Persistent Drug Shortages In The United States
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Persistent Drug Shortages In The United States
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Author : Hillary E. Robinson
language : en
Publisher: Nova Science Publishers
Release Date : 2014
Persistent Drug Shortages In The United States written by Hillary E. Robinson and has been published by Nova Science Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Drug accessibility categories.
From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful outcomes for patients of all ages. Over the last decade, an increasing number of prescription drugs -- including life-saving and life-sustaining drugs -- have been in short supply, preventing health care providers and patients from accessing medications that are essential for treatment. During shortages, providers -- including hospitals, physicians, and pharmacists -- may have to use medications that could be less effective for treating conditions or carry unwanted side-effects, if alternatives are available at all. The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. This book reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers; examines the causes of drug shortages; and evaluates the progress FDA has made in addressing drug shortages.
Drug Shortages Certain Factors Are Strongly Associated With This Persistent Public Health Challenge
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Author : United States. Government Accountability Office
language : en
Publisher:
Release Date : 2016
Drug Shortages Certain Factors Are Strongly Associated With This Persistent Public Health Challenge written by United States. Government Accountability Office 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.
Drug Shortages
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Author : United States Government Accountability Office
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-12-16
Drug Shortages written by United States Government Accountability Office and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-16 with categories.
Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge
Drug Shortages Certain Factors Are Strongly Associated With This Persistent Public Health Challenge
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Author : U.s. Government Accountability Office
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-07-26
Drug Shortages Certain Factors Are Strongly Associated With This Persistent Public Health Challenge written by U.s. Government Accountability Office and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-26 with Drug accessibility categories.
Drug shortages, certain factors are strongly associated with this persistent public health challenge : report to congressional committee.Drug shortages are a serious public health concern. GAO previously found that many shortages were of sterile injectable drugs and could generally be traced to supply disruptions caused by manufacturers slowing or halting production to address quality issues.Congress included a provision in statute for GAO to review several aspects of drug shortages. This report examines (1) trends in drug shortages, (2) FDA's efforts to prioritize reviews of drug submissions to address shortages, (3) trends in FDA warning letters issued to sterile injectable manufacturing establishments for noncompliance with manufacturing standards, and (4) the relationship between certain factors and shortages of sterile injectable drugs. GAO analyzed-using various methods including regression analyses-drug shortage data from the University of Utah Drug Information Service from 2010 through 2015; drug sales data from IMS Health from 2010 through 2014 for sterile injectable anti-infective and cardiovascular drugs (which have been subject to multiple and prolonged shortages); and FDA data, including data on warning letters related to inspections conducted from October 2006 through September 2013 and data on prioritized reviews from January 2010 through July 2014, which were generally the latest available data at the time GAO began its analysis. GAO also interviewed FDA officials"
Assessing Relationships Between Drug Shortages In The United States And Other Countries
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Author : Andrew W. Mulcahy
language : en
Publisher:
Release Date : 2021
Assessing Relationships Between Drug Shortages In The United States And Other Countries written by Andrew W. Mulcahy and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with categories.
Drug shortages, which occur when the supply of drugs does not meet the demand, are a persistent policy and public health concern in the United States and in other countries. Shortages can adversely affect the quality and safety of care provided to patients, and they have implications for morbidity and mortality. Although there is broad international agreement about the importance of mitigating or preventing drug shortages, approaches to defining and tracking them remain fragmented. As a result, the extent to which drug shortages are truly global in nature is often unclear. The authors of this report contribute to the developing literature on the global scope of drug shortages by assessing whether U.S. drug shortages result in (1) measurable changes in U.S. volume, price, and other metrics, and (2) measurable changes in the same outcomes in other countries. The authors combined information from two U.S. drug shortage databases, one from the Food and Drug Administration (FDA) and the other from the American Society of Health-System Pharmacists (ASHP). The authors also used international prescription drug market data from IQVIA's MIDAS database. They found that most U.S. shortages appear to be domestic in scope. The most-severe U.S. shortages, measured by decreases in volume, only occasionally affected other countries in the same way. Although it is important to keep the global perspective in mind when addressing drug shortages, regulators, other policymakers, and the entire health care system should explore ways to leverage the supply of drugs in other countries in response to U.S. shortages.
Drug Shortages
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Author : Marcia Crosse
language : en
Publisher:
Release Date : 2016-08-24
Drug Shortages written by Marcia Crosse and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-24 with categories.
Drug shortages are a serious public health concern. Previous reports found that many shortages were of sterile injectable drugs and could generally be traced to supply disruptions caused by manufacturers slowing or halting production to address quality issues. This report reviewed several aspects of drug shortages. It examines: (1) trends in drug shortages; (2) the Food and Drug Administration's (FDA's) efforts to prioritize reviews of drug submissions to address shortages; (3) trends in FDA warning letters issued to sterile injectable manufacturing establishments for noncompliance with manufacturing standards; and (4) the relationship between certain factors and shortages of sterile injectable drugs. Tables and figures. This is a print on demand report.
Making Medicines Affordable
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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.
Drug Shortages
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Author : Kara Stencel
language : en
Publisher:
Release Date : 2014
Drug Shortages written by Kara Stencel and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with categories.
Government and private-sector leaders have struggled to address persistent drug shortages driven by complex market forces.
Conf Rence Interprofessionnelle De L Apprentissage
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Author :
language : en
Publisher:
Release Date :
Conf Rence Interprofessionnelle De L Apprentissage written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Countering The Problem Of Falsified And Substandard Drugs
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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.