To the Federal Trade Commission in the Matter of a Trade Regulation Rule on Over-the-Counter Drug Advertising.

Science.gov (United States)

Council on Children, Media, and Merchandising, Washington, DC.

This report supports amending the proposed Federal Trade Commission (FTC) Rule on Over-the Counter (OTC) Drug Advertising to insure better protection for children, illiterate populations, the deaf and the blind, from advertising on the air-waves. Several points are addressed: (1) the difficulties of combining the rule making schedules of the Food…

Energy report of the Federal German Government

International Nuclear Information System (INIS)

1986-01-01

In its governmental declaration of May 4th, 1983, the Federal German Government has pointed out how it will safeguard the continuous, economical, and non-polluting supply of energy to the Federal Republic of Germany. By that report the Federal Government strikes a balance of its policy and defines its position with regard to topical questions, especially the peaceful use of nuclear energy. The report comprises four chapters: 1. peaceful use of nuclear energy in the Federal Republic of Germany, 2. Summary statement on energy policy, 3. Current situation in the energy market and long-term perspectives, 4. Points of main emphasis of future energy policy. (orig./UA) [de

Federal Agency for Limnology. Annual report 1991

International Nuclear Information System (INIS)

1992-01-01

The Federal Agency for Limnology (BfG) reports on its research and activities in 1991. Contents: environmental impact statement and environmental impact investigations in the area of the federal waterways, report of activities, research projects, list of scientific staff, publications, committee activities, science lectures, list of abbreviations and organization plan. (BBR) [de

Brazilian Federal Police drug chemical profiling - the PeQui project.

Science.gov (United States)

Zacca, Jorge J; Botelho, Elvio Dias; Vieira, Maurício L; Almeida, Fernanda L A; Ferreira, Luciana S; Maldaner, Adriano O

2014-07-01

Over the past six years the Brazilian Federal Police has undertaken major efforts in order to implement and to develop its own drug chemical profiling program. This paper aims to provide a broad perspective regarding the managerial strategies and some examples of subsequent technical issues involved in the implementation of such a project. Close collaboration with local drug enforcement and investigation teams, establishment of proper worldwide partnerships with well recognized institutions in the field of drug analysis and the attainment of suitable funding and human resources are shown to be key success factors. Some preliminary results concerning the chemical profile of cocaine seizures in Brazil during this process are presented. Copyright © 2014 Forensic Science Society. Published by Elsevier Ireland Ltd. All rights reserved.

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.

21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 862.9 Section 862.9 Food and Drugs FOOD AND DRUG... Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket...

21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 886.9 Section 886.9 Food and Drugs FOOD AND DRUG... Provisions § 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG... Provisions § 872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 888.9 Section 888.9 Food and Drugs FOOD AND DRUG... Provisions § 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 892.9 Section 892.9 Food and Drugs FOOD AND DRUG... Provisions § 892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 882.9 Section 882.9 Food and Drugs FOOD AND DRUG... Provisions § 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act...

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…

7 CFR 3015.83 - Federal cash transactions report.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Federal cash transactions report. 3015.83 Section 3015.83 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF THE CHIEF FINANCIAL OFFICER, DEPARTMENT OF AGRICULTURE UNIFORM FEDERAL ASSISTANCE REGULATIONS Financial Reporting...

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..., in evaluating the effectiveness of the operation and management of individual fleets to determine...

77 FR 34386 - Implementation of Federal Financial Report-Upcoming Mandatory Use of the Federal Financial Report...

Science.gov (United States)

2012-06-11

... of cumulative data only. Background The Office of Management and Budget has consolidated the Financial Status Report (FSR or SF-269/SF-269A) and the Federal Cash Transaction Report (FCTR or SF-272/SF..., 2010, CDC grantees have been required to report cash transaction data via the Payment Management System...

"It Goes on Everywhere": Injection Drug Use in Canadian Federal Prisons.

Science.gov (United States)

van der Meulen, Emily

2017-06-07

International and Canadian research on in-prison injection drug use has documented the frequency of its occurrence as well as some of the resulting consequences such as increased prevalence of HIV and hepatitis C virus. Access to prison-based harm reduction programing is thus important. The aim of this study was to learn from former prisoner experiences and insights on in-prison injection drug use in order to advance and improve access to harm reduction options, in particular prison-based needle and syringe programs (PNSPs). The qualitative and community-based study was conducted in 2014/2015 and included former prisoners from Ontario, Canada (N = 30) who had recent experience of incarceration in a federal prison and knowledge of injection drug use. Data analysis followed the deductive approach, drawing on the expertise of the academic and community-based research team members. Interview and focus group participants disclosed that drugs are readily available in Canadian federal prisons and that equipment used to inject is accessed in a variety of ways, sometimes gained through illicit means and sometimes made by prisoners themselves. Equipment sharing is a frequent occurrence, and disposal of such supplies is rare. Conclusions/Importance: While not yet available in Canada, PNSPs have led to positive outcomes in international contexts, including reductions in needle sharing and transmission of HIV and hepatitis C. Support for PNSPs among numerous Canadian organizations and associations, along with a recent change in government, could suggest a renewed opportunity for PNSP implementation.

41 CFR 102-41.220 - Is drug paraphernalia forfeited under 21 U.S.C. 863 available for transfer to other Federal...

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Is drug paraphernalia... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL... Personal Property Requiring Special Handling Drug Paraphernalia § 102-41.220 Is drug paraphernalia...

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 a...

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

Science.gov (United States)

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Reporting of and employee sanctions for convictions of criminal drug offenses. 17.635 Section 17.635 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY GENERAL GOVERNMENTWIDE...

[The legislation of subjects of the Russian Federation concerning prevention of alcoholism, drug addiction and toxicomania].

Science.gov (United States)

2011-01-01

The article deals with analysis of the laws "On prevention of alcoholism, drug addiction and toxicomania" introduced in some subjects of the Russian Federation (Permskaya, Tomskaya, Murmanskaya oblast, the Republics of Bashkortostan, Mordovia, Buryatia, Mari El, etc.). The laws stipulate the participation of the authorities of public and municipal administration, public health, social protection, home affairs and others in the prevention activities. The integral part of this activity is the approval of corresponding regional programs with adequate financing and coordination. The laws on prevention of alcoholism, drug addiction and toxicomania, adopted in the subjects of the Russian Federation are of advance character and testify the necessity of adoption of relevant Federal law.

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.

76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

Science.gov (United States)

2011-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

Federal Board of Health - annual report 1981

International Nuclear Information System (INIS)

1981-01-01

The emphases of the work of the Federal Board of Health is on drug control, consumer protection with regard to health, environmental hygiene, radiation hygiene, preventation and intervention as well as on special subjects, as for instance the control of animal experiments and the supervision of biological safety of genetic engineering. In addition, central services, systems of information and documentation, publications and courses for professional and advanced training are offered. (DG) [de

Report: Fiscal Year 2010 Federal Information Security Management Act Report

Science.gov (United States)

Report #11-P-0017, November 16, 2010. Attached is the Office of Inspector General’s (OIG’s) Fiscal Year 2010 Federal Information Security Management Act (FISMA) Reporting Template, as prescribed by the Office of Management and Budget (OMB).

Federal Facility Agreement progress report

Energy Technology Data Exchange (ETDEWEB)

1993-10-01

The (SRS) Federal Facility Agreement (FFA) was made effective by the US. Environmental Protection Agency Region IV (EPA) on August 16, 1993. To meet the reporting requirements in Section XXV of the Agreement, the FFA Progress Report was developed. The FFA Progress Report is the first of a series of quarterly progress reports to be prepared by the SRS. As such this report describes the information and action taken to September 30, 1993 on the SRS units identified for investigation and remediation in the Agreement. This includes; rubble pits, runoff basins, retention basin, seepage basin, burning pits, H-Area Tank 16, and spill areas.

Federal Facility Agreement progress report

International Nuclear Information System (INIS)

1993-10-01

The (SRS) Federal Facility Agreement (FFA) was made effective by the US. Environmental Protection Agency Region IV (EPA) on August 16, 1993. To meet the reporting requirements in Section XXV of the Agreement, the FFA Progress Report was developed. The FFA Progress Report is the first of a series of quarterly progress reports to be prepared by the SRS. As such this report describes the information and action taken to September 30, 1993 on the SRS units identified for investigation and remediation in the Agreement. This includes; rubble pits, runoff basins, retention basin, seepage basin, burning pits, H-Area Tank 16, and spill areas

Swiss Federal Energy Research Commission - Annual report 2009

International Nuclear Information System (INIS)

Maus, K.

2010-02-01

This annual report for the Swiss Federal Office of Energy (SFOE) provides an overview of the work carried out by the Swiss Federal Energy Research Commission CORE in 2009. The commission's main work included preparation work for the revised energy research concept for the period 2013 - 2016, a review of all research programmes operated by the Swiss Federal Office of Energy SFOE, the enhancement of cooperation with public and private research and promotion institutions, the coordination and consultation of research institutions and the improvement of international information exchange. The report summarises coordination work with the many CORE programmes and defines strategic main areas of interest for future work

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).

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.

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.

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...

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…

The Federal Research Report - facts as of 1986

International Nuclear Information System (INIS)

1986-01-01

The study abstracted reports on the present state of the Federal Republic of Germany. It contains data on the resources of science, research and development (including research programs), focuses of research and technology programs (including energy and energy technology research, environmental research, climatic research and safety research), the federal research and technology policies, international cooperation (IAEA included), promotion and research organizations (including the DKFZ, GKSS, GSF, KfK, HMI and IPP) as well as comprehensive statistics on federal and economic expenditures and expenditures on personnel. (DG) [de

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.

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.

Federal Agency for Limnology. Annual report 1990

International Nuclear Information System (INIS)

1991-01-01

The Federal Agency for Limnology (BfG) reports on its research and activities in 1990. Contents: the former institute for water management as new Berlin branch office of BfG, report of activities, research projects, list of scientific staff, publications, committee activities, science lectures, list of abbreviations and organization plan. (BBR) [de

41 CFR 102-41.225 - Are there special provisions to reporting and transferring drug paraphernalia forfeited under 21...

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Are there special provisions to reporting and transferring drug paraphernalia forfeited under 21 U.S.C. 863? 102-41.225 Section 102-41.225 Public Contracts and Property Management Federal Property Management Regulations System...

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.

21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 880.9 Section 880.9 Food and Drugs FOOD AND DRUG... Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification...

Factual report 1986 accompanying the Federal Research Report

International Nuclear Information System (INIS)

1986-05-01

The factual report 1986 presents the facts and data explaining the Federal Government's sponsorship of research and technology. The material given shows: this year's government expenditure for research and technology amounts to DM 52.000 millions, corresponding to 2.8 p.c. of the Federal German GNP, which means a top rank in spending on the international level. The re-orientation of research policy started in the year 1982 has induced industry and business to increasingly indevelop their own initiatives and play a more active part, both with regard to financing and performance of R and D activities. Direct project sponsorship and the redoubling of indirect promotion of the economy have had a positive effect primarily on small and medium-size enterprises. The prorated amount of the BMFT budget available for fundamental research will hopefully be increased to 35 p.c. this year, as compared to 26.5 p.c. in 1982, which reflects the growing significance of basic research as a pathfinder to future developments in terms of society, economy, and technology. Other points of main effort of the Federal Government's research policy include promotion of existance care and of modern technologies in order to safeguard the economic competitiveness of the German industry. (orig./HP) [de

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

International Nuclear Information System (INIS)

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

Swiss Federal Energy Research Commission - Annual report 2008

International Nuclear Information System (INIS)

Maus, K.

2009-01-01

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

21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 864.9 Section 864.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY...

41 CFR 102-41.215 - Do we report to GSA all forfeited, voluntarily abandoned, or unclaimed drug paraphernalia not...

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Do we report to GSA all forfeited, voluntarily abandoned, or unclaimed drug paraphernalia not required for official use? 102-41.215 Section 102-41.215 Public Contracts and Property Management Federal Property Management Regulations System...

21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 878.9 Section 878.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510...

21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 884.9 Section 884.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510...

21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 876.9 Section 876.9 Food and Drugs FOOD AND DRUG..., and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510...

Draft federal GHG accounting and reporting : technical support document

Science.gov (United States)

2010-07-01

This is a technical support document (TSD) that accompanies the Federal Greenhouse Gas Accounting and Reporting Guidance (or Guidance). This document provides detailed information on the inventory reporting process and accepted calculation methodolog...

21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 874.9 Section 874.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the...

21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 870.9 Section 870.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the...

21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 868.9 Section 868.9 Food and Drugs FOOD AND DRUG... Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the...

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...

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.

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...

75 FR 76260 - Conforming Changes to Applicant Submission Requirements; Implementing Federal Financial Report...

Science.gov (United States)

2010-12-08

... HUD regulations to reference the new governmentwide Federal Financial Report (FFR) approved by the... task of filing required financial reports. Similarly, CCR registration has been required of applicants...] RIN 2501-AD50 Conforming Changes to Applicant Submission Requirements; Implementing Federal Financial...

Federal Energy Resources Modernization Coordinating Committee. Semiannual Report, October 1, 1991 Through March 31, 1992

Energy Technology Data Exchange (ETDEWEB)

Parker, G B

1992-07-01

This report summarizes the broad range of activities supported by Federal Energy Management Program (FEMP) and other federal agencies 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 FERM Coordinating Committee, and as such include activities undertaken from October 1, 1991, through March 31, 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 the federal energy manager to better understand and characterize their energy resources; (2) federal energy systems testing and monitoring; (3) federal energy systems modernization 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.

Federal Student Loan Amounts and Terms for Loans Issued in 2016-17

Science.gov (United States)

Project on Student Debt, 2016

2016-01-01

U.S. citizens or permanent residents, enrolled at least half time in a qualified program at a participating school, not in default on a prior federal student loan, and not previously convicted of a drug offense while receiving federal financial aid are eligible to apply for a student loan. The chart presented in this report summarizes the interest…

Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

International Nuclear Information System (INIS)

Kishore, R.

1990-01-01

The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

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

International Nuclear Information System (INIS)

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

21 CFR 1301.91 - Employee responsibility to report drug diversion.

Science.gov (United States)

2010-04-01

... REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Employee Screening-Non-Practitioners § 1301.91 Employee responsibility to report drug diversion. Reports of drug diversion by fellow... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Employee responsibility to report drug diversion...

The pharmacist and adverse drug reaction reporting.

Science.gov (United States)

Pearson, K

1982-08-01

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

Analysis of the survey on the fifth research report of the Federal Government

International Nuclear Information System (INIS)

Bechmann, G.; Berg, I. von; Brune, D.; Coenen, R.; Folkers, H.; Wingert, B.

1976-11-01

On the occasion of the presentation of the Fifth Research Report of the Federal Government the Federal Minister for Research and Technology invited 352 organisations and persons to give their opinion on R and D goals and objectives and on whether the research report in its present form is a suitable instrument for a broad dialogue on R and D policy. At the request of the Federal Ministry for Research and Development the 241 replies received were evaluated by the Institut fuer Angewandte Systemanalyse (Institute for Applied Systems Analysis) of the Gesellschaft fuer Kernforschung according to an evaluation pattern with 8 central categories oriented along the main headings of the reseach report: 1) presentation and layout of the Federal Research Report no. V; dialogue on R and D policy 2) goals and objectives of R and D policy 3) relationship between government and industry 4) relationship between government and science 5) R and D planning (project supervision/control, consulting activities, evaluation of R and D results, etc.) 6) coordination and cooperation, international cooperation 7) priority programmes of government sponsored R and D 7) statistical part. A summary version of the main statements and proposals and the reply by the Federal Minister for Research and Technology are contained. (orig.) [de

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.

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

Science.gov (United States)

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

2018-03-01

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

Clinical neuropharmacology of drugs of abuse: a comparison of drug-discrimination and subject-report measures.

Science.gov (United States)

Kelly, Thomas H; Stoops, William W; Perry, Andrea S; Prendergast, Mark A; Rush, Craig R

2003-12-01

Advances in molecular pharmacology and behavioral science have helped elucidate the structure and function of the central nervous system and its relationship to behavior and has sparked the development of pharmacological agents that have increasingly selective and potent effects with fewer adverse side effects. The sensitivity and predictive validity of the two most commonly used methodologies for assessing the neuropharmacological effects of centrally active drugs, subject report of drug effects and drug discrimination, were examined. The sensitivity of the measures was comparable across stimulant, sedative, and opioid drugs. Results with drug-discrimination methodologies were generally consistent with hypothesized neuropharmacological mechanisms across all drug classes, whereas subject reports conformed under more limited testing conditions. Firm conclusions regarding the relative utility of drug-discrimination and subject-report measures for clinical studies of neuropharmacological mechanisms are limited by the small number of studies in which the two methodologies have been tested using identical pharmacological pretreatment manipulations.

Adverse drug reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.

Science.gov (United States)

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

2015-06-01

Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW). Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5. In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW. 'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.' © 2015 John Wiley & Sons Ltd.

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.

Science.gov (United States)

Ryu, JiHyeon; Lee, HeeYoung; Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

2015-01-01

We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p contrast media-induced adverse reactions. The World Health Organization-Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.

AFM annual report 1983 (Petroleum Industry). [Export Federation for Mineral Oil, Federal Republic of Germany]. AFM Jahresbericht 1983

Energy Technology Data Exchange (ETDEWEB)

1983-01-01

The annual report 1983 of the Export Federation for Mineral Oil (AFM) contains informations about the mineral oil economics, the market development for selected main products and the environmental protection. The AFM terms (standard conditions for barge transactions) for the mineral oil industry are given. The AFM Oil Market Report Daily has extended the frame of its reports in 1983.

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.

Development of Combination HIV Prevention Programs for People Who Inject Drugs through Government and Civil Society Collaboration in the Russian Federation

Directory of Open Access Journals (Sweden)

M. V. Volik

2012-01-01

Full Text Available Population Services International (PSI has worked collaboratively with several government institutions of the Russian Federation to develop and implement a model program to access health services for individuals who are opioid dependent, including those with HIV infection. Through the development of partnership agreements between government organizations (GOs and non-government organizations (NGOs, a model of the continuum of care has been developed that identifies a Recommended Package of HIV Prevention Services for Injecting Drug Users (RPS-IDU. The implementation of the RPS-IDU in the Russian Federation offers a model for other countries with HIV epidemics associated with injection drug use. This paper will describe the model program and its implementation in one of the pilot program regions.

Federally Chartered Corporation: Review of the Financial Statement Audit Reports for the National Federation of Music Clubs for Fiscal Years 1999 and 1998

National Research Council Canada - National Science Library

Steinhoff, Jeffrey

2000-01-01

As requested, we reviewed the audit reports covering the financial statements of the National Federation of Music Clubs, a federally chartered corporation, for the fiscal years ended June 30,1999 and 1998...

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.

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

OpenAIRE

Ahmad, Syed Rizwanuddin

2003-01-01

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

The analysis of drug consumption, drug trafficking and the fight against drug trafficking at the present day

Directory of Open Access Journals (Sweden)

Borisenko M.V.

2017-04-01

Full Text Available the article discusses the current drug situation in Russia, Siberian Federal District and Novosibirsk Region relating to drug consumption and drug trafficking and the main reasons of deaths of drug-dependent people.

Report: Fiscal Year 2011 Federal Information Security Management Act Report Status of EPA’s Computer Security Program

Science.gov (United States)

Report #12-P-0062, November 9, 2011. Attached is the Office of Inspector General’s (OIG’s) Fiscal Year 2011 Federal Information Security Management Act (FISMA) Reporting Template, as prescribed by the Office of Management and Budget (OMB).

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.

The effect of federal health policy on occupational medicine.

Science.gov (United States)

McCunney, R J; Cikins, W

1990-01-01

All three branches of the federal government affect occupational medicine. Notable examples include: 1) the Department of Transportation ruling (1988) requiring drug testing in diverse areas of the transportation industry (executive branch); 2) the Workplace Drug Act (1988) calling for organizations to have a policy towards drug and alcohol abuse (legislative branch); and 3) the Supreme Court ruling on the constitutionality of drug testing in the transportation industry (1989) and that infectious diseases are a handicap in accordance with the 1973 Federal Rehabilitation Act (1987). The executive branch plays a major role in occupational medicine primarily through the Occupational Safety and Health Administration (OSHA), which issues standards based on a rule making process; the executive branch can also affect occupational medicine indirectly, as evidenced by President Reagan's Executive Order 12291 calling for Office of Management and Budget oversight of regulatory initiatives. The legislative branch enacts laws, conducts hearings, and requests reports on the operations of federal agencies. The judicial branch addresses occupational health issues when people affected by an executive ruling want to challenge the ruling; or in the case of the Supreme Court, when deliberating an issue over which two circuit courts of appeal have come to divergent opinions. The Occupational Medicine profession can participate in the political process through awareness of proposed legislation and by responding accordingly with letters, resolutions, or testimony. Similar options exist within the executive branch by participating in the rule-making process. A representative of the Governmental Affairs Committee, through periodic visits with key Washington representatives, can keep members of the American College of Occupational Medicine informed about federal legislative and regulatory activities. In appropriate cases, the organization can then take a formal position on governmental

Piloting social engagement on a federal agency-administered Facebook page.

