Six Sigma Healthcare is a quality improvement methodology that also improves patient and stakeholder satisfaction. Six Sigma Healthcare delivery means helping improve patient outcomes while driving down the cost of patient care. Doing so empowers healthcare providers to become more productive. Now, more than ever, the healthcare industry needs to embrace the economic value proposition of improving productivity. Healthcare sector can learn a good deal from industries that are working toward the Six Sigma goal. Let's try it in healthcare and see how close we can get.

In this unprecedented account of the dynamics of Nigeria's pharmaceutical markets, Kristin Peterson connects multinational drug company policies, oil concerns, Nigerian political and economic transitions, the circulation of pharmaceuticals in the Global South, Wall Street machinations, and the needs and aspirations of individual Nigerians. Studying the pharmaceutical market in Lagos, Nigeria, she places local market social norms and credit and pricing practices in the broader context of regional, transnational, and global financial capital. Peterson explains how a significant and formerly profitable African pharmaceutical market collapsed in the face of U.S. monetary policies and neoliberal economic reforms, and she illuminates the relation between that collapse and the American turn to speculative capital during the 1980s. In the process, she reveals the mutual constitution of financial speculation in the drug industry and the structural adjustment plans that the IMF imposed on African nations. Her book is a sobering ethnographic analysis of the effects of speculation and "development" as they reverberate across markets and continents, and play out in everyday interpersonal transactions of the Lagos pharmaceutical market.  

Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.

A practical guide for those in pharmaceutical companies considering a reclassification (switch) project including Rx to OTC, POM to P, and P to GSL. The book covers past UK switches with key learning and a framework for initiating, setting up and running switch projects within companies. Plus case studies, insight and practical experience to help companies manage and implement successful switch projects.

Since the 1950s, the American pharmaceutical industry has been heavily criticized for its profit levels, the high cost of prescription drugs, drug safety problems, and more, yet it has, together with the medical profession, staunchly and successfully opposed regulation. "Pills, Power, and Policy" offers a lucid history of how the American drug industry and key sectors of the medical profession came to be allies against pharmaceutical reform. It details the political strategies they have used to influence public opinion, shape legislative reform, and define the regulatory environment of prescription drugs. Untangling the complex relationships between drug companies, physicians, and academic researchers, the book provides essential historical context for understanding how corporate interests came to dominate American health care policy after World War II.

Brand-name pharmaceutical companies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called "pay-for-delay" agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies. "Pay-for-delay" agreements are "win-win" for the companies: brand name pharmaceutical prices stay high, and the brand and generic share the benefits of the brand's monopoly profits. Consumers lose, however: they miss out on generic prices that can be as much as 90 percent less than brand prices. For example, brand-name medication that costs $300 per month, might be sold as a generic for as little as $30 per month. This book examines the "pay-for-delay' program and how drug company pay-offs cost consumers billions.

Pharmaceuticals are an essential component of health care. But for many people in low- and middle-income countries, access to the medicines they need to prevent or treat severe illnesses is limited. Typical problems are lack of availability, costs that exceed the individual s purchasing power or lack of competent agents health workers that are well trained to give the correct advice on which medicines to take. Pharmaceutical policy is the part of health policy that aims at addressing these problems and increasing access to safe, effective and affordable medicines for all patients. There are many obstacles against achieving these goals. Such obstacles can arise from financial interests on the side of suppliers and health care providers, who may benefit from charging higher prices and issuing more prescriptions than might be justified from a clinical and economic viewpoint. Or from rogue suppliers trying to introduce low quality or counterfeit drugs into markets with less effective regulation. Also, corruption and ineffective bureaucracies sometimes interfere with well intended programs to offer access to essential medicines for the poor. This book offers policy makers a hands-on approach, tested in the World Bank s field work in many countries, for assessing the pharmaceutical sector, recognizing typical patterns of dysfunction and developing strategies to quickly deal with the most urgent problems while at the same time building a platform for sustainable long term policy. It offers examples from a variety of low- and middle income countries and provides practical assessment tools for policy makers. The book ends with the author s outlook on future developments in this complex policy field."

