WorldWideScience

Sample records for reported federal drug

  1. Reported Federal Drug Abuse Expenditures--Fiscal Years 1981 to 1985.

    Science.gov (United States)

    2014-09-26

    RD-AI57 836 REPORTED FEDERAL DRUG ABUSE EXPENDITURES--FISCAL YEARS / 1981 TO i985(U) HERCULES AEROSPACE PRODUCTS CO MAGNA UTp BACCHUS NORKS 83 JUN 85...General Accounting Officec°- IReported Federal Drug Abuse Expenditures-- ~ Fiscal Years 1981 To 1985 GAO’s review centers on the Federal Drug Abuse Budget...Summary, a document which describes federal agencies’ budget author- ity and outlays for drug abuse programs, including drug law enforcement and pre

  2. Drug Control: Observations on Elements of the Federal Drug Control Strategy. Report to Congressional Requesters.

    Science.gov (United States)

    General Accounting Office, Washington, DC. General Government Div.

    Although the United States government invests vast sums of money in the war on drugs, the availability of drugs and the number of persons using illegal drugs are still serious problems. Information that Congress can use in improving drug control strategies is provided here. Some of the report's highlights include current research on promising…

  3. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration

    Institute of Scientific and Technical Information of China (English)

    Klaus Bielefeldt

    2016-01-01

    AIM:To investigate the nature and severity of AE related to sacral neurostimulation(SNS).METHODS:Based on Pubmed and Embase searches,we identified published trials and case series of SNS for fecal incontinence(FI)and extracted data on adverse events,requiring an active intervention.Those problems were operationally defined as infection,device removal explant or need for lead and/or generator replacement.In addition,we analyzed the Manufacturer and User Device Experience registry of the Federal Drug Administration for the months of August-October of2015.Events were included if the report specifically mentioned gastrointestinal(GI),bowel and FI as indication and if the narrative did not focus on bladder symptoms.The classification,reporter,the date of the recorded complaint,time between initial implant and report,the type of AE,steps taken and outcome were extracted from the report.In cases of device removal or replacement,we looked for confirmatory comments by healthcare providers or the manufacturer.RESULTS:Published studies reported adverse events and reoperation rates for 1954 patients,followed for 27(1-117)mo.Reoperation rates were 18.6%(14.2-23.9)with device explants accounting for 10.0%(7.8-12.7)of secondary surgeries;rates of device replacement or explant or pocket site and electrode revisions increased with longer follow up.During the period examined,the FDA received 1684 reports of AE related to SNS with FI or GI listed as indication.A total of 652 reports met the inclusion criteria,with 52.7%specifically listing FI.Lack or loss of benefit(48.9%),pain or dysesthesia(27.8%)and complication at the generator implantation site(8.7%)were most commonly listed.Complaints led to secondary surgeries in 29.7%of the AE.Reoperations were performed to explant(38.2%)or replace(46.5%)the device or a lead,or revise the generator pocket(14.6%).Conservative management changes mostly involved changes in stimulation parameters(44.5%),which successfully addressed concerns in 35

  4. Federal Fleet Report

    Data.gov (United States)

    General Services Administration — Annual report of Federal agencies' motor vehicle fleet data collected in the Federal Automotive Statistical Tool (FAST), a web-based reporting tool cosponsored by...

  5. Radioprotective drugs: a synopsis of current research and a proposed research plan for the Federal Emergency Management Agency. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Hickman, R.; Anspaugh, L.

    1985-04-01

    FEMA has broad roles in the management of disasters potentially involving substantial amounts of radioactive contamination. These could be either peacetime or wartime disasters. A meeting was held in March 1985 to see if there are any research contributions that FEMA might reasonably make in the area of radioprotective drugs that would substantially enhance its ability to perform its mission. The other federal agencies presently sponsoring research in the field were represented at the meeting. A few selected researchers also participated to provide complementary viewpoints. Activities of a modest scale that FEMA might undertake were identified, as were larger scale activities that might be undertaken in the event of long-term, major funding-level increases for FEMA. 2 refs.

  6. 76 FR 59574 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug Testing...

    Science.gov (United States)

    2011-09-27

    ... Alcohol Testing Programs: Federal Drug Testing Custody and Control Form; Technical Amendment AGENCY... of a new Federal Drug Testing Custody and Control Form (CCF) in its drug testing program. Use of the... amendment to its drug testing procedures by amending a provision of the rule which was inadvertently omitted...

  7. Promoting greater Federal energy productivity [Final report

    Energy Technology Data Exchange (ETDEWEB)

    Hopkins, Mark; Dudich, Luther

    2003-03-05

    This document is a close-out report describing the work done under this DOE grant to improve Federal Energy Productivity. Over the four years covered in this document, the Alliance To Save Energy conducted liaison with the private sector through our Federal Energy Productivity Task Force. In this time, the Alliance held several successful workshops on the uses of metering in Federal facilities and other meetings. We also conducted significant research on energy efficiency, financing, facilitated studies of potential energy savings in energy intensive agencies, and undertook other tasks outlined in this report.

  8. Report of the Federal Internetworking Requirements Panel

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-05-31

    The Federal Internetworking Requirements Panel (FIRP) was established by the National Institute of Standards and Technology (NIST) to reassess Federal requirements for open systems networks and to recommend policy on the Government`s use of networking standards. The Panel was chartered to recommend actions which the Federal Government can take to address the short and long-term issues of interworking and convergence of networking protocols--particularly the Internet Protocol Suite (IPS) and Open Systems Interconnection (OSI) protocol suite and, when appropriate, proprietary protocols. The Panel was created at the request of the Office of Management and Budget in collaboration with the Federal Networking Council and the Federal Information Resources Management Policy Council. The Panel`s membership and charter are contained in an appendix to this report.

  9. Validating Self-Reports of Illegal Drug Use to Evaluate National Drug Control Policy: A Reanalysis and Critique

    Science.gov (United States)

    Magura, Stephen

    2010-01-01

    Illicit drug use remains at high levels in the U.S. The federal Office of National Drug Control Policy evaluates the outcomes of national drug demand reduction policies by assessing annual changes in drug use from several federally sponsored annual national surveys. Such survey methods, relying exclusively on drug use as self-reported on…

  10. Underage Drinking: Information on Federal Funds Targeted at Prevention. Report to the Chairman, Subcommittee on Criminal Justice, Drug Policy, and Human Resources, House Committee on Government Reform, and to Representative John L. Mica.

    Science.gov (United States)

    Stana, Richard M.

    This document describes a project undertaken to identify the nature and extent of Federal efforts related to the prevention of underage drinking to assist Congress in its deliberations on whether additional attention to alcohol use is needed. The report specifically aims to identify the amount of appropriated fiscal year 2000 Federal funds that…

  11. What matters 2010. Annual report of the Federal Environment Agency

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-04-27

    The annual report under consideration of the Federal Environment Agency (Dessau-Rosslau, Federal Republic of Germany) reports on the following themes: (1) Future mobility - Today's best investment; (2) Environmental protection - A barrier to investment for agriculture ?; (3) Emissions trading - The engine of climate policy ?; (4) The Federal Environment Agency (Departmental research, credo, organisation, data and facts, publications).

  12. 78 FR 25749 - Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice...

    Science.gov (United States)

    2013-05-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Submission of New Drug Application/Abbreviated New Drug... submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports...

  13. Federal Power Commission 1977 final annual report

    Energy Technology Data Exchange (ETDEWEB)

    None

    1978-07-01

    This is the 57th and final annual report of the Federal Power Commission. It was prepared so that the Congress and the public will have a full record of the Commission's history. The Commission issued annual reports every year beginning in 1920, except for a five-year period during World War II when abbreviated versions were prepared. The Commission was originally charged with the licensing and regulation of certain uses of the country's water resources, and later was given additional responsibilities, including the regulation of electric rates and services for wholesale transactions, and the regulation of natural gas pipelines and producers, all operating in interstate commerce. The total budget for the Commission in fiscal 1977 was $41,582,000. The Commission's average monthly employment during the year was 1,378. Highlights of 1977 concerning natural gas, electric power, rules and regulations, and legislation are summarized. A history of the FPC is included, followed by in-depth information on natural gas; electric power; legal aspects; and statistics in 4 appendixes. (MCW)

  14. 2010 Northwest Federal Market Assessment Report

    Energy Technology Data Exchange (ETDEWEB)

    Scanlon, Tim; Sandusky, William F.

    2011-09-01

    The primary intent of this market assessment is to provide insights on the effectiveness of current energy efficiency and renewable energy program offerings available to Federal sites in the region. The level of detail, quality and currency of the data used in this market assessment varies significantly by Federal agency and energy efficiency service provider. Limited access to some Federal sites, limited availability of key points of contact, time/resource constraints, and other considerations limited the total number of Federal agencies and energy efficiency service providers participating in the survey.

  15. 76 FR 34086 - Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information...

    Science.gov (United States)

    2011-06-10

    ... Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Oral Fluid Specimen for Drug Testing AGENCY: Substance Abuse and Mental Health Services... Mandatory Guidelines for Federal Workplace Drug Testing Programs (oral fluid specimen). DATES: Comment Close...

  16. 75 FR 76478 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Science.gov (United States)

    2010-12-08

    ... HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing Programs AGENCY: Substance Abuse... Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing... drug testing results that seek approval by the Secretary must submit their qualifications and a sample...

  17. Framework for financial ratio analysis of audited federal financial reports

    OpenAIRE

    Brady, Richard T.

    1999-01-01

    Federal agencies have traditionally prepared financial reports to monitor and report the obligation and expenditure of federal funding. With the passage of the Chief Financial Officers Act of 1990, Congress called for the production of financial statements that fully disclose a federal entity's financial position and results of operations. The disclosure of this type of information, it was believed, would enable decision-makers to understand the financial implications of budgetary, policy and...

  18. 2016 Earth System Grid Federation Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Williams, Dean N. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2016-05-10

    The Earth System Grid Federation (ESGF) experienced a major setback in June 2015, when it experienced a security incident that brought all systems to a halt for more than half a year. However, federation developers and management committee members turned the incident into an opportunity to dramatically upgrade the system security and functionality and to develop planning and policy documents to guide ESGF evolution and success. Moreover, despite the incident, ESGF developer working teams continue to make strong and significant progress on various enhancement projects that will help ensure ESGF can meet the needs of the climate community in the coming years.

  19. Effects of Climate Change on Federal Hydropower. Report to Congress

    Energy Technology Data Exchange (ETDEWEB)

    None

    2013-08-01

    This is a formal Department of Energy report to Congress. It outlines the findings of an assessment directed by Congress in Section 9505 of the SECURE Water Act of 2009 (Public Law 111-11), the US Department of Energy (DOE), in consultation with the federal Power Marketing Administrations (PMAs) and other federal agencies, including federal dam owners, has prepared a comprehensive assessment examining the effects of climate change on water available for hydropower at federal facilities and on the marketing of power from these federal facilities.

  20. Report on Federal Individual Training Accounts.

    Science.gov (United States)

    President's Task Force on Federal Training Technology, Washington, DC.

    To explore options to establish Federal Individual Training Accounts (ITAs), a study reviewed Pennsylvania's Individual Learning Accounts, Cedar Company's Individual Learning Accounts, ITAs under the Workforce Investment Act, and the United Kingdom's Individual Learning Accounts. ITAs were defined as a base amount of resources--dollars or…

  1. 75 FR 22809 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Science.gov (United States)

    2010-04-30

    ...: Final rule: Change in effective date. SUMMARY: The Department of Health and Human Services (HHS) is changing the effective date of the Revisions to the Mandatory Guidelines for Federal Workplace Drug Testing... HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing Programs AGENCY: Substance Abuse...

  2. Federal Prevailing Rate Advisory Committee (FPRAC) Annual Reports

    Data.gov (United States)

    Office of Personnel Management — Annual reports of the Federal Prevailing Rate Advisory Committee (FPRAC), which studies the prevailing (market) rate system for wages and other matters pertinent to...

  3. 2008 Federal Energy Management Program (FEMP) Market Report

    Energy Technology Data Exchange (ETDEWEB)

    Tremper, C.

    2009-07-01

    This report assesses the market for Federal Energy Management Program (FEMP) services as it existed in FY 2008. It discusses Federal energy management goal progress in FY 2008, and examines the environment in which agencies implemented energy management projects over the last three years. The report also discusses some recent events that will increase the market for FEMP services, and outlines FEMP's major strategies to address these changes in FY 2009 and beyond.

  4. Federal Workplace Literacy Project. Internal Evaluation Report.

    Science.gov (United States)

    Matuszak, David J.

    This report describes the following components of the Nestle Workplace Literacy Project: six job task analyses, curricula for six workplace basic skills training programs, delivery of courses using these curricula, and evaluation of the process. These six job categories were targeted for training: forklift loader/checker, BB's processing systems…

  5. Federal Strategy for Prevention of Drug Abuse and Drug Trafficking, 1982. Prepared for the President Pursuant to the Drug Abuse Office and Treatment Act of 1972.

    Science.gov (United States)

    Office of Policy Development, Washington, DC.

    This document describes the Federal response to drug abuse and drug trafficking. The actions of President Reagan, in Executive Order 12368, establishing an official advisor on drug abuse policy matters, and the priorities, issues, and objectives (international cooperation, drug law enforcement, education and prevention, detoxification and…

  6. 41 CFR 102-34.330 - What is the Federal Fleet Report?

    Science.gov (United States)

    2010-07-01

    ... Fleet Report? 102-34.330 Section 102-34.330 Public Contracts and Property Management Federal Property... MANAGEMENT Federal Fleet Report § 102-34.330 What is the Federal Fleet Report? The Federal Fleet Report (FFR) is an annual summary of Federal fleet statistics based upon fleet composition at the end of...

  7. The Federal Technical Report Literature: Research Needs and Issues.

    Science.gov (United States)

    McClure, Charles R.

    1988-01-01

    Reviews the research on the role, importance, and impact of the federal technical report literature, and summarizes some ambiguities and gaps in the research. Different approaches to conceptual and methodological issues are discussed, and a typology of technical reports is provided. (38 notes with references) (Author/CLB)

  8. 28 CFR 0.138 - Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco...

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Federal Bureau of Investigation, Drug Enforcement Administration, Bureau of Alcohol, Tobacco, Firearms, and Explosives, Bureau of Prisons, Federal... Justice Programs, Executive Office for Immigration Review, Executive Office for United States...

  9. Drug Treatment within the U.S. Federal Prison System: Are Treatment Needs Being Met?

    Science.gov (United States)

    van Wormer, Katherine; Persson, Lance Edwards

    2010-01-01

    A large percentage of inmates in the U.S. federal prison system have serious drug problems and are in need of treatment before they return to society. Accordingly, the Federal Bureau of Prisons has revamped substance abuse programming consistent with the latest research and expanded treatment services throughout its institutions. This article…

  10. Assessment of socioeconomic consequences of drug abuse in the Ural federal district

    Directory of Open Access Journals (Sweden)

    Inessa Aleksandrovna Gurban

    2013-06-01

    Full Text Available The paper considers issues of the assessment of the socioeconomic consequences of drug abuse in today’s conditions, which have the following features — the approaching of drug-dealers to legalize the drug market, develop the illegal drug market and their analogs and derivatives by the introduction of modern production technologies and distribution of psychoactive agents. Key tendencies observed in the contemporary world in the field of dynamics of the drug market development, which are reflected in the regions of Russia including the Ural Federal District are revealed. The procedure of assessment of socioeconomic expenses of drug abuse including assessment of drug consumers’ expenses and their surrounding people; and also; maintenance costs of the state bodies supervising drug trafficking; expenses for health care and other social expenses connected to drug use; damage to individuals of drug abuse distribution; expenses of private institutions and establishments; socioeconomic impact of drug abuse distribution. The technique uses a tool allowing to carry out a calculation (a heroin equivalent, i.e. the drugs withdrawn by law enforcement agencies and the subsequent calculation of the corresponding number of consumers of each type of drug. This method is aimed at increasing the accuracy of estimates received. On the basis of results calculated according to offered technique, the shares of socioeconomic expenses of drug abuse concerning the income of the cumulative consolidated budget and a gross regional product of the Ural Federal District are defined.

  11. San Diego State U. Defends Its Role in Federal Drug Sting

    Science.gov (United States)

    Lipka, Sara

    2008-01-01

    When a freshman at San Diego State University (SDSU) died of a cocaine overdose last May, the campus police chief decided to pursue a full-scale investigation. In December, he summoned undercover agents from the federal Drug Enforcement Administration to pose as students and roam the campus in search of illegal drugs. According to college…

  12. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Science.gov (United States)

    2013-12-04

    ... Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B... register as outsourcing facilities (outsourcing facilities). DATES: Although you can comment on...

  13. 19 CFR 147.23 - Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.

    Science.gov (United States)

    2010-04-01

    ... Food, Drug, and Cosmetic Act. 147.23 Section 147.23 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION... Laws § 147.23 Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act. (a) Plant... the plant quarantine regulations. (b) Federal Food, Drug, and Cosmetic Act. The entry of food...

  14. Youth Reporters Discuss "Problem" Drugs. Youth Reports Number 2.

    Science.gov (United States)

    Herzog, Elizabeth; And Others

    This report on drugs is based on mail responses received from urban and suburban high school students enrolled in college preparatory courses. The questions asked of these students included: (1) how do teenagers feel about the use of the various kinds of drugs by people their age? (2) what makes some teenagers use such drugs? (3) what keeps some…

  15. Annual Report 2000: Arrestee Drug Abuse Monitoring.

    Science.gov (United States)

    Department of Justice, Washington, DC. Office of Justice Programs.

    This annual report reflects changes to the National Institute of Justice's Drug Use Forecasting program. After several years of development and testing, the restructured program was fully implemented in 2000 as Arrestee Drug Abuse Monitoring (ADAM). Probability-based sampling was adopted, the interview instrument (questionnaire) was enhanced to…

  16. 40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

    Science.gov (United States)

    2010-07-01

    ... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of...

  17. 40 CFR 23.10 - Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Timing of Administrator's action under the Federal Food, Drug, and Cosmetic Act. 23.10 Section 23.10 Protection of Environment ENVIRONMENTAL... action under the Federal Food, Drug, and Cosmetic Act. Unless the Administrator otherwise...

  18. Drug Law Violators, 1980-86. Bureau of Justice Statistics Special Report.

    Science.gov (United States)

    Chaiken, Jan; McDonald, Douglas

    This report looks at what happens to individuals arrested at the federal level for drug crimes, including the number of drug offenders who are prosecuted and convicted, the types of sentences they receive, the amount of time they actually serve in prisons, and their rates of recidivism after release from prison. Data are presented which indicate…

  19. 48 CFR 1852.223-76 - Federal Automotive Statistical Tool Reporting.

    Science.gov (United States)

    2010-10-01

    ... Statistical Tool Reporting. 1852.223-76 Section 1852.223-76 Federal Acquisition Regulations System NATIONAL... Provisions and Clauses 1852.223-76 Federal Automotive Statistical Tool Reporting. As prescribed at 1823.271 and 1851.205, insert the following clause: Federal Automotive Statistical Tool Reporting (JUL 2003) If...

  20. Examining Why the Canadian Federal Government Placed an Orphan Drug Strategy on Their Decision Agenda Now

    Directory of Open Access Journals (Sweden)

    Mark Gary Embrett

    2014-02-01

    Full Text Available The Ministry of Health’s announcement of a National Orphan Drug Framework on 3 October 2012 was the first federal public acknowledgement of orphan drugs since the 1997 Drugs Directorate (DD policy statement. The reform primarily announced an Orphan Drug Policy for Canada. This paper explains why the government decided to make this announcement now. Media and Parliamentary documents were analyzed for their use of symbols, numbers, and language in causal stories told by political actors. The initial story was that Canada’s population was too small and the cost too high for an orphan drug policy. Over the next fifteen years, a powerful interest group, the Canadian Organization for Rare Disorders (CORD, mobilized the rare disease community into a cooperative effort that generated collective action. They redefined the DD story from one of natural causes, to inadvertence, and finally to intentional causation. Their story invoked a federal response because it blamed the government directly for not acting on behalf of the 3 million Canadians with rare diseases, when patients in other countries were receiving better care.

  1. What does a study of nonsteroidal anti-inflammatory drug sales statistics give the Russian Federation?

    Directory of Open Access Journals (Sweden)

    Viktoriya Georgievna Barskova

    2011-01-01

    Full Text Available The paper analyzes the data obtained by Pharmexpert on the sales of nonsteroidal anti-inflammatory drugs in the Russian Federation. Ibuprofen, ketorolac, diclofenac, and nimesulide are sales leaders. Possible reasons for the popularity of a number of medications and whether it is expedient to use intramuscular formulations are considered. The WHO data on indi-cations for and contraindications to the use of injectable dosage form are given.

  2. 76 FR 79050 - Federal Home Loan Bank Housing Goals: Mortgage Reporting Amendments

    Science.gov (United States)

    2011-12-21

    ... AGENCY 12 CFR Part 1281 RIN 2590-AA48 Federal Home Loan Bank Housing Goals: Mortgage Reporting Amendments... Federal Home Loan Banks (Banks) to make those requirements consistent with other data reporting... Economic Recovery Act of 2008 (HERA) amended the Federal Home Loan Bank Act (Bank Act) by adding a...

  3. Annual report to Congress on Federal Government Energy Management and Conservation Programs, Fiscal Year 1998

    Energy Technology Data Exchange (ETDEWEB)

    None

    2000-03-20

    In fulfillment of statutory requirements, this report provides information on energy consumption in Federal buildings and operations and also documents activities conducted by Federal agencies in fulfilling those requirements during Fiscal Year 1998.

  4. Annual report to Congress on Federal Government Energy Management and Conservation Programs, Fiscal Year 1997

    Energy Technology Data Exchange (ETDEWEB)

    None

    1999-08-13

    In fulfillment of statutory requirements, this report provides information on energy consumption in Federal buildings and operations and also documents activities conducted by Federal agencies in fulfilling those requirements during Fiscal Year 1997.

  5. 75 FR 36414 - Federal Travel Regulation (FTR); Directions for Reporting Other Than Coach-Class Accommodations...

    Science.gov (United States)

    2010-06-25

    ... From the Federal Register Online via the Government Publishing Office GENERAL SERVICES ADMINISTRATION Federal Travel Regulation (FTR); Directions for Reporting Other Than Coach-Class Accommodations for Employees on Official Travel AGENCY: Office of Governmentwide Policy, General...

  6. Bioethical differences between drug addiction treatment professionals inside and outside the Russian Federation

    Directory of Open Access Journals (Sweden)

    Mendelevich Vladimir D

    2011-06-01

    Full Text Available Abstract This article provides an overview of a sociological study of the views of 338 drug addiction treatment professionals. A comparison is drawn between the bioethical approaches of Russian and foreign experts from 18 countries. It is concluded that the bioethical priorities of Russian and foreign experts differ significantly. Differences involve attitudes toward confidentiality, informed consent, compulsory treatment, opioid agonist therapy, mandatory testing of students for psychoactive substances, the prevention of mental patients from having children, harm reduction programs (needle and syringe exchange, euthanasia, and abortion. It is proposed that the cardinal dissimilarity between models for providing drug treatment in the Russian Federation versus the majority of the countries of the world stems from differing bioethical attitudes among drug addiction treatment experts.

  7. Consumer reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Aagaard, Lise; Nielsen, Lars Hougaard; Hansen, Ebba Holme

    2009-01-01

    BACKGROUND: Reporting adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. Since 2003 in Denmark, consumers have been able to report ADRs directly to the authorities. The objective of this study was to compare ADRs reported by consumers with ADRs...... reported from other sources, in terms of their type, seriousness and the suspected medicines involved. METHODS: The number of ADRs reported to the Danish ADR database from 2004 to 2006 was analysed in terms of category of reporter, seriousness, category of ADRs by system organ class (SOC) and the suspected...... medicines on level 1 of the anatomical therapeutic chemical (ATC) classification system. ADR reports from consumers were compared with reports from other sources (physicians, pharmacists, lawyers, pharmaceutical companies and other healthcare professionals). Chi-square and odds ratios (ORs) were calculated...

  8. Caveat medicus: consequences of federal investigations of marketing activities of pharmaceutical suppliers of prostate cancer drugs.

    Science.gov (United States)

    McKoy, June M; Lyons, E Allison; Obadina, Eniola; Carson, Kenneth; Pickard, A Simon; Schellhammer, Paul; McLeod, David; Boyd, Cynthia E; McWilliams, Norene; Sartor, Oliver; Schumock, Glen T; McCaffery, Kathryn; Bennett, Charles L

    2005-12-01

    In the course of recent health care fraud investigations against TAP Pharmaceuticals (Lake Forest, IL) and AstraZeneca International (London, United Kingdom), each pled guilty to one violation of the Prescription Drug Marketing Act, settled claims related to alleged violations of the False Claims Act without admitting guilt, and paid fines, settlements for liabilities, and reimbursements of dollar 850 million and dollar 355 million, respectively. In a unique aspect of these cases, federal investigators brought criminal charges against 14 TAP employees and investigated the billing practices of several urologists. These investigations resulted in guilty pleas from both urologists and industry employees relative to the Prescription Drug Marketing Act or the False Claims Act and probationary sentences with payments of fines and restitution to the government for urologists who cooperated with federal investigations. One uncooperative urologist was found guilty of violating the Federal False Claims Act and sentenced to 6 months of home arrest, excluded from Medicare for 5 years, required to provide 600 hours of free medical care to indigent patients and patients covered by Medicare or Medicaid, and paid fines and restitution to the government. The cases against TAP and AstraZeneca have been followed by federal and state investigations of allegedly illegal marketing practices of other pharmaceutical firms and have resulted in negotiated settlements of dollar 3.8 billion and dollar 71.5 million, respectively. Believing that an Average Wholesale Price-based reimbursement system was an important driving factor for these marketing activities, Medicare has shifted to an Average Sales Price-based reimbursement system. This is expected to greatly impact the practice of outpatient oncology nationwide.

  9. Multi-drug resistant tuberculosis in Chuuk State Federated States of Micronesia, 2008-2009.

    Science.gov (United States)

    Fred, D; Desai, M; Song, R; Bamrah, S; Pavlin, B I; Heetderks, A; Ekiek, M J

    2010-04-01

    Multi-drug resistant tuberculosis (MDR TB) is a growing public health concern, particularly for the Pacific, where rates of tuberculosis infection are extremely high. In May 2008, a cluster of patients with MDR TB were identified in Chuuk State, Federated States of Micronesia. A multi-agency investigation led to the eventual discovery of 21 cases, and over 100 latent TB infections. Incomplete implementation of Directly Observed Therapy (DOT) and contact investigation were major contributors to the outbreak. The problem of MDR TB in Chuuk was controlled only after a concerted effort on the part of multiple agencies coupled with the highest level of political commitment.

  10. Report on Implementing the Federal Cybersecurity Research and Development Strategy

    Data.gov (United States)

    Networking and Information Technology Research and Development, Executive Office of the President — In December 2011 the NSTC released Trustworthy Cyberspace: Strategic Plan for the Federal Cybersecurity Research and Development Program, outlining a vision for the...

  11. Inference of the Russian drug community from one of the largest social networks in the Russian Federation

    NARCIS (Netherlands)

    Dijkstra, L.J.; Yakushev, A.V.; Duijn, P.A.C.; Boukhanovsky, A.V.; Sloot, P.M.A.

    2014-01-01

    The criminal nature of narcotics complicates the direct assessment of a drug community, while having a good understanding of the type of people drawn or currently using drugs is vital for finding effective intervening strategies. Especially for the Russian Federation this is of immediate concern giv

  12. Federal Lighting Efficiency Program (FLEP). Volume 1. Study Report

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1977-05-06

    The study was conducted to develop a 10-year Federal Lighting Efficiency Program. It consisted of four analytical tasks: conduct a survey of recent lighting research and development;conduct a cost/benefit evaluation of energy-conserving options available as a result of the lighting research; develop a cost-effective Federal Lighting Efficiency Program plan based on the study results; and identify commercialization barriers that may exist that prevent widespread utilization of the energy-conserving options. The results are summarized in this volume. (ERA citation 04:044906)

  13. First interim report of the Federal Fleet Conversion Task Force

    Energy Technology Data Exchange (ETDEWEB)

    1993-08-01

    The Federal Fleet Conversion Task Force was created by Executive Order 12844, signed by President Clinton on April 21, 1993. In the Order, the President directed that purchases of alternative fueled vehicles by the Federal Government be substantially increased beyond the levels required by current law. The President charged the Task Force with developing recommendations for carrying out the Executive Order, with special emphasis on setting a course that will lead to the widespread use of alternative fueled vehicles by Federal, State, and local government fleets, by private fleets and, ultimately, by individuals. The chief recommendation of the Task Force is the establishment of a Presidential Clean Cities Initiative. To support creation of the Presidential Initiative, the Task Force identified 38 cities and regions, prioritized into three tiers, for concentrating the Initiative`s efforts in Fiscal Years 1994 through 1996. This concentration of effort is key to the effectiveness of the Initiative. The 38 cities and regions would receive priority funding for Federal vehicle purchases and for infrastructure development. In addition, the Task Force has made specific recommendations for overcoming numerous regulatory, economic, and technical barriers that have slowed the introduction of alternative fueled vehicles into general use.

  14. [Nursing role in reporting adverse drug reactions].

    Science.gov (United States)

    Zurita-Garaicoechea, Ana; Reis-Carvalho, Joana; Ripa-Aisa, Irantzu; Jiménez-Mendoza, Ana; Díaz-Balén, Almudena; Oroviogoicoechea, Cristina

    2015-01-01

    The spontaneous report system, in which suspected adverse drug reaction (ADR) are reported by healthcare workers, is currently one of the primary methods to prevent and discover new and serious ADR to marketed medicinal products. The collaboration of nursing professionals with this task makes it possible to improve patient safety and to reduce ADR costs. Although a total of 781 cases of ADR cases were reported in Navarra in 2011, only 7.33% were reported by nurses. The objectives werw to determine the factors that influence nurses in reporting of ADR, and second, to devise strategies which help to increase reporting. A bibliographic search for articles that included the words: reacciones adversas medicamentosas (adverse drug reactions), notificación (reporting) and enfermería (nursing) was conducted using the PubMed and Cinhal databases. A total of 107 articles were retrieved, of which 27 were selected according to inclusion and exclusion criteria. The conclusion learned by reading and analyzing the selected articles was that the factors that affect the notification depend on the attitude of the notifier, as well as personal and professional factors. The main strategies to encourage notification are education and training, motivation, and the availability of facilitating tools. The main factors that have an influence on under-notification are the lack of knowledge and motivation among professionals. To solve the problem of under-notification, the main actions and strategies to undertake are education, motivation and persistence. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  15. Annual report to Congress on Federal Government Energy Management and Conservation Programs

    Energy Technology Data Exchange (ETDEWEB)

    1994-02-01

    This report on Federal Energy Management for Fiscal year (FY) 1992 provides information on energy consumption in Federal buildings and operations and documents activities conducted by Federal agencies to meet the statutory requirements of Title V, Part 3, of the National Energy Conservation Policy Act (NECPA), as amended, 42 U.S.C. 8251-8261, and Title VIII of NECPA, 42 U.S.C. 8287-8287b. This report also describes the energy conservation and management activities of the Federal Government under the authorization of section 381 of the Energy Policy and Conservation Act (EPCA), as amended, 42 U.S.C. 6361. Implementation activities undertaken during FY 1992 by the Federal agencies under Executive Order 12759 on Federal Energy Management are also described in this report.

  16. Federal Energy Resources Modernization Coordinating Committee; Semiannual report, April 1, 1992--September 30, 1992

    Energy Technology Data Exchange (ETDEWEB)

    Parker, G. B.

    1993-04-01

    This report summarizes the broad range of activities that are focused on meeting the President's Executive Order on Federal Energy Management promulgated to meet energy savings goals and encourage more efficient management of all federal energy resources. These activities are reported semiannually under the auspices of the Federal Energy Resource Modernization (FERM) Coordinating Committee, and as such include activities undertaken from April 1, 1992, through September 30, 1992. The activities reported are classified into four major categories: (1) technology-base support, which includes development of processes, software, metering and monitoring equipment and strategies, and other tools for federal energy managers to better understand and characterize their energy resources; (2) federal energy systems testing and monitoring; (3) federal energy systems revitalization projects at federal installations in cooperation with the utilities serving the sites; and (4) energy supply, distribution and end-use conservation assessment for federal agencies and/or facilities. Lighting systems and air conditioning projects at federal facilities, especially military bases are updated.

  17. Fixed drug eruptions to ciprofloxacin - a case report

    Directory of Open Access Journals (Sweden)

    Rama R. Bhosale

    2012-06-01

    Full Text Available Fixed drug eruptions (FDE are common adverse drug reactions and they recur at the same site with each exposure to a particular drug. Drugs inducing FDE are usually those taken intermittently. Most common drugs causing fixed drug eruptions are antibiotics and analgesics. Here, we report a case of FDE to ciprofloxacin which was used in treatment of upper respiratory tract infection. [Int J Basic Clin Pharmacol 2012; 1(3.000: 221-222

  18. Brine migration test report: Asse Salt Mine, Federal Republic of Germany: Technical report

    Energy Technology Data Exchange (ETDEWEB)

    Coyle, A.J.; Eckert, J.; Kalia, H.

    1987-01-01

    This report presents a summary of Brine Migration Tests which were undertaken at the Asse mine of the Federal Republic of Germany (FRG) under a bilateral US/FRG agreement. This experiment simulates a nuclear waste repository at the 800-m (2624-ft) level of the Asse salt mine in the Federal Republic of Germany. This report describes the Asse salt mine, the test equipment, and the pretest properties of the salt in the mine and in the vicinity of the test area. Also included are selected test data (for the first 28 months of operation) on the following: brine migration rates, thermomechaical behavior of the salt (including room closure, stress reading, and thermal profiles), borehole gas pressures, and borehole gas analyses. In addition to field data, laboratory analyses of pretest salt properties are included in this report. The operational phase of these experiments was completed on October 4, 1985, with the commencement of cooldown and the start of posttest activities. 7 refs., 68 figs., 48 tabs.

  19. Report to the President, Federal Programs for the Retarded, A Review and Evaluation.

    Science.gov (United States)

    President's Committee on Mental Retardation, Washington, DC.

    Presented are the reports of 22 federal departments and agencies on their programs related to mental retardation. The review of governmental programs is seen as a needed first step toward mobilization of the full federal potential in coordinating efforts in the gamut of problems of mental retardation. The departments and agencies covered include…

  20. Report: Wells Band Council Needs to Improve Its Accounting System to Comply With Federal Regulations

    Science.gov (United States)

    Report #14-2-0316, July 14, 2014. The Wells Band Council’s accounting system did not comply with federal regulations, which resulted in $390,000 of questioned costs and proposed high-risk designation for the grantee.

  1. Fourth annual report to Congress, Federal Alternative Motor Fuels Programs

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-07-01

    This annual report to Congress presents the current status of the alternative fuel vehicle programs being conducted across the country in accordance with the Alternative Motor Fuels Act of 1988. These programs, which represent the most comprehensive data collection effort ever undertaken on alternative fuels, are beginning their fifth year. This report summarizes tests and results from the fourth year.

  2. Prescription drugs associated with reports of violence towards others.

    Directory of Open Access Journals (Sweden)

    Thomas J Moore

    Full Text Available CONTEXT: Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others. OBJECTIVE: To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association. METHODOLOGY: From the Food and Drug Administration (FDA Adverse Event Reporting System (AERS data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms. MAIN OUTCOME MEASURES: Disproportionality in reporting was defined as a 5 or more violence case reports, b at least twice the number of reports expected given the volume of overall reports for that drug, c a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p<0.01. RESULTS: We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation, 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7% of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs. CONCLUSIONS: Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and

  3. Doxycycline-induced drug fever: a case report.

    Science.gov (United States)

    Yuan, Hai-Ling; Lu, Ning-Wei; Xie, Hua; Zheng, Yuan-Yuan; Wang, Qiu-Hong

    2016-01-01

    Drug fever is a febrile reaction induced by a drug without additional clinical symptoms. This adverse reaction is not rare but under diagnosed and under reported. Doxycycline is a tetracycline compound with broad-spectrum antibiotic activity. Drug fever induced by doxycycline is rarely reported. In this study, we describe a patient in whom doxycycline induced drug fever after 17 days of therapy for brucellosis.

  4. 76 FR 49532 - Federal Motor Vehicle Safety Standards; Electronic Stability Control; Technical Report on the...

    Science.gov (United States)

    2011-08-10

    ... National Highway Traffic Safety Administration Federal Motor Vehicle Safety Standards; Electronic Stability Control; Technical Report on the Effectiveness of Electronic Stability Control Systems for Cars and LTVs... Technical Report on its existing Safety Standard 126, Electronic Stability Control Systems. The report's...

  5. Federal Facility Agreement Annual Progress Report for FY 1998

    Energy Technology Data Exchange (ETDEWEB)

    Palmer, E.

    1999-08-04

    This FFA Annual Progress Report has been developed to summarize the information for activities performed during the Fiscal Year 1998 (October 1, 1997, to September 30, 1998) and activities planned for Fiscal Year 1999 by U.S. EPA, SCDHEC, and SRS at those units and areas identified for remediation in the Agreement.

  6. The Data Dilemma: Reporting in the Era of Federal Stimulus

    Science.gov (United States)

    Weil, Marty

    2009-01-01

    Department of Education (DOE) secretary Arne Duncan has put school districts on notice: They must show how their students' scores on state tests compare with their scores in national evaluations. The Obama administration also wants states to track and disclose longitudinal data, according to a recent Wall Street Journal report. Of course,…

  7. The Data Dilemma: Reporting in the Era of Federal Stimulus

    Science.gov (United States)

    Weil, Marty

    2009-01-01

    Department of Education (DOE) secretary Arne Duncan has put school districts on notice: They must show how their students' scores on state tests compare with their scores in national evaluations. The Obama administration also wants states to track and disclose longitudinal data, according to a recent Wall Street Journal report. Of course,…

  8. 78 FR 48343 - Reporting and Paying Royalties on Federal Leases

    Science.gov (United States)

    2013-08-08

    ... effective would be $643,378 and $7,544 in subsequent years. We base the requests for alternate reporting... production that is commingled prior to the royalty measurement point. Thus, we held additional public... and method of Btu measurement as set forth in the lessee's contract shall be used to determine...

  9. The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine.

    Science.gov (United States)

    Wang, Bo; Studdert, David M; Sarpatwari, Ameet; Franklin, Jessica M; Landon, Joan; Kesselheim, Aaron S

    2017-01-01

    In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1.4 billion to the federal government and over $290 million to state governments. We examined the effect of these settlements on off-label prescribing of this medication, taking advantage of geographical differences in states' involvement in the investigations and the timing of the settlements. However, we did not find a reduction in off-label prescribing; rather, there were no prescribing changes among states that joined the federal investigation, those that pursued independent state investigations, and states that pursued no investigations at all. Since the settlements of state investigations of off-label prescribing do not appear to significantly impact prescribing rates, policymakers should consider alternate ways of reducing the prevalence of non-evidence-based off-label use to complement their ongoing investigations.

  10. Promoting adverse drug reaction reporting: comparison of different approaches

    Directory of Open Access Journals (Sweden)

    Inês Ribeiro-Vaz

    2016-01-01

    Full Text Available ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each, followed by first educational approach (265 reports, 20.31 €/report and by the hyperlink approach (136 reports, 15.59 €/report. Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs. Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report, followed by first educational approach (38.79 €/report. CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

  11. Comprehensive Output Measurement: The 'Missing Link' in U.S. Federal Government Performance Reporting

    OpenAIRE

    King, David Lorne

    2014-01-01

    Performance and accrual-based financial management systems as envisaged in the 1990 Chief Financial Officers (CFO) Act, the 1993 Government Performance and Results Act (GPRA), the 1996 Federal Financial Management Improvement Act (FFMIA) and related legislation have been in place since prior to the turn of the millennium. Nevertheless, although performance has been measured and financial accountability improved in U.S. federal government agencies, there remains a gap in reporting on operation...

  12. Aspirin induced fixed drug eruptions: a case report

    Directory of Open Access Journals (Sweden)

    Rama R. Bhosale

    2013-04-01

    Full Text Available Fixed drug eruptions are common cutaneous adverse drug reactions, commonly caused by anticonvulsants, antibiotics and analgesics. Here, we report a case of a 27-year-old male of fixed drug eruptions due to Aspirin which was used in treatment of headache. [Int J Basic Clin Pharmacol 2013; 2(2.000: 220-221

  13. Bringing the DERP to consumers: 'Consumer Reports Best Buy Drugs'.

    Science.gov (United States)

    Findlay, Steven D

    2006-01-01

    Consumers Union, publisher of Consumer Reports magazine, has used the drug class reviews of the Drug Effectiveness Review Project (DERP) as one critical component of a free public information project on the comparative effectiveness, safety, and cost of prescription drugs. The project translates the DERP findings for consumers. Drawing on other sources and adding information on drug costs, the project chooses Best Buy drugs in each category it evaluates. This guidance can help consumers save up to thousands of dollars per year, and it has the potential to reduce overall drug spending.

  14. 41 CFR 102-74.200 - What information are Federal agencies required to report to the Department of Energy (DOE)?

    Science.gov (United States)

    2010-07-01

    ...)? Federal agencies, upon approval of GSA, must report to the DOE the energy consumption in buildings... Federal agencies required to report to the Department of Energy (DOE)? 102-74.200 Section 102-74.200...) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 74-FACILITY MANAGEMENT Facility Management Energy...

  15. Federal Programs for the Retarded: A Review and Evaluation. Report to the President.

    Science.gov (United States)

    President's Committee on Mental Retardation, Washington, DC.

    Reports from 22 federal departments and agencies on their programs related to mental retardation have been compiled for submission to the President's Committee on Mental Retardation for review, analysis, and subsequent action. For each report, the overall mission is given, as well as unit identification, external programs (services or activities),…

  16. Research Reports: Hallucinogens and Dissociative Drugs

    Science.gov (United States)

    ... critical review of reportsof endogenous psychedelic N, N-dimethyltryptamines in humans: 1955-2010. Drug Test Anal . 2012; ... 76. Strassman RJ. Human psychopharmacology of N,N- dimethyltryptamine. Behav Brain Res. 1996;73(1-2):121- ...

  17. Annual report to Congress on Federal Government energy management and conservation programs, Fiscal year 1994

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-10-06

    This report provides sinformation on energy consumption in Federal buildings and operations and documents activities conducted by Federal agencies to meet statutory requirements of the National Energy Conservation Policy Act. It also describes energy conservation and management activities of the Federal Government under section 381 of the Energy Policy and Conservation Act. Implementation activities undertaken during FY94 by the Federal agencies under the Energy Policy Act of 1992 and Executive Orders 12759 and 12902 are also described. During FY94, total (gross) energy consumption of the US Government, including energy consued to produce, process, and transport energy, was 1.72 quadrillion Btu. This represents {similar_to}2.0% of the total 85.34 quads used in US.

  18. DOE uniform reporting system for Federal assistance (grants and cooperative agreements): guidelines

    Energy Technology Data Exchange (ETDEWEB)

    1981-04-01

    These guidelines establish a uniform reporting system (URS) for grants and cooperative agreements. The purpose is to simplify reporting requirements, standardize reporting, and ensure that no assistance recipient submits more reports than needed to achieve accountability for public funds. This system replaces the many reporting procedures previously imposed by DOE component organizations. Uniform terminology and data elements will minimize ambiguity of meaning and intent. A glossary of terms is provided. A checklist is used to identify all reporting requirements at the time of award. The recipient is encouraged to discuss the requirements before the time of award in order to ensure that they are appropriate. The Guidelines describe planning forms which can be included in the Federal assistance application or proposal to present the planned approach and desired results. Flexibility has been built into the system to ensure that the information requested is relative to the activity performed. A recipient of Federal assistance submits information only once in each reporting period. The reporting system provides recipients with a formal method for identifying problems, including those originated by the Federal government. For purposes of illustration, a hypothetical project - partially funded by DOE under a cooperative agreement - using all the Program Management forms is presented in Part II, Program Management. Part III, Technical Information uses a research grant to illustrate Technical Reporting. Appendix B provides a complete example of the reporting requirements on a research grant.

  19. Contribution of pharmacists to the reporting of adverse drug reactions

    NARCIS (Netherlands)

    van Grootheest, AC; van Puijenbroek, EP; de Jong-van den Berg, LTW

    2002-01-01

    Purpose The aim of the study is to get a better view about the possible contribution of pharmacists' reports to the quantity and the quality of reports and in this way to the quality of a voluntary reporting system of adverse drug reactions. Methods A total of 15 293 reports, sent to the Netherlands

  20. Annual Report on Federal Government Energy Management and Conservation Programs, Fiscal Year 2013

    Energy Technology Data Exchange (ETDEWEB)

    None

    2015-04-01

    Annual reports on Federal energy management respond to section 548 of the National Energy Conservation Policy Act (NECPA, Pub. L. No. 95-619), as amended, and provide information on energy consumption in Federal buildings, operations, and vehicles. Compiled by the Federal Energy Management Program, these reports document activities conducted by Federal agencies under the: Energy management and energy consumption requirements of section 543 of NECPA, as amended (42 U.S.C. § 8253); Energy savings performance contract authority of section 801 of NECPA, Pub. L. No. 95-619, as amended (42 U.S.C. §§ 8287-8287d); Renewable energy purchase goal of section 203 of the Energy Policy Act (EPAct) of 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 15852); Federal building performance standard requirements under Section 109 of EPAct 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 6834(a)); Requirements on the procurement and identification of energy efficient products under section 161 of EPAct 1992, Pub. L. No. 102-486 (codified at 42 U.S.C. § 8262g); Sections 431, 432, and 434 of the Energy Independence and Security Act of 2007 (EISA), Pub. L. No. 110-140 (42 U.S.C. § 8253) and section 527 of EISA (42 U.S.C. § 17143); Executive Order 13423, Strengthening Federal Environmental, Energy, and Transportation Management, 72 Fed. Reg. 3,919 (Jan. 26, 2007); Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, 74 Fed. Reg. 52,117 (Oct. 5, 2009).