Science.gov (United States)

Chiu, Kimberly; Wagner, Lindsay; Choe, Lena; Chew, Catherine; Kremzner, Mary

2016-01-01

To evaluate the impact of a Federal drug information center initiating engagement with stakeholders on a Facebook Page administered by a Federal Agency. The U.S. Food and Drug Administration (FDA) Facebook page from July 21, 2014, to October 18, 2014. FDA's Division of Drug Information (DDI) in the Center for Drug Evaluation and Research (CDER) Office of Communications serves as a federal drug information center providing timely, accurate, and useful information on CDER initiatives and CDER-regulated products. We report a 90-day (July 21 to October 18, 2014) pilot during which DDI pharmacists monitored and moderated comments received on FDA's Facebook page to identify those warranting a reply. Once identified, DDI pharmacists replied within 2 business days. Impact was measured by comparing the average number of Likes, Shares, and Reach for Facebook posts before and after the pilot. Additional metrics collected include the number of DDI replies provided to stakeholders' comments and the number of DDI replies provided on time (within 2 business days). During the pilot, DDI contributed 14 posts. On average, each post reached 23,582 more individuals (an increase of 187% compared with pre-pilot posts). On average, each post also received 463 more Likes (450% increase) and 130 more Shares (271% increase). DDI pharmacists replied to 3% (121/3994) and hid 0.58% (23/3994) of Facebook comments received during the 90-day period. All actions were taken within 2 business days. Initiating social engagement had a positive impact on FDA's Facebook page. Published by Elsevier Inc.

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

African Journals Online (AJOL)

Arun Kumar Agnihotri

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

75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

Science.gov (United States)

2010-04-29

...] Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic... and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...

Federal Highway Administration research and technology evaluation final report : Eco-Logical

Science.gov (United States)

2018-03-01

This report documents an evaluation of Federal Highway Administrations (FHWA) Research and Technology Programs activities on the implementation of the Eco-Logical approach by State transportation departments and metropolitan planning organizati...

Spontaneous reports on drug-induced pancreatitis in Denmark from 1968 to 1999

DEFF Research Database (Denmark)

Andersen, V; Sonne, J; Andersen, M

2001-01-01

valproate (two cases), clomipramine (one case) and azathioprine (one case). Definite relationship was stated for mesalazine (three cases), azathioprine (two cases) and simvastatin (one case) on the basis of re-challenge. A possible or probable causality was considered for a further 30 drugs including 5...... (measles" mumps/rubella) vaccination. CONCLUSION: Drug-induced pancreatitis is rarely reported. The incidence may be increasing and the course is often serious. This is the first report on definite simvastatin-induced pancreatitis. Further studies on the pancreotoxic potential of drugs are warranted.......OBJECTIVES: To present an update on drug-induced pancreatitis reported to the Danish Committee on Adverse Drug Reactions. DESIGN: Retrospective study of spontaneous case reports to the Danish reporting system on adverse drug reactions. METHODS: All cases of suspected drug-induced pancreatitis...

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

Science.gov (United States)

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

2013-12-01

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

77 FR 75259 - Joint Report: Differences in Accounting and Capital Standards Among the Federal Banking Agencies...

Science.gov (United States)

2012-12-19

... consistent with U.S. generally accepted accounting principles. There were no significant differences in...] FEDERAL RESERVE SYSTEM FEDERAL DEPOSIT INSURANCE CORPORATION Joint Report: Differences in Accounting and... submit an annual report to the Committee on Financial Services of the U.S. House of Representatives and...

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).

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).

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).

Results from the 2013 drug and alcohol testing survey.

Science.gov (United States)

2015-12-01

This report summarizes the results of the 2013 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of drivers with commercial drivers licenses (CDLs) that test positive fo...

Results from the 2008 Drug and Alcohol Testing Survey

Science.gov (United States)

2010-01-01

This report summarizes the results of the 2008 Federal Motor Carrier Safety Administration Drug and Alcohol Testing Survey. This annual survey measures the percentage of drivers with commercial drivers licenses who test positive for controlled sub...

75 FR 60258 - Federal Acquisition Regulation; Termination for Default Reporting

Science.gov (United States)

2010-09-29

..., Sequence 1] RIN 9000-AL45 Federal Acquisition Regulation; Termination for Default Reporting AGENCIES... terminations for cause or default and defective cost or pricing data, into the Past Performance Information... defective cost or pricing data and terminations for cause or default into the FAPIIS module of the PPIRS...

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

Science.gov (United States)

2011-12-30

...] Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; request for comments. SUMMARY: As part of the Transparency...

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.

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.

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

Science.gov (United States)

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

2017-09-01

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

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.

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... Part 230—Federal-Aid Highway Contractors Annual EEO Report (Form PR-1391) EC14OC91.000 ...

Federal Automated Information System of Nuclear Material Control and Accounting: Uniform System of Reporting Documents

International Nuclear Information System (INIS)

Pitel, M V; Kasumova, L; Babcock, R A; Heinberg, C

2003-01-01

One of the fundamental regulations of the Russian State System for Nuclear Material Accounting and Control (SSAC), ''Basic Nuclear Material Control and Accounting Rules,'' directed that a uniform report system be developed to support the operation of the SSAC. According to the ''Regulation on State Nuclear Material Control and Accounting,'' adopted by the Russian Federation Government, Minatom of Russia is response for the development and adoption of report forms, as well as the reporting procedure and schedule. The report forms are being developed in tandem with the creation of an automated national nuclear material control and accounting system, the Federal Information System (FIS). The forms are in different stages of development and implementation. The first report forms (the Summarized Inventory Listing (SIL), Summarized Inventory Change Report (SICR) and federal and agency registers of nuclear material) have already been created and implemented. The second set of reports (nuclear material movement reports and the special anomaly report) is currently in development. A third set of reports (reports on import/export operations, and foreign nuclear material temporarily located in the Russian Federation) is still in the conceptual stage. To facilitate the development of a unified document system, the FIS must establish a uniform philosophy for the reporting system and determine the requirements for each reporting level, adhering to the following principles: completeness--the unified report system provides the entire range of information that the FIS requires to perform SSAC tasks; requisite level of detail; hierarchical structure--each report is based on the information provided in a lower-level report and is the source of information for reports at the next highest level; consistency checking--reports can be checked against other reports. A similar philosophy should eliminate redundancy in the different reports, support a uniform approach to the contents of

Gender Differences in Major Federal External Grant Programs. Technical Report

Science.gov (United States)

Hosek, Susan D.; Cox, Amy G.; Ghosh-Dastidar, Bonnie; Kofner, Aaron; Ramphal, Nishal; Scott, Jon; Berry, Sandra H.

2005-01-01

The Wyden amendment to the National Science Foundation (NSF) Authorization Act of 2002 sought to determine whether federally funded educational programs other than sports comply with Title IX, which prohibits gender discrimination. At the request of NSF, this report analyzes administrative data from fiscal years 2001 through 2003 describing the…

78 FR 48343 - Reporting and Paying Royalties on Federal Leases

Science.gov (United States)

2013-08-08

... Federal Government may benefit because (1) the reduced burden of reporting may extend the life on marginal... its leases in the unit or communitization agreement. These imbalances led to numerous questions about... a member of such staff is required to perform work on a specific case. Section 304(b) of FLPMA...

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

Science.gov (United States)

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

2007-02-01

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

The Federal Health Office in 1990. An information brochure

International Nuclear Information System (INIS)

1991-01-01

The Federal Health Office is the central research institution in the Federal Republic of Germany in the public health sector. Its task is to recognize and assess health hazards, contain such hazards within the framework of its legal competencies, and to provide scientific advice also on such health hazards as arise from the environment. The FHO's research activities are in the fields of health protection and consumer health protection, environmental hygiene, drug safety, and preventive medicine. - Executive tasks have been conferred on the Federal Health Office under the law on drugs and narcotic drugs, epidemics, particides and the use of chemicals, and genetic engineering. (orig./UT) [de

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

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

Science.gov (United States)

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

2013-01-01

Introduction: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. Materials and Methods: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. Results: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Discussion and Conclusion: Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health. PMID:24347986

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.

Consumer reporting of adverse drug reactions

DEFF Research Database (Denmark)

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

2009-01-01

BACKGROUND: Reporting adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. Since 2003 in Denmark, consumers have been able to report ADRs directly to the authorities. The objective of this study was to compare ADRs reported by consumers with ADRs...... medicines on level 1 of the anatomical therapeutic chemical (ATC) classification system. ADR reports from consumers were compared with reports from other sources (physicians, pharmacists, lawyers, pharmaceutical companies and other healthcare professionals). Chi-square and odds ratios (ORs) were calculated...... to investigate the dependence between type of reporter and reported ADRs (classified by ATC or SOC). FINDINGS: We analysed 6319 ADR reports corresponding to 15 531 ADRs. Consumers reported 11% of the ADRs. Consumers' share of 'serious' ADRs was comparable to that of physicians (approximately 45%) but lower than...

Cutaneous drug reaction case reports: from the world literature.

Science.gov (United States)

2003-01-01

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

Fixed drug eruption resulting from fluconazole use: a case report

Directory of Open Access Journals (Sweden)

Tavallaee Mahkam

2009-07-01

Full Text Available Abstract Introduction Fluconazole is a widely used antifungal agent with a possible side effect of fixed drug eruption. However, this adverse drug effect is absent from the reported list of possible side effects of fluconazole. We are presenting a rare case in our report. Case presentation A 25-year-old Iranian woman developed fixed drug eruptions on different sites of her body after taking five doses of fluconazole to treat vaginal candidiasis. A positive patch test, positive oral challenge test and skin biopsy were all found to be consistent with fixed drug eruption. Conclusion Fluconazole is a widely prescribed drug, used mainly to treat candidiasis. Fixed drug eruption as a possible side effect of Fluconazole is not well known and thus, the lesions may be misdiagnosed and mistreated. Based on our findings, which are consistent with a number of other practitioners, we recommend adding fixed drug eruption to the list of possible side effects of fluconazole.

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

48 CFR 223.570 - Drug-free work force.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Drug-free work force. 223.570 Section 223.570 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM... TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 223.570 Drug-free work force. ...

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…

Results from the 2012 drug and alcohol testing survey : [analysis brief].

Science.gov (United States)

2014-12-01

This report summarizes the results of the 2012 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of drivers with commercial drivers licenses (CDLs) who test positive for...

Results from the 2015 Drug and Alcohol Testing Survey : analysis brief.

Science.gov (United States)

2017-06-01

This report summarizes the results of the 2015 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of commercial drivers license (CDL) drivers who test positive for contro...

Results from the 2014 drug and alcohol testing survey : analysis brief.

Science.gov (United States)

2016-10-01

This report summarizes the results of the 2014 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of commercial drivers license (CDL) drivers who test positive for contro...

Results from the 2016 Drug and Alcohol Testing Survey : Analysis Brief

Science.gov (United States)

2018-01-01

This report summarizes the results of the 2016 Federal Motor Carrier Safety Administration (FMCSA) Drug and Alcohol Testing Survey. This annual survey measures the percentage of commercial drivers license (CDL) drivers who test positive for contro...

15 CFR 310.9 - Report of the Secretary on Federal participation.

Science.gov (United States)

2010-01-01

... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Report of the Secretary on Federal participation. 310.9 Section 310.9 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) INTERNATIONAL TRADE ADMINISTRATION, DEPARTMENT OF COMMERCE MISCELLANEOUS REGULATIONS OFFICIAL U.S...

15 CFR 310.5 - Report of the Secretary on Federal recognition.

Science.gov (United States)

2010-01-01

... 15 Commerce and Foreign Trade 2 2010-01-01 2010-01-01 false Report of the Secretary on Federal recognition. 310.5 Section 310.5 Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) INTERNATIONAL TRADE ADMINISTRATION, DEPARTMENT OF COMMERCE MISCELLANEOUS REGULATIONS OFFICIAL U.S...

Gender Differences in Major Federal External Grant Programs. Technical Report Summary

Science.gov (United States)

Hosek, Susan D.; Cox, Amy G.; Ghosh-Dastidar, Bonnie; Kofner, Aaron; Rampal, Nishal; Scott, Jon; Berry, Sandra H.

2005-01-01

The Wyden amendment to the National Science Foundation (NSF) Authorization Act of 2002 sought to determine whether federally funded educational programs other than sports comply with Title IX, which prohibits gender discrimination. At the request of NSF, this report analyzes administrative data from fiscal years 2001 through 2003 describing the…

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.

76 FR 73564 - Federal Acquisition Regulation; Updates to Contract Reporting and Central Contractor Registration

Science.gov (United States)

2011-11-29

... Federal Acquisition Regulation; Updates to Contract Reporting and Central Contractor Registration AGENCIES... Procurement Data System (FPDS). Additionally, changes are proposed for the clauses requiring contractor registration in the Central Contractor Registration (CCR) database and DUNS number reporting. DATES: Interested...

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

Science.gov (United States)

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

2014-11-01

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

Federal Republic of Germany: Commodities report 2003

International Nuclear Information System (INIS)

2004-01-01

The Federal Institute for Geosciences and Natural Resources (BGR) has compiled the facts and figures in a commodities report for 25 years. This report summarises Germany's mineral and energy commodities trading, consumption and supply situation. After fears of shortages in the early 70s, this 25-year-period was mainly characterised by the feeling that mineral resources would always be available on the international markets in adequate quantities. And although there has been no change in the situation even up to the present day, the world markets for mineral resources are currently undergoing a structural change: the old rule of thumb that 20% of humanity in Europe, the USA and Japan consumed more than 80% of resource production is no longer valid. With India, the People's Republic of China, not to mention other heavily populated emerging countries, over half of the world's population is now involved in the demand for minerals. This means that the growth in world economic demand for natural resources is at the beginning of a new growth curve. (orig.)

Information about adverse drug reactions reported in children

DEFF Research Database (Denmark)

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

2010-01-01

AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We...... included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category...... of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS: We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring...

21 CFR 1403.41 - Financial reporting.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Financial reporting. 1403.41 Section 1403.41 Food... Enforcement § 1403.41 Financial reporting. (a) General. (1) Except as provided in paragraphs (a) (2) and (5...) Submitting financial reports to Federal agencies, or (ii) Requesting advances or reimbursements when letters...

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 Federal...

75 FR 65439 - Defense Federal Acquisition Regulation Supplement; Electronic Subcontracting Reporting System

Science.gov (United States)

2010-10-25

... Accounting Service or Missile Defense Agency. (2) For DoD, the authority to acknowledge receipt or reject... DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 219 and 252 [DFARS Case 2009-D002] Defense Federal Acquisition Regulation Supplement; Electronic Subcontracting Reporting...

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.

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

Science.gov (United States)

Castleden, C M; Pickles, H

1988-10-01

1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age group. 4. The reported ADR was more likely to be serious or fatal in the elderly. 5. The commonest ADRs reported for the elderly affected the gastrointestinal (GIT) and haemopoietic systems, where more reports were received than would be expected from prescription figures. 6. The drug suspected of causing a GIT reaction was a NSAI in 75% of the reports. 7. Ninety-one per cent of fatal reports of GIT bleeds and perforations associated with NSAI drugs were in patients over 60 years of age.

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

Science.gov (United States)

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

2018-02-27

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

Lawsuits allege price fixing by generic drug makers

Directory of Open Access Journals (Sweden)

Robbins RA

2016-12-01

Full Text Available No abstract available. Article truncated at 150 words. Two years after high generic drug prices became a public controversy, Reuters is reporting that 20 states filed a lawsuit Thursday against Mylan, Teva Pharmaceuticals and four other generic drug makers (1. The suit alleges the companies conspired to fix prices or allocated markets to prop up prices. The civil lawsuit, led by antitrust investigators in Connecticut, comes one day after the U.S. Department of Justice filed criminal charges against two former executives of the generic drug maker, Heritage. The states attorneys general asked the court to order the companies to disgorge ill-gotten gains, which were not defined, pay attorneys' fees and stop collusion. Of the states in the Southwest only Nevada is participating in the lawsuit. The cases are part of a broader generic drug pricing probe that remains under way at the state and federal level, as well as in the U.S. Congress. In 2014, media reports of …

Report raises questions about drug companies advertising budgets.

Science.gov (United States)

1999-08-06

A report by AIDS Action cites that data, indicates the pharmaceutical industry is spending more resources on marketing and advertising than on research and development (R&D). The pharmaceutical industry blames the high cost of AIDS drugs on R&D information compiled from annual reports and industry publications show excessive marketing as the source. A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA) disputes the information in the AIDS Action report as misleading. According to PhRMA, research spending has been steadily increasing, and at a greater rate than any other industry. In addition, PhRMA noted that pharmaceutical companies have already dedicated money to fund initiatives in developing countries. Solutions proposed by AIDS Action include lowering drug prices or transferring funds from marketing to research, and reestablishing the "reasonable pricing clause" between National Institutes of Health and those companies seeking tax breaks for R&D.

[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.

Factors associated with false-positive self-reported adherence to antihypertensive drugs.

Science.gov (United States)

Tedla, Y G; Bautista, L E

2017-05-01

Self-reported medication adherence is known to overestimate true adherence. However, little is known about patient factors that may contribute to the upward bias in self-reported medication adherence. The objective of this study is to examine whether demographic, behavioral, medication and mood factors are associated with being a false-positive self-reported adherer (FPA) to antihypertensive drug treatment. We studied 175 patients (mean age: 50 years; 57% men) from primary-care clinics starting antihypertensive drug treatment. Self-reported adherence (SRA) was measured with the Medication Adherence Report Scale (MARS) and by the number of drug doses missed in the previous week/month, and compared with pill count adherence ratio (PCAR) as gold standard. Data on adherence, demographic, behavioral, medication and mood factors were collected at baseline and every 3 months up to 1 year. FPA was defined as being a non-adherer by PCAR and an adherer by self-report. Mixed effect logistic regression was used for the analysis. Twenty percent of participants were FPA. Anxiety increased (odds ratio (OR): 3.00; P=0.01), whereas smoking (OR: 0.40; P=0.03) and drug side effects (OR: 0.46, P=0.03) decreased the probability for FPA by MARS. Education below high-school completion increased the probability of being an FPA as measured by missing doses in the last month (OR: 1.66; P=0.04) and last week (OR: 1.88; P=0.02). The validity of SRA varies significantly according to drug side effects, behavioral factors and patient's mood. Careful consideration should be given to the use of self-reported measures of adherence among patients likely to be false-positive adherers.

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.

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

Drugs + HIV, Learn the Link

Medline Plus

Full Text Available ... Drugged Driving Drug Testing Drugs and the Brain Genetics Global Health Health Consequences of Drug Misuse Hepatitis ( ... service of the U.S. Department of Health and Human Services (HHS), offers access to the latest, federally approved ... & Alcohol Chat Day HBO Addiction Project ...

Federal Technology Alert: Ground-Source Heat Pumps Applied to Federal Facilities-Second Edition; FINAL

International Nuclear Information System (INIS)

Hadley, Donald L

2001-01-01

This Federal Technology Alert, which was sponsored by the U.S. Department of Energy's Office of Federal Energy Management Programs, provides the detailed information and procedures that a Federal energy manager needs to evaluate most ground-source heat pump applications. This report updates an earlier report on ground-source heat pumps that was published in September 1995. In the current report, general benefits of this technology to the Federal sector are described, as are ground-source heat pump operation, system types, design variations, energy savings, and other benefits. In addition, information on current manufacturers, technology users, and references for further reading are provided

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......-sedating antihistamines. In general non-sedating antihistamines are associated with cardiac arrhythmia to a higher extent in comparison with other drugs (ADR reporting odds ratio 2.05 [95% CI: 1.45, 2.89]). The association between arrhythmias and non-sedating antihistamine drugs calculated before 1998...

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

Science.gov (United States)

2010-06-25

... GENERAL SERVICES ADMINISTRATION [Docket 2010-009; Sequence 3] Federal Travel Regulation (FTR); Directions for Reporting Other Than Coach-Class Accommodations for Employees on Official Travel AGENCY... Accountability Office (GAO) report, Premium Class Travel: Internal Control Weaknesses Governmentwide Led to...

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…

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.

Survey of reportable incidents in nuclear power plants of the Federal Republic of Germany in the year 1991

International Nuclear Information System (INIS)

1992-01-01

In 1991, there were 249 reportable nuclear power plant incidents in Germany (old and new federal Laender). The report comprehensively lists all these incidents. There was no release of radioactivity exceeding the maximum permissible limits, and there were no effects on man or the environment. There were no incidents of reporting category S (Urgent notification), and ten belonging to category E (immediate notification). The six incidents reported in the first half of 1991 from nuclear power plants in the new federal Laender all belonged to category AE 3, which is the lowest. (orig./DG) [de

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.

