian Compulsory Reporting Points

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... previously removed from service and taken out of the FAA aeronautical database. The FAA is removing these... FAA's aeronautical database. This will avoid confusion and eliminate safety issues with existing fixes... and not contained in the FAA's aeronautical database as reporting points. The reporting points...

77 FR 26160 - Modification of VOR Federal Airway V-14; Missouri

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-03

... aeronautical database, matches the depiction on the associated charts, and to ensure the safety and efficiency... in the FAA's aeronautical database or the charted depiction of the airway. When V-14 was amended in... description in error. The FAA aeronautical database retained the [[Page 26161

Cattle traceability system in Japan for bovine spongiform encephalopathy.

PubMed

Sugiura, Katsuaki; Onodera, Takashi

2008-01-01

To promote consumer confidence in the safety of beef and to ensure the proper implementation of eradication measures against bovine spongiform encephalopathy (BSE), the Cattle Traceability Law was approved by the Diet in June 2003 and a cattle traceability system has been in operation in Japan since December 2003. The system enables tracing the cohort and offspring animals of a BSE case within 24 h of its detection. The traceability database system also provides distributors, restaurants and consumers with information on the cattle from which the beef that they sell, serve and consume, originate.

Information Technology Support in the 8000 Directorate

NASA Technical Reports Server (NTRS)

2004-01-01

My summer internship was spent supporting various projects within the Environmental Management Office and Glenn Safety Office. Mentored by Eli Abumeri, I was trained in areas of Information Technology such as: Servers, printers, scanners, CAD systems, Web, Programming, and Database Management, ODIN (networking, computers, and phones). I worked closely with the Chemical Sampling and Analysis Team (CSAT) to redesign a database to more efficiently manage and maintain data collected for the Drinking Water Program. This Program has been established for over fifteen years here at the Glenn Research Center. It involves the continued testing and retesting of all drinking water dispensers. The quality of the drinking water is of great importance and is determined by comparing the concentration of contaminants in the water with specifications set forth by the Environmental Protection Agency (EPA) in the Safe Drinking Water Act (SDWA) and its 1986 and 1991 amendments. The Drinking Water Program consists of periodic testing of all drinking water fountains and sinks. Each is tested at least once every 2 years for contaminants and naturally occurring species. The EPA's protocol is to collect an initial and a 5 minute draw from each dispenser. The 5 minute draw is what is used for the maximum contaminant level. However, the CS&AT has added a 30 second draw since most individuals do not run the water 5 minutes prior to drinking. This data is then entered into a relational Microsoft Access database. The database allows for the quick retrieval of any test@) done on any dispenser. The data can be queried by building number, date or test type, and test results are documented in an analytical report for employees to read. To aid with the tracking of recycled materials within the lab, my help was enlisted to create a database that could make this process less cumbersome and more efficient. The date of pickup, type of material, weight received, and unit cost per recyclable. This information could then calculate the dollar amount generated by the recycling of certain materials. This database will ultimately prove useful in determining the amounts of materials consumed by the lab and will help serve as an indicator potential overuse.

The Extent of Consumer Product Involvement in Paediatric Injuries

PubMed Central

Catchpoole, Jesani; Walker, Sue; Vallmuur, Kirsten

2016-01-01

A challenge in utilising health sector injury data for Product Safety purposes is that clinically coded data have limited ability to inform regulators about product involvement in injury events, given data entry is bound by a predefined set of codes. Text narratives collected in emergency departments can potentially address this limitation by providing relevant product information with additional accompanying context. This study aims to identify and quantify consumer product involvement in paediatric injuries recorded in emergency department-based injury surveillance data. A total of 7743 paediatric injuries were randomly selected from Queensland Injury Surveillance Unit database and associated text narratives were manually reviewed to determine product involvement in the injury event. A Product Involvement Factor classification system was used to categorise these injury cases. Overall, 44% of all reviewed cases were associated with consumer products, with proximity factor (25%) being identified as the most common involvement of a product in an injury event. Only 6% were established as being directly due to the product. The study highlights the importance of utilising injury data to inform product safety initiatives where text narratives can be used to identify the type and involvement of products in injury cases. PMID:27399744

The Extent of Consumer Product Involvement in Paediatric Injuries.

PubMed

Catchpoole, Jesani; Walker, Sue; Vallmuur, Kirsten

2016-07-07

A challenge in utilising health sector injury data for Product Safety purposes is that clinically coded data have limited ability to inform regulators about product involvement in injury events, given data entry is bound by a predefined set of codes. Text narratives collected in emergency departments can potentially address this limitation by providing relevant product information with additional accompanying context. This study aims to identify and quantify consumer product involvement in paediatric injuries recorded in emergency department-based injury surveillance data. A total of 7743 paediatric injuries were randomly selected from Queensland Injury Surveillance Unit database and associated text narratives were manually reviewed to determine product involvement in the injury event. A Product Involvement Factor classification system was used to categorise these injury cases. Overall, 44% of all reviewed cases were associated with consumer products, with proximity factor (25%) being identified as the most common involvement of a product in an injury event. Only 6% were established as being directly due to the product. The study highlights the importance of utilising injury data to inform product safety initiatives where text narratives can be used to identify the type and involvement of products in injury cases.

Usability and Safety in Electronic Medical Records Interface Design: A Review of Recent Literature and Guideline Formulation.

PubMed

Zahabi, Maryam; Kaber, David B; Swangnetr, Manida

2015-08-01

The objectives of this study were to (a) review electronic medical record (EMR) and related electronic health record (EHR) interface usability issues, (b) review how EMRs have been evaluated with safety analysis techniques along with any hazard recognition, and (c) formulate design guidelines and a concept for enhanced EMR interfaces with a focus on diagnosis and documentation processes. A major impact of information technology in health care has been the introduction of EMRs. Although numerous studies indicate use of EMRs to increase health care quality, there remain concerns with usability issues and safety. A literature search was conducted using Compendex, PubMed, CINAHL, and Web of Science databases to find EMR research published since 2000. Inclusion criteria included relevant English-language papers with subsets of keywords and any studies (manually) identified with a focus on EMR usability. Fifty studies met the inclusion criteria. Results revealed EMR and EHR usability problems to include violations of natural dialog, control consistency, effective use of language, effective information presentation, and customization principles as well as a lack of error prevention, minimization of cognitive load, and feedback. Studies focusing on EMR system safety made no objective assessments and applied only inductive reasoning methods for hazard recognition. On the basis of the identified usability problems and structure of safety analysis techniques, we provide EMR design guidelines and a design concept focused on the diagnosis process and documentation. The design guidelines and new interface concept can be used for prototyping and testing enhanced EMRs. © 2015, Human Factors and Ergonomics Society.

You can't improve what you don't measure: Safety climate measures available in the German-speaking countries to support safety culture development in healthcare.

PubMed

Manser, Tanja; Brösterhaus, Mareen; Hammer, Antje

2016-01-01

Safety climate measurement is a key input into safety culture development. The aim of this review is to provide an overview of the safety climate measures that have been evaluated for their psychometric properties in a German-speaking country and to make recommendations on how to use them in quality and patient safety improvement. A systematic search strategy was implemented to obtain relevant articles. PubMed and Web of Science databases were searched, and 128 abstracts were identified. After application of limits, 33 full texts were retrieved for subsequent evaluation. Studies were included on the basis of predetermined inclusion criteria and independent assessment by two reviewers. Publications were reviewed concerning healthcare setting, target group, safety culture dimensions covered and results of their psychometric evaluation. This review identified 11 instruments for safety climate assessment in different healthcare settings (i. e. hospitals, nursing homes, primary care, dental care and community pharmacy) for which acceptable to good internal consistency was reported. We observed wide variability concerning the number of dimensions (1 to 14; in some cases including outcome dimensions) and items (9 to 128) that the instruments were comprised of. Nevertheless, consistency with regard to the thematic areas covered was rather high. While there is clear evidence that we can assess safety climate in healthcare, the application of safety climate measures by quality and patient safety practitioners has so far been rather limited. This review bridges this gap between research and improvement practice by highlighting the central role of safety climate assessment in a mixed methods approach to inform safety culture development. Copyright © 2016. Published by Elsevier GmbH.

[Informatics support for risk assessment and identification of preventive measures in small and micro-enterprises: occupational hazard datasheets].

PubMed

de Merich, D; Forte, Giulia

2011-01-01

Risk assessment is the fundamental process of an enterprise's prevention system and is the principal mandatory provision contained in the Health and Safety Law (Legislative Decree 81/2008) amended by Legislative Decree 106/2009. In order to properly comply with this obligation also in small-sized enterprises, the appropriate regulatory bodies should provide the enterprises with standardized tools and methods for identifying, assessing and managing risks. To assist in particular small and micro-enterprises (SMEs) with risk assessment, by providing a flexible tool that can also be standardized in the form of a datasheet, that can be updated with more detailed information on the various work contexts in Italy. Official efforts to provide Italian SMEs with information may initially make use of the findings of research conducted by ISPESL over the past 20 years, thanks in part to cooperation with other institutions (Regions, INAIL-National Insurance Institute for Occupational Accidents and Diseases), which have led to the creation of an information system on prevention consisting of numerous databases, both statistical and documental ("National System of Surveillance on fatal and serious accidents", "National System of Surveillance on work-related diseases", "Sector hazard profiles" database, "Solutions and Best Practices" database, "Technical Guidelines" database, "Training packages for prevention professionals in enterprises" database). With regard to evaluation criteria applicable within the enterprise, the possibility of combining traditional and uniform areas of assessment (by sector or by risk factor) with assessments by job/occupation has become possible thanks to the cooperation agreement made in 2009 by ISPESL, the ILO (International Labour Organisation) of Geneva and IIOSH (Israel Institute for Occupational Health and Hygiene) regarding the creation of an international Database (HDODB) based on risk datasheets per occupation. The project sets out to assist in particular small and micro-enterprises with risk assessment, providing a flexible and standardized tool in the form of a datasheet, that can be updated with more detailed information on the various work contexts in Italy. The model proposed by ISPESL selected the ILO's "Hazard Datasheet on Occupation" as an initial information tool to steer efforts to assess and manage hazards in small and micro-enterprises. In addition to being an internationally validated tool, the occupation datasheet has a very simple structure that is very effective in communicating and updating information in relation to the local context. According to the logic based on the providing support to enterprises by means of a collaborative network among institutions, local supervisory services and social partners, standardised hazard assessment procedures should be, irrespective of any legal obligations, the preferred tools of an "updatable information system" capable of providing support for the need to improve the process of assessing and managing hazards in enterprises.

Drug development and nonclinical to clinical translational databases: past and current efforts.

PubMed

Monticello, Thomas M

2015-01-01

The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

Methanol test

MedlinePlus

... Safety and Health. Emergency Response Safety and Health Database. Methanol: systemic agent. Updated May 28, 2015. www. ... ADAM Health Solutions. About MedlinePlus Site Map FAQs Customer Support Get email updates Subscribe to RSS Follow ...

Integrating Variances into an Analytical Database

NASA Technical Reports Server (NTRS)

Sanchez, Carlos

2010-01-01

For this project, I enrolled in numerous SATERN courses that taught the basics of database programming. These include: Basic Access 2007 Forms, Introduction to Database Systems, Overview of Database Design, and others. My main job was to create an analytical database that can handle many stored forms and make it easy to interpret and organize. Additionally, I helped improve an existing database and populate it with information. These databases were designed to be used with data from Safety Variances and DCR forms. The research consisted of analyzing the database and comparing the data to find out which entries were repeated the most. If an entry happened to be repeated several times in the database, that would mean that the rule or requirement targeted by that variance has been bypassed many times already and so the requirement may not really be needed, but rather should be changed to allow the variance's conditions permanently. This project did not only restrict itself to the design and development of the database system, but also worked on exporting the data from the database to a different format (e.g. Excel or Word) so it could be analyzed in a simpler fashion. Thanks to the change in format, the data was organized in a spreadsheet that made it possible to sort the data by categories or types and helped speed up searches. Once my work with the database was done, the records of variances could be arranged so that they were displayed in numerical order, or one could search for a specific document targeted by the variances and restrict the search to only include variances that modified a specific requirement. A great part that contributed to my learning was SATERN, NASA's resource for education. Thanks to the SATERN online courses I took over the summer, I was able to learn many new things about computers and databases and also go more in depth into topics I already knew about.

Patient Safety and Quality Improvement Act of 2005.

PubMed

Fassett, William E

2006-05-01

To review Public Law (PL) 109-41-the Patient Safety and Quality Improvement Act of 2005 (PSQIA)-and summarize key medication error research that contributed to congressional recognition of the need for this legislation. Relevant publications related to medication error research, patient safety programs, and the legislative history of and commentary on PL 109-41, published in English, were identified by MEDLINE, PREMEDLINE, Thomas (Library of Congress), and Internet search engine-assisted searches using the terms healthcare quality, medication error, patient safety, PL 109-41, and quality improvement. Additional citations were identified from references cited in related publications. All relevant publications were reviewed. Summarization of the PSQIA was carried out by legal textual analysis. PL 109-41 provides privilege and confidentiality for patient safety work product (PSWP) developed for reporting to patient safety organizations (PSOs). It does not establish federal mandatory reporting of significant errors; rather, it relies on existing state reporting systems. The Act does not preempt stronger state protections for PSWP. The Agency for Healthcare Research and Quality is directed to certify PSOs and promote the establishment of a national network of patient safety databases. Whistleblower protection and penalties for unauthorized disclosure of PSWP are among its enforcement mechanisms. The Act protects clinicians who report minor errors to PSOs and protects the information from disclosure, but providers must increasingly embrace a culture of interdisciplinary concern for patient safety if this protection is to have real impact on patient care.

Prevention of musculoskeletal disorders within management systems: A scoping review of practices, approaches, and techniques.

PubMed

Yazdani, Amin; Neumann, W Patrick; Imbeau, Daniel; Bigelow, Philip; Pagell, Mark; Wells, Richard

2015-11-01

The purpose of this study was to identify and summarize the current research evidence on approaches to preventing musculoskeletal disorders (MSD) within Occupational Health and Safety Management Systems (OHSMS). Databases in business, engineering, and health and safety were searched and 718 potentially relevant publications were identified and examined for their relevance. Twenty-one papers met the selection criteria and were subjected to thematic analysis. There was very little literature describing the integration of MSD risk assessment and prevention into management systems. This lack of information may isolate MSD prevention, leading to difficulties in preventing these disorders at an organizational level. The findings of this review argue for further research to integrate MSD prevention into management systems and to evaluate the effectiveness of the approach. Copyright © 2015 Elsevier Ltd and The Ergonomics Society. All rights reserved.

The Dynamic Aviation Data System (DADS).

PubMed

Soman, S; Strome, T; Francescutti, L H

1997-08-01

This paper proposes The Dynamic Aviation Data System (DADS), which integrates a variety of existing information sources regarding flight to serve as a tool to pilots in dealing with the challenges of flight. The system is composed of three main parts: a pilot's history on disk; a system that can read proposed flight plans and make suggestions based upon Geographical Information Systems, weather, aircraft, and case report databases that exist throughout North America; and a small hand-held computer that interfaces with the aircraft's instruments and that can be brought into the cockpit to aid the pilot before and during flight. The system is based upon technology that currently exists and information that is already regularly collected. While many issues regarding implementation and cost efficiency of the system need to be addressed, the system shows promise in its ability to make useful flight safety information available to all pilots in order to save lives.

AN ADVANCED TOOL FOR APPLIED INTEGRATED SAFETY MANAGEMENT

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

Potts, T. Todd; Hylko, James M.; Douglas, Terence A.

2003-02-27

WESKEM, LLC's Environmental, Safety and Health (ES&H) Department had previously assessed that a lack of consistency, poor communication and using antiquated communication tools could result in varying operating practices, as well as a failure to capture and disseminate appropriate Integrated Safety Management (ISM) information. To address these issues, the ES&H Department established an Activity Hazard Review (AHR)/Activity Hazard Analysis (AHA) process for systematically identifying, assessing, and controlling hazards associated with project work activities during work planning and execution. Depending on the scope of a project, information from field walkdowns and table-top meetings are collected on an AHR form. The AHAmore » then documents the potential failure and consequence scenarios for a particular hazard. Also, the AHA recommends whether the type of mitigation appears appropriate or whether additional controls should be implemented. Since the application is web based, the information is captured into a single system and organized according to the >200 work activities already recorded in the database. Using the streamlined AHA method improved cycle time from over four hours to an average of one hour, allowing more time to analyze unique hazards and develop appropriate controls. Also, the enhanced configuration control created a readily available AHA library to research and utilize along with standardizing hazard analysis and control selection across four separate work sites located in Kentucky and Tennessee. The AHR/AHA system provides an applied example of how the ISM concept evolved into a standardized field-deployed tool yielding considerable efficiency gains in project planning and resource utilization. Employee safety is preserved through detailed planning that now requires only a portion of the time previously necessary. The available resources can then be applied to implementing appropriate engineering, administrative and personal protective equipment controls in the field.« less

International travelers and unintentional fatal drowning in Australia--a 10 year review 2002-12.