  1. Annual Report on Federal Government Energy Management and Conservation Programs, Fiscal Year 2010

    Energy Technology Data Exchange (ETDEWEB)

    None

    2014-03-01

    Annual reports on Federal energy management respond to section 548 of the National Energy Conservation Policy Act (NECPA, Pub. L. No. 95-619), as amended, and provide information on energy consumption in Federal buildings, operations, and vehicles. Compiled by the Federal Energy Management Program, these reports document activities conducted by Federal agencies under the: Energy management and energy consumption requirements of section 543 of NECPA, as amended (42 U.S.C. § 8253); Energy savings performance contract authority of section 801 of NECPA, Pub. L. No. 95-619, as amended (42 U.S.C. §§ 8287-8287d); Renewable energy purchase goal of section 203 of the Energy Policy Act (EPAct) of 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 15852); Federal building performance standard requirements under Section 109 of EPAct 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 6834(a)); Requirements on the procurement and identification of energy efficient products under section 161 of EPAct 1992, Pub. L. No. 102-486 (codified at 42 U.S.C. § 8262g); Sections 431, 432, and 434 of the Energy Independence and Security Act of 2007 (EISA), Pub. L. No. 110-140 (42 U.S.C. § 8253) and section 527 of EISA (42 U.S.C. § 17143); Executive Order 13423, Strengthening Federal Environmental, Energy, and Transportation Management, 72 Fed. Reg. 3,919 (Jan. 26, 2007); Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, 74 Fed. Reg. 52,117 (Oct. 5, 2009).

  2. Annual Report on Federal Government Energy Management and Conservation Programs, Fiscal Year 2012

    Energy Technology Data Exchange (ETDEWEB)

    None

    2015-03-01

    Annual reports on Federal energy management respond to section 548 of the National Energy Conservation Policy Act (NECPA, Pub. L. No. 95-619), as amended, and provide information on energy consumption in Federal buildings, operations, and vehicles. Compiled by the Federal Energy Management Program, these reports document activities conducted by Federal agencies under the: Energy management and energy consumption requirements of section 543 of NECPA, as amended (42 U.S.C. § 8253); Energy savings performance contract authority of section 801 of NECPA, Pub. L. No. 95-619, as amended (42 U.S.C. §§ 8287-8287d); Renewable energy purchase goal of section 203 of the Energy Policy Act (EPAct) of 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 15852); Federal building performance standard requirements under Section 109 of EPAct 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 6834(a)); Requirements on the procurement and identification of energy efficient products under section 161 of EPAct 1992, Pub. L. No. 102-486 (codified at 42 U.S.C. § 8262g); Sections 431, 432, and 434 of the Energy Independence and Security Act of 2007 (EISA), Pub. L. No. 110-140 (42 U.S.C. § 8253) and section 527 of EISA (42 U.S.C. § 17143); Executive Order 13423, Strengthening Federal Environmental, Energy, and Transportation Management, 72 Fed. Reg. 3,919 (Jan. 26, 2007); Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, 74 Fed. Reg. 52,117 (Oct. 5, 2009).

  3. Annual Report on Federal Government Energy Management and Conservation Programs, Fiscal Year 2011

    Energy Technology Data Exchange (ETDEWEB)

    None

    2014-03-01

    Annual reports on Federal energy management respond to section 548 of the National Energy Conservation Policy Act (NECPA, Pub. L. No. 95-619), as amended, and provide information on energy consumption in Federal buildings, operations, and vehicles. Compiled by the Federal Energy Management Program, these reports document activities conducted by Federal agencies under the: Energy management and energy consumption requirements of section 543 of NECPA, as amended (42 U.S.C. § 8253); Energy savings performance contract authority of section 801 of NECPA, Pub. L. No. 95-619, as amended (42 U.S.C. §§ 8287-8287d); Renewable energy purchase goal of section 203 of the Energy Policy Act (EPAct) of 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 15852); Federal building performance standard requirements under Section 109 of EPAct 2005, Pub. L. No. 109-58 (codified at 42 U.S.C. § 6834(a)); Requirements on the procurement and identification of energy efficient products under section 161 of EPAct 1992, Pub. L. No. 102-486 (codified at 42 U.S.C. § 8262g); Sections 431, 432, and 434 of the Energy Independence and Security Act of 2007 (EISA), Pub. L. No. 110-140 (42 U.S.C. § 8253) and section 527 of EISA (42 U.S.C. § 17143); Executive Order 13423, Strengthening Federal Environmental, Energy, and Transportation Management, 72 Fed. Reg. 3,919 (Jan. 26, 2007); Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, 74 Fed. Reg. 52,117 (Oct. 5, 2009).

  4. Toward Interagency Coordination FY '75 Federal Research and Development Activities Pertaining to Early Childhood. Fifth Annual Report.

    Science.gov (United States)

    Hertz, Thomas W.; Mann, Ada Jo

    This report provides an overview of the federally-funded early childhood research activities of fiscal year 1975. In order to assess the directions in which federal research programs are moving, ongoing research projects are analyzed both within individual agencies and within the federal government as a whole. The first chapter reviews the…

  5. Progress Report on Coordinating Federal Science, Technology, Engineering, and Mathematics (STEM) Education

    Science.gov (United States)

    Executive Office of the President, 2016

    2016-01-01

    As called for in the America COMPETES Reauthorization Act of 2010, the National Science and Technology Council's (NSTC) Committee on STEM Education (CoSTEM) released, in May of 2013, the Federal Science, Technology, Engineering, and Mathematics (STEM) Education 5- Year Strategic Plan (Strategic Plan). As required by the Act, this report includes…

  6. 75 FR 47900 - Joint Report: Differences in Accounting and Capital Standards Among the Federal Banking Agencies...

    Science.gov (United States)

    2010-08-09

    ... Standards Among the Federal Banking Agencies; Report to Congressional Committees AGENCIES: Office of the... States House of Representatives and to the Committee on Banking, Housing, and Urban Affairs of the United...- 3621) or Kevin H. Wilson, Senior Financial Analyst (202-452-2362), Division of Banking Supervision and...

  7. Synthesis: A Report on Federally Funded Training to Local Education Agencies.

    Science.gov (United States)

    Paddock, Susan C.; Felix, B. Lane

    From 1976 to 1980, 27 projects developed by institutions of higher education received federal funding to train local educational agency personnel in the planning and operation of community education programs. In addition, four projects were funded to train personnel at the state level and seven to develop training materials. This report examines…

  8. 78 FR 76313 - Proposed Information Collection; Federal Fish and Wildlife Permit Applications and Reports...

    Science.gov (United States)

    2013-12-17

    ...; universities; antique dealers; exotic pet industry; hunters; taxidermists; commercial importers/exporters of wildlife and plants; freight forwarders/brokers; and State, tribal, local, and Federal governments.......... 52 1 hour 52 Report--American Alligator CITES Export 10 1 hour 10 Program. Application--Plant Rescue...

  9. Under-Reported Aspects of Platinum Drug Pharmacology

    Directory of Open Access Journals (Sweden)

    Dirk Theile

    2017-02-01

    Full Text Available Platinum drugs remain the backbone of many antineoplastic regimens. Among the numerous chemical or pharmacological effects of platinum drugs, some aspects tend to be under-reported. Thus, this perspective paper intends to stress some neglected properties of platinum drugs: first, the physico-chemical characteristics (aquation reaction kinetics that determine site-specific toxicity; second, the impact on RNA molecules. Knowledge of the ‘RNA world’ has dramatically changed our understanding of cellular and molecular biology. The inherent RNA-crosslinking properties should make platinum-based drugs interact with coding and non-coding RNAs. Third, we will discuss the impact on the immune system, which is now recognized to substantially contribute to chemotherapy efficacy. Together, platinum drugs are in fact old drugs, but are worth re-focusing on. Many aspects are still mysterious but can pave the way to new drugs or an improved application of the already existing compounds.

  10. Lichenoid drug eruption induced by colchicine: case report.

    Science.gov (United States)

    An, Isa; Demir, Vasfiye; Akdeniz, Sedat

    2016-07-15

    Lichenoid drug eruption (LDE) is a common cutaneous side effect of drugs including antimalarials, antihypertensives, nonsteroids, anti-inflammatory drugs and diuretics. The physiopathologic relationship between colchicine treatment and LDE is unclear. There is very little documentation of LDE induced by colchicine in the literature. In this report, we present a case that developed LDE on the abdomen and the legs during the colchicine treatment.

  11. ERIT-Italia, the Italian Federation for Professionals Working in the Field of Drug Abuse.

    Science.gov (United States)

    Nizzoli, Umberto; Foschini, Vittorio

    2002-11-01

    What is ERIT-Italia? In what cultural context was it founded and in what state were the services for drug dependency at that time? What has it produced in recent years? Can a professional association successfully work alongside administrations and governments to contribute to the development of effective treatment for drug addiction? It is these questions which are addressed in this description of the major Italian professional body concerned with drug misuse.

  12. Self-Reported Drug and Alcohol Use and Attitudes toward Drug Testing in High Schools with Random Student Drug Testing

    Science.gov (United States)

    DuPont, Robert L.; Campbell, Michael D.; Campbell, Teresa G.; Shea, Corinne L.; DuPont, Helen S.

    2013-01-01

    Many schools implement random student drug testing (RSDT) programs as a drug prevention strategy. This study analyzes self-report surveys of students in eight secondary schools with well-established RSDT programs, comparing students who understood they were subject to testing and students who understood they were not subject to testing. Students…

  13. Self-Reported Drug and Alcohol Use and Attitudes toward Drug Testing in High Schools with Random Student Drug Testing

    Science.gov (United States)

    DuPont, Robert L.; Campbell, Michael D.; Campbell, Teresa G.; Shea, Corinne L.; DuPont, Helen S.

    2013-01-01

    Many schools implement random student drug testing (RSDT) programs as a drug prevention strategy. This study analyzes self-report surveys of students in eight secondary schools with well-established RSDT programs, comparing students who understood they were subject to testing and students who understood they were not subject to testing. Students…

  14. Do pharmacists' reports of adverse drug reactions reflect patients' concerns?

    NARCIS (Netherlands)

    van Grootheest, A.C.; van Puijenbroek, E.P.; de Jong-van den Berg, Lolkje Theodora Wilhelmina

    2004-01-01

    Aim: The aim of the present study was to investigate whether the concerns patients express to a Drug Information Line about possible adverse drug reactions (ADRs) they have experienced, are sufficiently reflected by the ADR reports submitted by pharmacists to the Netherlands Pharmacovigilance Centre

  15. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region......%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. CONCLUSION: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR...

  16. Analysis of the premitting processes associated with exploration of Federal OCS leases. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1980-11-01

    Under contract to the Office of Leasing Policy Development (LPDO), Jack Faucett Associates is currently undertaking the description and analysis of the Outer Continental Shelf (OCS) regulatory process to determine the nature of time delays that affect OCS production of oil and gas. This report represents the results of the first phase of research under this contract, the description and analysis of regulatory activity associated with exploration activities on the Federal OCS. Volume 1 contains the following three sections: (1) study results; (2) Federal regulatory activities during exploration of Federal OCS leases which involved the US Geological Survey, Environmental Protection Agency, US Coast Guard, Corps of Engineers, and National Ocean and Atmospheric Administration; and (3) state regulatory activities during exploration of Federal OCS leases of Alaska, California, Louisiana, Massachusetts, New Jersey, North Carolina, and Texas. Volume II contains appendices of US Geological Survey, Environmental Protection Agency, Coast Guard, Corps of Engineers, the Coastal Zone Management Act, and Alaska. The major causes of delay in the regulatory process governing exploration was summarized in four broad categories: (1) the long and tedious process associated with the Environmental Protection Agency's implementation of the National Pollutant Discharge Elimination System Permit; (2) the lack of mandated time periods for the completion of individual activities in the permitting process; (3) the lack of overall coordination of OCS exploratory regulation; and (4) the inexperience of states, the Federal government and industry relating to the appropriate level of regulation for first-time lease sale areas.

  17. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

  18. Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

    NARCIS (Netherlands)

    van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

    2003-01-01

    The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the worl

  19. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...

  20. Swiss Federal Energy Research Commission - Annual report 2008; Eidgenoessische Energieforschungskommission CORE. Jahresbericht 2008

    Energy Technology Data Exchange (ETDEWEB)

    Maus, K.

    2009-07-01

    This annual report presents a review of the activities carried out by the Swiss Federal Energy Research Commission CORE in the year 2008. Main points of interest were the definition of a new CORE vision, a review of all research programmes, co-operation and co-ordination with public and private institutes, active consultancy, recommendations for further education and training, improved international information exchange and good communication with business, politics and the general public. The definition of a concept for Swiss energy research for the period 2012 to 2016 is mentioned. The annual report also reports on an internal visit made to various laboratories of the Swiss Federal Institute of Technology in Lausanne and the Energy Center in Zurich. The focussing of CORE activities on particular themes is discussed

  1. Bias in spontaneous reporting of adverse drug reactions in Japan.

    Directory of Open Access Journals (Sweden)

    Shinichi Matsuda

    Full Text Available Attitudes of healthcare professionals regarding spontaneous reporting of adverse drug reactions (ADRs in Japan are not well known, and Japan's unique system of surveillance, called early post-marketing phase vigilance (EPPV, may affect these reporting attitudes. Our objectives were to describe potential effects of EPPV and to test whether ADR seriousness, prominence, and frequency are related to changes in reporting over time.A manufacturer's database of spontaneous ADR reports was used to extract data from individual case safety reports for 5 drugs subject to EPPV. The trend of reporting and the time lag between ADR onset and reporting to the manufacturer were examined. The following indices for ADRs occurring with each drug were calculated and analyzed to assess reporting trends: Serious:Non-serious ratio, High prominence:Low prominence ratio, and High frequency:Low frequency ratio.For all 5 drugs, the time lag between ADR onset and reporting to the manufacturer was shorter in the EPPV period than in the post-EPPV period. All drugs showed higher Serious:Non-serious ratios in the post-EPPV period. No specific patterns were observed for the High prominence:Low prominence ratio. The High frequency:Low frequency ratio for peginterferon alpha-2a and sevelamer hydrochloride decreased steadily throughout the study period.Healthcare professionals may be more likely to report serious ADRs than to report non-serious ADRs, but the effect of event prominence on reporting trends is still unclear. Factors associated with ADR reporting attitude in Japan might be different from those in other countries because of EPPV and the involvement of medical representatives in the spontaneous reporting process. Pharmacovigilance specialists should therefore be cautious when comparing data between different time periods or different countries. Further studies are needed to elucidate the underlying mechanism of spontaneous ADR reporting in Japan.

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

    Science.gov (United States)

    Rawson, Nigel S B

    2015-01-01

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

  3. Patients Pressure Docs for Unneeded Drugs: Report

    Institute of Scientific and Technical Information of China (English)

    金秋日

    2001-01-01

    笔者常跑医院,被同事耻笑为“药罐”。读此文,感慨良多。我,被此文不幸言中!自以为“久病成良医”,去就诊时,面对医生,或暗示开什么药,或直截了当地提出要什么药。医生一般都依顺我。当我注意到别的病人时,似乎这种情况非属我一人。本文揭示:美国也同样存在这种现象!Overpresciption(开药过量;过量的处方)现象,主要责任不在医生:in many cases,doctors’over-prescribing of medication may not be due to misdiagnoses(误诊),but to insistent(坚持不懈的)requests and subtle hints from their patients。文章在其主题句中就点明了其危害:contributing to higher drug costs and the increasing prevalence(流行)of antibiotic-resistant bacteria(抗抗生素细菌)。读了此文,我决心实事求是地向医生说明病情,再也不向医生明示或暗示。读者朋友,你呢?】

  4. Economic evaluation in collaborative hospital drug evaluation reports.

    Science.gov (United States)

    Ortega, Ana; Fraga, María Dolores; Marín-Gil, Roberto; Lopez-Briz, Eduardo; Puigventós, Francesc; Dranitsaris, George

    2015-09-01

    economic evaluation is a fundamental criterion when deciding a drug's place in therapy. The MADRE method (Method for Assistance in making Decisions and Writing Drug Evaluation Reports) is widely used for drug evaluation. This method was developed by the GENESIS group of the Spanish Society of Hospital Pharmacy (SEFH), including economic evaluation. We intend to improve the economic aspects of this method. As for the direction to take, we have to first analyze our previous experiences with the current methodology and propose necessary improvements. economic evaluation sections in collaboratively conducted drug evaluation reports (as the scientific society, SEFH) with the MADRE method were reviewed retrospectively. thirty-two reports were reviewed, 87.5% of them included an economic evaluation conducted by authors and 65.6% contained published economic evaluations. In 90.6% of the reports, a Budget impact analysis was conducted. The cost per life year gained or per Quality Adjusted Life Year gained was present in 14 reports. Twenty-three reports received public comments regarding the need to improve the economic aspect. Main difficulties: low quality evidence in the target population, no comparative studies with a relevant comparator, non-final outcomes evaluated, no quality of life data, no fixed drug price available, dosing uncertainty, and different prices for the same drug. proposed improvements: incorporating different forms of aid for non-drug costs, survival estimation and adapting published economic evaluations; establishing criteria for drug price selection, decision-making in conditions of uncertainty and poor quality evidence, dose calculation and cost-effectiveness thresholds depending on different situations. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  5. Federally Sponsored Research at Educational Institutions: A Need for Improved Accountability. Report by the U.S. General Accounting Office.

    Science.gov (United States)

    General Accounting Office, Washington, DC.

    This report discusses federally sponsored research at educational institutions and suggests ways to improve accountability for these funds. The following suggestions are made for minimizing problems presented in this report: (1) development of more definitive cost principles for both the institutions and the Federal auditors to follow; (2) more…

  6. AVTA Federal Fleet PEV Readiness Data Logging and Characterization Study: Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Schey, Stephen [Idaho National Laboratory (INL), Idaho Falls, ID (United States); Francfort, Jim [Idaho National Laboratory (INL), Idaho Falls, ID (United States)

    2015-06-01

    Collect and evaluate data on federal fleet operations as part of the Advanced Vehicle Testing Activity’s Federal Fleet Vehicle Data Logging and Characterization Study. The Advanced Vehicle Testing Activity study seeks to collect and evaluate data to validate the utilization of advanced plug-in electric vehicle (PEV) transportation. This report summarizes the fleets studied to identify daily operational characteristics of select vehicles and report findings on vehicle and mission characterizations to support the successful introduction of PEVs into the agencies’ fleets. Individual observations of these selected vehicles provide the basis for recommendations related to electric vehicle adoption and whether a battery electric vehicle or plug-in hybrid electric vehicle (collectively referred to as PEVs) can fulfill the mission requirements.

  7. The Occurrence of Coral Species Reported as Threatened in Federally Protected Waters of the US Pacific

    Directory of Open Access Journals (Sweden)

    Jean Kenyon

    2011-01-01

    Full Text Available A recent study reported that seventy-five species of reef-building corals, considered to be at elevated extinction risk when assessed by the criteria of the International Union for Conservation of Nature, occur in Pacific waters under United States jurisdiction. Closer examination substantiates records of occurrence for 66 species, while records for the other 9 species were based on misinterpretations or are otherwise uncertain. Of these, at least 55 have been reported from reef habitat under federal protection within National Parks, Marine National Monuments, National Marine Sanctuaries, and National Wildlife Refuges. The highest number of species (31 is found within the Ofu Island unit of the National Park of American Samoa, followed by Kingman Reef (24 and Palmyra Atoll (21, both within the Pacific Remote Islands Marine National Monument. Federally protected areas already in place serve as important habitats for resources whose stewardship needs and priorities may vary over time.

  8. Does public reporting measure up? Federalism, accountability and child-care policy in Canada.

    Science.gov (United States)

    Anderson, Lynell; Findlay, Tammy

    2010-01-01

    Governments in Canada have recently been exploring new accountability measures within intergovernmental relations. Public reporting has become the preferred mechanism in a range of policy areas, including early learning and child-care, and the authors assess its effectiveness as an accountability measure. The article is based on their experience with a community capacity-building project that considers the relationship between the public policy, funding and accountability mechanisms under the federal/provincial/territorial agreements related to child-care. The authors argue that in its current form, public reporting has not lived up to its promise of accountability to citizens. This evaluation is based on the standards that governments have set for themselves under the federal/provincial/territorial agreements, as well as guidelines set by the Public Sector Accounting Board, an independent body that develops accounting standards over time through consultation with governments.

  9. Drug-related deaths with evidence of intracorporeal drug concealment at autopsy: five case reports.

    Science.gov (United States)

    Wilcher, Glenn

    2011-12-01

    Intracorporeal concealment of illicit drugs is a rare observation at coronial autopsy examinations. The article reports 5 cases of accidental drug overdoses at the Westmead Coronial Morgue, Sydney New South Wales, over a 6-year period with evidence of intracorporeal drug concealment known as body packing or body stuffing. Three different forms of anatomic concealment of drugs are illustrated, Case 2 involving therapeutic medication in the form of glass ampoules for parenteral injection not previously reported. Three deaths were the result of acute toxicity due to polydrug abuse rather than as a consequence of the body packing behavior and rupture of the drug packaging, with the intracorporeal drug concealments an adjunct finding at the autopsy examinations. The cause of death in Case 3 was the direct result of acute cocaine intoxication due to rupture of drug packages in the rectum and mucosal absorption. The article details forensic sociological aspects of drug concealment and subcultural group human behavior that can assist in providing information for the initiation of investigations.

  10. Sharing Drug 'Snorting Straws' Spreads Hepatitis C

    Science.gov (United States)

    ... journal Obstetrics & Gynecology . "Nearly all participants reported that opiates were the primary drug that was snorted," said ... or federal policy. More Health News on: Drug Abuse Prescription Drug Abuse Recent Health News Related MedlinePlus ...

  11. Adverse drug reactions to ibuprofen: a case report

    Directory of Open Access Journals (Sweden)

    Khobragade Yadneshwar

    2016-02-01

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

  12. [Reported adverse reactions of veterinary drugs and vaccines in 2005].

    Science.gov (United States)

    Müntener, C R; Bruckner, L; Gassner, B; Demuth, D C; Althaus, F R; Zwahlen, R

    2007-02-01

    We received 105 reports of suspected adverse events (SARs) following the use of veterinary drugs for the year 2005. This corresponds to a 35% increase compared to 2004. Practicing veterinarians sent most of these declarations. 73% of these concerned drugs used on companion animals. Antiparasitic drugs approved for topical use were the most frequently represented group with 48%, followed by drugs used to treat gastrointestinal disorders (11%) and drugs used off-label (14%; other target species or other indication). For the first time 2 declarations concerning the application of permethrin containing spot-on preparations used by mistake on cats were received. An overview of 20 declarations about adverse reactions following application of different vaccines is also presented with emphasis on the problem of fibrosarcoma in cats. We are pleased by the growing interest shown by practicing veterinarians for the vigilance system and hope to further develop this collaboration in the future.

  13. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

    Science.gov (United States)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne; Darsø, Perle; Christophersen, Anette Kvindebjerg; Borck, Bille; Christensen, Catrine; Hansen, Melissa Voigt; Halladin, Natalie Monica Løvland; Christensen, Mikkel Bring; Harboe, Kirstine Moll; Lund, Marie; Jimenez-Solem, Espen

    2017-01-01

    Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. none. not relevant. .

  14. Screening, testing, and reporting for drug and alcohol use on labor and delivery: a survey of Maryland birthing hospitals.

    Science.gov (United States)

    Miller, Catherine; Lanham, Amy; Welsh, Christopher; Ramanadhan, Shaalini; Terplan, Mishka

    2014-01-01

    Recent amendments to the Child Abuse Prevention and Treatment Act tie the receipt of federal block grants to mandatory reporting of substance-exposed newborns. To determine rates of screening, testing, and reporting of drug and alcohol use at the time of delivery, we administered a telephone survey of nursing managers and perinatal social workers at Maryland birthing hospitals. Of the 34 hospitals, 31 responded (response rate 91%). Although 97% of hospitals reported universal screening, only 6% used a validated instrument. Testing was reported by 94% with 45% reporting universal maternal testing and 7% universal newborn testing. Only 32% reported obtaining maternal consent prior to testing. There is significant heterogeneity in screening and testing for substance use in birthing hospitals. Given federal reporting mandates, state-level practices need to be standardized.

  15. [Regionalization of federal health reporting using the example of diabetes surveillance : Aims and results of the discussion between the Robert Koch Institute and the federal states].

    Science.gov (United States)

    Gabrys, Lars; Heidemann, Christin; Teti, Andrea; Borrmann, Brigitte; Gawrich, Stefan; Maulbecker-Armstrong, Catharina; Fertmann, Regina; Schubert, Ulrike; Schmidt, Christian; Baumert, Jens; Paprott, Rebecca; Du, Yong; Scheidt-Nave, Christa; Ziese, Thomas

    2017-09-04

    Insufficiently treated diabetes mellitus can lead to severe comorbidities. National and international analyses show a continuous increase in diabetes prevalence over the last decades. Currently, an indicator-based national diabetes surveillance system is implemented at the Robert Koch Institute (RKI) to monitor and report on diabetes development on the basis of available primary and secondary data. The aim of the meeting was to go into deeper discussions and to integrate expectations and expertise of the federal states into the design of the national surveillance system. A close collaboration between the RKI and the federal states is intended.

  16. Assessment of antimicrobial drug residues in beef in Abuja, the Federal Capital Territory, Nigeria

    Directory of Open Access Journals (Sweden)

    Okwoche J. Ode

    2012-09-01

    Full Text Available Drugs administered to food-producing animals close to the time of slaughter often result in prohibited antimicrobial residues in the animal tissues at slaughter. Evidence based on the Premi® test confirmed the occurrence of antimicrobial drug residues in 89.3% of kidney and urine samples from cattle slaughtered within Abuja town where the residents rely heavily on beef as a source of protein. The administration of antibiotics close to the time of slaughter by marketers/herd owners and transporters was found to be significantly (p<0.05 higher when compared with butchers and abattoir workers. The practice of administering antibiotics to animals close to the time of slaughter was believed to be profit-motivated. The research suggests that awareness campaigns amongst the stakeholders, the enactment of appropriate laws for the control of antibiotic use and the empowerment of veterinary public health practitioners in food regulatory agencies as some of the strategies which may positively reduce the risk of antimicrobial drug residues in food animals in Nigeria.

  17. Assessment of antimicrobial drug residues in beef in Abuja, the Federal Capital Territory, Nigeria.

    Science.gov (United States)

    Omeiza, Gabriel K; Ajayi, Itopa E; Ode, Okwoche J

    2012-01-01

    Drugs administered to food-producing animals close to the time of slaughter often result in prohibited antimicrobial residues in the animal tissues at slaughter. Evidence based on the Premi® test confirmed the occurrence of antimicrobial drug residues in 89.3% of kidney and urine samples from cattle slaughtered within Abuja town where the residents rely heavily on beef as a source of protein. The administration of antibiotics close to the time of slaughter by marketers/herd owners and transporters was found to be significantly (p<0.05) higher when compared with butchers and abattoir workers. The practice of administering antibiotics to animals close to the time of slaughter was believed to be profit-motivated. The research suggests that awareness campaigns amongst the stakeholders, the enactment of appropriate laws for the control of antibiotic use and the empowerment of veterinary public health practitioners in food regulatory agencies as some of the strategies which may positively reduce the risk of antimicrobial drug residues in food animals in Nigeria.

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

    Directory of Open Access Journals (Sweden)

    HOE SEE LEI

    2007-01-01

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

  19. Pulmonary fibrosis associated with psychotropic drug therapy: a case report

    Directory of Open Access Journals (Sweden)

    Thornton Clare

    2009-11-01

    Full Text Available Abstract Introduction Sertraline and Risperidone are commonly used psychotropic drugs. Sertraline has previously been associated with eosinopilic pneumonia. Neither drug is recognised as a cause of diffuse fibrotic lung disease. Our report represents the first such case. Case Presentation We describe the case of a 33 year old Asian male with chronic schizophrenia who had been treated for three years with sertraline and risperidone. He presented to hospital in respiratory failure following a six month history of progressive breathlessness. High resolution CT scan demonstrated diffuse pulmonary fibrosis admixed with patchy areas of consolidation. Because the aetiology of this man's diffuse parenchymal lung disease remained unclear a surgical lung biopsy was undertaken. Histological assessment disclosed widespread fibrosis with marked eosinophillic infiltration and associated organising pneumonia - features all highly suggestive of drug induced lung disease. Following withdrawal of both sertraline and risperidone and initiation of corticosteroid therapy the patient's respiratory failure resolved and three years later he remains well albeit limited by breathlessness on heavy exertion. Conclusion Drug induced lung disease can be rapidly progressive and if drug exposure continues may result in respiratory failure and death. Prompt recognition is critical as drug withdrawal may result in marked resolution of disease. This case highlights sertraline and risperidone as drugs that may, in susceptible individuals, cause diffuse pulmonary fibrosis.

  20. 23 CFR Appendix C to Subpart A of... - Federal-Aid Highway Contractors Annual EEO Report (Form PR-1391)

    Science.gov (United States)

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Federal-Aid Highway Contractors Annual EEO Report (Form PR-1391) C Appendix C to Subpart A of Part 230 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF... Construction Contracts (Including Supportive Services) Pt. 230, Subpt. A, App. C Appendix C to Subpart A...

  1. Annual Report to Congress on Federal Government Energy Management and Conservation Programs Fiscal Year 2006

    Energy Technology Data Exchange (ETDEWEB)

    None

    2008-11-26

    This document provides information on energy consumption in Federal buildings, operations, and vehicles and equipment, and documents activities conducted by Federal agencies to meet the statutory requirements.

  2. Annual report to Congress on Federal Government Energy Management and Conservation Programs Fiscal Year 1999

    Energy Technology Data Exchange (ETDEWEB)

    None

    2001-05-01

    This document provides information on energy consumption in Federal buildings, operations, and vehicles and equipment, and documents activities conducted by Federal agencies to meet the statutory requirements.

  3. Annual Report to Congress on Federal Government Energy Management and Conservation Programs Fiscal Year 2000

    Energy Technology Data Exchange (ETDEWEB)

    None

    2002-12-13

    This document provides information on energy consumption in Federal buildings, operations, and vehicles and equipment, and documents activities conducted by Federal agencies to meet the statutory requirements.

  4. Annual Report to Congress on Federal Government Energy Management and Conservation Programs Fiscal Year 2001

    Energy Technology Data Exchange (ETDEWEB)

    None

    2004-02-04

    This document provides information on energy consumption in Federal buildings, operations, and vehicles and equipment, and documents activities conducted by Federal agencies to meet the statutory requirements.

  5. Annual Report to Congress on Federal Government Energy Management and Conservation Programs Fiscal Year 2007

    Energy Technology Data Exchange (ETDEWEB)

    None

    2010-01-27

    This document provides information on energy consumption in Federal buildings, operations, and vehicles and equipment, and documents activities conducted by Federal agencies to meet the statutory requirements.

  6. Annual Report to Congress on Federal Government Energy Management and Conservation Programs Fiscal Year 2005

    Energy Technology Data Exchange (ETDEWEB)

    None

    2006-09-26

    This document provides information on energy consumption in Federal buildings, operations, and vehicles and equipment, and documents activities conducted by Federal agencies to meet the statutory requirements.

  7. Annual Report to Congress on Federal Government Energy Management and Conservation Programs Fiscal Year 2002

    Energy Technology Data Exchange (ETDEWEB)

    None

    2004-09-29

    This document provides information on energy consumption in Federal buildings, operations, and vehicles and equipment, and documents activities conducted by Federal agencies to meet the statutory requirements.

  8. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Science.gov (United States)

    2012-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Compliance Policy for... guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information Under... availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug...

  9. 45 CFR 61.7 - Reporting licensure actions taken by Federal or State licensing and certification agencies.

    Science.gov (United States)

    2010-10-01

    ...) Name of the agency taking the action; (vii) Name and address of the reporting entity; and (viii) The... reporting entity. (c) Entities described in paragraph (a) of this section should report, if known, the... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting licensure actions taken by Federal...

  10. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

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

    2010-01-01

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

  11. Capecitabine-induced lichenoid drug eruption: a case report.

    Science.gov (United States)

    Gehlhausen, Jeff R; Strausburg, Matthew B; Aouthmany, Mouhammad; Katona, Terrence M; Turner, Matthew J

    2017-02-15

    Capecitabine is a 5-fluorouracil basedchemotherapeutic drug widely used in the treatmentof solid tumors, especially colorectal and breast. Someof the most common side effects of capecitabine arecutaneous in nature, including hand-foot syndrome(palmar-plantar erythrodysesthesia). Several reports inthe literature link capecitabine use with photosensitivelichenoid eruptions. Herein, we present a case ofcapecitabine-induced lichenoid eruption in an elderlyfemale with metastatic breast cancer and discuss ourfindings in relationship to previously reported cases ofthis and other capecitabine-induced skin pathologies.

  12. Prevalência do consumo de álcool, tabaco e entorpecentes por estudantes de medicina da Universidade Federal de Minas Gerais Prevalence of alcohol, tobacco and psychotropic drug consumption by medical students of the "Universidade Federal de Minas Gerais"

    Directory of Open Access Journals (Sweden)

    Andy Petroianu

    2010-01-01

    Full Text Available OBJETIVO: Verificar a prevalência do consumo de álcool, tabaco e entorpecentes por estudantes da Faculdade de Medicina da Universidade Federal de Minas Gerais e determinar fatores relacionados a esse consumo. MÉTODOS: Este trabalho foi realizado com estudantes de todos os anos do curso de Medicina, convidados a participar, de forma anônima, respondendo a um questionário autoaplicável, que foi previamente avaliado e adequado à realidade brasileira. Esse questionário foi estruturado com base no World Health Organization's Guidelines for Student Substance Use Survey e consistiu de 25 perguntas relacionadas ao uso de drogas. A comparação das médias foi por teste T de Student e as proporções foram avaliadas usando o teste Qui quadrado. RESULTADOS: Contato com bebidas alcoólicas ocorreu em 85,2% e com tabaco em 16,3% dos entrevistados. Dentre as drogas entorpecentes, a maconha foi consumida por 16,5%, LSD por 6,9%, ansiolíticos por 12%, estimulantes por 7,5% e solventes por 16,8% dos estudantes. Foi raro o consumo de cocaína, crack, opioides, xaropes ou anabolizantes. CONCLUSÃO: A droga mais consumida foi o álcool. Seu uso relacionou-se com o consumo de outras substâncias, sendo que a adesão a drogas ocorreu mais em estudantes solteiros, do sexo masculino, que moram longe da família e não dependem de si para seu sustento ou o de sua família.OBJECTIVE: The purpose of this study was to assess the prevalence of alcohol, tobacco and psychotropic drug consumption by students of the Medical School of the Federal University of Minas Gerais, Brazil, and to verify aspects related to those addictions. METHODS: This study was carried out with students of all years of the medical course invited to participate anonymously, by answering a self-applied questionnaire which was previously evaluated and adapted to Brazilian reality. It was based upon the World Health Organization's Guidelines for Student Substance Use Survey and included 25

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

    NARCIS (Netherlands)

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

    2006-01-01

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

  14. Transparency of information of federal universities: study of management reports in light of governance principles

    Directory of Open Access Journals (Sweden)

    Luzia Zorzal

    2016-03-01

    Full Text Available This article is based on a doctoral research in Information Science which examines to what extent Management Reports of Federal Universities meet the governance principles established for the public sector, according to national and international guidelines. It is exploratory, descriptive, qualitative research whose interpretation of the data it is anchored on content analysis. It has as universe the 63 Brazilian federal universities, of which those that were ranked at the top of Ranking Webometrics, in each of the five geographic regions were selected. Results show that the five analyzed universities do not reach a high transparency level. Two universities ranked in the medium-high level and three in medium-low level. The compliance with principles of good governance on the Management Reports of these universities is still insufficient to achieve the highest level of transparency. The data show that to improve this profile to increase the active transparency under Brazilian law on access to information and the dissemination of information needs to be timely, with clarity and accuracy implanting good governance practices is necessary. Such initiative could mitigate informational asymmetry and democratize the relationship between State and citizens.

  15. 2012 drug packaging review: many dangerous, reportable flaws.

    Science.gov (United States)

    2013-05-01

    Drug packaging plays an important role in protecting and providing information to patients. The packaging examined by Prescrire in 2012, on the whole, still fails to perform all of these functions effectively. Two issues are especially worrisome. First, packaging too often poses a danger to children. In addition, too many patient leaflets provide incomplete information about adverse effects, thus failing to properly protect the most vulnerable patients. Yet, the method Prescrire used to analyse drug packaging shows that it is not difficult to detect and anticipate risks. It is up to healthcare professionals to take advantage of the method, to protect patients from, and report, dangerous packaging.

  16. 21 CFR 316.30 - Annual reports of holder of orphan-drug designation.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Annual reports of holder of orphan-drug designation. 316.30 Section 316.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... of holder of orphan-drug designation. Within 14 months after the date on which a drug was...

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  18. Radioprotective Drugs: A Synopsis of Current Research and a Proposed Research Plan for the Federal Emergency Management Agency.

    Science.gov (United States)

    1985-04-01

    Lawrence Livermore National Laboratory *P.O. Box 808 2431D Livermore, CA 94550 ______ 11. CONTROLLING OFFICE NAME AND ADDRESS 12. REPORT DATE April 1985...administration of drugs is preferred, to give the highest degree of control possible. Specific tumors are to be made more sensitive to radiation, while the...PJlanification c/Evaristo San Miguel, 8 Madrid-8 SPAIN Ministero dell Interno * ~Direzione Generale della -’- - Protezione Civile 00100 Rome ITALY

  19. The mental health of graduate students at the Federal University of São Paulo: a preliminary report

    Directory of Open Access Journals (Sweden)

    L.A. Nogueira-Martins

    2004-10-01

    Full Text Available We present data regarding the care provided to graduate level health professionals at the mental health center of the Federal University of São Paulo. From September 1996 to September 2003, 146 graduate students (99 in the Master's degree program and 47 in the Doctoral program were attended. This population was predominantly female (68.5%, with a mean (± SD age of 28.6 ± 4.42 years, not married (71.9%. Most of the subjects were professionals who had not graduated from the Federal University (78.1%. The students who sought help for psychological and/or psychiatric problems were classified into two categories: situational-adaptive crises and psychopathological crises. The main diagnoses were depression and anxiety disorders (44% causing 4.5% of the subjects to be temporarily suspended from their graduate studies; 19.2% reported that they had used psychotropic drugs within the previous month, and 47.9% referred to sleep disturbances. Suicidal tendencies were mentioned by 18% of those interviewed. Students with emotional disturbances and academic dysfunctions should be recognized at an early stage, and it is fundamental for them to have access to mental health programs that provide formal, structured and confidential care. Thus, it is important that professors and advisors in graduate programs build a warm and affective learning environment. If we consider the expressive growth in Brazilian scientific production resulting from the implementation of an extensive national system of graduate education, it is important to focus efforts on enhancing and upgrading the mental health care system.

  20. Federal regulation of the pipeline industry. A summary review. Technical report, Task 2

    Energy Technology Data Exchange (ETDEWEB)

    Banks, W. F.

    1977-05-31

    The principal purposes of this report are to identify the jurisdiction areas of the federal pipeline regulating agencies, and to examine the amenability of the regulatory system to the introduction of energy-conservative new technology into the pipeline industry. The history, scope, and agency structure of state and federal regulation are recounted and some gaps, overlaps, and ambiguities are identified. The only significant inhibitory effects upon technological innovation are found to derive from the FPC and ICC limits upon profit, the 1941 Justice Department consent decree limiting dividends to shipper-owned pipelines, and the income tax rules governing recovery of investment credits and startup losses. Effects of these limits are explored by simulation studies using the Systems, Science and Software pipeline economic model (PEM). Two new concepts of regulation are proposed which would neutralize the inhibitory effect of the present regulatory system and would motivate pipeline operators to conserve energy: one, the use of a national equivalent value in the economic trade-off analyses which justify entry of a technological innovation into the rate base (valuation); and two, a valuation allowance which would reverse the presently often-existing situation and insure that the pipeline operator would realize a greater profit from saving energy than from wasting it.

  1. D3.6 Report on implementation of the ECO Federated Search infrastructure

    OpenAIRE

    Ternier, Stefaan; Loozen, Kjeld; Viñuales, Javier; Tejera, Sara; Tomasini, Alessandra; Unruh, Sören

    2016-01-01

    This document describes the implementation of the ECO federated search architecture. It presents an analysis of various architectures and defines based on this analysis an architectural solution for federated search in ECO.

  2. Percutaneous drug-eluting stent implantation in dextrocardia: case report

    Institute of Scientific and Technical Information of China (English)

    ZHANG Qi; ZHANG Rui-yan; HU Jian; SHEN Wei-feng

    2007-01-01

    @@ Although situs inversus with dextrocardia is a rare clinical phenomenon, the association with coronary artery disease(CAD) is at the same frequency as in the general population.1,2 Few cases of dextrocardia complicated with CAD was reported before. The feasibility and prognosis of percutaneous coronary intervention (PCI) in such case still remains unclear because of the uncommon anatomical abnormality,especially in the drug-eluting stent (DES) era. Here we report a female case with dextrocardia and CAD was successfully treated by DES implantation.

  3. Improving reporting of adverse drug reactions: Systematic review

    Directory of Open Access Journals (Sweden)

    Mariam Molokhia

    2009-05-01

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

  4. DOE-HUD Initiative on Energy Efficiency in Housing: A federal partnership. Program summary report

    Energy Technology Data Exchange (ETDEWEB)

    Brinch, J. [Energetics, Inc., Columbia, MD (United States)

    1996-06-01

    One of the primary goals of the US Department of Housing and urban Development (HUD) is the expansion of home ownership and affordable housing opportunities. Recognizing that energy efficiency is a key component in an affordable housing strategy, HUD and the US Department of Energy (DOE) created the DOE-HUD Initiative on Energy Efficiency in Housing. The DOE-HUD Initiative was designed to share the results of DOE research with housing providers throughout the nation, to reduce energy costs in federally-subsidized dwelling units and improve their affordability and comfort. This Program Summary Report provides an overview of the DOE-HUD Initiative and detailed project descriptions of the twenty-seven projects carried out with Initiative funding.

  5. Intentional injury reported by young people in the Federated States of Micronesia, Kingdom of Tonga and Vanuatu

    Directory of Open Access Journals (Sweden)

    Havea Drew

    2008-04-01

    Full Text Available Abstract Background Intentional injury presents a threat to the physical and psychological well being of young people, especially in developing countries, which carry the greatest part of the global injury burden. While the importance of this problem is recognized, there are limited population data in low and middle income countries that can guide public health action. The present study investigates the prevalence and distribution of intentional injury among young people in three Pacific Island societies, and examines behavioural and psychosocial factors related to risk of intentional injury. Methods Population surveys were conducted with students aged 11–17 years in Pohnpei State in the Federated States of Micronesia (n = 1495, the Kingdom of Tonga (n = 2808 and Vanuatu (n = 4474. Surveys measured self-reported injury and intentional injury, sources of intentional injury, and the range of behavioural, psychological, educational and social variables that may be related to injury risk. Results Among boys and girls aged 14–17 years the respective period prevalence of intentional injury was 62% and 56% in Pohnpei, 58% and 41% in Tonga, and 33% and 24% in Vanuatu. The prevalence of intentional injury declined with age in Tonga and Vanuatu, but there was little evidence of an age-trend in Pohnpei. Across the three societies, the major sources of intentional injury among boys were 'other persons' followed by boyfriends/girlfriends and fathers. Mothers, boyfriends/girlfriends and other persons were primary sources of injury among girls. An intentional injury was reported more often by those who had been bullied (OR 1.40–1.66, P Conclusion Intentional injury was reported extensively in these three populations. Interventions directed towards the school environment and which take into account the role of bullying and drug use need to be considered.

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

    Directory of Open Access Journals (Sweden)

    Caterina Palleria

    2013-01-01

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

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

    Science.gov (United States)

    Royer, R J; Benichou, C

    1991-01-01

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

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

    NARCIS (Netherlands)

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

    2010-01-01

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

  9. Financial Audit. Federal Family Education Loan Program's Financial Statements for Fiscal Year 1992. Report to the Congress.

    Science.gov (United States)

    Comptroller General of the U.S., Washington, DC.