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

OpenAIRE

Castleden, C M; Pickles, H

1988-01-01

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

Anxiety sensitivity and self-reported reasons for drug use.

Science.gov (United States)

Stewart, S H; Karp, J; Pihl, R O; Peterson, R A

1997-01-01

Two studies examined the relationships between anxiety sensitivity (AS), drug use, and reasons for drug use. In Study 1, 229 university students (57% F) completed the Anxiety Sensitivity Index (ASI) and a drug use survey, assessing use of a variety of drugs within the last month, and coping reasons for drug use. Consistent with a modified tension-reduction hypothesis, ASI scores were positively correlated with the number of both anxiety- and depression-related reasons for drug use endorsed. In Study 2, 219 university students (74% F) completed the ASI and a drug use survey, assessing use of several drugs (e.g., alcohol, cigarettes, caffeine, and marijuana/hashish) within the last year, and primary reasons (coping, affiliative, or enhancement) for the use of each drug. Marijuana/hashish users reported lower ASI scores than non-users supporting a negative relation between AS and the use of cannabis. ASI scores were positively correlated with the use of alcohol primarily to cope, and negatively correlated with the use of alcohol primarily to affiliate, among both gender groups, and ASI scores were positively correlated with the use of nicotine primarily to cope among the females. Implications of these findings for understanding risk for abuse of stress-response-dampening drugs by high AS individuals are discussed.

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

Science.gov (United States)

2011-08-10

...-0112] Federal Motor Vehicle Safety Standards; Electronic Stability Control; Technical Report on the Effectiveness of Electronic Stability Control Systems for Cars and LTVs AGENCY: National Highway Traffic Safety..., Electronic Stability Control Systems. The report's title is: Crash Prevention Effectiveness in Light-Vehicle...

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

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 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......-sedating antihistamines. In general non-sedating antihistamines are associated with cardiac arrhythmia to a higher extent in comparison with other drugs (ADR reporting odds ratio 2.05 [95% CI: 1.45, 2.89]). The association between arrhythmias and non-sedating antihistamine drugs calculated before 1998...

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

Science.gov (United States)

Allen, Heather A

2015-05-13

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.

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

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...... 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...... contain more summary data on harms. Detailed information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All reports...

Drug hypersensitivity in children: report from the pediatric task force of the EAACI Drug Allergy Interest Group

NARCIS (Netherlands)

Gomes, E. R.; Brockow, K.; Kuyucu, S.; Saretta, F.; Mori, F.; Blanca-Lopez, N.; Ott, H.; Atanaskovic-Markovic, M.; Kidon, M.; Caubet, J.-C.; Terreehorst, I.

2016-01-01

When questioned, about 10% of the parents report suspected hypersensitivity to at least one drug in their children. However, only a few of these reactions can be confirmed as allergic after a diagnostic workup. There is still a lack of knowledge on drug hypersensitivity (DH) epidemiology, clinical

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

NRC drug-free workplace plan. Revision 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-11-01

On September 15, 1986, President Reagan signed Executive Order 12564, establishing the goal of a Drug-Free Federal Workplace. The Order made it a condition of employment that all Federal employees refrain from using illegal drugs on or off duty. On July 11, 1987, Congress passed legislation affecting implementation of the Executive Order under Section 503 of the Supplemental Appropriations Act of 1987, Public Law 100-71 (the Act). The Nuclear Regulatory Commission first issued the NRC Drug Testing Plan to set forth objectives, policies, procedures, and implementation guidelines to achieve a drug-free Federal workplace, consistent with the Executive Order and Section 503 of the Act. Revision 1, titled, ``NRC Drug-Free Workplace Plan,`` supersedes the previous version and its supplements and incorporates changes to reflect current guidance from the Department of Justice, the Department of Health and Human Services, as well as other guidance.

NRC drug-free workplace plan. Revision 1

International Nuclear Information System (INIS)

1997-11-01

On September 15, 1986, President Reagan signed Executive Order 12564, establishing the goal of a Drug-Free Federal Workplace. The Order made it a condition of employment that all Federal employees refrain from using illegal drugs on or off duty. On July 11, 1987, Congress passed legislation affecting implementation of the Executive Order under Section 503 of the Supplemental Appropriations Act of 1987, Public Law 100-71 (the Act). The Nuclear Regulatory Commission first issued the NRC Drug Testing Plan to set forth objectives, policies, procedures, and implementation guidelines to achieve a drug-free Federal workplace, consistent with the Executive Order and Section 503 of the Act. Revision 1, titled, ''NRC Drug-Free Workplace Plan,'' supersedes the previous version and its supplements and incorporates changes to reflect current guidance from the Department of Justice, the Department of Health and Human Services, as well as other guidance

Antiretroviral drug expenditure, pricing and judicial demand: an analysis of federal procurement data in Brazil from 2004–2011

Science.gov (United States)

2014-01-01

Background Previous studies have described expenditures for antiretroviral (ARV) medicines in Brazil through 2005. While prior studies examined overall expenditures, they have not have analyzed drug procurement data in order to describe the role of court litigation on access and pricing. Methods ARV drug procurement from private sector sources for the years 2004–2011 was obtained through the general procurement database of the Brazilian Federal Government (SIASG). Procurement was measured in Defined Daily Doses (DDD) per 1000 persons-under-treatment per day. Expenditures and price per DDD were calculated and expressed in U.S. Dollars. Justifications for ARV purchases were examined in order to determine the relationship between health litigation and incorporation into Brazil’s national treatment guidelines. Results Drug procurement of ARVs from private sources underwent marked expansion in 2005, peaked in 2009, and stabilized to 2008 levels by 2011. Expenditures followed procurement curves. Medications which were procured for the first time after 2007 cost more than medicines which were introduced before 2007. Judicial actions initially resulted in purchases of newer medications for a select number of patients in Brazil but ultimately expanded availability to a larger population through incorporation into the national treatment guidelines. Conclusions Drug procurement and expenditures for ARVs in Brazil varied between 2004–2011. The procurement of some drugs from the private sector ceased after public manufacturers started producing them locally. Judicial demand has resulted in the incorporation of newer drugs into the national treatment guidelines. In order for the AIDS treatment program to remain sustainable, efforts should be pursued to reduce prices through generic drugs, price negotiation and other public health flexibilities such as compulsory licensing. PMID:24735589

77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period

Science.gov (United States)

2012-09-26

.... FDA-2012-N-0447] Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment... its regulations relating to records and reports for approved antimicrobial new animal drugs. The... obtaining additional data and information about the extent of antimicrobial drug use in food-producing...

Prescription drugs for human use generally recognized as safe and effective and not misbranded: drugs used in research: radioactive drugs for certain research uses; amended reporting requirements

International Nuclear Information System (INIS)

Anon.

1978-01-01

This amendment revises the reporting requirements for research studies in which radioactive drugs are used. It deletes the requirement for detailed measurements and calculations for each subject in the study; instead, it permits submission of data on a representative subject. The effect will be to decrease the burden in reporting required of the Radioactive Drug Research Committee, but still provide the agency with data to evaluate the risk attributable to radioactive drugs

The safety analysis report for nuclear power plants in the Federal Republic of Germany

International Nuclear Information System (INIS)

Kohler, H.A.G.

1976-01-01

On the basis of the standard format for drawing up safety analysis reports for stationary fission reactors - this format was published in 1959 by the competent Federal Ministry for Atomic Energy - a report is made on the format and scope of German safety analysis reports. The reasons for drawing up a standard safety analysis report for nuclear power plants with pressurized water reactor or boiling water reactor and a KWU draft are discussed. (orig./RW) [de

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.

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

Science.gov (United States)

2010-11-24

... also asked what allowance is provided for contractors with accounting software that does not... RIN 0750-AG46 Defense Federal Acquisition Regulation Supplement; Cost and Software Data Reporting... Regulation Supplement (DFARS) to address DoD Cost and Software Data Reporting system requirements for Major...

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...

Prevalence of Sexual Violence and its Association with Depression among Male and Female Patients with Risky Drug Use in Urban Federally Qualified Health Centers.

Science.gov (United States)

Bone, Curtis W; Goodfellow, Amelia M; Vahidi, Mani; Gelberg, Lillian

2018-02-01

Sexual violence (SV) is common; however, the prevalence of SV and its long term sequela vary geographically and among subpopulations within the USA. As such, the aims of this study are the following: (1) to determine the prevalence of SV, (2) to identify correlates of SV, and (3) to determine if SV is associated with depression among male and female risky drug users in urban Federally Qualified Health Centers (FQHCs) in Los Angeles. This study includes adult patients of five urban FQHCs who self-reported risky drug use. We identified survivors of SV and those experiencing depression through survey questions that queried, before or after age 18, "Were you ever sexually assaulted, molested or raped?" and with the RAND Mental Health Index (MHI-5). We utilized Pearson's chi-square tests to assess predictors of SV and logistic regression to assess for an association between SV and depression. Data collection took place from February 2011 to November 2012. Of the 334 study patients, 49% of females and 25% of males reported surviving SV. Exposure to SV, (both before 18 years of age and after 18 years of age) was the strongest predictor of depression among men and women in this study (OR 4.7, p < 0.05). These data demonstrate that sexual violence is prevalent in this urban FQHC population and is strongly associated with depression. Providers should consider screening both men and women with risky drug use for SV while health systems should continue to align mental health and primary care services to appropriately care for these extremely vulnerable patients. Trial Registration Clinical Trials. gov ID NCT01942876, Protocol ID DESPR DA022445, http://www.clinicaltrials.gov.

77 FR 71009 - Framework for Pharmacy Compounding: State and Federal Roles

Science.gov (United States)

2012-11-28

...] Framework for Pharmacy Compounding: State and Federal Roles AGENCY: Food and Drug Administration, HHS... Federal Roles.'' At this public meeting, FDA and State representatives will share their perspectives. Date... would require compliance with Federal standards. In addition, there are open questions about whether...

Drug policy in United States of America

OpenAIRE

Stahl, Edmundo G.; Médico internista, President and Chief Executive Officer, LatAmScience. Florida, USA.

2009-01-01

The USA federal prescription drug policies are inconsistent. The federal government regulates the development, production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US popula...

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; Wieseler, Beate

2015-02-26

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"). 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. Retrospective analysis. 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 reports, journal publications, and registry reports

Federal Student Loan Programs

Science.gov (United States)

Federal Student Aid, US Department of Education, 2014

2014-01-01

For those needing a loan to attend college, think federal aid first. Federal student loans usually offer borrowers lower interest rates and have more flexible repayment terms and options than private student loans. This brief report answers the following questions about federal aid: (1) What is a federal student loan?; (2) What is a private…

Federal Energy Resources Modernization Coordinating Committee

Energy Technology Data Exchange (ETDEWEB)

Parker, G. B.

1992-07-01

This report summarizes the broad range of activities supported by Federal Energy Management Program (FEMP) and other federal agencies 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 FERM Coordinating Committee, and as such include activities undertaken from October 1, 1991, through March 31, 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 the federal energy manager to better understand and characterize their energy resources; (2) federal energy systems testing and monitoring; (3) federal energy systems modernization 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.

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.

Consumer Reports - Best Buy Drugs' Outreach Project in Minnesota

Directory of Open Access Journals (Sweden)

Jon C. Schommer

2013-01-01

Full Text Available The objectives for this study were to apply four different approaches for disseminating Consumer Reports Best Buy Drugs (CR-BBD information about effectiveness, safety, and cost to patients for therapeutic classes of medications that they were using and then (1 evaluate the usefulness of the information to participants and (2 document resultant information seeking. For the three approaches that utilized face-to-face contact (Approaches 2 through 4, we also compared them in terms of (1 number of medications reviewed per person, (2 availability of CR-BBD information per person, (3 changes that could be made for each person, and (4 potential/likely cost savings (per person per month. Finally, we described the availability of CR-BBD information for each participant categorized by the 19 therapeutic classes of medications for which there were Best Buy Drugs reports. Data were collected via self-administered surveys, in-person interviews, and telephone interviews. The results showed that almost all of the participants in the information sessions held for this study had at least one medication for which Best Buy Drug information was available with significant savings potential to be gained by using the recommended Best Buy Drug. Potential cost savings through the use of recommended Best Buy Drugs was $89.47 per person per month averaged over all participants (n = 172 and was $157.20 per person per month for those with savings over zero dollars (n = 98. Thirty-two percent of respondents to our evaluation survey reportedly sought more information from a physician and 30 percent sought more information from a pharmacist. We concluded that provision of information about effectiveness, safety, and cost to patients has the potential for achieving significant cost savings. Recommendations regarding (1 the timing of provision, (2 targeting of recipients and (3 traversing impediments are given.   Type: Original Research

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

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

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.

14 CFR 121.15 - Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances. 121.15 Section 121.15 Aeronautics and Space FEDERAL AVIATION....15 Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances. If a...

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

NARCIS (Netherlands)

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

2014-01-01

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

Code of Federal Regulations Title 21

Data.gov (United States)

U.S. Department of Health & Human Services — This database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs.

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…

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

Science.gov (United States)

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

2017-05-01

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

[Adverse drug reaction reporting in emergency medicine].

Science.gov (United States)

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

2004-01-01

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

14 CFR 137.23 - Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances. 137.23 Section 137.23 Aeronautics and Space FEDERAL AVIATION... drugs, marihuana, and depressant or stimulant drugs or substances. If the holder of a certificate issued...

14 CFR 133.14 - Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances. 133.14 Section 133.14 Aeronautics and Space FEDERAL AVIATION... narcotic drugs, marihuana, and depressant or stimulant drugs or substances. If the holder of a certificate...

14 CFR 141.18 - Carriage of narcotic drugs, marijuana, and depressant or stimulant drugs or substances.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Carriage of narcotic drugs, marijuana, and depressant or stimulant drugs or substances. 141.18 Section 141.18 Aeronautics and Space FEDERAL AVIATION... General § 141.18 Carriage of narcotic drugs, marijuana, and depressant or stimulant drugs or substances...

CHART OF ACCOUNTS OF THE RUSSIAN FEDERATION SHOULD BE DETAILED WITH REFORMING OF AN ACCOUNTING REPORTING ON THE BASIS OF THE INTERNATIONAL FINANCIAL REPORTING STANDARDS (IFRS

Directory of Open Access Journals (Sweden)

Gegetsik A. Tovmasyan

2013-01-01

Full Text Available The article deals with the problem related to information base of accounting (financial reporting, which depends on conducting accounting and creation of detailed classification of chart of accounts of the Russian Federation. It is offered to change the structure of the balance sheet and the report on changes of the capital in the Russian Federation with introduction of “paid-in capital” indicator which not only unifies the reporting according to IFRS, but also will allow objectively estimating and predicting results and risks of both business activity and investment activity.

41 CFR 105-74.645 - Federal agency or agency.

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Federal agency or agency. 105-74.645 Section 105-74.645 Public Contracts and Property Management Federal Property Management... Administration 74-GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 105-74...

Excluding Orphan Drugs from the 340B Drug Discount Program: the Impact on 18 Critical Access Hospitals

Directory of Open Access Journals (Sweden)

Madeline Carpinelli Wallack

2012-01-01

Full Text Available Purpose: The 340B Drug Pricing Program is a federal program designed to reduce the amount that safety net providers spend on outpatient drugs. The Patient Protection and Affordable Health Care Act of 2010 extended eligibility for 340B to critical access hospitals (CAHs for all drugs except those designated as “orphan.” Because this policy is unprecedented, this study quantifies the gross financial impact that this exemption has on a group of CAHs. Methods: Drug spending for 2010 from 18 CAHs in Minnesota and Wisconsin are reviewed to identify the prevalence of orphan drug purchases and to calculate the price differentials between the 340B price and the hospitals’ current cost. Results: The 18 CAHs’ purchases of orphan drugs comprise an average of 44% of the total annual drug budgets, but only 5% of units purchased, thus representing a very high proportion of their expenditures. In the aggregate, the 18 hospitals would have saved $3.1 million ($171,000 average per hospital had purchases of drugs with orphan designations been made at the 340B price. Because CAH claims for Medicare are reimbursed on a cost-basis, the Federal government is losing an opportunity for savings. Conclusion: The high prevalence of orphan drug use and considerable potential for cost reduction through the 340B program demonstrate the loss of benefit to the hospitals, Federal government and the states.

Federal report on research 1984

International Nuclear Information System (INIS)

1984-01-01

Current challenges to science and research in the field of scientific-technological innovation are: to safeguard the competitiveness of particularly high-grade and demanding products in those parts of the world market where competition is hard; careful, responsible and at the same time economically reasonable use of nature and the natural resources; scientific and technological efficiency of this country as a partner in the world. The newly oriented research policy approves technical progress and invites top performances. One of the most important immediate problems is the training of qualified young scientists. The federal government views the technological development also in relation to the risks, but is convinced that possible disadvantages can be reduced to become negligible. Information technology, new material, bio and laser technologies, having interindustrial importance, play a part in economy world-wide as key technologies. Besides expenditure for sciences, measures and promotion instruments, the main points of emphasis of promotion as well as the international cooperation are described in detail as to their tasks, structure and volume; furthermore the individual research institutions of the Federal Republic of Germany are pointed out. The statistics appended contain the financial data regarding science expenditure. (HSCH) [de

Reports of pathological gambling, hypersexuality, and compulsive shopping associated with dopamine receptor agonist drugs.

Science.gov (United States)

Moore, Thomas J; Glenmullen, Joseph; Mattison, Donald R

2014-12-01

Severe impulse control disorders involving pathological gambling, hypersexuality, and compulsive shopping have been reported in association with the use of dopamine receptor agonist drugs in case series and retrospective patient surveys. These agents are used to treat Parkinson disease, restless leg syndrome, and hyperprolactinemia. To analyze serious adverse drug event reports about these impulse control disorders received by the US Food and Drug Administration (FDA) and to assess the relationship of these case reports with the 6 FDA-approved dopamine receptor agonist drugs. We conducted a retrospective disproportionality analysis based on the 2.7 million serious domestic and foreign adverse drug event reports from 2003 to 2012 extracted from the FDA Adverse Event Reporting System. Cases were selected if they contained any of 10 preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) that described the abnormal behaviors. We used the proportional reporting ratio (PRR) to compare the proportion of target events to all serious events for the study drugs with a similar proportion for all other drugs. We identified 1580 events indicating impulse control disorders from the United States and 21 other countries:710 fordopamine receptor agonist drugs and 870 for other drugs. The dopamine receptor agonist drugs had a strong signal associated with these impulse control disorders (n = 710; PRR = 277.6, P < .001). The association was strongest for the dopamine agonists pramipexole (n = 410; PRR = 455.9, P < .001) and ropinirole (n = 188; PRR = 152.5, P < .001), with preferential affinity for the dopamine D3 receptor. A signal was also seen for aripiprazole, an antipsychotic classified as a partial agonist of the D3 receptor (n = 37; PRR = 8.6, P < .001). Our findings confirm and extend the evidence that dopamine receptor agonist drugs are associated with these specific impulse control disorders. At present

Ohio Department of Transportation State Infrastructure Bank Annual Financial Report : Federal Fiscal Year 2009

Science.gov (United States)

2009-01-01

The Ohio Department of Transportation is pleased to present the Federal : Fiscal Year (FFY) 2009 State Infrastructure Bank (SIB) Annual Financial : Report. : The portfolio of the FFY 2009 SIB had a total of nine loans totaling $9.0 : million and one ...

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.

How do Australian news media depict illicit drug issues? An analysis of print media reporting across and between illicit drugs, 2003-2008.

Science.gov (United States)

Hughes, Caitlin Elizabeth; Lancaster, Kari; Spicer, Bridget

2011-07-01

Media reporting on illicit issues has been frequently criticised for being sensationalised, biased and narrow. Yet, there have been few broad and systematic analyses of the nature of reporting. Using a large sample and methods commonly adopted in media communications analysis this paper sought to identify the dominant media portrayals used to denote illicit drugs in Australian newspapers and to compare and contrast portrayals across drug types. A retrospective content analysis of Australian print media was carried out over the period 2003-2008 from a sample comprised of 11 newspapers. Articles that contained one or more mention of five different drugs (or derivatives) were identified: cannabis, amphetamines, ecstasy, cocaine and heroin. A sub-sample of 4397 articles was selected for media content analysis (with 2045 selected for full content analysis) and a large number of text elements coded for each. Key elements included topic, explicit or implicit messages about the consequences of drugs/use and three value dimensions: overall tone, whether drugs were portrayed as a crisis issue and moral evaluations of drugs/use. The dominant media portrayals depicted law enforcement or criminal justice action (55%), but most articles were reported in a neutral manner, in the absence of crisis framings. Portrayals differed between drugs, with some containing more narrow frames and more explicit moral evaluations than others. For example, heroin was disproportionately framed as a drug that will lead to legal problems. In contrast, ecstasy and cocaine were much more likely to emphasise health and social problems. Media reporting on illicit drugs is heavily distorted towards crime and deviance framings, but may be less overtly sensationalised, biased and narrowly framed than previously suggested. This is not to suggest there is no sensationalism or imbalance, but this appears more associated with particular drug types and episodes of heightened public concern. Copyright © 2011

Pattern of adverse drug reactions reported by the community pharmacists in Nepal

Directory of Open Access Journals (Sweden)

Palaian S

2010-09-01

Full Text Available The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. Objectives: To collect the demographic details of the patients experiencing adverse drug reactions (ADR reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. Methods: The baseline Knowledge-Attitude-Practices (KAP of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61 KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4 maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Results: Altogether 71 ADRs, from 71 patients (37 males were reported. Antibiotics/ antibacterials caused 42% (n=37 of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20, followed by generalized edema [8.6 % (n=10]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49 of the cases. Over two third (69% of the ADRs had a ‘possible’ association with the suspected drugs and a high percentage (70.4% were of ‘mild (level 2’ type. Nearly two third [64.7 % (n=46] of the ADRs were ‘definitely preventable’. Conclusion: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen

The success of the citizen suit: protecting consumers from inaccurate food labeling by amending the Federal Food, Drug, and Cosmetic Act.