Public concerns about the regulation of the pharmaceutical industry have intensified in recent years. Paradoxically, these concerns center on the over-consumption of medicines of dubious benefit in Western societies and lack of access to essential medicines in the Global South. By demonstrating how the analysis of pharmaceutical drug regulation can provide rich insights into the operation of power and politics in contemporary society, the contributors challenge the prevailing construction of drug regulation as a sphere of "policy without politics" and suggest alternative ways of regulating medicines.Just two of the central questions that are explored in this book include: what are the implications for health that arise from the existing systems of pharmaceutical drug regulation?; what do the existing systems of drug regulation reveal about the power of transnational pharmaceutical corporations to shape regulatory and other policies? The importance attached to placing the Irish regulatory system in its international context is reflected in the inclusion of chapters that consider regulatory trends in Australia, Canada and Britain, and chapters that address the implications of World Trade Organisation and EU regulatory policies.

When I first joined the industry I searched for a book which could give some guidance as to what this role was all about. I never found that book so four years into my career I began writing Pharmaceutical Sales for Phools. Medical sales representatives who read this book will not encounter many surprises once they take their first steps out into the field, as this book has been designed to equip readers with a robust understanding of all the key dynamics of this sales role. Sahil Syed is an award winning representative who is now in his eighth year of frontline pharmaceutical sales. During this time he has worked with some of the largest and most successful pharmaceutical companies in the world. In this book he has given a highly practical account of how the role of a medical sales representative actually operates. "This book is the perfect read - not only for those who are trying to get into the industry, but also for experienced representatives who just want to keep up to date on the mechanics of the job. It is essential reading" Niall Barry - Director, Gem Resourcing "This book gives the first example I have seen of a common sense approach to the job which leaves nothing to the imagination" Charles Marshall - Director, Axis Development "This book is the medical representatives bible - it is indispensable, every rep should have a copy" Gary Fagg - Principal Sales Representative, Novartis

In some parts of the world spending on pharmaceuticals is astronomical. In others people do not have access to basic or life-saving drugs. Individuals struggle to afford medications; whole populations are neglected, considered too poor to constitute profitable markets for the development and distribution of necessary drugs. The ethnographies brought together in this timely collection analyze both the dynamics of the burgeoning international pharmaceutical trade and the global inequalities that emerge from and are reinforced by market-driven medicine. They demonstrate that questions about who will be treated and who will not filter through every phase of pharmaceutical production, from preclinical research to human testing, marketing, distribution, prescription, and consumption.Whether considering how American drug companies seek to create a market for antidepressants in Japan, how Brazil has created a model HIV/AIDS prevention and treatment program, or how the urban poor in Delhi understand and access healthcare, these essays illuminate the roles of corporations, governments, NGOs, and individuals in relation to global pharmaceuticals. Some essays show how individual and communal identities are affected by the marketing and availability of medications. Among these are an exploration of how the pharmaceutical industry shapes popular and expert understandings of mental illness in North America and Great Britain. There is also an examination of the agonizing choices facing Ugandan families trying to finance AIDS treatment. Several essays explore the inner workings of the emerging international pharmaceutical regime. One looks at the expanding quest for clinical research subjects; another at the entwining of science and business interests in the Argentine market for psychotropic medications. By bringing the moral calculations involved in the production and distribution of pharmaceuticals into stark relief, this collection charts urgent new territory for social scientific research. Contributors. Kalman Applbaum, Joao Biehl, Ranendra K. Das, Veena Das, David Healy, Arthur Kleinman, Betty Kyaddondo, Andrew Lakoff, Anne Lovell, Lotte Meinert, Adriana Petryna, Michael A. Whyte, Susan Reynolds Whyte

