Content of Publicly Issued FDA Reports about Black Box Warnings 5.21.08

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Leonard Davis Institute of Health Economics

The document analyzes FDA press releases, talk papers, and public health advisories about new black box warnings (BBWs) issued between 2003-2007. It finds that the reports consistently discuss the drug name, indications, and reason for the BBW, but inconsistently address issues like data quality, medical uncertainty, importance of follow-up, and potential benefits. There were minimal differences between report types. The conclusion suggests improving discussions of BBW data and providing reinforcing messages about follow-up and benefits could allow readers to more rationally process risk information and minimize unintended effects of BBWs on health behaviors.

Health & Medicine

Content of Publicly Issued FDA Reports about Black Box Warnings Pierre L Yong a,b,c,d , MD, MPH; Cabral Bigman e , BA; Danielle Mittermaier e , MA; Judith A Long a,d,f , MD a Philadelphia Veterans Affairs Medical Center, Philadelphia, PA; b Robert Wood Johnson Clinical Scholars Program, University of Pennsylvania School of Medicine, Philadelphia, PA; c Division of Pulmonary, Allergy and Critical Care, Hospital of University of Pennsylvania, Philadelphia, PA; d Leonard Davis Institute of Economics, University of Pennsylvania, Philadelphia, PA; e Annenberg School of Communication, University of Pennsylvania, Philadelphia, PA; f Division of General Internal Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA Pierre Yong is supported by a training grant from the Philadelphia Veterans Affairs Medical Center and the Robert Wood Johnson Clinical Scholars Program. He is also appreciative of the support of the Leonard Davis Institute of Health Economics and the GAPSA-Provost’s Award for Interdisciplinary Innovation. ,[object Object],[object Object],[object Object],[object Object],Background ,[object Object],[object Object],Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object],Methods Results ,[object Object],[object Object],[object Object],Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object],Policy Implications

El Estudio que Demostró el Control de la Industria de la Enfermedad sobre la Medicina Este nuevo estudio, el primero en su tipo, comparó específicamente el nivel de publicidad farmacéutica con la cantidad y tipo de publicaciones acerca de suplementos alimenticios. Los autores revisaron un año de publicaciones de los 11 journals más grandes del mundo como por ejemplo el Journal of the American Medical Association, New England Journal of Medicine, British Medical Journal, Canadian Medical Association, Annals of Internal Medicine, Archives of International Medicine, Archives of Pediatric and Adolescent Medicine, Pediatrics and Pediatric Research y el American Family Physician.

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UTSpeaks: A medicated nation Has Australia lost its way in a pharmaceutical love affair? Professor Charlie Benrimoj and Associate Professor Mary Bebawy from the University of Technology, Sydney present at this public lecture on prescription medication held on 13 September, 2011. How many pills will you take today? Do you really need them? What good (and bad) will they do you? For many of us prescription medications mean the difference between good and ill-health. There’s no denying their important place in fostering well-being for many. But is it time to reflect on the complex forces at work when managing disease and medications and how this impacts you the consumer? Featuring leading UTS researchers in pharmacy and using example case studies, this public lecture takes a critical look at how medications are prescribed and consumed in Australia. It considers whether we are getting value for money, the ideal health outcomes we hope for and whether new approaches to the responsible use and explanation of medications could be adopted. Speakers: Professor Shalom (Charlie) Benrimoj Charlie Benrimoj is head of the newly-created UTS School of Pharmacy. Formerly he was Foundation Professor of Pharmacy Practice then Dean of the Faculty of Pharmacy and then Pro-Vice Chancellor (Strategic Planning) at the University of Sydney. He is a visiting professor at the University of Granada with research interests in the future of community pharmacy. He is widely published - co-authoring Community Pharmacy: Strategic Change Management in 2007. He was Australian Pharmacist of the Year in 2000 and received the Andre Bedat award in 2010 from the International Pharmacy Federation. Associate Professor Mary Bebawy Mary Bebawy has spent more than 14 years in research and teaching positions in academia and two years in industry as a post doctoral preclinical drug development scientist with Johnson and Johnson, Research. She has consulted to academia and industry on assay development, drug discovery and cancer resistance mechanisms. At the UTS School of Pharmacy she specialises in the role and regulation of the xenobiotic cascade in drug disposition and in cancer multidrug resistance (MDR). UTSPEAKS: is a free public lecture series presented by UTS experts discussing a range of important issues confronting contemporary Australia. Use the hashtag #utspeaks to tweet about the lecture on Twitter.