PubMed

Peden, Amy E; Franklin, Richard C; Leggat, Peter A

2016-02-01

. Drowning deaths of travelers are commonly reported in the media, creating a perception that they are at a higher risk of drowning than residents. This may be true, due in part to unfamiliarity with the risks posed by the hazard, however there is limited information about drowning deaths of travelers in Australia. This study aims to identify the incidence of drowning among international travelers in Australia and examine the risk factors to inform prevention strategies. . Data on unintentional fatal drowning in Australian waterways of victims with a residential postcode from outside Australia were extracted from the Royal Life Saving Society-Australia National Fatal Drowning Database. . Between 1 July 2002 and 30 June 2012 drowning deaths among people known to be international travelers accounted for 4.3% (N = 123) of the 2870 drowning deaths reported in Australian waterways. Key locations for drowning deaths included beaches (39.0%), ocean/harbour (22.0%) and swimming pools (12.2%). Leading activities prior to drowning included swimming (52.0%), diving (17.9%) and watercraft incidents (13.0%). . International travelers pose a unique challenge from a drowning prevention perspective. The ability to exchange information on water safety is complicated due to potential language barriers, possible differences in swimming ability, different attitudes to safety in the traveler's home country and culture, a lack of opportunities to discuss safety, a relaxed attitude to safety which may result in an increase in risk taking behaviour and alcohol consumption. . Prevention is vital both to reduce loss of life in the aquatic environment and promote Australia as a safe and enjoyable holiday destination for international travelers. © International Society of Travel Medicine, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

Comprehensive Environmental Informatics System (CEIS) Integrating Crew and Vehicle Environmental Health

NASA Technical Reports Server (NTRS)

Nall, Mark E.

2006-01-01

Integrated Vehicle Health Management (IVHM) systems have been pursued as highly integrated systems that include smart sensors, diagnostic and prognostics software for assessments of real-time and life-cycle vehicle health information. Inclusive to such a system is the requirement to monitor the environmental health within the vehicle and the occupants of the vehicle. In this regard an enterprise approach to informatics is used to develop a methodology entitled, Comprehensive Environmental Informatics System (CEIS). The hardware and software technologies integrated into this system will be embedded in the vehicle subsystems, and maintenance operations, to provide both real-time and life-cycle health information of the environment within the vehicle cabin and of its occupants. This comprehensive information database will enable informed decision making and logistics management. One key element of the CEIS is interoperability for data acquisition and archive between environment and human system monitoring. With comprehensive components the data acquired in this system will use model based reasoning systems for subsystem and system level managers, advanced on-board and ground-based mission and maintenance planners to assess system functionality. Knowledge databases of the vehicle health state will be continuously updated and reported for critical failure modes, and routinely updated and reported for life cycle condition trending. Sufficient intelligence, including evidence-based engineering practices which are analogous to evidencebased medicine practices, will be included in the CEIS to result in more rapid recognition of off-nominal operation to enable quicker corrective actions. This will result from better information (rather than just data) for improved crew/operator situational awareness, which will produce significant vehicle and crew safety improvements, as well as increasing the chance for mission success, future mission planning as well as training. Other benefits include improved reliability, increase safety in operations and cost of operations. The cost benefits stem from significantly reduced processing and operations manpower, predictive maintenance for systems and subjects. The improvements in vehicle functionality and cost will result from increased prognostic and diagnostic capability due to the detailed total human exploration system health knowledge from CEIS. A collateral benefit is that there will be closer observations of the vehicle occupants as wrist watch sized devices are worn for continuous health monitoring. Additional database acquisition will stem from activities in countermeasure practices to ensure peak performance capability by occupants of the vehicle. The CEIS will provide data from advanced sensing technologies and informatics modeling which will be useful in problem troubleshooting, and improving NASA s awareness of systems during operation.

Department of Pesticide Regulation Databases

Science.gov Websites

; Safety Report an Illness | Food Safety | Risk Assessment & Mitigation | Human Health | Physicians Endangered Species Enforcement Food Safety Forms Human Health Laws Licensing Mill Assessment Permitting Pest Statewide search: Search Search Search this site: Search Search DPR California Home Programs Health &

Statewide traffic safety study phase I : review of current traffic safety research, practice, analytical procedures and databases.

DOT National Transportation Integrated Search

2005-05-01

This report synthesized the research findings of Phase I of the Statewide Traffic Safety Study of Louisiana, sponsored by the Louisiana Department of Transportation and Development. The objective of Phase I was to provide a comprehensive review of th...

Emerging modalities in dysphagia rehabilitation: neuromuscular electrical stimulation.

PubMed

Huckabee, Maggie-Lee; Doeltgen, Sebastian

2007-10-12

The aim of this review article is to advise the New Zealand medical community about the application of neuromuscular electrical stimulation (NMES) as a treatment for pharyngeal swallowing impairment (dysphagia). NMES in this field of rehabilitation medicine has quickly emerged as a widely used method overseas but has been accompanied by significant controversy. Basic information is provided about the physiologic background of electrical stimulation. The literature reviewed in this manuscript was derived through a computer-assisted search using the biomedical database Medline to identify all relevant articles published until from the initiation of the databases up to January 2007. The reviewers used the following search strategy: [(deglutition disorders OR dysphagia) AND (neuromuscular electrical stimulation OR NMES)]. In addition, the technique of reference tracing was used and very recently published studies known to the authors but not yet included in the database systems were included. This review elucidates not only the substantive potential benefit of this treatment, but also potential key concerns for patient safety and long term outcome. The discussion within the clinical and research communities, especially around the commercially available VitalStim stimulator, is objectively explained.

Toward designing for trust in database automation

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

Duez, P. P.; Jamieson, G. A.

Appropriate reliance on system automation is imperative for safe and productive work, especially in safety-critical systems. It is unsafe to rely on automation beyond its designed use; conversely, it can be both unproductive and unsafe to manually perform tasks that are better relegated to automated tools. Operator trust in automated tools mediates reliance, and trust appears to affect how operators use technology. As automated agents become more complex, the question of trust in automation is increasingly important. In order to achieve proper use of automation, we must engender an appropriate degree of trust that is sensitive to changes in operatingmore » functions and context. In this paper, we present research concerning trust in automation in the domain of automated tools for relational databases. Lee and See have provided models of trust in automation. One model developed by Lee and See identifies three key categories of information about the automation that lie along a continuum of attributional abstraction. Purpose-, process-and performance-related information serve, both individually and through inferences between them, to describe automation in such a way as to engender r properly-calibrated trust. Thus, one can look at information from different levels of attributional abstraction as a general requirements analysis for information key to appropriate trust in automation. The model of information necessary to engender appropriate trust in automation [1] is a general one. Although it describes categories of information, it does not provide insight on how to determine the specific information elements required for a given automated tool. We have applied the Abstraction Hierarchy (AH) to this problem in the domain of relational databases. The AH serves as a formal description of the automation at several levels of abstraction, ranging from a very abstract purpose-oriented description to a more concrete description of the resources involved in the automated process. The connection between an AH for an automated tool and a list of information elements at the three levels of attributional abstraction is then direct, providing a method for satisfying information requirements for appropriate trust in automation. In this paper, we will present our method for developing specific information requirements for an automated tool, based on a formal analysis of that tool and the models presented by Lee and See. We will show an example of the application of the AH to automation, in the domain of relational database automation, and the resulting set of specific information elements for appropriate trust in the automated tool. Finally, we will comment on the applicability of this approach to the domain of nuclear plant instrumentation. (authors)« less

The Role of Documentation Quality in Anesthesia-Related Closed Claims: A Descriptive Qualitative Study.

PubMed

Wilbanks, Bryan A; Geisz-Everson, Marjorie; Boust, Rebecca R

2016-09-01

Clinical documentation is a critical tool in supporting care provided to patients. Sound documentation provides a picture of clinical events that can be used to improve patient care. However, many other uses for clinical documentation are equally important. Such documentation informs clinical decision support tools, creates a legal record of patient care, assists in financial reimbursement of services, and serves as a repository for secondary data analysis. Conversely, poor documentation can impair patient safety and increase malpractice risk exposure by reflecting poor or inaccurate information that ultimately may guide patient care decisions.Through an examination of anesthesia-related closed claims, a descriptive qualitative study emerged, which explored the antecedents and consequences of documentation quality in the claims reviewed. A secondary data analysis utilized a database generated by the American Association of Nurse Anesthetists Foundation closed claim review team. Four major themes emerged from the analysis. Themes 1, 2, and 4 primarily describe how poor documentation quality can have negative consequences for clinicians. The third theme primarily describes how poor documentation quality that can negatively affect patient safety.

[Safety and tolerability of psychotropic medications in childhood: preliminary data of a pharmacovigilance study].

PubMed

Magazù, A; Masi, G; Germanò, E; Gagliostro, M S; Siracusano, R; Arcoraci, V; Spina, E; Gagliano, A

2014-06-01

The aim of this study was to evaluate adverse drug reactions (ADRs) of psychotropic medications in childhood. One hundred and two children and adolescents (M 82.4%, F 17.6%) followed-up at the Division of Child Neurology and Psychiatry at the University of Messina, and at the Scientific Institute Child Neurology and Psychiatry, IRCCS Stella Maris, Calambrone, Pisa, were recruited between January 2009 and December 2011. All participants met DSM-IV diagnostic criteria for psychiatric disorders. The data were collected using a recording sheet for ADRs. An electronic database was also used. The recording sheet was designed to note all relevant information about drug treatment and ADRs according to AIFA (Agenzia Italiana del Farmaco) suggestions. The most prescribed drugs were: risperidone (19.6%), aripiprazole (18.4%) and valproic acid (14.8%). The ADRs more frequently recorded had been: weight gain (12.6%), sleepiness (8.4%), and irritability (6.7%). None of recorded ADRs were classified as "serious". This study can provide a basic model to collect information on safety and tolerability of psychotropic drugs in childhood.

The Vehicular Information Space Framework

NASA Astrophysics Data System (ADS)

Prinz, Vivian; Schlichter, Johann; Schweiger, Benno

Vehicular networks are distributed, self-organizing and highly mobile ad hoc networks. They allow for providing drivers with up-to-the-minute information about their environment. Therefore, they are expected to be a decisive future enabler for enhancing driving comfort and safety. This article introduces the Vehicular Information Space framework (VIS). Vehicles running the VIS form a kind of distributed database. It enables them to provide information like existing hazards, parking spaces or traffic densities in a location aware and fully distributed manner. In addition, vehicles can retrieve, modify and delete these information items. The underlying algorithm is based on features derived from existing structured Peer-to-Peer algorithms and extended to suit the specific characteristics of highly mobile ad hoc networks. We present, implement and simulate the VIS using a motorway and an urban traffic environment. Simulation studies on VIS message occurrence show that the VIS implies reasonable traffic overhead. Also, overall VIS message traffic is independent from the number of information items provided.

Remote monitoring of patients with implanted devices: data exchange and integration.

PubMed

Van der Velde, Enno T; Atsma, Douwe E; Foeken, Hylke; Witteman, Tom A; Hoekstra, Wybo H G J

2013-06-01

Remote follow-up of implanted implantable cardioverter defibrillators (ICDs) may offer a solution to the problem of overcrowded outpatient clinics, and may also be effective in detecting clinical events early. Data obtained from remote follow up systems, as developed by all major device companies, are stored in a central database system, operated and owned by the device company. A problem now arises that the patient's clinical information is partly stored in the local electronic health record (EHR) system in the hospital, and partly in the remote monitoring database, which may potentially result in patient safety issues. To address the requirement of integrating remote monitoring data in the local EHR, the Integrating the Healthcare Enterprise (IHE) Implantable Device Cardiac Observation (IDCO) profile has been developed. This IHE IDCO profile has been adapted by all major device companies. In our hospital, we have implemented the IHE IDCO profile to import data from the remote databases from two device vendors into the departmental Cardiology Information System (EPD-Vision). Data is exchanged via a HL7/XML communication protocol, as defined in the IHE IDCO profile. By implementing the IHE IDCO profile, we have been able to integrate the data from the remote monitoring databases in our local EHRs. It can be expected that remote monitoring systems will develop into dedicated monitoring and therapy platforms. Data retrieved from these systems should form an integral part of the electronic patient record as more and more out-patient clinic care will shift to personalized care provided at a distance, in other words at the patient's home.

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

PubMed

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

2017-10-01

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

A concept for a visual computer interface to make error taxonomies useful at the point of primary care.

PubMed

Singh, Ranjit; Pace, Wilson; Singh, Sonjoy; Singh, Ashok; Singh, Gurdev

2007-01-01

Evidence suggests that the quality of care delivered by the healthcare industry currently falls far short of its capabilities. Whilst most patient safety and quality improvement work to date has focused on inpatient settings, some estimates suggest that outpatient settings are equally important, with up to 200,000 avoidable deaths annually in the United States of America (USA) alone. There is currently a need for improved error reporting and taxonomy systems that are useful at the point of care. This provides an opportunity to harness the benefits of computer visualisation to help structure and illustrate the 'stories' behind errors. In this paper we present a concept for a visual taxonomy of errors, based on visual models of the healthcare system at both macrosystem and microsystem levels (previously published in this journal), and describe how this could be used to create a visual database of errors. In an alphatest in a US context, we were able to code a sample of 20 errors from an existing error database using the visual taxonomy. The approach is designed to capture and disseminate patient safety information in an unambiguous format that is useful to all members of the healthcare team (including the patient) at the point of care as well as at the policy-making level.

Evaluating aspects of online medication safety in long-term follow-up of 136 Internet pharmacies: illegal rogue online pharmacies flourish and are long-lived.

PubMed

Fittler, Andras; Bősze, Gergely; Botz, Lajos

2013-09-10

A growing number of online pharmacies have been established worldwide. Among them are numerous illegal websites selling medicine without valid medical prescriptions or distributing substandard or counterfeit drugs. Only a limited number of studies have been published on Internet pharmacies with regard to patient safety, professionalism, long-term follow-up, and pharmaceutical legitimacy verification. In this study, we selected, evaluated, and followed 136 Internet pharmacy websites aiming to identify indicators of professional online pharmacy service and online medication safety. An Internet search was performed by simulating the needs of potential customers of online pharmacies. A total of 136 Internet pharmacy websites were assessed and followed for four years. According to the LegitScript database, relevant characteristics such as longevity, time of continuous operation, geographical location, displayed contact information, prescription requirement, medical information exchange, and pharmaceutical legitimacy verification were recorded and evaluated. The number of active Internet pharmacy websites decreased; 23 of 136 (16.9%) online pharmacies ceased operating within 12 months and only 67 monitored websites (49.3%) were accessible at the end of the four-year observation period. However, not all operated continuously, as about one-fifth (31/136) of all observed online pharmacy websites were inaccessible provisionally. Thus, only 56 (41.2%) Internet-based pharmacies were continuously operational. Thirty-one of the 136 online pharmacies (22.8%) had not provided any contact details, while only 59 (43.4%) displayed all necessary contact information on the website. We found that the declared physical location claims did not correspond to the area of domain registration (according to IP address) for most websites. Although the majority (120/136, 88.2%) of the examined Internet pharmacies distributed various prescription-only medicines, only 9 (6.6%) requested prior medical prescriptions before purchase. Medical information exchange was generally ineffective as 52 sites (38.2%) did not require any medical information from patients. The product information about the medicines was generally (126/136, 92.6%) not displayed adequately, and the contents of the patient information leaflet were incomplete in most cases (104/136, 76.5%). Numerous online operators (60/136, 44.1%) were defined as rogue Internet pharmacies, but no legitimate Internet-based pharmacies were among them. One site (0.7%) was yet unverified, 23 (16.9%) were unapproved, while the remaining (52/136, 38.2%) websites were not available in the LegitScript database. Contrary to our prior assumptions, prescription or medical information requirement, or the indication of contact information on the website, does not seem to correlate with "rogue pharmacy" status using the LegitScript online pharmacy verification standards. Instead, long-term continuous operation strongly correlated (P<.001) with explicit illegal activity. Most Internet pharmacies in our study sample were illegal sites within the definition of "rogue" Internet pharmacy. These websites violate professional, legal, and ethical standards and endanger patient safety. This work shows evidence that online pharmacies that act illegally appear to have greater longevity than others, presumably because there is no compelling reason for frequent change in order to survive. We also found that one in five websites revived (closed down and reopened again within four years) and no-prescription sites with limited medicine and patient information are flourishing.

