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Cancer Policy: Pharmaceutical Safety provides invaluable information on the interesting and compelling field of cancer drug safety. Identifying and understanding high-priority policy issues and key pharmacovigilance strategies is of paramount importance. In this volume, outstanding and original chapters provide an overview and synthesis of the latest thoughts and findings relating to drug safety in the cancer domain. Topics include natural language processing and pharmacovigilance of alternative cancer pharmaceuticals. The information presented in this volume will improve understanding of emerging strategies to identify adverse drug reactions and drug-drug interactions within the cancer setting and will highlight policies that have been instituted to improve cancer patient safety. In summary, Cancer Policy: Pharmaceutical Safety explores many of the important areas of pharmacovigilance research in oncology.
This book offers a wide-ranging description and analysis of recent developments and current trends in health policy with regard to cancer drug safety. The book opens with an overview of pharmacovigilance for cancer blockbuster drugs, covering both general considerations and efforts to develop a structured framework for the identification and reporting of adverse drug reactions (ADRs). A number of important examples of serious ADRs to hematology and oncology drugs are then reviewed, with evaluation of the lessons learned and the policy implications of the ensuing legal cases and their settlements. Further, the difficulty of reporting such blockbuster side effects in the medical literature is explored in an empirical study. Significant advances have been achieved in analytic methods for the identification of ADRs, and here there is a particular focus on the value of optimal discriminant analysis. Finally, the impacts on pharmacovigilance and drug safety of the huge fines paid under the U.S. False Claims Act relating to the defrauding of governmental programs also receive careful attention – these fines are playing an important role in changing the landscape for pharmaceutical safety.
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
To explore the issue of cancer drug costs and patient access to affordable, appropriate drug therapies, the Institute of Medicine's National Cancer Policy Forum convened a workshop on ensuring patient access to affordable cancer drugs in June 2014. Affordability was considered from both individual and societal perspectives. The workshop featured discussion panels as well as invited presentations from clinicians, researchers, representatives from the health insurance and pharmaceutical industries, and patient advocates.
Upper Tract Urothelial Carcinoma represents the first book of its kind to be dedicated solely to UTUC. It's aim is to improve understanding and eventually care of a disease that is greatly understudied and underappreciated, yet commonly dealt with by many medical and urologic oncologists. The volume features new data regarding genetic susceptibility, gene expression studies and causative factors; contemporary concepts and controversies regarding diagnosis and staging of UTUC; prediction tools and their value in treatment decisions within each disease stage and patient selection and treatment options such as endoscopic management, distal ureterectomy, radical nephroureterectomy and chemotherapy. Up-to-date information regarding boundaries of surgical resection, indication and extent of lymphadenectomy is covered as well as the role of perioperative/neoadjuvant chemotherapy in patients with high-risk UTUC. Upper Tract Urothelial Carcinoma will be of great value to all Urologists, Medical Oncologists and fellows in Urologic Oncology as well as upper level residents in training in Urology and Medical Oncology.
Mark Rushefsky confronts head-on the controversies surrounding federal cancer policy, within the context, however, of a balanced view of the politics and science involved. From 1976 to 1984, federal agencies such as the Consumer Product Safety Commission, the Environmental Protection Agency, the Food and Drug Administration, the Occupational Safety and Health Administration issued guidelines regulating public exposure to chemical carcinogens. These policies have engendered controversy and undergone numerous changes. Some of these are based on new scientific developments, others on new political developments. Making Cancer Policy analyzes the guidelines issued by these agencies in terms of their scientific and political environment. It addresses the issues of uncertainty in the scientific foundation of cancer policy, scientific controversies, the mixing of science and politics, and the political uses of science. This book shows just how “political” science can be.
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.
Holland-Frei Cancer Medicine, Ninth Edition, offers a balanced view of the most current knowledge of cancer science and clinical oncology practice. This all-new edition is the consummate reference source for medical oncologists, radiation oncologists, internists, surgical oncologists, and others who treat cancer patients. A translational perspective throughout, integrating cancer biology with cancer management providing an in depth understanding of the disease An emphasis on multidisciplinary, research-driven patient care to improve outcomes and optimal use of all appropriate therapies Cutting-edge coverage of personalized cancer care, including molecular diagnostics and therapeutics Concise, readable, clinically relevant text with algorithms, guidelines and insight into the use of both conventional and novel drugs Includes free access to the Wiley Digital Edition providing search across the book, the full reference list with web links, illustrations and photographs, and post-publication updates
This open access book provides a valuable resource for hospitals, institutions, and health authorities worldwide in their plans to set up and develop comprehensive cancer care centers. The development and implementation of a comprehensive cancer program allows for a systematic approach to evidence-based strategies of prevention, early detection, diagnosis, treatment, and palliation. Comprehensive cancer programs also provide a nexus for the running of clinical trials and implementation of novel cancer therapies with the overall aim of optimizing comprehensive and holistic care of cancer patients and providing them with the best opportunity to improve quality of life and overall survival. This book's self-contained chapter format aims to reinforce the critical importance of comprehensive cancer care centers while providing a practical guide for the essential components needed to achieve them, such as operational considerations, guidelines for best clinical inpatient and outpatient care, and research and quality management structures. Intended to be wide-ranging and applicable at a global level for both high and low income countries, this book is also instructive for regions with limited resources. The Comprehensive Cancer Center: Development, Integration, and Implementation is an essential resource for oncology physicians including hematologists, medical oncologists, radiation oncologists, surgical oncologists, and oncology nurses as well as hospitals, health departments, university authorities, governments and legislators.
Rising health care costs are a central fiscal challenge confronting the United States. National spending on health care currently accounts for 18 percent of gross domestic product (GDP), but is anticipated to increase to 25 percent of GDP by 2037. The Bipartisan Policy Center argues that "this rapid growth in health expenditures creates an unsustainable burden on America's economy, with far-reaching consequences". These consequences include crowding out many national priorities, including investments in education, infrastructure, and research; stagnation of employee wages; and decreased international competitiveness.In spite of health care costs that far exceed those of other countries, health outcomes in the United States are not considerably better. With the goal of ensuring that patients have access to high-quality, affordable cancer care, the Institute of Medicine's (IOM's) National Cancer Policy Forum convened a public workshop, Delivering Affordable Cancer Care in the 21st Century, October 8-9, 2012, in Washington, DC. Delivering Affordable Cancer Care in the 21st Century summarizes the workshop.