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/

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.

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…