Evaluating Aspects of Online Medication Safety in Long-Term Follow-Up of 136 Internet Pharmacies: Illegal Rogue Online Pharmacies Flourish and Are Long-Lived

PubMed Central

2013-01-01

Background A growing number of online pharmacies have been established worldwide. Among them are numerous illegal websites selling medicine without valid medical prescriptions or distributing substandard or counterfeit drugs. Only a limited number of studies have been published on Internet pharmacies with regard to patient safety, professionalism, long-term follow-up, and pharmaceutical legitimacy verification. Objective In this study, we selected, evaluated, and followed 136 Internet pharmacy websites aiming to identify indicators of professional online pharmacy service and online medication safety. Methods An Internet search was performed by simulating the needs of potential customers of online pharmacies. A total of 136 Internet pharmacy websites were assessed and followed for four years. According to the LegitScript database, relevant characteristics such as longevity, time of continuous operation, geographical location, displayed contact information, prescription requirement, medical information exchange, and pharmaceutical legitimacy verification were recorded and evaluated. Results The number of active Internet pharmacy websites decreased; 23 of 136 (16.9%) online pharmacies ceased operating within 12 months and only 67 monitored websites (49.3%) were accessible at the end of the four-year observation period. However, not all operated continuously, as about one-fifth (31/136) of all observed online pharmacy websites were inaccessible provisionally. Thus, only 56 (41.2%) Internet-based pharmacies were continuously operational. Thirty-one of the 136 online pharmacies (22.8%) had not provided any contact details, while only 59 (43.4%) displayed all necessary contact information on the website. We found that the declared physical location claims did not correspond to the area of domain registration (according to IP address) for most websites. Although the majority (120/136, 88.2%) of the examined Internet pharmacies distributed various prescription-only medicines, only 9 (6.6%) requested prior medical prescriptions before purchase. Medical information exchange was generally ineffective as 52 sites (38.2%) did not require any medical information from patients. The product information about the medicines was generally (126/136, 92.6%) not displayed adequately, and the contents of the patient information leaflet were incomplete in most cases (104/136, 76.5%). Numerous online operators (60/136, 44.1%) were defined as rogue Internet pharmacies, but no legitimate Internet-based pharmacies were among them. One site (0.7%) was yet unverified, 23 (16.9%) were unapproved, while the remaining (52/136, 38.2%) websites were not available in the LegitScript database. Contrary to our prior assumptions, prescription or medical information requirement, or the indication of contact information on the website, does not seem to correlate with “rogue pharmacy” status using the LegitScript online pharmacy verification standards. Instead, long-term continuous operation strongly correlated (P<.001) with explicit illegal activity. Conclusions Most Internet pharmacies in our study sample were illegal sites within the definition of “rogue” Internet pharmacy. These websites violate professional, legal, and ethical standards and endanger patient safety. This work shows evidence that online pharmacies that act illegally appear to have greater longevity than others, presumably because there is no compelling reason for frequent change in order to survive. We also found that one in five websites revived (closed down and reopened again within four years) and no-prescription sites with limited medicine and patient information are flourishing. PMID:24021777

Japan PGx Data Science Consortium Database: SNPs and HLA genotype data from 2994 Japanese healthy individuals for pharmacogenomics studies.

PubMed

Kamitsuji, Shigeo; Matsuda, Takashi; Nishimura, Koichi; Endo, Seiko; Wada, Chisa; Watanabe, Kenji; Hasegawa, Koichi; Hishigaki, Haretsugu; Masuda, Masatoshi; Kuwahara, Yusuke; Tsuritani, Katsuki; Sugiura, Kenkichi; Kubota, Tomoko; Miyoshi, Shinji; Okada, Kinya; Nakazono, Kazuyuki; Sugaya, Yuki; Yang, Woosung; Sawamoto, Taiji; Uchida, Wataru; Shinagawa, Akira; Fujiwara, Tsutomu; Yamada, Hisaharu; Suematsu, Koji; Tsutsui, Naohisa; Kamatani, Naoyuki; Liou, Shyh-Yuh

2015-06-01

Japan Pharmacogenomics Data Science Consortium (JPDSC) has assembled a database for conducting pharmacogenomics (PGx) studies in Japanese subjects. The database contains the genotypes of 2.5 million single-nucleotide polymorphisms (SNPs) and 5 human leukocyte antigen loci from 2994 Japanese healthy volunteers, as well as 121 kinds of clinical information, including self-reports, physiological data, hematological data and biochemical data. In this article, the reliability of our data was evaluated by principal component analysis (PCA) and association analysis for hematological and biochemical traits by using genome-wide SNP data. PCA of the SNPs showed that all the samples were collected from the Japanese population and that the samples were separated into two major clusters by birthplace, Okinawa and other than Okinawa, as had been previously reported. Among 87 SNPs that have been reported to be associated with 18 hematological and biochemical traits in genome-wide association studies (GWAS), the associations of 56 SNPs were replicated using our data base. Statistical power simulations showed that the sample size of the JPDSC control database is large enough to detect genetic markers having a relatively strong association even when the case sample size is small. The JPDSC database will be useful as control data for conducting PGx studies to explore genetic markers to improve the safety and efficacy of drugs either during clinical development or in post-marketing.

[Aripiprazole in pregnancy: a review of literature].

PubMed

Bellantuono, Cesario; Di Massimo, Giorgia; Mauro, Antonella; Martellini, Mariasole; Nardi, Bernardo

2015-01-01

Data on tolerability and safety of aripiprazolo during pregnancy and in childbirth are so far limited. Aim of the present study is to provide a review of the literature on the safety profile of aripiprazole during pregnancy and on maternal and neonatal outcomes, including two cases coming from our database (www.degradatabase.it). Medline database was searched for English language articles by using the following keywords: "aripiprazole", "atypical antipsychotic", "major malformations", "perinatal complications", "pregnancy". We reported 2 cases of women treated with aripiprazole during their pregnancy at the Clinic of Affective Disorders in Pregnancy and Postpartum of the United Hospital of Ancona (DEGRA Center - www.depressionegravidanza.it). The data available in the literature did not provide clear evidence about the safety and potential risks related to this drug during pregnancy. Data coming from our database did not detected any malformations and perinatal complications after exposure to aripiprazole in 2 newborns beyond the first trimester of pregnancy. From the evidence available, aripiprazole seems to be an antipsychotic effective and well tolerated in the treatment of women with psychotic disorders in pregnancy. However, further studies are needed to better establish the safety of aripiprazole during pregnancy, particularly as the risk of major malformtions and perinatal complications is concerned.

Herbal medicine for idiopathic central precocious puberty: A protocol for a systematic review of controlled trials.

PubMed

Lee, Hye Lim; Lee, Yoo Been; Choi, Jun-Yong; Lee, Ju Ah

2018-03-01

Herbal medicine is widely used in East Asia to treat idiopathic central precocious puberty (ICPP). Most of the available clinical trials that investigated herbal medicine for ICPP have been included in this review. This systematic review will assess the efficacy and safety of herbal medicine for ICPP. Eleven databases, including Asian databases, will be searched for studies conducted through 2018. We will include randomized controlled trials assessing herbal medicine for ICPP. The risk of bias will be evaluated using the Cochrane risk of bias assessment tool, and confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation instrument. This systematic review will be published in a peer-reviewed journal and disseminated both electronically and in print. The review will be updated to inform and guide health care practices. PROSPER 2018 CRD42018087988.

Investigated serious occupational accidents in the Netherlands, 1998-2009.

PubMed

Bellamy, Linda J; Manuel, Henk Jan; Oh, Joy I H

2014-01-01

Since 2003, a project has been underway to analyse the most serious occupational accidents in The Netherlands. All the serious occupational accidents investigated by the Dutch Labour Inspectorate for the 12 years of 1998-2009 inclusive have been entered into a database, a total of 20 030 investigations. This database uses a model of safety barriers supported by barrier tasks and management delivery systems such that, when combined with sector and year information, trends in the data can be analysed for their underlying causes. The trend analyses show that while the number of victims of serious reportable accidents is significantly decreasing, this is due to specific sectors, hazards and underlying causes. The significant results could not easily be directly associated with any specific regulation or action undertaken in The Netherlands although there have been many different approaches to reducing accidents during the period analysed, which could be contributing to the effect.

Assistive technology for ultrasound-guided central venous catheter placement.

PubMed

Ikhsan, Mohammad; Tan, Kok Kiong; Putra, Andi Sudjana

2018-01-01

This study evaluated the existing technology used to improve the safety and ease of ultrasound-guided central venous catheterization. Electronic database searches were conducted in Scopus, IEEE, Google Patents, and relevant conference databases (SPIE, MICCAI, and IEEE conferences) for related articles on assistive technology for ultrasound-guided central venous catheterization. A total of 89 articles were examined and pointed to several fields that are currently the focus of improvements to ultrasound-guided procedures. These include improving needle visualization, needle guides and localization technology, image processing algorithms to enhance and segment important features within the ultrasound image, robotic assistance using probe-mounted manipulators, and improving procedure ergonomics through in situ projections of important information. Probe-mounted robotic manipulators provide a promising avenue for assistive technology developed for freehand ultrasound-guided percutaneous procedures. However, there is currently a lack of clinical trials to validate the effectiveness of these devices.

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

PubMed

Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

2015-05-01

Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting; such data could provide vital information to help healthcare teams to educate and support users, and thereby prevent AEs. As well as requiring more from the manufacturing companies, we call for public funding of more research addressing clinically important questions in relation to pump therapy: both observational studies and clinical trials. At present there are significant differences in the regulatory systems between the USA and European Union at both pre- and post-marketing stages; improvements in the European system are more urgently required. This statement concludes with a series of recommended specific actions for 'meknovigilance' (i.e. a standardised safety approach to technology) which could be implemented to address the shortcomings we highlight.

Predicting clinical biological responses to dental materials.

PubMed

Wataha, John C

2012-01-01

Methods used to measure and predict clinical biological responses to dental materials remain controversial, confusing, and to some extent, unsuccessful. The current paper reviews significant issues surrounding how we assess the biological safety of materials, with a historical summary and critical look at the biocompatibility literature. The review frames these issues from a U.S. perspective to some degree, but emphasizes their global nature and universal importance. The PubMed database and information from the U.S. Food and Drug Administration, International Standards Organization, and American National Standards Institute were searched for prominent literature addressing the definition of biocompatibility, types of biological tests employed, regulatory and standardization issues, and how biological tests are used together to establish the biological safety of materials. The search encompassed articles published in English from approximately 1965-2011. The review does not comprehensively review the literature, but highlights significant issues that confront the field. Years ago, tests for biological safety sought to establish material inertness as the measure of safety, a criterion that is now deemed naive; the definition of biocompatibility has broadened along with the roles for materials in patient oral health care. Controversies persist about how in vitro or animal tests should be used to evaluate the biological safety of materials for clinical use. Controlled clinical trials remain the single best measure of the clinical response to materials, but even these tests have significant limitations and are less useful to identify mechanisms that shape material performance. Practice-based research networks and practitioner databases are emerging as important supplements to controlled clinical trials, but their final utility remains to be determined. Today we ask materials to play increasingly sophisticated structural and therapeutic roles in patient treatment. To accommodate these roles, strategies to assess, predict, and monitor material safety need to evolve. This evolution will be driven not only by researchers and manufacturers, but also by patients and practitioners, who want to use novel materials in new ways to treat oral disease. Copyright © 2011 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Problems with health information technology and their effects on care delivery and patient outcomes: a systematic review.

PubMed

Kim, Mi Ok; Coiera, Enrico; Magrabi, Farah

2017-03-01

To systematically review studies reporting problems with information technology (IT) in health care and their effects on care delivery and patient outcomes. We searched bibliographic databases including Scopus, PubMed, and Science Citation Index Expanded from January 2004 to December 2015 for studies reporting problems with IT and their effects. A framework called the information value chain, which connects technology use to final outcome, was used to assess how IT problems affect user interaction, information receipt, decision-making, care processes, and patient outcomes. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Of the 34 studies identified, the majority ( n  = 14, 41%) were analyses of incidents reported from 6 countries. There were 7 descriptive studies, 9 ethnographic studies, and 4 case reports. The types of IT problems were similar to those described in earlier classifications of safety problems associated with health IT. The frequency, scale, and severity of IT problems were not adequately captured within these studies. Use errors and poor user interfaces interfered with the receipt of information and led to errors of commission when making decisions. Clinical errors involving medications were well characterized. Issues with system functionality, including poor user interfaces and fragmented displays, delayed care delivery. Issues with system access, system configuration, and software updates also delayed care. In 18 studies (53%), IT problems were linked to patient harm and death. Near-miss events were reported in 10 studies (29%). The research evidence describing problems with health IT remains largely qualitative, and many opportunities remain to systematically study and quantify risks and benefits with regard to patient safety. The information value chain, when used in conjunction with existing classifications for health IT safety problems, can enhance measurement and should facilitate identification of the most significant risks to patient safety. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Data mining and visualization of the Alabama accident database

DOT National Transportation Integrated Search

2000-08-01

The Alabama Department of Public Safety has developed and maintains a centralized database that contain traffic accident data collected from crash report completed by local police officers and state troopers. The Critical Analysis Reporting Environme...

Taste and Safety: Is the Exceptional Cuisine Offered by High End Restaurants Paralleled by High Standards of Food Safety?

PubMed Central

Kanagarajah, Sanch; Mook, Piers; Crook, Paul; Awofisayo-Okuyelu, Adedoyin; McCarthy, Noel

2016-01-01

Introduction: Restaurant guides such as the Good Food Guide Top 50 create a hierarchy focussing on taste and sophistication. Safety is not explicitly included. We used restaurant associated outbreaks to assess evidence for safety. Methods: All foodborne disease outbreaks in England reported to the national database from 2000 to 2014 were used to compare the Top 50 restaurants (2015) to other registered food businesses using the Public Health England (PHE) outbreak database. Health Protection Teams were also contacted to identify any outbreaks not reported to the national database. Among Good Food Guide Top 50 restaurants, regression analysis estimated the association between outbreak occurrence and position on the list. Results: Four outbreaks were reported to the PHE national outbreak database among the Top 50 giving a rate 39 times higher (95% CI 14.5–103.2) than other registered food businesses. Eight outbreaks among the 44 English restaurants in the Top 50 were identified by direct contact with local Health Protection Teams. For every ten places higher ranked, Top 50 restaurants were 66% more likely to have an outbreak (Odds Ratio 1.66, 95% CI 0.89–3.13). Discussion: Top 50 restaurants were substantially more likely to have had reported outbreaks from 2000-2014 than other food premises, and there was a trend for higher rating position to be associated with higher probability of reported outbreaks. Our findings, that eating at some of these restaurants may pose an increased risk to health compared to other dining out, raises the question of whether food guides should consider aspects of food safety alongside the clearly important complementary focus on taste and other aspects of the dining experience. PMID:27617168

Directed use of the internet for health information by patients with chronic kidney disease: prospective cohort study.

PubMed

Diamantidis, Clarissa Jonas; Fink, Wanda; Yang, Shiming; Zuckerman, Marni R; Ginsberg, Jennifer; Hu, Peter; Xiao, Yan; Fink, Jeffrey C

2013-11-15

Health information technology has become common in the care of patients with chronic diseases; however, there are few such applications employed in kidney disease. The aim of the study was to evaluate the use of a website providing disease-specific safety information by patients with predialysis chronic kidney disease. As part of the Safe Kidney Care (SKC) study, an educational website was designed to provide information on safety concerns in chronic kidney disease. Phase I study participants were provided a medical alert accessory with a unique ID number, the Safe Kidney Care website, and an in-person tutorial on the use of the Internet and accessing the SKC website at baseline. Participants were asked to visit the website and enter their unique ID as frequently as they desired over the next 365 days or until their annual follow-up visit, whichever occurred first. Participants' visits and dwell times on specific safety modules were tracked using embedded webpage PHP scripts linked to a MySQL database, enabling the collection of website usage statistics. Of 108 Phase I participants, 28.7% (31/108) visited the website from 1-6 times during the observation period (median follow-up 365 days). Median access time was 7 minutes per visit (range <1-46) and 13 minutes per person (range <1-123). The three most frequently visited pages were "Renal function calculator", "Pills to avoid", and "Foods to avoid". High school education and frequent Internet use were significantly associated with website entry (P=.02 and P=.03, respectively). Preliminary results show general interest in a Web-based platform designed to improve patient safety in chronic kidney disease. Clinicaltrials.gov NCT01407367; http://clinicaltrials.gov/show/NCT01407367 (Archived by WebCite at http://www.webcitation.org/6KvxFKA6M).

Bathing an infant

MedlinePlus

National Resource Center for Health and Safety in Child Care and Early Education. Standard 2.2.0.4: Supervision near ... National Resource Center for Health and Safety in Child Care and Early Education; 2011. cfoc.nrckids.org/CFOC/Database/2. ...

77 FR 22322 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... Safety Databases (NPSD). The Common Formats include two general types of formats, generic and event... Common Formats. The inventory includes many systems from the private sector, including prominent academic...

77 FR 42736 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... Safety Databases (NPSD). Since the initial release of the Common Formats in August 2008, AHRQ has.... The inventory includes many systems from the private sector, including prominent academic settings...

Gendered role of appraisals of safety in psychological outcome in relation to trauma.

PubMed

Padmanabhanunni, Anita; Campbell, Jerome; Pretorius, Tyrone B

2017-09-01

This study investigated gender differences in the role of appraisals of safety in the relationship between exposure to violence and trauma-related symptoms among South African adolescents living in low socioeconomic settings. Limited research exists in developing contexts on the role of cognitive appraisals in mitigating outcome following exposure to violence. Given the prevalence of violence in South Africa and the vulnerability of youth, this type of research is valuable in identifying adolescents at risk of negative psychological outcome following exposure, and in informing intervention efforts. Adolescents (N = 498) completed an adapted version of the Harvard Trauma Questionnaire (Mollica et al., 1992) and the Safety Index (Ward, Flisher, Zissis, Muller, & Lombard, 2001). The results indicate a significant positive relationship between all violence subscales and trauma-related symptoms, whereas a significant negative relationship was found between sense of safety and trauma-related symptoms. Important gender differences were identified in the role of appraisals of safety, with more effects noted for women than men. For men, the obtained results only demonstrated a health-sustaining role. For women, the results indicated a health-sustaining role, an indirect effect, and a stress-reducing role. These findings stress the necessity of gender-specific interventions. Assessment of psychological trauma, particularly among female adolescents, needs to include measures of cognitive appraisals related to safety. Therapeutic techniques that may be particularly beneficial to adolescent girls are those focusing on promoting sense of safety and targeting dysfunctional threat appraisals. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Aviation Trends Related to Atmospheric Environment Safety Technologies Project Technical Challenges

NASA Technical Reports Server (NTRS)

Reveley, Mary S.; Withrow, Colleen A.; Barr, Lawrence C.; Evans, Joni K.; Leone, Karen M.; Jones, Sharon M.

