Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products's Books

Countering the Problem of Falsified and Substandard Drugs

By: Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products

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Countering the Problem of Falsified and Substandard Drugs

By: Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

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377

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National Academies Press

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ISBN 10

0309269393

ISBN 13

9780309269391

Countering the Problem of Falsified and Substandard Drugs

By: Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products

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Countering the Problem of Falsified and Substandard Drugs

By: Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products

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377

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National Academies Press

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ISBN 10

0309269393

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9780309269391

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

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ISBN 10

030922408X

ISBN 13

9780309224086

Stronger Food and Drug Regulatory Systems Abroad

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad

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Stronger Food and Drug Regulatory Systems Abroad

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad

Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

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243

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National Academies Press

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ISBN 10

0309670438

ISBN 13

9780309670432

Crossing the Global Quality Chasm

Improving Health Care Worldwide

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Global Health,Committee on Improving the Quality of Health Care Globally

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Crossing the Global Quality Chasm

Improving Health Care Worldwide

In 2015, building on the advances of the Millennium Development Goals, the United Nations adopted Sustainable Development Goals that include an explicit commitment to achieve universal health coverage by 2030. However, enormous gaps remain between what is achievable in human health and where global health stands today, and progress has been both incomplete and unevenly distributed. In order to meet this goal, a deliberate and comprehensive effort is needed to improve the quality of health care services globally. Crossing the Global Quality Chasm: Improving Health Care Worldwide focuses on one particular shortfall in health care affecting global populations: defects in the quality of care. This study reviews the available evidence on the quality of care worldwide and makes recommendations to improve health care quality globally while expanding access to preventive and therapeutic services, with a focus in low-resource areas. Crossing the Global Quality Chasm emphasizes the organization and delivery of safe and effective care at the patient/provider interface. This study explores issues of access to services and commodities, effectiveness, safety, efficiency, and equity. Focusing on front line service delivery that can directly impact health outcomes for individuals and populations, this book will be an essential guide for key stakeholders, governments, donors, health systems, and others involved in health care.

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