This updated and revised 2nd edition of "Drug Benefits and Risks" is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs, but in this context also highlighting the social impact which drugs have in modern societies. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose, the book covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases; the book gives guidance on how doctors should act so that drugs can be used effectively and safely; and it encourages the rational use of drugs in society.This publication brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.

This is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs but in this context also the social impact which drugs have in modern societies is highlighted. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book * Covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases * Gives guidance on how doctors should act so that drugs can be used effectively and safely * Encourages the rational use of drugs in society This book brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.

All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

If you believe that the latest blockbuster medication is worth a premium price over your generic brand, or that doctors have access to all the information they need about a drug’s safety and effectiveness each time they write a prescription, Dr. Jerry Avorn has some sobering news. Drawing on more than twenty-five years of patient care, teaching, and research at Harvard Medical School, he shares his firsthand experience of the wide gap in our knowledge of the effectiveness of one medication as compared to another. In Powerful Medicines, he reminds us that every pill we take represents a delicate compromise between the promise of healing, the risk of side effects, and an increasingly daunting price. The stakes on each front grow higher every year as new drugs with impressive power, worrisome side effects, and troubling costs are introduced. This is a comprehensive behind-the-scenes look at issues that affect everyone: our shortage of data comparing the worth of similar drugs for the same condition; alarming lapses in the detection of lethal side effects; the underuse of life-saving medications; lavish marketing campaigns that influence what doctors prescribe; and the resulting upward spiral of costs that places vital drugs beyond the reach of many Americans. In this engagingly written book, Dr. Avorn asks questions that will interest every consumer: How can a product judged safe by the Food and Drug Administration turn out to have unexpectedly lethal side effects? Why has the nation’s drug bill been growing at nearly 20 percent per year? How can physicians and patients pick the best medication in its class? How do doctors actually make their prescribing decisions, and why do those decisions sometimes go wrong? Why do so many Americans suffer preventable illnesses and deaths that proper drug use could have averted? How can the nation gain control over its escalating drug budget without resorting to rationing or draconian governmental controls? Using clinical case histories taken from his own work as a practitioner, researcher, and advocate, Dr. Avorn demonstrates the impressive power of the well-conceived prescription as well as the debacles that can result when medications are misused. He describes an innovative program that employs the pharmaceutical industry’s own marketing techniques to reduce use of some of the most overprescribed and overpriced products. Powerful Medicines offers timely and practical advice on how the nation can improve its drug-approval process, and how patients can work with doctors to make sure their prescriptions are safe, effective, and as affordable as possible. This is a passionate and provocative call for action as well as a compelling work of clear-headed science.

Understanding risk -- Putting risk in perspective -- Risk charts : a way to get perspective -- Judging the benefit of a health intervention -- Not all benefits are equal : understand the outcome -- Consider the downsides -- Do the benefits outweight the downsides? -- Beware of exaggerated importance -- Beware of exaggerated certainty -- Who's behind the numbers?

The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.

All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

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.