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In 2014, US healthcare spending exceeded $3.0 trillion with nearly 1/3 spent on hospitalizations. Informed by real-world data from an Electronic Health Record (EHR) database of clinical and administrative records spanning 273 million encounters for 60 million patients in 600+ hospitals across the US, Boston Strategic Partners (BSP) Clinical Insights report, Hospital Treated Sepsis, estimates 30% of all hospital discharges involve treatment of infectious organisms. Sepsis is responsible for an estimated 12% of all hospital stays. At an average cost of $15,500 per occurrence, we estimate that hospitalizations for severe infections account for $212 billion in annual spending or 7% of total healthcare expenditure. In this report, we conduct an in-depth analysis of sepsis patient characteristics, medication management, costs, and laboratory testing. The Hospital-Treated Sepsis Report is available at www.bostonsp.com/reports Gram-positive bacteria are the likely causative agents of most sepsis infections. Physicians treat the vast majority of these infections with vancomycin, piperacillin-tazobactam, levofloxacin, and ceftriaxone. From 2010-2015, drug-resistant organisms caused an astonishing 40% of bacterial sepsis infections. After confirmatory diagnosis, over half of sepsis patients undergo a change in antibiotic therapy. This report provides quantitative, objective data captured by hospitals contributing to Cerner Health Facts. This data provides real-world patient encounters and reflects real physician decisions and encounter characteristics (e.g. patient response to therapy and outcomes) in key areas, such as antibiotic resistant pathogens and antimicrobial stewardship.

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In 2014, US healthcare spending exceeded $3.0 trillion with nearly 1/3 spent on hospitalizations. Informed by real-world data from an Electronic Health Record (EHR) database of clinical and administrative records spanning 273 million encounters for 60 million patients in 600+ hospitals across the US, Boston Strategic Partners (BSP) Clinical Insights report, Hospital-Treated Pneumonia, estimates 30% of all hospital discharges involve treatment of infectious organisms. Pneumonia is responsible for an estimated 12% of all hospital stays. At an average cost of $15,500 per occurrence, we estimate that hospitalizations for severe infections account for around $212 billion in annual spending or 7% of total healthcare expenditure. In this report, we conduct an in-depth analysis of pneumonia patient characteristics, medication management, costs, and laboratory testing. Hospital-Treated Pneumonia is available at www.bostonsp.com/reports. Gram-negative bacteria are the likely causative agents of most pneumonia infections and physicians treat most of these patients with levofloxacin, ceftriaxone, and azithromycin. From 2010-2015, drug resistant organisms caused a surprising 20% of bacterial pneumonia infections. This report provides quantitative, objective data captured by hospitals contributing to Cerner Health Facts. This data provides real-world patient encounters and reflects real physician decisions and encounter characteristics (e.g. patient response to therapy and outcomes) in key areas, such as antibiotic resistant pathogens and antimicrobial stewardship.

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March 2, 2018 Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years. To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborated with Ropes & Gray LLP to host a one-day conference on value-based health care. This event brought together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system. For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/will-value-based-care-save-the-health-care-system

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In 2014, US healthcare spending exceeded $3.0 trillion with nearly 1/3 spent on hospitalizations. Informed by real-world data from an Electronic Health Record (EHR) database of clinical and administrative records spanning 273 million encounters for 60 million patients in 600+ hospitals across the US, Boston Strategic Partners (BSP) Clinical Insights report, Hospital-Treated Pneumonia, estimates 30% of all hospital discharges involve treatment of infectious organisms. Pneumonia is responsible for an estimated 12% of all hospital stays. At an average cost of $15,500 per occurrence, we estimate that hospitalizations for severe infections account for around $212 billion in annual spending or 7% of total healthcare expenditure. In this report, we conduct an in-depth analysis of pneumonia patient characteristics, medication management, costs, and laboratory testing. Hospital-Treated Pneumonia is available at www.bostonsp.com/reports. Gram-negative bacteria are the likely causative agents of most pneumonia infections and physicians treat most of these patients with levofloxacin, ceftriaxone, and azithromycin. From 2010-2015, drug resistant organisms caused a surprising 20% of bacterial pneumonia infections. This report provides quantitative, objective data captured by hospitals contributing to Cerner Health Facts. This data provides real-world patient encounters and reflects real physician decisions and encounter characteristics (e.g. patient response to therapy and outcomes) in key areas, such as antibiotic resistant pathogens and antimicrobial stewardship.

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Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye. Follow us on: Pinterest Introduction Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing . Early Life and Career Childhood and Athletic Beginnings Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle. Transition to Acting Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness. Fitness Regimen Workout Routine Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show. Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles. Importance of Flexibility and Mobility In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit

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