    This report presents the results of an audit of the Principal Financial Statements of the Department of Education's Federal Family Education Loan Program and its internal controls and compliance with laws and regulations for the fiscal year ended September 30, 1992. The report details the following findings: (1) the Statement of Cash Flows were…

  10. Two Case Reports on Use of Prazosin for Drug Dreams.

    Science.gov (United States)

    Gopalakrishna, Ganesh; Popoola, Oluwole; Campbell, Austin; Nemetalla, Marina A

    2016-01-01

    Substance abuse and dependence is estimated to cost roughly $700 billion annually including direct and indirect care in the United States. Drug dreams (DD), or using dreams, are a reportedly common phenomenon among patients with substance abuse, and have been postulated as triggers for relapse. Prazosin is an alpha-1 receptor antagonist originally approved by the United States Food and Drug Administration for the treatment of hypertension. Prazosin passes the blood brain barrier easily, contributing to central and cognitive effects. Prazosin's efficacy has been demonstrated in the management of posttraumatic stress disorder (PTSD), and associated nightmares. We present the cases of two patients with substance use disorder experiencing DD which resolved after the addition of prazosin during an acute psychiatric hospitalization. To our knowledge, this is the first time treatment of DD with prazosin has been reported in the literature. Both patients reported an alleviation of their DD after the medication was initiated. The effect was immediate and results were seen on the same night of the initial dose. The precise mechanism of this effect is unclear, but we hypothesize it is related to the decrease in noradrenaline effects at α-1 adrenoreceptors in the brain, similar to the effect on nightmares in PTSD. The key limitation is the low number of patients and lack of follow up presented in this report. No causal relationship can be established between the use of prazosin and resolution of DD in our patients.

  11. 49 CFR 199.119 - Reporting of anti-drug testing results.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Reporting of anti-drug testing results. 199.119... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY DRUG AND ALCOHOL TESTING Drug Testing § 199.119 Reporting of anti-drug testing results. (a) Each large operator...

  12. Drug-associated acute pancreatitis : twenty-one years of spontaneous reporting in The Netherlands

    NARCIS (Netherlands)

    Eland, I A; van Puijenbroek, E P; Sturkenboom, M J; Wilson, J H; Stricker, B H

    OBJECTIVE: Drugs are considered a rare cause of acute pancreatitis. We conducted a descriptive study to assess which drugs have been associated with acute pancreatitis in spontaneous adverse drug reaction reports in The Netherlands. METHODS: Our study is based on reports of drug-associated acute

  13. Drug-associated acute pancreatitis : twenty-one years of spontaneous reporting in The Netherlands

    NARCIS (Netherlands)

    Eland, I A; van Puijenbroek, E P; Sturkenboom, M J; Wilson, J H; Stricker, B H

    1999-01-01

    OBJECTIVE: Drugs are considered a rare cause of acute pancreatitis. We conducted a descriptive study to assess which drugs have been associated with acute pancreatitis in spontaneous adverse drug reaction reports in The Netherlands. METHODS: Our study is based on reports of drug-associated acute pan

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Abdullahi Rabiu Abubakar

    2015-01-01

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

  16. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Science.gov (United States)

    2013-11-27

    ...; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information... Operators to Report Contractor Management Information System (MIS) Data; and New Method for Operators to... ``user name'' and ``password'' for the Drug and Alcohol Management Information System (DAMIS)...

  17. Oak Ridge Reservation Federal Facility Agreement: Quarterly report for the Environmental Restoration Program. Volume 2, January--March 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-04-01

    This report provides information about ER Program activities conducted on the Oak Ridge Reservation under the Federal Facility Agreement (FFA). Specifically, it includes information on milestones scheduled for completion during the reporting period as well as scheduled for completion during the next reporting period (quarter), accomplishments of the ER Program, concerns related to program work, and scheduled activities for the next quarter. It also provides a listing of the identity and assigned tasks of contractors performing ER Program work under the FFA.

  18. Problem of drug addiction in the youth in the Republic of North Ossetia-Alania of the RF North Caucasian Federal District

    Directory of Open Access Journals (Sweden)

    Hasan Vladimirovich Dzutsev

    2015-03-01

    Full Text Available This article is based on the large-scale survey “the problem of drug addiction among the youth in the Republic of North Ossetia-Alania of the RF North Caucasian Federal District”. In April-May North Ossetian Center of Social Research of the Institute of Socio-Political Research RAS together with North Ossetian State University after K.L. Khetagurov conducted a monitoring aimed at evaluating the drug abuse situation in the Republic of North Ossetia-Alania and identifying the causes of drug abuse among young citizens of the republic. It studied the system of beliefs, habits and aspirations of young people. The research focused on the sociological assessment of the drug abuse situation in the Republic of North Ossetia and it was based on the study of systems of beliefs, habits and preferences of the residents, as well as on the identification of the reasons for the spread of drug addiction among the population. The achievement of this goal required solution of the following tasks: • to evaluate beliefs, value systems, life plans, the state of health of the North Ossetia-Alania citizens, learn their opinion on the possibility of rational leisure time and recreation by means of monitoring; • to assess bad habits of the republic citizens, estimate the society’s relation to the problems of drug addiction and drug addicts, analyze the reasons for the emergence and existence of this phenomenon in the society; • to evaluate effectiveness of the measures to combat drug addiction; • to identify reasons for drug addiction, most frequently used types of drugs, the cost of a single dose, a market place and consumers’ access to drugs; • to assess practical activities aimed at improving the drug abuse situation in the republic. The sample size was 600 people

  19. Statewide Writing Assessment Follow-Up; Federal Reporting Requirements; Preparing the School District Assessment Portfolio. Update # 5. STARS: School-Based Teacher-Led Assessment and Reporting System.

    Science.gov (United States)

    Nebraska State Dept. of Education, Lincoln.

    This update provides information about the Nebraska Statewide Writing Assessment follow-up, the federal reporting of assessment information, and preparing the school District Assessment Portfolio. The information is intended to assist local educators in the reporting of local assessment information in June 2001. The update on the writing…

  20. Trends in reports of driving following illicit drug consumption among regular drug users in Australia, 2007-2013: Has random roadside drug testing had a deterrent effect?

    Science.gov (United States)

    Horyniak, Danielle; Dietze, Paul; Lenton, Simon; Alati, Rosa; Bruno, Raimondo; Matthews, Allison; Breen, Courtney; Burns, Lucy

    2017-07-01

    Driving following illicit drug consumption ('drug-driving') is a potential road safety risk. Roadside drug testing (RDT) is conducted across Australia with the dual aims of prosecuting drivers with drugs in their system and deterring drug-driving. We examined trends over time in self-reported past six-month drug-driving among sentinel samples of regular drug users and assessed the impact of experiences of RDT on drug-driving among these participants. Data from 1913 people who inject drugs (PWID) and 3140 regular psychostimulant users (RPU) who were first-time participants in a series of repeat cross-sectional sentinel studies conducted in Australian capital cities from 2007 to 2013 and reported driving in the past six months were analysed. Trends over time were assessed using the χ(2) test for trend. Multivariable logistic regressions assessed the relationship between experiences of RDT and recent drug-driving, adjusting for survey year, jurisdiction of residence and socio-demographic and drug use characteristics. The percentage of participants reporting recent (past six months) drug-driving decreased significantly over time among both samples (PWID: 83% [2007] vs. 74% [2013], pdrug-driving remained prevalent. Lifetime experience of RDT increased significantly over time (PWID: 6% [2007] vs. 32% [2013], pdrug-driving among either PWID or RPU. Although there is some evidence that drug-driving among key risk groups of regular drug users is declining in Australia, possibly reflecting a general deterrent effect of RDT, experiencing RDT appears to have no specific deterrent effect on drug-driving. Further intervention, with a particular focus on changing attitudes towards drug-driving, may be needed to further reduce this practice among these groups. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Science.gov (United States)

    2010-09-29

    ... and Research (CDER)-related information are posted on the Internet at http://www.fda.gov/Drugs... that do not result in hospitalization, or the development of drug dependency or drug abuse.'' (Comment...

  2. The New State Achievement Gap: How Federal Waivers Could Make It Worse--or Better. Education Sector Reports

    Science.gov (United States)

    Chubb, John; Clark, Constance

    2013-01-01

    With the adoption of the No Child Left Behind Act (NCLB) in 2002, the federal government signaled its intention to close achievement gaps in K-12 education, particularly for minority students. While there has been surprising progress in educating disadvantaged students since the law was passed, according to a new report released today by Education…

  3. 77 FR 44177 - Antimicrobial Animal Drug Sales and Distribution Reporting

    Science.gov (United States)

    2012-07-27

    ... addressing the judicious use of medically important antimicrobial drugs in food-producing animals (Ref. 2... information about the extent of antimicrobial drug use in food-producing animals. Specifically, the Agency is... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales...

  4. Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

    Science.gov (United States)

    Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

    2012-05-01

    In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

  5. Knowledge of food and drug administration reportable deviations.

    Science.gov (United States)

    Lam, Rebecca; Bryant, Barbara J

    2011-07-01

    As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations. Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service. There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization. This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations. © 2011 American Association of Blood Banks.

  6. Electronic Health Record Vendors Reported by Health Care Providers Participating in Federal EHR Incentive Programs

    Data.gov (United States)

    U.S. Department of Health & Human Services — This public use file combines registration data compiled from two federal programs that are on-going since February 2009 – the Centers for Medicare & Medicaid...

  7. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  8. Data Intensive Scientific Workflows on a Federated Cloud: CRADA Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Garzoglio, Gabriele [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States)

    2015-10-31

    The Fermilab Scientific Computing Division and the KISTI Global Science Experimental Data Hub Center have built a prototypical large-scale infrastructure to handle scientific workflows of stakeholders to run on multiple cloud resources. The demonstrations have been in the areas of (a) Data-Intensive Scientific Workflows on Federated Clouds, (b) Interoperability and Federation of Cloud Resources, and (c) Virtual Infrastructure Automation to enable On-Demand Services.

  9. What Are Youth Asking about Drugs? A Report of NIDA Drug Facts Chat Day

    Science.gov (United States)

    Morton, Cory M.; Hoefinger, Heidi; Linn-Walton, Rebecca; Aikins, Ross; Falkin, Gregory P.

    2015-01-01

    The current study analyzes a sample of questions about drugs asked online by youth who participated in the National Institute on Drug Abuse's (NIDA) "Drug Facts Chat Day." The types of drugs youth asked about were coded into 17 substance categories, and the topics they raised were coded into seven thematic categories. The top five…

  10. What Are Youth Asking about Drugs? A Report of NIDA Drug Facts Chat Day

    Science.gov (United States)

    Morton, Cory M.; Hoefinger, Heidi; Linn-Walton, Rebecca; Aikins, Ross; Falkin, Gregory P.

    2015-01-01

    The current study analyzes a sample of questions about drugs asked online by youth who participated in the National Institute on Drug Abuse's (NIDA) "Drug Facts Chat Day." The types of drugs youth asked about were coded into 17 substance categories, and the topics they raised were coded into seven thematic categories. The top five…

  11. Drug abuse, a rare cause of stroke: Case report

    Directory of Open Access Journals (Sweden)

    Zeynep Özözen Ayas

    2017-04-01

    Full Text Available At the present time the incidence of illicit drug use increases worldwide among young adults. Abuse of these substances is a rare cause of stroke in young adults. Cocaine, heroin, cannabis, and amphetamines use increase the risk of stroke. Cannabis sativa induce main effects by delta-9-hydrocannabinol. The main mechanism of marijuana-related stroke in young patients is vasospazm. The other possible mechanisms are systemic hypotension, impaired cerebral autoregulation, alteration of cerebral blood flow, cardioembolism due to atrial fibrillation. In this article a 25-year-old young male patient with paresia and paresthesia of right side who had chronic abuse of marijuana is reported. Clinicians must be alert about marijuana can be seriously harmful to cerebrovascular system in chronic use.

  12. Patient knowledge on reporting adverse drug reactions in Poland

    Science.gov (United States)

    Staniszewska, Anna; Dąbrowska-Bender, Marta; Olejniczak, Dominik; Duda-Zalewska, Aneta; Bujalska-Zadrożny, Magdalena

    2017-01-01

    Aim The aim of the study was to assess patient knowledge on reporting of adverse drug reactions. Materials and methods A prospective study was conducted among 200 patients. The study was based on an original survey composed of 15 single- and multiple-choice questions. The study involved individuals who have experienced adverse reactions as well as individuals who have never experienced any adverse reactions; people over the age of 18; literate; residing in Mazowieckie Voivodeship, who have not been diagnosed with any disease that could compromise their logical thinking skills. Results The respondents who lived in the city had a greater knowledge compared to the respondents who lived in the countryside (Pearson’s χ2=47.70, P=0.0013). The respondents who lived in the city were also more statistically likely to provide a correct answer to the question about the type of adverse reactions to be reported (Pearson’s χ2=50.66, P=0.012). Statistically significant associations were found between the place of residence of the respondents and the correct answer to the question about the data that must be included in the report on adverse reactions (Pearson’s χ2=11.7, P<0.0001). PMID:28096661

  13. 77 FR 52696 - Federal Acquisition Regulation; Information Collection; Drug-Free Workplace (FAR 52.223-6)

    Science.gov (United States)

    2012-08-30

    ... Regulation; Information Collection; Drug-Free Workplace (FAR 52.223-6) AGENCY: Department of Defense (DOD... approved information collection requirement concerning drug- free workplace. Public comments are... Information Collection 9000- 0101, Drug-Free Workplace, by any of the following methods:...

  14. Governance and One Health: Exploring the Impact of Federalism and Bureaucracy on Zoonotic Disease Detection and Reporting

    Directory of Open Access Journals (Sweden)

    Heather A. Allen

    2015-05-01

    Full Text Available The merits of One Health have been thoroughly described in the literature, but how One Health operates in the United States federal system of government is rarely discussed or analyzed. Through a comparative case-study approach, this research explores how federalism, bureaucratic behavior, and institutional design in the United States may influence zoonotic disease outbreak detection and reporting, a key One Health activity. Using theoretical and empirical literature, as well as a survey/interview instrument for individuals directly involved in a past zoonotic disease outbreak, the impacts of governance are discussed. As predicted in the theoretical literature, empirical findings suggest that federalism, institutional design, and bureaucracy may play a role in facilitating or impeding zoonotic disease outbreak detection and reporting. Regulatory differences across states as well as compartmentalization of information within agencies may impede disease detection. However, the impact may not always be negative: bureaucracies can also be adaptive; federalism allows states important opportunities for innovation. While acknowledging there are many other factors that also matter in zoonotic disease detection and reporting, this research is one of the first attempts to raise awareness in the literature and stimulate discussion on the intersection of governance and One Health.

  15. Hallucinogens and Dissociative Drugs, Including LSD, PCP, Ketamine, Dextromethorphan. National Institute on Drug Abuse Research Report Series.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHHS/PHS), Rockville, MD.

    Research is developing a clearer picture of the dangers of mind-altering drugs. The goal of this report is to present the latest information to providers to help them strengthen their prevention and treatment efforts. A description is presented of dissociative drugs, and consideration is given as to why people take hallucinogens. The physical…

  16. JPRS Report, Science & Technology, Europe & Latin America, Brazil: Selections from the 1987 Federal S&T Budget.

    Science.gov (United States)

    1988-02-24

    Federal University of Santa Catarina 74 . Federal University of Santa Maria 74 . Federal Rural University of Pernambuco 75 . Federal Rural...Federal University of Pernambuco 5,645 Activities run by Federal University of Santa Catarina 107,350 Activities run by Federal University...Grande do Sul 1,800 Activities run by Federal University of Rio de Janeiro 84,292 Activities run by Federal University of Santa Catarina

  17. Analysis of the permitting processes associated with exploration of Federal OCS leases. Final report. Volume II. Appendices

    Energy Technology Data Exchange (ETDEWEB)

    1980-11-01

    Under contract to the Office of Leasing Policy Development (LPDO), Jack Faucett Associates is currently undertaking the description and analysis of the Outer Continental Shelf (OCS) regulatory process to determine the nature of time delays that affect OCS production of oil and gas. This report represents the results of the first phase of research under this contract, the description and analysis of regulatory activity associated with exploration activities on the Federal OCS. Volume 1 contains the following three sections: (1) study results; (2) Federal regulatory activities during exploration of Federal OCS leases which involved the US Geological Survey, Environmental Protection Agency, US Coast Guard, Corps of Engineers, and National Ocean and Atmospheric Administration; and (3) state regulatory activities during exploration of Federal OCS leases of Alaska, California, Louisiana, Massachusetts, New Jersey, North Carolina and Texas. Volume II contains appendices of US Geological Survey, Environmental Protection Agency, Coast Guard, Corps of Engineers, the Coastal Zone Management Act, and Alaska. The major causes of delay in the regulatory process governing exploration was summarized in four broad categories: (1) the long and tedious process associated with the Environmental Protection Agency's implementation of the National Pollutant Discharge Elimination System Permit; (2) thelack of mandated time periods for the completion of individual activities in the permitting process; (3) the lack of overall coordination of OCS exploratory regulation; and (4) the inexperience of states, the Federal government and industry relating to the appropriate level of regulation for first-time lease sale areas.

  18. Benefit-cost analysis of DOE's Current Federal Program to increase hydrothermal resource utilization. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1981-12-10

    The impact of DOE's Current Federal Program on the commercialization of hydrothermal resources between 1980 and 2000 is analyzed. The hydrothermal resources of the United States and the types of DOE activities used to stimulate the development of these resources for both electric power and direct heat use are described briefly. The No Federal Program and the Current Federal Program are then described in terms of funding levels and the resultant market penetration estimates through 2000. These market penetration estimates are also compared to other geothermal utilization forecasts. The direct benefits of the Current Federal Program are next presented for electric power and direct heat use applications. An analysis of the external impacts associated with the additional hydrothermal resource development resulting from the Current Federal Program is also provided. Included are environmental effects, national security/balance-of-payments improvements, socioeconomic impacts and materials requirements. A summary of the analysis integrating the direct benefits, external impacts and DOE program costs concludes the report.

  19. Comprehensive program and plan for federal energy education, extension, and information activities: Fiscal Year 1981. Fifth report to congress

    Energy Technology Data Exchange (ETDEWEB)

    1981-12-01

    The activities conducted solely in Fiscal Year (FY) 1981 in the areas of Federal energy education, extension service, and information dissemination are reported. The broad purpose of the FY 1981 activities addressed has been to inform governmental and private sectors about the methods and technologies to conserve energy and to utilize renewable energy sources. With the increase in awareness on the part of energy users and decisionmakers, as well as additional information sources available from the private sector, the emphasis of the various Federal energy information activities is being focused on reporting results of Federal programs. The course of activities related to conservation and renewable energy information has been one of consolidation, both in terms of programmatic substance and methods. The practical impetus has been the redirection of Federal progrms and related budgetary revisions for FY 1981 and FY 1982. Further, products conveying information on conservation and renewable energy technologies have been examined extensively, pursuant to the Administration's directive in April 1981 on elimination of wasteful spending on periodicals, audiovisuals and similar materials. Efforts in coordination of conservation and renewable energy information activities of the Department of Energy (DOE) as well as other Federal agencies have adjusted to timetables for review and redirection of programs initially planned for FY 1981. Mechanisms to coordinate existing Federal energy information activities employed in previous fiscal years were continued in FY 1981 to the extent applicable under current Administration policy and the above-noted circumstances of redirection. Coordinating actions requiring convening of groups were held in abeyance pending resolution of programmatic issues.

  20. Annual Report 2003. Research programme 'Electricity' of the Swiss Federal Office of Energy

    Energy Technology Data Exchange (ETDEWEB)

    Brueniger, R.

    2004-07-01

    This report for the Swiss Federal Office of Energy (SFOE) summarises the work done in 2003 in the various research areas covered by the Swiss Electricity Research programme. Work done in the programme's five main areas - electricity transport and storage, high-temperature superconductivity, energy and information technologies, drives and electric motors, and appliances is reviewed. In the electricity transport and storage area an agreement with the Swiss Association of Electricity Producers (VSE) on the transfer of findings was made and the focus of work was set on decentralised systems. Also, the use of compressed-air storage systems was looked at and the AC corrosion of pipelines was examined. Swiss participation in an IEA Implementing Agreement for a Co-operative Programme for Assessing the Impact of High-Temperature Superconductivity on the Electric Power Sector is mentioned, as is the market potential of superconductive current limiters. A total of 8 institutions and industries are involved in theoretical or practical research in the area of high-temperature superconductors. Information and communications technologies are reviewed, including work on energy-efficient EDP server management. Work in other areas summarised includes lighting and uninterruptible power-supplies and work on the energy consumption of process control units. In the electrical drives area, work is summarised in various areas ranging from an industry agreement on the energy-efficiency of motors through to the optimisation of compressed-air systems and energy-efficient gearless drives. Efficient hotel minibars, the energy-efficiency potential in the area of water dispensers and the energy-efficiency potential of hot beverage dispensers used in the area of staff catering and the standby consumption of household appliances are just a few of the topics dealt with. Co-operation with Swiss institutions and international organisations such as the IEA is reviewed. Implementation work in the

  1. Fluoroquinolone-associated anaphylaxis in spontaneous adverse drug reaction reports in Germany: differences in reporting rates between individual fluoroquinolones and occurrence after first-ever use.

    Science.gov (United States)

    Sachs, Bernhardt; Riegel, Stefan; Seebeck, Jörg; Beier, Rainer; Schichler, Dagmar; Barger, Antina; Merk, Hans F; Erdmann, Stephan

    2006-01-01

    The frequency of fluoroquinolone-associated anaphylaxis has been estimated to be 1.8-23 per 10 million days of treatment based on spontaneous reports. It is unknown whether there are differences between the reporting rates of anaphylaxis with individual fluoroquinolones. According to pathophysiology, anaphylaxis may be immune mediated (anaphylactic) or not (anaphylactoid). The latter may occur after first-ever intake since no sensitisation phase is necessary. To analyse spontaneous reports of fluoroquinolone-associated anaphylaxis contained in the spontaneous adverse drug reaction database of the Federal Institute for Drugs and Medical Devices in Germany with regard to differences in reporting rates between various fluoroquinolones, the previous intake and the time to onset of the reaction. All fluoroquinolone-associated cases of anaphylaxis, anaphylactic shock, and anaphylactic/anaphylactoid reaction spontaneously reported to the Federal Institute for Drugs and Medical Devices between 1 January 1993 and 31 December 2004 were identified and assessed with regard to the correctness of the diagnosis of anaphylaxis, the causal relationship with the drug, the previous intake of fluoroquinolones and the time to onset of the reaction. In 166 of 204 cases identified, the diagnosis of anaphylaxis and a causal relationship with the drug were considered at least possible. Moxifloxacin, levofloxacin, ciprofloxacin and ofloxacin accounted for 90 (54%), 25 (15%), 21 (13%) and 16 (10%) of the 166 cases, respectively. The corresponding reporting rates per 1 million defined daily doses based on crude estimates of exposure were 3.3, 0.6, 0.2 and 0.2 for moxifloxacin, levofloxacin, ciprofloxacin and ofloxacin, respectively. The occurrence of anaphylaxis after the first dose or within the first three days was reported in 71 of 166 (43%) cases, but no information on prior exposure with this or any other fluoroquinolone was provided with these reports. In 21 of 166 (13%) cases, the

  2. [The activity of drug addiction service of the Russian Federation: an assessment of statistical parameters and an analysis of results].

    Science.gov (United States)

    Koshkina, E A; Kirzhanova, V V; Babicheva, L P; Mugantseva, L A

    2013-01-01

    The authors studied changes in the structure of drug addiction services, the dynamics of outpatient and inpatient referrals for drug addiction treatment and effectiveness of drug addiction services in 2011 compared to the preceding period. There was a reduction of availability of drug treatment services due to the reduction of the number of drug addiction units and the depletion of human resource potential. The lack of structural development of rehabilitation sector of drug care services and low rates of its development as well as the decrease in the number of patients seeking treatment are highlighted. It has been concluded that the drug addiction services require reorganization of its regulatory and legal framework and need innovative organizational and management decisions and human resources trained in innovative thinking and technologies.

  3. Treatment of Drug Abuse: An Overview. National Clearinghouse for Drug Abuse Information Report Series 34, Number 1.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHEW/PHS), Rockville, MD. National Clearinghouse for Drug Abuse Information.

    This report presents a brief review of the development of methods and programs for treatment of drug abusers in the United States. In order to limit the scope of the report, discussion of the treatment of alcohol abuse and alcoholism is excluded. The report focuses primarily on the treatment of opiate dependence, since most of the experience on…

  4. Adverse Drug Reaction reports for cardiometabolic drugs from sub-Saharan Africa : a study in VigiBase

    NARCIS (Netherlands)

    Berhe, Derbew Fikadu; Juhlin, Kristina; Star, Kristina; Beyene, Kidanemariam G. M.; Dheda, Mukesh; Haaijer-Ruskamp, Flora M.; Taxis, Katja; Mol, Peter G. M.

    2015-01-01

    OBJECTIVE: Identifying key features of cardiometabolic ADR reports in sub Saharan Africa (SSA) compared with reports from the rest of the world (RoW). METHODS: Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from

  5. Oak Ridge Reservation Federal Facility Agreement for the Environmental Restoration Program. Volume 1, Quarterly report, October--December 1995

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-01

    This Oak Ridge Reservation Federal Facility Agreement Quarterly Report for the Environmental Restoration Program was prepared to satisfy requirements for progress reporting on Environmental Restoration Program (ER) activities as specified in the Oak Ridge Reservation Federal Facility Agreement (FFA) established between the US Department of Energy (DOE), the US Environmental Protection Agency, and the Tennessee Department of Environment and Conservation. The reporting period covered in this document is October through December 1995. This work was performed under Work Breakdown Structure 1.4.12.2.3.04 (Activity Data Sheet 8304). Publication of this document meets two FFA milestones. The FFA Quarterly Report meets an FFA milestone defined as 30 days following the end of the applicable reporting period. Appendix A of this report meets the FFA milestone for the Annual Removal Action Report for the period FYs 1991--95. This document provides information about ER Program activities conducted on the Oak Ridge Reservation under the FFA. Specifically, it includes information on milestones scheduled for completion during the reporting period, as well as scheduled for completion during the next reporting period (quarter); accomplishments of the ER Program; concerns related to program work; and scheduled activities for the next quarter. It also provides a listing of the identity and assigned tasks of contractors performing ER Program work under the FFA.

  6. Quantitative Analysis of Narrative Reports of Psychedelic Drugs

    OpenAIRE

    Coyle, Jeremy R.; Presti, David E.; Matthew J Baggott

    2012-01-01

    Background: Psychedelic drugs facilitate profound changes in consciousness and have potential to provide insights into the nature of human mental processes and their relation to brain physiology. Yet published scientific literature reflects a very limited understanding of the effects of these drugs, especially for newer synthetic compounds. The number of clinical trials and range of drugs formally studied is dwarfed by the number of written descriptions of the many drugs taken by people. Anal...

  7. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    Science.gov (United States)

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  8. Magnitude of drug resistant shigellosis: A report from Bangalore

    Directory of Open Access Journals (Sweden)

    Srinivasa H

    2009-01-01

    Full Text Available Shigella is an important cause of acute invasive diarrhea in children and others. Antimicrobial susceptibility of Shigella spp. isolated from diarrhoeal/ dysenteric patients in Bangalore was studied in our hospital from January 2002 to December 2007. One hundred and thirty-four isolates were identified as Shigella species. S. flexneri, S. sonnei , S. boydii and S. dysenteriae were accounted respectively for 64.9%, 21.6%, 8.2% and 3.7% of the total number of Shigella isolated. Of these 56 (41.8% were from children (0 to 14 years and 78 (58.2% were from adults and elderly patients. Over 70% of Shigella isolates were resistant to two or more drugs including Ampicillin and Co-trimoxazole. During 2002 to 2007, resistance to Ampicillin had increased from 46.7% to 68%. For Co-trimoxazole, though the resistance had gradually decreased from 100% to 72%, but still the resistance is high. Chloramphenicol resistance showed sudden decline from 73.3% to 25% from 2002 to 2003, but gradually has reached 48%. Nalidixic acid resistance was more than 70%. All isolates were sensitive to Ciprofloxacin during the period 2002 to 2004, but over the years the resistance pattern gradually increased up to 48%. Ceftriaxone had shown no resistance. The results of the study revealed the endemicity of Shigellosis with S. flexneri as the predominant serogroup. Children were at a higher risk of severe shigellosis. The results also suggest that Ampicillin, Co-trimoxazole, Chloramphenicol, Nalidixic acid and Ciprofloxacin should not be used empirically as the first line drugs in the treatment of Shigellosis. Periodic analysis and reporting of antibiotic susceptibility is an important measure to guide antibiotic treatment.

  9. Drug Advertising and the FDA.

    Science.gov (United States)

    Levesque, Cynthia

    With increases in consumer focused advertising for prescription drugs, the Federal Drug Administration has renewed efforts to protect the public from false advertising. In 1982, it charged that the press kits Eli Lilly and Company distributed to reporters on its new antiarthritis drug, Oraflex, misrepresented the product. It recommended that Lilly…

  10. Drug Advertising and the FDA.

    Science.gov (United States)

    Levesque, Cynthia

    With increases in consumer focused advertising for prescription drugs, the Federal Drug Administration has renewed efforts to protect the public from false advertising. In 1982, it charged that the press kits Eli Lilly and Company distributed to reporters on its new antiarthritis drug, Oraflex, misrepresented the product. It recommended that Lilly…

  11. The Federal Science, Technology, Engineering, and Mathematics (STEM) Education Portfolio. A Report from the Federal Inventory of STEM Education Fast-Track Action Committee, Committee on STEM Education

    Science.gov (United States)

    2011-12-01

    Track Action Committee on Federal Investments in STEM Education (FI-STEM) Co-chairs Michael Feder (OSTP) Joan Ferrini-Mundy (NSF) Susan Heller...Foundation Joan Ferrini-Mundy Analytic Support Science & Technology Policy Institute Executive Office of the President Greg Gershuny (OSTP) Sarah Watson...Feder (OSTP) Department of Commerce Larry Robinson Department of Health and Human Services Dora Hughes National Aeronautics and Space

  12. Oak Ridge Reservation Federal Facility Agreement. Quarterly report for the Environmental Restoration Program. Volume 4, July 1995--September 1995

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-10-01

    This quarterly progress report satisfies requirements for the Environmental Restoration (ER) Program that are specified in the Oak Ridge Reservation Federal Facility Agreement (FFA) established between the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA), and the Tennessee Department of Environment and Conservation (TDEC). The reporting period covered herein is July through September 1995 (fourth quarter of FY 1995). Sections 1.1 and 1.2 provide respectively the milestones scheduled for completion during the reporting period and a list of documents that have been proposed for transmittal during the following quarter but have not been approved as FY 1995 commitments.

  13. Oak Ridge reservation federal facility agreement for the Environmental Restoration Program. Volume 1. Quarterly report, October--December 1993

    Energy Technology Data Exchange (ETDEWEB)

    1994-01-01

    This quarterly progress report satisfies requirements for the Environmental Restoration (ER) Program that are specified in the Oak Ridge Reservation (ORR) Federal Facility Agreement (FFA) established between the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA), and the Tennessee Department of Environment and Conservation (TDEC). The reporting period covered is October through December 1993 (first quarter of FY 1994). Sections 1.1 and 1.2 provide respectively the milestones scheduled for completion during the reporting period and a list of documents that have been proposed for transmittal during the following quarter but have not been approved as FY 1994 commitments.

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

    Science.gov (United States)

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

    2012-01-01

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

  15. Polypharmacy in HIV: impact of data source and gender on reported drug utilization.

    Science.gov (United States)

    Furler, Michelle D; Einarson, Thomas R; Walmsley, Sharon; Millson, Margaret; Bendayan, Reina

    2004-10-01

    Drug use in HIV is complex and may involve multiple therapeutic and nontherapeutic agents including prescription, over-the-counter, complementary and alternative medicine, and social/recreational drugs. This study was designed to assess the extent of such drug use in HIV-infected men and women. One hundred four adults were recruited through the HIV Ontario Observational Database from HIV outpatient clinics throughout Ontario, Canada. Patient demographics and data on drug use and physician awareness of drug use were collected through in-person interviews and medical chart review. All patient interviews and 96% of medical charts revealed the use of at least one drug. Eighty-five percent of patients reported use of antiretroviral medications; nearly 70% used highly active antiretroviral therapy. Patients used significantly more drugs by patient report (15.7 +/- 7.7) than by medical chart review (8.4 +/- 5.0) reporting up to 39 drugs per person. Pill burden was substantial, averaging 20.7 +/- 12.5 and ranged up to 69 "pills-per-day." Patient-reported physician awareness of drug use was highest for prescription drugs and lowest for social/recreational drugs; correspondingly agreement between medical chart and patient report ranged from 80% for antiretrovirals to 10% for non-prescribed drugs. The drug and pill burden faced by patients with HIV is considerable. Prevalence of use for specific drug classes varied with both data source and gender while number of drugs used differed only by data source. Our findings emphasize the complexity of pharmacotherapy in HIV and the need for comprehensive drug assessment, particularly because of the risks of drug-drug interactions and decreased adherence secondary to therapeutic complexity.

  16. The Federal Role in Funding Children's Television Programming. Volume 1: Final Report.

    Science.gov (United States)

    Mielke, Keith W.; And Others

    The United States Office of Education (USOE) policy in funding purposive television programing for children was investigated. Information and policy recommendations were gathered from existing sources in the general literature, USOE file materials, 10 single-topic commissioned papers, a 10-member advisory board, a Federal advisory group, and…

  17. Joint federal/state motor fuel tax compliance project. Fiscal year 1994 midyear report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-11-02

    ;Table of Contents: List of Exhibits; Executive Summary: History of the Joint Federal/State Motor Fuel Tax Compliance Project; Update on Motor Fuel Tax Procedures; Joint Project Results; Status of the Regional Task Forces; Future Program Activities; References; Glossary of Acronyms; List of Exhibits.

  18. 6th Annual Earth System Grid Federation Face to Face Conference Report

    Energy Technology Data Exchange (ETDEWEB)

    Williams, D. N. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2017-03-06

    The Sixth Annual Face-to-Face (F2F) Conference of the Earth System Grid Federation (ESGF), a global consortium of international government agencies, institutions, and companies dedicated to the creation, management, analysis, and distribution of extreme-scale scientific data, was held December 5–9, 2016, in Washington, D.C.

  19. Review of Significant Immigration Cases Decided by the Federal Courts in 1985. Legal Report.

    Science.gov (United States)

    Isgro, Francesco

    1985-01-01

    Reviews immigration laws and Federal Court decisions of 1985 establishing precedents for immigration litigation. Focuses on decisions concerning asylum and deportation; agricultural workers; adjustment of immigrant status; and deferred action. Argues that the recent sharp increase in immigration litigation indicates a need for immigration reform…

  20. Annual report on reactor safety research projects sponsored by the Ministry of Economics and Labour of the Federal Republic of Germany. Reporting period 2004. Progress report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-07-01

    Within its competence for energy research, the Bundesministerium fuer Wirtschaft und Technology (BMWi) (Federal Ministry of Economics and Technology) sponsors investigations into the safety of nuclear power plants. The objective of these investigations is to provide fundamental knowledge, procedures and methods to contribute to realistic safety assessments of nuclear installations, to the further development of safety technology and to make use of the potential of innovative safety-related approaches. The Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) mbH, by order of the BMWi, continuously issues information on the status of such investigations by publishing semi-annual and annual progress reports within the series of GRS-F-Fortschrittsberichte (GRS-F-Progress Reports). Each progress report represents a compilation of individual reports about the objectives, work performed, results achieved, next steps of the work etc. The individual reports are prepared in a standard form by the research organisations themselves as documentation of their progress in work and are published by the Research Management Division of GRS within the framework of general information on the progress in reactor safety research. The compilation of the reports is classified according to general topics related to reactor safety research. Further, use is made of the classification system 'Joint Safety Research Index' of the CEC (Commission of the European Communities). The reports are arranged in sequence of their project numbers. It has to be pointed out that the authors of the reports are responsible for the contents of this compilation. The BMWi does not take any responsibility for the correctness, exactness and completeness of the information nor for the observance of private claims of third parties. (orig.)

  1. 78 FR 40731 - Deadline Dates for Reports and Other Records Associated With the Free Application for Federal...

    Science.gov (United States)

    2013-07-08

    ... (FAFSA), the Federal Pell Grant Program, the William D. Ford Federal Direct Loan Program, the Teacher... Loan Program; 84.063 Federal Pell Grant Program; 84.268 William D. Ford Federal Direct Loan Program; 84... deadline date notice are the Federal Pell Grant, William D. Ford Federal Direct Loan (Direct Loan),...

  2. 78 FR 72901 - Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal...

    Science.gov (United States)

    2013-12-04

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance; Pharmacy Compounding of Human Drug Products... Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled ``Pharmacy... the Compliance Program Guidance (CPG) Manual entitled, ``Pharmacy Compounding,'' which was issued in...

  3. Non-sedating antihistamine drugs and cardiac arrhythmias -- biased risk estimates from spontaneous reporting systems?

    DEFF Research Database (Denmark)

    De Bruin, M L; van Puijenbroek, E P; Egberts, A C G

    2002-01-01

    of these drugs. METHODS: All suspected adverse drug reactions (ADRs) reported until July 1999 to the Netherlands Pharmacovigilance Foundation Lareb were used to calculate the ADR reporting odds ratio, defined as the ratio of exposure odds among reported arrhythmia cases, to the exposure odds of other ADRs (non...

  4. Predicting Drug Use at Electronic Music Dance Events: Self-Reports and Biological Measurement

    Science.gov (United States)

    Johnson, Mark B.; Voas, Robert A.; Miller, Brenda A.; Holder, Harold D.

    2009-01-01

    Most information on the prevalence of drug use comes from self-report surveys. The sensitivity of such information is cause for concern about the accuracy of self-report measures. In this study, self-reported drug use in the last 48 hr is compared to results from biological assays of saliva samples from 371 young adults entering clubs. The…

  5. First report of drug-induced esophagitis by deferasirox.

    Science.gov (United States)

    Yoshikawa, Takeshi; Hara, Takeshi; Araki, Hiroshi; Tsurumi, Hisashi; Oyama, Masami; Moriwaki, Hisataka

    2012-06-01

    Deferasirox is a new oral iron chelator used to treat transfusional iron overload. We describe a case of a 79-year-old man with myelodysplastic syndrome (MDS) who developed esophagitis induced by deferasirox. He repeatedly received multiple red blood cell transfusions after a diagnosis of MDS. Two years after starting red blood cell transfusions, he was diagnosed with iron overload, and was then started on deferasirox at 1 g/day with about 400 ml of water. He was admitted to our institution because he was unable to swallow his own saliva 1 month after starting deferasirox. Esophagogastroendoscopy revealed white-coated mucosa covering the entire esophagus. A component analysis of biopsy specimens using high-performance liquid chromatography identified deferasirox. Symptoms resolved within about 2 weeks after discontinuing deferasirox, and repeated endoscopy showed marked improvement of esophagitis after 1 month. Re-administration of deferasirox was not attempted. Unfortunately, the patient died due to pneumonia 6 months after administration of deferasirox was started. This is the first report of drug-induced esophagitis associated with deferasirox.

  6. Project CHECO Southeast Asia Report. Drug Abuse in Southeast Asia

    Science.gov (United States)

    1975-01-01

    must encompass many aspects; it must involve the eradication of drug sources, strengthening of customs and postal procedures, utilization of marihuana ...pharmacological, social, cultural, and psychological aspects of drugs and their abuse. They were also provided with a background on the legal aspects of...were readily available in RVN and which covered the physical, psychologi- cal, and legal consequences of drug use. The briefings concentrated on being

  7. ORGAN DONATION AND TRANSPLANTATION IN THE RUSSIAN FEDERATION IN 2014 7th REPORT OF NATIONAL REGISTER

    Directory of Open Access Journals (Sweden)

    S. V. Gautier

    2015-01-01

    Full Text Available Aim. To carry out monitoring of the organization and development of organ donation and transplantation in the Russian Federation according to 2014. Materials and methods. Questioning of heads of all the centers of transplantation is carried out. The comparative analysis of the obtained data in dynamics of years, between certain regions of the Russian Federation, the transplantation centers, and also with data of the international registers is made. Results. According to the Register in 2014 in the Russian Federation functioned 36 centers of kidney transplantation, 14 centers of liver transplantation and 9 centers of heart transplantation. The waiting list of kidney transplantation in 2014 included 4636 potential recipients that makes 16% of total number of the patients 29 000 receiving dialysis. The rate of donor activity in 2014 made 3.2 per million population (pmp. Efficiency of donor programs in 2014 continued to increase: the share of effective donors after brain death in 2014 increased to 77.2%, the share of multiorgan explantation made 50.5%, average number of organs received from one effective donor made 2.6. In 2014 the rate of kidney transplantation made 7.0 pmp, the rate of liver transplantation made 2.1 pmp and the rate of heart transplantation made 1.1 pmp. In the Russian Federation the number of transplantations of liver and heart continues to increase. The significant contribution to development of the organ donation and transplantation brings the Moscow region in which 11 centers of transplantation function and nearly a half from all kidney transplantations and more than 65% of all liver and heart transplantations are carried out. Conclusion. In theRussian Federation the potential for further development of the transplantology remains. In particular, at the expense of increase in the efficiency of regional donation programs, introduction of technologies, expansion of the practices of multiorgan donation and transplantations of

  8. ORGAN DONATION AND TRANSPLANTATION IN THE RUSSIAN FEDERATION IN 2013 6th report of National Register

    Directory of Open Access Journals (Sweden)

    S.V. Gautier

    2014-01-01

    Full Text Available Aim. To carry out monitoring of the state and prospects of the development of organ donation and transplantation in the Russian Federation according to 2013. Materials and methods. Questioning of heads of all the centers of transplantation is carried out. The comparative analysis of the obtained data in dynamics of years, between certain regions of the Russian Federation, the transplantation centers, and also with data of the international registers is made. Results. According to the register in 2013 in the Russian Federation functioned 35 centers of kidney transplantation, 15 centers of liver transplantation and 10 centers of heart transplantation. The waiting list of kidney transplantation included more than 4000 potential recipients that makes 15–16% of total number of the patients receiving dialysis. The rate of donor activity made 2,9 per million population (pmp. Effi ciency of donor programs continues to increase: the share of effective donors after brain death in 2013 increased to 72,4%, the share of multiorgan explantation increased to 52,9%, average number of organs received from one effective donor made 2,6. The rate of kidney transplantation made 6,5 pmp, the rate of liver transplantation made 1,9 pmp; the rate of heart transplantation made 1,1 pmp. In the Russian Federation the number of transplantations of liver and heart continues to increase. The signifi cant contribution to development of the organ donation and transplantation brings the Moscow region in which 11 centers of transplantation function and nearly a half of all kidney transplantations and 70% of all liver and heart transplantations are carried out. In 2013 Ministry of Health of Russia continued development of the new federal law «On donation of human organs and their transplantation». Under the auspices of the Russian Transplant Society 11 clinical guidelines about organ donation and transplantation were developed and approved. Together with earlier approved

  9. Alternative scenarios for Federal transportation policy. Volume I. Summary. First year final report

    Energy Technology Data Exchange (ETDEWEB)

    Friedlaender, A.; Simpson, R.

    1977-01-01

    A summary is given of research evaluating the economic effects of existing and prospective federal policies governing intercity and international freight and passenger transportation enterprises in the economy of the United States. The analysis encompasses all modes of transportation, including rail, motor, water, air and intermodal coordinative institutions, and focuses upon the impact of alternative regulatory policies. However, other federal policies including subsidy, taxation, procurement, government ownership and investment, special programs for particular transportation industry problems and impacts of general national policies on transportation will be included when relevant. Economic evaluation includes the study of efficient resource allocation and distributional effects of alternative policies together with consideration of both partial and general equilibrium effects. The research is interdisciplinary in scope, drawing upon engineering, economics, statistics, law and administration.

  10. Quarterly report of solar federal buildings program in the MASEC region

    Energy Technology Data Exchange (ETDEWEB)

    None

    1981-06-01

    MASEC staff members contacted agencies coordinating the Solar Federal Buildings Program (SFBP) within the 12-state MASEC region (Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, and Wisconsin). SFBP agencies with projects in the region submitted all information available about the projects. This information (program coordinator, proposal number, and project status) is presented for projects in each state. Information was also disseminated concerning a SFBP Short Course August 17-21, 1981. (MCW)

  11. Ecological Investigations of the Federally Endangered Shivwits Milk-Vetch (Astragalus ampullarioides)--2006 Annual Report

    Science.gov (United States)

    Miller, Mark E.; Mann, Rebecca K.; Goldstein, Harland L.; Yount, James D.

    2007-01-01

    Astragalus ampullarioides (Welsh) Welsh, the Shivwits milk-vetch, is an herbaceous perennial legume that was listed as federally endangered in September 2001. Known populations of this edaphic endemic species are restricted to Washington County, Utah, with the majority of occurrences found on gently sloping outcrops of the Triassic Petrified Forest Member of the Chinle Formation at the edge of the Mojave Desert. At the time of listing in 2001, surveys estimated a total of 1000 individuals for the species. In April-May 2006, surveys estimated approximately 4205 individuals distributed among six populations. Of the total number of individuals estimated in spring 2006, over 75 percent were distributed among three subpopulations in Zion National Park and approximately 60 percent occurred at a single 0.3-ha site in the Park. In addition to small population sizes and limited geographic distributions, the species is threatened to varying degrees by urbanization, livestock grazing, off-road vehicle use, and invasive exotic plants. In April 2006, the U.S. Geological Survey (USGS) initiated ecological investigations of the Shivwits milk-vetch to support conservation management and recovery of the species by the National Park Service (NPS; Zion National Park), the U.S. Fish and Wildlife Service (USFWS), the Bureau of Land Management (BLM), the Shivwits Band of the Paiute Tribe, and other cooperators such as The Nature Conservancy of Utah (TNC). To date, funding for this research has been provided by the Southwest Biological Science Center of the USGS Biological Resources Discipline, the USGS-NPS Park-Oriented Biological Support Project, and the Earth Surface Dynamics Program of the USGS Geologic Discipline. Additional logistical support has been provided by the Bureau of Land Management, Grand Staircase-Escalante National Monument. General objectives of this research are (1) to develop a better understanding of species-environment relations to support habitat modelling

  12. Fighting Drugs and Alcohol in the Workplace: ILO Reports Success.

    Science.gov (United States)

    World of Work, 1998

    1998-01-01

    The economic costs of drug and alcohol abuse in the workplace are enormous. A new analysis of an International Labour Organisation (ILO) 5-year transnational program involving management and unions has shown positive results in decreasing drug and alcohol problems. (JOW)

  13. Students and Drugs at NCSU: 1977-1978 Report.

    Science.gov (United States)

    Fuller, Earl H.

