Drug Safety in Developing Countries

Drug Safety in Developing Countries PDF Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Business & Economics
Languages : en
Pages : 656

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Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Drug Safety in Developing Countries

Drug Safety in Developing Countries PDF Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Business & Economics
Languages : en
Pages : 656

Get Book

Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030922408X
Category : Medical
Languages : en
Pages : 366

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Book Description
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.

The Importance of Pharmacovigilance

The Importance of Pharmacovigilance PDF Author: World Health Organization
Publisher:
ISBN: 9789241590150
Category : Drug monitoring
Languages : en
Pages : 48

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Book Description
The purpose of this document is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health.

Patient Safety in Developing Countries

Patient Safety in Developing Countries PDF Author: Yaser Al-Worafi
Publisher: CRC Press
ISBN: 1000957020
Category : Medical
Languages : en
Pages : 579

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Book Description
Understanding the various aspects of patient safety education, practice, and research in developing countries is vital in preparing a plan to overcome the challenges of improving patient safety. This unique volume discusses patient safety in developing countries, and the achievements and challenges faced in those places when trying to improve patient safety education and practice.This book includes a compilation of over 100 case studies surrounding patient safety in all aspects of health care. Both real and simulated scenarios are provided to help medical students and professionals apply their knowledge to solve the cases and prepare for real practice. Features Describes the achievements and challenges of patient safety in developing countries. Includes real and simulated case studies and key answers on patient safety issues. Prepares medical students and practitioners for real-life situations. Diverse audience including those in medication to safety testing, patient education, dispensing changes, and the design of health systems. Aids medical students and practitioners to improve their skills to solve cases.

International Regulatory Harmonization Amid Globalization of Drug Development

International Regulatory Harmonization Amid Globalization of Drug Development PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309284791
Category : Medical
Languages : en
Pages : 129

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Book Description
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.

Disease Control Priorities in Developing Countries

Disease Control Priorities in Developing Countries PDF Author: Dean T. Jamison
Publisher: World Bank Publications
ISBN: 0821361805
Category : Medical
Languages : en
Pages : 1449

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Book Description
Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries.

Equitable Access to High-Cost Pharmaceuticals

Equitable Access to High-Cost Pharmaceuticals PDF Author: Zaheer-Ud-Din Babar
Publisher: Academic Press
ISBN: 0128119624
Category : Business & Economics
Languages : en
Pages : 238

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Book Description
Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs Incorporates existing guidelines and recommendations by international organizations Compares and contrasts how different countries fund and police high-cost drug access Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing Reviews novel pharmaceuticals of current research interest

Improving Drug Safety — A Joint Responsibility

Improving Drug Safety — A Joint Responsibility PDF Author: Rolf Dinkel
Publisher: Springer Science & Business Media
ISBN: 3642612504
Category : Medical
Languages : en
Pages : 338

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Book Description
As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).

Pharmacoepidemiology

Pharmacoepidemiology PDF Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220

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Book Description
This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

The Use of Drugs in Food Animals

The Use of Drugs in Food Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309175771
Category : Medical
Languages : en
Pages : 276

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Book Description
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.