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Author: Hillary E. Robinson
Publisher: Nova Science Publishers
ISBN: 9781633211742
Category : Drug accessibility
Languages : en
Pages : 0
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Book Description
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.
Author: Hillary E. Robinson
Publisher: Nova Science Publishers
ISBN: 9781633211742
Category : Drug accessibility
Languages : en
Pages : 0
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Book Description
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.
Author: United States. Government Accountability Office
Publisher:
ISBN:
Category : Drug accessibility
Languages : en
Pages : 70
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Book Description
Author: U.s. Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781973921714
Category : Drug accessibility
Languages : en
Pages : 76
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Book Description
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"
Author: United States Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781981763443
Category :
Languages : en
Pages : 76
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Book Description
Drug Shortages: Certain Factors Are Strongly Associated with This Persistent Public Health Challenge
Author: Andrew W. Mulcahy
Publisher:
ISBN:
Category :
Languages : en
Pages : 114
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Book Description
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.
Author: Marcia Crosse
Publisher:
ISBN: 9781457864063
Category :
Languages : en
Pages : 76
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
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Book Description
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.
Author: U.s. Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781973956594
Category :
Languages : en
Pages : 94
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Book Description
" From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful patient outcomes. FDA-an agency within the Department of Health and Human Services (HHS)-is responsible for protecting public health and works to prevent, alleviate, and resolve shortages. In 2011, GAO recommended that FDA should enhance its ability to respond to shortages. In 2012, FDASIA gave FDA new authorities to improve its responsiveness and mandated GAO to study drug shortages. In this report, GAO (1) reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers; (2) examines the causes of drug shortages; and (3) evaluates the progress FDA has made in addressing drug shortages. GAO analyzed data from FDA and the University of Utah Drug Information Service, which is generally regarded as the most comprehensive source of drug shortage information for the time period we reviewed. GAO interviewed officials from FDA and other federal agencies, organizations representing patients and providers, and drug manufacturers. GAO also reviewed the literature, relevant statutes, regulations, and documents. "
Author: Kara Stencel
Publisher:
ISBN:
Category :
Languages : en
Pages : 5
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Book Description
Government and private-sector leaders have struggled to address persistent drug shortages driven by complex market forces.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :
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