Poor Quality Pharmaceuticals In Global Public Health

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Poor Quality Pharmaceuticals in Global Public Health

Satoru Kimura,Yasuhide Nakamura
Poor Quality Pharmaceuticals in Global Public Health Book PDF

Author : Satoru Kimura,Yasuhide Nakamura
Publisher : Springer Nature
Page : 233 pages
File Size : 45,7 Mb
Release : 2020-01-16
Category : Medical
ISBN : 9789811520891

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Poor Quality Pharmaceuticals in Global Public Health by Satoru Kimura,Yasuhide Nakamura Pdf

This book aims to clarify the global aspects of poor quality pharmaceuticals, generic products in particular, becoming complicated through the process of IMPACT (International Medical Products Anti-Counterfeiting Taskforce) organized by the initiative of the World Health Organization (WHO) in 2006. The findings from this book provide a long-term perspective to policymakers. This book discusses from the following points: industrial standardization, healthcare market accessibility, motivation on supply side, WHO medicines policy and intellectual property rights. Standardization regulates the quality and enabled the generic medicines spreading to developing/emerging countries through technology transfer. However, quality is a part of cost and reflected to price. When a healthcare service market is divided according to wealth gap, compliance to standardization for quality on supply side is divided accordingly. Thus, poor quality pharmaceuticals are prevalent worldwide. Generic pharmaceuticals are essential resources in public health. The WHO has been involved in the dispute around the intellectual property rights under its intention to promote the new drug development for neglected diseases. Global pandemic of AIDs is a critical factor to accelerate the confusion. This created feelings of distrust among developing/emerging countries against developed countries if the WHO was in favour of developed countries. In addition to that, an easy and optimistic start of IMPACT stirred up conflicts of interests in the international community. The problem of poor quality pharmaceuticals became more complicated through the conflicts on intellectual property rights; patented drugs to generic drugs. A key for quality generic products is the formation of a single healthcare service market where good motivation on supply side together with fair competitiveness with patented pharmaceuticals and equitable access to services (both for the rich and the poor) are ensured. Political commitment to investment and regulatory infrastructure for the market is crucial.

Countering the Problem of Falsified and Substandard Drugs

Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
Countering the Problem of Falsified and Substandard Drugs Book PDF

Author : Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
Publisher : National Academies Press
Page : 377 pages
File Size : 55,9 Mb
Release : 2013-06-20
Category : Medical
ISBN : 9780309269391

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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 Pdf

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.

Saving Lives, Buying Time

Institute of Medicine,Board on Global Health,Committee on the Economics of Antimalarial Drugs
Saving Lives Buying Time Book PDF

Author : Institute of Medicine,Board on Global Health,Committee on the Economics of Antimalarial Drugs
Publisher : National Academies Press
Page : 384 pages
File Size : 46,8 Mb
Release : 2004-09-09
Category : Medical
ISBN : 9780309165938

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Saving Lives, Buying Time by Institute of Medicine,Board on Global Health,Committee on the Economics of Antimalarial Drugs Pdf

For more than 50 years, low-cost antimalarial drugs silently saved millions of lives and cured billions of debilitating infections. Today, however, these drugs no longer work against the deadliest form of malaria that exists throughout the world. Malaria deaths in sub-Saharan Africaâ€"currently just over one million per yearâ€"are rising because of increased resistance to the old, inexpensive drugs. Although effective new drugs called "artemisinins" are available, they are unaffordable for the majority of the affected population, even at a cost of one dollar per course. Saving Lives, Buying Time: Economics of Malaria Drugs in an Age of Resistance examines the history of malaria treatments, provides an overview of the current drug crisis, and offers recommendations on maximizing access to and effectiveness of antimalarial drugs. The book finds that most people in endemic countries will not have access to currently effective combination treatments, which should include an artemisinin, without financing from the global community. Without funding for effective treatment, malaria mortality could double over the next 10 to 20 years and transmission will intensify.

A Practical Approach to Pharmaceutical Policy

Andreas Seiter
A Practical Approach to Pharmaceutical Policy Book PDF

Author : Andreas Seiter
Publisher : World Bank Publications
Page : 238 pages
File Size : 52,5 Mb
Release : 2010-06-17
Category : Medical
ISBN : 0821383876

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A Practical Approach to Pharmaceutical Policy by Andreas Seiter Pdf

This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

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
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Book PDF

Author : 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
Publisher : National Academies Press
Page : 366 pages
File Size : 54,7 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086

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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 Pdf

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.

Equitable Access to High-Cost Pharmaceuticals

Zaheer-Ud-Din Babar
Equitable Access to High Cost Pharmaceuticals Book PDF

Author : Zaheer-Ud-Din Babar
Publisher : Academic Press
Page : 238 pages
File Size : 51,9 Mb
Release : 2018-02-27
Category : Business & Economics
ISBN : 9780128119624

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Equitable Access to High-Cost Pharmaceuticals by Zaheer-Ud-Din Babar Pdf

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

Crossing the Global Quality Chasm

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
Crossing the Global Quality Chasm Book PDF

Author : 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
Publisher : National Academies Press
Page : 399 pages
File Size : 55,9 Mb
Release : 2019-01-27
Category : Medical
ISBN : 9780309477895

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Crossing the Global Quality Chasm 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 Pdf

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.