    A survey conducted in 1977 at North Carolina State University on drugs was designed to measure usage rates for four types of drugs: marijuana, hallucinogens (such as LSD, mescaline, and psilocybin); amphetamines and barbituates; and narcotics (heroin, opium, and morphine). The questionnaire was also designed to determine student attitudes on…

  14. Hair drug testing results and self-reported drug use among primary care patients with moderate-risk illicit drug use.

    Science.gov (United States)

    Gryczynski, Jan; Schwartz, Robert P; Mitchell, Shannon Gwin; O'Grady, Kevin E; Ondersma, Steven J

    2014-08-01

    This study sought to examine the utility of hair testing as a research measure of drug use among individuals with moderate-risk drug use based on the internationally validated Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This study is a secondary analysis using baseline data from a randomized trial of brief intervention for drug misuse, in which 360 adults with moderate-risk drug use were recruited from two community clinics in New Mexico, USA. The current study compared self-reported drug use on the ASSIST with laboratory analysis of hair samples using a standard commercially available 5-panel test with assay screening and gas chromatography/mass spectrometry (GC/MS) confirmation. Both self-report and hair testing covered a 3-month period. Overall concordance between hair testing and self-report was 57.5% (marijuana), 86.5% (cocaine), 85.8% (amphetamines), and 74.3% (opioids). Specificity of hair testing at standard laboratory cut-offs exceeded 90% for all drugs, but sensitivity of hair testing relative to self-report was low, identifying only 52.3% (127/243) of self-disclosed marijuana users, 65.2% (30/46) of cocaine users, 24.2% (8/33) of amphetamine users, and 2.9% (2/68) of opioid users. Among participants who disclosed using marijuana or cocaine in the past 3 months, participants with a negative hair test tended to report lower-frequency use of those drugs (ptesting can be useful in studies with moderate-risk drug users, but the potential for under-identification of low-frequency use suggests that researchers should consider employing low detection cut-offs and using hair testing in conjunction with self-report. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. Facilitation of the Estuary/Ocean Subgroup for Federal Research, Monitoring and Evaluation FY08 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, GE; Diefenderfer, HL [Pacific Northwest National Laboratory

    2008-09-29

    The Estuary/Ocean Subgroup (EOS) is part of the research, monitoring, and evaluation (RME) effort that the Action Agencies (Bonneville Power Administration (BPA), U.S. Army Corps of Engineers, U.S. Bureau of Reclamation) developed in response to obligations arising from the Endangered Species Act as applied to operation of the Federal Columbia River Power System (FCRPS). The goal of the EOS project is to facilitate activities of the estuary/ocean RME subgroup as it coordinates design and implementation of federal RME in the lower Columbia River and estuary. In fiscal year 2008 (FY08), EOS project accomplishments included (1) subgroup meetings; (2) participation in the estuary work group of the Pacific Northwest Aquatic Monitoring Partnership; (3) project management via BPA's project tracking system, Pisces; (4) quarterly project status reports; and (5) a major revision to the Estuary RME document and its subsequent regional release (new version January 2008). Many of the estuary RME recommendations in this document were incorporated into the Biological Opinion on FCRPS operations (May 2008). In summary, the FY08 EOS project resulted in expanded, substantive coordination with other regional RME forums, a new version of the federal Estuary RME program document, and implementation coordination. This annual report is a FY08 deliverable for the project titled Facilitation of the Estuary/Ocean Subgroup.

  16. Facilitation of the Estuary/Ocean Subgroup for Federal Research, Monitoring, and Evaluation, FY08 Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Gary E.; Diefenderfer, Heida L.

    2008-09-29

    The Estuary/Ocean Subgroup (EOS) is part of the research, monitoring, and evaluation (RME) effort that the Action Agencies (Bonneville Power Administration, U.S. Army Corps of Engineers, U.S. Bureau of Reclamation) developed in response to obligations arising from the Endangered Species Act as applied to operation of the Federal Columbia River Power System (FCRPS). The goal of the EOS project is to facilitate activities of the estuary/ocean RME subgroup as it coordinates design and implementation of federal RME in the lower Columbia River and estuary. In fiscal year 2008 (FY08), EOS project accomplishments included 1) subgroup meetings; 2) participation in the estuary work group of the Pacific Northwest Aquatic Monitoring Partnership; 3) project management via the project tracking system, Pisces; 4) quarterly project status reports; and 5) a major revision to the Estuary RME document and its subsequent regional release (new version January 2008). Many of the estuary RME recommendations in this document were incorporated into the Biological Opinion on hydrosystem operations (May 2008). In summary, the FY08 EOS project resulted in expanded, substantive coordination with other regional RME forums, a new version of the federal Estuary RME program document, and implementation coordination. This annual report is a FY08 deliverable for the project titled Facilitation of the Estuary/Ocean Subgroup.

  17. 76 FR 11985 - Defense Federal Acquisition Regulation Supplement; Reporting of Government-Furnished Property

    Science.gov (United States)

    2011-03-04

    ... Acquisition Regulation Supplement; Reporting of Government-Furnished Property AGENCY: Defense Acquisition... expand reporting requirements for Government-furnished property to include items uniquely and non...

  18. Analysis of drug abuse data reported by medical institutions in Taiwan from 2002 to 2011

    Directory of Open Access Journals (Sweden)

    Jui Hsu

    2014-06-01

    Full Text Available Drug abuse has become a global issue of concern. It affects not only individual users, but also their families and communities. Data were retrieved from the database of the Taiwan Surveillance System of Drug Abuse and Addiction Treatment (SSDAAT from 2002 to 2011, and 147,660 cases reported by medical institutions in Taiwan were reviewed. This study showed that the top five reported abused drugs by medical institutions during the last decade were heroin, methamphetamine, benzodiazepines, ketamine, and zolpidem. Heroin and methamphetamine continued to be the first two abused drugs reported by medical institutions. Heroin abuse was significant, but has shown a downward trend. However, emerging abused drugs, such as ketamine and zolpidem, presented upward trends. 3,4-Methylenedioxy-N-methylamphetamine (MDMA abuse seems to have re-emerged and has increased gradually since 2010. Injection without needle sharing has become the most common route of administration of abused drugs since 2002. The majority of causes for these reported drug abuses were drug dependence, followed by peer influence and stress relief. Hepatitis C was the most commonly reported infectious disease, followed by hepatitis B and AIDS in the drug abusers reported by medical institutions. It should be noted that access to drugs via the Internet increased year by year, and this is clearly an area needing constant monitoring.

  19. Tracking federal land management: Report No. 3 on federal land management actions impacting geothermal commecialization at selected target prospects in the five Pacific Rim states

    Energy Technology Data Exchange (ETDEWEB)

    1980-05-20

    Generic land management actions affecting geothermal commerializtion in Pacific River states are reviewed. Specific federal land management actions affecting geothermal prospects in California and the Pacific Northwest are described. (MHR)

  20. 45 CFR 61.10 - Reporting exclusions from participation in Federal or State health care programs.

    Science.gov (United States)

    2010-10-01

    ...) Name and address of the reporting entity; and (viii) The name, title and telephone number of the responsible official submitting the report on behalf of the reporting entity. (c) Entities described in... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting exclusions from participation in...

  1. Basic Program Elements for Federal employee Occupational Safety and Health Programs and related matters; Subpart I for Recordkeeping and Reporting Requirements. Final rule.

    Science.gov (United States)

    2013-08-05

    OSHA is issuing a final rule amending the Basic Program Elements to require Federal agencies to submit their occupational injury and illness recordkeeping information to the Bureau of Labor Statistics (BLS) and OSHA on an annual basis. The information, which is already required to be created and maintained by Federal agencies, will be used by BLS to aggregate injury and illness information throughout the Federal government. OSHA will use the information to identify Federal establishments with high incidence rates for targeted inspection, and assist in determining the most effective safety and health training for Federal employees. The final rule also interprets several existing basic program elements in our regulations to clarify requirements applicable to Federal agencies, amends the date when Federal agencies must submit to the Secretary of Labor their annual report on occupational safety and health programs, amends the date when the Secretary of Labor must submit to the President the annual report on Federal agency safety and health, and clarifies that Federal agencies must include uncompensated volunteers when reporting and recording occupational injuries and illnesses.

  2. Oak Ridge Reservation Federal Facility Agreement quarterly report for the environmental restoration program. Volume 2: January--March 1995

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-04-01

    This quarterly progress report satisfies requirements for the Environmental Restoration (ER) Program that are specified in the Oak Ridge Reservation (ORR) Federal Facility Agreement (FFA) established between the US Department of Energy (DOE), the US Environmental Protection Agency (EPA), and the Tennessee Department of Environment and Conservation (TDEC). Sections 1.1 and 1.2 provide respectively the milestones scheduled for completion during the reporting period and a list of documents that have been proposed for transmittal during the following quarter but have not been approved as FY 1995 commitments. The report describes the technical status of the following: Y-12 Plant; Oak Ridge National Lab; K-25 Plant; and Oak Ridge Reservation boundary areas. The report also describes technical programs, namely: the Oak Ridge environmental information system, remote sensing and special survey program, and the risk assessment program.

  3. Oak Ridge Reservation Federal Facility Agreement quarterly report for the environmental restoration program. Volume 3: April--June 1995

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-07-01

    This quarterly progress report satisfies requirements for the Environmental Restoration (ER) Program that are specified in the Oak Ridge Reservation (ORR) Federal Facility Agreement (FFA) established between the US Department of Energy (DOE), the US Environmental Protection Agency (EPA), and the Tennessee Department of Environment and Conservation (TDEC). Sections 1.1 and 1.2 provide respectively the milestones scheduled for completion during the reporting period and a list of documents that have been proposed for transmittal during the following quarter but have not been approved as FY 1995 commitments. The report describes the technical status of the following: Y-12 Plant; Oak Ridge National Lab; K-25 Plant; and Oak Ridge Reservation boundary areas. The report also describes technical programs, namely: the Oak Ridge environmental information system, remote sensing and special survey program, and the risk assessment program.

  4. International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice.

    Science.gov (United States)

    2004-02-05

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" (the ICH E2C guidance). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In the Federal Register of May 19, 1997 (62 FR 27470), FDA published the ICH E2C guidance, which recommends a unified standard for the format, content, and reporting frequency for postmarketing periodic safety update reports (PSURs) for drug and biological products. This guidance, an addendum to the ICH E2C guidance, provides additional information on the content and format of PSURs, including clarification of the objectives, general principles, and model for PSURs. This guidance is intended to help harmonize collection and submission of postmarketing clinical safety data.

  5. Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review

    OpenAIRE

    Amélie van der Meersch; Agnès Dechartres; Philippe Ravaud

    2011-01-01

    BACKGROUND: Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. OBJECTIVE: To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. METHODOLOGY/PRINCIPAL FINDINGS: PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic ...

  6. 2014 Earth System Grid Federation and Ultrascale Visualization Climate Data Analysis Tools Conference Report

    Energy Technology Data Exchange (ETDEWEB)

    Williams, Dean N. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2015-01-27

    The climate and weather data science community met December 9–11, 2014, in Livermore, California, for the fourth annual Earth System Grid Federation (ESGF) and Ultrascale Visualization Climate Data Analysis Tools (UV-CDAT) Face-to-Face (F2F) Conference, hosted by the Department of Energy, National Aeronautics and Space Administration, National Oceanic and Atmospheric Administration, the European Infrastructure for the European Network of Earth System Modelling, and the Australian Department of Education. Both ESGF and UVCDATremain global collaborations committed to developing a new generation of open-source software infrastructure that provides distributed access and analysis to simulated and observed data from the climate and weather communities. The tools and infrastructure created under these international multi-agency collaborations are critical to understanding extreme weather conditions and long-term climate change. In addition, the F2F conference fosters a stronger climate and weather data science community and facilitates a stronger federated software infrastructure. The 2014 F2F conference detailed the progress of ESGF, UV-CDAT, and other community efforts over the year and sets new priorities and requirements for existing and impending national and international community projects, such as the Coupled Model Intercomparison Project Phase Six. Specifically discussed at the conference were project capabilities and enhancements needs for data distribution, analysis, visualization, hardware and network infrastructure, standards, and resources.

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  8. Federal Funds for Research and Development: Fiscal Years 1980, 1981, and 1982, Volume XXX. Final Report. Surveys of Science Resources Series.

    Science.gov (United States)

    National Science Foundation, Washington, DC. Div. of Science Resources Studies.

    This report is the 30th in a series that covers research and development (R&D) as shown in successive Presidential budgets. The Federal budget for 1982 was unusual in the extent to which it was subjected to change, reflecting the new administration's philosophy to reduce Federal spending. R&D funding data reflect the first series of 1981…

  9. International Reports. International Federation of Library Associations and Institutions; A Canadian-American Librarianship or an American-Canadian Librarianship in the 21st Century?

    Science.gov (United States)

    Tabb, Winston; Birdsall, William F.

    2002-01-01

    Includes two reports: one from the International Federation of Library Associations and Institutions (IFLA) that discusses digital libraries, standards, collaboration, and membership and structure of IFLA; and one that considers Canadian-American librarianship in the 21st century, including federal government policy, copyright reform, and…

  10. 75 FR 41486 - Federal Acquisition Regulation; Information Collection; Reporting Purchases From Sources Outside...

    Science.gov (United States)

    2010-07-16

    ... Regulation; Information Collection; Reporting Purchases From Sources Outside the United States AGENCY... and approve an extension of a currently approved information collection requirement concerning reporting purchases from sources outside the United States. Public comments are particularly invited on...

  11. Uso de drogas por estudantes de Farmácia da Universidade Federal do Espírito Santo Use of drugs by Pharmacy students at the Federal University in Espírito Santo

    Directory of Open Access Journals (Sweden)

    Flávia Batista Portugal

    2008-01-01

    Full Text Available OBJETIVO: Traçar o perfil dos usuários de substâncias psicoativas do curso de Farmácia do Centro de Ciências da Saúde (CCS da Universidade Federal do Espírito Santo (Ufes. MÉTODOS: Tratou-se de estudo exploratório, descritivo, transversal e quantitativo. Foram pesquisados 148 alunos (80,4% matriculados no curso de Farmácia. O instrumento utilizado foi o questionário da Organização Mundial de Saúde adaptado à realidade brasileira. Os dados foram tabulados e analisados por meio do programa Statistical Packcage for the Social Science (SPSS. RESULTADOS: Dos pesquisados, a maior representação foi na faixa etária de 20 a 22 anos (52,7%, do sexo feminino (67,6%, e da classe socioeconômica B (47,3%. Quanto ao uso de álcool, o " uso na vida" foi de 87,8%, " uso no ano" de 77,7% e " uso no mês" de 58,1%. Entre as outras drogas, o " uso na vida" mais prevalente foi dos inalantes (18,2%. CONCLUSÃO: Conforme observado, o uso de substâncias psicoativas entre universitários é questão preocupante, demonstrando a importância de maior abordagem à temática no currículo acadêmico.OBJECTIVE: To trace the profile of the drug use between the university students of the course of Pharmacy Sciences Health Center of Federal University of Espírito Santo. METHODS: One is about explorer, descriptive, transversal and quantitative study. A survey was conducted with 148 undergraduate pharmacy students (80.4%. The instrument used is an adaptation of the developed one for the WHO. The data had been tabulated and analyzed through the Statistical Packcage for the Social Science (SPSS. RESULTS: 67.6% of the university students are female, 52.7% it had between 20 and 22 years and 47.3% belong to the social class B. Regarding the use of alcohol, 87.8% made use in the life, 77.7% in the year and 58.1% in the month. Between the other drugs, the use in life of inahaled drugs (18.2% was the most common. CONCLUSION: As observed, the undergraduate students

  12. Key Senator Scrutinizes Pharmacy 340B Selling Practices: Federal Office in Charge of Drug Discounts Begins to Feel the Heat.

    Science.gov (United States)

    Barlas, Stephen

    2013-07-01

    Upselling takes place when a safety-net hospital increases its profits by selling discounted drugs to privately insured patients at full price. Senator Charles Grassley is on the case to increase transparency and to curtail the misuse of 340B purchases.

  13. 28 CFR 50.21 - Procedures governing the destruction of contraband drug evidence in the custody of Federal law...

    Science.gov (United States)

    2010-07-01

    ...) The term Marijuana is as defined in 21 U.S.C. 801(15) but does not include, for the purposes of this... date of these regulations, the threshold amount of any substance therein listed, except marijuana... contraband drug substances in excess of the threshold amount or in the case of marijuana a quantity in...

  14. ORGAN DONATION AND TRANSPLANTATION IN RUSSIAN FEDERATION IN 2015. 8th report of National Register

    Directory of Open Access Journals (Sweden)

    S. V. Gautier

    2016-01-01

    Full Text Available Aim. To carry out monitoring of the organization and development of the organ donation and transplantation in theRussian Federationaccording to 2015.Materials and methods. Questioning of heads of all the centers of transplantation is carried out. The comparative analysis of the obtained data in dynamics by years, between certain regions of theRussian Federation, the transplantation centers is done.Results. According to the register in2015 inthe Russian Federation 36 centers of renal transplantation, 17 centers of liver transplantation and 10 centers of heart transplantation were functioning. The waiting list of kidney transplantation in 2015 included 4167 potential recipients that make 13% of the total number of the patients (31 500 receiving a dialysis. The rate of donor activity in 2015 made 3.0 pmp. Efficiency of donor programs in 2015 continues to increase: the share of multiorgan retrievals made 57.8%, average number of organs, received from one effective donor, made 2.7. In 2015 the rate of kidney transplantation made 6.5 pmp; the rate of liver transplantation made 2.2 pmp; the rate of heart transplantation made 1.2 pmp. The number of transplantations of liver and heart in theRussian Federationcontinues to increase. The number of transplantations of kidney remains approximately at one level in the range of 950–1050.Moscowcapital region continues to be the center of stability and development of the organ donation and transplantation in the country, in which 10 centers of transplantation are functioning and nearly a half from all kidney transplantations and more than 65% of all liver and heart transplantations are carried out.Conclusion. The potential for further development of the transplantation care in theRussian Federationcontinues to persist. In particular, at the expense of increasing efficiency of regional donation programs, expanding practices of multiorgan recuperation and transplantations of extrarenal organs, through

  15. Developing the Metodology to Form Integrated Reporting of Agroholdings in the Russian Federation

    Directory of Open Access Journals (Sweden)

    N. N. Balashova

    2015-12-01

    Full Text Available The article represents the efficient methodological principles on preparing the integrated reporting, as well as the scheme of the agroholding coherently integrated registration system based on the analysis of the concept and methodology in the field of the integrated reporting; it specifies "growth points" of the methodology development and best practical applications of the concept of uniform reporting on a global scale. The authors propose the developed by them "road map" on the organization process forming the integrated reports, and define the guidelines on improving the process of preparing and quality of the integrated reporting for the medium-term period.

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

    Science.gov (United States)

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

    2010-11-01

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

  17. Oak Ridge Reservation Federal Facility agreement quarterly report for the Environmental Restoration Program, January--March 1994. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    1994-04-01

    This quarterly progress report satisfies requirements for the Environmental Restoration (ER) Program that are specified in the Oak Ridge Reservation (ORR) Federal Facility Agreement (FFA) established between the US Department of Energy (DOE), the US Environmental Protection Agency (EPA), and the Tennessee Department of Environment and Conservation (TDEC). The reporting period covered herein is January through March 1994 (second quarter of FY 1994). Sections 1.1 and 1.2 provide respectively the milestones scheduled for completion during the reporting period and a list of documents that have been proposed for transmittal during the following quarter but have not been approved as FY 1994 commitments. Section 2 covers significant accomplishments. Section 3 discusses technical status at the Oak Ridge Y-12 Plant, Oak Ridge National Laboratory, Oak Ridge K-25 Site, and Clinch River. Technical oversight and technical programs are also covered. Section 4 covers responds action contractor assignments.

  18. 45 CFR 61.8 - Reporting Federal or State criminal convictions related to the delivery of a health care item or...

    Science.gov (United States)

    2010-10-01

    ... address of the reporting entity; and (xiv) The name, title and telephone number of the responsible official submitting the report on behalf of the reporting entity. (c) Entities described in paragraph (a... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting Federal or State criminal...

  19. PROGRESS IN ORGAN DONATION AND TRANSPLANTATION IN RUSSIAN FEDERATION IN 2006–2010. 3RD REPORT OF NATIONAL REGISTRY

    Directory of Open Access Journals (Sweden)

    S. V. Gautier

    2011-01-01

    Full Text Available The article presents the third report of the Registry of Russian transplant society, taking into account donor and transplant activity in the Russian Federation in 2006–2010. Data analysis proves clear positive trends during the last 5 years. The further progress is possible through the creation and modernization of regional donor infra- structures whose activities should be aimed at increasing of the number of donor hospitals and its rational use by expansion of brain death verification and performance of multiorgan procurement. 

  20. Facilitation of the Estuary/Ocean Subgroup for Federal Research, Monitoring, and Evaluation, FY09 Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Gary E.

    2009-10-22

    This document is the annual report for fiscal year 2009 (FY09) for the project called Facilitation of the Estuary/Ocean Subgroup (EOS). The EOS is part of the research, monitoring, and evaluation (RME) effort developed by the Action Agencies (Bonneville Power Administration [BPA], U.S. Army Corps of Engineers [Corps or USACE], U.S. Bureau of Reclamation) in response to obligations arising from the Endangered Species Act as a result of operation of the Federal Columbia River Power System (FCRPS).

  1. [Opinion of the National Federation of Education and Health Promotion on report "New approaches to public health prevention"].

    Science.gov (United States)

    Cambon, Linda; Ferron, Christine

    2011-01-01

    In 2009, the Center for Strategic Analysis initiated a study, entitled Neurosciences and Public Policies, to assess the use of neurosciences in prevention policy. Subsequently, a report highlighted the inefficiency of the "traditional" prevention programs and the potential contribution of neurosciences to defining a new prevention approach. For the French National Federation for Health Education and Promotion, health promotion cannot be limited to a "counter-manipulation" of consumers confronted with marketing strategies from the food and tobacco industries. Promoting health helps people increase control over the determinants of their health, by means of educational empowering strategies.

  2. Conference report: hot topics in antibody-drug conjugate development.

    Science.gov (United States)

    Thudium, Karen; Bilic, Sanela

    2013-12-01

    American Association of Pharmaceutical Scientists National Biotechnology Conference Sheraton San Diego Hotel and Marina, San Diego, CA, USA, 19-23 May 2013 The National Biotechnology Conference, is a premier meeting for biotechnology professionals covering a broad range of hot topics in the biotechnology industry. Attracting participants from academia, industry and regulatory, this meeting features sessions that aim to address emerging subjects of interest and allows for open exchange between scientists. The 2013 conference featured leading researchers in the fields of antibody-drug conjugates (ADCs) and immunogenicity. Herein, we present a summary of the ADC hot topics, including bioanalytical and PK considerations, quantitative evaluation of the impact of immunogenicity and ADME to understand ADC drug-drug interactions, and clinical considerations for ADC development. This article aims to summarize the recommendations that were made by the speakers during various sessions throughout the conference.

  3. Asia Federation Report on International Symposium on Grid Computing 2009 (ISGC 2009)

    Science.gov (United States)

    Grey, Francois

    This report provides an overview of developments in the Asia-Pacific region, based on presentations made at the International Symposium on Grid Computing 2009 (ISGC 09), held 21-23 April. This document contains 14 sections, including a progress report on general Asia-EU Grid activities as well as progress reports by representatives of 13 Asian countries presented at ISGC 09. In alphabetical order, these are: Australia, China, India, Indonesia, Japan, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.

  4. Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review.

    Science.gov (United States)

    van der Meersch, Amélie; Dechartres, Agnès; Ravaud, Philippe

    2011-01-01

    Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic and brand-name drugs. We excluded case studies, pharmaco-economic evaluations, and validation dosage assays of drugs. We evaluated whether important information about funding, methodology, location of trials, and participants were reported. We also assessed whether the criteria required by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) to conclude bioequivalence were reported and that the conclusions were in agreement with the results. We identified 134 potentially relevant articles but eliminated 55 because the brand-name or generic drug status of the reference drug was unknown. Thus, we evaluated 79 articles. The funding source and location of the trial were reported in 41% and 56% of articles, respectively. The type of statistical analysis was reported in 94% of articles, but the methods to generate the randomization sequence and to conceal allocation were reported in only 15% and 5%, respectively. In total, 65 articles of single-dose trials (89%) concluded bioequivalence. Of these, 20 (31%) did not report the 3 criteria within the limits required by the FDA and 11 (17%) did not report the 2 criteria within the limits required by the EMA. Important information to judge the validity and relevance of results are frequently missing in published reports of trials assessing generic drugs. The quality of reporting of such trials is in need of improvement.

  5. Treatment Services in Adult Drug Courts: Report on the 1999 National Drug Court Treatment Survey. Drug Courts Resource Series.

    Science.gov (United States)

    Pexton, Elizabeth A.; Gossweiler, Robert

    In October 1999, National Treatment Accountability for Safer Communities (TASC), in cooperation with the Office of Justice Programs, Drug Courts Program Office and the Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, developed and distributed a questionnaire designed to describe substance abuse…

  6. Fixed drug eruption due to metronidazole: a case report

    Directory of Open Access Journals (Sweden)

    Dr. Maxilline D. Marak

    2014-06-01

    Full Text Available Metronidazole is commonly used for the treatment of amebiasis, giardiasis and trichomonous vaginitis. Its side effects are relatively frequent and unpleasant, but nonserious. It has the potential to cause fixed drug eruption (FDE. Case Presentation: This 10 year male boy presented for the itching in some part of the body including an itchy, erythematous oval lesion over the right side of the lower part of anterior abdominal wall. He developed these problems after intake of metronidazole tablet. He was diagnosed to be a case of FDE due to metronidazole. This case of adverse drug reaction (ADR was “probable” type (Score=7 of reaction based on Naranjo ADR probability scale and severity assessment showed “mild” type (level 2 based on Hartwig et al scale. The offending drug was stopped immediately and managed with deflazacort tablet 12 mg for 10 days and Fusidic acid+Betamethasone cream for topical application. Discussion: FDE due to metronidazole usually occur within 30 min to 8 hours following its administration and mean length of time from drug intake to the onset of symptoms is approximately 2 hr. Tissue damage in FDE results from the preferential activation of intraepidermal CD8+T cells

  7. Automatic Indexing of Drug Information. Project MEDICO Final Report.

    Science.gov (United States)

    Artandi, Susan

    The broad objective of this investigation was to explore the potential and applicability of automatic methods for the indexing of drug-related information appearing in English natural language text and to find out what can be learned about automatic indexing in general from the experience. More specific objectives were the development,…

  8. Integrating Federal and State data records to report progress in establishing agricultural conservation practices on Chesapeake Bay farms

    Science.gov (United States)

    Hively, W. Dean; Devereux, Olivia H.; Claggett, Peter

    2013-01-01

    In response to the Executive Order for Chesapeake Bay Protection and Restoration (E.O. #13508, May 12, 2009), the U.S. Geological Survey (USGS) took on the task of acquiring and assessing agricultural conservation practice data records for U.S. Department of Agriculture (USDA) programs, and transferred those datasets in aggregated format to State jurisdictional agencies for use in reporting conservation progress to the Chesapeake Bay Program Partnership (CBP Partnership). Under the guidelines and regulations that have been developed to protect and restore water-quality in the Chesapeake Bay, the six State jurisdictions that fall within the Chesapeake Bay watershed are required to report their progress in promoting agricultural conservation practices to the CBP Partnership on an annual basis. The installation and adoption of agricultural best management practices is supported by technical and financial assistance from both Federal and State conservation programs. The farm enrollment data for USDA conservation programs are confidential, but agencies can obtain access to the privacy-protected data if they are established as USDA Conservation Cooperators. The datasets can also be released to the public if they are first aggregated to protect farmer privacy. In 2012, the USGS used its Conservation Cooperator status to obtain implementation data for conservation programs sponsored by the USDA Natural Resources Conservation Service (NRCS) and the USDA Farm Service Agency (FSA) for farms within the Chesapeake Bay watershed. Three jurisdictions (Delaware, Pennsylvania, and West Virginia) used the USGS-provided aggregated dataset to report conservation progress in 2012, whereas the remaining three jurisdictions (Maryland, New York, and Virginia) used jurisdictional Conservation Cooperator Agreements to obtain privacy-protected data directly from the USDA. This report reviews the status of conservation data sharing between the USDA and the various jurisdictions, discusses the

  9. Status report on the use of nuclear energy in the Federal Republic of Germany 2015; Statusbericht zur Kernenergienutzung in der Bundesrepublik Deutschland 2015

    Energy Technology Data Exchange (ETDEWEB)

    Bredberg, Ines; Hutter, Johann; Kuehn, Kerstin; Niedzwiedz, Katarzyna; Philippczyk, Frank; Thoemmes, Achim

    2016-05-15

    Status report on the use of nuclear energy in the Federal Republic of Germany 2015 covers the following topics: electricity generation on Germany, nuclear power plants in Germany, research reactors, facilities of nuclear fuel supply and nuclear waste management.

  10. 78 FR 56230 - Federal Acquisition Regulation; Information Collection; Reporting Purchases From Sources Outside...

    Science.gov (United States)

    2013-09-12

    ... Regulation; Information Collection; Reporting Purchases From Sources Outside the United States AGENCY... request to review and approve an extension of a currently approved information collection requirement concerning reporting purchases from sources outside the United States. DATES: Submit comments on or before...

  11. 75 FR 71560 - Defense Federal Acquisition Regulation Supplement; Cost and Software Data Reporting System (DFARS...

    Science.gov (United States)

    2010-11-24

    ... is provided for contractors with accounting software that does not accommodate the additional data... Acquisition Regulation Supplement; Cost and Software Data Reporting System (DFARS Case 2008-D027) AGENCY... Cost and Software Data Reporting system requirements for Major Defense Acquisition Programs and...

  12. 77 FR 30365 - Defense Federal Acquisition Regulation Supplement: Report on Waiver of Prohibition on Acquisition...

    Science.gov (United States)

    2012-05-22

    ... Regulation Supplement: Report on Waiver of Prohibition on Acquisition From Communist Chinese Military... prohibition on acquisition of United States Munitions List items from Communist Chinese military companies... Chinese military companies. The prior requirement was for a report within 30 days after the date of the...

  13. 75 FR 25165 - Defense Federal Acquisition Regulation Supplement; Cost and Software Data Reporting System

    Science.gov (United States)

    2010-05-07

    ... reporting requirements that are essential for the DoD to estimate the cost of current and future weapon... and not cost allocations. The description will also show how the data from the offeror's accounting... Regulation Supplement; Cost and Software Data Reporting System AGENCY: Defense Acquisition Regulations...

  14. 75 FR 70263 - Federal Acquisition Regulation; Submission for OMB Review; Reporting Purchases From Sources...

    Science.gov (United States)

    2010-11-17

    ... Regulation; Submission for OMB Review; Reporting Purchases From Sources Outside the United States AGENCY... reporting purchases from sources outside the United States. Public comments are particularly invited on... technological collection techniques or other forms of information technology. DATES: Submit comments on...

  15. Non-Family Medicine Resident Training for Primary Care: A Comparative Evaluation of Federally and Non-Federally Supported Primary Care Oriented Medical Residency Programs. Final Report.

    Science.gov (United States)

    Rosinski, Edwin F.; Dagenais, Fred

    Data collected as part of the Robert Wood Johnson Foundation study of residency programs for training in primary medicine and pediatrics are analyzed. The seven residencies supported by the federal government and the nine residencies supported by the Foundation are compared. A brief description of the programs as they existed in 1978 are…

  16. [Comment on “Federal funding at a time of budget austerity”] Report overlooks National Labs' integral role in research and training

    Science.gov (United States)

    Toran, Laura

    Should we emphasize universities over national laboratories in times of limited federal science funding? Frank Press raised this question in his March 26, 1996, Eos article on “Federal Funding at a Time of Budget Austerity,” which summarized a report by the committee of the National Academies of Sciences and Engineering. Although he states that in the report “The unique and complementary roles of universities and federal laboratories are spelled out clearly,” he goes on to say “the committee proposed that universities be given credit for combining research and training.”

  17. Monitoring of Downstream Salmon and Steelhead at Federal Hydroelectric Facilities, 1997 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Martinson, Rick D.; Kamps, Jeffrey W.; Mills, Robert B. (Northwest and Alaska Fisheries Science Center, Environmental and Technical Services Division, Portland, OR)

    1998-06-01

    All juvenile fish numbers, sample, collection, and index were down almost 50% from the previous year at John Day Dam (JDA). At Bonneville Dam, sample numbers increased while collection and index numbers stayed about the same. The following report presents results from the 1997 smolt monitoring at John Day and Bonneville dams and represents the fourteenth annual report under this project. The report also contains summaries of data for all years of the program at John Day and Bonneville dams in Appendices C and D.

  18. [Classification and variability of drug assessment reports on the GENESIS group (SEFH) webpage].

    Science.gov (United States)

    Ortega Eslava, A; Puigventós Latorre, F; Santos-Ramos, B; Calderon Hernanz, B; Vilanova Boltó, M

    2011-01-01

    To analyse the assessment reports published on the GENESIS webpage (Group for Innovation, Assessment, Standardisation and Research in the Selection of Drugs) and assess the variability of the group's proposals to include drugs in the Formulary. We analysed reports published by hospitals on the GENESIS webpage between 2004 and 2007. Data were collected on drugs and indications, ATC group, open or restricted access publications, hospital, and publication date. We drafted a questionnaire that would measure to what extent to what extent the 9-section model recommended by GENESIS was included in each report. For drugs with two or more reports, we analysed whether the recommendation coincided and the possible cause in the event of conflict. We analysed 416 reports corresponding to 185 different drug indications. 93% included 6 or more of the recommended sections, a number which increased over time. The most frequently included sections were: approved indications (92%), mechanism of action (95%), and references (86%) (percentages from 2007). Sections which had an increasing but lower percentage were: differential characteristics (60%), literature search method (40%) and conclusions with a summary of efficacy, safety and cost data (52%). 73% of which had definite recommendations, which coincided for 42 out of the 67 drugs with more than one recommendation report. The work carried out by the GENESIS group has enabled Spanish hospitals to share their drug assessment reports and making them more complete, although there are still some aspects that can be improved. Copyright © 2010 SEFH. Published by Elsevier Espana. All rights reserved.

  19. Self-reported risks for multiple-drug resistance among new tuberculosis cases: implications for drug susceptibility screening and treatment.

    Directory of Open Access Journals (Sweden)

    Timothy F Brewer

    Full Text Available BACKGROUND: Multiple drug-resistance in new tuberculosis (TB cases accounts for the majority of all multiple drug-resistant TB (MDR-TB worldwide. Effective control requires determining which new TB patients should be tested for MDR disease, yet the effectiveness of global screening recommendations of high-risk groups is unknown. METHODS: Sixty MDR-TB cases with no history of previous TB treatment, 80 drug-sensitive TB and 80 community-based controls were recruited in Lima, Peru between August and December, 2008 to investigate whether recommended screening practices identify individuals presenting with MDR-TB. Odd ratios (OR and 95% confidence intervals (CI were calculated using logistic regression to study the association of potential risk factors with case/control variables. RESULTS: MDR-TB cases did not differ from drug-sensitive TB and community controls in rates of human immunodeficiency virus infection, reported hospital or prison visits in the 3 years prior to diagnosis. MDR-TB cases were more likely than drug-sensitive TB controls to have had a recent MDR-TB household contact (OR 4.66, (95% CI 1.56-13.87; however, only 15 cases (28.3% reported this exposure. In multivariate modeling, recent TB household contact, but not contact with an MDR-TB case, remained predictive of MDR-TB, OR 7.47, (95% CI 1.91-29.3. Living with a partner rather than parents was associated with a lower risk of MDR-TB, OR 0.15, (95% CI 0.04-0.51. CONCLUSION: Targeted drug susceptibility testing (DST linked to reported MDR-TB contact or other high-risk exposures does not identify the majority of new TB cases with MDR disease in Lima where it is endemic. All new TB cases should be screened with DST to identify MDR patients. These findings are likely applicable to other regions with endemic MDR-TB.

  20. Drug-dependent inpatients reporting continuous absence of spontaneous drug craving for the main substance throughout detoxification treatment.

    Science.gov (United States)

    De Los Cobos, José Pérez; Siñol, Núria; Trujols, Joan; Bañuls, Enrique; Batlle, Fanny; Tejero, Antoni

    2011-07-01

    Drug craving is considered to be an essential component of substance dependence. We aimed to characterise drug-dependent inpatients reporting continuous absence of subjective spontaneous drug craving. This is a 3 year chart-review study designed to compare drug-dependent inpatients who did not report craving everyday (non-cravers) and their counterparts who did (cravers). All participants were recruited consecutively and completed a 14 day detoxification treatment. Craving was defined as a desire to use the main detoxification substance. This substance was chosen by patients, who completed a craving visual analogue scale, the Beck Depression Inventory and the State-Trait Anxiety Inventory daily. The Temperament and Character Inventory and the Addiction Severity Index were also used. Of the 195 patients who completed the detoxification treatment, 45 (23.1%) were non-cravers and 32 (16.4%) were cravers. The main detoxification substances were alcohol, benzodiazepines, cannabis, cocaine, heroin and methadone. Non-cravers named methadone as the main detoxification substance more frequently than cravers, and benzoylecgonine was less frequently present in their urine at treatment entry. A decreased score on the Temperament and Character Inventory dimension of harm avoidance (i.e. trait anxiety) was the only independent predictor of absence of craving (odds ratio = 1.16, 95% confidence interval = 1.03-1.31). During admission, non-cravers had lower Beck Depression Inventory and State-Trait Anxiety Inventory scores than cravers. These differences were not accounted for by pharmacological treatment. Drug -dependent inpatients who report absence of craving are characterised by relatively low levels of depression and anxiety throughout detoxification treatment, and relatively low levels of trait anxiety. © 2010 Australasian Professional Society on Alcohol and other Drugs.

  1. Nevada Department of Wildlife Statewide Fisheries Management Federal Aid Job Completion Report

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — A report documenting physical and chemical parameters limiting game fish production in regulating reservoirs as well as angler use and harvest in reservoir...

  2. [FY 2015 progress report]: Inventory and Monitoring for the Federally Endangered Northern Red-bellied Cooter

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This is a FY2015 progress report for development of a standardized field protocol for surveying ponds for northern red-bellied cooter occupancy and new maps...

  3. Monitoring of Downstream Salmon and Steelhead at Federal Hydroelectric Facilities, 1998 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Martinson, Rick D.; Kamps, Jeffrey W.; Kovalchuk, Gregory M. (Northwest and Alaska Fisheries Science Center, Environmental and Technical Services Division, Portland, OR)

    1999-03-01

    Project 84-014 has been part of the annual integrated and coordinated Columbia River Basin Smolt Monitoring Program since 1984, and currently addresses measure 5.9A.1 of the 1994 Northwest Power Planning Council's (NPPC) Fish and Wildlife Program. This report presents results from the 1998 smolt monitoring at John Day and Bonneville dams and represents the fifteenth annual report under this project.

  4. Asia Federation Report on International Symposium on Grid Computing (ISGC) 2010

    Science.gov (United States)

    Grey, Francois; Lin, Simon C.

    This report provides an overview of developments in the Asia-Pacific region, based on presentations made at the International Symposium on Grid Computing 2010 (ISGC 2010), held 5-12 March at Academia Sinica, Taipei. The document includes a brief overview of the EUAsiaGrid project as well as progress reports by representatives of 13 Asian countries presented at ISGC 2010. In alphabetical order, these are: Australia, China, India, Indonesia, Japan, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.

  5. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    and analysed descriptively. RESULTS: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11...... reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad....

  6. Constructing virtual combinatorial fragment libraries based upon MDL Drug Data Report database

    Institute of Scientific and Technical Information of China (English)

    ZHANG Min; SHENG ChunQuan; XU Hui; SONG YunLong; ZHANG WanNian

    2007-01-01

    Structural analysis of known drugs or drug-like compounds provides important information for drug design. The 142553 drug molecules in the MDL Drug Data Report database were analyzed, and then the common structural features were extracted. According to the common structural features, drug molecules were segmented into 32017 fragments, including 13642 ring fragments, 10076 linker fragments,and 8299 side chain fragments. These fragments were further used to establish three types of virtual combinatorial fragment libraries: a basic framework library containing 13574 rings; a linker library of 8051 linkers and a pharmacophore library of 34244 fragments combined by rings and side chains. After energy minimization, all fragments in the above three libraries maintain reasonable geometrical features and spatial conformations, and would be useful for building a virtual combinatorial database and de novo drug design.

  7. Constructing virtual combinatorial fragment libraries based upon MDL Drug Data Report database

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Structural analysis of known drugs or drug-like compounds provides important information for drug design. The 142553 drug molecules in the MDL Drug Data Report database were analyzed, and then the common structural features were extracted. According to the common structural features, drug molecules were segmented into 32017 fragments, including 13642 ring fragments, 10076 linker fragments, and 8299 side chain fragments. These fragments were further used to establish three types of virtual combinatorial fragment libraries: a basic framework library containing 13574 rings; a linker library of 8051 linkers and a pharmacophore library of 34244 fragments combined by rings and side chains. After energy minimization, all fragments in the above three libraries maintain reasonable geometrical features and spatial conformations, and would be useful for building a virtual combinatorial database and de novo drug design.

  8. Therapeutic Drug Monitoring of Everolimus: A Consensus Report.

    Science.gov (United States)

    Shipkova, Maria; Hesselink, Dennis A; Holt, David W; Billaud, Eliane M; van Gelder, Teun; Kunicki, Paweł K; Brunet, Mercè; Budde, Klemens; Barten, Markus J; De Simone, Paolo; Wieland, Eberhard; López, Olga Millán; Masuda, Satohiro; Seger, Christoph; Picard, Nicolas; Oellerich, Michael; Langman, Loralie J; Wallemacq, Pierre; Morris, Raymond G; Thompson, Carol; Marquet, Pierre

    2016-04-01

    In 2014, the Immunosuppressive Drugs Scientific Committee of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology called a meeting of international experts to provide recommendations to guide therapeutic drug monitoring (TDM) of everolimus (EVR) and its optimal use in clinical practice. EVR is a potent inhibitor of the mammalian target of rapamycin, approved for the prevention of organ transplant rejection and for the treatment of various types of cancer and tuberous sclerosis complex. EVR fulfills the prerequisites for TDM, having a narrow therapeutic range, high interindividual pharmacokinetic variability, and established drug exposure-response relationships. EVR trough concentrations (C0) demonstrate a good relationship with overall exposure, providing a simple and reliable index for TDM. Whole-blood samples should be used for measurement of EVR C0, and sampling times should be standardized to occur within 1 hour before the next dose, which should be taken at the same time everyday and preferably without food. In transplantation settings, EVR should be generally targeted to a C0 of 3-8 ng/mL when used in combination with other immunosuppressive drugs (calcineurin inhibitors and glucocorticoids); in calcineurin inhibitor-free regimens, the EVR target C0 range should be 6-10 ng/mL. Further studies are required to determine the clinical utility of TDM in nontransplantation settings. The choice of analytical method and differences between methods should be carefully considered when determining EVR concentrations, and when comparing and interpreting clinical trial outcomes. At present, a fully validated liquid chromatography tandem mass spectrometry assay is the preferred method for determination of EVR C0, with a lower limit of quantification close to 1 ng/mL. Use of certified commercially available whole-blood calibrators to avoid calibration bias and participation in external proficiency-testing programs to allow continuous cross

  9. Self-reported drug allergies and the diagnostic work-up in the surgical population

    OpenAIRE

    Tamayo, E; Álvarez, FJ; Castrodeza, J.; Yánez, J.; Arnaiz, P.; Lajo, C.; Soria, S.

    2010-01-01

    Producción Científica Objective The diagnostic work-up of a drug hypersensitivity reaction is indeed difficult. In general, medical documentation of allergic reactions in medical reports is usually highly deficient or non-existent. The aim of this study was to analyse the prevalence of selfreported drug allergies in the surgical population as well as the criteria used in the diagnosis of drug hypersensitivity reactions. Methods A prospective study with the consecutive partic...

  10. In the National Interest: The Federal Government and Research-Intensive Universities. A Report from the Ad Hoc Working Group on Research-Intensive Universities and the Federal Government.

    Science.gov (United States)

    Federal Coordinating Council for Science, Engineering and Technology, Washington, DC.

    This report looks at the relationship between the federal government and research intensive universities (RIUs), identifies critical trends and issues that are affecting their relationship, and offers principles and recommendations for the future. Following an introduction, the origins and characteristics of the relations between the federal…

  11. [Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].

