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Conflict of Interest in Medical Research, Education, and Practice

Conflict of Interest in Medical Research, Education, and Practice
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 436
Release: 2009-09-16
Genre: Medical
ISBN: 0309145449

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Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.


Ethical Criteria for Medicinal Drug Promotion

Ethical Criteria for Medicinal Drug Promotion
Author: World Health Organization
Publisher:
Total Pages: 32
Release: 1988
Genre: Business & Economics
ISBN:

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"Resolution WHA41.17 adopted by the Forty-first World Health Assembly, 13 May 1988" -- p.1.


Effects of Physician-directed Pharmaceutical Promotion on Prescription Behaviors

Effects of Physician-directed Pharmaceutical Promotion on Prescription Behaviors
Author: Anusua Datta
Publisher:
Total Pages: 0
Release: 2013
Genre: Economics
ISBN:

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Spending on prescription drugs (Rx) represents one of the fastest growing components of U.S. healthcare spending, and has coincided with an expansion of pharmaceutical promotional spending. Most (83%) of Rx promotion is directed at physicians in the form of visits by pharmaceutical representatives (known as detailing) and drug samples provided to physicians' offices. Such promotion has come under increased public scrutiny, with critics contending that physician-directed promotion may play a role in raising healthcare costs and may unduly affect physicians' prescribing habits towards more expensive, and possibly less cost-effective, drugs. In this study, we bring longitudinal evidence to bear upon the question of how detailing impacts physicians' prescribing behaviors. Specifically, we examine prescriptions and promotion for a particular drug class based on a nationally-representative sample of 150,000 physicians spanning 24 months. The use of longitudinal physician-level data allows us to tackle some of the empirical concerns in the extant literature, virtually all of which has relied on aggregate national data. We estimate fixed-effects specifications that bypass stable unobserved physician-specific heterogeneity and address potential targeting bias. In addition, we also assess differential effects at both the extensive and intensive margins of prescribing behaviors, and differential effects across physician- and market-level characteristics, questions which have not been explored in prior work. The estimates suggest that detailing has a significant and positive effect on the number of new scripts written for the detailed drug, with an elasticity magnitude of 0.06. This effect is substantially smaller than those in the literature based on aggregate information, suggesting that most of the observed relationship between physician-directed promotion and drug sales is driven by selection bias. Qualitatively consistent with the literature, we find that detailing impacts selective brand-specific demand but does not have any substantial effects on class-level demand. Results also indicate that most of the detailing response may operate at the extensive margin; detailing affects the probability of prescribing the drug more than it affects the number of prescriptions conditional on any prescribing. We draw some implications from these estimates with respect to effects on healthcare costs and public health.


Resident Duty Hours

Resident Duty Hours
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 427
Release: 2009-04-27
Genre: Medical
ISBN: 0309131529

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Medical residents in hospitals are often required to be on duty for long hours. In 2003 the organization overseeing graduate medical education adopted common program requirements to restrict resident workweeks, including limits to an average of 80 hours over 4 weeks and the longest consecutive period of work to 30 hours in order to protect patients and residents from unsafe conditions resulting from excessive fatigue. Resident Duty Hours provides a timely examination of how those requirements were implemented and their impact on safety, education, and the training institutions. An in-depth review of the evidence on sleep and human performance indicated a need to increase opportunities for sleep during residency training to prevent acute and chronic sleep deprivation and minimize the risk of fatigue-related errors. In addition to recommending opportunities for on-duty sleep during long duty periods and breaks for sleep of appropriate lengths between work periods, the committee also recommends enhancements of supervision, appropriate workload, and changes in the work environment to improve conditions for safety and learning. All residents, medical educators, those involved with academic training institutions, specialty societies, professional groups, and consumer/patient safety organizations will find this book useful to advocate for an improved culture of safety.


The Effect of Variability in Substance Abuse and Dependence Terminology on Physicians' Prescribing Decisions

The Effect of Variability in Substance Abuse and Dependence Terminology on Physicians' Prescribing Decisions
Author: Lisa Rochelle Burroughs Phipps
Publisher:
Total Pages: 304
Release: 2006
Genre:
ISBN:

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Prescription drug abuse is a continuing problem in the United States. Educating physicians on issues related to prescription drug abuse is a key factor in preventing and treating this problem. High variability has been found in substance abuse terminology in the literature, textbooks, and FDA-approved product labeling. This dissertation describes a survey study designed to address how the variability in substance abuse terminology, specifically package inserts, affects the prescribing decisions made by physicians. A random sample of 1008 physicians currently licensed and residing in the Commonwealth of Virginia received a letter of explanation, a self-administered questionnaire, and a follow-up reminder and thank you. To increase response rate, a second questionnaire was sent to non-responders. Prescribing decisions made by physicians were measured as three variables: comfort level with a prior physician's choice, likelihood of refilling the prescription, and likelihood of prescribing a drug or drug class as the first physician seeing a particular patient. Physicians were presented with four case scenarios which included package insert information and selected patient characteristics. Other factors affecting physicians' decisions in prescribing controlled substances include ideas about addiction, and characteristics of the physician, patient, disease state, and drug. The patient case scenarios and other items on the questionnaire addressed these covariates. Based on the number of deliverable questionnaires returned and included in analysis, the response rate was 32.3%. More physicians associated abuse, craving, drug-seeking behavior, psychological dependence, and withdrawal with addiction than with drug dependence, while more physicians felt that physical dependence and tolerance were necessary for drug dependence. The most frequently used sources for drug information were the Physicians' Desk Reference (PDR), package inserts, and pharmacists. Four linear regression models were created for physician prescribing decisions. Physician, patient and package insert characteristics were all significant (p


Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 483
Release: 2017-09-28
Genre: Medical
ISBN: 0309459575

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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.


Making Medicines Affordable

Making Medicines Affordable
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 235
Release: 2018-03-01
Genre: Medical
ISBN: 0309468086

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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.