2014-01-01

Current and future aviation safety trends related to the National Aeronautics and Space Administration's Atmospheric Environment Safety Technologies Project's three technical challenges (engine icing characterization and simulation capability; airframe icing simulation and engineering tool capability; and atmospheric hazard sensing and mitigation technology capability) were assessed by examining the National Transportation Safety Board (NTSB) accident database (1989 to 2008), incidents from the Federal Aviation Administration (FAA) accident/incident database (1989 to 2006), and literature from various industry and government sources. The accident and incident data were examined for events involving fixed-wing airplanes operating under Federal Aviation Regulation (FAR) Parts 121, 135, and 91 for atmospheric conditions related to airframe icing, ice-crystal engine icing, turbulence, clear air turbulence, wake vortex, lightning, and low visibility (fog, low ceiling, clouds, precipitation, and low lighting). Five future aviation safety risk areas associated with the three AEST technical challenges were identified after an exhaustive survey of a variety of sources and include: approach and landing accident reduction, icing/ice detection, loss of control in flight, super density operations, and runway safety.

HNS-MS : Improving Member States preparedness to face an HNS pollution of the Marine System

NASA Astrophysics Data System (ADS)

Legrand, Sebastien; Le Floch, Stéphane; Aprin, Laurent; Parthenay, Valérie; Donnay, Eric; Parmentier, Koen; Ovidio, Fabrice; Schallier, Ronny; Poncet, Florence; Chataing, Sophie; Poupon, Emmanuelle; Hellouvry, Yann-Hervé

2016-04-01

When dealing with a HNS pollution incident, one of the priority requirements is the identification of the hazard and an assessment of the risk posed to the public and responder safety, the environment and socioeconomic assets upon which a state or coastal community depend. The primary factors which determine the safety, environmental and socioeconomic impact of the released substance(s) relate to their physico-chemical properties and fate in the environment. Until now, preparedness actions at various levels have primarily aimed at classifying the general environmental or public health hazard of an HNS, or at performing a risk analysis of HNS transported in European marine regions. Operational datasheets have been (MIDSIS-TROCS) or are being (MAR-CIS) developed collating detailed, substance-specific information for responders and covering information needs at the first stage of an incident. However, contrary to oil pollution preparedness and response tools, only few decision-support tools used by Member State authorities (Coastguard agencies or other) integrate 3D models that are able to simulate the drift, fate and behaviour of HNS spills in the marine environment. When they do, they usually consider simplified or steady-state environmental conditions. Moreover, the above-mentioned available HNS information is currently not sufficiently detailed or not suitably classified to be used as an input for an advanced HNS support decision tool. HNS-MS aims at developing a 'one-stop shop' integrated HNS decision-support tool that is able to predict the drift, behaviour and Fate of HNS spills under realistic environmental conditions and at providing key product information - drawing upon and in complement to existing studies and databases - to improve the understanding and evaluation of a HNS spill situation in the field and the environmental and safety-related issues at stake. The 3D HNS drift and fate model and decision-support tool will also be useful at the preparedness stage. The expected results will be an operational HNS decision-support tool (prototype) for the Bonn Agreement area that can also be viewed as a demonstrator tool for other European marine regions. The developed tool will have a similar operational level as OSERIT, the Belgian oil spill drift model. The HNS decision-support tool will integrate the following features: 1. A database containing the physico-chemical parameters needed to compute the behaviour in the marine environment of 100+ relevant HNS; 2. A database of environmental and socioeconomic HNS-sensitive features; 3. A three dimensional HNS spill drift and fate model able to simulate HNS behaviour in the marine environment (including floaters, sinkers, evaporators and dissolvers). 4. A user-friendly web-based interface allowing Coastguard stations to launch a HNS drift simulation and visualize post-processed results in support of an incident evaluation and decision-making process. In this contribution, we will present the methodology followed to develop these four features.

The status of blood safety in ECO member states

PubMed Central

Seighali, Fariba; Hosseini Divkolaye, Nasim S.; Koohi, Ebrahim; Pourfathollah, Ali A.; Rahmani, Ahmad M.

2015-01-01

Background Access to the information concerning blood safety is essential for managing problems and overcoming the challenges that are faced in any given region. Information on the availability and safety of blood in countries of the Economic Cooperation Organisation (ECO) is largely lacking. To address this problem, the Iranian Blood Transfusion Organisation, in collaboration with other ECO member states, initiated a research project in 2009 to collect, analyse and compare statistics on blood safety in the region. Materials and methods A modified and summarised version of the Global Database on Blood Safety (GDBS) questionnaire was used to collect data. The questionnaire was sent to all ten countries in the ECO region. The heads of the national transfusion services or focal points were requested to complete the form. Related literature and websites were also reviewed. Results Only three countries (Afghanistan, Iran and Turkey) completed the questionnaire, while other countries provided their available data on some parts of the questionnaire. The number of donations per year varied from 5 to 27/1,000 population. The rate of donors positive for human immunodeficiency virus ranged from 0.003% to 0.2%. The rate of donors positive for hepatitis C virus antibody varied from 0.05% to 3.9% while that of hepatitis B virus surface antigen ranged from 0.15% to 3.91% respectively. Discussion There is very clear diversity in blood transfusion services among ECO member states. Most countries in the region do not have a data-recording system. It is generally estimated that the need for blood is much higher than the supply in this region. Deficiencies in donor screening and a high prevalence of transfusion-transmitted infections are other important challenges. PMID:26192779

Analysis of Runway Incursion Data

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2013-01-01

A statistical analysis of runway incursion (RI) events was conducted to ascertain relevance to the top ten challenges of the National Aeronautics and Space Administration Aviation Safety Program (AvSP). The information contained in the RI database was found to contain data that may be relevant to several of the AvSP top ten challenges. When combined with other data from the FAA documenting air traffic volume from calendar year 2000 through 2011, the structure of a predictive model emerges that can be used to forecast the frequency of RI events at various airports for various classes of aircraft and under various environmental conditions.

Work-Facilitating Information Visualization Techniques for Complex Wastewater Systems

NASA Astrophysics Data System (ADS)

Ebert, Achim; Einsfeld, Katja

The design and the operation of urban drainage systems and wastewater treatment plants (WWTP) have become increasingly complex. This complexity is due to increased requirements concerning process technology, technical, environmental, economical, and occupational safety aspects. The plant operator has access not only to some timeworn filers and measured parameters but also to numerous on-line and off-line parameters that characterize the current state of the plant in detail. Moreover, expert databases and specific support pages of plant manufactures are accessible through the World Wide Web. Thus, the operator is overwhelmed with predominantly unstructured data.

Computer-aided prediction of xenobiotic metabolism in the human body

NASA Astrophysics Data System (ADS)

Bezhentsev, V. M.; Tarasova, O. A.; Dmitriev, A. V.; Rudik, A. V.; Lagunin, A. A.; Filimonov, D. A.; Poroikov, V. V.

2016-08-01

The review describes the major databases containing information about the metabolism of xenobiotics, including data on drug metabolism, metabolic enzymes, schemes of biotransformation and the structures of some substrates and metabolites. Computational approaches used to predict the interaction of xenobiotics with metabolic enzymes, prediction of metabolic sites in the molecule, generation of structures of potential metabolites for subsequent evaluation of their properties are considered. The advantages and limitations of various computational methods for metabolism prediction and the prospects for their applications to improve the safety and efficacy of new drugs are discussed. Bibliography — 165 references.

[Accidents at work in construction workers: a peculiar utilization of the information flow INAIL-ISPESL-Regions].

PubMed

Madeo, G; Giaimo, M

2007-01-01

Indicators generally used to describe the work accident risk, i.e. frequency and injuries severity, are not suitable for comparison among single companies in order to point out those with major risk. We propose a method to draw out construction companies with higher risk of occupational injuries in the period 2003-2005 from INAIL-ISPESL-Regioni database. These companies will be object of specific interventions for the prevention, training and supervision from Prevention and Safety in Working Environments Services, from Provincial Labor Directions and Provincial Territorial Construction Committees.

Assessment of statewide intersection safety performance.

DOT National Transportation Integrated Search

2011-06-01

This report summarizes the results of an analysis of the safety performance of Oregons intersections. Following a pilot : study, a database of 500 intersections randomly sampled from around the state of Oregon in both urban and rural : environment...

Model minimum inventory of roadway elements--MMIRE

DOT National Transportation Integrated Search

2007-08-01

Safety data provide the key to making sound decisions on the design and operation of roadways, but deficiencies in many States safety databases do not allow for good decisionmaking. The Federal Highway Administration, American Association of State...

Development of a Nevada Statewide Database for Safety Analyst Software

DOT National Transportation Integrated Search

2017-02-02

Safety Analyst is a software package developed by the Federal Highway Administration (FHWA) and twenty-seven participating state and local agencies including the Nevada Department of Transportation (NDOT). The software package implemented many of the...

Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

PubMed Central

Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

2011-01-01

Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

Polar bear attacks on humans: Implications of a changing climate

USGS Publications Warehouse

Wilder, James; Vongraven, Dag; Atwood, Todd C.; Hansen, Bob; Jessen, Amalie; Kochnev, Anatoly A.; York, Geoff; Vallender, Rachel; Hedman, Daryll; Gibbons, Melissa

2017-01-01

Understanding causes of polar bear (Ursus maritimus) attacks on humans is critical to ensuring both human safety and polar bear conservation. Although considerable attention has been focused on understanding black (U. americanus) and grizzly (U. arctos) bear conflicts with humans, there have been few attempts to systematically collect, analyze, and interpret available information on human-polar bear conflicts across their range. To help fill this knowledge gap, a database was developed (Polar Bear-Human Information Management System [PBHIMS]) to facilitate the range-wide collection and analysis of human-polar bear conflict data. We populated the PBHIMS with data collected throughout the polar bear range, analyzed polar bear attacks on people, and found that reported attacks have been extremely rare. From 1870–2014, we documented 73 attacks by wild polar bears, distributed among the 5 polar bear Range States (Canada, Greenland, Norway, Russia, and United States), which resulted in 20 human fatalities and 63 human injuries. We found that nutritionally stressed adult male polar bears were the most likely to pose threats to human safety. Attacks by adult females were rare, and most were attributed to defense of cubs. We judged that bears acted as a predator in most attacks, and that nearly all attacks involved ≤2 people. Increased concern for both human and bear safety is warranted in light of predictions of increased numbers of nutritionally stressed bears spending longer amounts of time on land near people because of the loss of their sea ice habitat. Improved conflict investigation is needed to collect accurate and relevant data and communicate accurate bear safety messages and mitigation strategies to the public. With better information, people can take proactive measures in polar bear habitat to ensure their safety and prevent conflicts with polar bears. This work represents an important first step towards improving our understanding of factors influencing human-polar bear conflicts. Continued collection and analysis of range-wide data on interactions and conflicts will help increase human safety and ensure the conservation of polar bears for future generations.

Safe and inclusive research practices for qualitative research involving people with dementia: A review of key issues and strategies.

PubMed

Novek, Sheila; Wilkinson, Heather

2017-01-01

Aim Developing strategies to ensure the safe participation of people with dementia in research is critical to support their wider inclusion in research and to advance knowledge in the areas of dementia policy and practice. Objectives This literature review synthesizes and critically appraises different approaches to promote the safe participation of people with dementia in qualitative research. Methods Two databases were searched for articles that discuss the methodological or ethical aspects of qualitative research involving people with dementia. We did not focus on informed consent or ethical review processes as these have been reviewed elsewhere. Findings Key issues that impact participant safety include: language, gatekeepers, the research relationship, communication, dealing with distress, knowledge dissemination, and researcher skills. Conclusion By synthesizing different approaches to safety and highlighting areas of debate, we hope to advance discussion and to contribute to the development of inclusive research methods.

RDS - A systematic approach towards system thermal hydraulics input code development for a comprehensive deterministic safety analysis

NASA Astrophysics Data System (ADS)

Salim, Mohd Faiz; Roslan, Ridha; Ibrahim, Mohd Rizal Mamat @

2014-02-01

Deterministic Safety Analysis (DSA) is one of the mandatory requirements conducted for Nuclear Power Plant licensing process, with the aim of ensuring safety compliance with relevant regulatory acceptance criteria. DSA is a technique whereby a set of conservative deterministic rules and requirements are applied for the design and operation of facilities or activities. Computer codes are normally used to assist in performing all required analysis under DSA. To ensure a comprehensive analysis, the conduct of DSA should follow a systematic approach. One of the methodologies proposed is the Standardized and Consolidated Reference Experimental (and Calculated) Database (SCRED) developed by University of Pisa. Based on this methodology, the use of Reference Data Set (RDS) as a pre-requisite reference document for developing input nodalization was proposed. This paper shall describe the application of RDS with the purpose of assessing its effectiveness. Two RDS documents were developed for an Integral Test Facility of LOBI-MOD2 and associated Test A1-83. Data and information from various reports and drawings were referred in preparing the RDS. The results showed that by developing RDS, it has made possible to consolidate all relevant information in one single document. This is beneficial as it enables preservation of information, promotes quality assurance, allows traceability, facilitates continuous improvement, promotes solving of contradictions and finally assisting in developing thermal hydraulic input regardless of whichever code selected. However, some disadvantages were also recognized such as the need for experience in making engineering judgments, language barrier in accessing foreign information and limitation of resources. Some possible improvements are suggested to overcome these challenges.

Electroacupuncture for women with stress urinary incontinence: Protocol for a systematic review and meta-analysis.

PubMed

Huang, Weixin; Li, Xiaohui; Wang, Yuanping; Yan, Xia; Wu, Siping

2017-12-01

Stress urinary incontinence (SUI) is a widespread complaint in the adult women. Electroacupuncture has been widely applied in the treatment of SUI. But its efficacy has not been evaluated scientifically and systematically. Therefore, we provide a protocol of systematic evaluation to assess the effectiveness and safety of electroacupuncture treatment on women with SUI. The retrieved databases include 3 English literature databases, namely PubMed, Embase, and Cochrane Library, and 3 Chinese literature databases, namely Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), and Wanfang Database. The randomized controlled trials (RCTs) of the electroacupuncture treatment on women with SUI will be searched in the above-mentioned databases from the time when the respective databases were established to December 2017. The change from baseline in the amount of urine leakage measured by the 1-hour pad test will be accepted as the primary outcomes. We will use RevMan V.5.3 software as well to compute the data synthesis carefully when a meta-analysis is allowed. This study will provide a high-quality synthesis to assess the effectiveness and safety of electroacupuncture treatment on women with SUI. The conclusion of our systematic review will provide evidence to judge whether electroacupuncture is an effective intervention for women with SUI. PROSPERO CRD42017070947.

Duties and functions of veterinary public health for the management of food safety: present needs and evaluation of efficiency.

PubMed

Trevisani, M; Rosmini, R

2008-09-01

Functions of veterinarians in the context of food safety assurance have changed very much in the last ten years as a consequence of new legislation. The aim of this review is to evaluate the management tools in veterinary public health that shall be used in response to the actual need and consider some possible key performance indicators. This review involved an examination of the legislation, guidelines and literature, which was then discussed to analyse the actual need, the strategies and the procedures with which the public veterinary service shall comply. The management of information gathered at different stages of the food chain, from both food production operators and veterinary inspectors operating in primary production, food processing and feed production should be exchanged and integrated in a database, not only to produce annual reports and plan national sampling plans, but also to verify and validate the effectiveness of procedures and strategies implemented by food safety operators to control risks. Further, the surveillance data from environmental agencies and human epidemiological units should be used for assessing risks and addressing management options.

Two NextGen Air Safety Tools: An ADS-B Equipped UAV and a Wake Turbulence Estimator

NASA Astrophysics Data System (ADS)

Handley, Ward A.

Two air safety tools are developed in the context of the FAA's NextGen program. The first tool addresses the alarming increase in the frequency of near-collisions between manned and unmanned aircraft by equipping a common hobby class UAV with an ADS-B transponder that broadcasts its position, speed, heading and unique identification number to all local air traffic. The second tool estimates and outputs the location of dangerous wake vortex corridors in real time based on the ADS-B data collected and processed using a custom software package developed for this project. The TRansponder based Position Information System (TRAPIS) consists of data packet decoders, an aircraft database, Graphical User Interface (GUI) and the wake vortex extension application. Output from TRAPIS can be visualized in Google Earth and alleviates the problem of pilots being left to imagine where invisible wake vortex corridors are based solely on intuition or verbal warnings from ATC. The result of these two tools is the increased situational awareness, and hence safety, of human pilots in the National Airspace System (NAS).

The effectiveness of risk communication regarding drug safety information: a nationwide survey by the Japanese public health insurance claims data.

PubMed

Hagiwara, Hiromi; Nakano, Shun; Ogawa, Yoshihiro; Tohkin, Masahiro

2015-06-01

We evaluated the effectiveness of warning letters published by the pharmaceutical regulatory agency in Japan on communication of drug safety and risk by quantitative analysis of the national health insurance claims database (NHICD). We then explored what factors may have affected risk communication. We measured the implementation rate of the hepatitis virus-monitoring test among methotrexate (MTX)-treated patients; a warning letter had been issued regarding the use of MTX, as it apparently activates the hepatitis virus. Data from the NHICD, which include 99·3% of Japanese residents, were used. A total of 4,933,481 patients with rheumatoid arthritis (RA) (January-June, 2010) were the focus of this study. The implementation rate of the hepatitis virus-monitoring test increased from 1·4% before to 1·8% after the warning letter announcement. Logistic regression analysis suggested that the installation of a drug information management room is one of the important factors affecting risk communication. Further analysis revealed that the hepatitis virus monitoring rates in hospitals without drug information management rooms increased from 2·3% to 4·1% due to the issue of the warning letter. The warning letter from the regulatory agency plays an important role in risk communication in hospitals without drug information management rooms. © 2015 John Wiley & Sons Ltd.