Science.gov (United States)

Springer, James

2013-01-01

The Federal Food, Drug, and Cosmetic Act ("FDCA"), amended in 1990 by the Nutrition Education and Labeling Act ("NLEA"), established a national framework for the administration and promulgation of uniform food labeling standards. Specifically, the NLEA created affirmative obligations for the food--requiring detailed disclosure of food content and strict adherence to regulations governing the use of health and nutritional claims on food packaging. To accomplish these goals, Congress tasked the Food and Drug Administration ("FDA") with the sole responsibility of the enforcement of these new requirements. Under the statutory framework of the FDCA, the United States Supreme Court ("Court") has held that there is no private right of action, of which extended to the enforcement of NLEA standards. This interpretation has left individuals with no federal outlet for relief in the enforcement of federal food labeling standards. Adherence to this interpretation is especially concerning when the FDA currently faces exponential growth in administrative responsibilities while simultaneously experiencing employment reduction, a $206 million "Sequester," and a recent government-wide shutdown. As a result, the American people are left to depend on an Agency that is struggling with drastic resource reduction while being accountable for ever increasing enforcement responsibilities. To ensure consumer protection, this Article argues that Congress should amend the FDCA to include a citizen suit provision in order to provide individuals with a right of private action for the enforcement of NLEA standards. Borrowing from the successes realized under similar citizen suit provisions found in environmental legislation, this Article argues that a citizen suit provision is amendable to the FDCA and would relieve fiscal pressures, strengthen the current enforcement framework of the FDCA, encourage more robust enforcement by the FDA and states, and ensure uniform interpretation of NLEA

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

inspected, and patients were interviewed about their drug use. Additional blood samples were drawn for drug analysis. The median age of included patients was 72 years, and 298 patients (60%) were women. Patients reported use of 3 (median) prescription-only medications (range, 0-14) during the structured...... interview. The congruence between self-report and drug analysis was high for all 5 drugs measured (all kappa >0.8). However, 9 patients (2%) reported use of drugs that were not detected in their blood samples. In 29 patients (6%), the blood samples contained drugs not reported during the structured...... 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...

Relationship between self-reported adherence, antiretroviral drug concentration measurement and self-reported symptoms in patients treated for HIV-1 infection.

Science.gov (United States)

Fabbiani, Massimiliano; Di Giambenedetto, Simona; Cingolani, Antonella; Fanti, Iuri; Colafigli, Manuela; Tamburrini, Enrica; Cauda, Roberto; Navarra, Pierluigi; De Luca, Andrea; Murri, Rita

2016-01-01

The aim of the study was to explore relationships between self-reported adherence, antiretroviral drug concentration measurement (TDM) and self-reported symptoms. We systematically administered to human immunodeficiency (HIV)-infected outpatients a questionnaire evaluating measures of self-reported adherence (missing doses during last week, deviations from the prescribed timing of therapy, self-initiated discontinuations for > 24 or 48 h, exhausting drugs and present sense of how patients are taking therapy) and a panel of referred symptoms (a symptom score was built summing self-reported scores for each listed symptom). We selected patients who completed the questionnaire and also had a TDM (mainly reflecting adherence in the past few days or weeks), thus comparing these two tools as measures of adherence. A total of 130 patients (64.6% males, median age 44 years, 76.2% with HIV RNA HIV RNA symptom score was associated with a lower self-reported adherence and with a higher proportion of undetectable drug levels. Self-reported adherence and TDM showed a correlation and seemed to be comparable tools for adherence estimation. Self-reported symptoms were associated with lower adherence and undetectable drug levels.

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.

Maritime security report. November 2000 [Commercial maritime drug smuggling

Science.gov (United States)

2000-11-01

Port and security programs being implemented in Colombia's port facilities, maritime jurisdictions, and the marine intermodal shipping cycle are producing successful results against commercial maritime drug smuggling. This security reports examines t...

Ohio Department of Transportation State Infrastructure Bank Annual Financial Report : Federal Fiscal Year 2004

Science.gov (United States)

2004-01-01

The Ohio Department of Transportation is pleased to present the Federal Fiscal : Year 2004 State Infrastructure Bank (SIB) Annual Financial Report. The portfolio of : the FFY 04 SIB had a total of nineteen loans in the amount of $47,340,891. : A comp...

Ohio Department of Transportation State Infrastructure Bank Annual Financial Report : Federal Fiscal Year 2008

Science.gov (United States)

2008-01-01

The Ohio Department of Transportation is pleased to present the Federal Fiscal Year (FFY) 2008 State Infrastructure Bank (SIB) Annual Financial Report. The portfolio of the FFY 2008 SIB had a total of five loans totaling $22.1 million. Since the begi...

Ohio Department of Transportation State Infrastructure Bank Annual Financial Report : Federal Fiscal Year 2007

Science.gov (United States)

2007-01-01

The Ohio Department of Transportation is pleased to present the Federal : Fiscal Year (FFY) 2007 State Infrastructure Bank (SIB) Annual Financial : Report. : The portfolio of the FFY 2007 SIB had a total of 13 loans and 1 bond in the : amount of $17....

BPS Pharmacology 2014 - Drug Discovery Pathways symposium Report

OpenAIRE

Marsh, Andrew

2015-01-01

Report on BPS Pharmacology 2014, BPS Industry Committe and Learned Societies Drug Discovery Pathways Group symposium: "Realizing the potential of new approaches to target identification and validation" by Dr Andrew Marsh Associate Professor Department of Chemistry University of Warwick go.warwick.ac.uk/marshgroup Twitter @marshgroup

Hair analysis and its concordance with self-report for drug users presenting in emergency department.

Science.gov (United States)

Sharma, Gaurav; Oden, Neal; VanVeldhuisen, Paul C; Bogenschutz, Michael P

2016-10-01

Secondary analysis using data from the National Drug Abuse Treatment Clinical Trials Network randomized trial (NCT # 01207791), in which 1285 adult ED patients endorsing moderate to severe problems related to drug use were recruited from 6 US academic hospitals. To investigate the utility of hair analysis in drug use disorder trials with infrequent visits, and its concordance with Timeline Follow Back (TLFB). This study compared the self-reported drug use on the TLFB instrument with the biological measure of drug use from hair analysis for four major drug classes (Cannabis, Cocaine, Prescribed Opioids and Street Opioids). Both hair analysis and TLFB were conducted at 3, 6 and 12 month follow-up visit and each covered a 90-day recall period prior to the visit. The concordance between the hair sample results and the TLFB was high for cannabis and street opioids, but was low to moderate for cocaine and prescribed opioids. Under-reporting of drug use given the positive hair sample was always significantly lower for the drug the study participant noted as their primary drug of choice compared with other drugs the participant reported taking, irrespective of whether the drug of choice was cannabis, cocaine, street opioids and prescribed opioids. Over-reporting of drug use given the negative hair sample was always significantly higher for the drug of choice, except for cocaine. This study extends the literature on hair analysis supporting its use as a secondary outcome measure in clinical trials. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Just say "I don't": lack of concordance between teen report and biological measures of drug use.

Science.gov (United States)

Delaney-Black, Virginia; Chiodo, Lisa M; Hannigan, John H; Greenwald, Mark K; Janisse, James; Patterson, Grace; Huestis, Marilyn A; Ager, Joel; Sokol, Robert J

2010-11-01

Prevalence estimates of illicit drug use by teens are typically generated from confidential or anonymous self-report. While data comparing teen self-report with biological measures are limited, adult studies identify varying degrees of under-reporting. Hair analyses for cocaine, opiates and marijuana were compared to confidential teen self- and parent-reported teen drug use in a longitudinal cohort of >400 high-risk urban teens and parents. Both teens and parents substantially underreported recent teen cocaine and opiate use. However, compared with parents, teens were more likely to deny biomarker-verified cocaine use. Teen specimens (hair) were 52 times more likely to identify cocaine use compared with self-report. Parent hair analyses for cocaine and opiate use were 6.5 times and 5.5 times, respectively, more likely to indicate drug use than were parental self-report. The lack of concordance between self-report and bioassay occurred despite participant's knowledge that a "certificate of confidentiality" protected both teen and adult participants, and that the biological specimens would be tested for drugs. These findings confirm prior reports of adult under-reporting of their own drug use while extending our understanding of teen's self-admitted drug use. The lack of concordance between teen self- or parent-reported teen drug use and biomarkers confirm our concerns that both teen- and parent-reported teen drug use is limited, at least for youth in high-risk urban settings. Methods of ascertainment other than self- or parent-report must be considered when health care providers, researchers and public health agencies attempt to estimate teen drug-use prevalence.

Report of the Federal Government on the consequences of the report 'Global 2000'

International Nuclear Information System (INIS)

1983-01-01

The required equipment for environmental policy and planning in the Federal Republic of Germany is largely available. At present, the Federal Government is intensively cooperating in the United Nations' Environmental Programme (UNEP). (orig./HSCH) [de

Cross sectional study of factors associated to self-reported blood-borne infections among drug users.

Science.gov (United States)

Reyes-Urueña, Juliana; Brugal, M Teresa; Majo, Xavier; Domingo-Salvany, Antonia; Caylà, Joan A

2015-11-13

The study's aim was to estimate the self-reported prevalence of Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV), and to describe their associated risk factors in a population of users of illicit drugs recruited in Catalonia- Spain, during 2012. Cross-sectional study. People with illicit drugs use were selected in three different types of healthcare centres. The questionnaire was a piloted, structured ad hoc instrument. An analysis was made to identify factors associated to self-reported HCV, HIV and co-infection. Correlates of reported infections were determined using univariate and multivariate Poisson regression (with robust variance). Among 512 participants, 39.65% self-reported positive serostatus for HCV and 14.84% for HIV, co-infection was reported by 13.48%. Among the 224 injecting drug users (IDUs), 187 (83.48%), 68 (30.36%) and 66 (29.46%) reported being positive for HCV, HIV and co-infection, respectively. A higher proportion of HIV-infected cases was observed among women, (18.33% vs. 13.78% in men). Prevalence of HCV, HIV and co-infection were higher among participants with early onset of drug consumption, long periods of drug injection or who were unemployed. A positive serostatus was self-reported by 21(7.34%) participants who did not report any injection; among them 16 and eight, reported being positive for HCV and HIV, respectively; three reported co-infection. Only two people declared exchanging sex for money. For those that reported a negative test, the median time since the last HIV test was 11.41 months (inter-quartile range (IQR) 4-12) and for the HCV test was 4.5 months (IQR 2-7). Among drug users in Catalonia, HIV, HCV and co-infection prevalence are still a big issue especially among IDUs. Women and drug users who have never injected drugs are groups with a significant risk of infection; this might be related to their high-risk behaviours and to being unaware of their serological status.

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.

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

Directory of Open Access Journals (Sweden)

Protić D

2016-02-01

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

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.

Amount of self-reported illicit drug use compared to quantitative hair test results in community-recruited young drug users in Amsterdam

NARCIS (Netherlands)

Welp, Esther A. E.; Bosman, Ingrid; Langendam, Miranda W.; Totté, Maja; Maes, Robert A. A.; van Ameijden, Erik J. C.

2003-01-01

To assess the dose-effect relationship between self-reported drug intake and the concentration of drugs and/or their metabolites in hair and to examine factors that may mediate this relationship. A cohort study among young drug users (YDU) in Amsterdam, the Netherlands, which began in July 2000. At

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.

14 CFR 125.39 - Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances. 125.39 Section 125.39 Aeronautics and Space FEDERAL AVIATION... AIRCRAFT Certification Rules and Miscellaneous Requirements § 125.39 Carriage of narcotic drugs, marihuana...

National Drug Control Strategy, 2011

Science.gov (United States)

Office of National Drug Control Policy, 2011

2011-01-01

In May of 2010, President Obama released the Administration's inaugural "National Drug Control Strategy". Based on the premise that drug use and its consequences pose a threat not just to public safety, but also to public health, the 2010 "Strategy" represented the first comprehensive rebalancing of Federal drug control policy in the nearly 40…

Center for Drug Evaluation and Research

Data.gov (United States)

Federal Laboratory Consortium — The Center for Drug Evaluation and Research(CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the...

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

Science.gov (United States)

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

2016-03-01

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

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.

Nurse-midwives in federally funded health centers: understanding federal program requirements and benefits.

Science.gov (United States)

Carter, Martha

2012-01-01

Midwives are working in federally funded health centers in increasing numbers. Health centers provide primary and preventive health care to almost 20 million people and are located in every US state and territory. While health centers serve the entire community, they also serve as a safety net for low-income and uninsured individuals. In 2010, 93% of health center patients had incomes below 200% of the Federal Poverty Guidelines, and 38% were uninsured. Health centers, including community health centers, migrant health centers, health care for the homeless programs, and public housing primary care programs, receive grant funding and enjoy other benefits due to status as federal grantees and designation as federally qualified health centers. Clinicians working in health centers are also eligible for financial and professional benefits because of their willingness to serve vulnerable populations and work in underserved areas. Midwives, midwifery students, and faculty working in, or interacting with, health centers need to be aware of the regulations that health centers must comply with in order to qualify for and maintain federal funding. This article provides an overview of health center regulations and policies affecting midwives, including health center program requirements, scope of project policy, provider credentialing and privileging, Federal Tort Claims Act malpractice coverage, the 340B Drug Pricing Program, and National Health Service Corps scholarship and loan repayment programs. © 2012 by the American College of Nurse-Midwives.

Federal response to the environmental assessment report of the NRCB-CEAA joint review panel on the Little Bow project/Highwood diversion plan

International Nuclear Information System (INIS)

1999-01-01

In June 1998, a joint review panel released a report on a dam and diversion project proposed by Alberta Public Works, Supply and Services. This document is the response to that report addressing its recommendations to the federal government and other recommendations or statements pertinent to federal areas of jurisdiction and interest. It begins with background on the proposed project, then presents the report's recommendations or statements along with the federal responses with regard to the following issue areas: Regulatory approval; navigable waters and the public right of navigation; fish and fish habitat; wetlands and wildlife; and Aboriginal concerns

Progress report 1981-1982 - Instituto de Fisica - Universidade Federal do Rio Grande do Sul

International Nuclear Information System (INIS)

1983-01-01

Several works, covering the 1981 and 1982 years, from the Physical Institut of the Federal University of Rio Grande do Sul - Brazil are reported. They treat both experimental and theoretical aspects of almost the totality of the physical areas, including also the instrumentation part. (L.C.) [pt

Drug-Free Schools and Communities Act Compliance at Michigan Community Colleges

Science.gov (United States)

Custer, Bradley D.

2018-01-01

In 1989, Congress passed the Drug-Free Schools and Communities Act Amendments to address illegal alcohol and drug abuse on college campuses. To receive federal funding, each college must comply by implementing an alcohol and drug prevention program, but the federal government and some colleges have paid little attention to this policy. Recently,…

14 CFR 135.41 - Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances. 135.41 Section 135.41 Aeronautics and Space FEDERAL AVIATION... PERSONS ON BOARD SUCH AIRCRAFT General § 135.41 Carriage of narcotic drugs, marihuana, and depressant or...

Signalling possible drug-drug interactions in a spontaneous reporting system : delay of withdrawal bleeding during concomitant use of oral contraceptives and itraconazole

NARCIS (Netherlands)

Van Puijenbroek, E P; Egberts, A C; Meyboom, R H; Leufkens, H G

AIMS: In spontaneous adverse drug reaction reporting systems, there is a growing need for methods facilitating the automated detection of signals concerning possible adverse drug reactions. In addition, special attention is needed for the detection of adverse drug reactions resulting from possible

[Injecting drug abuse: survival after intensive care admission and forensic toxicology reports at death].

Science.gov (United States)

Sigvaldason, Kristinn; Ingvarsson, Thoroddur; Thordardottir, Svava; Kristinsson, Jakob; Karason, Sigurbergur

2014-10-01

Injecting drug abuse is a worldwide problem with serious consequences for the individual and for society. The purpose of this study was to gather information on the most serious complications of injecting drug use from two perspectives, intensive care admissions and forensic toxicology reports. Firstly, intensive care admissions related to injecting drug abuse during a five year period were reviewed for demographics, complications and 5 year survival. Secondly, information from forensic toxicology reports regarding deaths amongst known injecting drug abusers were gathered for the same period. A total of 57 patients with a history of active injecting drug use were admitted to intensive care or approximately 1% of admissions, most often for overdose (52%) or life threatening infections (39%). Median age was 26, males were 66%. The most common substances used were prescription drugs. Hospital mortality was 16% and five year survival 65%. Average time from hospital discharge to death was 916±858 days. During the study period 38 deaths of individuals with a history of injecting drugs were identified by forensic toxicology reports or 4.1/10(5) population/year (age 15-59). Cause of death was most often overdose (53%), usually from prescription opiates but multiple drug use was common. The life expectancy of injecting drug abusers after intensive care admission is substantially decreased, with 35% death rate within five years. A widespread use of prescription drugs is of concern. Injecting drug abuse seems to be a similar health problem in magnitude in Iceland as in other Scandinavian countries.

Advanced Practice Nursing in Pediatric Urology: experience report in the Federal District.

Science.gov (United States)

Souza, Bruna Marcela Lima de; Salviano, Cristiane Feitosa; Martins, Gisele

2018-01-01

To describe the creation and implementation of the extension program Advanced Practice Nursing in Pediatric Urology, developed in the outpatient clinic of a teaching hospital in the Federal District. This is an experience report regarding the implementation of an outpatient service aimed at children and adolescents with symptoms of bladder and bowel dysfunction. Because it is an extension program linked to the university, it follows a different model of care, valuing empowerment, informed and shared decision making, which results in a stronger bond between patients, family and the Pediatric Urology nursing team. It has also become a privileged space for the production and use of scientific knowledge, associated with the principles of evidence-based practice. This project shows a different performance of the nurse-specialist-professor-researcher in Pediatric Urology Nursing, and it has become a reference in the Federal District, mainly for undergraduate and graduate nursing students.

Toxic Hazards Research Unit Annual Technical Report: 1984

Science.gov (United States)

1984-09-01

exposed to TOCP exhibited the classic lesions of delayed neuropathy (Smith and Lillie, 1931; Barnes and Denz, 1953; (avanagh, 1954; and Fenton , 1955...Safety of *.i Chemicals in Food, Drugs, and Cosmetics , The staff of the Divi- sion of Pharmacology of the Federal Food and Drug Administration, Austin...Annual Technical Report: 1967, AMRL-TR-67-137 (AD 834723), Aerospace Medical Research Laboratory, Wright-Patterson Air Force Base, Ohio. Fenton , J. C

Progress report 1983-1984 - Instituto de Fisica - Universidade Federal do Rio Grande do Sul

International Nuclear Information System (INIS)

1985-01-01

The work abstracts done at the Physics Institute of the Rio Grande do Sul Federal University in Brazil during the years of 1983 and 1984 are reported. They cover since low-energy to high-energy physics and both aspects, the theory and experiment, are treated. (L.C.) [pt

Consequences of the exclusion of known adverse drug reactions in a spontaneous reporting system on the possibility to detect unknown drug/ADR combinations

NARCIS (Netherlands)

Borgsteede, Sander; Van Puijenbroek, Eugene; Van Grootheest, Kees

Background: The Reporting Odds Ratio (ROR) is one of the expressions to analyse disproportionallity of adverse drug reactions (ADRs) in a spontaneous reporting system. The ROR is defined as the extent to which the association between a suspected drug and ADR stands out against the background

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

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

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.

49 CFR 40.163 - How does the MRO report drug test results?

Science.gov (United States)

2010-10-01

... How does the MRO report drug test results? (a) As the MRO, it is your responsibility to report all... copy of that report in a format suitable for inspection and auditing by a DOT representative. (f) You...

Privacy effects on self-reported drug use: interactions with survey mode and respondent characteristics.

