Drug Shortages Pricing And Regulatory Activity

DOWNLOAD

Download Drug Shortages Pricing And Regulatory Activity PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Drug Shortages Pricing And Regulatory Activity book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page

Drug Shortages Pricing And Regulatory Activity

DOWNLOAD
Author : Christopher Stomberg
language : en
Publisher:
Release Date : 2016

Drug Shortages Pricing And Regulatory Activity written by Christopher Stomberg and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016 with Drug accessibility categories.

This study examines the patterns and causes of shortages in generic non-injectable drugs (e.g., tablets and topicals) in the United States. While shortages for injectable drugs have garnered more attention, shortages of other forms of prescription drugs have also been on the increase. In fact, they follow a strikingly similar trend with a number of important tablet drugs having recently been affected by shortage. This poses important questions about the root causes of these trends since most explanations found in the literature are specific to generic injectable drugs. Using a simple heuristic framework, three contributing factors are explored: regulatory oversight, potential market failures in pricing/reimbursement, and competition. This paper features an empirical examination of the contribution of changes in regulatory oversight to drug shortages. A pooled dynamic regression model using FDA data on inspections and citations reveals a statistically significant relationship between FDA regulatory activity (inspections and citations) and drug shortage rates. This result cuts across both injectable and non-injectable drugs, and could reveal a transition in equilibrium quality that should be transitory in nature, but it should also be interpreted with care given the other factors likely affecting shortage rates.

Fda S Contribution To The Drug Shortage Crisis

DOWNLOAD
Author : Darrell Issa
language : en
Publisher:
Release Date : 2013-02-24

Fda S Contribution To The Drug Shortage Crisis written by Darrell Issa and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-24 with Medical categories.

American patients and doctors confront an unprecedented shortage of critical drugs. The widespread shortages are causing inferior treatment regimens, interruptions in care, higher health care costs, and even premature death. The drugs in shortage are mostly generic injectable medications, many of which have been on the market for decades. Although the shortages have been attributed to a myriad of factors from a lack of raw materials to increased demand, information obtained by a Congressional Comm. shows that the crisis was largely sparked by actions of the Food and Drug Admin. (FDA). The Comm. learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of America's largest producers of generic injectable medications. The drug shortage crisis began in 2010 shortly after Margaret Hamburg became FDA Commissioner. Since then, the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs. Contents of this report: Extent of the Drug Shortage Crisis; Economics of Shortages; Growing Market Concentration Laid the Groundwork for the Drug Shortage; FDA's Role in Causing the Drug Shortages; Conclusion; Recommendations. Figures. This is a print on demand report.

Making Medicines Affordable

DOWNLOAD
Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-03-01

Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-01 with Medical categories.

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Regulating Medicines In A Globalized World

DOWNLOAD
Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-04-25

Regulating Medicines In A Globalized World written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-25 with Medical categories.

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Who Guideline On Country Pharmaceutical Pricing Policies

DOWNLOAD
Author :
language : en
Publisher: World Health Organization
Release Date : 2020-09-29

Who Guideline On Country Pharmaceutical Pricing Policies written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-09-29 with Business & Economics categories.

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.

Innovative Solutions For Sustainable Supply Chains

DOWNLOAD
Author : Hassan Qudrat-Ullah
language : en
Publisher: Springer
Release Date : 2018-08-28

Innovative Solutions For Sustainable Supply Chains written by Hassan Qudrat-Ullah and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-28 with Business & Economics categories.

This book presents the latest tools, techniques, and solutions that decision makers use to overcome the challenges faced by their sustainable supply chains. Given the ever increasing significance of socio-economic and environmental factors, the management of sustainable supply chains has become a complex and dynamic task. Multiple and conflicting objectives of stakeholders including suppliers, manufacturers, service providers, and retailers add to the complexity of decisions that modern day managers of supply chains face. With the unprecedented technological developments and innovations at hand, sustainability can be maximized for all the activities of a supply chain including: service concept and product design, material sourcing and procurement, manufacturing processes, delivery of the final product, and end-of-life management of the product. Consequently, the sustainable supply chains' problems require a systematic and integrated approach. Modeling and simulation, in general, as well as system dynamics and agent-based modeling, in particular, have the capabilities to deal with the complexity of sustainable supply chain related problems. This book will appeal to professionals and researchers in the field.

Countering The Problem Of Falsified And Substandard Drugs

DOWNLOAD
Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-06-20

Countering The Problem Of Falsified And Substandard Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-20 with Medical categories.

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.

Pharmaceutical Supply Chains Medicines Shortages

DOWNLOAD
Author : Ana Paula Barbosa-Povoa
language : en
Publisher: Springer
Release Date : 2019-06-01

Pharmaceutical Supply Chains Medicines Shortages written by Ana Paula Barbosa-Povoa and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-01 with Medical categories.

This book provides an insight of relevant case studies and updated practices in “PharmaceuticalSupply Chains” (PharmSC) while addressing the most relevant topics within the COST Action “Medicines Shortages” (CA15105).The volume focuses on the most recent developments in the design, planning and scheduling ofPharmSC, broadening from the suppliers’ selection to the impact on patients and healthcaresystems, addressing uncertainty and risk mitigation, and computational issues. It is directed at MSc/PhD students and young researchers (Post-Docs) in Pharmaceutics/Pharmaceutical sciences, Engineering fields, Economics/Management, as well as pharmaceutical decision makers, managers, and practitioners, and advanced readers demanding a fresh approach to decision making for PharmSC. The contributed chapters are associated with the homonymous COST Training Schools (TS), and the book creates a better understanding of the Action “Medicines Shortages” challenges and opportunities.

Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad

DOWNLOAD
Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-09-03

Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-03 with Medical categories.

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.

Measuring And Modeling Health Care Costs

DOWNLOAD
Author : Ana Aizcorbe
language : en
Publisher: University of Chicago Press
Release Date : 2018-03-05

Measuring And Modeling Health Care Costs written by Ana Aizcorbe and has been published by University of Chicago Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-05 with Business & Economics categories.

Health care costs represent a nearly 18% of U.S. gross domestic product and 20% of government spending. While there is detailed information on where these health care dollars are spent, there is much less evidence on how this spending affects health. The research in Measuring and Modeling Health Care Costs seeks to connect our knowledge of expenditures with what we are able to measure of results, probing questions of methodology, changes in the pharmaceutical industry, and the shifting landscape of physician practice. The research in this volume investigates, for example, obesity’s effect on health care spending, the effect of generic pharmaceutical releases on the market, and the disparity between disease-based and population-based spending measures. This vast and varied volume applies a range of economic tools to the analysis of health care and health outcomes. Practical and descriptive, this new volume in the Studies in Income and Wealth series is full of insights relevant to health policy students and specialists alike.