Implementation of a Data-Based Medical Event Reporting System in the U.S. Department of Defense

DTIC Science & Technology

2005-05-01

where patient safety events warrant further investigation. Introduction Department of Defense Instruction 6025.17 established the Military Health ...Administration (VHA) Patient Safety Reporting Program for error tracking and reporting within all military health care facilities. 5 On August 16, 2001...DoD Instruction number 6025.17 “established a Military Health System Patient Safety Center (MHSPSC), including a MHS Patient Safety Registry (MHSPSR

49 CFR 229.311 - Review of SAs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... railroad shall maintain a database of all safety-relevant hazards encountered with the product. The database shall include all hazards identified in the SA and those that had not been previously identified...

49 CFR 229.311 - Review of SAs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... railroad shall maintain a database of all safety-relevant hazards encountered with the product. The database shall include all hazards identified in the SA and those that had not been previously identified...

49 CFR 229.311 - Review of SAs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION... railroad shall maintain a database of all safety-relevant hazards encountered with the product. The database shall include all hazards identified in the SA and those that had not been previously identified...

Privacy issues and the monitoring of sumatriptan in the New Zealand Intensive Medicines Monitoring Programme.

PubMed

Coulter, D M

2001-12-01

The purpose of this paper is to describe how the New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) functions in relation to NZ privacy laws and to describe the attitudes of patients to drug safety monitoring and the privacy of their personal and health information. The IMMP undertakes prospective observational event monitoring cohort studies on new drugs. The cohorts are established from prescription data and the events are obtained using prescription event monitoring and spontaneous reporting. Personal details, prescribing history of the monitored drugs and adverse events data are stored in databases long term. The NZ Health Information Privacy Code is outlined and the monitoring of sumatriptan is used to illustrate how the IMMP functions in relation to the Code. Patient responses to the programme are described. Sumatriptan was monitored in 14,964 patients and 107,646 prescriptions were recorded. There were 2344 reports received describing 3987 adverse events. A majority of the patients were involved in the recording of events data either personally or by telephone interview. There were no objections to the monitoring process on privacy grounds. Given the fact that all reasonable precautions are taken to ensure privacy, patients perceive drug safety to have greater priority than any slight risk of breach of confidentiality concerning their personal details and health information.

Recent updates on recombinant human growth hormone outcomes and adverse events.

PubMed

Watson, Sara E; Rogol, Alan D

2013-02-01

To provide up-to-date information on outcomes and adverse events associated with the use of recombinant human growth hormone (rhGH). We will focus on patients with Prader Willi Syndrome and Idiopathic Short Stature. We will also discuss recent reports on long-term adverse events from the European database. Prader Willi Syndrome is associated with hypogonadism, which does not appear to be affected by treatment with rhGH. However, there is new evidence that treatment may improve cognition. For patients with Idiopathic Short Stature, the gain in near adult height with treatment with rhGH appears to be 3-4 cm. Although a recent analysis of this group shows that certain patient characteristics may help identify those most likely to have a good response to treatment. Additionally, the safety and appropriateness of growth hormone treatments in Europe study released preliminary data from patients treated in two separate locations that showed conflicting information on risk of mortality from treatment with rhGH. Although we will continue to receive new information regarding the safety and effects of treatment with rhGH, it is important to discuss the risks and benefits with our patients. Additionally, it is incumbent on us to help guide the treatment to those most likely to benefit.

The contribution of nurses to incident disclosure: a narrative review.

PubMed

Harrison, Reema; Birks, Yvonne; Hall, Jill; Bosanquet, Kate; Harden, Melissa; Iedema, Rick

2014-02-01

To explore (a) how nurses feel about disclosing patient safety incidents to patients, (b) the current contribution that nurses make to the process of disclosing patient safety incidents to patients and (c) the barriers that nurses report as inhibiting their involvement in disclosure. A systematic search process was used to identify and select all relevant material. Heterogeneity in study design of the included articles prohibited a meta-analysis and findings were therefore synthesised in a narrative review. A range of text words, synonyms and subject headings were developed in conjunction with the York Centre for Reviews and Dissemination and used to undertake a systematic search of electronic databases (MEDLINE; EMBASE; CENTRAL; PsycINFO; Health Management and Information Consortium; CINAHL; ASSIA; Science Citation Index; Social Science Citation Index; Cochrane Database of Systematic Reviews; Database of Abstracts of Reviews of Effects; Health Technology Assessment Database; Health Systems Evidence; PASCAL; LILACS). Retrieval of studies was restricted to those published after 1980. Further data sources were: websites, grey literature, research in progress databases, hand-searching of relevant journals and author contact. The title and abstract of each citation was independently screened by two reviewers and disagreements resolved by consensus or consultation with a third person. Full text articles retrieved were further screened against the inclusion and exclusion criteria then checked by a second reviewer (YB). Relevant data were extracted and findings were synthesised in a narrative empirical synthesis. The systematic search and selection process identified 15 publications which included 11 unique studies that emerged from a range of locations. Findings suggest that nurses currently support both physicians and patients through incident disclosure, but may be ill-prepared to disclose incidents independently. Barriers to nurse involvement included a lack of opportunities for education and training, and the multiple and sometimes conflicting roles within nursing. Numerous potential benefits were identified that may result from nurses having a greater contribution to the disclosure process, but the provision of support and training is essential to overcome the reported barriers faced by nurses internationally. Copyright © 2013 Elsevier Ltd. All rights reserved.

Michigan urban trunkline intersections safety performance functions (SPFs) development and support.

DOT National Transportation Integrated Search

2015-06-01

This study involves the development of safety performance functions (SPFs) for signalized and stop-controlled intersections : located along urban and suburban arterials in the state of Michigan. Extensive databases were developed that resulted in the...

Target crashes and safety benefits estimation methodology for pedestrian crash avoidance/mitigation systems

DOT National Transportation Integrated Search

2014-04-01

Through the analysis of national crash databases from the National Highway Traffic Safety Administration, pre-crash scenarios are identified, prioritized, and described for the development of objective tests for pedestrian crash avoidance/mitigation ...

A nationwide hospital survey on patient safety culture in Belgian hospitals: setting priorities at the launch of a 5-year patient safety plan.

PubMed

Vlayen, Annemie; Hellings, Johan; Claes, Neree; Peleman, Hilde; Schrooten, Ward

2012-09-01

To measure patient safety culture in Belgian hospitals and to examine the homogeneous grouping of underlying safety culture dimensions. The Hospital Survey on Patient Safety Culture was distributed organisation-wide in 180 Belgian hospitals participating in the federal program on quality and safety between 2007 and 2009. Participating hospitals were invited to submit their data to a comparative database. Homogeneous groups of underlying safety culture dimensions were sought by hierarchical cluster analysis. 90 acute, 42 psychiatric and 11 long-term care hospitals submitted their data for comparison to other hospitals. The benchmark database included 55 225 completed questionnaires (53.7% response rate). Overall dimensional scores were low, although scores were found to be higher for psychiatric and long-term care hospitals than for acute hospitals. The overall perception of patient safety was lower in French-speaking hospitals. Hierarchical clustering of dimensions resulted in two distinct clusters. Cluster I grouped supervisor/manager expectations and actions promoting safety, organisational learning-continuous improvement, teamwork within units and communication openness, while Cluster II included feedback and communication about error, overall perceptions of patient safety, non-punitive response to error, frequency of events reported, teamwork across units, handoffs and transitions, staffing and management support for patient safety. The nationwide safety culture assessment confirms the need for a long-term national initiative to improve patient safety culture and provides each hospital with a baseline patient safety culture profile to direct an intervention plan. The identification of clusters of safety culture dimensions indicates the need for a different approach and context towards the implementation of interventions aimed at improving the safety culture. Certain clusters require unit level improvements, whereas others demand a hospital-wide policy.

Mobile Location-Based Services for Trusted Information in Disaster Management

NASA Astrophysics Data System (ADS)

Ragia, Lemonia; Deriaz, Michel; Seigneur, Jean-Marc

The goal of the present chapter is to provide location-based services for disaster management. The application involves services related to the safety of the people due to an unexpected event. The current prototype is implemented for a specific issue of disaster management which is road traffic control. The users can ask requests on cell phones or via Internet to the system and get an answer in a display or in textual form. The data are in a central database and every user can input data via virtual tags. The system is based on spatial messages which can be sent from any user to any other in a certain distance. In this way all the users and not a separate source provide the necessary information for a dangerous situation. To avoid any contamination problems we use trust security to check the input to the system and a trust engine model to provide information with a considerable reliability.

Searching Online Chemical Data Repositories via the ChemAgora Portal.

PubMed

Zanzi, Antonella; Wittwehr, Clemens

2017-12-26

ChemAgora, a web application designed and developed in the context of the "Data Infrastructure for Chemical Safety Assessment" (diXa) project, provides search capabilities to chemical data from resources available online, enabling users to cross-reference their search results with both regulatory chemical information and public chemical databases. ChemAgora, through an on-the-fly search, informs whether a chemical is known or not in each of the external data sources and provides clikable links leading to the third-party web site pages containing the information. The original purpose of the ChemAgora application was to correlate studies stored in the diXa data warehouse with available chemical data. Since the end of the diXa project, ChemAgora has evolved into an independent portal, currently accessible directly through the ChemAgora home page, with improved search capabilities of online data sources.

Outcomes of Trauma-Informed Interventions for Incarcerated Women.

PubMed

King, Erin A

2017-05-01

The purpose of this article was to conduct a review of experimental, quasi-experimental, and pre-test/post-test studies using manualized, trauma-informed interventions with incarcerated women. A systematic search of electronic databases, reference harvesting, and communication with experts were used to identify relevant primary studies. Nine studies meeting the specified inclusion/exclusion criteria were identified. Three studies used random assignment and five used a comparison or waitlist group. Interventions identified included Seeking Safety, Helping Women Recover/Beyond Trauma, Esuba, and Beyond Violence. Results of the studies indicate a decrease in post-traumatic stress disorder (PTSD) symptomatology and an additive effect to treatment as usual. Initial evidence for trauma-informed interventions for incarcerated women appears positive; however, replication using more rigorous research designs and inclusion of effect sizes are recommended. Limitations of this review include exclusion of the gray literature and lack of meta-analysis.

The Microphysiology Systems Database for Analyzing and Modeling Compound Interactions with Human and Animal Organ Models

PubMed Central

Vernetti, Lawrence; Bergenthal, Luke; Shun, Tong Ying; Taylor, D. Lansing

2016-01-01

Abstract Microfluidic human organ models, microphysiology systems (MPS), are currently being developed as predictive models of drug safety and efficacy in humans. To design and validate MPS as predictive of human safety liabilities requires safety data for a reference set of compounds, combined with in vitro data from the human organ models. To address this need, we have developed an internet database, the MPS database (MPS-Db), as a powerful platform for experimental design, data management, and analysis, and to combine experimental data with reference data, to enable computational modeling. The present study demonstrates the capability of the MPS-Db in early safety testing using a human liver MPS to relate the effects of tolcapone and entacapone in the in vitro model to human in vivo effects. These two compounds were chosen to be evaluated as a representative pair of marketed drugs because they are structurally similar, have the same target, and were found safe or had an acceptable risk in preclinical and clinical trials, yet tolcapone induced unacceptable levels of hepatotoxicity while entacapone was found to be safe. Results demonstrate the utility of the MPS-Db as an essential resource for relating in vitro organ model data to the multiple biochemical, preclinical, and clinical data sources on in vivo drug effects. PMID:28781990

Image Encryption Algorithm Based on Hyperchaotic Maps and Nucleotide Sequences Database

PubMed Central

2017-01-01

Image encryption technology is one of the main means to ensure the safety of image information. Using the characteristics of chaos, such as randomness, regularity, ergodicity, and initial value sensitiveness, combined with the unique space conformation of DNA molecules and their unique information storage and processing ability, an efficient method for image encryption based on the chaos theory and a DNA sequence database is proposed. In this paper, digital image encryption employs a process of transforming the image pixel gray value by using chaotic sequence scrambling image pixel location and establishing superchaotic mapping, which maps quaternary sequences and DNA sequences, and by combining with the logic of the transformation between DNA sequences. The bases are replaced under the displaced rules by using DNA coding in a certain number of iterations that are based on the enhanced quaternary hyperchaotic sequence; the sequence is generated by Chen chaos. The cipher feedback mode and chaos iteration are employed in the encryption process to enhance the confusion and diffusion properties of the algorithm. Theoretical analysis and experimental results show that the proposed scheme not only demonstrates excellent encryption but also effectively resists chosen-plaintext attack, statistical attack, and differential attack. PMID:28392799

Trampoline-associated injuries are more common in children in spring.

PubMed

Yule, Michael S; Krishna, Sanjeev; Rahiri, Jamie-Lee; Hill, Andrew G

2016-06-10

Trampoline use is a popular pastime amongst children in New Zealand, and has many advantages for child development. However, recent reports claim that trampoline-associated injuries are still highly prevalent. In order to help prevent these injuries in the future, this study aims to provide more up-to-date epidemiological information in children, with emphasis on the time of year that injuries most commonly occur. A retrospective review was carried out utilising a prospective maintained trauma database. The database was searched electronically for injuries involving trampolines in children aged 0-15 years. Patient demographics and information regarding month of injury, injury type and management were extracted. There were 344 admissions to hospital for trampoline-related injuries between June 2000 and January 2015. Injuries were uncommon in winter, but rose in spring and summer. Fracture of the radius and/or ulna was the most common injury (34.0%), followed by humeral fracture (32.0%). The peak incidence of trampoline-related injuries occurred around the beginning of spring daylight savings time each year. This could therefore prove an opportune time to remind children and parents about trampoline safety at the same time as daylight savings reminders.

Cutaneous lichen planus: A systematic review of treatments.

PubMed

Fazel, Nasim

2015-06-01

Various treatment modalities are available for cutaneous lichen planus. Pubmed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database were searched for all the systematic reviews and randomized controlled trials related to cutaneous lichen planus. Two systematic reviews and nine relevant randomized controlled trials were identified. Acitretin, griseofulvin, hydroxychloroquine and narrow band ultraviolet B are demonstrated to be effective in the treatment of cutaneous lichen planus. Sulfasalazine is effective, but has an unfavorable safety profile. KH1060, a vitamin D analogue, is not beneficial in the management of cutaneous lichen planus. Evidence from large scale randomized trials demonstrating the safety and efficacy for many other treatment modalities used to treat cutaneous lichen planus is simply not available.

The effectiveness of Teratology Information Services (TIS).

PubMed

Hancock, Rebecca L; Koren, Gideon; Einarson, Adrienne; Ungar, Wendy J

2007-02-01

Women and their health care providers have few reliable sources of information regarding the safety of exposures in pregnancy and lactation. Evidence-based information on these topics is provided by Teratology Information Services (TIS). Access to TIS, however, is limited in many regions, and many services have difficulty maintaining ongoing funding. The objective of this review is to highlight published reports of the effectiveness of TIS in improving maternal and neonatal health. A search of the Pub Med and Econ Lit databases was performed with no date restriction, using the search terms teratology, information, counseling, pregnancy, effectiveness, birth defects. Information disseminated from TIS has been shown to prevent congenital malformations, unnecessary pregnancy terminations, and occupational risks. TIS support optimal nutritional supplementation in pregnancy and optimal drug therapy in pregnancy and breast-feeding. In addition, they correct misperceptions of risk and facilitate knowledge transfer and translation. TIS have the potential to provide health care cost savings. TIS are vital services in supporting optimal maternal and neonatal health. A formal economic evaluation of TIS is required in order to inform resource allocation decision-making and continued funding of these services.

Patient safety in dentistry - state of play as revealed by a national database of errors.

PubMed

Thusu, S; Panesar, S; Bedi, R

2012-08-01

Modern dentistry has become increasingly invasive and sophisticated. Consequently the risk to the patient has increased. The aim of this study is to investigate the types of patient safety incidents (PSIs) that occur in dentistry and the accuracy of the National Patient Safety Agency (NPSA) database in identifying those attributed to dentistry. The database was analysed for all incidents of iatrogenic harm in the speciality of dentistry. A snapshot view using the timeframe January to December 2009 was used. The free text elements from the database were analysed thematically and reclassified according to the nature of the PSI. Descriptive statistics were provided. Two thousand and twelve incident reports were analysed and organised into ten categories. The commonest was due to clerical errors - 36%. Five areas of PSI were further analysed: injury (10%), medical emergency (6%), inhalation/ingestion (4%), adverse reaction (4%) and wrong site extraction (2%). There is generally low reporting of PSIs within the dental specialities. This may be attributed to the voluntary nature of reporting and the reluctance of dental practitioners to disclose incidences for fear of loss of earnings. A significant amount of iatrogenic harm occurs not during treatment but through controllable pre- and post-procedural checks. Incidences of iatrogenic harm to dental patients do occur but their reporting is not widely used. The use of a dental specific reporting system would aid in minimising iatrogenic harm and adhere to the Care Quality Commission (CQC) compliance monitoring system on essential standards of quality and safety in dental practices.