Science.gov (United States)

Aquilino, W S

1997-01-01

This chapter examines the impact of interview privacy on self-reported illicit drug use. In 1991, interviews were completed with an urban-suburban sample of 2,417 adults aged 18 to 45. Results show that the presence of third parties during the interview significantly influences respondents' willingness to reveal illicit drug use. Among married respondents, presence of a spouse resulted in higher reporting of illicit drug use, while the presence of adults other than the spouse had a consistent negative effect on drug use reports. A parent's presence during the interview significantly reduced respondents' willingness to report illicit drug use. The pattern of findings suggests that the direction of effects due to third party presence is linked to two factors: the extent of the third party's knowledge of the information requested, and the degree of personal stake the third party may have in the respondent's answers. The differential impact of privacy by interview mode was also examined. Tests of interactions between privacy and interview mode failed to support the hypothesis that the use of self-administered answer sheets reduces privacy effects compared with interviewer-administered interviews.

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

Science.gov (United States)

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

2012-01-01

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

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.

Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: an example with diuretics and non-steroidal anti-inflammatory drugs.

Science.gov (United States)

van Puijenbroek, E P; Egberts, A C; Heerdink, E R; Leufkens, H G

2000-12-01

Drug-drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug-drug interactions. We developed a method that may enable signalling of these possible interactions, which are often not explicitly reported, utilising reports of adverse drug reactions in data sets of SRS. As an example, the influence of concomitant use of diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) on symptoms indicating a decreased efficacy of diuretics was examined using reports received by the Netherlands Pharmacovigilance Foundation Lareb. Reports received between 1 January 1990 and 1 January 1999 of patients older than 50 years were included in the study. Cases were defined as reports with symptoms indicating a decreased efficacy of diuretics, non-cases as all other reports. Exposure categories were the use of NSAIDs or diuretics versus the use of neither of these drugs. The influence of the combined use of both drugs was examined using logistic regression analysis. The odds ratio of the statistical interaction term of the combined use of both drugs was increased [adjusted odds ratio 2.0, 95% confidence interval (CI) 1.1-3.7], which may indicate an enhanced effect of concomitant drug use. The findings illustrate that spontaneous reporting systems have a potential for signal detection and the analysis of possible drug-drug interactions. The method described may enable a more active approach in the detection of drug-drug interactions after marketing.

Advanced Practice Nursing in Pediatric Urology: experience report in the Federal District

Directory of Open Access Journals (Sweden)

Bruna Marcela Lima de Souza

Full Text Available ABSTRACT Objective: To describe the creation and implementation of the extension program Advanced Practice Nursing in Pediatric Urology, developed in the outpatient clinic of a teaching hospital in the Federal District. Method: This is an experience report regarding the implementation of an outpatient service aimed at children and adolescents with symptoms of bladder and bowel dysfunction. Results: Because it is an extension program linked to the university, it follows a different model of care, valuing empowerment, informed and shared decision making, which results in a stronger bond between patients, family and the Pediatric Urology nursing team. It has also become a privileged space for the production and use of scientific knowledge, associated with the principles of evidence-based practice. Conclusion: This project shows a different performance of the nurse-specialist-professor-researcher in Pediatric Urology Nursing, and it has become a reference in the Federal District, mainly for undergraduate and graduate nursing students.

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

NARCIS (Netherlands)

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

2013-01-01

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

Just Say “I Don’t”: Lack of Concordance Between Teen Report and Biological Measures of Drug Use

Science.gov (United States)

Delaney-Black, Virginia; Chiodo, Lisa M.; Hannigan, John H.; Greenwald, Mark K.; Janisse, James; Patterson, Grace; Huestis, Marilyn A.; Ager, Joel; Sokol, Robert J.

2012-01-01

BACKGROUND Prevalence estimates of illicit drug use by teens are typically generated from confidential or anonymous self-report. While data comparing teen self-report with biological measures are limited, adult studies identify varying degrees of under-reporting. METHODS Hair analyses for cocaine, opiates and marijuana were compared to confidential teen self- and parent-reported teen drug use in a longitudinal cohort of >400 high-risk urban teens and parents. RESULTS Both teens and parents substantially underreported recent teen cocaine and opiate use. However, compared with parents, teens were more likely to deny biomarker-verified cocaine use. Teen specimens (hair) were 52 times more likely to identify cocaine use compared with self-report. Parent hair analyses for cocaine and opiate use were 6.5 times and 5.5 times, respectively, more likely to indicate drug use than were parental self-report. The lack of concordance between self-report and bioassay occurred despite participant’s knowledge that a “certificate of confidentiality” protected both teen and adult participants, and that the biological specimens would be tested for drugs. CONCLUSIONS These findings confirm prior reports of adult under-reporting of their own drug use while extending our understanding of teen’s self-admitted drug use. The lack of concordance between teen self- or parent-reported teen drug use and biomarkers confirm our concerns that both teen- and parent-reported teen drug use is limited, at least for youth in high-risk urban settings. Methods of ascertainment other than self- or parent-report must be considered when health care providers, researchers and public health agencies attempt to estimate teen drug-use prevalence. PMID:20974792

76 FR 53050 - New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin...

Science.gov (United States)

2011-08-25

... with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to improve the accuracy and... in 21 CFR Parts 520 and 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act...) * * * (c) [Reserved] (d) Conditions of use--(1) Dogs--(i) Amount. Administer 2 to 40 mg (up to 120 mg in...

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

76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

Science.gov (United States)

2011-06-21

... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act... the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug... statutory definitions for these terms set forth in sections 201(g) and 201(h) of the Federal Food, Drug, and...

Consumers' reports on the health effects of direct-to-consumer drug advertising.

Science.gov (United States)

Weissman, Joel S; Blumenthal, David; Silk, Alvin J; Zapert, Kinga; Newman, Michael; Leitman, Robert

2003-01-01

We conducted a national telephone survey about health care experiences associated with direct-to-consumer advertising (DTCA) of prescription drugs. Among the 35 percent of our sample who had a physician visit during which DTCA was discussed, 25 percent received a new diagnosis, of which 43 percent were considered high priority according to authoritative sources. More than half also reported actions taken by their physician other than prescribing the advertised drug. Despite concerns about DTCA's negative consequences, we found no differences in health effects between patients who took advertised drugs and those who took other prescription drugs.

78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

Science.gov (United States)

2013-02-06

... utility of the prescription drug labeling as a communication tool and to discuss strategies for making it... the Web site after this document publishes in the Federal Register.) All holders of marketing... before June 30, 2001, and for generic drugs. The initiative is anticipated to take place over several...

What's the agreement between self-reported and biochemical verification of drug use? A look at permanent supportive housing residents.

Science.gov (United States)

Rendon, Alexis; Livingston, Melvin; Suzuki, Sumihiro; Hill, Whitney; Walters, Scott

2017-07-01

Self-reported substance use is commonly used as an outcome measure in treatment research. We evaluated the validity of self-reported drug use in a sample of 334 adults with mental health problems who were residing in supportive housing programs. The primary analysis was the calculation of the positive predictive values (PPVs) of self-report compared to an oral fluid test taken at the same time. A sensitivity analysis compared the positive predictive values of two self-reported drug use histories: biological testing window (ranging between the past 96h to 30days depending on drug type) or the full past 90-day comparison window (maximum length recorded during interview). A multivariable logistic regression was used to predict discordance between self-report and the drug test for users. Self-reported drug use and oral fluid drug tests were compared to determine the positive predictive value for amphetamines/methamphetamines/PCP (47.1% agreement), cocaine (43.8% agreement), and marijuana (69.7% agreement) drug tests. Participants who misreported their drug use were more likely to be older, non-White, have no medical insurance, and not report any alcohol use. In general, amphetamine/methamphetamine/PCP and cocaine use was adequately captured by the biological test, while marijuana use was best captured by a combination of self-report and biological data. Using the full past 90day comparison window resulted in higher concordance with the oral fluid drug test, indicating that self-reported drug use in the past 90days may be a proxy for drug use within the biological testing window. Self-report has some disadvantages when used as the sole measure of drug use in this population. Copyright © 2017 Elsevier Ltd. All rights reserved.

Undocumented Immigration, Drug Problems, and Driving Under the Influence in the United States, 1990-2014.

Science.gov (United States)

Light, Michael T; Miller, Ty; Kelly, Brian C

2017-09-01

To examine the influence of undocumented immigration in the United States on 4 different metrics of drug and alcohol problems: drug arrests, drug overdose fatalities, driving under the influence (DUI) arrests, and DUI deaths. We combined newly developed state-level estimates of the undocumented population between 1990 and 2014 from the Center for Migration Studies with arrest data from the Federal Bureau of Investigation Uniform Crime Reports and fatality information from the Fatality Analysis Reporting System and the Centers for Disease Control and Prevention Underlying Cause of Death database. We used fixed-effects regression models to examine the longitudinal association between increased undocumented immigration and drug problems and drunk driving. Increased undocumented immigration was significantly associated with reductions in drug arrests, drug overdose deaths, and DUI arrests, net of other factors. There was no significant relationship between increased undocumented immigration and DUI deaths. This study provides evidence that undocumented immigration has not increased the prevalence of drug or alcohol problems, but may be associated with reductions in these public health concerns.

48 CFR 1823.570 - Drug- and alcohol-free workforce.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Drug- and alcohol-free..., OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 1823.570 Drug- and alcohol-free workforce. This section sets sets forth NASA requirements for mandatory drug and alcohol testing of certain...

How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

Science.gov (United States)

Fleuranceau-Morel, P

2002-01-01

It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated

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.

Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies.

Science.gov (United States)

Sequi, Marco; Campi, Rita; Clavenna, Antonio; Bonati, Maurizio

2013-03-01

To evaluate the quality of data reporting and statistical methods performed in drug utilization studies in the pediatric population. Drug utilization studies evaluating all drug prescriptions to children and adolescents published between January 1994 and December 2011 were retrieved and analyzed. For each study, information on measures of exposure/consumption, the covariates considered, descriptive and inferential analyses, statistical tests, and methods of data reporting was extracted. An overall quality score was created for each study using a 12-item checklist that took into account the presence of outcome measures, covariates of measures, descriptive measures, statistical tests, and graphical representation. A total of 22 studies were reviewed and analyzed. Of these, 20 studies reported at least one descriptive measure. The mean was the most commonly used measure (18 studies), but only five of these also reported the standard deviation. Statistical analyses were performed in 12 studies, with the chi-square test being the most commonly performed test. Graphs were presented in 14 papers. Sixteen papers reported the number of drug prescriptions and/or packages, and ten reported the prevalence of the drug prescription. The mean quality score was 8 (median 9). Only seven of the 22 studies received a score of ≥10, while four studies received a score of statistical methods and reported data in a satisfactory manner. We therefore conclude that the methodology of drug utilization studies needs to be improved.

Information by the Federal Government. Report of the Federal Governement on 'Environmental radioactivity and radiation load in 1975'

International Nuclear Information System (INIS)

1977-01-01

The report on environmental radioactivity and radiation load, to be published annually by the Federal government, contains data on artificial exposure from nuclear facilities, data on the application of radioactive substances and ionizing rays in research and technology, on occupational activities, medical application and special occurrences. Not only the annual release of radioactive substances from nuclear fcilities is presented but also data on the maximum permissible radiation exposures and the average gonadal exposure within the vicinity of plants. Furthermore, data is presented on the influence of X-ray investigations on the genetically significant dose as well as on the proportion in percent of the various radionuclides when applied in nuclear medicine. (ORU) [de

Proposals for the Future Development of the Russian Automated Federal Information System for Nuclear Material Control and Accounting: The Universal Reporting Concept

International Nuclear Information System (INIS)

Martyanov, Alexander; Pitel, Victor; Kasumova, Leila; Babcock, Rose A.; Heinberg, Cynthia L.

2004-01-01

Development of the automated Russian Federation Federal Information System for Nuclear Material Control and Accounting (FIS) started in 1996. From the beginning, the creation of the FIS was based on the concept of obtaining data from the material balance areas of the organizations, which would enable the system to collect detailed information on nuclear material. In December 2000, the organization-level summarized reporting method was mandated by the Russian Federation and subsequently implemented for all organizations. Analysis of long-term FIS objectives, reporting by all the MBAs in Russia, showed that the present summarized reporting approach decreed by regulations posed a fair number of problems. We need alternative methods that allow the FIS to obtain more detailed information on nuclear material but which accurately reflect the technical and economic resources available to Russian organizations. One possible solution is the universal reporting method. In August 2003, the proposals of the FIS working group to transition to the universal reporting method were approved at the fourth meeting of the Joint Coordinating Committee for Implementation of the Russian Federation and U.S. Government-to-Government Agreement on Cooperation in the Area of Nuclear Material Physical Protection, Control and Accounting (JCC). One of the important elements of universal reporting is that organizations handling nuclear material will establish 'reporting areas' in cooperation with MinAtom of Russia. A reporting area may consist of one MBA, several MBAs, or even an entire organization. This paper will discuss the universal reporting concept and its major objectives and methods for the FIS.

78 FR 21613 - Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas...

Science.gov (United States)

2013-04-11

... Availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the selection of disease areas to... selection criteria, which were published in the September 24, 2012, Federal Register notice: Disease areas... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0967...

How patient outcomes are reported in drug advertisements.

Science.gov (United States)

Lexchin, J

1999-05-01

To examine how changes in outcomes are reported in drug advertisements in medical journals. Advertisements from a convenience sample of 38 issues of Canadian Family Physician, Canadian Journal of Anaesthesia, Canadian Journal of Psychiatry, Canadian Medical Association Journal, and the New England Journal of Medicine. Method of reporting changes in clinical outcomes (relative risk reduction [RRR], absolute risk reduction [ARR], number needed to treat [NNT]), name of product, and company marketing product were sought. In the 22 advertisements included in the analysis, 11 reported results as RRRs; two reported results as RRRs, but readers could calculate ARRs or NNTs from figures given in the advertisement; and nine gave no measure of results, but readers could calculate RRRs, ARRs, or NNTs from figures given. Most companies report changes in outcomes as RRRs, and this bias could influence the way physicians prescribe. Changes to the rules governing journal advertising and increased emphasis on critical appraisal skills would help mitigate this bias.

Federal databases

International Nuclear Information System (INIS)

Welch, M.J.; Welles, B.W.

1988-01-01

Accident statistics on all modes of transportation are available as risk assessment analytical tools through several federal agencies. This paper reports on the examination of the accident databases by personal contact with the federal staff responsible for administration of the database programs. This activity, sponsored by the Department of Energy through Sandia National Laboratories, is an overview of the national accident data on highway, rail, air, and marine shipping. For each mode, the definition or reporting requirements of an accident are determined and the method of entering the accident data into the database is established. Availability of the database to others, ease of access, costs, and who to contact were prime questions to each of the database program managers. Additionally, how the agency uses the accident data was of major interest

Development, implementation and management of a drug testing program in the workplace

Energy Technology Data Exchange (ETDEWEB)

Burtis, C.A.

1990-01-01

To combat the rising use of drugs in the workplace many American companies have implemented drug testing programs and are testing employees and job applicants for use of illegal drugs. In addition, on September 15, 1986, Executive Order No.12564 was issued by President Reagan, which requires all federal agencies to develop programs and policies, one of the goals of which is to achieve a drug-free federal workplace. Included in this Executive Order is the requirement that federal agencies implement drug testing has become a prevalent practice as a means to detect and deter drug use in the workplace. Before a drug testing program is implemented, it is imperative that policies and procedures are developed that (1) ensure the accuracy of test results, (2) protect the validity and integrity of the specimen, (3) guarantee due process, and (4) maintain confidentiality. To make certain that these prerequisites were met in the government drug testing programs, the US Department of Health and Human Services (HHS) was directed to develop technical and scientific guidelines for conducting such programs. 15 refs., 1 fig., 2 tabs.

7 CFR 3405.20 - Other Federal statutes and regulations that apply.

Science.gov (United States)

2010-01-01

... Drug-Free Workplace (Grants), implementing Executive Order 12549 on debarment and suspension and the Drug-Free Workplace Act of 1988 (41 U.S.C. 701). 7 CFR Part 3018—Restrictions on Lobbying, prohibiting... statute), prohibiting discrimination based upon physical or mental handicap in Federally assisted programs...

Eculizumab for drug-induced de novo posttransplantation thrombotic microangiopathy: A case report.

Science.gov (United States)

Safa, Kassem; Logan, Merranda S; Batal, Ibrahim; Gabardi, Steven; Rennke, Helmut G; Abdi, Reza

2015-02-01

De novo thrombotic microangiopathy (TMA) following renal transplantation is a severe complication associated with high rates of allograft failure. Several immunosuppressive agents are associated with TMA. Conventional approaches to managing this entity, such as withdrawal of the offending agent and/or plasmapheresis, often offer limited help, with high rates of treatment failure and graft loss. We herein report a case of drug induced de novo TMA successfully treated using the C5a inhibitor eculizumab in a renal transplant patient. This report highlights a potentially important role for eculizumab in settings where drug-induced de novo TMA is refractory to conventional therapies.

Detecting drug-drug interactions using a database for spontaneous adverse drug reactions : an example with diuretics and non-steroidal anti-inflammatory drugs

NARCIS (Netherlands)

van Puijenbroek, E P; Egberts, A C; Heerdink, E R; Leufkens, H G

2000-01-01

OBJECTIVE: Drug-drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug-drug interactions. We developed a method that may enable

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

Science.gov (United States)

Bigi, Caterina; Tuccori, Marco; Bocci, Guido

2017-02-17

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

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

Science.gov (United States)

2011-12-21

... FEDERAL HOUSING FINANCE AGENCY 12 CFR Part 1281 RIN 2590-AA48 Federal Home Loan Bank Housing Goals... governing housing goals for the Federal Home Loan Banks (Banks) to make those requirements consistent with... Section 1205 of the Housing and Economic Recovery Act of 2008 (HERA) amended the Federal Home Loan Bank...

On the Potential Implications of Reports of Fictitious Drug Use for Survey Research on Juvenile Delinquency.

Science.gov (United States)

Meldrum, Ryan Charles; Piquero, Alex R

2015-08-01

A variety of methodological issues have been raised over self-reports of delinquency and its correlates. In this study, we call attention to the provision of untruthful information and provide an investigation of this issue using a survey item that assesses a respondent's use of a fictitious drug in relation to reports of delinquency and traditional criminological correlates. Bivariate and multivariate analyses were conducted based on data drawn from a probability sample of middle and high school students in Florida. Results show (a) there are important differences on key criminological variables between respondents who report use of a fictitious drug and those who do not; (b) the internal consistency of a variety index of delinquency is particularly sensitive to the inclusion of respondents reporting the use of a fictitious drug; and (c) the effect size of some criminological variables on delinquency may be sensitive to controlling for reports of fictitious drug use. Overall, the inclusion of fictitious drug use items within etiological models may serve as a useful approach to further establishing the reliability and validity of information provided by survey respondents. © The Author(s) 2014.

78 FR 37694 - Federal Acquisition Regulation; Deletion of Report to Congress on Foreign-Manufactured Products

Science.gov (United States)

2013-06-21

... U.S.C. chapter 35). List of Subject in 48 CFR Part 25 Government procurement. Dated: June 13, 2013...: July 22, 2013. FOR FURTHER INFORMATION CONTACT: Ms. Cecelia L. Davis, Procurement Analyst, at 202-219... report to Congress is no longer required but the collection of the data in the Federal Procurement Data...

30 CFR 210.155 - What reports must I submit for Federal onshore stripper oil properties?

Science.gov (United States)

2010-07-01

... Minerals Management Service, P.O. Box 25165, MS 392B2, Denver, Colorado 80217-0165; or (ii) Special courier... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What reports must I submit for Federal onshore stripper oil properties? 210.155 Section 210.155 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT...

78 FR 27411 - National Institute on Drug Abuse Notice of Closed Meetings

Science.gov (United States)

2013-05-10

... funding cycle. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse...

77 FR 58855 - National Institute on Drug Abuse Notice of Closed Meetings

Science.gov (United States)

2012-09-24

....gov . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...

78 FR 19499 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-04-01

... . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Profile...

75 FR 25278 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2010-05-07

..., MD 21224, (410) 550-1547. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse... Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as... conducted by the National Institute on Drug Abuse, including consideration of personnel qualifications and...

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 convictions...

Spontaneous adverse drug reaction reporting in rural districts of Mozambique.

Science.gov (United States)

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

2008-01-01

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

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

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,...

21 CFR 2.110 - Definition of ammonia under Federal Caustic Poison Act.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Definition of ammonia under Federal Caustic Poison... SERVICES GENERAL GENERAL ADMINISTRATIVE RULINGS AND DECISIONS Caustic Poisons § 2.110 Definition of ammonia under Federal Caustic Poison Act. For the purpose of determining whether an article containing ammonia...

76 FR 35226 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2011-06-16

...-402-6626, [email protected] . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel...

