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 redo 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 Edmond is a professor of internal medicine and chair, division of infectious diseases, VCU Medical Center, Richmond, VA. He blogs at Controversies in Hospital Infection Prevention.