    Science.gov (United States)

    Renisch, B; Lauer, W

    2014-12-01

    An integral part of the conformity assessment process for medical devices is a clinical evaluation based on clinical data. Particularly in the case of implantable devices and products of risk class III clinical trials must be performed. Since March 2010 applications for the authorization of clinical trials as well as for the waiver of the authorization requirement must be submitted centrally in Germany to the appropriate federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). In addition to authorization, approval by the responsible ethics committee is also required under law in order to begin clinical testing of medical devices in Germany. In this paper, the legal framework for the clinical testing of medical devices as well as those involved and possible procedures including evaluation criteria for the initial application of a trial and subsequent amendments are presented in detail. In addition, the reporting requirements for serious adverse events (SAEs) are explained and possible consequences of the evaluation are presented. Finally, a summary of application and registration numbers for all areas of extensive experience of the BfArM as well as requests and guidance for applicants are presented.

  12. 76 FR 64885 - Defense Federal Acquisition Regulation Supplement: Reporting of Government-Furnished Property...

    Science.gov (United States)

    2011-10-19

    ... generally accepted accounting principles. Unit of issue or unit of measure means the physical measurement of....25-2, Military Standard Transaction Reporting and Accounting Procedures manual, along with a... establish the Defense Property Accountability System (DPAS) as its property accounting system of record,...

  13. 44 CFR 17.635 - Reporting of and employee sanctions for convictions of criminal drug offenses.

    Science.gov (United States)

    2010-10-01

    ... REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS) § 17.635 Reporting of and employee sanctions for convictions of... convicted for a violation of a criminal drug statute occurring in the workplace, it shall take the following... notice of the conviction, the grantee shall do the following with respect to the employee who was...

  14. Self-Reported Consumption of Alcohol and Other Drugs in a Spanish University Population

    Science.gov (United States)

    Zaldivar, Flor; Lopez, Francisca; Garcia-Montes, Jose Manuel; Molina, Antonio

    2011-01-01

    Introduction: This study aims to explore the consumption of alcohol and other drugs in university students and to verify whether there are gender differences in the consumption of these substances. Method: A descriptive study using self-reports. Drug consumption was evaluated in 506 students from the University of Almeria (60.9% women and 34.6%…

  15. National Clearinghouse for Drug Abuse Information Report Series, Series 15, No. 1.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHEW/PHS), Rockville, MD. National Clearinghouse for Drug Abuse Information.

    Concerned with clarifying some of the more complex issues in drug abuse, the National Clearinghouse for Drug Abuse Information has prepared this special report on mescaline. Background information is provided through a summary of its history, legal status, and the opinions of authorities in the field. Significant research on the subject is…

  16. Fixed drug eruption to fluconazole: A case report and review of literature

    Directory of Open Access Journals (Sweden)

    Varadraj V Pai

    2012-01-01

    Full Text Available Fixed drug eruption (FDE is mainly characterized by skin lesions that recur at the same anatomic sites upon repeated exposures to an offending agent. It represents the most common cutaneous adverse drug reaction pattern in Indian patients. Here, we report an FDE to fluconazole.

  17. 78 FR 59308 - Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables

    Science.gov (United States)

    2013-09-26

    ... antimicrobial new animal drugs approved for use in food-producing animals by amending section 512(l) of the FD&C... sponsors of antimicrobial new animal drugs approved for use in food-producing animals, and further provides... Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals......

  18. Self-Reported Consumption of Alcohol and Other Drugs in a Spanish University Population

    Science.gov (United States)

    Zaldivar, Flor; Lopez, Francisca; Garcia-Montes, Jose Manuel; Molina, Antonio

    2011-01-01

    Introduction: This study aims to explore the consumption of alcohol and other drugs in university students and to verify whether there are gender differences in the consumption of these substances. Method: A descriptive study using self-reports. Drug consumption was evaluated in 506 students from the University of Almeria (60.9% women and 34.6%…

  19. Surveillance of poisoning and drug overdose through hospital discharge coding, poison control center reporting, and the Drug Abuse Warning Network.

    Science.gov (United States)

    Blanc, P D; Jones, M R; Olson, K R

    1993-01-01

    There is no gold standard for determining poisoning incidence. We wished to compare four measures of poisoning incidence: International Classification of Diseases 9th Revision (ICD-9) principal (N-code) and supplemental external cause of injury (E-code) designations, poison control center (PCC) reporting, and detection by the Drug Abuse Warning Network (DAWN). We studied a case series at two urban hospitals. We assigned ICD-9 N-code and E-code classifications, determining whether these matched with medical records. We ascertained PCC and DAWN system reporting. A total of 724 subjects met entry criteria; 533 were studied (74%). We matched poisoning N-codes for 278 patients (52%), E-code by cause in 306 patients (57%), and E-code by intent in 171 patients (32%). A total of 383 patients (72%) received any poisoning N-code or any E-code. We found that PCC and DAWN reporting occurred for 123 of all patients (23%) and 399 of 487 eligible patients (82%), respectively. In multiple logistic regression, factors of age, hospital admission, suicidal intent, principal poisoning or overdose type, and mixed drug overdose were statistically significant predictors of case match or report varying by surveillance measure. Our findings indicate that common surveillance measures of poisoning and drug overdose may systematically undercount morbidity.

  20. Quality site seasonal report, Fort Devens Launderette, SFBP (Solar in Federal Buildings Program) 1751, December 1984 through June 1985

    Energy Technology Data Exchange (ETDEWEB)

    Logee, T.L.

    1987-10-15

    The active solar Domestic Hot Water (DHW) system at the Fort Devens Launderette was designed and constructed as part of the Solar in Federal Buildings Program (SFBP). This retrofitted system was one of eight systems selected for quality monitoring. The purpose of this monitoring effort was to document the performance of quality state-of-the-art solar systems in large federal buildings. The launderette is part of the Post Exchange complex at the Fort Devens Army Post in Fort Devens, Massachusetts. The solar system preheats hot water for the coin operated laundry which has an estimated 25,000 customers per year. There are 108 collector panels comprising the 2563-square foot collector array. Collected solar energy is stored in a 3800-gallon tank. Propylene glycol is used to protect the solar array from freezing. Two immersed heat exchangers provide heat transfer from the propylene glycol to directly heat the DHW supply water in the storage tank. Auxiliary energy is supplied by gas and oil boilers. This solar system can be considered one of a kind and as such is a prototype. The lessons learned from building and operating this system should be used to correct design deficiencies and improve the performance of future solar systems for this application. Highlights of the system performance at the Fort Devens Launderette solar system during the December 1984 through June 1985 monitoring period are presented in this report.

  1. Federal Holidays

    Data.gov (United States)

    Office of Personnel Management — Federal law (5 U.S.C. 6103) establishes the following public holidays for Federal employees. Please note that most Federal employees work on a Monday through Friday...

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  4. Exploring Neural Correlates of Different Dimensions in Drug Craving Self-Reports among Heroin Dependents.

    Science.gov (United States)

    Hassani-Abharian, Peyman; Ganjgahi, Habib; Tabatabaei-Jafari, Hosein; Oghabian, Mohammad Ali; Mokri, Azarakhsh; Ekhtiari, Hamed

    2015-10-01

    Drug craving could be described as a motivational state which drives drug dependents towards drug seeking and use. Different types of self-reports such as craving feeling, desire and intention, wanting and need, imagery of use, and negative affect have been attributed to this motivational state. By using subjective self-reports for different correlates of drug craving along with functional neuroimaging with cue exposure paradigm, we investigated the brain regions that could correspond to different dimensions of subjective reports for heroin craving. A total of 25 crystalline-heroin smokers underwent functional magnetic resonance imaging (fMRI), while viewing heroin-related and neutral cues presented in a block-design task. During trial intervals, subjects verbally reported their subjective feeling of cue induced craving (CIC). After fMRI procedure, participants reported the intensity of their "need for drug use" and "drug use imagination" on a 0-100 visual analog scale (VAS). Afterwards, they completed positive and negative affect scale (PANAS) and desire for drug questionnaire (DDQ) with 3 components of "desire and intention to drug use," "negative reinforcement," and "loss of control." The study showed significant correlation between "subjective feeling of craving" and activation of the left and right anterior cingulate cortex, as well as right medial frontal gyrus. Furthermore, the "desire and intention to drug use" was correlated with activation of the left precentral gyrus, left superior frontal gyrus, and left middle frontal gyrus. Subjects also exhibited significant correlation between the "need for drug use" and activation of the right inferior temporal gyrus, right middle temporal gyrus, and right parahippocampal gyrus. Correlation between subjective report of "heroin use imagination" and activation of the cerebellar vermis was also observed. Another significant correlation was between the "negative affect" and activation of the left precuneus, right

  5. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database

    OpenAIRE

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

    2016-01-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was de...

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

    Science.gov (United States)

    2010-04-01

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

  7. Federal assistance program. Quarterly project progress report, January 1998--March 1998

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-04-01

    This report summarizes geothermal technical assistance, R&D and technology transfer activities of the Geo-Heat Center at Oregon Institute of Technology for the second quarter of FY-98-98 (January-March, 1998). It describes 268 contacts with parties during this period related to technical assistance with geothermal direct heat projects. Areas dealt with include requests for general information including maps and material for high school debates, and material on geothermal heat pumps, resource and well data, spacing heating and cooling, greenhouses, aquaculture, equipment, district heating, resorts and spas, industrial applications, electric power and snow melting. Research activities include work on model construction specifications for line shaft submersible pumps and plate heat exchangers and a comprehensive aquaculture developer package. The revised Geothermal Direct Use Engineering and Design Guidebooks was completed, published and is available for distribution. Outreach activities include the publication of the Quarterly Bulletin (Vol. 19, No. 1) which was devoted entirely to geothermal equipment, dissemination of information mainly through mailings of publications, tours of local geothermal uses, geothermal library acquisitions and use, participation in workshops, short courses and technical meetings by the staff, and progress monitor reports on geothermal activities.

  8. HIV transmission as a result of drug market violence: a case report

    Directory of Open Access Journals (Sweden)

    Kerr Thomas

    2008-07-01

    Full Text Available Abstract While unprotected sexual intercourse and the use of contaminated injection equipment account for the majority of HIV infections worldwide, other routes of HIV transmission have received less attention. We report on a case of HIV transmission attributable to illicit drug market violence involving a participant in a prospective cohort study of injection drug users. Data from a qualitative interview was used in addition to questionnaire data and nursing records to document an episode of violence which likely resulted in this individual acquiring HIV infection. The case report demonstrates that the dangers of drug market violence go beyond the immediate physical trauma associated with violent altercations to include the possibility for infectious disease transmission. The case highlights the need to consider antiretroviral post-exposure prophylaxis in cases of drug market violence presenting to the emergency room, as well strategies to reduce violence associated with street-based drug markets.

  9. Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial.

    Science.gov (United States)

    Singh, Kern; Phillips, Frank M; Park, Dan K; Pelton, Miguel A; An, Howard S; Goldberg, Edward J

    2012-05-01

    The excellent clinical results of five US Federal Drug Administration (FDA) trials approved for cervical total disc replacement (TDR) (Prestige [Medtronic Sofamor Danek, Memphis, TN, USA], Bryan [Medtronic Sofamor Danek], ProDisc-C [Synthes, West Chester, PA, USA], Kineflex|C [SpinalMotion, Mountain View, CA, USA], and Mobi-C [LDR Spine, Austin, TX, USA]) have recently been published. In these prospective randomized studies, superiority or equivalency of TDR was claimed, citing an 8.7% (23/265), 9.5% (21/221), 8.5% (9/106), 12.2% (14/115), and 6.2% (5/81) (mean = 9.02%) rate of additional related cervical surgical procedures within 2 years in control anterior cervical discectomy and fusion (ACDF) patients, respectively, compared with 1.8% (5/276), 5.8% (14/242), 1.9% (2/103), 11% (15/136), and 1.2% (2/164) (mean = 4.34%) in patients receiving the cervical TDR. The rate of reoperation within 2 years after ACDF seems unusually high. To assess the rate of and specific indications for early reoperation after ACDF in a cohort of patients receiving the ACDF as part of their customary care. These results are contrasted with similar patients receiving ACDF as the control arm of five FDA investigational device exemption (IDE) studies. Multisurgeon retrospective clinical series from a single institution. One hundred seventy-six patients with spondylotic radiculopathy or myelopathy underwent ACDF by three surgeons between 2001 and 2005 as part of their clinical practices. All patients had at least 2 years of follow-up with final follow-up within 6 months of completion of this study. Cervical reoperation rates at 2-year follow-up and at 3.5-year follow-up. Review of medical records and telephone conversations were completed to determine the number of patients who had undergone a revision cervical procedure. At final follow-up, complete data were available for 159 ACDF patients. Of the 48 patients who underwent single-level ACDF and met criteria for inclusion in the IDE studies

  10. Strategic Energy Planning (Area 1) Consultants Reports to Citizen Potawatomi Nation Federally Recognized Indian Tribe

    Energy Technology Data Exchange (ETDEWEB)

    Smith, Marvin; Bose, James; Beier, Richard; Chang, Young Bae

    2004-12-01

    The assets that Citizen Potawatomi Nation holds were evaluated to help define the strengths and weaknesses to be used in pursuing economic prosperity. With this baseline assessment, a Planning Team will create a vision for the tribe to integrate into long-term energy and business strategies. Identification of energy efficiency devices, systems and technologies was made, and an estimation of cost benefits of the more promising ideas is submitted for possible inclusion into the final energy plan. Multiple energy resources and sources were identified and their attributes were assessed to determine the appropriateness of each. Methods of saving energy were evaluated and reported on and potential revenue-generating sources that specifically fit the tribe were identified and reported. A primary goal is to create long-term energy strategies to explore development of tribal utility options and analyze renewable energy and energy efficiency options. Associated goals are to consider exploring energy efficiency and renewable economic development projects involving the following topics: (1) Home-scale projects may include construction of a home with energy efficiency or renewable energy features and retrofitting an existing home to add energy efficiency or renewable energy features. (2) Community-scale projects may include medium to large scale energy efficiency building construction, retrofit project, or installation of community renewable energy systems. (3) Small business development may include the creation of a tribal enterprise that would manufacture and distribute solar and wind powered equipment for ranches and farms or create a contracting business to include energy efficiency and renewable retrofits such as geothermal heat pumps. (4) Commercial-scale energy projects may include at a larger scale, the formation of a tribal utility formed to sell power to the commercial grid, or to transmit and distribute power throughout the tribal community, or hydrogen production

  11. 76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

    Science.gov (United States)

    2011-12-30

    .... Margaret A. Hamburg, called for a cross- Agency working group to prepare a report identifying FDA's ``best... operations and decisionmaking processes more transparent and to foster more efficient and...

  12. NASA/DoD Aerospace Knowledge Diffusion Research Project. Paper 29: The US government technical report and the transfer of federally funded aerospace R and D

    Science.gov (United States)

    Pinelli, Thomas E.; Barclay, Rebecca O.; Kennedy, John M.

    1993-01-01

    This article discusses the U.S. government technical report and the transfer of federally funded aerospace research and development in a conceptual framework of the federal government as a producer of scientific and technical information. The article summarizes current literature and research and discusses U.S. government technical report use and the importance of using data obtained from the NASA/DoD Aerospace Knowledge Diffusion Research Project. The authors make a case for changing existing U.S. technology policy and present a research agenda for the U.S. government technical report.

  13. Monitoring of Downstream Salmon and Steelhead at Federal Hydroelectric Facilities, 1990 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Hawkes, Lynette A.

    1991-03-01

    The seaward migration of salmonid smolts was monitored by the National Marine Fisheries Service (NMFS) at three sites on the Columbia River system in 1990. This project is a part of the continuing Smolt Monitoring Program to monitor Columbia Basin salmonid stocks coordinated by the Fish Passage Center (FPC) for the Columbia Basin Fish and Wildlife Agencies and Indian Tribes. It's purpose is to provide timely data to the Fish Passage Managers for in season flow and spill management for fish passage and post-season analysis for travel time, relative magnitude and timing and the smolt migration. This program is carried out under the auspices of the Northwest Power Planning Council Fish and Wildlife Program and is funded by the Bonneville Power Administration (BPA). Sampling sites were John Day and Bonneville Dams under the Smolt Monitoring program, and the Dallas Dam under the Fish Spill Memorandum of Agreement'' for 1990. All pertinent fish capture, condition and brand data, as well as dam operations and river flow data were reported daily to FPC. These data were incorporated into the FPC Fish Passage Data Information System (FPDIS). 10 refs., 8 figs., 1 tab.

  14. Monitoring of Downstream Salmon and Steelhead at Federal Hydroelectric Facilities, 1992 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Hawkes, Lynnette A.; Martinson, Rick D.; Absolon, Randall F. (Northwest and Alaska Fisheries Science Center, Environmental and Technical Services Division, Portland, OR)

    1993-05-01

    The seaward migration of salmonid smolts was monitored by the National marine Fisheries Service (NMFS) at two sites on the Columbia River in 1992. The NMFS Smolt Monitoring Project is part of a larger Smolt Monitoring Program to index Columbia Basin juvenile salmonied stocks. It is coordinated by the Fish Passage Center (FPC) for the Columbia Basin Fish and Wildlife Agencies and Tribes. Its purpose is to facilitate fish passage through reservoirs and at dams by providing FPC with timely smolt migration data used for flow and spill management. Data is also used for travel time, migration timing and relative run size magnitude analysis. This program is carried out under the auspices of the Northwest Power Planning Council Fish and Wildlife Program and is funded by the Bonneville Power Administration (BPA). Sampling sites were John Day and Bonneville Dams under the 1992 Smolt Monitoring Program. All pertinent fish capture, condition, brand recovery, and flow data, were reported daily to FPC. These data were incorporated into the FPC`s Fish Passage Data System (FPDS).

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

    Science.gov (United States)

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

    2012-08-01

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

  16. Consistency of self-reported drug use events in a mixed methods study of people who inject drugs.

    Science.gov (United States)

    Dyal, Stephanie R; Kral, Alex H; Dominguez Gonzalez, Karina; Wenger, Lynn D; Bluthenthal, Ricky N

    2015-01-01

    Little is known about the consistency of information provided by people who inject drugs (PWID) during quantitative and qualitative interviews in mixed methods studies. We illustrate the use of the intraclass correlation coefficient, descriptive statistics, and regression to assess the consistency of information provided during a mixed methods study of PWID living in Los Angeles and San Francisco, California, USA. Age of first use of heroin, methamphetamine, marijuana, powder cocaine, and crack cocaine and first injection of heroin, methamphetamine, and powder cocaine were collected during an interviewer administered computer-assisted personal interview followed by an in-depth qualitative interview (n = 102). Participants were 63% male, racially/ethnically diverse. 80.4% between the ages of 40 and 60 years old, 89% US-born, and 57% homeless. Consistency of self-reported data was adequate for most drug use events. Exact concordance between quantitative and qualitative measures of age of onset ranged from 18.2-50%. Event ordering was consistent across qualitative and quantitative results for 90.2% of participants. Analyses indicated that age of onset for heroin use, heroin injection, and injection of any drug was significantly lower when assessed by qualitative methods as compared to quantitative methods. While inconsistency will emerge during mixed method studies, confidence in the timing and ordering of major types of events such as drug initiation episodes appear to be warranted.

  17. Monitoring of Downstream Salmon and Steelhead at Federal Hydroelectric Facilities, 2004-2005 Annual Report.

    Energy Technology Data Exchange (ETDEWEB)

    Martinson, Rick D.; Kamps, Jeffrey W.; Kovalchuk, Gregory M. (Pacific States Marine Fisheries Commission, Portland, OR)

    2005-02-02

    yearling Chinook and unclipped steelhead runs took longer to pass Bonneville than any previous year, at 44 and 45 days, respectively. For subyearling Chinook, the middle 80% of the fish passed during the last three weeks of June and the first week of July, taking 35 days to pass the project, the same as last year. Descaling for all species was slightly higher than the average of the last five years. Compared to last year, descaling varied by species, increasing for yearling Chinook, coho, and sockeye and lower for subyearling Chinook and steelhead. Since sampling began in the juvenile monitoring facility, descaling has been quite consistent, staying below 3.6% for yearling and subyearling Chinook, unclipped steelhead and coho, and above 4.7% for clipped steelhead and sockeye. Mortality was slightly higher than last year and the historical average for yearling and subyearling Chinook and steelhead. Coho and sockeye mortality was lower than last year and the historical average. Mortality for all species was below 1%. Powerhouse 2 operational priority and research results showing higher survival of fish passing through the PH1 turbines rather than through the bypass system resulted in a complete disuse of the PH1 bypass system. Consequently, we removed the historic PH1 data from this report and refer readers to any prior report for information regarding first powerhouse fish sampling.

  18. Patient-reported multiple drug reactions: Clinical profile and results of challenge testing

    Directory of Open Access Journals (Sweden)

    Ramam M

    2010-01-01

    Full Text Available Background: Some patients report hypersensitivity reactions to many drugs making it difficult to prescribe medications when they fall ill. Aim: To describe the clinical profile of multiple drug hypersensitivity and the results of challenge testing in a large teaching hospital.Methods: We performed a five-year retrospective review of the records of patients who complained of reactions to two or more unrelated drugs and avoided medication because of a fear of developing reactions. Oral challenge testing was carried out in hospital with drugs suspected by the patient to cause reactions and/or commonly prescribed medications. A positive reaction was diagnosed when symptoms and signs resembled previously experienced episodes and there was no such reaction with placebo. Results: Twenty three patients (aged 14-65 years; 19 females underwent challenge testing. Their complaints had been present for 1-30 years, with 2-40 drug reaction episodes reported. Antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs were most commonly implicated, and urticaria/angioedema were the most often reported manifestations. The patients underwent 3-27 challenges with 1-24 drugs. Three had positive challenge reactions with various NSAIDs, 13 developed symptoms and signs that were judged not to be true reactions, and 7 had no reactions. None of our patients qualified for a diagnosis of true multiple drug hypersensitivity. Conclusion: Patients who believe they are allergic to multiple, pharmacologically unrelated drugs are usually mistaken. Challenge testing is a reliable way of demonstrating this and providing patients with a list of safe drugs.

  19. Federal Facility Agreement Annual Progress Report for Fiscal Year 1999 Oak Ridge, Tennessee

    Energy Technology Data Exchange (ETDEWEB)

    Bechtel Jacobs Company LLC

    2000-01-01

    Environmental Response, Compensation, and Liability Act and/or the Resource Conservation and Recovery Act. This plan will be implemented by means of a Memorandum of Understanding (MOU) incorporating its terms with the United States EPA and TDEC. The majority of projects described in this report are grouped into five watersheds. They are the East Tennessee Technical Park (ETTP) Watershed (formerly the K-25 Site), the Melton Valley (MV) and Bethel Valley (BV) Watersheds at the Oak Ridge National Laboratory (ORNL), and the Bear Creek Valley (BCV) and Upper East Fork Poplar Creek (UEFPC) Watersheds at the Y-12 Plant.

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

    Science.gov (United States)

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

    2003-03-01

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

  1. Quality site seasonal report, Eisenhower Museum, SFBP (Solar in Federal Buildings Program) 4008, March 1985 through September 1985

    Energy Technology Data Exchange (ETDEWEB)

    Raymond, M.G.

    1987-10-15

    The active solar Domestic Hot Water (DHW) and space heating system at the Eisenhower Museum was designed and constructed as part of the Solar in Federal Buildings Program (SFBP). This retrofitted system is one of eight of the systems in the SFBP slected for quality monitoring. The purpose of this monitoring effort is to document the performance of quality state-of-the-art solar systems in large federal building applications. These systems are unique prototypes. Design errors and system faults discovered during the monitoring period could not always be corrected. Therefore, the aggregate, overall performance is often considerably below what might be expected had similar systems been constructed consecutively with each repetition incorporating corrections and improvements. The solar system is a retrofit, designed to supply part of the space heating (and reheating for humidity control) load at the museum, located at President Eisenhower's boyhood home in Abilene, Kansas. The small DHW load is also served by the solar system. The museum and adjacent library entertain approximately 200,000 visitors per year, and require controlled temperature and humidity for preservation of artifacts. The summer reheating load for humidity control is comparable to the space heating load in winter. The solar system has 110 US Solar flat plate collectors with a gross area of 4201 square feet, using ethylene glycol as the collector fluid. The energy from the collector loop is transferred to two 1980 gallon storage tanks via an external heat exchanger. Solar energy is used for DHW preheating and for space heating. Highlights of the performance monitoring at the Eisenhower Museum during the period March 1985 through September 1985 are summarized in this report.

  2. Quality site seasonal report, Tucson Job Corps Center, SFBP (Solar in Federal Buildings Program) 1751, November 1984 through July 1985

    Energy Technology Data Exchange (ETDEWEB)

    Logee, T.L.

    1987-10-15

    The active solar Domestic Hot Water (DHW) system at the Tucson Job Corps Center was designed and constructed as part of the Solar in Federal Buildings Program (SFBP). This retrofitted system is one of eight of the systems in the SFBP selected for quality monitoring. The purpose of this monitoring effort is to document the performance of quality state-of-the-art solar systems in large Federal buildings. The systems are unique prototypes. Design errors and system faults discovered during the monitoring period could not always be corrected. Therefore, the aggregated overall performance is often considerably below what might be expected had similar systems been constructed consecutively with each repetition incorporating corrections and improvements. The solar collector system is installed on a two story dormitory at the Job Corps Center. The solar system preheats hot water for about two hundred students. The solar system provided about 50% of the energy needed for water heating in the winter and nearly 100% of the water heating needs in the summer. There are about 70,000 gallons of water used per month. There are seventy-nine L.O.F. panels or 1659 square feet of collectors (1764 square feet before freeze damage occurred) mounted in two rows on the south facing roof. Collected solar energy is stored in the 2200-gallon storage tank. The control system is by Johnson Controls. City water is piped directly to the storage tank and is circulated in the collectors. Freeze protection is provided by recirculation of storage water. There is an auxiliary gas fired boiler and 750 gallon DHW storage tank to provide backup for the solar system. Highlights of the performance monitoring from the solar collection system at the Tucson Job Corps Center during the November 1984 through July 1985 monitoring period are presented in this report.

  3. 49 CFR Appendix C to Part 40 - DOT Drug Testing Semi-Annual Laboratory Report to DOT

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false DOT Drug Testing Semi-Annual Laboratory Report to... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. C Appendix C to Part 40—DOT Drug Testing... of Drug and Alcohol Policy and Compliance, W62-300, 1200 New Jersey Avenue, SE., Washington, DC 20590...

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

    Science.gov (United States)

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

    2008-01-01

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

  5. The Spatial Association Between Federally Qualified Health Centers and County-Level Reported Sexually Transmitted Infections: A Spatial Regression Approach.

    Science.gov (United States)

    Owusu-Edusei, Kwame; Gift, Thomas L; Leichliter, Jami S; Romaguera, Raul A

    2017-08-16

    The number of categorical sexually transmitted disease (STD) clinics is declining in the United States. Federally qualified health centers (FQHCs) have the potential to supplement the needed sexually transmitted infection (STI) services. In this study, we describe the spatial distribution of FQHC sites and determine if reported county-level nonviral STI morbidity were associated with having FQHC(s) using spatial regression techniques. We extracted map data from the Health Resources and Services Administration data warehouse on FQHCs (ie, geocoded health care service delivery [HCSD] sites) and extracted county-level data on the reported rates of chlamydia, gonorrhea and, primary and secondary (P&S) syphilis (2008-2012) from surveillance data. A 3-equation seemingly unrelated regression estimation procedure (with a spatial regression specification that controlled for county-level multiyear (2008-2012) demographic and socioeconomic factors) was used to determine the association between reported county-level STI morbidity and HCSD sites. Counties with HCSD sites had higher STI, poverty, unemployment, and violent crime rates than counties with no HCSD sites (P < 0.05). The number of HCSD sites was associated (P < 0.01) with increases in the temporally smoothed rates of chlamydia, gonorrhea, and P&S syphilis, but there was no significant association between the number of HCSD per 100,000 population and reported STI rates. There is a positive association between STI morbidity and the number of HCSD sites; however, this association does not exist when adjusting by population size. Further work may determine the extent to which HCSD sites can meet unmet needs for safety net STI services.

  6. Reporting of conflicts of interest from drug trials in Cochrane reviews : cross sectional study

    NARCIS (Netherlands)

    Roseman, Michelle; Turner, Erick H.; Lexchin, Joel; Coyne, James C.; Bero, Lisa A.; Thombs, Brett D.

    2012-01-01

    Objectives To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Design Cross sectional study. Data sources Cochr

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

    NARCIS (Netherlands)

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

    2001-01-01

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

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

    NARCIS (Netherlands)

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

    2003-01-01

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

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

    NARCIS (Netherlands)

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

    2001-01-01

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

  10. Hyperacute drug-induced hepatitis with intravenous amiodarone: case report and review of the literature.

    Science.gov (United States)

    Nasser, Mohammad; Larsen, Timothy R; Waanbah, Barryton; Sidiqi, Ibrahim; McCullough, Peter A

    2013-01-01

    Amiodarone is a benzofuran class III antiarrhythmic drug used to treat a wide spectrum of ventricular tachyarrhythmias. The parenteral formulation is prepared in polysorbate 80 diluent. We report an unusual case of acute elevation of aminotransaminase concentrations after the initiation of intravenous amiodarone. An 88-year-old Caucasian female developed acute hepatitis and renal failure after initiating intravenous amiodarone for atrial fibrillation with a rapid ventricular response in the setting of acutely decompensated heart failure and hepatic congestion. Liver transaminases returned to baseline within 7 days after discontinuing the drug. Researchers hypothesized that this type of injury is related to liver ischemia with possible superimposed direct drug toxicity. The CIOMS/RUCAM scale identifies our patient's acute hepatitis as a highly probable adverse drug reaction. Future research is needed to understand the mechanisms by which hyperacute drug toxicity occurs in the setting of impaired hepatic perfusion and venous congestion.

  11. 49 CFR Appendix B to Part 40 - DOT Drug Testing Semi-Annual Laboratory Report to Employers

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false DOT Drug Testing Semi-Annual Laboratory Report to... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. B Appendix B to Part 40—DOT Drug Testing...) (b) Negative and Dilute (number) 3. Specimens Reported as Rejected for Testing (total number) By...

  12. Systemic provocation in doxycycline induced fixed drug eruption: a case report

    Directory of Open Access Journals (Sweden)

    Anik Murwaningsih Rosmarini Estri Sih Hananti Niken Indrastuti

    2014-04-01

    Full Text Available Fixed drug eruption (FDE is recurrent lesions that upon repeated uptake of causative drug, always appears at the same skin and mucosal site. Determination of causal relationship in drug allergy is very important. In this case report, cases of doxycycline-induced FDE was reported. The subject of the research was a 29-year-old male, referred by dermatologist, with history of reccurent FDE. Physical examination revealed an oval well demarcated patch hyperpigmentation. Patch test was perfomed on previous involved and uninvolved site. The result of the patch test was irrelevant. Retesting patch test gave similar result. Systemic provocation test or drug provocation test (DPT  with doxcycline were done with suspected drug under ambulatory survelance and gave positive result. In this case, the DPT succeeded to identify doxycycline as the causal agent of FDE. The work-up of a suspected drug hypersensitivity includes a detailed clinical history, physical examination, skin tests, and provocation tests. The DPT is recommended to confirm drug’s hypersensitivity reactions. Systemic provocation test is considered as the gold standard for diagnosing FDE.Keywords:   fixed drug eruption - doxycycline - causal relationship - patch test - systemic provocation test

  13. Systemic provocation in doxycycline induced fixed drug eruption: a case report

    Directory of Open Access Journals (Sweden)

    Anik Murwaningsih Rosmarini Estri Sih Hananti Niken Indrastuti

    2014-04-01

    Full Text Available Fixed drug eruption (FDE is recurrent lesions that upon repeated uptake of causative drug, always appears at the same skin and mucosal site. Determination of causal relationship in drug allergy is very important. In this case report, cases of doxycycline-induced FDE was reported. The subject of the research was a 29-year-old male, referred by dermatologist, with history of reccurent FDE. Physical examination revealed an oval well demarcated patch hyperpigmentation. Patch test was perfomed on previous involved and uninvolved site. The result of the patch test was irrelevant. Retesting patch test gave similar result. Systemic provocation test or drug provocation test (DPT  with doxcycline were done with suspected drug under ambulatory survelance and gave positive result. In this case, the DPT succeeded to identify doxycycline as the causal agent of FDE. The work-up of a suspected drug hypersensitivity includes a detailed clinical history, physical examination, skin tests, and provocation tests. The DPT is recommended to confirm drug’s hypersensitivity reactions. Systemic provocation test is considered as the gold standard for diagnosing FDE. Keywords:   fixed drug eruption - doxycycline - causal relationship - patch test - systemic provocation test

  14. Prescription drug abuse as a public health problem in Ohio: a case report.

    Science.gov (United States)

    Winstanley, Erin L; Gay, Joe; Roberts, Lisa; Moseley, Judi; Hall, Orman; Beeghly, B Christine; Winhusen, Theresa; Somoza, Eugene

    2012-11-01

    Prescription drug overdose is the leading cause of injury death in Ohio, as well as in 16 other states. Responding to the prescription drug epidemic is particularly challenging given the fragmentation of the health care system and that the consequences of addiction span across systems that have not historically collaborated. This case study reports on how Ohio is responding to the prescription drug epidemic by developing cross-system collaboration from local public health nurses to the Governor's office. In summary, legal and regulatory policies can be implemented relatively quickly whereas changing the substance abuse treatment infrastructure requires significant financial investments.

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

    Directory of Open Access Journals (Sweden)

    Rosliana Rosli

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

  16. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.

    Science.gov (United States)

    2014-06-10

    The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

  17. Quality of Reporting of Serious Adverse Drug Events to an Institutional Review Board

    Science.gov (United States)

    Dorr, David A.; Burdon, Rachel; West, Dennis P.; Lagman, Jennifer; Georgopoulos, Christina; Belknap, Steven M.; McKoy, June M.; Djulbegovic, Benjamin; Edwards, Beatrice J.; Weitzman, Sigmund A.; Boyle, Simone; Tallman, Martin S.; Talpaz, Moshe; Sartor, Oliver; Bennett, Charles L.

    2009-01-01

    Purpose Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P < 0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P < 0.05). Some key clinical information was discrepant between the two sources. Conclusions The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients. PMID:19458059

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

    Science.gov (United States)

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

    1990-04-01

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

  19. Analysis of extensively washed hair from cocaine users and drug chemists to establish new reporting criteria.

    Science.gov (United States)

    Morris-Kukoski, Cynthia L; Montgomery, Madeline A; Hammer, Rena L

    2014-01-01

    Samples from a self-proclaimed cocaine (COC) user, from 19 drug users (postmortem) and from 27 drug chemists were extensively washed and analyzed for COC, benzoylecgonine, norcocaine (NC), cocaethylene (CE) and aryl hydroxycocaines by liquid chromatography-tandem mass spectrometry. Published wash criteria and cutoffs were applied to the results. Additionally, the data were used to formulate new reporting criteria and interpretation guidelines for forensic casework. Applying the wash and reporting criteria, hair that was externally contaminated with COC was distinguished from hair collected from individuals known to have consumed COC. In addition, CE, NC and hydroxycocaine metabolites were only present in COC users' hair and not in drug chemists' hair. When properly applied, the use of an extended wash, along with the reporting criteria defined here, will exclude false-positive results from environmental contact with COC.

  20. Federalism Lives.

    Science.gov (United States)

    Howard, A. E. Dick

    1987-01-01

    Examines the concept of federalism in terms of its past history and its encouraging future. Calls for a revival of concern for federalism not simply as a convenient administrative arrangement but as a fundamental constitutional value. (BSR)

  1. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov.

    Science.gov (United States)

    Law, Michael R; Kawasumi, Yuko; Morgan, Steven G

    2011-12-01

    Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.

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

    Directory of Open Access Journals (Sweden)

    Yun Mi Yu

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

  3. Uncertainties in Cancer Risk Coefficients for Environmental Exposure to Radionuclides. An Uncertainty Analysis for Risk Coefficients Reported in Federal Guidance Report No. 13

    Energy Technology Data Exchange (ETDEWEB)

    Pawel, David [U.S. Environmental Protection Agency; Leggett, Richard Wayne [ORNL; Eckerman, Keith F [ORNL; Nelson, Christopher [U.S. Environmental Protection Agency

    2007-01-01

    Federal Guidance Report No. 13 (FGR 13) provides risk coefficients for estimation of the risk of cancer due to low-level exposure to each of more than 800 radionuclides. Uncertainties in risk coefficients were quantified in FGR 13 for 33 cases (exposure to each of 11 radionuclides by each of three exposure pathways) on the basis of sensitivity analyses in which various combinations of plausible biokinetic, dosimetric, and radiation risk models were used to generate alternative risk coefficients. The present report updates the uncertainty analysis in FGR 13 for the cases of inhalation and ingestion of radionuclides and expands the analysis to all radionuclides addressed in that report. The analysis indicates that most risk coefficients for inhalation or ingestion of radionuclides are determined within a factor of 5 or less by current information. That is, application of alternate plausible biokinetic and dosimetric models and radiation risk models (based on the linear, no-threshold hypothesis with an adjustment for the dose and dose rate effectiveness factor) is unlikely to change these coefficients by more than a factor of 5. In this analysis the assessed uncertainty in the radiation risk model was found to be the main determinant of the uncertainty category for most risk coefficients, but conclusions concerning the relative contributions of risk and dose models to the total uncertainty in a risk coefficient may depend strongly on the method of assessing uncertainties in the risk model.

  4. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

    Science.gov (United States)

    Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; de Graeff, Pieter A; Mol, Peter G M

    2011-11-01

    Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our

  5. VALIDITY OF SELF-REPORTED DRUG USE INFORMATION AMONG PREGNANT WOMEN

    Science.gov (United States)

    Garg, Mahek; Garrison, Laura; Leeman, Lawrence; Hamidovic, Ajna; Borrego, Matthew; Rayburn, William F.

    2015-01-01

    Introduction This study assesses validity of self-report for the use of major classes of illicit drugs and opioid-maintenance therapy among pregnant women at a substance abuse treatment program. Methods Analyses used data collected from 83 pregnant women in a prospective cohort study at the University of New Mexico. Study participants with a history of substance abuse were screened and, if eligible, enrolled during an early prenatal care visit. A follow-up interview was conducted shortly after delivery. Self-reported information about drug use later in pregnancy was compared with urine drug screen (UDS) results collected during the third trimester. Simple kappa (k) and prevalence-and-bias-adjusted kappa (PABAK) coefficients were calculated as the measures of agreement. Sensitivity and specificity of self-report for each drug class were estimated using UDS as the ‘gold standard’. Results The sample included a large proportion of ethnic minority (80% Hispanic/Latina and 7% American Indian) and socially disadvantaged (50% < less than high school education and 94% Medicaid-insured) pregnant women. On average, patients had 4.8 ± 3.0 urine drug screens during the third trimester. Sensitivity of self-report was low (<60%) for all classes of illicit drugs; however, marijuana and opioids demonstrated slightly higher sensitivity (57.9% and 58.3%, respectively) than other classes (<47%). Conclusions This study found substantial underreporting for all classes of illicit drugs among pregnant women in a substance abuse treatment program. Rates of underreporting are expected to be higher among the general population of pregnant women. PMID:26175273

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2003-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Ioanna Martínez

    2015-04-01

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

  9. International Reports. International Federation of Library Associations and Institutions; Canada's Libraries in 2002: A Year of Partnerships; A Golden Celebration: The National Library of Canada at 50.

    Science.gov (United States)

    Wiggins, Beacher; Adams, Karen G.; Starr, Mary Jane

    2003-01-01

    These three reports discuss international library organization issues, including awards and grants, digital technology, and membership; and Canadian library issues, including federal information policy issues, library services, projected shortage of librarians, mergers, digital divide, and a history of the National Library of Canada. (LRW)

  10. FIXED DRUG ERUPTION DUE TO METRONIDAZOLE: REVIEW OF LITERATURE AND A CASE REPORT

    Directory of Open Access Journals (Sweden)

    Wahlang JB

    2012-03-01

    Full Text Available Fixed drug eruption (FDE is common type of drug eruption seen in skin clinics. FDE usually occurs within hours of administration of the offending agent. Most commonly implicated are sulphonamides, salicylates, oxyphenbutazones, tetracycline, dapsone, chlordiazepoxide, barbiturates, phenolphthalein, morphine, codeine,quinine and derivatives, phenacetin, erythromycin, griseofulvin, mebendazole, meprobamate etc. We hereby report a case of fixed drug eruption on glans penis due to metronidazole, a nitroimidazole-derivative clinically indicated in trichomoniasis, amebiasis, giardiasis, anaerobic and mixed antibacterial infections. A patientadministered metronidazole IV developed erythematous superficial non-tender ulceration over the glans penis on the second day of treatment with Inj. Metronidazole. A provisional diagnosis of metronidazole induced fixed drug eruption was made, metronidazole inj. was stopped and the patient was managed with Tab. Prednisolone30mg/day tapered over 10 days and Fusidic acid+Betamethasone cream.

  11. A CASE REPORT STUDY OF DICLOFENAC–INDUCED SEVERE FIXED DRUG ERUPTION

    Directory of Open Access Journals (Sweden)

    Ravindra Kumar

    2016-03-01

    Full Text Available Diclofenac is a widely used non-steroidal anti-inflammatory drug (NSAID. The most common reported adverse drug reactions (ADRs of diclofenac are nausea, vomiting, epigastric pain, headache and dizziness. Fixed drug eruption (FDE is also one ADR due to diclofenac, which is even though not uncommon, in this case the severity is very high. That has made us to focus on this case. A 52-year-old male patient attended the skin OPD (outpatient department with multiple erythematous patches over face, neck, upper limbs and lower limbs which were started after taking diclofenac for sprain injury. After complete history, the patient said he had similar complaints in the past for same drug. Patient started showing improvement after stopping diclofenac. Completely recovered after 10 days.

  12. Uso de psicotrópicos entre universitários da área da saúde da Universidade Federal do Amazonas, Brasil Use of psychoactive drugs by health sciences undergraduate students at the Federal University in Amazonas, Brazil

    Directory of Open Access Journals (Sweden)

    Ana Cyra dos Santos Lucas

    2006-03-01

    Full Text Available Foi realizado um levantamento sobre uso de psicotrópicos entre estudantes da Faculdade de Ciências da Saúde da Universidade Federal do Amazonas, Manaus, Brasil, em uma amostra de 521 alunos. O "uso na vida" de álcool foi relatado por 87,7% dos estudantes (IC95%: 85,34-90,06 e o de tabaco por 30,7% (IC 95%: 27,39-34,01, sendo o último maior entre estudantes do sexo masculino (39,7%; IC95%: 33,33-46,01. As substâncias ilegais mais usadas foram: solventes (11,9%; IC95%: 9,57-14,23, maconha (9,4%; IC95%: 7,30-11,50, anfetamínicos e ansiolíticos (ambos com 9,2%; IC95%: 7,12-11,28, cocaína (2,1%; IC95%: 1,07- 3,13 e alucinógenos (1,2%; IC95%: 0,42-1,98. O principal motivo relatado para o uso de drogas ilegais foi a curiosidade. O "uso na vida" de esteróides anabolizantes foi citado por 2,1% dos estudantes. O uso abusivo de álcool nos últimos 30 dias foi relatado por 12,4% dos universitários. Entre os eventos ocorridos após a ingestão de bebidas alcoólicas, os estudantes citaram envolvimento em briga (4,7%, acidentes (2,4%, faltaà escola (33,7%, falta ao trabalho (11,8% e condução de veículos (47,3%. A opinião sobre as drogas e o padrão de uso dos estudantes não diferem muito dos estudos semelhantes em outras regiões do Brasil.A survey was conducted with 521 undergraduate health sciences students from the Federal University in Amazonas, Manaus, Brazil. Lifetime alcohol consumption was reported by 87.7% students, as compared to 30.7% for tobacco, with the latter reported more frequently by males (39.7%. The most common illicit drugs were solvents (11.9%, marijuana (9.4%, amphetamines and anxiolytics (9.2% each, cocaine (2.1%, and hallucinogens (1.2%. The main reason for illicit drug use was curiosity. Lifetime use of anabolic steroids was reported by 2.1% of the students. Alcohol abuse in the previous 30 days was reported by 12.4% of the students. Events following drinking included: fights (4.7%, accidents (2.4%, classroom

  13. National Institute on Drug Abuse symposium report: drugs of abuse, dopamine, and HIV-associated neurocognitive disorders/HIV-associated dementia.

    Science.gov (United States)

    Purohit, Vishnudutt; Rapaka, Rao; Frankenheim, Jerry; Avila, Albert; Sorensen, Roger; Rutter, Joni

    2013-04-01

    The National Institute on Drug Abuse organized a symposium on drugs of abuse, dopamine, and HIV-associated neurocognitive disorders (HAND)/HIV-associated dementia (HAD) in Rockville, Maryland, October 4, 2011. The purpose of this symposium was to evaluate the potential role of dopamine in the potentiation of HAND/HAD by drugs of abuse. A summary of the symposium has been presented in this report.

  14. Facilitation of the Estuary/Ocean Subgroup for Federal Research, Monitoring, and Evaluation, FY10 Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Gary E.