Historical analysis of US pipeline accidents triggered by natural hazards

NASA Astrophysics Data System (ADS)

Girgin, Serkan; Krausmann, Elisabeth

2015-04-01

Natural hazards, such as earthquakes, floods, landslides, or lightning, can initiate accidents in oil and gas pipelines with potentially major consequences on the population or the environment due to toxic releases, fires and explosions. Accidents of this type are also referred to as Natech events. Many major accidents highlight the risk associated with natural-hazard impact on pipelines transporting dangerous substances. For instance, in the USA in 1994, flooding of the San Jacinto River caused the rupture of 8 and the undermining of 29 pipelines by the floodwaters. About 5.5 million litres of petroleum and related products were spilled into the river and ignited. As a results, 547 people were injured and significant environmental damage occurred. Post-incident analysis is a valuable tool for better understanding the causes, dynamics and impacts of pipeline Natech accidents in support of future accident prevention and mitigation. Therefore, data on onshore hazardous-liquid pipeline accidents collected by the US Pipeline and Hazardous Materials Safety Administration (PHMSA) was analysed. For this purpose, a database-driven incident data analysis system was developed to aid the rapid review and categorization of PHMSA incident reports. Using an automated data-mining process followed by a peer review of the incident records and supported by natural hazard databases and external information sources, the pipeline Natechs were identified. As a by-product of the data-collection process, the database now includes over 800,000 incidents from all causes in industrial and transportation activities, which are automatically classified in the same way as the PHMSA record. This presentation describes the data collection and reviewing steps conducted during the study, provides information on the developed database and data analysis tools, and reports the findings of a statistical analysis of the identified hazardous liquid pipeline incidents in terms of accident dynamics and consequences.

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2016-10-01

the Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA), W81XWH-16-PRORP-CTA, was submitted. Database development and Pre...and Safety Months Identify database and partner – Clinical Research Unit 1-2 Completed Develop Case Report Forms, consent forms 6-12 Case...report forms completed, consent forms pending – 80% completed Develop database and multicenter submission process 12-18 In progress, 30% completed

Evaluation of personal digital assistant drug information databases for the managed care pharmacist.

PubMed

Lowry, Colleen M; Kostka-Rokosz, Maria D; McCloskey, William W

2003-01-01

Personal digital assistants (PDAs) are becoming a necessity for practicing pharmacists. They offer a time-saving and convenient way to obtain current drug information. Several software companies now offer general drug information databases for use on hand held computers. PDAs priced less than 200 US dollars often have limited memory capacity; therefore, the user must choose from a growing list of general drug information database options in order to maximize utility without exceeding memory capacity. This paper reviews the attributes of available general drug information software databases for the PDA. It provides information on the content, advantages, limitations, pricing, memory requirements, and accessibility of drug information software databases. Ten drug information databases were subjectively analyzed and evaluated based on information from the product.s Web site, vendor Web sites, and from our experience. Some of these databases have attractive auxiliary features such as kinetics calculators, disease references, drug-drug and drug-herb interaction tools, and clinical guidelines, which may make them more useful to the PDA user. Not all drug information databases are equal with regard to content, author credentials, frequency of updates, and memory requirements. The user must therefore evaluate databases for completeness, currency, and cost effectiveness before purchase. In addition, consideration should be given to the ease of use and flexibility of individual programs.

Feasibility of Genome-Wide Screening for Biosafety Assessment of Probiotics: A Case Study of Lactobacillus helveticus MTCC 5463.

PubMed

Senan, S; Prajapati, J B; Joshi, C G

2015-12-01

Recent years have witnessed an explosion in genome sequencing of probiotic strains for accurate identification and characterization. Regulatory bodies are emphasizing on the need for performing phase I safety studies for probiotics. The main hypothesis of this study was to explore the feasibility of using genome databases for safety screening of strains. In this study, we attempted to develop a framework for the safety assessment of a potential probiotic strain, Lactobacillus helveticus MTCC 5463 based on genome mining for genes associated with antibiotic resistance, production of harmful metabolites, and virulence. The sequencing of MTCC 5463 was performed using GS-FLX Titanium reagents. Genes coding for antibiotic resistance and virulence were identified using Antibiotic Resistance Genes Database and Virulence Factors Database. Results indicated that MTCC 5463 carried antibiotic resistance genes associated with beta-lactam and fluoroquinolone. There is no threat of transfer of these genes to host gut commensals because the genes are not plasmid encoded. The presence of genes for adhesion, biofilm, surface proteins, and stress-related proteins provides robustness to the strain. The presence of hemolysin gene in the genome revealed a theoretical risk of virulence. The results of in silico analysis complemented the in vitro studies and human clinical trials, confirming the safety of the probiotic strain. We propose that the safety assessment of probiotic strains administered live at high doses using a genome-wide screening could be an effective and time-saving tool for identifying prognostic biomarkers of biosafety.

A site of communication among enterprises for supporting occupational health and safety management system.

PubMed

Velonakis, E; Mantas, J; Mavrikakis, I

2006-01-01

The occupational health and safety management constitutes a field of increasing interest. Institutions in cooperation with enterprises make synchronized efforts to initiate quality management systems to this field. Computer networks can offer such services via TCP/IP which is a reliable protocol for workflow management between enterprises and institutions. A design of such network is based on several factors in order to achieve defined criteria and connectivity with other networks. The network will be consisted of certain nodes responsible to inform executive persons on Occupational Health and Safety. A web database has been planned for inserting and searching documents, for answering and processing questionnaires. The submission of files to a server and the answers to questionnaires through the web help the experts to make corrections and improvements on their activities. Based on the requirements of enterprises we have constructed a web file server. We submit files in purpose users could retrieve the files which need. The access is limited to authorized users and digital watermarks authenticate and protect digital objects. The Health and Safety Management System follows ISO 18001. The implementation of it, through the web site is an aim. The all application is developed and implemented on a pilot basis for the health services sector. It is all ready installed within a hospital, supporting health and safety management among different departments of the hospital and allowing communication through WEB with other hospitals.

Prokinetics prescribing in paediatrics: evidence on cisapride, domperidone, and metoclopramide.

PubMed

Mt-Isa, Shahrul; Tomlin, Stephen; Sutcliffe, Alastair; Underwood, Martin; Williamson, Paula; Croft, Nicholas M; Ashby, Deborah

2015-04-01

Domperidone and metoclopramide are prokinetics commonly prescribed off-label to infants and younger children in an attempt to treat gastro-oesophageal reflux symptoms. Another prokinetic drug, cisapride, was used but withdrawn in 2000 in the United Kingdom because of serious arrhythmic adverse events. Medicines and Healthcare Products Regulatory Agency issued safety warnings for domperidone in May 2012 and restricted its indications. We report here national primary care prescribing trends and safety signals of these drugs in children. We used data from the General Practice Research Database between 1990 and 2006 for children <18 years. Descriptive statistics and Poisson regressions were performed to characterise prescribing trends. We examined safety signals in nested case-control studies. The proportion of children <2 years old being prescribed one of the medications doubled during the study period. Prescriptions of domperidone increased 10-fold, mainly following the withdrawal of cisapride in 2000. Prescriptions of metoclopramide did not change significantly. Despite the increase in prescriptions of domperidone, no new safety signals were identified. These data showed dramatic changes in prescribing of cisapride and domperidone despite the lack of good-quality supporting evidence. It is possible that these prescribing trends were influenced by published guidelines. Even if produced without robust efficacy and safety evidence, published guidelines can influence clinicians and consequently affect prescribing. Therefore, improving the evidence base on prokinetics to inform future guidelines is vital. The lack of new safety signals during this period would support the development of suitable powered clinical studies.

Descriptions of Adverse Drug Reactions Are Less Informative in Forums Than in the French Pharmacovigilance Database but Provide More Unexpected Reactions

PubMed Central

Karapetiantz, Pierre; Bellet, Florelle; Audeh, Bissan; Lardon, Jérémy; Leprovost, Damien; Aboukhamis, Rim; Morlane-Hondère, François; Grouin, Cyril; Burgun, Anita; Katsahian, Sandrine; Jaulent, Marie-Christine; Beyens, Marie-Noëlle; Lillo-Le Louët, Agnès; Bousquet, Cédric

2018-01-01

Background: Social media have drawn attention for their potential use in Pharmacovigilance. Recent work showed that it is possible to extract information concerning adverse drug reactions (ADRs) from posts in social media. The main objective of the Vigi4MED project was to evaluate the relevance and quality of the information shared by patients on web forums about drug safety and its potential utility for pharmacovigilance. Methods: After selecting websites of interest, we manually evaluated the relevance of the content of posts for pharmacovigilance related to six drugs (agomelatine, baclofen, duloxetine, exenatide, strontium ranelate, and tetrazepam). We compared forums to the French Pharmacovigilance Database (FPVD) to (1) evaluate whether they contained relevant information to characterize a pharmacovigilance case report (patient’s age and sex; treatment indication, dose and duration; time-to-onset (TTO) and outcome of the ADR, and drug dechallenge and rechallenge) and (2) perform impact analysis (nature, seriousness, unexpectedness, and outcome of the ADR). Results: The cases in the FPVD were significantly more informative than posts in forums for patient description (age, sex), treatment description (dose, duration, TTO), and outcome of the ADR, but the indication for the treatment was more often found in forums. Cases were more often serious in the FPVD than in forums (46% vs. 4%), but forums more often contained an unexpected ADR than the FPVD (24% vs. 17%). Moreover, 197 unexpected ADRs identified in forums were absent from the FPVD and the distribution of the MedDRA System Organ Classes (SOCs) was different between the two data sources. Discussion: This study is the first to evaluate if patients’ posts may qualify as potential and informative case reports that should be stored in a pharmacovigilance database in the same way as case reports submitted by health professionals. The posts were less informative (except for the indication) and focused on less serious ADRs than the FPVD cases, but more unexpected ADRs were presented in forums than in the FPVD and their SOCs were different. Thus, web forums should be considered as a secondary, but complementary source for pharmacovigilance. PMID:29765326

The Application of Lidar to Synthetic Vision System Integrity

NASA Technical Reports Server (NTRS)

Campbell, Jacob L.; UijtdeHaag, Maarten; Vadlamani, Ananth; Young, Steve

2003-01-01

One goal in the development of a Synthetic Vision System (SVS) is to create a system that can be certified by the Federal Aviation Administration (FAA) for use at various flight criticality levels. As part of NASA s Aviation Safety Program, Ohio University and NASA Langley have been involved in the research and development of real-time terrain database integrity monitors for SVS. Integrity monitors based on a consistency check with onboard sensors may be required if the inherent terrain database integrity is not sufficient for a particular operation. Sensors such as the radar altimeter and weather radar, which are available on most commercial aircraft, are currently being investigated for use in a real-time terrain database integrity monitor. This paper introduces the concept of using a Light Detection And Ranging (LiDAR) sensor as part of a real-time terrain database integrity monitor. A LiDAR system consists of a scanning laser ranger, an inertial measurement unit (IMU), and a Global Positioning System (GPS) receiver. Information from these three sensors can be combined to generate synthesized terrain models (profiles), which can then be compared to the stored SVS terrain model. This paper discusses an initial performance evaluation of the LiDAR-based terrain database integrity monitor using LiDAR data collected over Reno, Nevada. The paper will address the consistency checking mechanism and test statistic, sensitivity to position errors, and a comparison of the LiDAR-based integrity monitor to a radar altimeter-based integrity monitor.

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

PubMed

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

2014-09-01

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

Decision support methods for the detection of adverse events in post-marketing data.

PubMed

Hauben, M; Bate, A

2009-04-01

Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

76 FR 19376 - Statement of Organizations, Functions, and Delegations of Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-07

... safety mission. These outside groups include academic organizations, private organizations, and other Federal Agencies. 3. Coordinates the access to large databases for pharmacoepidemiologic and..., procedures, training, and security or databases available to OSE. 3. Acts as focal point for all hardware...

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence

PubMed Central

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-01-01

Introduction Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. Methods and analysis A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in ‘patient safety’ and ‘economic analyses’ has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Ethics and dissemination Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. Trial registration number CRD42017057853. PMID:28821527

[A web-based integrated clinical database for laryngeal cancer].

PubMed

E, Qimin; Liu, Jialin; Li, Yong; Liang, Chuanyu

2014-08-01

To establish an integrated database for laryngeal cancer, and to provide an information platform for laryngeal cancer in clinical and fundamental researches. This database also meet the needs of clinical and scientific use. Under the guidance of clinical expert, we have constructed a web-based integrated clinical database for laryngeal carcinoma on the basis of clinical data standards, Apache+PHP+MySQL technology, laryngeal cancer specialist characteristics and tumor genetic information. A Web-based integrated clinical database for laryngeal carcinoma had been developed. This database had a user-friendly interface and the data could be entered and queried conveniently. In addition, this system utilized the clinical data standards and exchanged information with existing electronic medical records system to avoid the Information Silo. Furthermore, the forms of database was integrated with laryngeal cancer specialist characteristics and tumor genetic information. The Web-based integrated clinical database for laryngeal carcinoma has comprehensive specialist information, strong expandability, high feasibility of technique and conforms to the clinical characteristics of laryngeal cancer specialties. Using the clinical data standards and structured handling clinical data, the database can be able to meet the needs of scientific research better and facilitate information exchange, and the information collected and input about the tumor sufferers are very informative. In addition, the user can utilize the Internet to realize the convenient, swift visit and manipulation on the database.

76 FR 53912 - FDA's Public Database of Products With Orphan-Drug Designation: Replacing Non-Informative Code...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

...] FDA's Public Database of Products With Orphan-Drug Designation: Replacing Non-Informative Code Names... replaced non- informative code names with descriptive identifiers on its public database of products that... on our public database with non-informative code names. After careful consideration of this matter...

Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation.

PubMed

Duffy, Jmn; Hirsch, M; Pealing, L; Showell, M; Khan, K S; Ziebland, S; McManus, R J

2018-06-01

Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-eclampsia trials. Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. © 2017 Royal College of Obstetricians and Gynaecologists.

Behavioral ecology of captive species: using behavioral adaptations to assess and enhance welfare of nonhuman zoo animals.

PubMed

Koene, Paul

2013-01-01

This project aimed to estimate a species' adaptations in nature and in captivity, assess welfare, suggest environmental changes, and find species characteristics that underlie welfare problems in nonhuman animals in the zoo. First, the current status of zoo animal welfare assessment was reviewed, and the behavioral ecology approach was outlined. In this approach, databases of species characteristics were developed using (a) literature of natural behavior and (b) captive behavior. Species characteristics were grouped in 8 functional behavioral ecological fitness-related categories: space, time, metabolic, safety, reproductive, comfort, social, and information adaptations. Assessments of the strength of behavioral adaptations in relation to environmental demands were made based on the results available from the literature. The databases with literature at the species level were coupled with databases of (c) behavioral observations and (d) welfare assessments under captive conditions. Observation and welfare assessment methods were adapted from the animal on the farm realm and applied to zoo species. It was expected that the comparison of the repertoire of behaviors in natural and captive environments would highlight welfare problems, provide solutions to welfare problems by environmental changes, and identify species characteristics underlying zoo animal welfare problems.

An RFID solution for enhancing inpatient medication safety with real-time verifiable grouping-proof.

PubMed

Chen, Yu-Yi; Tsai, Meng-Lin

2014-01-01

The occurrence of a medication error can threaten patient safety. The medication administration process is complex and cumbersome, and nursing staffs are prone to error when they are tired. Proper Information Technology (IT) can assist the nurse in correct medication administration. We review a recent proposal regarding a leading-edge solution to enhance inpatient medication safety by using RFID technology. The proof mechanism is the kernel concept in their design and worth studying to develop a well-designed grouping-proof scheme. Other RFID grouping-proof protocols could be similarly applied in administering physician orders. We improve on the weaknesses of previous works and develop a reading-order independent RFID grouping-proof scheme in this paper. In our scheme, tags are queried and verified under the direct control of the authorized reader without connecting to the back-end database server. Immediate verification in our design makes this application more portable and efficient and critical security issues have been analyzed by the threat model. Our scheme is suitable for the safe drug administration scenario and the drug package scenario in a hospital environment to enhance inpatient medication safety. It automatically checks for correct drug unit-dose and appropriate inpatient treatments. Copyright © 2013. Published by Elsevier Ireland Ltd.

What Can We Learn about Workplace Heat Stress Management from a Safety Regulator Complaints Database?

PubMed Central

Hansen, Alana; Pisaniello, Dino; Varghese, Blesson; Rowett, Shelley; Hanson-Easey, Scott; Bi, Peng; Nitschke, Monika

2018-01-01

Heat exposure can be a health hazard for many Australian workers in both outdoor and indoor situations. With many heat-related incidents left unreported, it is often difficult to determine the underlying causal factors. This study aims to provide insights into perceptions of potentially unsafe or uncomfortably hot working conditions that can affect occupational health and safety using information provided by the public and workers to the safety regulator in South Australia (SafeWork SA). Details of complaints regarding heat exposure to the regulator’s “Help Centre” were assembled in a dataset and the textual data analysed thematically. The findings showed that the majority of calls relate to indoor work environments such as kitchens, factories, and warehouses. The main themes identified were work environment, health effects, and organisational issues. Impacts of hot working conditions ranged from discomfort to serious heat-related illnesses. Poor management practices and inflexibility of supervisors featured strongly amongst callers’ concerns. With temperatures predicted to increase and energy prices escalating, this timely study, using naturalistic data, highlights accounts of hot working conditions that can compromise workers’ health and safety and the need for suitable measures to prevent heat stress. These could include risk assessments to assess the likelihood of heat stress in workplaces where excessively hot conditions prevail. PMID:29509710

What Can We Learn about Workplace Heat Stress Management from a Safety Regulator Complaints Database?

