Technology And Prescription Drug Safety

v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

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.

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.

Medication safety is the most challenging goal for pharmacy practice and patient safety professionals in all health care facilities. This book serves as an essential reference guide for planning and implementing a medication safety program. Written by nationally-recognized experts, Medication Safety: A Guide for Health Care Facilities provides a comprehensive analysis of principles and practices associated with the prevention and identification of medication errors, as well as interdisciplinary, facility-wide recommendations for achieving medication safety in all settings. This book is divided into four sections so users can easily find the information they need: the Importance of Medication Safety, the Medication Safety Team, Building a Safe Medication Use System, and Measuring Medication Safety.

This book presents information about the use of technology to support the prevention and management of drug safety issues: pharmacovigilance (PV), medication errors, drug-related problems (DRPs), counterfeit medicines and other drug safety issues. Adapting new technologies/information technologies, mobile technologies and social media has contributed effectively to safety practices for medications, with this book providing comprehensive information as a guide to its challenges and potential. Technology for Drug Safety provides practicing and trainee pharmacists, pharmacy technicians, pharmacy educators, researchers, public health policy makers, healthcare professionals and medical educators with vital information about the impact of technology on drug safety-related issues. It describes the current status of the practice, the challenges in the field and recommendations for the effective use of technology in drug safety practice including clinical trials and drug development, PV, detection of adverse drug reactions, reporting and management, medication errors detection, reporting and management, DRPs, counterfeit and substandard medications, and other safety issues.

In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.