Say It Ain’t So!

Posted by James

In an academic medical center in a galaxy far, far away, the chairman of the P&T committee’s subcommittee on medication quality received a disturbing phone call from the institution’s Chief Medical Officer, who hurriedly related a most extraordinary story. The account went something like the following:

A critically ill post-bone marrow transplant patient develops a rare skin condition, known as steroid-refractory graft-versus-host disease (GVHD). An attending oncologist, well respected in the local community, desperately searches for a way to help the patient.
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(So far, our story has all of the usual ingredients of pride, control, and a sworn allegiance to do the best we can for our patients.)

The attending oncologist, eager to maintain his devotion to lifelong learning, goes to a local national conference sponsored by the American Society of Hematology. Serendipitously, while at the conference, he sees a poster presentation on the same malady afflicting his patient. Armed with new information based on an observational study of 14 patients [sic], the oncologist, emboldened with a new approach for the clinical challenge at hand, returns to the academic medical center. He then writes an order for this new therapy and continues on his rounds to visit other ill patients.

Hours later, the pharmacy department informs him that the new therapy is not on the formulary and is not stocked by the hospital—not even a single dose or a single vial. Reportedly upset by the news but still wanting to do the best he can for his patient, our oncologist calls another academic medical center in a nearby galaxy.

‘Yes,” the second center replies, “we do stock this new product, but, of course, we can’t give you any samples, as our two institutions are in competing galaxies.”

Undaunted, the oncologist calls the pharmaceutical manufacturer’s representative, who happily hand-delivers two doses of the drug to the oncologist, for the benefit of our patient in need.

Meeting the representative at the door, the oncologist hand-delivers the medication to the pharmacist in the satellite pharmacy closest to the patient’s room. Here, he convinces the pharmacist (himself a relative newcomer simply finishing his busy shift) to mix the medication and deliver it to the nurses caring for the patient. The patient receives the medication without incident.
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Say it ain’t so!

I cannot reveal the galaxy in question, but many readers might recognize such a scenario. To me, living in this “post-Institute of Medicine report” world, which is heavily focused on medication safety and stricter adherence to practice by protocol, this story appears even more unbelievable.

A situation such as the one depicted here represents a system failure at an exponential level—failure to follow agreed-upon standards of practice; failure to adhere to hospital policy with regard to nonformulary products; failure to enforce pharmaceutical representative behavioral limits; and, worst of all, pulling professional rank to violate policy in the name of “improved patient care.” This behavior has effectively short-circuited the procedures in place that are intended to ensure safety and quality, including P&T committee review, determining safe handling and administration by pharmacists and nurses, checking for drug interactions, and the like.

While exposing our galaxy to a staggering level of liability in terms of not only clinical practice but also research compliance, our story’s attending physician has requested and received samples for the ill patient and, subsequently, for other patients in the same institution—in effect running a clinical trial without approval of the institution’s review board or oversight of any kind. One might ask: How could a scenario like this happen in 2003? Why does our slavish adherence to personal clinical autonomy continue despite mountains of evidence that is it just this sort of behavior that can bring down the house of cards upon our heads? Is there a moral to this story? I suggest the following measures:
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• All P&T committees ought to re-examine their policies and procedures to prevent similar events from happening in their galaxies.
• All pharmacy directors should be prepared to support their staffs, in writing, indicating that if they believe the administration of any product to be in violation of hospital policy, then staff members have every right to refuse to administer such therapy.
• All P&T committees should also re-evaluate the quality of their connection to the on-call hospital administrator to ensure that effective, reciprocal communication exists across the clinical and managerial domains in which we practice.

I hope that your P&T committee rigorously defends its formulary decision-making procedures and that it holds accountable anyone in its galaxy who is found to have violated this collective trust. Here’s hoping that your P&T chairman never utters the phrase, “Say it ain’t so!”