    2010-10-26

    The Estuary/Ocean Subgroup (EOS) is part of the research, monitoring, and evaluation (RME) effort that the Action Agencies (Bonneville Power Administration, U.S. Army Corps of Engineers, U.S. Bureau of Reclamation) developed in response to obligations arising from the Endangered Species Act as applied to operation of the Federal Columbia River Power System (FCRPS). The goal of the EOS project is to facilitate activities of the estuary/ocean RME subgroup as it coordinates design and implementation of federal RME in the lower Columbia River and estuary. The EOS is one of multiple work groups in the federal research, monitoring, and evaluation (RME) effort developed in response to responsibilities arising from the Endangered Species Act as a result of operation of the FCRPS. The EOS is tasked by NOAA Fisheries and the Action Agencies to design and coordinate implementation of the federal RME plan for the lower Columbia River and estuary, including the plume.

  15. Construct and concurrent validity of a patient-reported adverse drug event questionnaire : a cross-sectional study

    NARCIS (Netherlands)

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

    2014-01-01

    Background: Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is

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

    Directory of Open Access Journals (Sweden)

    Johnson Segun Showande

    2013-01-01

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

  17. Anabolic Steroids: A Threat to Body and Mind. National Institute on Drug Abuse Research Report Series.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHHS/PHS), Rockville, MD.

    This report, based on findings of recent studies on the use of anabolic steroids in the United States, was written to educate the public about these drugs and the dangers of misusing them. It notes that the nonmedical use of anabolic/androgenic steroids among adolescents and young adults is of growing concern, with possibly as many as half a…

  18. Non-sedating antihistamine drugs and cardiac arrhythmias : biased risk estimates from spontaneous reporting systems?

    NARCIS (Netherlands)

    De Bruin, M L; van Puijenbroek, E P; Egberts, A C G; Hoes, A W; Leufkens, H G M

    2002-01-01

    AIMS: This study used spontaneous reports of adverse events to estimate the risk for developing cardiac arrhythmias due to the systemic use of non-sedating antihistamine drugs and compared the risk estimate before and after the regulatory action to recall the over-the-counter status of some of these

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

    NARCIS (Netherlands)

    Van Hunsel, F.; Van Puijenbroek, E.

    2013-01-01

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

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

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

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

  1. Project MEDICO; Model Experiment in Drug Indexing by Computer. First Progress Report.

    Science.gov (United States)

    Artandi, Susan; Baxendale, Stanley

    This report describes Phase 1 of a research project with the over-all objective of exploring the applicability of automatic methods in the indexing of drug information appearing in English natural language text. Two major phases of the research have been completed: (1) development of the automatic indexing method and its implementation on the test…

  2. Practical Aspects of Drug Calculations. Mathematics Education Centre. Report No. 24.

    Science.gov (United States)

    Sullivan, Peter; Clarkson, P., Ed.

    Concern has been expressed in recent years about the accuracy of medication administered by nurses in Papua New Guinean hospitals. Attention has been focused on the calculation of the drug dosages. This paper discusses the processes involved in the administration of medication, and reports on a study to evaluate the competence of student nurses at…

  3. 21 CFR 1404.645 - Do other Federal agencies know if the Office of National Drug Control Policy agrees to a...

    Science.gov (United States)

    2010-04-01

    ... National Drug Control Policy agrees to a voluntary exclusion? 1404.645 Section 1404.645 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) General... Office of National Drug Control Policy agrees to a voluntary exclusion? (a) Yes, we enter...

  4. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    Science.gov (United States)

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

    2016-09-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability.

  5. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database

    Science.gov (United States)

    2016-01-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability. PMID:27510377

  6. Drug Fever Induced by Piperacillin/Tazobactam in a Scoliosis Patient: A Case Report.

    Science.gov (United States)

    Li, Zheng; Shen, Jianxiong; Li, Qiyi; Chan, Matthew Tak Vai; Wu, William Ka Kei

    2015-11-01

    Drug fever is frequently underrecognized by clinicians despite its common occurrence. Fever induced by piperacillin/tazobactam has not been reported in scoliosis correction surgery.Drug fever caused by piperacillin/tazobactam in a scoliosis patient was described.A 36-year-old woman with adult scoliosis undergoing correction surgery was reported. She developed a fever after an intake of piperacillin/tazobactam for 3 days. Eosinophil count, erythrocyte sedimentation rate, and C-reactive proteins were increased in her blood examination. Thorough history, chest radiography, blood cultures, physical examination, and urinalysis revealed no evidences of fever. A drug fever is therefore considered. The fever lasted for 2 weeks and her body temperature come back to normal 4 days after piperacillin/tazobactam cessation.Fever could be caused by piperacillin/tazobactam. The drug fever's diagnosis is easily confounded by a co-occurring infection. Therefore, it is crucial for clinicians to doubt drugs as a reason when no other origin of fever could be identified in a patient.

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

    Science.gov (United States)

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

    2016-01-01

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

  8. Measuring the value of treatment to patients: patient-reported outcomes in drug development.

    Science.gov (United States)

    Willke, Richard J

    2008-02-01

    Patient-reported outcomes (PROs) can be important measures of the impact and value of new drug treatments to patients. Recently, both multisector stakeholder groups and the U.S. Food and Drug Administration have carefully considered and issued guidance on best practices for the use of PROs in measuring treatment impact. When best practices are followed and PRO data are appropriately included in drug development strategy and clinical trials, these data can be part of the evidence submitted for drug approval and included in drug labeling. One study showed that PRO data were included in 30% of a sample of new drug labels and were more concentrated in certain therapeutic areas, such as anti-inflammatory agents, vaccines, gastrointestinal agents, and respiratory and urologic agents. PRO data included in labeling, or generated in a similar scientific manner, may often then be used in other communication vehicles, such as formulary submission dossiers, journal or direct-to-consumer advertisements, publications, or continuing medical education. Meaningful and reliable PRO results regarding the effects of new treatments on how patients feel and function provide useful information to those who must make decisions about the availability and utilization of such treatments.

  9. Phenytoin induced drug rash with eosinophilia and systemic symptoms syndrome: a case report

    Directory of Open Access Journals (Sweden)

    Yogesh Devaraj

    2016-06-01

    Full Text Available DRESS syndrome (drug rash with eosinophilia and systemic symptoms is a severe adverse drug reaction characterised by rash, fever, lymphadenopathy and internal organ involvement. Although the death rate can reach 10%, rapid diagnosis and prompt withdrawal of the offending drug is the key to limit morbidity and mortality. The potential role of corticosteroids remains controversial. We report a case of a 45-year-old male patient who suffered a head injury, for which he was prescribed phenytoin. Five weeks later he developed features of DRESS syndrome including facial and peri-orbital oedema, generalized erythematous, maculo-papular rash, conjunctivitis, inguinal lymphadenopathy, leucocytosis, eosinophilia and elevated liver enzymes. Skin biopsy revealed acanthosis and spongiosis of epidermis and dense inflammatory cell infiltrate comprising eosinophils and lymphocytes. In this case, causalty assessment using Naranjo adverse drug reaction probability scale showed that phenytoin was a probable cause for the adverse drug reaction (score-7. Phenytoin was immediately stopped and patient was treated with systemic corticosteroids. The patient improved dramatically within the next few days. Early recognition of symptoms of DRESS and immediate withdrawal of the offending drug followed by prompt treatment with corticosteroids and other supportive measures will ensure quick recovery and will avoid fatal outcomes. [Int J Basic Clin Pharmacol 2016; 5(3.000: 1148-1151

  10. Hyperacute drug-induced hepatitis with intravenous amiodarone: case report and review of the literature

    Directory of Open Access Journals (Sweden)

    Nasser M

    2013-09-01

    Full Text Available Mohammad Nasser, Timothy R Larsen, Barryton Waanbah, Ibrahim Sidiqi, Peter A McCullough Providence Hospitals and Medical Centers, Department of Medicine, Division of Cardiology, Southfield and Novi, MI, USA Abstract: Amiodarone is a benzofuran class III antiarrhythmic drug used to treat a wide spectrum of ventricular tachyarrhythmias. The parenteral formulation is prepared in polysorbate 80 diluent. We report an unusual case of acute elevation of aminotransaminase concentrations after the initiation of intravenous amiodarone. An 88-year-old Caucasian female developed acute hepatitis and renal failure after initiating intravenous amiodarone for atrial fibrillation with a rapid ventricular response in the setting of acutely decompensated heart failure and hepatic congestion. Liver transaminases returned to baseline within 7 days after discontinuing the drug. Researchers hypothesized that this type of injury is related to liver ischemia with possible superimposed direct drug toxicity. The CIOMS/RUCAM scale identifies our patient’s acute hepatitis as a highly probable adverse drug reaction. Future research is needed to understand the mechanisms by which hyperacute drug toxicity occurs in the setting of impaired hepatic perfusion and venous congestion. Keywords: intravenous amiodarone, acute hepatotoxicity, liver transaminases, drug-induced liver toxicity

  11. Spontaneous reporting of adverse drug events by Korean regional pharmacovigilance centers.

    Science.gov (United States)

    Shin, Yoo Seob; Lee, Yong-Won; Choi, Young Hwa; Park, Byungjoo; Jee, Young Koo; Choi, Sung-Kyu; Kim, Eung-Gyu; Park, Jung-Won; Hong, Chein-Soo

    2009-10-01

    Patterns of prescriptions are markedly influenced by regional disease entities, medical education, culture, economic status, and available pharmaceutical companies. Features of adverse drug reactions (ADRs) may vary in different countries. In this study, we analyzed the causative drugs and clinical manifestations of spontaneously reported ADRs in Korea. Six Korean Regional Pharmacovigilance Centers collected 1418 cases of spontaneously reported adverse drug events (ADEs) by doctors, pharmacists, and nurses, and the clinical features and causative drugs were evaluated. The data were collected from general hospitals (76.5%), primary clinics, and pharmacies (23.5%). Based upon the World Health Organization (WHO)-Uppsala Monitoring Center criteria (certain-13.7%, probable-46.1%, possible-32.1%), 91.9% of the collected events were suspected to be ADRs and 15.8% of patients experienced serious ADRs. The most prevalent causative drugs were antibiotics (31.6%), followed by contrast dyes (14.0%), non-steroidal anti-inflammatory drugs (NSAIDs) (11.1%), anti-psychotics (5.4%), anti-convulsants (5.2%), cardiovascular agents (4.8%), anti-neoplastics (4.6%), and opiates and non-opiate pain killers (3.5%). Among the antibiotics, cephalosporins (8.1%) were the most common, followed by anti-tuberculosis agents (5.7%), quinolones (4.0%), vancomycin (3.1%), and penicillin (2.8%). The most common side effect was skin manifestations, which were seen in 42% of the patients, followed by neurologic manifestations (14%), gastrointestinal involvements (12.9%), generalized reactions (9.4%), and respiratory involvements (4.5%). Antibiotics, contrast dyes, and NSAIDs were the most common causative drugs for ADRs, which reflects the prescription pattern and the prevalence of diseases in Korea. These data may be useful in establishing a Korean pharmacovigilance system. 2009 John Wiley & Sons, Ltd.

  12. 77 FR 72905 - Pipeline Safety: Random Drug Testing Rate; Contractor MIS Reporting; and Obtaining DAMIS Sign-In...

    Science.gov (United States)

    2012-12-06

    ... Pipeline and Hazardous Materials Safety Administration Pipeline Safety: Random Drug Testing Rate... for random drug testing, reminder for operators to report contractor MIS data, and new method for... minimum random drug testing rate for covered employees will remain at 25 percent during calendar year 2013...

  13. ACA Federal Upper Limits

    Data.gov (United States)

    U.S. Department of Health & Human Services — Affordable Care Act Federal Upper Limits (FUL) based on the weighted average of the most recently reported monthly average manufacturer price (AMP) for...

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

    Directory of Open Access Journals (Sweden)

    Anant D. Patil

    2013-12-01

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

  15. The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.

    Science.gov (United States)

    Jarow, Jonathan P; Casak, Sandra; Chuk, Meredith; Ehrlich, Lori A; Khozin, Sean

    2016-05-01

    Sponsors of human drug and biologic products subject to an investigational new drug (IND) application are required to distribute expedited safety reports of serious and unexpected suspected adverse reactions to participating investigators and the FDA to assure the protection of human subjects participating in clinical trials. On September 29, 2010, the FDA issued a final rule amending its regulations governing expedited IND safety reporting requirements that revised the definitions used for reporting and clarified when to submit relevant and useful information to reduce the number of uninformative reports distributed by sponsors. From January 1, 2006, to December 31, 2014, the FDA's Office of Hematology and Oncology Products received an average of 17,686 expedited safety reports per year. An analysis of FDA submissions by commercial sponsors covering this time period suggested a slight increase in the number of expedited safety reports per IND per year after publication of the final rule. An audit of 160 randomly selected expedited safety reports submitted to the FDA's Office of Hematology and Oncology Products in 2015 revealed that only 22 (14%) were informative. The submission of uninformative expedited safety reports by commercial sponsors of INDs continues to be a significant problem that can compromise detection of valid safety signals. Clin Cancer Res; 22(9); 2111-3. ©2016 AACR.

  16. [Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database].

    Science.gov (United States)

    Sakai, Takamasa; Ohtsu, Fumiko; Sekiya, Yasuaki; Mori, Chiyo; Sakata, Hiroshi; Goto, Nobuyuki

    2016-01-01

    Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women.

  17. Federal energy conservation programs pursuant to section 381 of the Energy Policy and Conservation Act (Public Law 94-163). Annual report to Congress

    Energy Technology Data Exchange (ETDEWEB)

    1979-02-21

    This report provides an overview of the activities and achievements of the executive branch of the Federal Government in implementing the energy conservation requirements and provisions of section 381 of the Energy Policy and Conservation Act (EPCA) of 1975 (Public Law 94-163). The report describes Federal actions to develop procurement policies that promote energy conservation and efficiency, develop a Federal 10-Year Buildings Energy Conservation Plan, develop responsible public education and information programs, encourage energy conservation and energy efficiency, and promote vanpooling and carpooling arrangements. About half of the Nation's energy is used in our homes and automobiles. Another 48 percent is used by State and local governments, business and insutry, in providing needed goods and services. The Federal Government is the Nation's largest energy user, accouting for 2.2 percent of the total national energy used in 1977. This energy is used by nearly 6 million people in more than 400 thousand buildings and in the operation of more than 600 thousand vehicles. While energy conservation and energy efficiency measures alone cannot solve our immediate problems, they are an essential part of our transition to an era of scarce and expensive energy supplies.

  18. 77 FR 5171 - Further Amendments to General Regulations of the Food and Drug Administration to Incorporate...

    Science.gov (United States)

    2012-02-02

    ... importance. II. Legal Authority FDA is issuing this final rule under provisions of the Federal Food, Drug... response (22 hours for recordkeeping) \\3\\ from previously reported estimates relating to drugs and medical... notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and...

  19. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports

    Science.gov (United States)

    Köhler, Michael; Haag, Susanne; Biester, Katharina; Brockhaus, Anne Catharina; McGauran, Natalie; Grouven, Ulrich; Kölsch, Heike; Seay, Ulrike; Hörn, Helmut; Moritz, Gregor; Staeck, Kerstin

    2015-01-01

    Background When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug’s added benefit over an appropriate comparator treatment. The added benefit is mainly determined using patient relevant outcomes. The “dossier assessment” is generally performed by the Institute for Quality and Efficiency in Health Care (IQWiG) and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers. The dossier assessment refers to the patient population for which the new drug is approved according to the summary of product characteristics. This patient population may comprise either the total populations investigated in the studies submitted to regulatory authorities in the drug approval process, or the specific subpopulations defined in the summary of product characteristics (“approved subpopulations”). Objective To determine the information gain from AMNOG documents compared with non-AMNOG documents for methods and results of studies available at market entry of new drugs. AMNOG documents comprise dossier assessments done by IQWiG and publicly available modules of company dossiers; non-AMNOG documents comprise conventional, publicly available sources—that is, European public assessment reports, journal publications, and registry reports. The analysis focused on the approved patient populations. Design Retrospective analysis. Data sources All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment. We also considered all European public assessment

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

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

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

  1. Sex differences in self-report of physical health by injection drug users.

    Science.gov (United States)

    Singh, B K; Koman, J J; Williams, J S; Catan, V M; Souply, K L

    1994-01-01

    Through heterosexual contact, injection drug users (IDUs) put others at risk of contracting Human Immunodeficiency Virus (HIV) disease. Self-report of health was compared among IDUs in Laredo, Texas, San Diego, California, and San Juan, Puerto Rico, and in a subsample which contained HIV positive subjects from these cities. These data were compared with similar National Opinion Research Center data and indicated that IDUs do not report their health to be different from that of the general public. Previous research has reported sex differences in morbidity and mortality in the non-IDU population. This study found sex differences in perception of health by IDUs in Laredo and San Diego.

  2. The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Abdel-Sattar, Maher; Bero, Lisa

    2015-01-01

    1, 2011 and December 31, 2012 from the FDA and EMA Web sites were eligible. RESULTS: We included 27 drug reports. Most were searchable, but the FDA table of contents did not match the file's page numbers. Several FDA documents must be searched compared with a single EMA document, but the FDA reports......OBJECTIVES: To compare the accessibility, comprehensiveness, and usefulness of data available from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) drug reports. STUDY DESIGN AND SETTING: This is a cross-sectional study. All new molecular drugs approved between January...

  3. Association between Selective Beta-adrenergic Drugs and Blood Pressure Elevation: Data Mining of the Japanese Adverse Drug Event Report (JADER) Database.

    Science.gov (United States)

    Ohyama, Katsuhiro; Inoue, Michiko

    2016-01-01

    Selective beta-adrenergic drugs are used clinically to treat various diseases. Because of imperfect receptor selectivity, beta-adrenergic drugs cause some adverse drug events by stimulating other adrenergic receptors. To examine the association between selective beta-adrenergic drugs and blood pressure elevation, we reviewed the Japanese Adverse Drug Event Reports (JADERs) submitted to the Japan Pharmaceuticals and Medical Devices Agency. We used the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms extracted from Standardized MedDRA queries for hypertension to identify events related to blood pressure elevation. Spontaneous adverse event reports from April 2004 through May 2015 in JADERs, a data mining algorithm, and the reporting odds ratio (ROR) were used for quantitative signal detection, and assessed by the case/non-case method. Safety signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. A total of 2021 reports were included in this study. Among the nine drugs examined, significant signals were found, based on the 95%CI for salbutamol (ROR: 9.94, 95%CI: 3.09-31.93) and mirabegron (ROR: 7.52, 95%CI: 4.89-11.55). The results of this study indicate that some selective beta-adrenergic drugs are associated with blood pressure elevation. Considering the frequency of their indications, attention should be paid to their use in elderly patients to avoid adverse events.

  4. Report on the establishment and operation of the Federal Energy Regulatory Commission's Daycare Center

    Energy Technology Data Exchange (ETDEWEB)

    1991-09-16

    We have completed an inspection of the Federal Energy Regulatory Commission's (FERC) Daycare Center (Center). The purpose of the inspection was to review for efficiency, economy and compliance with laws and regulations, FERC's establishment and operation of the Center. The inspection objectives were to review: (1) FERC's compliance with Federal laws and requirements of the General Services Administration and the District of Columbia; (2) the source and amount of funds for establishing and operating the Center; and (3) the organizational relationships between FERC, the Center and the contractor operating the Center.

  5. Guidance on the implementation and reporting of a drug safety Bayesian network meta-analysis.

    Science.gov (United States)

    Ohlssen, David; Price, Karen L; Xia, H Amy; Hong, Hwanhee; Kerman, Jouni; Fu, Haoda; Quartey, George; Heilmann, Cory R; Ma, Haijun; Carlin, Bradley P

    2014-01-01

    The Drug Information Association Bayesian Scientific Working Group (BSWG) was formed in 2011 with a vision to ensure that Bayesian methods are well understood and broadly utilized for design and analysis and throughout the medical product development process, and to improve industrial, regulatory, and economic decision making. The group, composed of individuals from academia, industry, and regulatory, has as its mission to facilitate the appropriate use and contribute to the progress of Bayesian methodology. In this paper, the safety sub-team of the BSWG explores the use of Bayesian methods when applied to drug safety meta-analysis and network meta-analysis. Guidance is presented on the conduct and reporting of such analyses. We also discuss different structural model assumptions and provide discussion on prior specification. The work is illustrated through a case study involving a network meta-analysis related to the cardiovascular safety of non-steroidal anti-inflammatory drugs.

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

    Directory of Open Access Journals (Sweden)

    Upadhyaya P

    2012-06-01

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

  7. Attitudes and Beliefs of Pig Farmers and Wild Boar Hunters Towards Reporting of African Swine Fever in Bulgaria, Germany and the Western Part of the Russian Federation.

    Science.gov (United States)

    Vergne, T; Guinat, C; Petkova, P; Gogin, A; Kolbasov, D; Blome, S; Molia, S; Pinto Ferreira, J; Wieland, B; Nathues, H; Pfeiffer, D U

    2016-04-01

    This study investigated the attitudes and beliefs of pig farmers and hunters in Germany, Bulgaria and the western part of the Russian Federation towards reporting suspected cases of African swine fever (ASF). Data were collected using a web-based questionnaire survey targeting pig farmers and hunters in these three study areas. Separate multivariable logistic regression models identified key variables associated with each of the three binary outcome variables whether or not farmers would immediately report suspected cases of ASF, whether or not hunters would submit samples from hunted wild boar for diagnostic testing and whether or not hunters would report wild boar carcasses. The results showed that farmers who would not immediately report suspected cases of ASF are more likely to believe that their reputation in the local community would be adversely affected if they were to report it, that they can control the outbreak themselves without the involvement of veterinary services and that laboratory confirmation would take too long. The modelling also indicated that hunters who did not usually submit samples of their harvested wild boar for ASF diagnosis, and hunters who did not report wild boar carcasses are more likely to justify their behaviour through a lack of awareness of the possibility of reporting. These findings emphasize the need to develop more effective communication strategies targeted at pig farmers and hunters about the disease, its epidemiology, consequences and control methods, to increase the likelihood of early reporting, especially in the Russian Federation where the virus circulates.

  8. Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

    Science.gov (United States)

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

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

    Directory of Open Access Journals (Sweden)

    Anshi Singh

    2012-01-01

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

  10. Reporting of drug induced depression and fatal and non-fatal suicidal behaviour in the UK from 1998 to 2011

    OpenAIRE

    Thomas, Kyla H.; Richard M. Martin; Potokar, John; Pirmohamed, Munir; Gunnell, David

    2014-01-01

    Background Psychiatric adverse drug reactions (ADRs) are distressing for patients and have important public health implications. We identified the drugs with the most frequent spontaneous reports of depression, and fatal and non-fatal suicidal behaviour to the UK’s Yellow Card Scheme from 1998 to 2011. Methods We obtained Yellow Card data from the Medicines and Healthcare products Regulatory Agency for the drugs with the most frequent spontaneous reports of depression and suicidal behaviour f...

  11. Federal Assistance Program Quarterly Project Progress Report. Geothermal Energy Program: Information Dissemination, Public Outreach, and Technical Analysis Activities. Reporting Period: January 1 - March 31, 2001 [Final report

    Energy Technology Data Exchange (ETDEWEB)

    Lund, John W.

    2002-03-22

    The final report of the accomplishments of the geothermal energy program: information dissemination, public outreach and technical analysis activities by the project team consisting of the Geo-Heat Center, Geothermal Resources Council, Geothermal Education Office, Geothermal Energy Association and the Washington State University Energy Program.

  12. NADA/DOD Aerospace Knowledge Diffusion Research Project. Report number 19: The US government technical report and the transfer of federally funded aerospace R/D: An analysis of five studies

    Science.gov (United States)

    Pinelli, Thomas E.; Barclay, Rebecca O.; Kennedy, John M.

    1994-01-01

    The U.S. government technical report is a primary means by which the results of federally funded research and development are transferred to the U.S. aerospace industry. However, little is known about this information product in terms of its actual use, importance, and value in the transfer of federally funded R&D. To help establish a body of knowledge, the U.S. government technical report is being investigated as part of the 'NASA/DoD Aerospace Knowledge Diffusion Research Project'. In this report, we summarize the literature on technical reprts and provide a model that depicts the transfer of federally funded aerospace R&D via the U.S. government technical report. We present results from five studies of our investigation of aerospace knowledge diffusion vis-a-vis the U.S. government technical report and close with a brief overview of on-going research into the use of the U.S. government technical report as a rhetorical device for transferring federally funded aerospace R&D.

  13. Key Aspects of the Federal Direct Loan Program's Cost Estimates: Department of Education. Report to Congressional Requesters.

    Science.gov (United States)

    Calbom, Linda M.; Ashby, Cornelia M.

    Because of concerns about the Department of Education's reliance on estimates to project costs of the William D. Ford Federal Direct Loan Program (FDLP) and a lack of historical information on which to base those estimates, Congress asked the General Accounting Office (GAO) to review how the department develops its cost estimates for the program,…

  14. Building a time-saving and adaptable tool to report adverse drug events.

    Science.gov (United States)

    Parès, Yves; Declerck, Gunnar; Hussain, Sajjad; Ng, Romain; Jaulent, Marie-Christine

    2013-01-01

    The difficult task of detecting adverse drug events (ADEs) and the tedious process of building manual reports of ADE occurrences out of patient profiles result in a majority of adverse reactions not being reported to health regulatory authorities. The SALUS individual case safety report (ICSR) reporting tool, a component currently developed within the SALUS project, aims to support semi-automatic reporting of ADEs to regulatory authorities. In this paper, we present an initial design and current state of of our ICSR reporting tool that features: (i) automatic pre-population of reporting forms through extraction of the patient data contained in an Electronic Health Record (EHR); (ii) generation and electronic submission of the completed ICSRs by the physician to regulatory authorities; and (iii) integration of the reporting process into the physician's work-flow to limit the disturbance. The objective is to increase the rates of ADE reporting and the quality of the reported data. The SALUS interoperability platform supports patient data extraction independently of the EHR data model in use and allows generation of reports using the format expected by regulatory authorities.

  15. R&D in the Federal Budget: FY 1979, R&D, Industry, and the Economy. Research & Development, AAAS Report III.

    Science.gov (United States)

    Shapley, Willis H.; Phillips, Don I.

    The federal government's budgeting process for allocating resources to research and development (R&D) is described. The report includes: (1) a review of the FY 1979 R&D budget; (2) a statistical overview of the budget and a critique of the administration's policies on R&D; (3) a general picture of R&D in industry; and (4) a discussion of some of…

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

    Directory of Open Access Journals (Sweden)

    Shastri Veeranna

    2006-01-01

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

  17. Discrimination Between Drug Abuse and Medical Therapy: Case report of a tranylcypromine overdose-related fatality

    Directory of Open Access Journals (Sweden)

    Maryam Akhgari

    2017-06-01

    Full Text Available Tranylcypromine is an effective antidepressant from the class of monoamine oxidase inhibitors and is structurally related to amphetamine. However, reports differ regarding the potential metabolism of tranylcypromine to amphetamine and methamphetamine within the human body. We report a 25-year-old woman with severe depression who died due to a fatal tranylcypromine overdose in 2016. She had been prescribed tranylcypromine one day previously and had no history of previous suicide attempts or substance abuse. The body was transferred to a forensic medicine department in Tehran, Iran for the autopsy. A urine sample was positive for tranylcypromine, amphetamine and methamphetamine using gas chromatography/mass spectrometry after derivatisation with heptafluorobutyric acid. As amphetamines were present in the urine sample, it was assumed that the tranylcypromine had been converted to amphetamines metabolically. As such, it is possible that the legitimate use of certain prescription drugs may complicate the interpretation of test results for illegal drugs.

  18. LIPAEMIC report: results of clinical use of intravenous lipid emulsion in drug toxicity reported to an online lipid registry.

    Science.gov (United States)

    Cave, Grant; Harvey, Martyn; Willers, Johann; Uncles, David; Meek, Tim; Picard, John; Weinberg, Guy

    2014-06-01

    The use of intravenous lipid emulsion (ILE) as an antidote has prompted significant academic and clinical interest. Between August 2009 and August 2012, data from cases of ILE use in intoxicated patients in different hospitals on different continents were voluntarily entered into a registry based on the world wide web (www.lipidregistry.org). Here, we report data from this project. Participating centers were given access to the registry following institutional subscription. Specifically sought were details of the individual patients' presenting condition, indications for ILE use, ILE administration regimen, potential complications, and of clinical outcome. Forty-eight uses of ILE were reported from 61 participating centers. Ten cases of local anesthetic systemic toxicity were reported; all (10/10) survived. Thirty-eight cases of intoxication by other agents were reported [30 decreased conscious state, 8 cardiovascular collapse (3 deaths)]. There was an elevation in GCS (p adverse effects of ILE use were recorded in 48 reported cases (one case of bronchospastic reaction, one case of hyperamylasemia and one case of interference with laboratory testing). In this series of cases reported to the registry, improvements were seen for GCS in patients with central nervous system toxicity and in systolic blood pressure in shocked patients over a short time frame after the injection of ILE. Few adverse effects were recorded. Clinical trials and the reporting of drug concentrations after ILE use are necessary to further elucidate the role of ILE in clinical toxicology.

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

    Directory of Open Access Journals (Sweden)

    Tarik Catic

    2016-04-01

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

  20. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications.

    Science.gov (United States)

    Wieseler, Beate; Kerekes, Michaela F; Vervoelgyi, Volker; McGauran, Natalie; Kaiser, Thomas

    2012-01-03

    To investigate to what extent three types of documents for reporting clinical trials provide sufficient information for trial evaluation. Retrospective analysis Primary studies and corresponding documents (registry reports, clinical study reports, journal publications) from 16 health technology assessments of drugs conducted by the German Institute for Quality and Efficiency in Health Care between 2006 and February 2011. Data analysis We assessed reporting quality for each study and each available document for six items on methods and six on outcomes, and dichotomised them as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of studies with complete reporting for methods and outcomes, per item and overall, and compared the findings. We identified 268 studies. Publications, study reports and registry reports were available for 192 (72%), 101 (38%), and 78 (29%) studies, respectively. Reporting quality was highest in study reports, which overall provided complete information for 90% of items (1086/1212). Registry reports provided more complete information on outcomes than on methods (overall 330/468 (71%) v 147/468 (31%)); the same applied to publications (594/1152 (52%) v 458/1152 (40%)). In the matched pairs analysis, reporting quality was poorer in registry reports than in study reports for overall methods and outcomes (P<0.001 in each case). Compared with publications, reporting quality was poorer in registry reports for overall methods (P<0.001), but better for outcomes (P=0.005). Registry reports and publications insufficiently report clinical trials but may supplement each other. Measures to improve reporting include the mandatory worldwide implementation of adequate standards for results registration.

  1. AIDS AS A CHALLENGE FOR THE DEVELOPMENT OF THE TREATMENT OF OPIOID DEPENDENTS IN CHINA Report on the 9th National Conference on Drug Dependence, MMT and HIV Prevention in Sanya/Hainan (VR China), 1-5 November 2006

    Institute of Scientific and Technical Information of China (English)

    Ingo Ilja Michels

    2007-01-01

    @@ Nearly 100 experts from all over China attended the Chinese National Conference on Drug Dependence in Sanya/Hainan. The participants came from drug abuse treatment centers, methadone clinics and drug research institutes. The conference's focus was on the question how drug abuse treatment shall and might be part of HIV prevention. CHINALi xiao(The Federal Drug Commissioner with the Federal Ministry of Health, Berlin)

  2. Drug-induced taste and smell alterations: a case/non-case evaluation of an italian database of spontaneous adverse drug reaction reporting.

    Science.gov (United States)

    Tuccori, Marco; Lapi, Francesco; Testi, Arianna; Ruggiero, Elisa; Moretti, Ugo; Vannacci, Alfredo; Bonaiuti, Roberto; Antonioli, Luca; Fornai, Matteo; Giustarini, Giulio; Scollo, Carla; Corona, Tiberio; Ferrazin, Fernanda; Sottosanti, Laura; Blandizzi, Corrado

    2011-10-01

    The frequency and clinical features of drug-related taste and/or smell impairments are currently unclear. The aim of this study was to identify major drug classes associated with taste and smell alterations reported to the Italian spontaneous adverse drug reaction (ADR) reporting database. The association between drug and altered taste or smell was investigated by case/non-case methodology. The reporting odds ratio (ROR) was used as a measure of disproportionality. Cases were defined as patients with at least one ADR related to taste or smell impairments. The non-cases included all patients without any ADRs related to taste or smell alterations. According to the selection criteria, 52 166 reports were included in the analysis. Overall, 182 cases of drug-related taste and/or smell dysfunctions were identified. Statistically significant unadjusted RORs were reported for macrolides (n = 31; 7.1; 95% CI 4.8, 10.5), terbinafine (the only drug reported within the group of antimycotics belonging to the Anatomical Therapeutic Chemical class D01AE) [n = 17; 76.4; 95% CI 44.0, 132.6], fluoroquinolones (n = 15; 1.7; 95% CI 1.0, 2.8) and protein kinase inhibitors (n = 10; 4.0; 95% CI 2.1, 7.7). When RORs were adjusted for sex and age category, the disproportion remained statistically significant for all of the previously mentioned drug classes. Taste and/or smell abnormalities are common, sometimes unexpected and often persistent complaints of patients during pharmacological treatments. Physicians should be aware of the impact of these ADRs on patients' quality of life.

  3. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

    Science.gov (United States)

    Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

    2016-12-15

    Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

  4. Federal Lands

    Data.gov (United States)

    Department of Homeland Security — This map layer consists of federally owned or administered lands of theUnited States, Puerto Rico, and the U.S. Virgin Islands. Only areas of 640 acres or more are...

  5. 2001 ''You Have the Power'' campaign [Federal Energy Management Program]. Final technical report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-01-01

    The Tasks of 2001 ''You Have the Power'' campaign by the Federal Energy Management Program (FEMP) are: Task 1--Interagency Planning Meetings; Task 2--Ear Day Event; Task 3--Earth Day and Energy Awareness Month Activities; Task 4--Regional Target; Task 5--Outreach Tools and Campaign Products; Task 6--Private Sector Participation; Task 7--''You Have the Power'' on the FEMP Web Site; and Task 8--Effective Communications.

  6. Neutronics Benchmarks for the Utilization of Mixed-Oxide Fuel: Joint US/Russian Progress Report for Fiscal 1997. Volume 3 - Calculations Performed in the Russian Federation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-06-01

    This volume of the progress report provides documentation of reactor physics and criticality safety studies conducted in the Russian Federation during fiscal year 1997 and sponsored by the Fissile Materials Disposition Program of the US Department of Energy. Descriptions of computational and experimental benchmarks for the verification and validation of computer programs for neutron physics analyses are included. All benchmarks include either plutonium, uranium, or mixed uranium and plutonium fuels. Calculated physics parameters are reported for all of the contaminated benchmarks that the United States and Russia mutually agreed in November 1996 were applicable to mixed-oxide fuel cycles for light-water reactors.

  7. Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases.

    Science.gov (United States)

    Hatahira, Haruna; Abe, Junko; Hane, Yuuki; Matsui, Toshinobu; Sasaoka, Sayaka; Motooka, Yumi; Hasegawa, Shiori; Fukuda, Akiho; Naganuma, Misa; Ohmori, Tomofumi; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2017-01-01

    Drug-induced gingival hyperplasia (DIGH) causes problems with chewing, aesthetics, and pronunciation, and leads to the deterioration of the patient's quality of life (QOL). Thus, the aim of this study was to evaluate the incidence of DIGH using spontaneous reporting system (SRS) databases. We analyzed reports of DIGH from SRS databases and calculated the reporting odds ratios (RORs) of suspected drugs (immunosuppressants, calcium channel blockers, and anticonvulsants). The SRS databases used were the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) database. With the data, we evaluated the time-to-onset profile and the hazard type using the Weibull shape parameter (WSP). Furthermore, we used the association rule mining technique to discover undetected relationships such as possible risk factors. The FAERS contained 5,821,716 reports. The RORs (95% confidence interval: CI) for cyclosporine, everolimus, sirolimus, mycophenolate mofetil, amlodipine, nifedipine, carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, and valproic acid, were 39.4 (95% CI: 30.3-51.2), 4.2 (1.7-10.0), 6.6 (2.5-17.7), 13.1 (7.2-23.2), 94.8 (80.0-112.9), 57.9 (35.7-94.0), 15.1 (10.3-22.3), 65.4 (33.8-126.7), 6.5 (3.6-11.8), 19.7 (8.8-44.0), 65.4 (52.4-82.9), 56.5 (21.1-151.7), 2.9 (1.1-7.7), and 17.5 (12.6-24.4), respectively. The JADER database contained 430,587 reports. The median time-to-onset of gingival hyperplasia values for immunosuppressants, calcium channel blockers, and anticonvulsants use were 71, 262, and 37 days, respectively. Furthermore, the 95% CI of the WSP β for anticonvulsants was over and excluded 1, which meant that they were wear-out failure type. Our results suggest that DIGH monitoring of patients administered immunosuppressants, calcium channel blockers, or anticonvulsants is important. We demonstrated the potential risk of DIGH following the long

  8. Quarterly report on the electric power industry in the Federal Republic of Germany. 1st quarter 2000. Power generation in public-owned electric utilities, the industrial independent units and the Federal Railways and overall power consumption in the Federal Republic of Germany; Vierteljahresbericht ueber die Elektrizitaetswirtschaft in der Bundesrepublik Deutschland. 1. Vierteljahr 2000. Stromerzeugung der oeffentlichen Elektrizitaetswerke, der industriellen Eigenanlagen und der Deutschen Bahn AG sowie Gesamtstromverbrauch in der Bundesrepublik

    Energy Technology Data Exchange (ETDEWEB)

    Schmidt, L.

    2000-12-01

    The report provides data on public electricity supply, on power generation in plants of the mining industry and the manufacturing industry, and on the German Federal Railways. The data have been derived from the monthly reports of the Federal Office of Statistics. (orig.) [German] Der Bericht enthaelt Zahlen fuer die oeffentliche Versorgung, fuer die Eigenanlagen im Bergbau und Verarbeitenden Gewerbe und fuer die Deutsche Bundesbahn. Die Zahlen sind den monatlichen Berichten des Statistischen Bundesamtes entnommen. (orig.)

  9. Quarterly report on the electric power industry in the Federal Republic of Germany. 3rd quarter 1996. Power generation in publicly-owned electric utilities, the industrial independent units and the Federal Railways, and overall power consumption in the Federal Republic of Germany; Vierteljahresbericht ueber die Elektrizitaetswirtschaft in der Bundesrepublik Deutschland. 3. Vierteljahr 1996. Stromerzeugung der oeffentlichen Elektrizitaetswerke, der industriellen Eigenanlagen und der Deutschen Bahn AG sowie Gesamtstromverbrauch in der Bundesrepublik

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-02-01

    The report provides data on public electricity supply, on power generation in plants of the mining industry and the manufacturing industry, and on the German Federal Railways. The data have been derived from the monthly reports of the Federal Office of Statistics. (HS) [Deutsch] Der Bericht enthaelt Zahlen fuer die oeffentliche Versorgung, fuer die Eigenanlagen im Bergbau und Verarbeitenden Gewerbe und fuer die Deutsche Bundesbahn. Die Zahlen sind den monatlichen Berichten des Statistischen Bundesamtes entnommen. (HS)

  10. Quarterly report on the electric power industry in the Federal Republic of Germany. 3. quarter 2000. Power generation in public-owned electric utilities, the industrial independent units and the Federal Railways and overall power consumption in the Federal Republic of Germany; Vierteljahresbericht ueber die Elektrizitaetswirtschaft in der Bundesrepublik Deutschland. 3. Vierteljahr 2000. Stromerzeugung der oeffentlichen Elektrizitaetswerke, der industriellen Eigenanlagen und der Deutschen Bahn AG sowie Gesamtstromverbrauch in der Bundesrepublik

    Energy Technology Data Exchange (ETDEWEB)

    Schmidt, L.

    2001-04-01

    The report provides data on public electricity supply, on power generation plants of the mining industry and the manufacturing industry, and on the German Federal Railways. The data have been derived from the monthly reports of the Federal Office of Statistics. (HS) [German] Der Bericht enthaelt Zahlen fuer die oeffentliche Versorgung, fuer die Eigenanlagen im Bergbau und Verarbeitenden Gewerbe und fuer die Deutsche Bundesbahn. Die Zahlen sind den monatlichen Berichten des Statistischen Bundesamtes entnommen. (HS)

  11. Quarterly report on the electric power industry in the Federal Republic of Germany. 4th quarter 1996. Power generation in publicly-owned electric utilities, the industrial independent units and the Federal Railways, and overall power consumption in the Federal Republic of Germany; Vierteljahresbericht ueber die Elektrizitaetswirtschaft in der Bundesrepublik Deutschland. 4. Vierteljahr 1996. Stromerzeugung der oeffentlichen Elektrizitaetswerke, der industriellen Eigenanlagen und der Deutschen Bahn AG sowie Gesamtstromverbrauch in der Bundesrepublik

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-09-01

    The report provides data on public electricity supply, on power generation in plants of the mining industry and the manufacturing industry, and on the German Federal Railways. The data have been derived from the monthly reports of the Federal Office of Statistics. (orig.) [Deutsch] Der Bericht enthaelt Zahlen fuer die oeffentliche Versorgung, fuer die Eigenanlagen im Bergbau und Verarbeitenden Gewerbe und fuer die Deutsche Bundesbahn. Die Zahlen sind den monatlichen Berichten des Statistischen Bundesamtes entnommen. (orig.)

  12. Quarterly report on the electric power industry in the Federal Republic of Germany. 2nd quarter 1999. Power generation in publicly-owend electric utilities, the industrial independent units and the Federal Railways, and overall power consumption in the Federal Republic of Germany; Vierteljahresbericht ueber die Elektrizitaetswirtschaft in der Bundesrepublik Deutschland. 2. Vierteljahr 1999. Stromerzeugung der oeffentlich Elektrizitaetswerke, der industriellen Eigenanlagen und der Deutschen Bahn AG sowie Gesamtstromverbrauch in der Bundesrepublik

    Energy Technology Data Exchange (ETDEWEB)

    Schmidt, L.

    1999-11-01

    The report provides data on public electricity supply, on power generation in plants of the mining industry and the manufacturing industry, and on the German Federal Railways. The data have been derived from the monthly reports of the Federal Office of Statistics. (orig.) [German] Der Bericht enthaelt Zahlen fuer die oeffentliche Versorgung, fuer die Eigenanlagen im Bergbau und Verarbeitenden Gewerbe und fuer die Deutsche Bundesbahn. Die Zahlen sind den monatlichen Berichten des Statistischen Bundesamtes entnommen. (orig.)

  13. NASA/DoD Aerospace Knowledge Diffusion Research Project. Report Number 19. The U. S. Government Technical Report and the Transfer of Federally Funded Aerospace R&D: An Analysis of Five Studies

    Science.gov (United States)

    1994-01-01

    Merrill. D. W. Stevenson 1976 McClure, C. R. "The Federal Technical Report Literature: Research Needs and 1988 Issues." Government Information Quarterly 5...T. E., "The NASA/DoD Aerospace Knowledge Diffusion Research J. M. Kennedy, and Project." Government Information Quarterly 8(2): 219-233. R. 0

  14. NASA/DoD Aerospace Knowledge Diffusion Research Project: Chronology of Selected Literature, Reports, Policy Instruments, and Significant Events Affecting Federal Scientific and Technical Information (STI) in the United States, 1945-1990. Report Number 11.

    Science.gov (United States)

    Pinelli, Thomas E.; And Others

    The chronology is a comprehensive bibliography covering a variety of selected literature, reports, policy instruments, and significant events affecting federal scientific and technical information (STI) from 1945 to 1990. It includes some publications and events of historic interest that relate to the evolution of aerospace and aerospace knowledge…

  15. Racial/ethnic differences in report of drug testing practices at the workplace level in the U.S.

    Science.gov (United States)

    Becker, William C; Meghani, Salimah; Tetrault, Jeanette M; Fiellin, David A

    2014-01-01

    It is unknown whether racial/ethnic differences in report of workplace drug testing persist when analyzed within and across various occupations. We sought to examine the association between worker demographics, workplace characteristics, and report of employment in a workplace that performs drug testing. We performed a cross-sectional study of the 2008-2010 National Survey on Drug Use and Health examining the relationship between race/ethnicity and report of workplace drug testing among employed, white, black, or Hispanic respondents ≥18 years old. In logistic regression analysis, we adjusted for demographic, occupational, and other relevant variables and performed stratified analyses among three specific occupations. Among 69,163 respondents, 48.2% reported employment in a workplace that performs drug testing. On multivariable analysis, younger age, male sex, black race, income greater than $20,000, completion of high school and non-urban residence were associated with report of drug testing at one's workplace among the full sample as were non-white collar occupation, work in medium or large workplace, and absence of other substance abuse/dependence. In stratified analyses, black race was associated with report of workplace level drug testing among executive/administrative/managerial/financial workers and technicians/related support occupations; Hispanic ethnicity was associated with the outcome among technicians/related support occupations. Racial/ethnic differences in report of workplace drug testing exist within and across various occupations. These differences have important public health implications deserving further study. Increased report of drug testing where racial/ethnic minorities work highlights the potential bias that can be introduced when drug testing policies are not implemented in a universal fashion. © American Academy of Addiction Psychiatry.

  16. Adverse drug reaction reports for cardiometabolic drugs from sub Sahara Africa: A study in VigiBase

    NARCIS (Netherlands)

    Berhe, Derbew F.; Juhlin, Kristina; Star, Kristina; Haaijer-Ruskamp, Flora M.; Michael, Kidane; Taxis, Katja; Mol, Peter G.M.

