Lacking specialized knowledge in this area I’m not well situated to evaluate the contents of this letter from reader J.W., but perspectives and advice from medically knowledgeable readers would be more than welcome:
One of our friends apparently has focal segmental glomerulosclerosis, which has a substantial risk for progression to end-stage renal disease.
Apparently, getting a nurse to come and administer albumin, which is a blood product, is a real problem. About three years ago, liability laws stopped the companies that produce albumin from allowing it to be used at home. There is a real possibility she will have to go to “Day Hospital” every day for five hours and perhaps have to be readmitted every weekend.
Given the likelihood that she will die from her disease, I’m sure she is comforted by the fact that she’ll spend so much time in the hospital for legal reasons.
But I feel safer, so that’s nice.
4 Comments
I’m a doctor of pharmacy. Whether we like it or not, drug manufacturers are the ones who determine appropriate use for their products. Some drugs are made so patients can take them at home (pills and inhalers; some are made so home nurses can use them (most IV fluids and IV nutrition); and some must be administered with supervision only a hospital can provide. And, unless your friend is a hospice patient waiting to die, no health care practitioner is going to go against published administration specifications if something goes wrong.
In no way was I complaining that health care professionals should go againgst published administrative specifications.
If, however, “my” friend (loosely, as she’s really a friend of the family) would have been able to get home administration of the albumin, say, 5 years ago, and the reason she can’t now stems from liability (not health, but risk of legal action) concerns, then this would seem to be a case of overlawyerage, if you will.
And, to further delve into Jon’s comment, I agree that drug companies determine appropriate use for their products. This is just one more case where the determination came through the legal department…
No! The prescribing doctor decides the conditions of use. That is practice of medicine, and the AMA has vigorously guarded it against intrusion by FDA or pharmaceutical companies.
The manufacturer negotiated with FDA for the label, describing the intended conditions of use. The doctor can prescribe off-label, meaning that he or she can give you a medicine that isn’t approved for an indication, or give the medicine in a different way. The doctor could tell the pharmacy to give the patient the meds and let the patient take it home. The doctor could get the albumin himself/herself, and then give it to the patient.
Sure, the manufacturer may be partially to blame, but the patient should be chewing on the doctor. Or getting a different doctor.
I agree with Dusty over jon, and from personal experience. A coronary artery bypass graft surgery went bad. I got mediastinitis, an infection in the sternum. Very bad; 25% chance of dying. Two nasty sternal debredement surgeries later, I was sent home with a Rx for nafcillin to be administered by my wife (and later me) via a PICC line installed in my left arm, 6 times a day. For 6 weeks.
Nafcillian was delivered to me at home weekly in premixed bags of solution I had to keep cold. Two months later, mediastinitis reappears. Two more sternal debredement surgeries. But this time I was coherent rather that septic, and from my hospital room I surfed the web (dial-up back then!) and discovered that nafcillin declines in potency over time. In other words, my re-infection was probably due to antibiotics that were destined to become ineffective midway through each of the 6 weeks of therapy. Huh.
I asked of the chief of infectious disease what exactly the time-temperature profile was. He didn’t know. He said the hospital just assumes that it’s effective at home because it’s effective in the hospital. But in the hospital, the pharmacist does not mix Sunday’s dose the previous Monday. The drug was approved many years ago by FDA for hospital administration. Nobody seems to have bothered to determine whether home administration under very different conditions works as well.
I called around and found a pharmacy that sold nafcillin in powder form that I could mix myself. I encountered brief objections from the hospital, which I perceived (but cannot prove) to be motivated by concerns about liability.
I solved the problem by refusing to be discharged until they agreed to my terms.
In my studies of regulatory policy and practice, I have encountered many instances in which it is alleged that something must be done because “government regulations” require it. Oftentimes, that’s just not true, and the real reason is an organization’s own policies, which often are rooted in liability defense. For a recent (and also personal) example involving blood donation, see my post at:
http://neutralsource.org/content/blog/detail/961/