Therapeutic Risk

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle

Every day we make decisions about our health - some big and some small. What we eat, how we live and even where we live can affect our health. But how can we be sure that the advice we are given about these important matters is right for us? This book will provide you with the right tools for assessing health advice.

I guess everyone has a cousin Ernest. He is the fellow of whom your mother asks . . . "Why can't you be more like your cousin Ernest?" Cousin Ernest went to the high school for genius children and got all A's, even in French. As the years went by, I lost contact with Cousin Ernest. Then last year, at a family gathering, I met him again. Sure enough, he had gone to Harvard and become a doctor, a radiologist. We began discussing his practice and he mentioned that he performs some fairly risky diagnostic tests. While legally he was compelled to tell patients about the risks they were undertaking, he said that risk disclosure was a useless exercise. "No one has ever refused to undergo the procedure," he said. It was difficult to argue with his observation that no patient ever refused to undergo his tests. I understood that the lack of refusals did not necessarily mean that risk disclosure was a useless exercise, but his underlying argument was quite compelling.

First published in 2008.

Consideration of ethics has established a firm place in the affairs of psychiatrists. An increased professional commitment to accountability, together with a growing "consumer" movement has paved the way for a creative engagement with the ethical movement. Psychiatric Ethics has carved out a niche for itself as a major comprehensive text and core reference covering the many complex ethical dilemmas which face clinicians and researchers in their everyday practice. This new edition takes a fresh look at recent trends and developments at the interface between ethics and psychiatric practice.For this edition, Sydney Bloch and Paul Chodoff are joined by Stephen Green, a clinical professor in ethics and psychiatry at Georgetown University, in leading 29 of the finest scholars in the field from around the world. Eleven new contributors join the team of authors. They include Drs. Beauchamp, Gutheils, Sabin, McGuffin, Szmulter, Gabbard and Holmes. Since the second edition, the editors have observed several emerging aspects of psychiatric practice requiring coverage. As a result, six new chapters have been added covering the ethical aspects of community psychiatry, managed care, psychiatric genetics, resource allocation, codes of ethics and boundary violations. All others chapters have been fully revised and updated.The book will continue to be essential reading for psychiatrists and other mental health professionals, as well as of interest to ethicists, policy makers, managers and lawyers.

This textbook offers a comprehensive analysis of medical decision-making under uncertainty by combining test information theory with expected utility theory. The authors show how the parameters of Bayes’ theorem can be combined with a value function of health states in order to arrive at informed test and treatment decisions in the face of diagnostic and therapeutic risks. Distinguishing between risk-neutral, risk-averse, and prudent decision-makers, they demonstrate the effects of risk preferences on medical decisions. Furthermore, they analyze individual and multiple tests as well as diagnostic models in which the decision-maker chooses the test outcome. The consequences of test and treatment decisions for the patient are encompassed by quality-adjusted life years (QALYs) and the standard economic model, which applies the willingness to pay for health approach. Lastly, non-expected utility models of choice under risk and uncertainty are presented. Although these models can explain some of the test and treatment decisions observed, they are less suitable for normative analyses aimed at providing guidance on medical decision-making. This third edition provides extensively revised versions of all chapters and reflects recent innovations in medical decision-making such as decision curve analysis. New chapters focus on the health economics of and revealed preferences in medical decisions. The book is intended for students of (health) economics and medicine as well as for medical decision-makers and physicians dealing with uncertainty in their test and treatment decisions.

Revised and updated to incorporate the latest research findings, this economical paperback abridgement of the Textbook presents, in distilled form, the core knowledge base of clinical psychiatry by focusing on information of greatest relevance to the practicing clinician.

Risk assessment and risk management are top of every mental health trust’s agenda. This concise and easy-to-read book provides an informative and practical guide to the process of undertaking a risk assessment, arriving at a formulation and then developing a risk management plan. Covering everything a practitioner may have to think about when undertaking risk assessments in an accessible, logical form, the book includes practice recommendations rooted in the latest theory and evidence base. Attractively presented, plentiful clinical tip boxes, tables, diagrams and case examples make it easy to identify key information. Samples of authentic dialogue demonstrate ways in which to formulate questions and think about complex problems with the person being assessed. A series of accompanying films, professionally made and based on actual case studies, are available on a companion website, further illustrate key risk assessment and management skills. This accessible guidebook is designed for all mental health professionals, and professionals-in-training. It will also be a useful reference for healthcare practitioners who regularly come into contact with people experiencing mental health problems.