An in-depth look at big pharma's flagship company
The Merck Druggernaut takes readers inside Merck, the world's second most profitable drug company and maker of the world's bestselling drug, Prilosec. Consistently named one of Fortune magazine's Most Admired Companies, Merck struggles to maintain its reputation for being the most ethical of the big drug makers, refusing to slash research and development budgets in the face of declining profits, falling stock market prices, and questionable accounting. Author Fran Hawthorne, one of the leading journalists covering healthcare, has written an excellent examination of a business paragon with much-needed insight on the cutthroat world of pharmaceuticals. It's a story that will interest the business world as well as consumer and healthcare advocates by detailing the vital issues in medicine and healthcare today. More than just a compelling story of success in a difficult industry, more than simply the biography of one of big business's most recognizable names, The Merck Druggernaut takes a thoughtful look at some of the major issues of our time and the way those issues intertwine with the world of business.

Fran Hawthorne (New York, NY) is the Assistant Managing Editor at Crain's New York Business. She has been covering business for more than twenty years for such publications as Fortune, BusinessWeek, and Institutional Investor, with a prevailing interest in healthcare and pharmaceuticals. At Crain's, she spearheads the publication of two to three special healthcare issues per year.

Drugs play a crucial role in saving lives, restoring health, and preventing diseases and epidemics. But they need to be safe, efficacious, of good quality, and used rationally. This means that their production, import/export, storage, supply and distribution should be subject to government control through prescribed norms and standards and an effective regulatory system. Substandard and counterfeit drugs proliferate primarily in an environment where drug regulation has proved ineffective. This publication presents a synthesis of studies on drug regulation carried out in 10 countries: Australia, Cuba, Cyprus, Estonia, Malaysia, the Netherlands, Tunisia, Uganda, Venezuela, and Zimbabwe in 1998-1999. It gives an overview of the development of drug regulation in these countries as well as the resources available and the strategies applied in drug regulation implementation at the time the studies were conducted. An analysis of the strengths and weaknesses in drug regulation in these countries is also provided.

This book is intended for scientists, engineers, physicians, business people, and service providers at all levels who are interested in and support the process of life science commercialization. - The authors provide a hands-on template for success based on their years of experience practicing and teaching bioentrepreneurship and consulting to clients, students, economic development agencies, and faculty around the world.

This book tells the story of two generations of Pietist ministers sent from Halle, in Brandenburg Prussia during the eighteenth century, to the German communities of North America. In conjunction with their clerical office, these ministers provided medical services using pharmaceuticals and medical texts brought with them from Europe. Their practice is an example of how different medical markets and medical cultures evolved in North America.

At the heart of the story is the Francke Orphanage, a famous religious and philanthropic foundation started in Halle in 1696. Pharmaceuticals from Halle were manufactured and sold throughout Europe as part of a commercial enterprise designed to support Francke's charitable goals. Halle's reputation for consistent product quality and safety soon spread to North America, where men and women became actively engaged in providing medical care to Lutheran and Reformed congregations along the east coast, mainly the backcountry of Pennsylvania, New Jersey, Maryland, and Virginia. The story continues to about 1810, when Halle's North American clergy had become independent from the motherhouse and American medical practice and education began to follow its own course.

Wilson draws upon a large array of correspondence, trading ledgers, and daybooks in European and American archives. Through these records she enables us to see firsthand the experience of men and women as both patients and practitioners. The result is a rare glimpse into the world of German medicine and the pharmaceutical trade in eighteenth-century North America.

* What are the principal features of the system responsible for the production, regulation, distribution and funding of therapeutic drugs? * What are the major problem areas and issues of policy concern that have arisen in the pharmaceutical sector and how have the participants - particularly the State - responded to such controversies? Medicines, and the policy issues they raise, are the subject of this book. Therapeutic drugs are widely used - some on a routine basis, others in a highly selective and specialized fashion. Although we take the availability of such potent agents for granted, there stands behind them a complex and sophisticated system of scientific innovation, industrial production, State audit, and professional distribution. Major issues of price, innovation, safety, professional practice and consumer autonomy arise. Pharmaceuticals account for about ten per cent of health care costs, they are produced by a flagship industrial sector, they are jealously guarded by key professional groups, they raise formidable questions of quality and safety, and they are watched over by a vigilant and vociferous consumer movement. Managing Medicines seeks to disentangle these issues and come up with concrete suggestions as to how we might move forward in an area of public policy that is hotly disputed. It will be of interest to health professionals and policy makers as well as students of public health, nursing studies, social policy and social work.