PubMed

Hansen, Alana; Pisaniello, Dino; Varghese, Blesson; Rowett, Shelley; Hanson-Easey, Scott; Bi, Peng; Nitschke, Monika

2018-03-06

Heat exposure can be a health hazard for many Australian workers in both outdoor and indoor situations. With many heat-related incidents left unreported, it is often difficult to determine the underlying causal factors. This study aims to provide insights into perceptions of potentially unsafe or uncomfortably hot working conditions that can affect occupational health and safety using information provided by the public and workers to the safety regulator in South Australia (SafeWork SA). Details of complaints regarding heat exposure to the regulator's "Help Centre" were assembled in a dataset and the textual data analysed thematically. The findings showed that the majority of calls relate to indoor work environments such as kitchens, factories, and warehouses. The main themes identified were work environment, health effects, and organisational issues. Impacts of hot working conditions ranged from discomfort to serious heat-related illnesses. Poor management practices and inflexibility of supervisors featured strongly amongst callers' concerns. With temperatures predicted to increase and energy prices escalating, this timely study, using naturalistic data, highlights accounts of hot working conditions that can compromise workers' health and safety and the need for suitable measures to prevent heat stress. These could include risk assessments to assess the likelihood of heat stress in workplaces where excessively hot conditions prevail.

Exploring the theory, barriers and enablers for patient and public involvement across health, social care and patient safety: a protocol for a systematic review of reviews.

PubMed

Ocloo, Josephine; Garfield, Sarah; Dawson, Shoba; Dean Franklin, Bryony

2017-10-24

The emergence of patient and public involvement (PPI) in healthcare in the UK can be traced as far back as the 1970s. More recently, campaigns by harmed patients and their relatives have emerged as a result of clinical failings in the NHS, challenging paternalistic healthcare, which have led to a new focus on PPI in quality and safety, nationally and internationally. Evidence suggests that PPI within patient safety is often atheoretical and located within a biomedical discourse. This review will explore the literature on PPI across patient safety, healthcare and social care to identify theory, barriers and enablers that can be used to develop PPI in patient safety. Systematic searches of three electronic bibliographic databases will be conducted, using both MeSH and free-text terms to identify empirical literature published from database inception to May 2017. The screening process will involve input from at least two researchers and any disagreement will be resolved through discussion with a third reviewer. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Data extraction from included articles will be conducted by at least two researchers using a data extraction form. Extracted information will be analysed using a narrative review approach, which synthesises data using a descriptive method. No ethical approval is required for this review as no empirical data were collected. We believe that the findings and recommendations from this review will be particularly relevant for an audience of academics and policymakers. The findings will, therefore, be written up and disseminated in international peer-reviewed journals and academic conferences with a health focus. They will also be disseminated to leading health policy organisations in the NHS, such as NHS England and NHS Improvement and national policy bodies such as the Health Foundation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

PubMed

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-08-18

Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. CRD42017057853. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Rivaroxaban in patients with atrial fibrillation: from ROCKET AF to everyday practice.

PubMed

Barón-Esquivias, Gonzalo; Marín, Francisco; Sanmartín Fernandez, Marcelo

2017-05-01

Registries and non-interventional studies offer relevant and complementary information to clinical trials, since they have a high external validity. Areas covered: The information regarding the efficacy and safety of rivaroxaban compared with warfarin, or rivaroxaban alone in clinical practice was reviewed in this manuscript. For this purpose, a search on MEDLINE and EMBASE databases was performed. The MEDLINE and EMBASE search included both medical subject headings (MeSH) and keywords including: atrial fibrillation (AF) OR warfarin OR clinical practice OR ROCKET AF AND rivaroxaban. Case reports were not considered. Expert commentary: In ROCKET AF, rivaroxaban was at least as effective as warfarin for the prevention of stroke in patients with nonvalvular AF at high risk of stroke, but, importantly, with a lesser risk of intracranial, critical and fatal bleedings. A number of observational comparative and non-comparative studies, with more than 60,000 patients included treated with rivaroxaban, have analyzed the efficacy and safety of rivaroxaban in real-life patients with AF in different clinical settings. These studies have shown that in clinical practice, rates of stroke and major bleeding were consistently lower than those reported in ROCKET AF, likely due to the lower thromboembolic and bleeding risk observed in these patients.

75 FR 57437 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

... a Food Safety Education and Training Materials Database. The Database is a centralized gateway to... creating previously available education materials) (2) provide a central gateway to access the education materials (3) create a systematic and efficient method of collecting data from USDA grantees and (4) promote...

78 FR 69040 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... a Food Safety Education and Training Materials Database. The Database is a centralized gateway to... creating previously available education materials), (2) provide a central gateway to access the education materials, (3) create a systematic and efficient method of collecting data from USDA grantees, and (4...

Assessment of tissue allograft safety monitoring with administrative healthcare databases: a pilot project using Medicare data.

PubMed

Dhakal, Sanjaya; Burwen, Dale R; Polakowski, Laura L; Zinderman, Craig E; Wise, Robert P

2014-03-01

Assess whether Medicare data are useful for monitoring tissue allograft safety and utilization. We used health care claims (billing) data from 2007 for 35 million fee-for-service Medicare beneficiaries, a predominantly elderly population. Using search terms for transplant-related procedures, we generated lists of ICD-9-CM and CPT(®) codes and assessed the frequency of selected allograft procedures. Step 1 used inpatient data and ICD-9-CM procedure codes. Step 2 added non-institutional provider (e.g., physician) claims, outpatient institutional claims, and CPT codes. We assembled preliminary lists of diagnosis codes for infections after selected allograft procedures. Many ICD-9-CM codes were ambiguous as to whether the procedure involved an allograft. Among 1.3 million persons with a procedure ascertained using the list of ICD-9-CM codes, only 1,886 claims clearly involved an allograft. CPT codes enabled better ascertainment of some allograft procedures (over 17,000 persons had corneal transplants and over 2,700 had allograft skin transplants). For spinal fusion procedures, CPT codes improved specificity for allografts; of nearly 100,000 patients with ICD-9-CM codes for spinal fusions, more than 34,000 had CPT codes indicating allograft use. Monitoring infrequent events (infections) after infrequent exposures (tissue allografts) requires large study populations. A strength of the large Medicare databases is the substantial number of certain allograft procedures. Limitations include lack of clinical detail and donor information. Medicare data can potentially augment passive reporting systems and may be useful for monitoring tissue allograft safety and utilization where codes clearly identify allograft use and coding algorithms can effectively screen for infections.

Comparative safety profiles of intravitreal bevacizumab, ranibizumab and pegaptanib: the analysis of the WHO database of adverse drug reactions.

PubMed

Biagi, C; Conti, V; Montanaro, N; Melis, M; Buccellato, E; Donati, M; Covezzoli, A; Amato, R; Pazzi, L; Venegoni, M; Vaccheri, A; Motola, D

2014-12-01

The purpose of this study is to conduct a comparative analysis of the suspected adverse drug reactions (ADRs) associated with intravitreal bevacizumab, ranibizumab and pegaptanib in the WHO database in order to have a real-life information on these drugs, which now is only based on data coming from clinical trials. ADR reports for intravitreal use of bevacizumab, ranibizumab and pegaptanib from January 2002 to December 2012 were selected from the WHO-VigiBase. Reporting odds ratio (ROR) with confidence interval of 95 % and p value was calculated. The analysis was performed for drug-reaction pairs. The Medical Dictionary for Regulatory Activities (MedDRA) terminology for ADRs was used. The analysis was performed on 3180 reports corresponding to 7753 drug-reaction pairs. Significant RORs for endophthalmitis and uveitis (1.90, 95 % confidence interval (CI) 1.48-2.43, and 10.62, 6.62-17.05, respectively) were retrieved for bevacizumab, and cerebrovascular accident and myocardial infarction produced significant ROR (1.54, 1.14-2.10 and 1.73, 1.18-2.53, respectively) for ranibizumab. Pegaptanib was significantly associated with visual impairment (1.98, 1.12-3.5, p = 0.02), nausea (3.29, 1.57-6.86, p < 0.001), vomiting (2.91, 1.2-7.07, p = 0.01) and drug hypersensitivity (8.75, 3.1-24.66, p < 0.001). Our data showed an elevated disproportionality for cardiovascular ADRs in patients treated with ranibizumab and for infective ocular reactions in those treated with bevacizumab. No relevant safety issues were identified for pegaptanib. These findings suggest bevacizumab as a suitable choice for AMD therapy due to its effectiveness similar to that of ranibizumab, its favourable safety profile and for its lower cost.

Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase.

PubMed

de Campaigno, Emilie Patras; Kebir, Inès; Montastruc, Jean-Louis; Rueter, Manuela; Maret, Delphine; Lapeyre-Mestre, Maryse; Sallerin, Brigitte; Despas, Fabien

2017-12-01

Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. In this study, we identified drugs suspected to induce dental caries as adverse drug reactions (ADRs) and then studied a possible pathogenic mechanism for each drug that had a statistically significant disproportionality. We extracted individual case safety reports of dental caries associated with drugs from VigiBase ® (the World Health Organization global individual case safety report database). We calculated disproportionality for each drug with a reporting odds ratio (ROR) and 99% confidence interval. We analysed the pharmacodynamics of each drug that had a statistically significant disproportionality. In VigiBase ® , 5229 safety reports for dental caries concerning 733 drugs were identified. Among these drugs, 88 had a significant ROR, and for 65 of them (73.9%), no information about dental caries was found in the summaries of the product characteristics, the Micromedex ® DRUGDEX, or the Martindale databases. Regarding the pharmacological classes of drugs involved in dental caries, we identified bisphosphonates, atropinic drugs, antidepressants, corticoids, immunomodulating drugs, antipsychotics, antiepileptics, opioids and β 2 -adrenoreceptor agonist drugs. Regarding possible pathogenic mechanisms for these drugs, we identified changes in salivary flow/composition for 54 drugs (61.4%), bone metabolism changes for 31 drugs (35.2%), hyperglycaemia for 32 drugs (36.4%) and/or immunosuppression for 23 drugs (26.1%). For nine drugs (10.2%), the mechanism was unclear. We identified 88 drugs with a significant positive disproportionality for dental caries. Special attention has to be paid to bisphosphonates, atropinic drugs, immunosuppressants and drugs causing hyperglycaemia.

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

Sheu, R; Ghafar, R; Powers, A

Purpose: Demonstrate the effectiveness of in-house software in ensuring EMR workflow efficiency and safety. Methods: A web-based dashboard system (WBDS) was developed to monitor clinical workflow in real time using web technology (WAMP) through ODBC (Open Database Connectivity). Within Mosaiq (Elekta Inc), operational workflow is driven and indicated by Quality Check Lists (QCLs), which is triggered by automation software IQ Scripts (Elekta Inc); QCLs rely on user completion to propagate. The WBDS retrieves data directly from the Mosaig SQL database and tracks clinical events in real time. For example, the necessity of a physics initial chart check can be determinedmore » by screening all patients on treatment who have received their first fraction and who have not yet had their first chart check. Monitoring similar “real” events with our in-house software creates a safety net as its propagation does not rely on individual users input. Results: The WBDS monitors the following: patient care workflow (initial consult to end of treatment), daily treatment consistency (scheduling, technique, charges), physics chart checks (initial, EOT, weekly), new starts, missing treatments (>3 warning/>5 fractions, action required), and machine overrides. The WBDS can be launched from any web browser which allows the end user complete transparency and timely information. Since the creation of the dashboards, workflow interruptions due to accidental deletion or completion of QCLs were eliminated. Additionally, all physics chart checks were completed timely. Prompt notifications of treatment record inconsistency and machine overrides have decreased the amount of time between occurrence and execution of corrective action. Conclusion: Our clinical workflow relies primarily on QCLs and IQ Scripts; however, this functionality is not the panacea of safety and efficiency. The WBDS creates a more thorough system of checks to provide a safer and near error-less working environment.« less

Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre.

PubMed

Watson, Sarah; Chandler, Rebecca E; Taavola, Henric; Härmark, Linda; Grundmark, Birgitta; Zekarias, Alem; Star, Kristina; van Hunsel, Florence

2018-02-01

Patient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries. Our objective was to explore the contribution of patient reports to global signal detection in VigiBase. Data were retrieved from VigiBase in September 2016. Drug-event-combination series were restricted to those with >50% patient reports, defined as reporter type "Consumer/non-health professional" per E2B reporting standard. vigiRank was applied to patient reports to prioritize combinations for assessment. Product information for healthcare professionals (HCPs) as well as patient information leaflets (PILs) were used as reference for information on adverse drug reactions (ADRs). Staff from the Uppsala Monitoring Centre and the Netherlands Pharmacovigilance Centre Lareb categorized the combinations. Potential signals proceeded to a more in-depth clinical review to determine whether the safety concern should be communicated as a "signal." Of the 212 combinations assessed, 20 (9%) resulted in eight signals communicated within the World Health Organization (WHO) programme for international drug monitoring. Review of PILs revealed insufficient ADR descriptions for patients and examples of poor consistency with product information for HCPs. Patient narratives provided details regarding the experience and impact of ADRs and evidence that patients make causality and personal risk assessments. Safety concerns described in patient reports can be identified in a global database including previously unknown ADRs as well as new aspects of known ADRs. Patient reports provide unique information valuable in signal assessment and should be included in signal detection. Novel approaches to highlighting patient reports in statistical signal detection can further improve the contribution of patient reports to pharmacovigilance.

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

PubMed

Heinemann, Lutz; Fleming, G Alexander; Petrie, John R; Holl, Reinhard W; Bergenstal, Richard M; Peters, Anne L

2015-04-01

Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilized due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices [EUDAMED]) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to "predicate" products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting; such data could provide vital information to help health care teams to educate and support users and thereby prevent AEs. As well as requiring more from the manufacturing companies, we call for public funding of more research addressing clinically important questions in relation to pump therapy: both observational studies and clinical trials. At present, there are significant differences in the regulatory systems between the US and European Union at both pre- and postmarketing stages; improvements in the European system are more urgently required. This statement concludes with a series of recommended specific actions for "meknovigilance" (i.e., a standardized safety approach to technology) that could be implemented to address the shortcomings we highlight. © 2015 by the American Diabetes Association and Springer-Verlag. Copying with attribution allowed for any noncommercial use of the work.

Thermal Performance Data Services (TPDS)

NASA Technical Reports Server (NTRS)

French, Richard T.; Wright, Michael J.

2013-01-01

Initiated as a NASA Engineering and Safety Center (NESC) assessment in 2009, the Thermal Performance Database (TPDB) was a response to the need for a centralized thermal performance data archive. The assessment was renamed Thermal Performance Data Services (TPDS) in 2012; the undertaking has had two fronts of activity: the development of a repository software application and the collection of historical thermal performance data sets from dispersed sources within the thermal performance community. This assessment has delivered a foundational tool on which additional features should be built to increase efficiency, expand the protection of critical Agency investments, and provide new discipline-advancing work opportunities. This report contains the information from the assessment.

Common sense behavior modification: a guide for practitioners.

PubMed

Horwitz, Debra F; Pike, Amy L

2014-05-01

Behavior problems are often given as a reason for pet relinquishment to shelters. When presented with any behavior problem, veterinarians should perform a thorough physical examination (including neurologic and orthopedic examination) and a minimum database, including a complete blood cell count, chemistry panel, and total T4 and free T4 by equilibrium dialysis if values are low to rule out any medical contributions. Veterinarians should be a source of information regarding management, safety, and basic behavior modification for common behavior problems. Additionally, various control devices offer pet owners the ability to better manage their pets in difficult situations. Copyright © 2014 Elsevier Inc. All rights reserved.

Comparison of Online Agricultural Information Services.

ERIC Educational Resources Information Center

Reneau, Fred; Patterson, Richard

1984-01-01

Outlines major online agricultural information services--agricultural databases, databases with agricultural services, educational databases in agriculture--noting services provided, access to the database, and costs. Benefits of online agricultural database sources (availability of agricultural marketing, weather, commodity prices, management…

Towards the implementation of a spectral database for the detection of biological warfare agents

NASA Astrophysics Data System (ADS)

Carestia, M.; Pizzoferrato, R.; Gelfusa, M.; Cenciarelli, O.; D'Amico, F.; Malizia, A.; Scarpellini, D.; Murari, A.; Vega, J.; Gaudio, P.

2014-10-01

The deliberate use of biological warfare agents (BWA) and other pathogens can jeopardize the safety of population, fauna and flora, and represents a concrete concern from the military and civil perspective. At present, the only commercially available tools for fast warning of a biological attack can perform point detection and require active or passive sampling collection. The development of a stand-off detection system would be extremely valuable to minimize the risk and the possible consequences of the release of biological aerosols in the atmosphere. Biological samples can be analyzed by means of several optical techniques, covering a broad region of the electromagnetic spectrum. Strong evidence proved that the informative content of fluorescence spectra could provide good preliminary discrimination among those agents and it can also be obtained through stand-off measurements. Such a system necessitates a database and a mathematical method for the discrimination of the spectral signatures. In this work, we collected fluorescence emission spectra of the main BWA simulants, to implement a spectral signature database and apply the Universal Multi Event Locator (UMEL) statistical method. Our preliminary analysis, conducted in laboratory conditions with a standard UV lamp source, considers the main experimental setups influencing the fluorescence signature of some of the most commonly used BWA simulants. Our work represents a first step towards the implementation of a spectral database and a laser-based biological stand-off detection and identification technique.

