Thursday, February 4, 2016

When the Patient is Anesthetized

Bad jokes about the sleeping patient? Maybe. Or just telling some stories? Doctors who say “oops” have big liability issues if there is a malpractice action. So they never say, “oops,” choosing some other word instead, like “there,” that doesn’t sound so bad to a jury. Other stuff also happens when you are asleep on the surgical table. Like if there is a shortage of a vital drug, doctors often have to decide who gets the drug… and who gets to take the risk without it.
In recent years, shortages of all sorts of drugs — anesthetics, painkillers, antibiotics, cancer treatments — have become the new normal in American medicine. The American Society of Health-System Pharmacists currently lists inadequate supplies of more than 150 drugs and therapeutics, for reasons ranging from manufacturing problems to federal safety crackdowns to drugmakers abandoning low-profit products. But while such shortages have periodically drawn attention, the rationing that results from them has been largely hidden from patients and the public.” New York Times, January 28th.

So doctors have to make on-the-spot decisions to ration their precious stores to those patients who might need it most. If they guess wrong, the patient whose life would have been saved… well let’s just say his or her luck just ran out. And no one will ever know.
The NY Times presents this example, which sent my skin crawling: “In the operating room at the Cleveland Clinic, Dr. Brian Fitzsimons has long relied on a decades-old drug to prevent hemorrhages in patients undergoing open-heart surgery. The drug, aminocaproic acid, is widely used, cheap and safe. ‘It never hurt,’ he said. ‘It only helps.’
“Then manufacturing issues caused a national shortage. ‘We essentially did military-style triage,’ said Dr. Fitzsimons, an anesthesiologist, restricting the limited supply to patients at the highest risk of bleeding complications. Those who do not get the once-standard treatment at the clinic, the nation’s largest cardiac center, are not told. ‘The patient is asleep,’ he said. ‘The family never knows about it.’”
The doctors and hospitals just can’t get what they need; it just isn’t there. So how do they decide who gets the drugs and who does not? “At medical institutions across the country, choices about who gets drugs have often been made in ad hoc ways that have resulted in contradictory conclusions, murky ethical reasoning and medically questionable practices, according to interviews with dozens of doctors, hospital officials and government regulators.
“Some institutions have formal committees that include ethicists and patient representatives; in other places, individual physicians, pharmacists and even drug company executives decide which patients receive a needed drug — and which do not.
“An international group of pediatric cancer specialists was so troubled about the profession’s unsystematic approach to distributing scarce medicine that it developed rationing guidelines that are being released Friday in The Journal of the National Cancer Institute.
“‘It was painful,’ said Dr. Yoram Unguru, an oncologist at the Children’s Hospital at Sinai in Baltimore and a faculty member at the Berman Institute of Bioethics at Johns Hopkins University. ‘We kept coming back to wow, we’ve got that tragic choice: two kids in front of you, you only have enough for one. How do you choose?’…
“Such decisions have real consequences. For some shortages, doctors can soon see the effects of rationing, such as increased pain or nausea when drugs typically used to control symptoms are withheld, or patients who have to undergo invasive surgery to control cancer when anti-tumor medications are delayed.
“Studies have associated alternative treatments during drug shortages with higher rates of medication errors, side effects, disease progression and deaths. For example, children with Hodgkin’s lymphoma who received a substitute to the preferred drug had a higher rate of relapse, researchers found, and adults with a genetic disorder called Fabry disease had decreased kidney function when their medication was cut by two-thirds. One alternative guideline adopted during a shortage of intravenous nitroglycerin ‘was downright scary from a clinical perspective,’ according to Dr. Nicole Lurie, a senior federal health official.

“Physicians say that many of the changes they are compelled to make appear to do no harm. But, they acknowledge, typically no one is tracking outcomes in patients who get a drug and others who get a substitute or delayed treatment.” NY Times. Surgeons are used to playing God, but sometimes these decisions haunt them like no other.
It gets worse as hospitals horde some of these medications, making it that much more difficult for everyone else. And let’s face it, some procurement administrators are better are finding the unfindable better than others. For those who wait for the drugs to become available, they may well be trumped (sorry) by hospitals who know how to advance up the pharmaceutical company’s waiting list. And there’s nothing on the horizon to tell you it’s getting better. It isn’t.
“In a survey of cancer doctors conducted in 2012 and 2013, 83 percent of respondents who regularly prescribed cancer drugs reported having been unable to provide the preferred chemotherapy agent at least once during the previous six months. More than a third of them said they had to delay treatment ‘and make difficult choices about which patients to exclude,’ according to a letter published in The New England Journal of Medicine.

“The threat of future shortages in children’s treatments is serious enough that Dr. Peter Adamson, who leads the Children’s Oncology Group, the largest international group of children’s cancer researchers, assigned his organization to set priorities. ‘We’ve been forced into what we think is a highly unethical corner,’ he said in an interview.” NY Times. Why do I think older patients are the first to be skipped over? And exactly how do we motivate pharmaceutical companies to solve this problem. That they don’t have price controls hasn’t worked, so perhaps we can create a compulsory licensing schema where supply doesn’t remotely keep up with demand. What’s your idea?
I’m Peter Dekom, and the more your learn about what’s really happening, the more concerned we should be.

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