This book is intended to help newly graduated chemists, particularly organic chemists, at all levels from bachelors to post-doctorates, find careers in the North American pharmaceutical industry. It will serve as a practical, detailed guiedbook for job seekers as well a reference work for faculty advisers, research supervisors, development officers, employment agents, and personnel managers in the industry. The book gathers in a single volume the fundamentals of getting an industrial job as a medicinal or process chemist, and covers all aspects of a chemist's job--scientific, financial, and managerial--within a pharmaceutical/biotechnology company. Other scientists looking for jobs as analytical or physical chemists and even biochemists and biologists will find the book useful. The valuable appendix is a unique compendium of 365 commercial, governmental, or non-profit institutions that comprise the North American pharmaceutical industry.
Key Features
* Learn How To:
* Discover the 12 permanent, big-pharma jobs for B.S. chemists
* Use the 500+ company index to locate potential employers
* Track pharma openings with 190+ corporate and chemist-specific job banks
* Add industry veterans to your employment network
* Find the 50+ companies offering paid summer internships to students
* Include the one resume item that wins interviews for B.S. and M.S. chemists
* Express a knowledgeable preference for drug discovery or development
* Research over 360 drug companies through their Web sites
* Discover the 70+ firms offering stock purchase plans or stock options3/4and which two represent big pharma
* Find out your salary offer in time to negotiate your wages

Drug coverage for seniors is better addressed by private-sector plans than by forcing manufacturers to offer Federal Supply Schedule discounts to the retail sector.

This study examines the effect of existing regulations on US pharmaceutical firms. The author explores the indirect spillovers from the regulatory use of international price comparisons and the threat from parallel trade, concluding that competition promises more efficiency and incentives.

"Vital reading for anyone who wants to understand the public's decades-long love affair with vitamin supplements. Rima Apple deftly explores the science, politics, history, marketing, and mystique that have kept vitamins a hot-button issue for the American public."--Bonnie Liebman, Director of Nutrition, Center for Science in the Public Interest "Have you taken your vitamins today?" That question echoes daily through American households. Thanks to intensive research in nutrition and medicine, the importance of vitamins to health is undisputed. But millions of Americans believe that the vitamins they get in their food are not enough. Vitamin supplements have become a multibillion-dollar industry. At the same time, many scientists, consumer advocacy groups, and the federal Food and Drug Administration doubt that most people need to take vitamin pills. Vitamania tells how and why vitamins have become so important to so many Americans. Rima Apple examines the claims and counterclaims of scientists, manufacturers, retailers, politicians, and consumers from the discovery of vitamins in the early twentieth century to the present. She reveals the complicated interests--scientific, professional, financial--that have propelled the vitamin industry and its would-be regulators. From early advertisements linking motherhood and vitamin D, to Linus Pauling's claims for vitamin C, to recent congressional debates about restricting vitamin products, Apple's insightful history shows the ambivalence of Americans toward the authority of science. She also documents how consumers have insisted on their right to make their own decisions about their health and their vitamins. Vitamania makes fascinating reading for anyone who takes--or refuses to take--vitamins. It will be of special interest to students, scholars, and professionals in public health, the biomedical sciences, history of medicine and science, twentieth-century history, nutrition, marketing, and consumer studies. Rima D. Apple teaches at the University of Wisconsin, Madison, where she holds a joint appointment in the Department of Consumer Science and the Women's Studies Program. She is the author of Mothers and Medicine: A Social History of Infant Feeding, 1890-1950 and editor of Women, Health, and Medicine in America: A Historical Handbook.