    2014-01-01

    Background: Many pharmacovigilance centers have been established in Sub Sahara Africa (SSA) in recent years. Their focus has been on ADRs to drugs for communicable diseases. Little is known about ADRs caused by drugs for cardiometabolic diseases, although its burden is increasing rapidly in SSA. Obj

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

    Directory of Open Access Journals (Sweden)

    Lense Temesgen Gurmesa

    2016-01-01

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

  18. Are patients reliable when self-reporting medication use? Validation of structured drug interviews and home visits by drug analysis and prescription data in acutely hospitalized patients

    DEFF Research Database (Denmark)

    Glintborg, Bente; Hillestrøm, Peter René; Olsen, Lenette Holm

    2007-01-01

    The medication history among hospitalized patients often relies on patients' self-reports due to insufficient communication between health care professionals. The aim of the present study was to estimate the reliability of patients' self-reported medication use. Five hundred patients admitted...... to an acute medical department at a Danish university hospital were interviewed on the day of admission about their recent medication use. Blood samples drawn immediately after admission were screened for contents of 5 drugs (digoxin, bendroflumethiazide, amlodipine, simvastatin, glimepiride), and the results...... were compared to the patients' self-reported medication history. Information on prescribed drugs dispensed from any Danish pharmacy was collected from nationwide real-time pharmacy records. The authors performed home visits in a subgroup of 115 patients 4 weeks after their discharge. Stored drugs were...

  19. NASA/DOD Aerospace Knowledge Diffusion Research Project. Report 11: Chronology of selected literature, reports, policy instruments, and significant events affecting Federal Scientific and Technical Information (STI) in the United States

    Science.gov (United States)

    Pinelli, Thomas E.; Henderson, Madeline; Bishop, Ann P.; Doty, Philip

    1992-01-01

    The chronology is a comprehensive bibliography. It contains 512 entries covering a variety of selected literature, reports, policy instruments, and significant events affecting Federal Scientific and Technical Information (STI) from 1945 to 1990. It includes some publications and events of historic interest which relate to the evaluation of aerospace and aerospace knowledge diffusion. Each entry has been given an item number and items are arranged by columns. To provide an overview of Federal STI developments, the entries are generally arranged by date of publication and event.

  20. Office of Inspector General report on audit of Southwestern Federal Power System combined financial statements and supplemental schedules (with independent auditors` reports thereon) for the years ended September 30, 1997 and 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-10-06

    Southwestern Federal Power System (SWFPS) encompasses the operation of 24 hydroelectric power plants by the US Army Corps of Engineers and the marketing of power and energy from those plants by the Southwestern Power Administration (Southwestern) of the US Department of Energy. This report presents the results of the independent certified public accountants` audit of the SWFPS`s combined power system statements of assets, Federal investments and liabilities, and the related combined statements of revenues, expenses and accumulated net revenues, and cash flows.

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

    Directory of Open Access Journals (Sweden)

    Bhuvan K C

    2013-02-01

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

  2. Industry survey of the need for a Federal grant-assisted geothermal demonstration power plant. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1978-06-01

    Findings are presented from two separate studies: a preliminary study of leaders of the geothermal industry and a second study of a ten percent representative sample of other firms. The studies are intended to determine if a need still exists for a federal grant-assisted geothermal demonstration power plant. The following are included: selection of the survey samples from the population comprising the geothermal industry; the development of the survey instrument; the collection and analysis of the results; and a summary. The responses of financial firms are discussed. (MHR)

  3. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.

    Science.gov (United States)

    Schwartz, Lisa M; Woloshin, Steven; Zheng, Eugene; Tse, Tony; Zarin, Deborah A

    2016-09-20

    Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. To validate results posted on ClinicalTrials.gov against publicly available U.S. Food and Drug Administration (FDA) reviews on Drugs@FDA. ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical and statistical reviews). 100 parallel-group, randomized trials for new drug approvals (January 2013 to July 2014) with results posted on ClinicalTrials.gov (15 March 2015). 2 assessors extracted, and another verified, the trial design, primary and secondary outcomes, adverse events, and deaths. Most trials were phase 3 (90%), double-blind (92%), and placebo-controlled (73%) and involved 32 drugs from 24 companies. Of 137 primary outcomes identified from ClinicalTrials.gov, 134 (98%) had corresponding data at Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results. Most differences were nominal (that is, relative difference gov, Drugs@FDA mentioned 1061 (55%) and included results data for 367 (19%). Of 96 trials with 1 or more serious adverse events in either source, 14 could be compared and 7 had discordant numbers of persons experiencing the adverse events. Of 62 trials with 1 or more deaths in either source, 25 could be compared and 17 were discordant. Unknown generalizability to uncontrolled or crossover trial results. Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half the secondary outcomes, as well as serious events and deaths, could not be validated because Drugs@FDA includes only "key outcomes" for regulatory decision making and frequently includes only adverse event results aggregated across multiple trials. National Library of Medicine.

  4. 21 CFR 100.2 - State enforcement of Federal regulations.

    Science.gov (United States)

    2010-04-01

    ... Federal regulations. (a) Under section 307 of the Federal Food, Drug, and Cosmetic Act (the act), a State...-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch... notification pursuant to section 307(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C....

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

    Science.gov (United States)

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

    2014-01-01

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

  6. Reports of evidence planting by police among a community-based sample of injection drug users in Bangkok, Thailand

    Directory of Open Access Journals (Sweden)

    Lai Calvin

    2009-10-01

    Full Text Available Abstract Background Drug policy in Thailand has relied heavily on law enforcement-based approaches. Qualitative reports indicate that police in Thailand have resorted to planting drugs on suspected drug users to extort money or provide grounds for arrest. The present study sought to describe the prevalence and factors associated with this form of evidence planting by police among injection drug users (IDU in Bangkok. Methods Multivariate logistic regression was used to identify factors associated with evidence planting of drugs by police among a community-based sample of IDU in Bangkok. We also examined the prevalence and average amount of money paid by IDU to police in order to avoid arrest. Results 252 IDU were recruited between July and August, 2008, among whom 66 (26.2% were female and the median age was 36.5 years. In total, 122 (48.4% participants reported having drugs planted on them by police. In multivariate analyses, this form of evidence planting was positively associated with midazolam use (Adjusted Odds Ratio [AOR] = 2.84; 95% Confidence Interval [CI]: 1.58 - 5.11, recent non-fatal overdose (AOR = 2.56; 95%CI: 1.40 - 4.66, syringe lending (AOR = 2.08; 95%CI: 1.19 - 3.66, and forced drug treatment (AOR = 1.88; 95%CI: 1.05 - 3.36. Among those who reported having drugs planted on them, 59 (48.3% paid police a bribe in order to avoid arrest. Conclusion A high proportion of community-recruited IDU participating in this study reported having drugs planted on them by police. Drug planting was found to be associated with numerous risk factors including syringe sharing and participation in government-run drug treatment programs. Immediate action should be taken to address this form of abuse of power reportedly used by police.

  7. Antihypertensive drugs and erectile dysfunction as seen in spontaneous reports, with focus on angiotensin II type 1 receptor blockers

    Science.gov (United States)

    Ekman, Elisabet; Hägg, Staffan; Sundström, Anders; Werkström, Viktoria

    2010-01-01

    Aim: To describe spontaneously reported cases of erectile dysfunction (ED) in association with angiotensin II type I blockers (ARB) and other antihypertensive drugs. Subjects and methods: All spontaneously reported cases of ED submitted to the Swedish Medical Products Agency (MPA) between 1990 and 2006, where at least one antihypertensive drug was the suspected agent, were scrutinized. Patient demographics, drug treatment and adverse reactions were recorded. Using the Bayesian Confidence Propagation Neural Network (BCPNN) method, the information component (IC) was calculated. Results: Among a total of 225 reports of ED, 59 involved antihypertensive drugs including ARB (9 cases) as suspected agents. A positive IC value was found indicating that ED was reported more often in association with antihypertensive drugs classes, except for angiotensin-converting enzyme inhibitors, compared with all other drugs in the database. Positive dechallenge was reported in 43 cases (72%). Discussion: All classes of major antihypertensive drugs including ARB were implicated as suspected agents in cases of ED. Few risk factors were identified. The relatively high reporting of ED in association with ARB is in contrast with previous studies, suggesting that ARB have neither a positive nor any effect on ED. This discrepancy suggests that further studies are warrnted on this potential adverse reaction to ARB. PMID:21701615

  8. Independent Auditor’s Report on the FY 2014 DoD Performance Summary Report of the Funds Obligated for National Drug Control Program Activities

    Science.gov (United States)

    2015-01-30

    enforcement agencies in counternarcotics-related money laundering investigations by analyzing more than 90,000 financial documents and producing 1,181...analytical reports. These investigations helped identify 713 suspects and 730 money laundering methods, and resulted in the dismantling of 537 and...program components include compulsory random drug testing with punitive consequences and anti -drug education and outreach programs. The effectiveness

  9. Torsadogenic risk of antipsychotics: combining adverse event reports with drug utilization data across Europe.

    Directory of Open Access Journals (Sweden)

    Emanuel Raschi

    Full Text Available BACKGROUND: Antipsychotics (APs have been associated with risk of torsade de Pointes (TdP. This has important public health implications. Therefore, (a we exploited the public FDA Adverse Event Reporting System (FAERS to characterize their torsadogenic profile; (b we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. METHODS: FAERS data (2004-2010 were analyzed based on the following criteria: (1 ≥ 4 cases of TdP/QT abnormalities; (2 Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers; (3 ≥ 4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD; (4 Significant ROR for VA/SCD; (5 Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled to group E (unclear/uncertain signal: only 2/5 criteria. Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID. RESULTS: Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone. In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia to 13.99 (France, 2009. Considerable increment of Group A agents was found in several Countries (+3.47 in France: the exposure to olanzapine increased across all Countries (+1.84 in France and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009. Among Group B drugs, levomepromazine peaked 3.78 (Serbia; fluphenazine 1.61 (Slovenia. CONCLUSIONS: This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and

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

    Science.gov (United States)

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

    2016-03-16

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

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

    NARCIS (Netherlands)

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

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

  12. Fiscal Federalism

    DEFF Research Database (Denmark)

    Feng, Xingyuan; Ljungwall, Christer; Guo, Sujian

    2013-01-01

    in the Western literature? Second, are there any problems with existing principles of fiscal federalism and, if so, how to refine them? Third, how are refined principles relevant to the Chinese case and what policies should the Chinese government pursue in the future? Based on an in-depth and critical review...... relations is not without controversy. This paper aims to make a theoretical contribution to the ongoing debate on ‘fiscal federalism’ by addressing crucial questions regarding China's central–local fiscal relations: first, to what extent do Chinese central–local fiscal relations conform to fiscal federalism...

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

    Institute of Scientific and Technical Information of China (English)

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

    2004-01-01

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

  14. PingFederate

    Data.gov (United States)

    US Agency for International Development — PingFederate Server provides Identity Federation and Single Sign On Capabilities. Federated identity management (or identity federation) enables enterprises to...

  15. Treatment of Gonorrhea by Acupuncture plus Drugs: A Case of Report

    Institute of Scientific and Technical Information of China (English)

    WANG Sheng; ZHANG Xi-an; ZHU Zhu-chun

    2005-01-01

    @@ Gonorrhea is a sexually transmitted diseases caused by bacteria called Neisseria gonorrhoeae. The bacteria can be passed from one person to another through sexual intercourse, and one can also catch gonorrhea from the infected clothing, bed-sheet and quilt cover. It often can be treated with antibiotics in modern medicine and drugs of clearing away heat and toxic material in Chinese medicine. The authors adopted acupuncture and moxibustion combined with oral administration of western medicine Ciprofloxacin and Chinese herbs Longdan Xiegan Wan (Pill of Gentiana for purging the liver fire) to cure a case of gonorrhea, now it is reported as follows.

  16. A report to Congress on a role for federal purchasing in commercializing new energy-efficient and renewable-energy technologies

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-16

    The purpose of this study is to satisfy the requirements of Section 152 of the Energy Policy Act of 1992 (EPAct 92), which directs the Secretary of Energy to ``evaluate the potential use of the purchasing power of the Federal government to promote the development and commercialization of energy efficient products`` (US Congress 1992). Here, purchasing power implies a market presence by the Federal government that is large enough to influence decisions by manufacturers and suppliers about new-product introduction. In recent years, as energy use has become more efficient in the United States in both the public and private sectors, a major contributor to this transition has been the development of innovative technologies and products that reduce the use of energy and/or that use renewable forms of energy. Although the Nation`s efforts toward greater efficiency have been impressive, there are still many opportunities for the widespread introduction of even more energy-saving innovations. This report outlines the actions that DOE can take, in partnership with other Federal agencies, to address the barriers and realize the opportunities from commercializing new technologies.

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

    Directory of Open Access Journals (Sweden)

    Maryam Aghakouchakzadeh

    2017-03-01

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

  18. Association between addressing antiseizure drug side effects and patient-reported medication adherence in epilepsy

    Directory of Open Access Journals (Sweden)

    Moura LMVR

    2016-10-01

    Full Text Available Lidia M V R Moura,1 Thiago S Carneiro,1 Andrew J Cole,1 John Hsu,2,3 Barbara G Vickrey,4 Daniel B Hoch1 1Department of Neurology, 2Mongan Institute for Health Policy, Department of Medicine, Massachusetts General Hospital, 3Department of Health Care Policy, Harvard Medical School, Boston, MA, 4Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA Background and aim: Adherence to treatment is a critical component of epilepsy management. This study examines whether addressing antiepileptic drug (AED side effects at every visit is associated with increased patient-reported medication adherence.Patients and methods: This study identified 243 adults with epilepsy who were seen at two academic outpatient neurology settings and had at least two visits over a 3-year period. Demographic and clinical characteristics were abstracted. Evidence that AED side effects were addressed was measured through 1 phone interview (patient-reported and 2 medical records abstraction (physician-documented. Medication adherence was assessed using the validated Morisky Medication Adherence Scale-4. Complete adherence was determined as answering “no” to all questions.Results: Sixty-two (25% patients completed the interviews. Participants and nonparticipants were comparable with respect to demographic and clinical characteristics; however, a smaller proportion of participants had a history of drug-resistant epilepsy than nonparticipants (17.7% vs 30.9%, P=0.04. Among the participants, evidence that AED side effects were addressed was present in 48 (77% medical records and reported by 51 (82% patients. Twenty-eight (45% patients reported complete medication adherence. The most common reason for incomplete adherence was missed medication due to forgetfulness (n=31, 91%. There was no association between addressing AED side effects (neither physician-documented nor patient-reported and complete medication adherence (P=0.22 and 0.20.Discussion and

  19. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Science.gov (United States)

    2010-04-01

    ... the new animal drug (or abstracts of them) including clinical trials on safety and effectiveness... approved new animal drugs. 514.80 Section 514.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL...

  20. Creeping Federalization

    DEFF Research Database (Denmark)

    Sweeney, Richard J.

    2003-01-01

    that make taxharmonization difficult to impose. Other types of harmonization have a less clear-cut costbenefitanalysis. A federal commercial code that is uniform across member states reducestransaction and information costs, compared to leaving important code issues to memberstates; further, many states may...

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

    Directory of Open Access Journals (Sweden)

    Guenka Petrova

    2017-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  3. [Impairment - disability - participation for all : New federal reporting in light of the UN Convention on the Rights of Persons with Disabilities].

    Science.gov (United States)

    Wacker, Elisabeth

    2016-09-01

    The new Federal Government's Report on Participation explores the contexts in which impairments become disabilities for those individuals who experience them. In parallel, it outlines the factors that foster inclusion and opportunities to act for everyone in society - despite existing impairments.From a sociopolitical and health policy perspective, disability refers to unequal opportunities based on impairment. Hence, the focus here is on the equalisation of these participation opportunities to match those of the entire population - but always from differentiated perspectives on the various social arenas. The human rights approach stresses protection against discrimination as well as dignity and self-determination for all. From a human resources angle, the emphasis is on the performance of individuals in favourable conditions and the attainment of personal goals within their actual everyday circumstances.The new reporting concept is indebted to these perspectives and thus focuses on individual life circumstances, while referring to the WHO's International Classification of Functioning, Disability and Health (ICF) - an approach now validated on a global scale. Therefore, it does not only report on measures provided by services for persons with disabilities but, more crucially, investigates determinants on the personal and environmental levels, unequal opportunities and the interdependency between context and competence for particular sections of the population. Two groups are singled out in the process: elderly persons and individuals with mental health impairments.The participation report is part of the National Action Plan to implement the UN Convention on the Rights of Persons with Disabilities (UNCRPD). An independent scientific committee conceptualises the design of the report while accompanying and commenting upon its realisation. Currently, a second federal report on participation is emerging from the new concept.

  4. Cutaneous drug toxicity from 2,4-dinitrophenol (DNP): Case report and histological description.

    Science.gov (United States)

    Le, Patricia; Wood, Benjamin; Kumarasinghe, Sujith Prasad

    2015-11-01

    The use of 2,4-dinitrophenol (DNP) has regained popularity as a weight loss aid in the last two decades due to increased marketing to bodybuilders and the increasing availability of this banned substance via the Internet. 2,4-DNP is a drug of narrow therapeutic index and toxicity results in hyperthermia, diaphoresis, tachycardia, tachypnoea and possible cardiac arrest and death. Skin toxicity from 2,4-DNP has not been reported since the 1930s. We report a case of a 21-year-old bodybuilding enthusiast who presented with a toxic exanthem after taking 2,4-DNP, and describe the first skin biopsy findings in a case of 2,4-DNP toxicity.

  5. Lichenoid drug reaction following influenza vaccination in an HIV-positive patient: a case report and literature review.

    Science.gov (United States)

    de Golian, Emily W; Brennan, Christina B; Davis, Loretta S

    2014-07-01

    Lichenoid drug reactions to vaccinations are rare but well-documented events. The vast majority of these reported reactions have been triggered by Hepatitis B vaccination (HBV). We describe an impressive generalized lichenoid drug reaction following the influenza vaccination. A 46-year-old African-American woman with a history of treated human immunodeficiency virus (HIV) disease developed a diffuse, pruritic rash one day following vaccination against the influenza virus. Physical exam and histopathology were consistent with a lichenoid drug eruption. This is only the fifth reported case of lichenoid drug reaction, and only the second generalized case, following influenza vaccination. The patient's underlying HIV disease, known to be a risk factor for both cutaneous drug reactions and more severe manifestations of lichen planus, likely predisposed her to this generalized hypersensitivity phenomenon.

  6. Longitudinal Study of Maternal Report of Sleep Problems in Children with Prenatal Exposure to Cocaine and Other Drugs

    Science.gov (United States)

    Stone, Kristen C.; High, Pamela C.; Miller-Loncar, Cynthia L.; LaGasse, Linda L.; Lester, Barry M.

    2009-01-01

    Sleep data were collected by maternal report in a prospective longitudinal follow-up of cocaine exposed and unexposed children. There were 139 subjects: 23 with no prenatal drug exposure, 55 exposed to cocaine alone or in combination with other drugs, and 61 exposed to drugs other than cocaine. Characteristics differed between exposure groups, including birth size, caretaker changes, and maternal SES and postnatal drug use. Compared to those with no drug exposure, children with prenatal drug exposure other than cocaine experienced greater sleep problems (mean [SD], 5 [4.93] vs 7.7 [4.85], p = .026). Prenatal nicotine exposure was a unique predictor of sleep problems (R2 = .028, p = .048). Early sleep problems predicted later sleep problems (all p’s <.01). Together, these preliminary findings suggest possible neurotoxic sleep effects that persist over time. Larger studies, however, need to be conducted that better control for potential postnatal confounding factors. PMID:19787489

  7. Longitudinal study of maternal report of sleep problems in children with prenatal exposure to cocaine and other drugs.

    Science.gov (United States)

    Stone, Kristen C; High, Pamela C; Miller-Loncar, Cynthia L; Lagasse, Linda L; Lester, Barry M

    2009-01-01

    Sleep data were collected by maternal report in a prospective longitudinal follow up of cocaine-exposed and unexposed children. There were 139 participants: 23 with no prenatal drug exposure, 55 exposed to cocaine alone or in combination with other drugs, and 61 exposed to drugs other than cocaine. Characteristics differed between exposure groups including birth size, caretaker changes, maternal socioeconomic status, and postnatal drug use. Compared to those with no drug exposure, children with prenatal drug exposure other than cocaine experienced greater sleep problems (p = .026). Prenatal nicotine exposure was a unique predictor of sleep problems (p = .048). Early sleep problems predicted later sleep problems (all ps effects that persist over time. Larger studies, however, need to be conducted that better control for potential postnatal confounding factors.

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

    Science.gov (United States)

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

    2015-06-09

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

  9. Case Reports of Aripiprazole Causing False-Positive Urine Amphetamine Drug Screens in Children.

    Science.gov (United States)

    Kaplan, Justin; Shah, Pooja; Faley, Brian; Siegel, Mark E

    2015-12-01

    Urine drug screens (UDSs) are used to identify the presence of certain medications. One limitation of UDSs is the potential for false-positive results caused by cross-reactivity with other substances. Amphetamines have an extensive list of cross-reacting medications. The literature contains reports of false-positive amphetamine UDSs with multiple antidepressants and antipsychotics. We present 2 cases of presumed false-positive UDSs for amphetamines after ingestion of aripiprazole. Case 1 was a 16-month-old girl who accidently ingested 15 to 45 mg of aripiprazole. She was lethargic and ataxic at home with 1 episode of vomiting containing no identifiable tablets. She remained sluggish with periods of irritability and was admitted for observation. UDS on 2 consecutive days came back positive for amphetamines. Case 2 was of a 20-month-old girl who was brought into the hospital after accidental ingestion of an unknown quantity of her father's medications which included aripiprazole. UDS on the first day of admission came back positive only for amphetamines. Confirmatory testing with gas chromatography-mass spectrometry (GC-MS) on the blood and urine samples were also performed for both patients on presentation to detect amphetamines and were subsequently negative. Both patients returned to baseline and were discharged from the hospital. To our knowledge, these cases represent the first reports of false-positive amphetamine urine drug tests with aripiprazole. In both cases, aripiprazole was the drug with the highest likelihood of causing the positive amphetamine screen. The implications of these false-positives include the possibility of unnecessary treatment and monitoring of patients.

  10. Clinical outcomes of the inclusion of the therapeutic drug monitoring report in the electronic clinical record

    Directory of Open Access Journals (Sweden)

    Marina Sáez Belló

    2016-12-01

    Full Text Available Objectives: To assess the inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record (ECR. Method: An observational ambispective cohort study with a duration of 149 days: PRE (retrospective, 49 days with the TDMR printed in paper, and POST (prospective, 100 days with the TDMR included in the ECR. Exclusion criteria: Patients not hospitalized, applications for Therapeutic Drug Monitoring by Critical Care and Neonatal Units, as well as monitoring with an objective other than dose adjustment. Variables: Number of TDMRs prepared, number of patients admitted with TDMR, time of delay for treatment adjustment, defined as the number of adjustments made to the treatment within over or under 24 hours from the time of TDMR preparation, and medication errors (MEs associated with said delay, as well as the degree of acceptance of the TDMR. Results: 690 TDMRs were conducted in 391 patients, 339 in PRE (n = 206 and 351 in POST (n = 185. The number of treatment modifications made in under 24 hours increased from 73.9% in PRE to 87.3% in POST [RR = 1.2 (CI95% = 0.97-1.43. We identified 35 patients with ME, 9.7% of them in PRE and 8.1% in POST (RR = 0.84 (CI95% = 0.44-1.58]. The degree of acceptance of the pharmacist recommendation increased from 53.3% in PRE to 68.3% in POST [RR = 1.3 (CI95% = 1.02- 1.62]. Conclusions: The inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record increases the degree of acceptance of recommendations, and may reduce the delay in treatment modifications, reducing MEs and improving the process quality in terms of efficacy and safety

  11. The understanding of law professionals from the Federal District about drug users under the current new law / A compreensão dos operadores de direito do Distrito Federal sobre o usuário de drogas na vigência da nova lei

    Directory of Open Access Journals (Sweden)

    Maria Fátima Olivier Sudbrack

    2010-01-01

    Full Text Available Drugs users have been receiving contradictory treatments thereby promoting their stigma besides hiding and limiting the understanding of the phenomenon. The objective of this study was to investigate how the District Attorneys and Judges are considering and applying the new law which legislates on the conduct of drug use in Brazil. Eleven Law professionals from the Federal District participated in semi-structured interviews divided in three areas: the point of view in relation to the user of drugs, how the law is being applied, and how they conceive the work of the multidisciplinary teams. The results showed very heterogeneous positions, showing that there is no unanimity on the understanding of the new law. For some, there is a shared belief that drugs abuse is a public health problem, for others, it is believed that the user must receive a punishment for his/her illegal act. An effective and efficient interdisciplinary dialogue should allow a reflective action aiming at favoring those who come to justice.

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

    Science.gov (United States)

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

    2010-01-01

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

  13. Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

    Science.gov (United States)

    Adams, Wallace P; Ahrens, Richard C; Chen, Mei-Ling; Christopher, David; Chowdhury, Badrul A; Conner, Dale P; Dalby, Richard; Fitzgerald, Kevin; Hendeles, Leslie; Hickey, Anthony J; Hochhaus, Günther; Laube, Beth L; Lucas, Paul; Lee, Sau L; Lyapustina, Svetlana; Li, Bing; O'Connor, Dennis; Parikh, Neil; Parkins, David A; Peri, Prasad; Pitcairn, Gary R; Riebe, Michael; Roy, Partha; Shah, Tushar; Singh, Gur Jai Pal; Sharp, Sandra Suarez; Suman, Julie D; Weda, Marjolein; Woodcock, Janet; Yu, Lawrence

    2010-02-01

    This March 2009 Workshop Summary Report was sponsored by Product Quality Research Institute (PQRI) based on a proposal by the Inhalation and Nasal Technology Focus Group (INTFG) of the American Association of Pharmaceutical Scientists (AAPS). Participants from the pharmaceutical industry, academia and regulatory bodies from the United States, Europe, India, and Brazil attended the workshop with the objective of presenting, reviewing, and discussing recommendations for demonstrating bioequivalence (BE) that may be considered in the development of orally inhaled drug products and regulatory guidances for new drug applications (NDAs), abbreviated NDAs (ANDAs), and postapproval changes. The workshop addressed areas related to in vitro approaches to demonstrating BE, biomarker strategies, imaging techniques, in vivo approaches to establishing local delivery equivalence and device design similarity. The workshop presented material that provided a baseline for the current understanding of orally inhaled drug products (OIPs) and identified gaps in knowledge and consensus that, if answered, might allow the design of a robust, streamlined method for the BE assessment of locally acting inhalation drugs. These included the following: (1) cascade impactor (CI) studies are not a good 2 predictor of the pulmonary dose; more detailed studies on in vitro/in vivo correlations (e.g., suitability of CI studies for assessing differences in the regional deposition) are needed; (2) there is a lack of consensus on the appropriate statistical methods for assessing in vitro results; (3) fully validated and standardized imaging methods, while capable of providing information on pulmonary dose and regional deposition, might not be applicable to the BE of inhaled products mainly due to the problems of having access to radiolabeled innovator product; (4) if alternatives to current methods for establishing local delivery BE of OIPs cannot be established, biomarkers (pharmacodynamic or clinical

  14. A Wildlife Habitat Protection, Mitigation and Enhancement Plan for Eight Federal Hydroelectric Facilities in the Willamette River Basin: Final Report.

    Energy Technology Data Exchange (ETDEWEB)

    Preston, S.K.

    1987-05-01

    The development and operation of eight federal hydroelectric projects in the Willamette River Basin impacted 30,776 acres of prime wildlife habitat. This study proposes mitigative measures for the losses to wildlife and wildlife habitat resulting from these projects, under the direction of the Columbia River Basin (CRB) Fish and Wildlife Program. The CRB Fish and Wildlife Program was adopted in 1982 by the Northwest Power Planning Council, pursuant to the Northwest Power Planning Act of 1980. The proposed mitigation plan is based on the findings of loss assessments completed in 1985, that used a modified Habitat Evaluation Procedure (HEP) to assess the extent of impact to wildlife and wildlife habitat, with 24 evaluation species. The vegetative structure of the impacted habitat was broken down into three components: big game winter range, riparian habitat and old-growth forest. The mitigation plan proposes implementation of the following, over a period of 20 years: (1) purchase of cut-over timber lands to mitigate, in the long-term, for big game winter range, and portions of the riparian habitat and old-growth forest (approx. 20,000 acres); (2) purchase approximately 4,400 acres of riparian habitat along the Willamette River Greenway; and (3) three options to mitigate for the outstanding old-growth forest losses. Monitoring would be required in the early stages of the 100-year plan. The timber lands would be actively managed for elk and timber revenue could provide O and M costs over the long-term.

  15. Discriminating Between Legitimate and Predatory Open Access Journals: Report from the International Federation for Emergency Medicine Research Committee

    Directory of Open Access Journals (Sweden)

    Bhakti Hansoti

    2016-09-01

    Full Text Available Introduction: Open access (OA medical publishing is growing rapidly. While subscription-based publishing does not charge the author, OA does. This opens the door for “predatory” publishers who take authors’ money but provide no substantial peer review or indexing to truly disseminate research findings. Discriminating between predatory and legitimate OA publishers is difficult. Methods: We searched a number of library indexing databases that were available to us through the University of California, Irvine Libraries for journals in the field of emergency medicine (EM. Using criteria from Jeffrey Beall, University of Colorado librarian and an expert on predatory publishing, and the Research Committee of the International Federation for EM, we categorized EM journals as legitimate or likely predatory. Results: We identified 150 journal titles related to EM from all sources, 55 of which met our criteria for OA (37%, the rest subscription based. Of these 55, 25 (45% were likely to be predatory. We present lists of clearly legitimate OA journals, and, conversely, likely predatory ones. We present criteria a researcher can use to discriminate between the two. We present the indexing profiles of legitimate EM OA journals, to inform the researcher about degree of dissemination of research findings by journal. Conclusion: OA journals are proliferating rapidly. About half in EM are legitimate. The rest take substantial money from unsuspecting, usually junior, researchers and provide no value for true dissemination of findings. Researchers should be educated and aware of scam journals.

  16. 13 CFR 124.601 - What reports does SBA require concerning parties who assist Participants in obtaining federal...

    Science.gov (United States)

    2010-01-01

    ... Credit and Assistance SMALL BUSINESS ADMINISTRATION 8(a) BUSINESS DEVELOPMENT/SMALL DISADVANTAGED... the activities performed for such compensation. (b) Failure to submit the report is good cause for...

  17. Cotrimoxazole, a wonder drug in the era of multiresistance: Case report and review of literature

    Directory of Open Access Journals (Sweden)

    Priyam Batra

    2017-01-01

    Full Text Available Antimicrobial resistance is one of the greatest threats to human health worldwide. The rate of development of newer antibiotics is much slower than the rate of development of antibiotic resistance. A survey reported that it takes 15 years and US$800 million (including preclinical and clinical costs to bring a single drug to the market, whereas the reuse of the older drugs for antimicrobial use takes $17 million, thereby circumventing 40% of the overall cost. The first case is a patient with nosocomial pyrexia of unknown origin who was given treatment with tigecycline and cefepime/tazobactam but failed to respond to the same. However, the patient responded to the treatment with cotrimoxazole. The second case is a patient with meningitis caused by an atypical zoonotic pathogen, Staphylococcus chromogenes. This is the first report of human infection with S. chromogenes, this being a common cause of bovine mastitis. The isolate was obtained from a patient of neurotrauma who developed meningitis after decompressive craniotomy. The strain was obtained from cerebrospinal fluid, blood, and shunt chamber pus. Cotrimoxazole was given for the treatment, and the patient improved after the treatment. Although the newer antibiotics have replaced sulfonamides in the treatment of many infections, they are still of great value and are the agents of choice in many infections. Sulfonamides have wide antimicrobial activity against both Gram-positive and Gram-negative bacteria, but their usefulness has diminished with the emergence of resistant strains. This paper reports cases of two different kinds of infections from a level 1 trauma center, who failed to respond to the newer antibiotics but showed a response to administration of cotrimoxazole.

  18. Drug-induced hepatic injury : analysis of clinicopathological patterns with the help of voluntary reporting

    NARCIS (Netherlands)

    B.H.Ch. Stricker (Bruno)

    1987-01-01

    textabstractThis study is focused on drug-induced hepatic injury. Drug-induced hepatic injury includes many different patterns varying from necrosis or cholestasis to vascular and neoplastic disorders. These may present acutely or insidiously after years of use of the suspected drug. Some drugs

  19. 21 CFR 314.80 - Postmarketing reporting of adverse drug experiences.

    Science.gov (United States)

    2010-04-01

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

  20. Effect of reporting bias on meta-analyses of drug trials

    DEFF Research Database (Denmark)

    Hart, Beth; Lundh, Andreas; Bero, Lisa

    2012-01-01

    To investigate the effect of including unpublished trial outcome data obtained from the Food and Drug Administration (FDA) on the results of meta-analyses of drug trials.......To investigate the effect of including unpublished trial outcome data obtained from the Food and Drug Administration (FDA) on the results of meta-analyses of drug trials....

  1. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Science.gov (United States)

    2011-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j)...

  2. Guerra Federal e Instrucción Pública en las Memorias de los Secretarios del Gobierno Venezolano entre 1859 – 1863 / Federal War and Public Instruction in the reports of the Secretaries of the Venezuelan government between 1859 – 1863

    Directory of Open Access Journals (Sweden)

    Ramón Alexander Uzcátegui Pacheco

    2016-12-01

    Full Text Available La Guerra Federal fue la contienda bélica que involucró a los habitantes del territorio venezolano entre 1859 y 1863. Este acontecimiento histórico marca de forma decisiva la configuración política del Estado venezolano, incluso en la actualidad. Qué impacto tuvo este enfrentamiento social generalizado en la marcha de la instrucción pública. En este trabajo se analiza la exposición de las memorias que los Secretarios de gobierno presentan al Congreso Nacional o su equivalente entre 1858 y 1863. La revisión permite identificar los efectos de la guerra en la instrucción pública. Dependiendo de la orientación política del Gobierno, el Secretario encargado expresará su visión sobre la instrucción pública. La información que disponen los Secretarios pone en evidencia la gestión pública de la instrucción elemental, los colegios nacionales y la universidad en las circunstancias de la guerra civil. Serias dificultades en el funcionamiento de los centros de enseñanza se deducen de la lectura de la fuente indicada. Finalizada la guerra se propone fortalecer la instrucción pública como medio garante de la paz. Los efectos de la guerra en la institucionalidad educativa tendrán expresión en sus aspectos políticos doctrinarios con la incorporación histórica de la idea de libertad de enseñanza. Federal War and Public Instruction in the reports of the Secretaries of the Venezuelan government between 1859 – 1863 ABSTRACT The Federal War was the military conflict involved the inhabitants of Venezuela between 1859 and 1863. This historic event marked a decisive political configuration of the Venezuelan State, until today. What did impact this widespread social confrontation in the progress of public instruction? This paper is analyzed the expositions presented between 1858 and 1863 for government of Secretaries to Congress or its equivalent. The review can be identifies the effects of war on public education. Depending on the

  3. DRUG INDUCED HYPOGLYCEMIC COMA IN A NONDIABETIC WITH CHRONIC LIVER DISEASE: A CASE REPORT OF DRUG DISPENSING ERROR

    Directory of Open Access Journals (Sweden)

    Krishna M

    2014-08-01

    Full Text Available Hypoglycemia is a common, potentially fatal, yet preventable problem. Drug-induced hypoglycemia remains the commonest cause of hypoglycemia. A 63 year old non-diabetic male, a known case of chronic liver disease, on regular medications, presented with unconsciousness, unresponsiveness since two hours. Immediate random blood sugar was 11 mg/dl. On proper history and clinical examination, diagnosis of oral hypoglycemic agent induced hypoglycemic coma was made and immediately intravenous dextrose resuscitation was started. Patient regained consciousness after four hours and became fully oriented after 24 hours. Throughout his hospital course, strict and frequent glucose monitoring was done and dextrose infused accordingly. Patient remained hemodynamically stable throughout the hospital course. He was discharged from the hospital after 72 hours in an otherwise healthy condition. Drug induced hypoglycemia is now so relatively common that virtually every unconscious patient should be considered hypoglycemic until immediate estimation of the blood sugar level rules the condition in or out.

  4. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

    Science.gov (United States)

    2016-06-23

    The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

  5. South Carolina Department of Health and Environmental Control federal facility agreement. Annual progress report, fiscal year 1995

    Energy Technology Data Exchange (ETDEWEB)

    Hucks, R.L.

    1996-01-30

    South Carolina Department of Health and Environmental Control (SCDHEC) reviewed 105 primary documents during fiscal year 1995 (October 1, 1994 through September 30, 1995). The primary documents reviewed consisted of 27 RCRA Facility Investigation/Remedial Investigation (RFI/RI) workplans, 13 RFI/RI Reports, 12 Baseline Risk Assessments (BRA`s), 27 Site Evaluation (SE) Reports, 8 Proposed Plans, 5 Record of Decisions (ROD`s), 6 Remedial Design Workplans, 6 Remedial Action Workplans and 10 miscellaneous primary documents. Numerous other administrative duties were conducted during the reporting period that are not accounted for above. These included, but were not limited to, extension requests, monitoring well approvals, and Treatability Studies. The list of outgoing correspondence from SCDHEC to the Department of Energy (DOE) and Westinghouse Savannah River Company (WSRC) is attached.

  6. A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

    Science.gov (United States)

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

    Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work.

  7. Prevalência do tabagismo e associação com o uso de outras drogas entre escolares do Distrito Federal Prevalence of smoking and its association with the use of other drugs among students in the Federal District of Brasília, Brazil

    Directory of Open Access Journals (Sweden)

    Márcia Cardoso Rodrigues

    2009-10-01

    Full Text Available OBJETIVO: Estimar a prevalência do tabagismo e sua associação com o uso de outras drogas entre escolares, do ensino fundamental e médio, do Distrito Federal (DF. MÉTODOS: Estudo epidemiológico, tendo como população de referência escolares do DF. Nossa amostra consistiu de 2.661 alunos com idades entre 9 e 19 anos de todas as séries do ensino fundamental II e do ensino médio que responderam a um questionário padrão. Os resultados foram analisados por gênero e tipo de rede escolar. RESULTADOS: A prevalência do tabagismo entre escolares do DF foi de 10,5%, sendo observada uma associação entre o uso do cigarro e o uso de álcool e outras drogas. CONCLUSÕES: O tabagismo é uma porta de entrada para o uso de outras drogas.OBJECTIVE: To estimate the prevalence of smoking, as well as to determine the association between smoking and the use of other drugs, among middle and high school students in the Federal District of Brasília, Brazil. METHODS: Epidemiological study involving a reference population of students in the District. Our sample comprised 2,661 students from 9 to 19 years of age, in all middle and high school grades. All participating students completed a standard questionnaire. Results were analyzed by gender and type of school (public or private. RESULTS: The prevalence of smoking among students in the District was 10.5%. Smoking was found to be associated with the use of alcohol and other drugs. CONCLUSIONS: Smoking is a gateway to the use of other drugs.

  8. Geothermal direct-heat utilization assistance. Quarterly project progress report, July 1996--September 1996. Federal Assistance Program

    Energy Technology Data Exchange (ETDEWEB)

    Lienau, P.

    1996-11-01

    This report summarizes geothermal technical assistance, R&D and technology transfer activities of the Geo-Heat Center at Oregon Institute of Technology for the fourth quarter of FY-96. It describes 152 contacts with parties during this period related to technical assistance with geothermal direct heat projects. Areas dealt with include geothermal heat pumps, space heating, greenhouses, aquaculture, equipment, economics and resources. Research activities are summarized on greenhouse peaking. Outreach activities include the publication of a geothermal direct use Bulletin, dissemination of information, geothermal library, technical papers and seminars, and progress monitor reports on geothermal resources and utilization.

  9. A Case Report of Clonazepam Dependence: Utilization of Therapeutic Drug Monitoring During Withdrawal Period.

    Science.gov (United States)

    Kacirova, Ivana; Grundmann, Milan; Silhan, Petr; Brozmanova, Hana

    2016-03-01

    Clonazepam is long-acting benzodiazepine agonist used in short-acting benzodiazepine withdrawal; however, recent observations suggest the existence of its abuse. We demonstrate a 40-year-old man with a 20-year history of psychiatric care with recently benzodiazepine dependence (daily intake of ∼60 mg of clonazepam and 10 mg of alprazolam). High serum levels of both drugs were analyzed 3 weeks before admission to hospitalization (clonazepam 543.9 ng/mL, alprazolam 110 ng/mL) and at the time of admission (clonazepam 286.2 ng/mL, alprazolam 140 ng/mL) without any signs of benzodiazepine intoxication. Gradual withdrawal of clonazepam with monitoring of its serum levels and increase of gabapentin dose were used to minimize physical signs and symptoms of clonazepam withdrawal. Alprazolam was discontinued promptly. Clinical consequences of the treatment were controllable tension, intermittent headache, and rarely insomia. It is the first case report showing utilization of therapeutic drug monitoring during withdrawal period in the patient with extreme toleration to severe benzodiazepine dependence.

  10. SARM-S4 and metabolites detection in sports drug testing: a case report.

    Science.gov (United States)

    Grata, Elia; Perrenoud, Laurent; Saugy, Martial; Baume, Norbert

    2011-12-10

    Recently, pharmaceutical industry developed a new class of therapeutics called Selective Androgen Receptor Modulator (SARM) to substitute the synthetic anabolic drugs used in medical treatments. Since the beginning of the anti-doping testing in sports in the 1970s, steroids have been the most frequently detected drugs mainly used for their anabolic properties. The major advantage of SARMs is the reduced androgenic activities which are the main source of side effects following anabolic agents' administration. In 2010, the Swiss laboratory for doping analyses reported the first case of SARMs abuse during in-competition testing. The analytical steps leading to this finding are described in this paper. Screening and confirmation results were obtained based on liquid chromatography tandem mass spectrometry (LC-MS/MS) analyses. Additional information regarding the SARM S-4 metabolism was investigated by ultra high-pressure liquid chromatography coupled to quadrupole time-of-flight mass spectrometer (UHPLC-QTOF-MS). Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  11. Adverse events associated with incretin-based drugs in Japanese spontaneous reports: a mixed effects logistic regression model

    Directory of Open Access Journals (Sweden)

    Daichi Narushima

    2016-03-01

    Full Text Available Background: Spontaneous Reporting Systems (SRSs are passive systems composed of reports of suspected Adverse Drug Events (ADEs, and are used for Pharmacovigilance (PhV, namely, drug safety surveillance. Exploration of analytical methodologies to enhance SRS-based discovery will contribute to more effective PhV. In this study, we proposed a statistical modeling approach for SRS data to address heterogeneity by a reporting time point. Furthermore, we applied this approach to analyze ADEs of incretin-based drugs such as DPP-4 inhibitors and GLP-1 receptor agonists, which are widely used to treat type 2 diabetes. Methods: SRS data were obtained from the Japanese Adverse Drug Event Report (JADER database. Reported adverse events were classified according to the MedDRA High Level Terms (HLTs. A mixed effects logistic regression model was used to analyze the occurrence of each HLT. The model treated DPP-4 inhibitors, GLP-1 receptor agonists, hypoglycemic drugs, concomitant suspected drugs, age, and sex as fixed effects, while the quarterly period of reporting was treated as a random effect. Before application of the model, Fisher’s exact tests were performed for all drug-HLT combinations. Mixed effects logistic regressions were performed for the HLTs that were found to be associated with incretin-based drugs. Statistical significance was determined by a two-sided p-value <0.01 or a 99% two-sided confidence interval. Finally, the models with and without the random effect were compared based on Akaike’s Information Criteria (AIC, in which a model with a smaller AIC was considered satisfactory. Results: The analysis included 187,181 cases reported from January 2010 to March 2015. It showed that 33 HLTs, including pancreatic, gastrointestinal, and cholecystic events, were significantly associated with DPP-4 inhibitors or GLP-1 receptor agonists. In the AIC comparison, half of the HLTs reported with incretin-based drugs favored the random effect

  12. HIV-1 subtypes and mutations associated to antiretroviral drug resistance in human isolates from Central Brazil Subtipos e mutações associadas à resistência aos anti-retrovirais em isolados de HIV-1 do Distrito Federal

    Directory of Open Access Journals (Sweden)

    Daniela Marreco Cerqueira

    2004-09-01

    Full Text Available The detection of polymorphisms associated to HIV-1 drug-resistance and genetic subtypes is important for the control and treatment of HIV-1 disease. Drug pressure selects resistant variants that carry mutations in the viral reverse transcriptase (RT and protease (PR genes. For a contribution to the public health authorities in planning the availability of therapeutic treatment, we therefore described the genetic variability, the prevalence of mutations associated to drug resistance and the antiretroviral resistance profile in HIV-1 isolates from infected individuals in Central Brazil. Nineteen HIV-1 RNA samples from a Public Health Laboratory of the Federal District were reversely transcribed and cDNAs were amplified by nested PCR. One fragment of 297 bp coding the entire protease gene, and another of 647 bp, corresponding to the partial RT gene (codons 19-234, were obtained. Automated sequencing and BLAST analysis revealed the presence of 17 B and 2 F1 HIV-1 subtypes. The amino acid sequences were analyzed for the presence of resistance-associated mutations. A total of 6 PR mutations, 2 major and 4 accessory, and 8 RT mutations related to drug resistance were found. Our data suggest a high prevalence of HIV-1 B subtype in the studied population of Federal District as well as the presence of genetically-resistant strains in individuals failing treatment.A detecção de polimorfismos do HIV-1 que estejam associados à resistência às drogas anti-retrovirais e aos subtipos genéticos é importante para o controle e tratamento da infecção pelo HIV-1. A pressão exercida pela terapia anti-retroviral seleciona variantes resistentes com mutações nos genes virais da transcriptase reversa (RT e da protease (PR. Assim, visando contribuir com as autoridades de saúde pública na perspectiva de planejar a disponibilidade de um tratamento terapêutico, nós descrevemos a variabilidade genética e a prevalência de mutações associadas à resist

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

    NARCIS (Netherlands)

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

    2002-01-01

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

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

    NARCIS (Netherlands)

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

    2006-01-01

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

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

    Science.gov (United States)

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

    2014-09-01

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

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

    NARCIS (Netherlands)

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

    2002-01-01

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

  17. Revisiting the Coleman Report: Deficit Ideologies and Federal Compensatory Funding in Low-Income Latino School Communities

    Science.gov (United States)

    Jimenez-Castellanos, Oscar

    2012-01-01

    The essay argues that the Coleman Report helped give credence to contemporary deficit ideologies in education by proclaiming that schools do not make much of a difference in the educational outcomes of students in poverty including Latino communities. Furthermore, the author explores how deficit ideologies influence compensatory funding, in…

  18. Bilateral macular hemorrhage as a complication of drug-induced anemia: a case report

    Directory of Open Access Journals (Sweden)

    Belfort Rubens N

    2009-01-01

    Full Text Available Abstract Introduction Bilateral macular hemorrhage is a rare ocular finding and to the best of our knowledge, this is the first report of such hemorrhages as a presentation of drug-induced anemia. Case presentation We describe the case of a 14-year-old Caucasian boy who presented with a toxoplasmic retinochoroiditis and was treated with sulfadiazine and pyrimethamine. Three months later, he presented with a bilateral macular hemorrhage as a complication of a toxic induced anemia. Conclusion Our patient presented with toxic anemia secondary to the treatment of a very common disease, ocular toxoplasmosis. Prophylactic use of folinic acid could prevent such complications but in many cases, it is not prescribed owing to its cost or is mistakenly substituted with folic acid, which does not present as a valid substitute.

