Committee on the Assessment of the US Drug Safety System's Books

The Future of Drug Safety

Promoting and Protecting the Health of the Public

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System

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The Future of Drug Safety

Promoting and Protecting the Health of the Public

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

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Page Count

347

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National Academies Press

Published Date

ISBN 10

0309103045

ISBN 13

9780309103046

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

By: Institute of Medicine,National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II

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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.

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Page Count

206

Publisher

National Academies Press

Published Date

ISBN 10

0309212804

ISBN 13

9780309212809

Preventing Medication Errors

By: Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors

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Preventing Medication Errors

By: Institute of Medicine,Board on Health Care Services,Committee on Identifying and Preventing Medication Errors

In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

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481

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National Academies Press

Published Date

ISBN 10

0309101476

ISBN 13

9780309101479

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

By: Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries

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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

By: Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

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366

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National Academies Press

Published Date

ISBN 10

030922408X

ISBN 13

9780309224086

The Future of Drug Safety

Promoting and Protecting the Health of the Public

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System

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The Future of Drug Safety

Promoting and Protecting the Health of the Public

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System

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347

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National Academies Press

Published Date

ISBN 10

0309103045

ISBN 13

9780309103046

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

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Page Count

292

Publisher

National Academies Press

Published Date

ISBN 10

0309218160

ISBN 13

9780309218160

Book's by Committee on the Assessment of the US Drug Safety System

The Future of Drug Safety

The Future of Drug Safety

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

Preventing Medication Errors

Preventing Medication Errors

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

The Future of Drug Safety

The Future of Drug Safety

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

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