To retain their usefulness, cultures that manufacture economically valuable products must be uncontaminated, viable, and genetically stable. Maintaining Cultures for Biotechnology and Industry gives practical advice necessary to preserve and maintain cells and microorganisms important to the biotechnology and pharmaceutical industries in ways that ensure they will continue to be able to synthesize those valuable metabolites. This book covers not just those strains currently being used but also those yet to be discovered and engineered.
This text is essential for anyone working with cultures who wants to avoid the frustration of losing strains and needs to be able to devise and evaluate new strategies for preservation.
Key Features
* Written by hands-on experts in their respective fields
* Contains helpful tables and protocols for preserving or maintaining cells, cultures and viruses
* Discusses means to preserve cells by freezing, lyophilization, drying, cyoprotection, spore storage, continuous propagation and subculturing when absolutely necessary, and others
* Gives information needed to test cultures for stable retention of important characteristics
* Gives principles needed to devise and evaluate preservation strategies for newly identified and newly engineered cells and organisms
* Lists culture sources for each class of organism
* Includes information for characterizing and monitoring recombinant organisms, especially important because of their propensity for genetic stability
* Discusses the history of the continually evolving field of culture preservation
* Examines the importance of genetically stable cultures as it relates to maintaining patent positions

There are numerous reasons to hasten the introduction of new and improved contraceptives?from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptives?in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena? This book presents an overall examination of contraceptive development in the United States?covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public. The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchers?everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations. Table of Contents Front Matter Executive Summary 1 Introduction 2 The Need for New Contraceptives 3 The Current Status of Contraceptive Research 4 Values and Contraceptive Development 5 Organizational Structure of Contraceptive Development 6 Funding for Contraceptive Development 7 Regulation and Contraceptive Development 8 Products Liability and Contraceptive Development 9 Contraceptive Development: Obstacles and Opportunities References Legal Cases Related to Contraceptive Development Glossary Index

This searing indictment, David Healy's most comprehensive and forceful argument against the pharmaceuticalization of medicine, tackles problems in health care that are leading to a growing number of deaths and disabilities. Healy, who was the first to draw attention to the now well-publicized suicide-inducing side effects of many anti-depressants, attributes our current state of affairs to three. Key factors: product rather than process patents on drugs, the classification of certain drugs as prescription-only, and industry-controlled drug trials. These developments have tied the survival of pharmaceutical companies to the development of blockbuster drugs, so that they must overhype benefits and deny real hazards. Healy further explains why these trends have basically ended the possibility of universal health care in the United States and elsewhere around the world. He concludes with suggestions for reform of our currently corrupted evidence-based medical system.

From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful outcomes for patients of all ages. Over the last decade, an increasing number of prescription drugs -- including life-saving and life-sustaining drugs -- have been in short supply, preventing health care providers and patients from accessing medications that are essential for treatment. During shortages, providers -- including hospitals, physicians, and pharmacists -- may have to use medications that could be less effective for treating conditions or carry unwanted side-effects, if alternatives are available at all. The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. This book reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers; examines the causes of drug shortages; and evaluates the progress FDA has made in addressing drug shortages.

Everyone knows that antidepressant drugs are miracles of modern medicine. Professor Irving Kirsch knew this as well as anyone. But, as he discovered during his research, there is a problem with what everyone knows about antidepressant drugs. It isn't true. How did antidepressant drugs gain their reputation as a magic bullet for depression? And why has it taken so long for the story to become public? Answering these questions takes us to the point where the lines between clinical research and marketing disappear altogether. Using the Freedom of Information Act, Kirsch accessed clinical trials that were withheld, by drug companies, from the public and from the doctors who prescribe antidepressants. What he found, and what he documents here, promises to bring revolutionary change to the way our society perceives, and consumes, antidepressants. The Emperor's New Drugs exposes what we have failed to see before: depression is not caused by a chemical imbalance in the brain; antidepressants are significantly more dangerous than other forms of treatment and are only marginally more effective than placebos; and, there are other ways to combat depression, treatments that don't only include the empty promise of the antidepressant prescription. This is not a book about alternative medicine and its outlandish claims. This is a book about fantasy and wishful thinking in the heart of clinical medicine, about the seductions of myth, and the final stubbornness of facts.