77 FR 63846 - National Institute on Drug Abuse; Notice of Closed Meetings

Science.gov (United States)

2012-10-17

[email protected] . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction... Abuse; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis...

Federalism, the economic-industrial health care complex and high-cost pharmaceutical assistance in Brazil.

Science.gov (United States)

da Fonseca, Elize Massard; Costa, Nilson do Rosario

2015-04-01

Brazil has a relevant, although relatively unknown, special medicines programme that distributes high-cost products, such as drugs needed for cancer treatments. In 2009, the purchase of these medicines became the responsibility of the Brazilian Federal Government. Until then, there were no clear norms regarding the responsibilities, in terms of the management/financing of these medicines, of the Brazilian Federal Government and of the states themselves. This qualitative study analyses the policy process needed to transfer this programme to the central government. The study examines the reports of the Tripartite Commission between 2000 and 2012, and in-depth interviews with eleven key informants were conducted. The study demonstrates that throughout the last decade, institutional changes have been made in regard to the federal management of these programmes (such as recentralisation of the purchasing of medicines). It concludes that these changes can be explained because of the efficiency of the coordinating mechanisms of the Federal Government. These findings reinforce the idea that the Ministry of Health is the main driver of public health policies, and it has opted for the recentralisation of activities as a result of the development project implicit in the agenda of the Industrial and Economic Heal.

Mental Health and Family Relations: Correlated Reports from People Who Inject Drugs and their Family Members in Vietnam

Science.gov (United States)

Li, Li; Tuan, Nguyen Anh; Liang, Li-Jung; Lin, Chunqing; Farmer, Shu C.; Flore, Martin

2013-01-01

Background This article explores the association of people who inject drugs and their family members in terms of mental health and family relations. The objective was to understand the family context and its impact on people who inject drugs in a family-oriented culture in Vietnam. Methods Cross-sectional assessment data were gathered from 83 people who inject drugs and 83 of their family members recruited from four communes in Phú Thọ province, Vietnam. Depressive symptoms and family relations were measured for both people who inject drugs and family members. Internalized shame and drug-using behavior were reported by people who inject drugs, and caregiver burden was reported by family members. Results We found that higher level of drug using behavior of people who inject drugs was significantly associated with higher depressive symptoms and lower family relations reported by themselves as well as their family members. Family relations reported by people who inject drugs and their family members were positively correlated. Conclusion The findings highlight the need for interventions that address psychological distress and the related challenges faced by family members of people who inject drugs. The article has policy implication which concludes with an argument for developing strategies that enhance the role of families in supporting behavioral change of people who inject drugs. PMID:23910167

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

Directory of Open Access Journals (Sweden)

R. Gehring

2001-07-01

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

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

10 CFR 26.31 - Drug and alcohol testing.

Science.gov (United States)

2010-01-01

... Transportation Workplace Drug and Alcohol Testing Programs” (65 FR 41944; August 9, 2001) to collect specimens... could be construed as a potential conflict of interest. The forensic toxicologist may not be an employee... or drug metabolites in Federal workplace drug testing programs and the licensee or other entity...

Hanford Federal Facility Agreement and Consent Order, quarterly progress report, March 31, 1992

International Nuclear Information System (INIS)

1992-05-01

This is the twelfth quarterly report as required by the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) (Ecology et al. 1990), established between the US Department of Energy (DOE), the US Environmental Protection Agency (EPA), and the Washington State Department of Ecology (Ecology). The Tri-Party Agreement sets the plan and schedule for achieving regulatory compliance and cleanup of waste sites at the Hanford Site. This report covers progress for the quarter that ended March 31, 1992. Topics covered under technical status include: disposal of tank wastes; cleanup of past-practice units; permitting and closure of treatment, storage, and disposal units; and other tri-party agreement activities and issues

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program.

Science.gov (United States)

Zeta, Lowell M

2015-01-01

The 40B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discounts on outpatient prescription drugs to qualifying safety net health care providers. The federal program is intended as a safeguard to ensure access to affordable drugs to the indigeut. However, over the last two decades safety net health care providers have exploited financial incentives under the 340B Program at the expense of drug manufacturers and patients, including the most needy and vulnerable populations-they are committed to serve. Although the federal government has been applauded for increasing effortsto combat health care fraud and abuse including recovering $3.3 billion in 2014, federal officials and the general public have paid markedly less attention to pervasive abuse of the 340B Program. In 2014, drug purchases of 340B-designated drugs totaled $7 billion and are expected to increase to $12 billion: by 2016 as a result of the expansion of the program under the Affordable Care Act. The 340B Program has completely lost its way, and comprehensive legislation is necessary to realign the program with its intent.

Perceived neighborhood illicit drug selling, peer illicit drug disapproval and illicit drug use among U.S. high school seniors

Science.gov (United States)

2014-01-01

Background This study examined associations between perceived neighborhood illicit drug selling, peer illicit drug disapproval and illicit drug use among a large nationally representative sample of U.S. high school seniors. Methods Data come from Monitoring the Future (2007–2011), an annual cross-sectional survey of U.S. high school seniors. Students reported neighborhood illicit drug selling, friend drug disapproval towards marijuana and cocaine use, and past 12-month and past 30-day illicit drug use (N = 10,050). Multinomial logistic regression models were fit to explain use of 1) just marijuana, 2) one illicit drug other than marijuana, and 3) more than one illicit drug other than marijuana, compared to “no use”. Results Report of neighborhood illicit drug selling was associated with lower friend disapproval of marijuana and cocaine; e.g., those who reported seeing neighborhood sales “almost every day” were less likely to report their friends strongly disapproved of marijuana (adjusted odds ratio [AOR] = 0.38, 95% CI: 0.29, 0.49) compared to those who reported never seeing neighborhood drug selling and reported no disapproval. Perception of neighborhood illicit drug selling was also associated with past-year drug use and past-month drug use; e.g., those who reported seeing neighborhood sales “almost every day” were more likely to report 30-day use of more than one illicit drug (AOR = 11.11, 95% CI: 7.47, 16.52) compared to those who reported never seeing neighborhood drug selling and reported no 30-day use of illicit drugs. Conclusions Perceived neighborhood drug selling was associated with lower peer disapproval and more illicit drug use among a population-based nationally representative sample of U.S. high school seniors. Policy interventions to reduce “open” (visible) neighborhood drug selling (e.g., problem-oriented policing and modifications to the physical environment such as installing and monitoring surveillance cameras) may

75 FR 51521 - Federal Motor Vehicle Safety Standards; Air Brake Systems; Technical Report on the Effectiveness...

Science.gov (United States)

2010-08-20

....121) mandates antilock braking systems (ABS) on all new air-braked vehicles with a GVWR of 10,000...-0116] Federal Motor Vehicle Safety Standards; Air Brake Systems; Technical Report on the Effectiveness of Antilock Braking Systems in Heavy Truck Tractors and Trailers AGENCY: National Highway Traffic...

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

Science.gov (United States)

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting licensure actions taken by Federal or State licensing and certification agencies. 61.7 Section 61.7 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION HEALTHCARE INTEGRITY AND PROTECTION DATA BANK FOR FINAL ADVERSE...

29 CFR 1472.220 - By when must I publish my drug-free workplace statement and establish my drug-free awareness...

Science.gov (United States)

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false By when must I publish my drug-free workplace statement and establish my drug-free awareness program? 1472.220 Section 1472.220 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements...

7 CFR 1775.8 - Other Federal statutes.

Science.gov (United States)

2010-01-01

... Workplace (Grants), implementing Executive Order 12549 on debarment and suspension and the Drug-Free Workplace Act of 1988 (41 U.S.C. 701). (i) 7 CFR part 3018—Restrictions on Lobbying, prohibiting the use of... implementation of statute), prohibiting discrimination based upon physical or mental handicap in Federally...

7 CFR 2903.21 - Applicable Federal statutes and regulations.

Science.gov (United States)

2010-01-01

... Requirements for Drug-Free Workplace (Grants). 7 CFR Part 3018—USDA implementation of Restrictions on Lobbying...)—prohibiting discrimination based upon physical or mental handicap in Federally assisted programs. 35 U.S.C...

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.

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

Science.gov (United States)

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

2012-08-16

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. Cross sectional study. Cochrane Database of Systematic Reviews. Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials. Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed. Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews.

The Legal Status of the Federal Copyright Law. Final Report.

Science.gov (United States)

Forsythe, Ralph A.; Nolte, M. Chester

The historical and legal background of the Federal Copyright Law with special implications for education was studied within five general areas of concern. The areas included: (1) historical development, (2) copyright revision issues, (3) principles of copyright law embodied in state and Federal statutes, (4) decisions of the courts pertaining to…

76 FR 51310 - Branded Prescription Drug Fee

Science.gov (United States)

2011-08-18

... Branded Prescription Drug Fee AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed... issue of the Federal Register, the IRS is issuing temporary regulations relating to the branded... business of manufacturing or importing certain branded prescription drugs. The text of the temporary...

Federal Funds for Research and Development. Fiscal Years 1982, 1983, and 1984. Volume XXXII. Final Report. Surveys of Science Resources Series.

Science.gov (United States)

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

This report discusses the support of research and development (R&D) by the federal government through appropriate agencies; it uses data from an annual survey of federal agencies following the preparation of their budgets for 1984. Therefore, this information reflects the continuation of Reagan administration policies to strengthen the United…

Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India

Directory of Open Access Journals (Sweden)

Prasad Thota

2018-01-01

Conclusion: In India, spontaneous reporting of ADRs existed since 1998 under passive surveillance method, but there is an urgent need to initiate TSR, which is a complementary method to spontaneous reporting on these drug safety alerts for further regulatory action by Central Drugs Standard Control Organization.

African Journal of Drug & Alcohol Studies, 16(1), 2017 Copyright ...

African Journals Online (AJOL)

The early age at initiation begs for more comprehensive drug prevention programmes especially in ... in terms of prevention, treatment and care of drug ... drug treatment unit in a Federal Neuropsy- .... sonal income or from family and friends,.

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.

Youth Violence and Illicit Drug Use. The NSDUH Report. Issue 5

Science.gov (United States)

Substance Abuse and Mental Health Services Administration, 2006

2006-01-01

The National Survey on Drug Use and Health (NSDUH) asks youths aged 12 to 17 to report on their involvement in violent behaviors during the 12 months before the survey. This report presents the estimated number and percentage of youths aged 12 to 17 who engaged in violent behavior in the past year. It further compares rates of violent behavior for…

To dope or not to dope: neuroenhancement with prescription drugs and drugs of abuse among Swiss university students.

Science.gov (United States)

Maier, Larissa J; Liechti, Matthias E; Herzig, Fiona; Schaub, Michael P

2013-01-01

Neuroenhancement is the use of substances by healthy subjects to enhance mood or cognitive function. The prevalence of neuroenhancement among Swiss university students is unknown. Investigating the prevalence of neuroenhancement among students is important to monitor problematic use and evaluate the necessity of prevention programs. To describe the prevalence of the use of prescription medications and drugs of abuse for neuroenhancement among Swiss university students. In this cross-sectional study, students at the University of Zurich, University of Basel, and Swiss Federal Institute of Technology Zurich were invited via e-mail to participate in an online survey. A total of 28,118 students were contacted, and 6,275 students completed the survey. Across all of the institutions, 13.8% of the respondents indicated that they had used prescription drugs (7.6%) or drugs of abuse including alcohol (7.8%) at least once specifically for neuroenhancement. The most frequently used prescription drugs for neuroenhancement were methylphenidate (4.1%), sedatives (2.7%), and beta-blockers (1.2%). Alcohol was used for this purpose by 5.6% of the participants, followed by cannabis (2.5%), amphetamines (0.4%), and cocaine (0.2%). Arguments for neuroenhancement included increased learning (66.2%), relaxation or sleep improvement (51.2%), reduced nervousness (39.1%), coping with performance pressure (34.9%), increased performance (32.2%), and experimentation (20%). Neuroenhancement was significantly more prevalent among more senior students, students who reported higher levels of stress, and students who had previously used illicit drugs. Although "soft enhancers", including coffee, energy drinks, vitamins, and tonics, were used daily in the month prior to an exam, prescription drugs or drugs of abuse were used much less frequently. A significant proportion of Swiss university students across most academic disciplines reported neuroenhancement with prescription drugs and drugs of

To dope or not to dope: neuroenhancement with prescription drugs and drugs of abuse among Swiss university students.

Directory of Open Access Journals (Sweden)

Larissa J Maier

Full Text Available BACKGROUND: Neuroenhancement is the use of substances by healthy subjects to enhance mood or cognitive function. The prevalence of neuroenhancement among Swiss university students is unknown. Investigating the prevalence of neuroenhancement among students is important to monitor problematic use and evaluate the necessity of prevention programs. STUDY AIM: To describe the prevalence of the use of prescription medications and drugs of abuse for neuroenhancement among Swiss university students. METHOD: In this cross-sectional study, students at the University of Zurich, University of Basel, and Swiss Federal Institute of Technology Zurich were invited via e-mail to participate in an online survey. RESULTS: A total of 28,118 students were contacted, and 6,275 students completed the survey. Across all of the institutions, 13.8% of the respondents indicated that they had used prescription drugs (7.6% or drugs of abuse including alcohol (7.8% at least once specifically for neuroenhancement. The most frequently used prescription drugs for neuroenhancement were methylphenidate (4.1%, sedatives (2.7%, and beta-blockers (1.2%. Alcohol was used for this purpose by 5.6% of the participants, followed by cannabis (2.5%, amphetamines (0.4%, and cocaine (0.2%. Arguments for neuroenhancement included increased learning (66.2%, relaxation or sleep improvement (51.2%, reduced nervousness (39.1%, coping with performance pressure (34.9%, increased performance (32.2%, and experimentation (20%. Neuroenhancement was significantly more prevalent among more senior students, students who reported higher levels of stress, and students who had previously used illicit drugs. Although "soft enhancers", including coffee, energy drinks, vitamins, and tonics, were used daily in the month prior to an exam, prescription drugs or drugs of abuse were used much less frequently. CONCLUSIONS: A significant proportion of Swiss university students across most academic disciplines reported

The law on the streets: Evaluating the impact of Mexico's drug decriminalization reform on drug possession arrests in Tijuana, Mexico.

Science.gov (United States)

Arredondo, J; Gaines, T; Manian, S; Vilalta, C; Bañuelos, A; Strathdee, S A; Beletsky, L

2018-04-01

In 2009, Mexican Federal Government enacted "narcomenudeo" reforms decriminalizing possession of small amounts of drugs, delegating prosecution of retail drug sales to the state courts, and mandating treatment diversion for habitual drug users. There has been insufficient effort to formally assess the decriminalization policy's population-level impact, despite mounting interest in analagous reforms across the globe. Using a dataset of municipal police incident reports, we examined patterns of drug possession, and violent and non-violent crime arrests between January 2009 and December 2014. A hierarchical panel data analysis with random effects was conducted to assess the impact of narcomenudeo's drug decriminalization provision. The reforms had no significant impact on the number of drug possession or violent crime arrests, after controlling for other variables (e.g. time trends, electoral cycles, and precinct-level socioeconomic factors). Time periods directly preceding local elections were observed to be statistically associated with elevated arrest volume. Analysis of police statistics parallel prior findings that Mexico's reform decriminalizing small amounts of drugs does not appear to have significantly shifted drug law enforcement in Tijuana. More research is required to fully understand the policy transformation process for drug decriminalization and other structural interventions in Mexico and similar regional and international efforts. Observed relationship between policing and political cycles echo associations in other settings whereby law-and-order activities increase during mayoral electoral campaigns. Copyright © 2017 Elsevier B.V. All rights reserved.

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

Science.gov (United States)

2013-07-08

... DEPARTMENT OF EDUCATION Deadline Dates for Reports and Other Records Associated With the Free... Direct Loan Program, the Teacher Education Assistance for College and Higher Education (TEACH) Grant... Student Aid, Department of Education. ACTION: Notice. Catalog Federal Domestic Assistance (CFDA) Numbers...

14 CFR 65.12 - Offenses involving alcohol or drugs.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Offenses involving alcohol or drugs. 65.12... alcohol or drugs. (a) A conviction for the violation of any Federal or state statute relating to the... narcotic drugs, marihuana, or depressant or stimulant drugs or substances is grounds for— (1) Denial of an...

14 CFR 63.12 - Offenses involving alcohol or drugs.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Offenses involving alcohol or drugs. 63.12... alcohol or drugs. (a) A conviction for the violation of any Federal or state statute relating to the... narcotic drugs, marihuana, or depressant or stimulant drugs or substances is grounds for— (1) Denial of an...

Federal Buildings Supplemental Survey 1993

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-11-01

The Energy Information Administration (EIA) of the US Department of Energy (DOE) is mandated by Congress to be the agency that collects, analyzes, and disseminates impartial, comprehensive data about energy including the volume consumed, its customers, and the purposes for which it is used. The Federal Buildings Supplemental Survey (FBSS) was conducted by EIA in conjunction with DOE`s Office of Federal Energy Management Programs (OFEMP) to gain a better understanding of how Federal buildings use energy. This report presents the data from 881 completed telephone interviews with Federal buildings in three Federal regions. These buildings were systematically selected using OFEMP`s specifications; therefore, these data do not statistically represent all Federal buildings in the country. The purpose of the FBSS was threefold: (1) to understand the characteristics of Federal buildings and their energy use; (2) to provide a baseline in these three Federal regions to measure future energy use in Federal buildings as required in EPACT; and (3) to compare building characteristics and energy use with the data collected in the CBECS.

Research activities in radiation protection. Programme report 1997. Report on the departmental research programme of the Federal Ministry for Environment, Nature Conservation and Reactor Safety (BMU), performed under the scientific and administrative project management of the Federal Office for Radiation Protection (BfS)

International Nuclear Information System (INIS)

Schmitt-Hannig, A.; Goedde, R.; Thieme, M.

1998-03-01

On behalf of the Federal Ministry for Environment, Nature Conservation and Nuclear Safety (BMU), the Federal Office for Radiation Protection (BfS) is placing research and study contracts in the field of radiation protection. The results of these projects are used for developing radiation protection rules and to fulfill the special radiation protection tasks of the BMU, required by law. Planning, expert and administrative management, placing, assistance as well as expert evaluation of the results from these research projects lies within the responsibility of the Federal Office for Radiation Protection. This report provides information on preliminary and final results of radiation protection projects within the BMU Departmental Research Programme of the year 1997. (orig.) [de

7 CFR 3400.8 - Other Federal statutes and regulations that apply.

Science.gov (United States)

2010-01-01

... and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants). 7... implementation of statute), prohibiting discrimination based upon physical or mental handicap in Federally...

Getting through the maze of federal and state radiation regulations

International Nuclear Information System (INIS)

Marshall, C.H.

1987-01-01

This course is designed to help radiologists, physicists, technologists, and administrators understand the complex system of federal and state radiation safety regulations that have an impact on the practice of radiology, nuclear medicine, and radiation therapy, and biomedical research. Emphasis is placed on the practical impact of these regulations and on strategies to meet individual and institutional responsibilities. Topics to be covered include the relative roles of the NRC, FDS, DOT, EPA, OSHA, and state and local agencies; the obligations of manufactures, institutions, and individuals; and licensing, documentation, and reporting requirements JCAH standards will also be mentioned. The role and responsibilities of the Radiation Safety Officer and of institutional radiation safety, radioactive drug, and human research committees are discussed

The Federal Role in Meeting the Education Needs of Chicanos and Puerto Ricans with Special Emphasis on Higher Education. Final Report.

Science.gov (United States)

Miranda (L.) and Associates, Bethesda, MD.

Federal efforts to meet higher educational needs of Chicanos and Puerto Ricans are analyzed in this report. As part of a study conducted by L. Miranda and Associates, 15 Federal agencies were surveyed to determine their programs and their financial commitment to Hispanic postsecondary education, and the participation of Hispanics in each agency's…

Drug hypersensitivity in children: report from the pediatric task force of the EAACI Drug Allergy Interest Group.

Science.gov (United States)

Gomes, E R; Brockow, K; Kuyucu, S; Saretta, F; Mori, F; Blanca-Lopez, N; Ott, H; Atanaskovic-Markovic, M; Kidon, M; Caubet, J-C; Terreehorst, I

2016-02-01

When questioned, about 10% of the parents report suspected hypersensitivity to at least one drug in their children. However, only a few of these reactions can be confirmed as allergic after a diagnostic workup. There is still a lack of knowledge on drug hypersensitivity (DH) epidemiology, clinical spectrum, and appropriate diagnostic methods particularly in children. Meanwhile, the tools used for DH management in adults are applied also for children. Whereas this appears generally acceptable, some aspects of DH and management differ with age. Most reactions in children are still attributed to betalactams. Some manifestations, such as nonsteroidal anti-inflammatory drug-associated angioedema and serum sickness-like reactions, are more frequent among young patients as compared to adults. Risk factors such as viral infections are particularly frequent in children, making the diagnosis challenging. The practicability and validity of skin test and other diagnostic procedures need further assessment in children. This study presents an up-to-date review on epidemiology, clinical spectrum, diagnostic tools, and current management of DH in children. A new general algorithm for the study of these reactions in children is proposed. Data are presented focusing on reported differences between pediatric and adult patients, also identifying unmet needs to be addressed in further research. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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.

