National Adverse Drug Reaction Directory

National Adverse Drug Reaction Directory PDF

Author: United States. Food and Drug Administration

Publisher:

Published: 1970

Total Pages: 296

ISBN-13:

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Listing of coding symbols accepted as controlled vocabulary applicable to reports of adverse reactions associated with drugs. Purpose of such vocabulary is to aid storage and retrieval by computer of such adverse reactions. Arrangement: categories and subcategories, coding symbols, and index of adverse reaction terms.

National Adverse Drug Reaction Directory

National Adverse Drug Reaction Directory PDF

Author: United States. Food and Drug Administration

Publisher:

Published: 1970

Total Pages: 296

ISBN-13:

DOWNLOAD EBOOK →

Listing of coding symbols accepted as controlled vocabulary applicable to reports of adverse reactions associated with drugs. Purpose of such vocabulary is to aid storage and retrieval by computer of such adverse reactions. Arrangement: categories and subcategories, coding symbols, and index of adverse reaction terms.

Adverse Effects of Vaccines

Adverse Effects of Vaccines PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-04-26

Total Pages: 894

ISBN-13: 0309214351

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In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children. Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

Advances in Patient Safety

Advances in Patient Safety PDF

Author: Kerm Henriksen

Publisher:

Published: 2005

Total Pages: 526

ISBN-13:

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v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis

Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis PDF

Author: World Health Organization

Publisher:

Published: 2015-04-20

Total Pages: 0

ISBN-13: 9789241501583

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This 2011 update of Guidelines for the programmatic management of drug-resistant tuberculosis is intended as a tool for use by public health professionals working in response to the Sixty-second World Health Assembly's resolution on prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. Resolution WHA62.15, adopted in 2009, calls on Member States to develop a comprehensive framework for the management and care of patients with drug-resistant TB. The recommendations contained in these guidelines address the most topical questions concerning the programmatic management of drug-resistant TB: case-finding, multidrug resistance, treatment regimens, monitoring the response to treatment, and selecting models of care. The guidelines primarily target staff and medical practitioners working in TB treatment and control, and partners and organizations providing technical and financial support for care of drug-resistant TB in settings where resources are limited.

Adverse Drug Event Reporting

Adverse Drug Event Reporting PDF

Author: Board on Health Sciences Policy

Publisher: National Academies Press

Published: 2007-04-12

Total Pages: 0

ISBN-13: 9780309102766

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Recent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting these events during premarket studies, but also about the responsibility for ongoing surveillance of drugs once they are on the market. Sometimes serious adverse drug reactions are fully appreciated only after a drug has been on the market for years. Therefore, when a drug is approved and released to the market, large numbers of patients will be exposed before all the potential adverse effects have been identified and thoroughly studied. Currently, there is no clearly defined process for addressing safety questions about drugs after premarketing research has occurred. In November 2005, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation convened a workshop to explore issues associated with the reporting of ADEs. The workshop addressed the following questions: How can ADEs be effectively identified, particularly when the adverse effects are rare? How can the direct, causal effects of drugs be distinguished from simple associations? How can health-care professionals and their patients' aid in the identification of drug-related adverse events? How can knowledge of ADEs be more effectively used in clinical practice? Adverse Drug Event Reporting reviews current sources of information on adverse drug events, including the FDA's MedWatch program and the AERS, institutional review boards, and the CMS. This report considers the ways that consumers and advocacy groups can be involved in reporting adverse events, and discusses drug interactions, problems with current databases for capturing and evaluating interactions, and difficulties in communicating information about adverse drug interactions. This report also describes new requirements for information contained on drug labels and how labels can be used to communicate information about risks and drug interactions to consumers and practitioners.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 396

ISBN-13: 1587634333

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Side Effects of Drugs Annual

Side Effects of Drugs Annual PDF

Author: Jeffrey K. Aronson

Publisher: Elsevier

Published: 2011-08-19

Total Pages: 715

ISBN-13: 0080522815

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The Side Effects of Drugs Annual was first published in 1977. It has been continually published since then, as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs. Each new Annual continues to provide clinicians and medical investigators with a reliable and critical yearly survey of new data and trends in the area of Adverse Drug Reactions and Interactions. An international team of specialists has contributed to the Annuals by selecting critically from each year's writing all that is truly new and informative, by critically interpreting it, and by pointing to whatever is misleading. Provides a critical yearly survey of new data and trends Includes an essay that describes the modern approach to classifying adverse drug reactions Special reviews in this Annual include, among other topics: Antipsychotic drugs and now-onset diabetes mellitus, Treating asthma during pregnancy, and MMR vaccine and autism