The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO database.

PubMed

Bate, A; Lindquist, M; Edwards, I R

2008-04-01

After market launch, new information on adverse effects of medicinal products is almost exclusively first highlighted by spontaneous reporting. As data sets of spontaneous reports have become larger, and computational capability has increased, quantitative methods have been increasingly applied to such data sets. The screening of such data sets is an application of knowledge discovery in databases (KDD). Effective KDD is an iterative and interactive process made up of the following steps: developing an understanding of an application domain, creating a target data set, data cleaning and pre-processing, data reduction and projection, choosing the data mining task, choosing the data mining algorithm, data mining, interpretation of results and consolidating and using acquired knowledge. The process of KDD as it applies to the analysis of spontaneous reports can be exemplified by its routine use on the 3.5 million suspected adverse drug reaction (ADR) reports in the WHO ADR database. Examples of new adverse effects first highlighted by the KDD process on WHO data include topiramate glaucoma, infliximab vasculitis and the association of selective serotonin reuptake inhibitors (SSRIs) and neonatal convulsions. The KDD process has already improved our ability to highlight previously unsuspected ADRs for clinical review in spontaneous reporting, and we anticipate that such techniques will be increasingly used in the successful screening of other healthcare data sets such as patient records in the future.

WMC Database Evaluation. Case Study Report

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

Palounek, Andrea P. T

The WMC Database is ultimately envisioned to hold a collection of experimental data, design information, and information from computational models. This project was a first attempt at using the Database to access experimental data and extract information from it. This evaluation shows that the Database concept is sound and robust, and that the Database, once fully populated, should remain eminently usable for future researchers.

MIPS: analysis and annotation of proteins from whole genomes

PubMed Central

Mewes, H. W.; Amid, C.; Arnold, R.; Frishman, D.; Güldener, U.; Mannhaupt, G.; Münsterkötter, M.; Pagel, P.; Strack, N.; Stümpflen, V.; Warfsmann, J.; Ruepp, A.

2004-01-01

The Munich Information Center for Protein Sequences (MIPS-GSF), Neuherberg, Germany, provides protein sequence-related information based on whole-genome analysis. The main focus of the work is directed toward the systematic organization of sequence-related attributes as gathered by a variety of algorithms, primary information from experimental data together with information compiled from the scientific literature. MIPS maintains automatically generated and manually annotated genome-specific databases, develops systematic classification schemes for the functional annotation of protein sequences and provides tools for the comprehensive analysis of protein sequences. This report updates the information on the yeast genome (CYGD), the Neurospora crassa genome (MNCDB), the database of complete cDNAs (German Human Genome Project, NGFN), the database of mammalian protein–protein interactions (MPPI), the database of FASTA homologies (SIMAP), and the interface for the fast retrieval of protein-associated information (QUIPOS). The Arabidopsis thaliana database, the rice database, the plant EST databases (MATDB, MOsDB, SPUTNIK), as well as the databases for the comprehensive set of genomes (PEDANT genomes) are described elsewhere in the 2003 and 2004 NAR database issues, respectively. All databases described, and the detailed descriptions of our projects can be accessed through the MIPS web server (http://mips.gsf.de). PMID:14681354

MIPS: analysis and annotation of proteins from whole genomes.

PubMed

Mewes, H W; Amid, C; Arnold, R; Frishman, D; Güldener, U; Mannhaupt, G; Münsterkötter, M; Pagel, P; Strack, N; Stümpflen, V; Warfsmann, J; Ruepp, A

2004-01-01

The Munich Information Center for Protein Sequences (MIPS-GSF), Neuherberg, Germany, provides protein sequence-related information based on whole-genome analysis. The main focus of the work is directed toward the systematic organization of sequence-related attributes as gathered by a variety of algorithms, primary information from experimental data together with information compiled from the scientific literature. MIPS maintains automatically generated and manually annotated genome-specific databases, develops systematic classification schemes for the functional annotation of protein sequences and provides tools for the comprehensive analysis of protein sequences. This report updates the information on the yeast genome (CYGD), the Neurospora crassa genome (MNCDB), the database of complete cDNAs (German Human Genome Project, NGFN), the database of mammalian protein-protein interactions (MPPI), the database of FASTA homologies (SIMAP), and the interface for the fast retrieval of protein-associated information (QUIPOS). The Arabidopsis thaliana database, the rice database, the plant EST databases (MATDB, MOsDB, SPUTNIK), as well as the databases for the comprehensive set of genomes (PEDANT genomes) are described elsewhere in the 2003 and 2004 NAR database issues, respectively. All databases described, and the detailed descriptions of our projects can be accessed through the MIPS web server (http://mips.gsf.de).

A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

PubMed

Allan, M C

1992-01-01

To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered to facilitate communication of a review of adverse event data for various audiences. Careful drug safety surveillance is beneficial to the health of the public and the commercial well-being of the manufacturer. Attention to the basic principles is essential and, as illustrated, may be sufficient to resolve some problems.

Three Library and Information Science Databases Revisited: Currency, Coverage and Overlap, Interindexing Consistency.

ERIC Educational Resources Information Center

Blackwell, Michael Lind

This study evaluates the "Education Resources Information Center" (ERIC), "Library and Information Science Abstracts" (LISA), and "Library Literature" (LL) databases, determining how long the databases take to enter records (indexing delay), how much duplication of effort exists among the three databases (indexing…

An Integrated Molecular Database on Indian Insects.

PubMed

Pratheepa, Maria; Venkatesan, Thiruvengadam; Gracy, Gandhi; Jalali, Sushil Kumar; Rangheswaran, Rajagopal; Antony, Jomin Cruz; Rai, Anil

2018-01-01

MOlecular Database on Indian Insects (MODII) is an online database linking several databases like Insect Pest Info, Insect Barcode Information System (IBIn), Insect Whole Genome sequence, Other Genomic Resources of National Bureau of Agricultural Insect Resources (NBAIR), Whole Genome sequencing of Honey bee viruses, Insecticide resistance gene database and Genomic tools. This database was developed with a holistic approach for collecting information about phenomic and genomic information of agriculturally important insects. This insect resource database is available online for free at http://cib.res.in. http://cib.res.in/.

Safety of Gadobutrol

PubMed Central

Endrikat, Jan; Vogtlaender, Kai; Dohanish, Susan; Balzer, Thomas; Breuer, Josy

2016-01-01

Objective The aim of this study was to provide a systematic safety analysis of gadobutrol after more than 29 million applications in clinical routine. Materials and Methods Forty-two clinical development phase II to IV studies on gadobutrol or comparator and the postmarketing safety surveillance database for gadobutrol (1998–2015) were analyzed. Adverse events (AEs) and drug-related AEs were evaluated in the clinical development database and spontaneous adverse drug reactions (ADRs) in the postmarketing database. Subgroup analyses were run on patients with special medical history and on patients of different age groups. Results In the clinical development studies, 6809 and 2184 patients received gadobutrol or comparators, respectively. The incidence of drug-related AEs was 3.5% for both groups. With the exception of nausea (0.7% related cases in both groups), all other drug-related AEs were 0.3% or less in both groups. Hypersensitivity reactions were sporadic (<0.1%). Patients with history of allergies to contrast agents experienced slightly more drug-related AEs. No differences were seen between age groups. The overall reporting rate of ADRs from postmarketing surveillance was 0.05%. The most frequent ADRs were anaphylactoid/hypersensitivity reactions, nausea, vomiting, and dyspnea. For 3 single-agent reports of nephrogenic systemic fibrosis, using a conservative approach, association with gadobutrol could not be excluded. Conclusions Gadobutrol is well tolerated and has a favorable safety profile for patients of all age groups. PMID:26964075

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.

Patient safety and systematic reviews: finding papers indexed in MEDLINE, EMBASE and CINAHL.

PubMed

Tanon, A A; Champagne, F; Contandriopoulos, A-P; Pomey, M-P; Vadeboncoeur, A; Nguyen, H

2010-10-01

To develop search strategies for identifying papers on patient safety in MEDLINE, EMBASE and CINAHL. Six journals were electronically searched for papers on patient safety published between 2000 and 2006. Identified papers were divided into two gold standards: one to build and the other to validate the search strategies. Candidate terms for strategy construction were identified using a word frequency analysis of titles, abstracts and keywords used to index the papers in the databases. Searches were run for each one of the selected terms independently in every database. Sensitivity, precision and specificity were calculated for each candidate term. Terms with sensitivity greater than 10% were combined to form the final strategies. The search strategies developed were run against the validation gold standard to assess their performance. A final step in the validation process was to compare the performance of each strategy to those of other strategies found in the literature. We developed strategies for all three databases that were highly sensitive (range 95%-100%), precise (range 40%-60%) and balanced (the product of sensitivity and precision being in the range of 30%-40%). The strategies were very specific and outperformed those found in the literature. The strategies we developed can meet the needs of users aiming to maximise either sensitivity or precision, or seeking a reasonable compromise between sensitivity and precision, when searching for papers on patient safety in MEDLINE, EMBASE or CINAHL.

Person identification by using 3D palmprint data

NASA Astrophysics Data System (ADS)

Bai, Xuefei; Huang, Shujun; Gao, Nan; Zhang, Zonghua

2016-11-01

Person identification based on biometrics is drawing more and more attentions in identity and information safety. This paper presents a biometric system to identify person using 3D palmprint data, including a non-contact system capturing 3D palmprint quickly and a method identifying 3D palmprint fast. In order to reduce the effect of slight shaking of palm on the data accuracy, a DLP (Digital Light Processing) projector is utilized to trigger a CCD camera based on structured-light and triangulation measurement and 3D palmprint data could be gathered within 1 second. Using the obtained database and the PolyU 3D palmprint database, feature extraction and matching method is presented based on MCI (Mean Curvature Image), Gabor filter and binary code list. Experimental results show that the proposed method can identify a person within 240 ms in the case of 4000 samples. Compared with the traditional 3D palmprint recognition methods, the proposed method has high accuracy, low EER (Equal Error Rate), small storage space, and fast identification speed.

Pregnancy outcomes following maternal and paternal exposure to teriflunomide during treatment for relapsing-remitting multiple sclerosis.

PubMed

Kieseier, Bernd C; Benamor, Myriam

2014-12-01

Teriflunomide, indicated for the treatment of relapsing-remitting multiple sclerosis, is contraindicated in pregnancy based on signs of developmental toxicity in the offspring of rats and rabbits; developmental toxicity has also been observed in preclinical studies of other disease-modifying therapies. Despite the requirement to use reliable contraception in clinical trials evaluating the safety and efficacy of teriflunomide, a number of pregnancies have been reported. This work reports pregnancy outcomes in teriflunomide clinical trials. Pregnancy outcomes were evaluated in a retrospective analysis of the global pharmacovigilance database. The following information was collected from the pharmacovigilance database or individual patient files: treatment allocation, pregnancy outcome, teriflunomide exposure, and use of the accelerated elimination procedure. At data cut-off, 83 pregnancies were reported in female patients and 22 pregnancies were documented in partners of male patients. All newborns were healthy and did not have any structural or functional abnormalities at birth. Available data do not indicate any teratogenic signals in patients treated with teriflunomide.

Exploring relationships between hospital patient safety culture and Consumer Reports safety scores.

PubMed

Smith, Scott Alan; Yount, Naomi; Sorra, Joann

2017-02-16

A number of private and public companies calculate and publish proprietary hospital patient safety scores based on publicly available quality measures initially reported by the U.S. federal government. This study examines whether patient safety culture perceptions of U.S. hospital staff in a large national survey are related to publicly reported patient safety ratings of hospitals. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (Hospital SOPS) assesses provider and staff perceptions of hospital patient safety culture. Consumer Reports (CR), a U.S. based non-profit organization, calculates and shares with its subscribers a Hospital Safety Score calculated annually from patient experience survey data and outcomes data gathered from federal databases. Linking data collected during similar time periods, we analyzed relationships between staff perceptions of patient safety culture composites and the CR Hospital Safety Score and its five components using multiple multivariate linear regressions. We analyzed data from 164 hospitals, with patient safety culture survey responses from 140,316 providers and staff, with an average of 856 completed surveys per hospital and an average response rate per hospital of 56%. Higher overall Hospital SOPS composite average scores were significantly associated with higher overall CR Hospital Safety Scores (β = 0.24, p < 0.05). For 10 of the 12 Hospital SOPS composites, higher patient safety culture scores were associated with higher CR patient experience scores on communication about medications and discharge. This study found a relationship between hospital staff perceptions of patient safety culture and the Consumer Reports Hospital Safety Score, which is a composite of patient experience and outcomes data from federal databases. As hospital managers allocate resources to improve patient safety culture within their organizations, their efforts may also indirectly improve consumer-focused, publicly reported hospital rating scores like the Consumer Reports Hospital Safety Score.

Communication failure: analysis of prescribers' use of an internal free-text field on electronic prescriptions.

PubMed

Ai, Angela; Wong, Adrian; Amato, Mary; Wright, Adam

2018-06-01

Electronic prescribing promises to improve the safety and clarity of prescriptions. However, it also can introduce miscommunication between prescribers and pharmacists. There are situations where information that is meant to be sent to pharmacists is not sent to them, which has the potential for dangerous errors. To examine how frequently prescribers or administrative personnel put information intended for pharmacists in a field not sent to pharmacists, classify the type of information included, and assess the potential harm associated with these missed messages. Medication record data from our legacy electronic health record were requested for ambulatory care patients seen at an academic medical center from January 1, 2000, to May 31, 2015 (20 123 881 records). From this database, 6 060 272 medication orders met our inclusion criteria. We analyzed a random sample of 10 000 medication orders with internal comments. Reviewers classified internal comments for intent. Comments intended for pharmacists were also sorted into descriptive categories and analyzed for the potential for patient harm. We found that 11.7% of the prescriptions in our sample contained comments that were intended to be sent to pharmacists. Many comments contained information about the dose, route, or duration of the prescription (38.0%). Approximately a third of the comments intended for pharmacists contained information that had the potential for significant or severe harm if not communicated. We found undelivered comments that were clearly intended for pharmacists and contained important information for either pharmacists or patients. This poses a legitimate safety concern, as a portion of comments contained information that could have prevented severe or significant harm.

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus.

PubMed

Tamminga, Cindy; Kavanaugh, Michael; Fedders, Charlotte; Maiolatesi, Santina; Abraham, Neethu; Bonhoeffer, Jan; Heininger, Ulrich; Vasquez, Carlos S; Moorthy, Vasee S; Epstein, Judith E; Richie, Thomas L

2013-08-02

Malaria, tuberculosis (TB) and human immunodeficiency virus (HIV) are diseases with devastating effects on global public health, especially in the developing world. Clinical trials of candidate vaccines for these diseases are being conducted at an accelerating rate, and require accurate and consistent methods for safety data collection and reporting. We performed a systematic review of publications describing the safety results from clinical trials of malaria, TB and HIV vaccines, to ascertain the nature and consistency of safety data collection and reporting. The target for the review was pre-licensure trials for malaria, TB and HIV vaccines published in English from 2000 to 2009. Search strategies were customized for each of the databases utilized (MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Database of Reviews and Effects). Data extracted included age of trial participants, vaccine platform, route and method of vaccine administration, duration of participant follow-up, reporting of laboratory abnormalities, and the type, case definitions, severity, reporting methods and internal reporting consistency of adverse events. Of 2278 publications screened, 124 were eligible for inclusion (malaria: 66, TB: 9, HIV: 49). Safety data reporting was found to be highly variable among publications and often incomplete: overall, 269 overlapping terms were used to describe specific adverse events. 17% of publications did not mention fever. Descriptions of severity or degree of relatedness to immunization of adverse events were frequently omitted. 26% (32/124) of publications failed to report data on serious adverse events. The review demonstrated lack of standardized safety data reporting in trials for vaccines against malaria, TB and HIV. Standardization of safety data collection and reporting should be encouraged to improve data quality and comparability. The search strategy missed studies published in languages other than English and excluded studies reporting on vaccine trials for diseases besides malaria, TB and HIV. Copyright © 2013 Elsevier Ltd. All rights reserved.

Statewide traffic safety study phase II : identification of major traffic safety problem areas in Louisiana.

DOT National Transportation Integrated Search

2012-04-01

This report summarizes a study that seeks to identify the factors leading to the high crash rate experienced on Louisiana highways. Factors were identified by comparing statistics from the Louisiana Crash Database with those from peer states using th...

A review and discussion of flight management system incidents reported to the Aviation Safety Reporting System

DOT National Transportation Integrated Search

1992-02-01

This report covers the activities related to the description, classification and : analysis of the types and kinds of flight crew errors, incidents and actions, as : reported to the Aviation Safety Reporting System (ASRS) database, that can occur as ...

Do safety checklists improve teamwork and communication in the operating room? A systematic review.

PubMed

Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles

2013-12-01

The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and communication and this may be one mechanism through which patient outcomes are improved. Future research should aim to further elucidate the relationship between how safety checklists are used and team skills in the OR using more consistent methodological approaches and utilizing validated measures of teamwork such that best practice guidelines can be established.