Reports of evidence planting by police among a community-based sample of injection drug users in Bangkok, Thailand.

Science.gov (United States)

Fairbairn, Nadia; Kaplan, Karyn; Hayashi, Kanna; Suwannawong, Paisan; Lai, Calvin; Wood, Evan; Kerr, Thomas

2009-10-07

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. 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. 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. 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 CFR 3415.8 - Other Federal statutes and regulations that apply.

Science.gov (United States)

2010-01-01

... Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace... implementation of the statute), prohibiting discrimination based upon physical or mental handicap in Federally...

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

Science.gov (United States)

2013-11-27

... PHMSA-2013-0248] Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline... Management Information System (MIS) Data; and New Method for Operators to Obtain User Name and Password for...

The US Opioid Crisis: Current Federal and State Legal Issues.

Science.gov (United States)

Soelberg, Cobin D; Brown, Raeford E; Du Vivier, Derick; Meyer, John E; Ramachandran, Banu K

2017-11-01

The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing. Other federal agencies involved with the federal regulatory effort include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Department of Justice. Each federal agency has a unique role in helping to stem the burgeoning opioid misuse epidemic. The DEA, working with the Department of Justice, has enforcement power to prosecute pill mills and physicians for illegal prescribing. The DEA could also implement use of prescription drug monitoring programs (PDMPs), currently administered at the state level, and use of electronic prescribing for schedule II and III medications. The FDA has authority to approve new and safer formulations of immediate- and long-acting opioid medications. More importantly, the FDA can also ask pharmaceutical companies to cease manufacturing a drug. Additionally, state agencies play a critical role in reducing overdose deaths, protecting the public safety, and promoting the medically appropriate treatment of pain. One of the states' primary roles is the regulation of practice of medicine and the insurance industry within their borders. Utilizing this authority, states can both educate physicians about the dangers of opioids and make physician licensure dependent on registering and using PDMPs when prescribing controlled substances. Almost every state has implemented a PDMP to some degree; however, in addition to mandating their use, increased interstate

Good research practices for measuring drug costs in cost-effectiveness analyses: a societal perspective: the ISPOR Drug Cost Task Force report--Part II.

Science.gov (United States)

Garrison, Louis P; Mansley, Edward C; Abbott, Thomas A; Bresnahan, Brian W; Hay, Joel W; Smeeding, James

2010-01-01

Major guidelines regarding the application of cost-effectiveness analysis (CEA) have recommended the common and widespread use of the "societal perspective" for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices-Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring drug costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. The societal perspective can be defined by three conditions: 1) the inclusion of time costs, 2) the use of opportunity costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded drug costs have typically used actual acquisition cost rather than the much lower social opportunity costs that would reflect only short-run manufacturing and distribution costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a "limited societal" or "health systems" perspective, using acquisition drug prices while including indirect costs and community preferences. The

76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

Science.gov (United States)

2011-01-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

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…

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. Published by Elsevier Inc.

Uso de substâncias psicoativas entre estudantes de odontologia da Universidade Federal do Espírito Santo Psychoactive substance use among Espírito Santo Federal University odontology students

Directory of Open Access Journals (Sweden)

Renata Frossard Teixeira

2010-05-01

Full Text Available O objetivo deste trabalho é traçar o perfil do uso de substâncias psicoativas entre os universitários do curso de odontologia do Centro de Ciências da Saúde da Universidade Federal do Espírito Santo. Trata-se de um estudo exploratório, descritivo, transversal e quantitativo, desenvolvido com universitários do primeiro ao último ano do curso de odontologia. O instrumento utilizado na coleta de dados é uma adaptação do proposto pela OMS e desenvolvido pela WHO - Research and Reporting Project on the Epidemiology of Drug Dependence. Os dados foram tabulados e analisados através do Programa Statistical Package for the Social Science. 60,3% dos universitários são do sexo feminino, 48,9% se encontram na faixa etária de 20 a 22 anos e 41,3% e 43,7% pertencem à classe social A e B, respectivamente. Quanto ao uso de substâncias psicoativas, 72,4% fizeram uso na vida de alguma substância, exceto álcool e tabaco; 25,9% fizeram uso de solventes, 13,2% uso de maconha, 10,9%, de anfetamínicos, 27%, de tabaco e 87,9%, de álcool. Faz-se necessário a prevenção do uso indevido de substâncias psicoativas entre universitários, através da abordagem dessa temática no currículo acadêmico e da criação de programas específicos para universitários.The objective of this article is to trace the psychoactive substance use profile among odontology college students from the Espírito Santo Federal University Health Sciences Center. It is an explorative, descriptive, transversal and quantitative study developed with first to last year college students of the odontology course. The instrument used for data collection was an adaptation of one proposed by WHO and developed by WHO - Research and Reporting Project on the Epidemiology of Drug Dependence. Data were listed and analyzed through the Statistical Package Program for the Social Science. The results showed that 60.3% colleges student are female, 48.9% age between 20 and 22 years, 41

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

Science.gov (United States)

2013-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] 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...

Self-reported drug use among secondary school students in two rapidly developing Nigerian towns.

Science.gov (United States)

Nevadomsky, J

1982-01-01

A 32-item standardized multiple-choice and open-ended questionnaire was completed by nearly 500 male and female secondary school students in two rapidly developing Nigerian towns. About two thirds of the students reported some exposure to alcohol, and about one quarter reported some experience with tobacco. There was much less use of caffeine, methaqualone in combination with diphenhydramine, 2-ethylamino-3-phenylorcamphane in combination with vitamins, chlordiazepoxide, diazepam, cannabis and dexamphetamine. Many students fell into the "past use" category. Parents were extremely disapproving of the use of almost any drug. Many students supported stronger penalties for the use of cannabis. Non-users claimed that drugs were dangerous to health. In addition, religious beliefs were associated with abstinence from drugs.

[The actual Russian legislation in sphere of turn-over of drug agents and psychotropic substances].

Science.gov (United States)

Abramov, A Yu; Kosolapova, N V; Mikhaiylova, Yu V

2014-01-01

The drug abuse is a social occurrence. Hence, the social economic methods are the first of all means of combating this evil. At the same time, measures of especially juridical character possess significant value since they develop corresponding legal base for applying another measures. In the Russian Federation, during fifteen years the new policy of public regulation and normative legal base in the area of legal turn-over of drug agents, psychotropic substances and their precursors were developed factually from zero ground. However, the current national legislation is not deprived of some flaws and contradictions. Frequently a uniform practice of interpretation and application of legal rules regulating the controlled turn-over is lacking. On the one hand, this circumstance decreases effectiveness of action of such rules and on the other hand favors development of situations for outflow of pharmaceuticals from legal turn-over to illegal traffic. The becoming of the Russian legislation in the area of turn-over of drug agents, precursors and psychotropic substances relates to the period of late 1990s when the Federal Law No 3 FZ "On drug agents and psychotropic substances" of January 8 1998 was developed and passed by the State Duma of the Russian Federation. The given law completely conforms to principles of legal regulation of turn-over of drug agents and psychotropic substances determined by the Constitution of the Russian Federation (provisions 76, 90, 104, 105) and federal laws ("On the government of the Russian Federation" of December 17 1997, "On the ombudsman in the Russian Federation" of February 26 1997). The main characteristic of legal rules included into given group of sources of law is that they contain regulations of general disposition as basic ones for inferior sources of law. The analysis of basic Federal law No 3 FZ "On drug agents and psychotropic substances" of January 8 1998 makes it possible to conclude that in in Russia the international legal

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

Science.gov (United States)

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

2013-11-01

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

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

Science.gov (United States)

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

2012-12-23

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

Drug Products in the Medicaid Drug Rebate Program

Data.gov (United States)

U.S. Department of Health & Human Services — Active drugs that have been reported by participating drug manufacturers under the Medicaid Drug Rebate Program. All drugs are identified by National Drug Code...

76 FR 18072 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Science.gov (United States)

2011-04-01

... Workplace Drug and Alcohol Testing Programs CFR Correction In Title 49 of the Code of Federal Regulations...) * * * (2) * * * (i) Positive, with drug(s)/metabolite(s) noted, with numerical values for the drug(s) or drug metabolite(s). (ii) Positive-dilute, with drug(s)/metabolite(s) noted, with numerical values for...

Drug-induced chest pain and myocardial infarction. Reports to a national centre and review of the literature

NARCIS (Netherlands)

J.P. Ottervanger (Jan Paul); J.H.P. Wilson (Paul); B.H.Ch. Stricker (Bruno)

1997-01-01

textabstractObjectives: To analyse reports of drug-induced myocardial infarction and chest pain sent to a national reporting centre. To review which drugs were suspected of exhibiting these adverse events and what mechanisms were involved. Methods: During the 20-year period 1975 through 1994, a

78 FR 77196 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

Science.gov (United States)

2013-12-20

... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Random Drug and Alcohol Testing... the minimum random drug and alcohol testing percentage rates for the period January 1, 2014, through... Federal Regulations Title 14, section 120.109(b) (for drug testing), and 120.217(c) (for alcohol testing...

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

Science.gov (United States)

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

2017-10-01

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

76 FR 12135 - Publication Procedures for Federal Register Documents During a Funding Hiatus

Science.gov (United States)

2011-03-04

... Public Law 101-508, 104 Stat. 1388 (31 U.S.C. 1341), the Office of the Federal Register (OFR) announces... more Federal agencies, the OFR will remain open to accept and process documents authorized to be... as those related to the constitutional duties of the President, food and drug inspection, air traffic...

The Economics of the Drug War: Effective Federal Policy of Missed Opportunity?

National Research Council Canada - National Science Library

McGuire, Marvin

2002-01-01

.... Using the 1999 illegal quantities and prices, the derived legal prices, and the estimated demand elasticities for four illegal drugs, we calculated the estimated quantity demanded for these drugs in legal markets...

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.

THE ANALYSIS OF DIFFERENCES IN DOCTORS PREFERENCES IN THE PRESCRIPTIONS OF ANTIHYPERTENSIVE DRUGS IN FOUR REGIONS OF THE FAR EASTERN FEDERAL DISTRICT

Directory of Open Access Journals (Sweden)

M. S. Soboleva

2018-01-01

Full Text Available Aim. To study regional features and preferences of specialists in the choice of drug therapy of arterial hypertension in four subjects of the Far Eastern Federal District.Material and methods. Statistical data, demographic indicators, state and municipal drug procurements in Chukotka Autonomous Okrug, the Sakha Republic (Yakutia, the Magadan Region, and Kamchatka Krai were analyzed. The studied period was 2012-2016. Dynamics of the use (procurements of five main therapeutic classes of antihypertensive drugs was studied.Results. Among β-blockers the leaders were metoprolol (from 2% to 30.8% and bisoprolol (from 2.4% to 20.3%, in group of angiotensin converting enzyme inhibitors – enalapril (from 3.6% to 27%, lisinopril (from 4.4% to 23.9% and perindopril (from 0.9% to 7.8%, among calcium channel blockers – amlodipine (from 5.6% to 11.3%, in group of diuretics – indapamide (from 2.5% to 13% and spironolactone (from 3% to 12.5%, and in group of angiotensin II antagonists – losartan (from 0.4% to 15.6%. Angiotensin converting enzyme inhibitors were the most used therapeutic class of antihypertensive drugs in Chukotka Autonomous Okrug, the Magadan region and Kamchatka Krai. At the same time, β-blockers accounted for more than a half of state and municipal procurements in the Sakha Republic (Yakutia.Conclusion. It is necessary to study regional aspects and approaches to therapy to assess the extent and specificity of the implementation of research results, standards and recommendations in real clinical practice.

The pivotal role of multimodality reporter sensors in drug discovery: from cell based assays to real time molecular imaging.

Science.gov (United States)

Ray, Pritha

2011-04-01

Development and marketing of new drugs require stringent validation that are expensive and time consuming. Non-invasive multimodality molecular imaging using reporter genes holds great potential to expedite these processes at reduced cost. New generations of smarter molecular imaging strategies such as Split reporter, Bioluminescence resonance energy transfer, Multimodality fusion reporter technologies will further assist to streamline and shorten the drug discovery and developmental process. This review illustrates the importance and potential of molecular imaging using multimodality reporter genes in drug development at preclinical phases.

78 FR 59974 - Publication Procedures for Federal Register Documents During a Funding Hiatus

Science.gov (United States)

2013-09-30

... Public Law 101-508, 104 Stat. 1388 (31 U.S.C. 1341), the Office of the Federal Register (OFR) announces... hiatus affecting one or more Federal agencies, the OFR will remain open to accept and process documents... activities such as those related to the constitutional duties of the President, food and drug inspection, air...

Environment report 1990 of the Federal Minister for the Environment, Nature Protection and Reactor Safety

International Nuclear Information System (INIS)

1990-01-01

The 'Environment Report 1990' describes the environmental situation in the Federal Republic of Germany; draws a balance of environmental policy measures taken and introduced; gives information on future fields of action in environmental policy. The 'Environment Report 1990' also deals with the 'Environment Expert Opinion 1987', produced by the board of experts on environmental questions. It contains surveys of the following sectors: Protection against hazardous materials air pollution abatement, water management, waste management, nature protection and preservation of the countryside, soil conservation, noise abatement, radiation protection, reactor safety. A separate part of the 'Environment Report 1990' deals with the progress made in 'interdisciplinary fields' (general law on the protection of the environment, instruments of environmental policy, environmental information and environmental research, transfrontier environmental policy). (orig./HP) [de

Nuclear waste repository simulation experiments, Asse salt mine, Federal Republic of Germany. Annual report 1984

International Nuclear Information System (INIS)

Rothfuchs, T.; Feddersen, H.K.; Schwarzianeck, P.; Staupendahl, G.; Coyle, A.J.; Eckert, J.; Kalia, H.

1986-07-01

This is the second joint annual report (1984) on experiments simulating 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 test data for the first 19 months of operation on the following: brine migration rates, thermal mechanical behavior of the salt (including room closure, stress reading, and thermal profiles), and borehole gas pressures. In addition to field data, laboratory analyses of results are included in this report. The duration of the experiment will be 2 years, ending in December 1985

Report of the 10(th) Asia-Pacific Federation of Societies for Surgery of the Hand Congress (Organising Chair and Scientific Chair).

Science.gov (United States)

A, Roohi Sharifah; Abdullah, Shalimar

2016-10-01

A report on the 10(th) Asia-Pacific Federation of Societies for the Surgery of the Hand and 6(th) Asia-Pacific Federation of Societies for Hand Therapists is submitted detailing the numbers of attendees participating, papers presented and support received as well the some of the challenges faced and how best to overcome them from the local conference chair and scientific chair point of view.

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.

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.

41 CFR 105-74.625 - Criminal drug statute.

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Criminal drug statute. 105-74.625 Section 105-74.625 Public Contracts and Property Management Federal Property Management... Administration 74-GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 105-74...

41 CFR 105-74.635 - Drug-free workplace.

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Drug-free workplace. 105-74.635 Section 105-74.635 Public Contracts and Property Management Federal Property Management... Administration 74-GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 105-74...

The drugs phenomenon from the perspective of nursing students: patterns of consumption, attitudes and beliefs

Directory of Open Access Journals (Sweden)

Luciana de Souza Pereira de Magalhães

2018-02-01

Full Text Available Abstract Objective: To describe and analyze patterns of drug use and abuse of first- and fifth-year undergraduate nursing students and to investigate their attitudes and beliefs regarding drugs and users. Method: A quantitative, descriptive and cross-sectional study of 160 students from the Federal University of the State of Rio de Janeiro was performed. Participants were interviewed using the instruments: ASSIST and NEADA FACULTY SURVEY. Collected data were analyzed with significance being set for p-values < 0.05. Results: Students of the first and the fifth years reported that alcohol had been the most frequently used drug in the previous three months (69.4% and 80.0%, respectively. Students believe they have adequate basic education about drugs however they present a prejudiced view and negative attitudes toward users. Conclusion: The pattern of drug use among students and the lack of education about the care of drug users reinforce the need to review and reformulate course contents and practices on the subject.

Drug related problems with Antiparkinsonian agents: consumer Internet reports versus published data.

Science.gov (United States)

Schröder, Sabrina; Zöllner, York Francis; Schaefer, Marion

2007-10-01

There is currently a lack of detailed information concerning drug related problems in the outpatient treatment of Parkinson's disease. Problems associated with drug treatment communicated anonymously in Parkinson's disease online forums were therefore retrospectively searched and documented for 1 year. Based on postings concerning 12 drugs for the treatment of Parkinson's disease, a total of 238 drug related problems were identified and categorised using the Problem Intervention Documentation (PI-Doc). Of these, 153 were adverse drug reactions. Adverse drug reactions associated with the skin were relatively common, but central effects such as cognitive or psychiatric changes, effects on the sleep/waking system and other problems like headache and dizziness accounted for the highest percentage of adverse events. A comparison with data from scientific literature revealed a number of differences. This means that an analysis of online forums detected a number of drug related problems that were otherwise largely invisible. These were mainly associated with the qualitative aspects of treatment such as medication handling, dosage and individual problems concerning adverse events. In addition, the described method of identifying and classifying drug related problems in Internet forums may also be seen as a contribution to the international discussion about consumer reports and pharmacovigilance. The information about adverse drug reactions given by Internet users can be seen as a valuable adjunct to clinical trial data and as being very timely with regard to the event itself. Online forums may be considered as a suitable source of observational information to complement data from randomised clinical trials.

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

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......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...

Comparing the Medicaid Retrospective Drug Utilization Review Program Cost-Savings Methods Used by State Agencies.

Science.gov (United States)

Prada, Sergio I

2017-12-01

The Medicaid Drug Utilization Review (DUR) program is a 2-phase process conducted by Medicaid state agencies. The first phase is a prospective DUR and involves electronically monitoring prescription drug claims to identify prescription-related problems, such as therapeutic duplication, contraindications, incorrect dosage, or duration of treatment. The second phase is a retrospective DUR and involves ongoing and periodic examinations of claims data to identify patterns of fraud, abuse, underutilization, drug-drug interaction, or medically unnecessary care, implementing corrective actions when needed. The Centers for Medicare & Medicaid Services requires each state to measure prescription drug cost-savings generated from its DUR programs on an annual basis, but it provides no guidance or unified methodology for doing so. To describe and synthesize the methodologies used by states to measure cost-savings using their Medicaid retrospective DUR program in federal fiscal years 2014 and 2015. For each state, the cost-savings methodologies included in the Medicaid DUR 2014 and 2015 reports were downloaded from Medicaid's website. The reports were then reviewed and synthesized. Methods described by the states were classified according to research designs often described in evaluation textbooks. In 2014, the most often used prescription drugs cost-savings estimation methodology for the Medicaid retrospective DUR program was a simple pre-post intervention method, without a comparison group (ie, 12 states). In 2015, the most common methodology used was a pre-post intervention method, with a comparison group (ie, 14 states). Comparisons of savings attributed to the program among states are still unreliable, because of a lack of a common methodology available for measuring cost-savings. There is great variation among states in the methods used to measure prescription drug utilization cost-savings. This analysis suggests that there is still room for improvement in terms of

Nuclear waste repository simulation experiments, Asse Salt Mine, Federal Republic of Germany. Annual report, 1983

International Nuclear Information System (INIS)

Rothfuchs, T.; Luebker, D.; Coyle, A.; Kalia, H.

1984-10-01

This is the First Annual report (1983) which describes experiments simulating a nuclear waste respository at the 800-meter level of the Asse Salt Mine in the Federal Republic of Germany. The report describes the test equipment, the Asse Salt Mine, the pretest properties of the salt in the test gallery, and the mine proper. Also included are test data for the first six months of operations on brine migration rates, room closure rates, extensometer readings, stress measurements, and thermal mechanical behavior of the salt. The duration of the experiments will be two years, ending in December 1985. 3 references, 34 figures, 13 tables

41 CFR 105-74.110 - Are any of my Federal assistance awards exempt from this part?

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Are any of my Federal... Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION Regional Offices-General Services Administration 74-GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE...

Attitudes and practices regarding the use of methadone in US state and federal prisons.

Science.gov (United States)

Rich, Josiah D; Boutwell, Amy E; Shield, David C; Key, R Garrett; McKenzie, Michelle; Clarke, Jennifer G; Friedmann, Peter D

2005-09-01

In the United States, vigorous enforcement of drug laws and stricter sentencing guidelines over the past 20 years have contributed to an expanded incarcerated population with a high rate of drug use. One in five state prisoners reports a history of injection drug use, and many are opiate dependent. For over 35 years, methadone maintenance therapy has been an effective treatment for opiate dependence; however, its use among opiate-dependent inmates in the United States is limited. In June 2003, we conducted a survey of the medical directors of all 50 US states and the federal prison system to describe their attitudes and practices regarding methadone. Of the 40 respondents, having jurisdiction over 88% (n =1,266,759) of US prisoners, 48% use methadone, predominately for pregnant inmates or for short-term detoxification. Only 8% of respondents refer opiate-dependent inmates to methadone programs upon release. The results highlight the need to destigmatize the use of methadone in the incarcerated setting, expand access to methadone during incarceration, and to improve linkage to methadone treatment for opiate-dependent offenders who return to the community.