  19. Drug-Induced Lichen Planus Pigmentosus-Inversus Treated with Propolis Cream. A Case Report

    Directory of Open Access Journals (Sweden)

    Francisco Nelson Matos Figueredo

    2013-12-01

    Full Text Available Lichen planus has numerous clinical variants; one of them is lichen planus pigmentosus which is rarely mentioned in the medical literature. When located in the skin folds, it is known as lichen planus pigmentosus-inversus. In order to communicate a rare variant of lichen planus and its first presentation associated with drugs, we report the case of a 51 year-old mixed-race female patient from Latin America who was treated in the Department of Dermatology at the Celia Sanchez Manduley Clinical-Surgical Hospital in Granma. She presented with pigmented lesions in the inframammary folds that had evolved over several years. The clinical diagnosis was confirmed by histopathological elements. Some dermatoses with similar characteristics were dismissed. Treatment with propolis cream was beneficial.

  20. Improvement in Hemodynamics After Methylene Blue Administration in Drug-Induced Vasodilatory Shock: A Case Report.

    Science.gov (United States)

    Laes, JoAn R; Williams, David M; Cole, Jon B

    2015-12-01

    The purpose of this study is to describe a case where methylene blue improved hemodynamics in a poisoned patient. This is a single case report where a poisoned patient developed vasodilatory shock following ingestion of atenolol, amlodipine, and valsartan. Shock persisted after multiple therapies including vasopressors, high-dose insulin, hemodialysis, and 20% intravenous fat emulsion. Methylene blue (2 mg/kg IV over 30 min) was administered in the ICU with temporal improvement as measured by pulmonary artery catheter hemodynamic data pre- and post-methylene blue administration. Within 1 h of methylene blue administration, systemic vascular resistance improved (240 dyn s/cm5 increased to 1204 dyn s/cm5), and vasopressor requirements decreased with maintenance of mean arterial pressure 60 mmHg. Methylene blue may improve hemodynamics in drug-induced vasodilatory shock and should be considered in critically ill patients poisoned with vasodilatory medications refractory to standard therapies.

  1. Action of anti-TNF-α drugs on the progression of Alzheimer's disease: A case report

    Directory of Open Access Journals (Sweden)

    Carlos Henrique Ferreira Camargo

    Full Text Available The aim of this study was to describe a clinical case of a patient with Alzheimer's disease (AD in use of an anti-TNF-α agent for rheumatoid arthritis (RA. The patient reported is an 81-year-old Caucasian man and retired teacher, diagnosed with RA in 2008 and AD in 2011. Treatment with donepezil was started in 2011 and the use of etanercept introduced in 2012. He was previously treated with adalimumab in 2010 for 18 months. In 2013, the subject was engaged in a clinical trial to assess a complementary non-pharmacological approach for AD, presenting significant cognitive improvement during the follow-up period. We propose the hypothesis of a synergistic effect of anti-TNF-α medication used for the treatment of RA as the cause of the improvement in cognitive response observed. These findings could suggest a possible use of this drug class in the therapeutic management of AD.

  2. Drug-Induced Methemoglobinemia: a Case Report and Review of Literature

    Directory of Open Access Journals (Sweden)

    Ahmed Zedan

    2014-01-01

    Full Text Available Drugs, including those used during diagnostic procedures, can have adverse effects and potentially serious side-effects, especially in complicated patients with significant comorbidity. Benzocaine is frequently used as an oropharyngeal anesthetic agent during bronchoscopy, transesophageal echocardiography, and upper GI endoscopy and can cause methemoglobinemia, a potentially life-threatening event if not diagnosed and treated quickly. Co-oximetry is the gold standard for the diagnosis of methemoglobinemia and can quantitate blood levels, which in turn correlate with the clinical presentation and the urgency for treatment. Methylene blue is the treatment of choice for methemoglobinemia. In this case report we discuss the pathophysiology, the clinical presentation, the diagnosis, and the treatment of benzocaine-induced methemoglobinemia.

  3. Antiretroviral Drug-Associated Oral Lichenoid Reaction in HIV Patient: A Case Report

    Directory of Open Access Journals (Sweden)

    Pratanporn Arirachakaran

    2010-01-01

    Full Text Available Antiretroviral therapy has changed the course of HIV disease and improved quality of life in HIV patients. Incidence of an oral lichenoid drug reaction induced by zidovudine is not common. Once it occurs, it affects a patient's well being, in particular their oral functions. Here we report the first case of a 34-year-old Thai man with painful erosive lesions involving the lip and buccal mucosa. Treatment with topical fluocinolone acetonide 0.1% alleviated the patient's oral pain, but it was not until the subsequent withdrawal of zidovudine that the patient showed improvement and resolution of the lesions. Long-term follow-up was useful in the management of this patient, and no recurrence of the lesion was found during 21-month follow-up in this patient.

  4. The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015.

    Science.gov (United States)

    van Hunsel, Florence; de Waal, Susan; Härmark, Linda

    2017-08-01

    The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports. In addition to source, the analysis included ATC code of the drug, MedDRA® system organ class and preferred term for the adverse drug reaction (ADR), seriousness of the ADR, and 7 other factors like reports on over-the-counter medication, and how often an ADR listed in the important medical event terms list was present. Secondly, we determined the proportion of reports submitted by the individual groups to signals, in a cross-sectional manner. A total of 150 signals were included, including 1691 ADR reports. Our results show that 26.3% of all ADR reports in Dutch drug safety signals were reported by patients, and 30.5% of the patient reports in the signals contained one or more terms listed as important medical events. The proportion of reports by patients which were included the signals was 2% and 3.9% for health care professional reports and 0.2% for marketing authorization holders reports. Patients had an important contribution to signals overall, but especially for ADRs related to generic drug substitution and psychiatric ADRs. Copyright © 2017 John Wiley & Sons, Ltd.

  5. The mental health sector and the social sciences in post- World War II USA. Part 2: The impact of federal research funding and the drugs revolution.

    Science.gov (United States)

    Scull, Andrew

    2011-09-01

    The second of two linked papers examining the interactions of psychiatry and the social sciences since World War II examines the role of NIMH on these disciplines. It analyses the effects of the prominence and the decline of psychoanalysis, and the impact of the psychotropic drugs revolution and the associated rise of biological psychiatry on relations between psychiatry and clinical psychology; and it explores the changing relationships between psychiatry and sociology, from collaboration to conflict to mutual disdain.

  6. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    Science.gov (United States)

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  7. Reporting of consistency of blood pressure control in randomized controlled trials of antihypertensive drugs: a systematic review of 1372 trial reports.

    Science.gov (United States)

    Fischer, Urs; Webb, Alastair J S; Howard, Sally C; Rothwell, Peter M

    2012-07-01

    Hypertension is a powerful treatable risk factor for stroke. Reports of randomized controlled trials (RCTs) of antihypertensive drugs rightly concentrate on clinical outcomes, but control of blood pressure (BP) during follow-up is also important, particularly given that inconsistent control is associated with a high risk of stroke and that antihypertensive drug classes differ in this regard. We performed a systematic review of reporting of BP control in RCTs of antihypertensive drugs. We searched bibliographic databases (1950-2009) for systematic reviews of RCTs of BP-lowering and identified the main report of all trials. We identified 94 larger trials (>100 participants/arm, >1-year follow-up) and 1278 smaller/shorter trials. Ninety-one (96.8%) larger trials reported some data on mean BP during follow-up, but none reported effects on the consistency of control of BP over time. Although 81 (86.2%) larger trials reported group distribution of BP at baseline (usually SD), only 22 (23.4%) reported such data at any follow-up visit. Eleven (11.7%) larger trials reported group distribution of the change in BP from baseline to follow-up, but 61 (64.9%) reported no data at all on group distribution of BP at follow-up. Thirty-nine (41.5%) trials reported the proportion of patients reaching some BP target during follow-up, but no trial reported data on the consistency of control to target within individuals over time. Similar proportions were observed in the 1278 smaller/short trials. Reporting of BP control is limited in RCTs of BP-lowering drugs. We suggest reporting guidelines.

  8. Geothermal direct-heat utilization assistance: Federal assistance program. Quarterly project progress report, October--December 1995

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-02-01

    The report summarizes geothermal technical assistance, R&D and technology transfer activities of the Geo-Heat Center at Oregon Institute of Technology for the first quarter of FY-96. It describes 90 contacts with parties during this period related to technical assistance with geothermal direct heat projects. Areas dealt with include geothermal heat pumps, space heating, greenhouses, aquaculture, equipment and resources. Research activities are summarized on low-temperature resource assessment, geothermal district heating system cost evaluation and silica waste utilization project. Outreach activities include the publication of a geothermal direct use Bulletin, dissemination of information, geothermal library, technical papers and seminars, development of a webpage, and progress monitor reports on geothermal resources and utilization.

  9. Pressure ulcers induced by drug administration: A new concept and report of four cases in elderly patients.

    Science.gov (United States)

    Mizokami, Fumihiro; Takahashi, Yoshiko; Hasegawa, Keiko; Hattori, Hideyuki; Nishihara, Keiji; Endo, Hidetoshi; Furuta, Katsunori; Isogai, Zenzo

    2016-04-01

    Drug-induced akinesia is a potential cause of pressure ulcers. However, pressure ulcers that are caused by drug-induced akinesia are not considered an adverse drug reaction (ADR). We propose that drug-induced pressure ulcers (DIPU) are pressure ulcers that are caused by an external force that is experienced after drug administration, and we considered resolution of these ulcers after drug discontinuation to be a supportive finding. In this report, we reviewed the medical records of pressure ulcer cases from a 300-bed hospital. Among 148 patients, four patients with pressure ulcers met the criterion for DIPU. In these cases, the suspected DIPU were related to treatment with olanzapine, fluvoxamine, valproic acid, clotiazepam, triazolam and rilmazafone. These drugs were administrated to manage the patients' behavioral and psychological symptoms that accompanied dementia. The DIPU in these patients were categorized as stage IV according to the National Pressure Ulcer Advisory Panel criteria. Discontinuation of the causal drugs led to significant improvements or complete healing of the pressure ulcers, and the patients subsequently recovered their mobility. Therefore, we propose that DIPU are potential ADR that have been overlooked in clinical practice. Thus, recognition of DIPU as an ADR may be important in preventing and appropriately managing pressure ulcers among elderly patients. © 2015 Japanese Dermatological Association.

  10. Drugs to be Discontinued

    Data.gov (United States)

    U.S. Department of Health & Human Services — Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and...

  11. Sulfites--a food and drug administration review of recalls and reported adverse events.

    Science.gov (United States)

    Timbo, Babgaleh; Koehler, Kathleen M; Wolyniak, Cecilia; Klontz, Karl C

    2004-08-01

    Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested > or = 10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

  12. Federal employees--random drug and alcohol testing--subject matter jurisdiction--issue preclusion--exhaustion. Whitman v. Department of Transportation.

    Science.gov (United States)

    2007-01-01

    The Supreme Court, in a per curium decision, vacated a ruling against an air traffic controller in his claim that he was subjected to more than random drug testing and remanded the matter to the Ninth Circuit to determine whether the petitioner exhausted his administrative remedies and whether exhaustion is required, or, if necessary, whether the Civil Service Reform Act precludes employees from pursuing claims beyond those set out in that act, i.e., whether Congress intended to remove such actions from the general grant of subject matter jurisdiction under 28 U.S.C. paragraph 1331.

  13. Are patients reliable when self-reporting medication use? Validation of structured drug interviews and home visits by drug analysis and prescription data in acutely hospitalized patients

    DEFF Research Database (Denmark)

    Glintborg, Bente; Hillestrøm, Peter René; Olsen, Lenette Holm;

    2007-01-01

    to an acute medical department at a Danish university hospital were interviewed on the day of admission about their recent medication use. Blood samples drawn immediately after admission were screened for contents of 5 drugs (digoxin, bendroflumethiazide, amlodipine, simvastatin, glimepiride), and the results......The medication history among hospitalized patients often relies on patients' self-reports due to insufficient communication between health care professionals. The aim of the present study was to estimate the reliability of patients' self-reported medication use. Five hundred patients admitted...

  14. Annual report 1999 of the air pollution monitoring network of the German Federal Environmental Agency; Jahresbericht 1999 aus dem Messnetz des Umweltbundesamtes

    Energy Technology Data Exchange (ETDEWEB)

    Beilke, S.; Uhse, K. [comps.

    2000-12-01

    In this annual report the results of the air pollution monitoring network of the German Federal Environmental Agency (FEA) are presented for the year 1999. The network consists of 23 stations (9 stations with personnel and 14 automatically working container stations) which are situated in rural areas. As the data set was thoroughly quality controlled reliable statements on trends can be made. (orig.) [German] Im vorliegenden Jahresbericht werden die Ergebnisse aus dem Messnetz des Umweltbundesamtes fuer das Jahr 1999 vorgestellt, interpretiert und mit den Messungen aus frueheren Jahren verglichen. Das UBA-Messnetz besteht heute aus insgesamt 23 in laendlichen Regionen gelegenen Stationen, wovon 9 Messstellen personell besetzt und 14 automatisch arbeitende Containerstationen sind. Die Datensaetze sind in sich homogen, d.h. es wurden im Verlauf der Jahre keine gravierenden Veraenderungen an den Messbedingungen vorgenommen, weder bei der Probenahme noch bei der Analytik. Die Daten wurden einer eingehenden Qualitaetspruefung unterzogen, sowohl intern als auch bei internationalen Ringvergleichen der Analysenverfahren. (orig.)

  15. Geothermal direct-heat utilization assistance. Federal Assistance Program quarterly project progress report, April 1--June 30, 1998

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-07-01

    This report summarizes geothermal technical assistance, R and D and technology transfer activities of the Geo-Heat Center at Oregon Institute of Technology for the third quarter of FY98 (April--June, 1998). It describes 231 contacts with parties during this period related to technical assistance with geothermal direct heat projects. Areas dealt with included requests for general information including material for high school and university students, and material on geothermal heat pumps, resource and well data, spacing heating and cooling, greenhouses, aquaculture, equipment, district heating, resorts and spas, industrial applications, snow melting and electric power. Research activities include work on model construction specifications for line shaft submersible pumps and plate heat exchangers, and a comprehensive aquaculture developers package. A brochure on Geothermal Energy in Klamath County was developed for state and local tourism use. Outreach activities include the publication of the Quarterly Bulletin (Vol. 19, No. 2) with articles on research at the Geo-Heat Center, sustainability of geothermal resources, injection well drilling in Boise, ID and a greenhouse project in the Azores. Other outreach activities include dissemination of information mainly through mailings of publications, tours of local geothermal uses, geothermal library acquisitions and use, participation in workshops, short courses and technical meetings by the staff, and progress monitor reports on geothermal activities.

  16. Aviation Weather Observations for Supplementary Aviation Weather Reporting Stations (SAWRS) and Limited Aviation Weather Reporting Stations (LAWRS). Federal Meteorological Handbook No. 9.

    Science.gov (United States)

    Department of Transportation, Washington, DC.

    This handbook provides instructions for observing, identifying, and recording aviation weather at Limited Aviation Weather Reporting Stations (LAWRS) and Supplementary Aviation Weather Reporting Stations (SAWRS). Official technical definitions, meteorological and administrative procedures are outlined. Although this publication is intended for use…

  17. Multicentric Castleman's Disease in a Hepatitis C-Positive Intravenous Drug User: A Case Report

    Directory of Open Access Journals (Sweden)

    D. Y. Talukder

    2011-01-01

    Full Text Available Introduction. We report a rare presentation of Castleman's disease in a hepatitis C-positive patient and present a short review of treatments described in other similar case reports and studies. Case Presentation. A 46-year-old male with untreated hepatitis C and a 16-year history of intravenous drug use presented with pleuritic chest pain and bony pain in the knee, hip, and lower back, on a background of unexplained weight loss of 40 kilograms, fevers, night sweats, and repeated infections over the last two years. Examination discovered tender hepatomegaly, a warm right knee effusion, and painless lymphadenopathy. The patient was reactive to Epstein Barr virus and cytomegalovirus; however, HIV and HHV-8 viral testing was negative. Osteomyelitis of vertebrae T8–T11 and septic arthritis of the knee were found on investigation. A lymph node biopsy revealed histology suggestive of plasmacytic Castleman's disease. The patient is to commence rituximab treatment. Conclusion. Castleman's disease continues to present in novel ways, which may lead to difficulties in clinicopathologic diagnosis. A growing body of evidence suggests larger studies are required to determine the best treatment for multicentric Castleman's disease, particularly in patients with a concomitant disease, including hepatitis C.

  18. Multicentric Castleman's Disease in a Hepatitis C-Positive Intravenous Drug User: A Case Report

    Science.gov (United States)

    Talukder, D. Y.; Delpachitra, S. N.

    2011-01-01

    Introduction. We report a rare presentation of Castleman's disease in a hepatitis C-positive patient and present a short review of treatments described in other similar case reports and studies. Case Presentation. A 46-year-old male with untreated hepatitis C and a 16-year history of intravenous drug use presented with pleuritic chest pain and bony pain in the knee, hip, and lower back, on a background of unexplained weight loss of 40 kilograms, fevers, night sweats, and repeated infections over the last two years. Examination discovered tender hepatomegaly, a warm right knee effusion, and painless lymphadenopathy. The patient was reactive to Epstein Barr virus and cytomegalovirus; however, HIV and HHV-8 viral testing was negative. Osteomyelitis of vertebrae T8–T11 and septic arthritis of the knee were found on investigation. A lymph node biopsy revealed histology suggestive of plasmacytic Castleman's disease. The patient is to commence rituximab treatment. Conclusion. Castleman's disease continues to present in novel ways, which may lead to difficulties in clinicopathologic diagnosis. A growing body of evidence suggests larger studies are required to determine the best treatment for multicentric Castleman's disease, particularly in patients with a concomitant disease, including hepatitis C. PMID:21577263

  19. Generation of a Drug-inducible Reporter System to Study Cell Reprogramming in Human Cells*

    Science.gov (United States)

    Ruiz, Sergio; Panopoulos, Athanasia D.; Montserrat, Nuria; Multon, Marie-Christine; Daury, Aurélie; Rocher, Corinne; Spanakis, Emmanuel; Batchelder, Erika M.; Orsini, Cécile; Deleuze, Jean-François; Izpisua Belmonte, Juan Carlos

    2012-01-01

    Reprogramming of somatic cells into induced pluripotent stem cells is achieved by the expression of defined transcription factors. In the last few years, reprogramming strategies on the basis of doxycycline-inducible lentiviruses in mouse cells became highly powerful for screening purposes when the expression of a GFP gene, driven by the reactivation of endogenous stem cell specific promoters, was used as a reprogramming reporter signal. However, similar reporter systems in human cells have not been generated. Here, we describe the derivation of drug-inducible human fibroblast-like cell lines that express different subsets of reprogramming factors containing a GFP gene under the expression of the endogenous OCT4 promoter. These cell lines can be used to screen functional substitutes for reprogramming factors or modifiers of reprogramming efficiency. As a proof of principle of this system, we performed a screening of a library of pluripotent-enriched microRNAs and identified hsa-miR-519a as a novel inducer of reprogramming efficiency. PMID:23019325

  20. 77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period

    Science.gov (United States)

    2012-09-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales and... antimicrobial new animal drugs. The Agency is taking this action in response to requests for an extension to... use in food-producing animals. The Agency has received requests for a 60-day extension of the...

  1. [Surveillance report of drug-resistant bacteria from 2007 to 2012 in Saga Prefecture, Japan (the second report)].

    Science.gov (United States)

    Kiyosuke, Makiko; Nagasawa, Zenzo; Hotta, Taeko; Utsumi, Takashi; Kang, Dongchon; Miyamoto, Hiroshi

    2014-06-01

    Drug-resistant bacteria are a problematic issue in Japan. Surveillance of drug-resistant bacteria is important because the frequency of isolation and kinds of such bacteria vary between hospitals and local areas. This study summarizes the results of detection of drug-resistant bacteria in Saga Prefecture from July 2007 to June 2012. Data presented in this study were collected through questionnaire survey that was conducted in 12 hospitals. Frequency of drug-resistant bacteria are as follows: 62.5% of Staphylococcus aureus was methicillin-resistant S. aureus (MRSA); 62.2% of Streptococcus pneumoniae was penicillin-intermediate S. pneumoniae (PISP) or penicillin-resistant S. pneumoniae (PRSP); 26.4% of Haemophilus influenzae was beta-lactamase negative ampicillin-resistant H. influenzae (BLNAR); 0.5% of Pseudomonas aeruginosa was metallo-beta-lactamase (MBL) P. aeruginosa; 0.5% of P. aeruginosa was multi-drug resistant P. aeruginosa (MDRP); 12.9% and 5.1% of Escherichia coli and Klebsiella pneumoniae, respectively, were extended-spectrum beta-lactamase (ESBL) producing organisms. While the isolation frequencies of MRSA and PISP/PRSP were unchanged, those of BLNAR, ESBL producing E. coli and ESBL producing K. pneumoniae raised from 15.4% to 34.2%, from 5.7% to 18.4% and from 2.6% to 8.2%, respectively, over the past 5 years. The frequencies of isolation of MDRP and two drug resistant P. aeruginosa declined. This study revealed that the overall trend in the long-term changes of isolation frequency of drug-resistant bacteria in Saga Prefecture is similar to the trend in the national data. It also showed that the frequency and kinds of drug-resistant bacteria are variable between hospitals and local areas. Further study, such as examination of the usage and MIC value of antimicrobial drugs, will enable us to gain more detailed information on the drug-resistant bacteria.

  2. A compreensão dos operadores de direito do Distrito Federal sobre o usuário de drogas na vigência da nova lei The understanding of law professionals from the Federal District about drug users under the current new law

    Directory of Open Access Journals (Sweden)

    Luiza Barros Santoucy

    2010-04-01

    Full Text Available O usuário de drogas tem recebido tratamentos contraditórios que promovem sua estigmatização e clandestinidade e limitam a compreensão do fenômeno. O objetivo foi investigar como Promotores e Juízes estão entendendo e aplicando a nova lei que legisla sobre a conduta de usar e portar drogas no Brasil. Onze operadores do Direito do Distrito Federal (DF participaram de entrevistas semi-estruturadas divididas em três eixos: a visão em relação ao usuário de droga; como a lei vem sendo aplicada; e como concebe o trabalho da equipe multidisciplinar. As respostas demonstraram posições muito heterogêneas, denotando não haver ainda unanimidade quanto à compreensão da nova lei: se por um lado há uma crença compartilhada de que o uso de drogas é um problema de saúde pública, por outro, acredita-se que o usuário deve receber uma punição por seu ato ilegal. Um diálogo interdisciplinar efetivo permitiria uma atuação eficaz e reflexiva visando a beneficiar as pessoas que chegam à justiça.Drugs users have been receiving contradictory treatments thereby promoting their stigma besides hiding and limiting the understanding of the phenomenon. The objective of this study was to investigate how the District Attorneys and Judges are considering and applying the new law which legislates on the conduct of drug use in Brazil. Eleven Law professionals from the Federal District participated in semi-structured interviews divided in three areas: the point of view in relation to the user of drugs, how the law is being applied, and how they conceive the work of the multidisciplinary teams. The results showed very heterogeneous positions, showing that there is no unanimity on the understanding of the new law. For some, there is a shared belief that drugs abuse is a public health problem, for others, it is believed that the user must receive a punishment for his/her illegal act. An effective and efficient interdisciplinary dialogue should allow a

  3. Federal Aircraft Cost and Utilization Data

    Data.gov (United States)

    General Services Administration — Federal aviation data is submitted quarterly to the Federal Aviation Interactive Reporting System (FARIS) IT application. This is a GSA system which is a secure,...

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

    Directory of Open Access Journals (Sweden)

    Maša Amrain

    2014-09-01

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

  5. Drug reaction with eosinophilia and systemic symptoms syndrome in a patient taking phenytoin and levetiracetam: a case report

    Directory of Open Access Journals (Sweden)

    Hall David Jeffrey

    2013-01-01

    Full Text Available Abstract Introduction Drug reaction with eosinophilia and systemic symptoms syndrome is a potentially life-threatening hypersensitivity reaction with rash, fever, and internal organ involvement, often hepatitis, occurring most commonly two to eight weeks after initiation of a medication. The present case is an example of severe and potentially life-threatening hepatitis as a manifestation of drug reaction with eosinophilia and systemic symptoms syndrome. Case presentation We report a case of anti-epileptic-induced drug reaction with eosinophilia and systemic symptoms syndrome in an 18-year-old African-American man who presented with a five-day history of rash, periorbital and upper extremity edema, hepatitis and fever. Laboratory findings revealed an atypical lymphocytosis, eosinophilia, and elevated serum transaminases. No drug allergies were reported at the time of presentation, but phenytoin and levetiracetam therapy had been initiated five weeks prior to hospital admission for new-onset seizures. Both medications were discontinued on hospital admission, and after three days of high-dose corticosteroid therapy the patient experienced resolution of both his symptoms and laboratory markers of inflammation. Conclusion Given the significant mortality attributed to drug reaction with eosinophilia and systemic symptoms syndrome, medical personnel should be aware of the potential for this severe hypersensitivity reaction and should ensure close follow-up and offer anticipatory guidance when beginning any new medication, particularly anti-epileptic therapy. Early recognition of drug reaction with eosinophilia and systemic symptoms syndrome and initiation of appropriate therapy are imperative in limiting morbidity.

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

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Rafati

    2009-01-01

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

  7. Time-to-Onset Analysis of Drug-Induced Long QT Syndrome Based on a Spontaneous Reporting System for Adverse Drug Events

    Science.gov (United States)

    Sasaoka, Sayaka; Matsui, Toshinobu; Hane, Yuuki; Abe, Junko; Ueda, Natsumi; Motooka, Yumi; Hatahira, Haruna; Fukuda, Akiho; Naganuma, Misa; Hasegawa, Shiori; Kinosada, Yasutomi

    2016-01-01

    Long QT syndrome (LQTS) is a disorder of the heart’s electrical activity that infrequently causes severe ventricular arrhythmias such as a type of ventricular tachycardia called torsade de pointes (TdP) and ventricular fibrillation, which can be fatal. There have been no previous reports on the time-to-onset for LQTS based on data from spontaneous reporting systems. The aim of this study was to assess the time-to-onset of LQTS according to drug treatment. We analyzed the association between 113 drugs in 37 therapeutic categories and LQTS including TdP using data obtained from the Japanese Adverse Drug Event Report database. For signal detection, we used the reporting odds ratio (ROR). Furthermore, we analyzed the time-to-onset data and assessed the hazard type using the Weibull shape parameter. The RORs (95% confidence interval) for bepridil, amiodarone, pilsicainide, nilotinib, disopyramide, arsenic trioxide, clarithromycin, cibenzoline, donepezil, famotidine, sulpiride, and nifekalant were 174.4 (148.6–204.6), 17.3 (14.7–20.4), 52.0 (43.4–62.4), 13.9 (11.5–16.7), 69.3 (55.3–86.8), 54.2 (43.2–68.0), 4.7 (3.8–5.8), 19.9 (15.9–25.0), 8.1 (6.5–10.1), 3.2 (2.5–4.1), 7.1 (5.5–9.2), and 254.8 (168.5–385.4), respectively. The medians and quartiles of time-to-onset for aprindine (oral) and bepridil were 20.0 (11.0–35.8) and 18.0 (6.0–43.0) days, respectively. The lower 95% confidence interval of the shape parameter β of bepridil was over 1 and the hazard was considered to increase over time.Our study indicated that the pattern of LQTS onset might differ among drugs. Based on these results, careful long-term observation is recommended, especially for specific drugs such as bepridil and aprindine. This information may be useful for the prevention of sudden death following LQTS and for efficient therapeutic planning. PMID:27723808

  8. Extending Climate Analytics as a Service to the Earth System Grid Federation Progress Report on the Reanalysis Ensemble Service

    Science.gov (United States)

    Tamkin, G.; Schnase, J. L.; Duffy, D.; Li, J.; Strong, S.; Thompson, J. H.

    2016-12-01

    We are extending climate analytics-as-a-service, including: (1) A high-performance Virtual Real-Time Analytics Testbed supporting six major reanalysis data sets using advanced technologies like the Cloudera Impala-based SQL and Hadoop-based MapReduce analytics over native NetCDF files. (2) A Reanalysis Ensemble Service (RES) that offers a basic set of commonly used operations over the reanalysis collections that are accessible through NASA's climate data analytics Web services and our client-side Climate Data Services Python library, CDSlib. (3) An Open Geospatial Consortium (OGC) WPS-compliant Web service interface to CDSLib to accommodate ESGF's Web service endpoints. This presentation will report on the overall progress of this effort, with special attention to recent enhancements that have been made to the Reanalysis Ensemble Service, including the following: - An CDSlib Python library that supports full temporal, spatial, and grid-based resolution services - A new reanalysis collections reference model to enable operator design and implementation - An enhanced library of sample queries to demonstrate and develop use case scenarios - Extended operators that enable single- and multiple reanalysis area average, vertical average, re-gridding, and trend, climatology, and anomaly computations - Full support for the MERRA-2 reanalysis and the initial integration of two additional reanalyses - A prototype Jupyter notebook-based distribution mechanism that combines CDSlib documentation with interactive use case scenarios and personalized project management - Prototyped uncertainty quantification services that combine ensemble products with comparative observational products - Convenient, one-stop shopping for commonly used data products from multiple reanalyses, including basic subsetting and arithmetic operations over the data and extractions of trends, climatologies, and anomalies - The ability to compute and visualize multiple reanalysis intercomparisons

  9. Impact of state and federal law on development of geothermal resources in Texas. Project L/R-9, final report

    Energy Technology Data Exchange (ETDEWEB)

    Edwards, T.

    1974-10-31

    The significant geothermal resource in Texas consists of enormous reservoirs of hot, geopressed water, which formed along the Gulf Coast when water-laden sediments were deposited between surrounding impermeable features, so that the water which would otherwise have been forced out of the sediments was unable to escape. These deposits exist under tremendous pressure created by the weight of the overburden. A geopressure source absorbs heat indirectly, because the geopressured deposits create an insulating barrier that traps and absorbs the thermal energy of the underlying magma. The water from a geopressure source will not be as hot as water from a dry steam or wet steam source, but the quantity available is enormous, and the water pressure itself would be an additional energy source along with the thermal energy. The water may be fresh, or nearly so, and it will contain significant amounts of recoverable methane gas in solution. It may be possible to utilize the water pressure, thermal energy, and the methane gas to generate electricity in small power plants at the recovery site, and the water that has been passed through the turbines and heat exchangers may be a valuable by-product in itself, depending on its quality and regional demands for agriculture and industry. One of the impediments to the development of this resource, given the very sizable commitments of capital entailed, is the uncertain legal status of geothermal resources. This report attempts to locate geothermal resources within the general framework of Texas property law and to determine whether these resources can be developed under the law as it now exists. (MCW)

  10. Follow-up analysis of federal process of care data reported from three acute care hospitals in rural Appalachia

    Directory of Open Access Journals (Sweden)

    Sills ES

    2013-03-01

    Full Text Available E Scott Sills,1,2 Liubomir Chiriac,3 Denis Vaughan,4 Christopher A Jones,5 Shala A Salem11Division of Reproductive Endocrinology, Pacific Reproductive Center, Irvine, CA, USA; 2Graduate School of Life Sciences, University of Westminster, London, UK; 3Department of Mathematics, California Institute of Technology, Pasadena, CA, USA; 4Department of Obstetrics and Gynaecology, School of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland; 5Global Health Economics Unit and Department of Surgery, Center for Clinical and Translational Science, University of Vermont College of Medicine, Burlington, VT, USABackground: This investigation evaluated standardized process of care data collected on selected hospitals serving a remote rural section of westernmost North Carolina.Methods: Centers for Medicare and Medicaid Services data were analyzed retrospectively for multiple clinical parameters at Fannin Regional Hospital, Murphy Medical Center, and Union General Hospital. Data were analyzed by paired t-test for individual comparisons among the three study hospitals to compare the three facilities with each other, as well as with state and national average for each parameter.Results: Centers for Medicare and Medicaid Services “Hospital Compare” data from 2011 showed Fannin Regional Hospital to have significantly higher composite scores on standardized clinical process of care measures relative to the national average, compared with Murphy Medical Center (P = 0.01 and Union General Hospital (P = 0.01. This difference was noted to persist when Fannin Regional Hospital was compared with Union General Hospital using common state reference data (P = 0.02. When compared with national averages, mean process of care scores reported from Murphy Medical Center and Union General Hospital were both lower but not significantly different (−3.44 versus −6.07, respectively, P = 0.54.Conclusion: The range of process of care scores submitted by acute care

  11. 我院251例药品不良反应报告分析%Analysis of 251 cases of adverse drug reactions in our hospital report

    Institute of Scientific and Technical Information of China (English)

    唐锦辉

    2013-01-01

      purpose: to understand adverse drug reactions in our hospital (Adverse Drug Reaction) the incidence and relevant factors, provide reference for rational drug use, avoid the occurrence of adverse drug reactions. Methods: 251 cases on our 2011 colection statistics, analysis of ADR reports. Results 251 cases ADR report total involved 16 class drugs, vein drops note is caused ADR of main to drug way (201 cases); antibiotics occurred rate Supreme (142 cases), second is proprietary Chinese medicines (28 cases), and antipyretic analgesia drug (20 cases), and anti-tumor drug (16 cases), and effect blood and hematopoietic system of drug (12 cases); clinical performance main for skin and damage (99 cases), accounted for 39.44%, digestive system of of damage (75 cases) accounted for 29.88%. Conclusion: ADR is related to many factors relevant to clinical ADR monitoring work should be strengthened to reduce or avoid the occurrence of ADR.

  12. Fiscal Federalism

    Directory of Open Access Journals (Sweden)

    Tatiana Mosteanu

    2007-06-01

    Full Text Available The central budget of a country collects only a fraction of the total fiscal revenues and executes only o fraction of the national public expenditures, the rest of the revenues and expenditures becoming the responsability of subnational governments. The economist Charles Tiebout developed a theoretical model which although makes an imperfect description of the reality, shows that people’s mobility is being influenced by tax rates and the amount of state/local expenditures. Thus, he suggests that the degree of responsibility that can be appointed to the local budgets should subscribe to the tax – benefits ratio, the extend of the positive externalities and the scale economies of public goods. Also, the issue of revenues distribution among communities is being raised, being identified three kinds of grants used by the public authorities: matching grants, block grants and conditional block grants. In the concept of fiscal federalism there can be found a limited analogy between national public finance theory and international public finance theory, with the international taxation as the pivotal element.

  13. Results of hair analyses for drugs of abuse and comparison with self-reports and urine tests.

    Science.gov (United States)

    Musshoff, F; Driever, F; Lachenmeier, K; Lachenmeier, D W; Banger, M; Madea, B

    2006-01-27

    Urine as well as head and pubic hair samples from drug abusers were analysed for opiates, cocaine and its metabolites, amphetamines, methadone and cannabinoids. Urine immunoassay results and the results of hair tests by means of gas chromatography-mass spectrometry were compared to the self-reported data of the patients in an interview protocol. With regard to the study group, opiate abuse was claimed from the majority in self-reports (89%), followed by cannabinoids (55%), cocaine (38%), and methadone (32%). Except for opiates the comparison between self-reported drug use and urinalysis at admission showed a low correlation. In contrast to urinalysis, hair tests revealed consumption in more cases. There was also a good agreement between self-reports of patients taking part in an official methadone maintenance program and urine test results concerning methadone. However, hair test results demonstrated that methadone abuse in general was under-reported by people who did not participate in a substitution program. Comparing self-reports and the results of hair analyses drug use was dramatically under-reported, especially cocaine. Cocaine hair tests appeared to be highly sensitive and specific in identifying past cocaine use even in settings of negative urine tests. In contrast to cocaine, hair lacks sensitivity as a detection agent for cannabinoids and a proof of cannabis use by means of hair analysis should include the sensitive detection of the metabolite THC carboxylic acid in the lower picogram range.

  14. Nationwide survey of the development of drug-resistant pathogens in the pediatric field in 2007 and 2010: drug sensitivity of Streptococcus pneumoniae in Japan (second report).

    Science.gov (United States)

    Tajima, Takeshi; Sato, Yoshitake; Toyonaga, Yoshikiyo; Hanaki, Hideaki; Sunakawa, Keisuke

    2013-06-01

    We previously conducted nationwide surveillance of Streptococcus pneumoniae in 2000-2001 (period 1) and 2004 (period 2) and reported the findings. Subsequent surveillance surveys conducted in 2007 (period 3) and 2010 (period 4) are now reported. Bacterial strains were clinically isolated from children with meningitis, sepsis, and respiratory tract infections at 27 hospitals participating in the Drug-Resistant Pathogen Surveillance Group in Pediatric Infectious Disease. Twenty-one drugs were investigated for 283 isolated strains in period 3, and 24 drugs were investigated for 459 strains in period 4. In period 3, 43.8 % of strains were penicillin-susceptible S. pneumoniae (PSSP), 52.3 % were penicillin-intermediate S. pneumoniae (PISP), and 3.9 % were penicillin-resistant S. pneumoniae (PRSP). In period 4, the percentages were PSSP 23.1 %, PISP 49.9 %, and PRSP 27.0 %. The resistance rates were 56.2 % and 76.9 %, respectively. Drug sensitivity was best with panipenem, at a minimum inhibitory concentration (MIC)90 ≤0.063 μg/ml in period 3, and with tebipenem (MIC90 ≤ 0.063 μg/ml) in period 4. Patients' background factors related to increased bacterial resistance were investigated, and significant differences were found depending on whether a child had siblings (P = 0.0056) or was a daycare center attendee (P = 0.0195) in period 3, and age category (P = 0.0256) in period 4. No factors were common to both periods 3 and 4. Pneumococcus is a major causative organism of pediatric infectious disease, and we plan to continue conducting surveillance and providing information in the future.

  15. Vocational Education and Training for the Hotel and Catering Industry in the Federal Republic of Germany. Report of a Visiting Party. Studies in Vocational Education and Training in the Federal Republic of Germany. Number Eight.

    Science.gov (United States)

    Ripper, Chris, Ed.; Russell, Russ, Ed.

    A party of vocational educators from the United Kingdom (UK) traveled to the Federal Republic of Germany (FRG) to examine West German vocational education and training for the hotel and catering industry. During the study, the investigators examined the training with respect to regulations, the content of training, and the structure of the…

  16. Vocational Education and Training for the Hotel and Catering Industry in the Federal Republic of Germany. Report of a Visiting Party. Studies in Vocational Education and Training in the Federal Republic of Germany. Number Eight.

    Science.gov (United States)

    Ripper, Chris, Ed.; Russell, Russ, Ed.

    A party of vocational educators from the United Kingdom (UK) traveled to the Federal Republic of Germany (FRG) to examine West German vocational education and training for the hotel and catering industry. During the study, the investigators examined the training with respect to regulations, the content of training, and the structure of the…

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

    OpenAIRE

    2011-01-01

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

  18. Quarterly report on the electric power industry in the Federal Republic of Germany. 4. quarter 2000. Power generation in public-owned electric utilities, the industrial independent units and the Federal Railways and overall power consumption in the Federal Republic of Germany; Vierteljahresbericht ueber die Elektrizitaetswirtschaft in der Bundesrepublik Deutschland. 4. Vierteljahr 2000. Stromerzeugung der allgemeinen Elektrizitaetswerke einschliesslich der Deutschen Bahn AG und der industriellen Eigenanlagen sowie Gesamtstromverbrauch in der Bundesrepublik

    Energy Technology Data Exchange (ETDEWEB)

    Karasch, G.M.

    2002-01-01

    The report provides data on public electricity supply, on power generation in plants of the mining industry and the manufacturing industry, and on the Deutsche Bahn AG. The data have been derived from the monthly reports of the Federal Office of Statistics. [German] Der Bericht enthaelt Zahlen fuer die oeffentliche Versorgung, fuer die Eigenanlagen im Bergbau und Verarbeitenden Gewerbe und fuer die Deutsche Bundesbahn. Die Zahlen sind den monatlichen Berichten des Statistischen Bundesamtes entnommen.

  19. Health Technology Assessment report on the presurgical evaluation and surgical treatment of drug-resistant epilepsy.

    Science.gov (United States)

    Marras, Carlo Efisio; Canevini, Maria Paola; Colicchio, Gabriella; Guerrini, Renzo; Rubboli, Guido; Scerrati, Massimo; Spreafico, Roberto; Tassi, Laura; LoRusso, Giorgio; Tinuper, Paolo

    2013-10-01

    Epilepsy is a neurologic disorder with major social impact. Surgery is a valuable option in patients who are not responding to antiepileptic drugs. The literature reports demonstrate that a proportion ranging from 40 to 100% of patients with epilepsy achieve seizure remission after surgery. A presurgical evaluation (clinical and instrumental) must be performed in all patients with drug-resistant epilepsy to assess their suitability for surgical intervention. Health Technology Assessment (HTA) represents a modern approach to the analysis of technologies used for health care. HTA could be considered a bridge between science that produces evidence and the decisions that can be taken on the basis of that evidence at different levels of the health care system. The aim of this study is the HTA of epilepsy surgery including clinical, ethical, social, and economic features. The present study includes an analysis of the diagnostic and surgical workup performed at the Italian centers for the diagnosis and treatment of drug-resistant epilepsy (DRE). The study includes the following issues: (1) social, ethical impact, and costs of the disease; (2) clinical results, efficacy, and safety of surgery; (3) ethics and quality of life after surgery; and (4) economic impact and productivity regained after surgery. The cost of managing a patient with DRE included in the presurgical study was estimated by the bottom-up microcosting technique that starts from a detailed collection of data on consumption of resources and full costing. The phases analyzed were (1) noninvasive diagnostic workup; (2) neurosurgical intervention; and (3) follow-up. The literature reports indicate epilepsy surgery as an effective treatment both on clinical results and on ethical, social, and quality of life aspects. The workup including the noninvasive presurgical study followed by surgery has a total cost of €20,827. Management of short-term follow-up increases the overhead to €22,291 at the first year

  20. State-of-Art Review and Report of New Tool for Drug Discovery.

    Science.gov (United States)

    Martínez-López, Yoan; Caballero, Yaile; Barigye, Stephen J; Marrero-Ponce, Yovani; Millán-Cabrera, Reisel; Madera, Julio; Torrens, Francisco; Castillo-Garit, Juan A

    2017-08-21

    There are a great number of tools that can be used in QSAR/QSPR studies; they are implemented in several programs that are reviewed in this report. The usefulness of new tools can be proved through comparison, with previously published approaches. In order to perform the comparison the most usual is the use of several benchmark datasets such as DRAGON and Sutherland's datasets. Here, an exploratory study of Atomic Weighted Vectors (AWVs), a new tool useful for drug discovery using different datasets, is presented. In order to evaluate the performance of the new tool, several statistics and QSAR/QSPR experiments are performed. Variability analyses are used to quantify the information content of the AWVs obtained from the tool, by means of an information theory-based algorithm. Principal components analysis is used to analyze the orthogonality of these descriptors, for which the new MDs from AWVs provide different information from those codified by DRAGON descriptors (0-2D). The QSAR models are obtained for every Sutherland's dataset, according to the original division into training/test sets, by means of the multiple linear regression with genetic algorithm (MLR-GA). These models are been validated and compare favorably to several previously published approaches, using the same benchmark datasets. The obtained results show that this tool should be a useful strategy for the QSAR/QSPR studies, despite its simplicity. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.