Making Medicines Affordable

Making Medicines Affordable
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 235
Release: 2018-03-01
Genre: Medical
ISBN: 0309468086

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.

Treating Drug Problems:

Treating Drug Problems:
Author: Committee for the Substance Abuse Coverage Study
Publisher: National Academies Press
Total Pages: 332
Release: 1992-01-01
Genre: Medical
ISBN: 9780309043960

Treating Drug Problems, Volume 2 presents a wealth of incisive and accessible information on the issue of drug abuse and treatment in America. Several papers lay bare the relationship between drug treatment and other aspects of drug policy, including a powerful overview of twentieth century narcotics use in America and a unique account of how the federal government has built and managed the drug treatment system from the 1960s to the present. Two papers focus on the criminal justice system. The remaining papers focus on Employer policies and practices toward illegal drugs. Patterns and cycles of cocaine use in subcultures and the popular culture. Drug treatment from a marketing, supply-and-demand perspective, including an analysis of policy options. Treating Drug Problems, Volume 2 provides important information to policy makers and administrators, drug treatment specialists, and researchers.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 107
Release: 2014-02-06
Genre: Medical
ISBN: 0309292492

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Countering the Problem of Falsified and Substandard Drugs

Countering the Problem of Falsified and Substandard Drugs
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 377
Release: 2013-06-20
Genre: Medical
ISBN: 0309269393

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.

Research and Development in the Pharmaceutical Industry (A CBO Study)

Research and Development in the Pharmaceutical Industry (A CBO Study)
Author: Congressional Budget Office
Publisher: Lulu.com
Total Pages: 65
Release: 2013-06-09
Genre: Science
ISBN: 1304121445

Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

WHO guideline on country pharmaceutical pricing policies

WHO guideline on country pharmaceutical pricing policies
Author:
Publisher: World Health Organization
Total Pages: 70
Release: 2020-09-29
Genre: Business & Economics
ISBN: 9240011870

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.

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 483
Release: 2017-09-28
Genre: Medical
ISBN: 0309459575

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.

Pharmaceutical Economics and Policy

Pharmaceutical Economics and Policy
Author: Stuart O. Schweitzer
Publisher: Oxford University Press
Total Pages: 433
Release: 2018
Genre: Business & Economics
ISBN: 0190623780

The pharmaceutical industry -- The biotechnology industry -- Generics and biosimilars -- The global pharmaceutical industry -- The demand for pharmaceuticals -- The demand for pharmaceuticals in major international markets -- Pharmaceutical prices -- Economic evaluation of new drugs -- Pricing pharmaceuticals in a world environment -- Pharmaceutical marketing -- Patent protection -- Drug approval process in the United States -- Pharmaceutical regulation in the European Union -- Pharmaceuticals and public policy : a look ahead

Managed Care Pharmacy Practice

Managed Care Pharmacy Practice
Author: Navarro
Publisher: Jones & Bartlett Publishers
Total Pages: 659
Release: 2008-12-11
Genre: Medical
ISBN: 076378883X

Managed Care Pharmacy Practice, Second Edition offers information critical to the development and operation of a managed care pharmacy program. The text also covers the changes that have taken place within the delivery of pharmacy services, as well as the evolving role of pharmacists.