The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already existâ€"like evidence-based medicationsâ€"are not being deployed to maximum impact. To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.

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.

For more than 50 years, low-cost antimalarial drugs silently saved millions of lives and cured billions of debilitating infections. Today, however, these drugs no longer work against the deadliest form of malaria that exists throughout the world. Malaria deaths in sub-Saharan Africaâ€"currently just over one million per yearâ€"are rising because of increased resistance to the old, inexpensive drugs. Although effective new drugs called "artemisinins" are available, they are unaffordable for the majority of the affected population, even at a cost of one dollar per course. Saving Lives, Buying Time: Economics of Malaria Drugs in an Age of Resistance examines the history of malaria treatments, provides an overview of the current drug crisis, and offers recommendations on maximizing access to and effectiveness of antimalarial drugs. The book finds that most people in endemic countries will not have access to currently effective combination treatments, which should include an artemisinin, without financing from the global community. Without funding for effective treatment, malaria mortality could double over the next 10 to 20 years and transmission will intensify.

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.

It’s the business of saving lives. Miracle Medicines goes behind the scenes of the pharmaceutical industry and into the high-security laboratories to tell the stories of the men and women---chemists, physiologists, medical and clinical researchers, engineers---who have chosen to toil for years in the lab in order to transform scientific theories into new lifesaving medicines. You’ll witness the day-to-day labors, victories and defeats of the dedicated professionals who are waging a war against the diseases that still plague mankind. From the confines of their laboratories, these pharmaceutical adventurers explore unknown territories in health and science. Miracle Medicines reveals what really happens during the long and uncertain journey that each new drug and its creators must endure from theory, to research, to testing and, finally, FDA approval and delivery to the public. It’s a very human story within the context of fascinating scientific innovation. Through first hand interviews you’ll also meet the patients who benefit from these manmade miracles and learn how, within their bloodstreams, an ongoing battle is raging. The drugs profiled are: Advair: GlaxoSmithKline’s revolutionary asthma medication, the first packaged as both a control and emergency drug. Gleevec: The Novartis’ chronic myeloid leukemia treatment born from decades of medical research in a field of study that was once considered hopeless. Humalog: Eli Lilly’s reinvention of insulin to control diabetes has been described as being better than nature Lipitor: Pfizer’s miracle antidote for high cholesterol that was nearly lost to the pharmaceutical vaults and has since become the world’s top-selling medicine. Norvir: Abbott’s contribution to the fight against HIV that nearly erases all traces of the disease from the bloodstream and prolongs the life of patients. Remicade: Created for the treatment of Crohn’s disease, rheumatoid arthritis and other Immune Mediated Inflammatory Diseases, Johnson & Johnson’s revolutionary biomedicine was developed from technology that once was only found in science fiction. Seroquel: AstraZeneca’s treatment for both schizophrenia and bipolar mania that has given millions of psychiatrics a new lease on life. This compelling and truth-revealing book will forever change the way you view the medicines in your medicine cabinet, and the people who create them.

Few people realize that prescription drugs have become a leading cause of death, disease, and disability. Adverse reactions to widely used drugs, such as psychotropics and birth control pills, as well as biologicals, result in FDA warnings against adverse reactions. The Risks of Prescription Drugs describes how most drugs approved by the FDA are under-tested for adverse drug reactions, yet offer few new benefits. Drugs cause more than 2.2 million hospitalizations and 110,000 hospital-based deaths a year. Serious drug reactions at home or in nursing homes would significantly raise the total. Women, older people, and people with disabilities are least used in clinical trials and most affected. Health policy experts Donald Light, Howard Brody, Peter Conrad, Allan Horwitz, and Cheryl Stults describe how current regulations reward drug companies to expand clinical risks and create new diseases so millions of patients are exposed to unnecessary risks, especially women and the elderly. They reward developing marginally better drugs rather than discovering breakthrough, life-saving drugs. The Risks of Prescription Drugs tackles critical questions about the pharmaceutical industry and the privatization of risk. To what extent does the FDA protect the public from serious side effects and disasters? What is the effect of giving the private sector and markets a greater role and reducing public oversight? This volume considers whether current rules and incentives put patients' health at greater risk, the effect of the expansion of disease categories, the industry's justification of high U.S. prices, and the underlying shifts in the burden of risk borne by individuals in the world of pharmaceuticals. Chapters cover risks of statins for high cholesterol, SSRI drugs for depression and anxiety, and hormone replacement therapy for menopause. A final chapter outlines six changes to make drugs safer and more effective. Suitable for courses on health and aging, gender, disability, and minority studies, this book identifies the Risk Proliferation Syndrome that maximizes the number of people exposed to these risks. Additional Columbia / SSRC books on the privatization of risk and its implications for Americans: Bailouts: Public Money, Private ProfitEdited by Robert E. Wright Disaster and the Politics of InterventionEdited by Andrew Lakoff Health at Risk: America's Ailing Health System-and How to Heal ItEdited by Jacob S. Hacker Laid Off, Laid Low: Political and Economic Consequences of Employment InsecurityEdited by Katherine S. Newman Pensions, Social Security, and the Privatization of RiskEdited by Mitchell A. Orenstein

Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.