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GAO-07-54 Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising
Book Synopsis Gao-07-54 Prescription Drugs by : United States Government Accountability Office
Download or read book Gao-07-54 Prescription Drugs written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2018-01-29 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAO-07-54 Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
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.
Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
On October 25,1999, the President directed the Secretary of Health and Human Services to study prescription drug costs and trends for Medicare beneficiaries. He asked that the study investigate: price differences for the most commonly used drugs for people with and without coverage; drug spending by people of various ages, as a percentage of income and of total health spending; and trends in drug expenditures by people of different ages, as a percentage of income and of total health spending. This report is the Department's response to that request. It represents the work of individuals and agencies throughout the Department, including the Agency for Healthcare Research and Quality (AHRQ), the Food and Drug Administration (FDA), the Health Care Financing Administration (HCFA), and the Office of the Assistant Secretary for Planning and Evaluation (ASPE).
Book Synopsis Report to the President by :
Download or read book Report to the President written by and published by . This book was released on 2000 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: On October 25,1999, the President directed the Secretary of Health and Human Services to study prescription drug costs and trends for Medicare beneficiaries. He asked that the study investigate: price differences for the most commonly used drugs for people with and without coverage; drug spending by people of various ages, as a percentage of income and of total health spending; and trends in drug expenditures by people of different ages, as a percentage of income and of total health spending. This report is the Department's response to that request. It represents the work of individuals and agencies throughout the Department, including the Agency for Healthcare Research and Quality (AHRQ), the Food and Drug Administration (FDA), the Health Care Financing Administration (HCFA), and the Office of the Assistant Secretary for Planning and Evaluation (ASPE).
Book Synopsis Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising by :
Download or read book Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising written by and published by DIANE Publishing. This book was released on with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
The FDA regulates the promotion of prescription drugs (PD) to ensure that promotional materials are not false and misleading and that they comply with applicable laws and regulations. FDA prohibits drug co. from promoting PD for off-label uses -- that is, for a condition or patient population for which the PD has not been approved or in a manner that is inconsistent with info. found on the approved PD label. Although doctors may prescribe PD off label, it is not permissible for drug co. to promote PD for off-label uses. FDA may take regulatory actions for violations. This report provides info. about the promotion of PD for off-label uses. It reviewed: how FDA oversees the promotion of off-label uses of PD; and what actions have been taken to address off-label PD.
Book Synopsis Prescription Drugs by : Marcia Crosse
Download or read book Prescription Drugs written by Marcia Crosse and published by DIANE Publishing. This book was released on 2008-12 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt: The FDA regulates the promotion of prescription drugs (PD) to ensure that promotional materials are not false and misleading and that they comply with applicable laws and regulations. FDA prohibits drug co. from promoting PD for off-label uses -- that is, for a condition or patient population for which the PD has not been approved or in a manner that is inconsistent with info. found on the approved PD label. Although doctors may prescribe PD off label, it is not permissible for drug co. to promote PD for off-label uses. FDA may take regulatory actions for violations. This report provides info. about the promotion of PD for off-label uses. It reviewed: how FDA oversees the promotion of off-label uses of PD; and what actions have been taken to address off-label PD.
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Adverse reactions to over-the-counter and prescription drugs are currently estimated to kill more than 100,000 Americans a year (making this the fourth leading cause of death in the United States behind cancer, heart disease, and stroke). Drawing on more than twenty years of scientific research, Dr. Michael T. Murray reveals how the pharmaceutical treatments of the most common diseases that plague our society are often ineffective and result in serious, widespread side effects—and then explains how natural treatments can help us avoid them. What the Drug Companies Won’t Tell You and Your Doctor Doesn’t Know makes clear that we must radically reevaluate the way that we take care of ourselves, and Dr. Murray provides clear guidance on the steps necessary to help you lead a fitter, happier, and healthier life.
Book Synopsis What the Drug Companies Won't Tell You and Your Doctor Doesn't Know by : Michael T. Murray
Download or read book What the Drug Companies Won't Tell You and Your Doctor Doesn't Know written by Michael T. Murray and published by Simon and Schuster. This book was released on 2009-06-30 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adverse reactions to over-the-counter and prescription drugs are currently estimated to kill more than 100,000 Americans a year (making this the fourth leading cause of death in the United States behind cancer, heart disease, and stroke). Drawing on more than twenty years of scientific research, Dr. Michael T. Murray reveals how the pharmaceutical treatments of the most common diseases that plague our society are often ineffective and result in serious, widespread side effects—and then explains how natural treatments can help us avoid them. What the Drug Companies Won’t Tell You and Your Doctor Doesn’t Know makes clear that we must radically reevaluate the way that we take care of ourselves, and Dr. Murray provides clear guidance on the steps necessary to help you lead a fitter, happier, and healthier life.
The fed. gov¿t. is the world's largest and most complex entity, with about $3 trillion in outlays in FY 2008. Reports on high-risk areas bring focus to areas needing attention due to their greater vulnerabilities to fraud, waste, abuse, and mismanagement. These reports also identify areas needing transformation to address major economy, efficiency, or effectiveness challenges. This 2009 update presents the status of high-risk areas listed in 2007 and identifies new high-risk areas. Solutions to high-risk problems offer the potential to save billions of dollars, dramatically improve service to the public, strengthen confidence and trust in the performance and accountability of the U.S. gov¿t., and ensure the ability of gov¿t. to deliver on its promises. Illus.
Book Synopsis High-Risk Series by : Gene L. Dodaro
Download or read book High-Risk Series written by Gene L. Dodaro and published by DIANE Publishing. This book was released on 2009-12 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fed. gov¿t. is the world's largest and most complex entity, with about $3 trillion in outlays in FY 2008. Reports on high-risk areas bring focus to areas needing attention due to their greater vulnerabilities to fraud, waste, abuse, and mismanagement. These reports also identify areas needing transformation to address major economy, efficiency, or effectiveness challenges. This 2009 update presents the status of high-risk areas listed in 2007 and identifies new high-risk areas. Solutions to high-risk problems offer the potential to save billions of dollars, dramatically improve service to the public, strengthen confidence and trust in the performance and accountability of the U.S. gov¿t., and ensure the ability of gov¿t. to deliver on its promises. Illus.
In the U.S., most nonprescription drugs are available over-the-counter in pharmacies and other stores. Experts have suggested that drug availability could be increased by establishing an additional class of nonprescription drugs that would be held behind the counter (BTC) but would require the intervention of a pharmacist before being dispensed; a similar class of drugs exists in many other countries. This is a report on: (1) arguments supporting and opposing a U.S. BTC drug class; (2) changes in drug availability in 5 countries and the impact of restricted nonprescription classes on availability; and (3) issues important to the establishment of a BTC drug class. The author studied 5 countries: Australia, Italy, the Netherlands, the U.K., and the U.S.
Book Synopsis Nonprescription Drugs by : Marcia Crosse
Download or read book Nonprescription Drugs written by Marcia Crosse and published by DIANE Publishing. This book was released on 2009-11 with total page 59 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the U.S., most nonprescription drugs are available over-the-counter in pharmacies and other stores. Experts have suggested that drug availability could be increased by establishing an additional class of nonprescription drugs that would be held behind the counter (BTC) but would require the intervention of a pharmacist before being dispensed; a similar class of drugs exists in many other countries. This is a report on: (1) arguments supporting and opposing a U.S. BTC drug class; (2) changes in drug availability in 5 countries and the impact of restricted nonprescription classes on availability; and (3) issues important to the establishment of a BTC drug class. The author studied 5 countries: Australia, Italy, the Netherlands, the U.K., and the U.S.