Stronger Food and Drug Regulatory Systems Abroad

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

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad
Publisher : National Academies Press
Page : 243 pages
File Size : 45,8 Mb
Release : 2020-04-09
Category : Medical
ISBN : 9780309670432

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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 Pdf

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.

Bottle of Lies

Katherine Eban
Bottle of Lies Book PDF

Author : Katherine Eban
Publisher : HarperCollins
Page : 512 pages
File Size : 49,5 Mb
Release : 2020-06-23
Category : Medical
ISBN : 9780063054103

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Bottle of Lies by Katherine Eban Pdf

A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

Disease Control Priorities in Developing Countries

Dean T. Jamison,Joel G. Breman,Anthony R. Measham,George Alleyne,Mariam Claeson,David B. Evans,Prabhat Jha,Anne Mills,Philip Musgrove
Disease Control Priorities in Developing Countries Book PDF

Author : Dean T. Jamison,Joel G. Breman,Anthony R. Measham,George Alleyne,Mariam Claeson,David B. Evans,Prabhat Jha,Anne Mills,Philip Musgrove
Publisher : World Bank Publications
Page : 1449 pages
File Size : 48,7 Mb
Release : 2006-04-02
Category : Medical
ISBN : 9780821361801

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Disease Control Priorities in Developing Countries by Dean T. Jamison,Joel G. Breman,Anthony R. Measham,George Alleyne,Mariam Claeson,David B. Evans,Prabhat Jha,Anne Mills,Philip Musgrove Pdf

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.

WHO guideline on country pharmaceutical pricing policies

Anonim
WHO guideline on country pharmaceutical pricing policies Book PDF

Author : Anonim
Publisher : World Health Organization
Page : 70 pages
File Size : 42,5 Mb
Release : 2020-09-29
Category : Business & Economics
ISBN : 9789240011878

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WHO guideline on country pharmaceutical pricing policies by Anonim Pdf

In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Ten years in public health 2007-2017

Margaret Chan
Ten years in public health 2007 2017 Book PDF

Author : Margaret Chan
Publisher : World Health Organization
Page : 152 pages
File Size : 50,9 Mb
Release : 2018-04-27
Category : Business & Economics
ISBN : 9789241512442

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Ten years in public health 2007-2017 by Margaret Chan Pdf

Ten years in public health 2007-2017 chronicles the evolution of global public health over the decade that Margaret Chan served as Director-General at the World Health Organization. This series of chapters evaluates successes setbacks and enduring challenges during the decade. They show what needs to be done when progress stalls or new threats emerge. The chapters show how WHO technical leadership can get multiple partners working together in tandem under coherent strategies. The importance of country leadership and community engagement is stressed repeatedly throughout the chapters. Together we have made tremendous progress. Health and life expectancy have improved nearly everywhere. Millions of lives have been saved. The number of people dying from malaria and HIV has been cut in half. WHO efforts to stop TB saved 49 million lives since the start of this century. In 2015 the number of child deaths dropped below 6 million for the first time a 50% decrease in annual deaths since 1990. Every day 19 000 fewer children die. We are able to count these numbers because of the culture of measurement and accountability instilled in WHO. These chapters tell a powerful story of global challenges and how they have been overcome. In a world facing considerable uncertainty international health development is a unifying – and uplifting – force for the good of humanity.

International Regulatory Harmonization Amid Globalization of Drug Development

Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
International Regulatory Harmonization Amid Globalization of Drug Development Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 129 pages
File Size : 53,5 Mb
Release : 2013-11-24
Category : Medical
ISBN : 9780309284790

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International Regulatory Harmonization Amid Globalization of Drug Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Vaccines, Medicines and COVID-19

Germán Velásquez
Vaccines Medicines and COVID 19 Book PDF

Author : Germán Velásquez
Publisher : Springer Nature
Page : 129 pages
File Size : 49,7 Mb
Release : 2022-01-01
Category : Medical
ISBN : 9783030891251

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Vaccines, Medicines and COVID-19 by Germán Velásquez Pdf

This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19.

Global Pharmaceutical Policy

Frederick M. Abbott,Maurice Nelson Graham Dukes,Graham Dukes
Global Pharmaceutical Policy Book PDF

Author : Frederick M. Abbott,Maurice Nelson Graham Dukes,Graham Dukes
Publisher : Edward Elgar Publishing
Page : 319 pages
File Size : 51,6 Mb
Release : 2009-01-01
Category : Law
ISBN : 9781849801843

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Global Pharmaceutical Policy by Frederick M. Abbott,Maurice Nelson Graham Dukes,Graham Dukes Pdf

There is a strong argument that people throughout the world have a right to receive the medicines they need in an appropriate, affordable, and timely way. Global Pharmaceutical Policy describes the laws, policies, and customs relating to the development and provision of medicines, identifies their strengths and weakness, and then proposes global solutions for getting things better. Here is a masterpiece written in a clear and elegant style. Together, Dukes and Abbott have experience and insight that are unrivalled. Joe Collier, Emeritus Professor of Medicines Policy, St George s, University of London, UK Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world s poor see little effort to address diseases prevalent in less affluent societies, while the world s wealthy are overusing prescription drugs, risking their health and wasting resources. As the global economic crisis exacerbates pressure on health care budgets, a new presidential administration in Washington, DC has committed to broad health care reform. These circumstances form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.