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

Science.gov (United States)

2010-10-01

... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. B Appendix B to Part 40—DOT Drug Testing.... Specimen Results Reported (total number) By Test Reason (a) Pre-employment (number) (b) Post-Accident...

Assessment of the Effects of Climate Change on Federal Hydropower

Energy Technology Data Exchange (ETDEWEB)

Sale, Michael J. [M.J. Sale and Associates, Hanson, MA (United States); Shih-Chieh, Kao [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Ashfaq, Moetasim [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Kaiser, Dale P. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Martinez, Rocio [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Webb, Cindy [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wei, Yaxing [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

2012-10-01

As 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. This Oak Ridge National Laboratory report, referred to as the “9505 Assessment,” describes the technical basis for the report to Congress that was called for in the SECURE Water Act.

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

NARCIS (Netherlands)

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.

41 CFR 105-74.220 - By when must I publish my drug-free workplace statement and establish my drug-free awareness...

Science.gov (United States)

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false By when must I publish my drug-free workplace statement and establish my drug-free awareness program? 105-74.220 Section 105-74.220 Public Contracts and Property Management Federal Property Management Regulations System...

Monitoring drug use among HIV/AIDS patients in Brazil: should we combine self-report and urinalysis?

Science.gov (United States)

Malbergier, Andre; do Amaral, Ricardo A; Cardoso, Luciana R D; Castel, Saulo

2012-12-01

Illicit drug use in HIV-infected patients can be linked to impairment of physical and mental health, low health related quality of life, and suboptimal adherence to HIV treatment. This study aimed to evaluate the correlation of self report illicit drug use, urinalysis for cocaine and cannabis metabolites, and severity of dependence among HIV-infected patients on antiretroviral therapy (ART) in a treatment center in Brazil. Four hundred and thirty-eight outpatients of an HIV referral center were interviewed and assessed for drug use (lifetime, last year and last month). Urinalysis was performed to detect the presence of cocaine and cannabis metabolites in urine samples. Overall agreement between self report and urinalysis was almost 68% for cannabis and higher than 85% for cocaine. Positive urinalysis was significantly associated with more than once a week cannabis (pdrugs were correlated. Our findings suggest that positive self-report is a reliable predictor of positive urine sample both for cannabis and cocaine, but since the agreement was not perfect, there is a role for urine drug screening in the care of patients with HIV-related conditions.

Drug use patterns among Thai illicit drug injectors amidst increased police presence

Directory of Open Access Journals (Sweden)

Suwannawong Paisan

2009-07-01

Full Text Available Abstract Thailand has traditionally pursued an aggressive enforcement-based anti-illicit drug policy in an effort to make the country "drug-free." In light of this ongoing approach, we sought to assess impacts of enforcement on drug use behaviors among a cohort of injection drug users (IDU in Thailand. We examined drug use patterns among IDU participating in a cross-sectional study conducted in Bangkok (n = 252. Participants were asked to provide data regarding patterns of drug use in the previous six months, including types of drugs consumed, method of consumption, frequency of use, and weekly income spent on drugs. We also conducted bivariate analyses to identify a possible effect of a reported increase in police presence on measures of drug use and related risk behaviors among study participants. One hundred fifty-five (61.5% individuals reported injection heroin use and 132 (52.4% individuals reported injection midazolam use at least daily in the past six months. Additionally, 86 (34.1% individuals reported at least daily injection Yaba and Ice (i.e., methamphetamine use. Participants in our study reported high levels of illicit drug use, including the injection of both illicit and licit drugs. In bivariate analyses, no association between increased police presence and drug use behaviors was observed. These findings demonstrate high ongoing rates of drug injecting in Thailand despite reports of increased levels of strict enforcement and enforcement-related violence, and raise questions regarding the merits of this approach.

The Effect of Drug Treatment on Inmate Misconduct in Federal Prisons.

Science.gov (United States)

Langan, Neal P.; Pelissier, Bernadette M. M.

2001-01-01

Evaluates the Federal Bureau of Prisons' substance abuse treatment program's effectiveness in reducing prisoner misconduct. Results show that program graduates are 74 percent less likely to engage in misconduct over a 14-month period than a comparison group. This benefit is shared by male and female inmates alike. (Contains 25 references and 2…

48 CFR 1852.223-74 - Drug- and alcohol-free workforce.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Drug- and alcohol-free... and Clauses 1852.223-74 Drug- and alcohol-free workforce. As prescribed in 1823.570-2, insert the following clause: Drug- and Alcohol-Free Workforce (MAR 1996) (a) Definitions. As used in this clause the...

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

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...

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.

77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting

Science.gov (United States)

2012-12-05

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

Science.gov (United States)

2012-02-23

...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

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

Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

Science.gov (United States)

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-01-01

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of

Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

Science.gov (United States)

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-06-01

The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative-nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. The investigative site's responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors'"filtering" of reports and increased sponsor communication. Sponsors

Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.

Science.gov (United States)

Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I

2018-06-01

The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.

Federal procurement of unlicensed medicines in Brazil; findings and implications.

Science.gov (United States)

Teodoro, Cristiane Roberta Dos Santos; Caetano, Rosângela; Godman, Brian; Dos Reis, André Luís Almeida; Maia, Aurélio de Araújo; Ramos, Mariana de Carvalho Barbosa; Osorio-de-Castro, Claudia Garcia Serpa

2017-12-01

There are safety concerns with using unlicensed medicines across countries including Brazil. Consequently this needs to be evaluated and concerns address if pertinent. Investigate such purchases by the Brazilian Federal Government from 2004 to 2013. Procurement data from a public-access databank that contains procurement information of the Brazilian Federal Government. Each procured item was cross-referenced to its active drug approval status in the Brazilian National Register (DOU). Exploratory analysis and trend measures were performed for the variables for mapping and characterizing the purchases of non-market approved drugs. 614 (0.14%) purchases in ten years corresponding to 64 unlicensed medicines - some of which had orphan drug status - and 48 different active substances; with a growing trend in recent years. Medicines in 51% of purchases were procured before obtaining marketing approval - with eventual refusals occurring in 17.8% and cancellation due to lack of efficacy and/or safety concerns in 1.1%. Health litigation accounted for 81.9% of purchases and growing in recent years. Overall a low rate of unlicensed medicine use. However there are concerns given the current regulations in Brazil and the recent increase in the use of unlicensed medicines with increased litigation.

Drugs + HIV, Learn the Link

Medline Plus

Full Text Available ... latest, federally approved HIV/AIDS medical practice guidelines, HIV treatment and prevention clinical trials, and other research information ... of this virus. Although we currently have medical therapies that ... infected with HIV, drug misuse can interfere with an individual's likelihood ...

78 FR 43890 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-07-22

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel...., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, Room 4228... . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting

Science.gov (United States)

2011-08-18

... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation.

Science.gov (United States)

Ozcan, Gulnihal; Aykac, Emel; Kasap, Yelda; Nemutlu, Nergiz T; Sen, Ebru; Aydinkarahaliloglu, N Demet

2016-03-01

In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter. The annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years. This study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities.

Solar Photovoltaic Financing: Deployment by Federal Government Agencies

Energy Technology Data Exchange (ETDEWEB)

Cory, K.; Coggeshall, C.; Coughlin, J.; Kreycik, C.

2009-07-01

The goal of this report is to examine how federal agencies can finance on-site PV projects. It explains state-level cash incentives available, the importance of solar renewable energy certificate revenues (in certain markets), existing financing structures, as well as innovative financing structures being used by federal agencies to deploy on-site PV. Specific examples from the DOD, DOE, and other federal agencies are highlighted to explain federal project financing in detail.

Canadian Drug Policy and the Reproduction of Indigenous Inequities

Directory of Open Access Journals (Sweden)

Shelley G. Marshall

2015-01-01

Full Text Available Canada’s federal drug policy under the Harper government (2006 to present is “tough on crime” and dismissive of public health and harm reduction approaches to problematic drug use. Drawing on insights from discourse and critical race theories, and Bacchi’s (2009 poststructural policy analysis framework, problematic representations in Canada’s federal drug policy discourse are examined through proposed and passed legislation, government documents, and parliamentary speaker notes. These problem representations are situated within their social, historical, and colonial context to demonstrate how this policy is poised to intersect with persistent racial inequalities that position Indigenous peoples for involvement with illicit substances and markets, and racialized discourses and practices within law and law enforcement that perpetuate Indigenous over-representation in the criminal justice system.

7 CFR 3402.20 - Other Federal statutes and regulations that apply.

Science.gov (United States)

2010-01-01

... Requirements for Drug-Free Workplace (Grants). 7 CFR part 3018—USDA implementation of New Restrictions on... discrimination based upon physical or mental handicap in Federally assisted programs. 35 U.S.C. 200 et seq.—Bayh...

The Unprincipled War: Looking at the War on Drugs

Science.gov (United States)

1993-06-18

Unidad Movid de Patrullaje Rural iv CHAPTER I INTRODUCTION Drug war - reality or rhetoric? Drugs from Latin America kill an estimated 10,000...PiP), the Peruvian equivalent to the U.S. Federal Bureau of Investigation; the Unidad Movil de Patrullaje Rural (UMOPR), the agency charged exclusively

Sexual Harassment in the Federal Workplace: Is It a Problem? A Report of the U.S. Merit Systems Protection Board Office of Merit Systems Review and Studies.

Science.gov (United States)

Mathis, Patricia A.; Prokop, Ruth T.

This report represents the culmination of a year-long evaluation of the nature and extent of sexual harassment in the federal government. The various chapters explore the: (1) attitudes of federal employees toward sexual harassment; (2) extent of sexual harassment in the federal workplace; (3) characteristics of victims and perpetrators of sexual…

75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

Science.gov (United States)

2010-08-16

... provides this draft guidance for public review and comment to ensure accessibility of Federal accounting... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting... recommended Federal GHG reporting and accounting procedures. On April 5, 2010, DOE-FEMP submitted the final...

Energy report of the Federal Government

International Nuclear Information System (INIS)

1986-01-01

The Federal Government strikes a positive balance of its energy policy. It is an effective policy due to its making use of the capacities of the market, due to its leaving enough room for investors and consumers to make decisions at their own discretion and due to the fact that governmental intervention is limited to cases where it is considered indispensable. Progress in the reduction of dependencies, in energy conservation, international competitive conditions and low-pollution measures are particularly stressed as being positive developments. Emphasize is on topical problems of nuclear energy, the present situation of the energy market, the dominant aims of future energy policy with regard to the market in general and with respect to individual sectors. (HSCH) [de

Prevalence of recreational drug use reported by men who have sex with men attending sexual health clinics in Manchester, UK.

Science.gov (United States)

Tomkins, A; Ahmad, S; Cannon, L; Higgins, S P; Kliner, M; Kolyva, A; Ward, C; Vivancos, R

2018-03-01

Recreational drug use (RDU) has been reported to be disproportionately higher in men who have sex with men (MSM) when compared to their heterosexual counterparts. To identify RDU, links to risky sexual practices and infections for MSM attending three sexual health clinics across Manchester, United Kingdom, a retrospective case note review was conducted using a random powered sample of service users attending three sites during 2014. Three hundred and fifty-seven case notes were reviewed across three sites. Eighteen per cent of service users reported any type of RDU. Use of at least one of the three drugs associated with chemsex (crystal methamphetamine, mephedrone, gamma hydroxybutyrate/gamma butyrolactone) was reported by 3.6%. A statistically significant difference was identified between non-drug users and any-drug users reporting: group sex (odds ratio [OR] 5.88, p = 0.013), condomless receptive anal intercourse (CRAI) (OR 2.77, p = 0.003) and condomless oral intercourse (OR 2.52, p = 0.016). A statistically significant difference was identified between chemsex-related drug user and non-drug user groups reporting: group sex (OR 13.05, p = 0.023), CRAI (OR 3.69, p = 0.029) and condomless insertive anal intercourse (OR 1.27, p = 0.039). There was also a statistically higher incidence of gonorrhoea infection in chemsex-related drug use compared with those not using drugs (p = 0.002, OR 6.88). This study identifies that substance use is common in MSM attending sexual health clinics in Manchester. High-risk sexual practices and certain sexually transmitted infections are more common in MSM reporting RDU.

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

Directory of Open Access Journals (Sweden)

Alessia De Angelis

2015-12-01

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

Report: EPA Has Adequate Controls to Manage Advice From Science and Research Federal Advisory Committees, but Transparency Could Be Improved

Science.gov (United States)

Report #17-P-0124, March 13, 2017. Science plays an integral role in the EPA's mission. The EPA has an adequate system of controls to manage recommendations from its science and research federal advisory committees.

Ethnicity, self reported psychiatric illness, and intake of psychotropic drugs in five ethnic groups in Sweden.

Science.gov (United States)

Bayard-Burfield, L; Sundquist, J; Johansson, S E

2001-09-01

This study hypothesises that the presumed increased risk of self reported longstanding psychiatric illness and intake of psychotropic drugs among Iranian, Chilean, Turkish, and Kurdish adults, when these groups are compared with Polish adults, can be explained by living alone, poor acculturation, unemployment, and low sense of coherence. Data from a national sample of immigrants/refugees, who were between the ages of 20-44 years old, upon their arrival in Sweden between 1980 and 1989. Unconditional logistic regression was used in the statistical modelling. Sweden. 1059 female and 921 male migrants from Iran, Chile, Turkey, Kurdistan and Poland and a random sample of 3001 Swedes, all between the ages of 27-60 years, were interviewed in 1996 by Statistics Sweden. Compared with Swedes, all immigrants had an increased risk of self reported longstanding psychiatric illness and for intake of psychotropic drugs, with results for the Kurds being non-significant. Compared with Poles, Iranian and Chilean migrants had an increased risk of psychiatric illness, when seen in relation to a model in which adjustment was made for sex and age. The difference became non-significant for Chileans when marital status was taken into account. After including civil status and knowledge of the Swedish language, the increased risks for intake of psychotropic drugs for Chileans and Iranians disappeared. Living alone, poor knowledge of the Swedish language, non-employment, and low sense of coherence were strong risk factors for self reported longstanding psychiatric illness and for intake of psychotropic drugs. Iranian, Chilean, Turkish and Kurdish immigrants more frequently reported living in segregated neighbourhoods and having a greater desire to leave Sweden than their Polish counterparts. Evidence substantiates a strong association between ethnicity and self reported longstanding psychiatric illness, as well as intake of psychotropic drugs. This association is weakened by marital status

Affirmative Action in Federal Employment: Reconciling Government Policy with Federal Law and the Constitution

National Research Council Canada - National Science Library

Willson, Stephanie

2003-01-01

...), "Instructions for the Development and Submission of Federal Affirmative Employment Multi-Year Program Plans, Annual Accomplishment Reports, and Annual Plan Updates for FY 1988 through FY 1992" MD...

The Blue Book: Accounting, Recordkeeping, and Reporting by Postsecondary Educational Institutions for Federally Funded Student Financial Aid Programs.

Science.gov (United States)

Department of Education, Washington, DC.

This book provides guidance to school business office personnel who handle fiscal recordkeeping, accounting, and reporting functions for federal Title IV student financial aid programs authorized by the Higher Education Act of 1965, as amended. It provides a technical resource for Title IV management responsibilities that are shared among various…

76 FR 59415 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2011-09-26

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Multisites... Administrator, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4234, MSC 9550... funding cycle. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction...

78 FR 63994 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-10-25

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Substance Use...., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

78 FR 40755 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-07-08

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIH Summer...., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

78 FR 37835 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-06-24

... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIH Summer...., Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, 6001... . (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

78 FR 73866 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2013-12-09

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75 FR 14175 - National Institute on Drug Abuse; Notice of Closed Meeting

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2010-03-24

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76 FR 35227 - National Institute on Drug Abuse; Notice of Closed Meeting

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2011-06-16

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75 FR 9606 - National Institute on Drug Abuse; Notice of Closed Meeting

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2010-03-03

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77 FR 3481 - National Institute on Drug Abuse Notice of Closed Meeting

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2012-01-24

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78 FR 22892 - National Institute on Drug Abuse; Notice of Closed Meeting

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2013-04-17

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76 FR 31968 - National Institute on Drug Abuse; Notice of Closed Meeting

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2011-06-02

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Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

Science.gov (United States)

Suyagh, Maysa; Farah, Doaa; Abu Farha, Rana

2015-04-01

Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice. This study is considered the first study in the region to evaluate pharmacist's knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan. A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study. The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them. The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist's role in the reporting process, and thus to have a positive impact on the overall patient caring process.

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....

Drug-resistant tuberculosis in two children in Greece: report of the first extensively drug-resistant case.

Science.gov (United States)

Katragkou, Aspasia; Antachopoulos, Charalampos; Hatziagorou, Elpis; Sdougka, Maria; Roilides, Emmanuel; Tsanakas, John

2013-04-01

Extensively drug-resistant (XDR) tuberculosis (TB) represents a serious and growing problem in both endemic and non-endemic countries. We describe a 2.5-year-old girl with XDR-pulmonary TB and an 18-month-old boy with pre-XDR-central nervous system TB. Patients received individualized treatment with second-line anti-TB agents based on genotypic and phenotypic drug susceptibility testing results. Both children achieved culture conversion 3 months and 1 month after treatment initiation, respectively. The child with XDR-pulmonary TB showed evidence of cure while treatment adverse events were managed without treatment interruption. The child with pre-XDR-central nervous system TB after 6-month hospitalization with multiple infectious complications had a dismal end due to hepatic insufficiency possibly related to anti-TB treatment. This is the first report of children with pre-XDR and XDR TB in Greece, emphasizing the public health dimensions and management complexity of XDR TB.

ANALYSIS OF CHP POTENTIAL AT FEDERAL SITES

Energy Technology Data Exchange (ETDEWEB)

HADLEY, S.W.

2002-03-11

This document was prepared at the request of the U.S. Department of Energy's (DOE's) Federal Energy Management Program (FEMP) under its Technical Guidance and Assistance and Project Financing Programs. The purpose was to provide an estimate of the national potential for combined heat and power (also known as CHP; cogeneration; or cooling, heating, and power) applications at federal facilities and the associated costs and benefits including energy and emission savings. The report provides a broad overview for the U.S. Department of Energy (DOE) and other agencies on when and where CHP systems are most likely to serve the government's best interest. FEMP's mission is to reduce the cost to and environmental impact of the federal government by advancing energy efficiency and water conservation, promoting the use of renewable energy, and improving utility management decisions at federal sites. FEMP programs are driven by its customers: federal agency sites. FEMP monitors energy efficiency and renewable energy technology developments and mounts ''technology-specific'' programs to make technologies that are in strong demand by agencies more accessible. FEMP's role is often one of helping the federal government ''lead by example'' through the use of advanced energy efficiency/renewable energy (EERE) technologies in its own buildings and facilities. CHP was highlighted in the Bush Administration's National Energy Policy Report as a commercially available technology offering extraordinary benefits in terms of energy efficiencies and emission reductions. FEMP's criteria for emphasizing a technology are that it must be commercially available; be proven but underutilized; have a strong constituency and momentum; offer large energy savings and other benefits of interest to federal sites and FEMP mission; be in demand; and carry sufficient federal market potential. As discussed in the report, CHP meets all

Drug-induced hepatic injury

DEFF Research Database (Denmark)

Friis, Henrik; Andreasen, P B

1992-01-01

The Danish Committee on Adverse Drug Reactions received 1100 reports of suspected drug-induced hepatic injury during the decade 1978-1987. The causal relationship between drug and hepatic injury was classified as definite in 57 (5.2%) reports, probable in 989 (89.9%) reports, possible in 50 (4.......5%) reports and unclassifiable in four (0.4%) reports. Hepatic injuries accounted for 5.9% of all adverse drug reactions reported, and 14.7% of the lethal adverse drug reactions. A total of 47.2% were classified as acute cytotoxic, 16.2% as acute cholestatic and 26.9% as abnormal hepatic function. In 52 (4.......7%) cases the hepatic injury was lethal; only 14 (1.3%) cases were chronic. Halothane accounted for 25% of the cases. The incidence of halothane-induced hepatic injury is decreasing, and only one lethal case has been reported since 1981. Next to halothane, sulfasalazine was the drug most often suspected...

75 FR 21006 - National Institute on Drug Abuse; Notice of Closed Meeting

Science.gov (United States)

2010-04-22

... unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, 6101 Executive Blvd., Rm. 213, MSC.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...