Wednesday, February 19, 2014
There's got to be a better way
There are reports from across the country regarding severe influenza in young people. In addition to mechanical ventilation, many are requiring extracorporeal membrane oxygenation (ECMO). Given the severity of illness and the presence of multiple organ dysfunction, relying on an oral antiviral for influenza therapy seems unwise. However, at this point, the only option for intravenous therapy is IV zanamivir, which is not approved by the FDA, but available on a compassionate use basis.
I recently had the misfortune of experiencing the compassionate use process. During my last stint on the Infectious Diseases consult service we were crazy busy, and on a Friday morning, with my fellow in clinic and unavailable, and with eight new consults to see, I was asked to see a patient on ECMO for severe influenza.
I did a quick Google search to see how I could obtain IV zanamivir and learned that I needed to contact the drug manufacturer, the FDA and my IRB. I soon learned there were numerous forms to complete, almost all of which required me to record the same information over and over. From start to finish it took approximately 4 hours and the best word to describe the situation was Kafkaesque.
Some of the forms had pages of instructions, and after reading these instructions I still had no idea as to how to complete them. I finally called the FDA and said, “Just tell me which boxes to check.” Is there anyone who thinks that physicians have 4 hours to spend filling out forms to get 1 patient 1 drug? I made the mistake of including the patient’s initials on 1 form and the drug company called me to say that they would have to destroy the document and I would need to re-do it and re-send.
Maybe I’m just a simpleton, but couldn’t there be a website where information is entered once and then routed to the appropriate agencies? I’m sure we could leverage the technology to include the patient initials on the FDA’s but not the company’s forms. Over the ensuing weeks, I have spent several additional hours submitting more documents to the FDA, the drug company and the institutional review board. All of this makes me wonder how many patients don’t receive treatment with potentially lifesaving drugs because the process is so painful, duplicative, time intensive and byzantine.
At dinner a few nights ago, my wife (also a physician) and I were lamenting about how much each of our days is filled with activities that don’t add value to the care of patients. Every time I watch “House MD” I am immediately struck by what the physicians in the hospital are doing. They are either interacting with patients or discussing cases with each other. Those activities are the joy of medicine. But it seems that with every passing year, we do less true patient care as we heap on more nonvalue added activities. Unfortunately, 25 years into this career, I frequently find myself thinking, I didn’t sign up for this!
Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Richmond, Va., with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.
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Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital.
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.
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Run by three ACP Fellows, this blog ponders vexing issues in infection prevention and control, inside and outside the hospital. Daniel J Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands).
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Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.
Suneel Dhand, MD, ACP Member
Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health care.
Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.
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Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients.
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.
Vineet Arora, MD, FACP, is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist.
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Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.
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Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.
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