Thursday, January 16, 2014

Shortage of Norepinephrine Hampers Sepsis Management

A national shortage of norepinephrine has critical care clinicians scrambling for alternative drugs to help treat patients with sepsis.

Norepinephrine is a key drug in the treatment of sepsis, which affects approximately three in 1,000 hospital patients (Crit Care Med 2001;7:1303-1310).

Norepinephrine is not a drug that can be easily replaced, said Peter J. Papadakos, MD, professor in the department of anesthesiology at the University of Rochester Medical Center, which is feeling the pinch. “It’s as if there were a national shortage of oxygen.”

Drugs that could be used as alternatives to norepinephrine include epinephrine and dopamine, but Dr. Papadakos considers these “tertiary” options, as they do not have entirely similar vasopressive effects. He also said there is no easy way to predict how long patients will require treatment with norepinephrine, which makes conserving the drug a difficult task.

As of Jan. 14, the FDA’s index of current drug shortages does not include norepinephrine. The American Society of Health-System Pharmacists, an organization that also tracks drugs that are in short supply, lists ongoing shortages of 1 mg/mL norepinephrine vials and ampules.

At the end of 2013, Ben Venue Laboratories, a manufacturer in Bedford, Ohio, ceased production of norepinephrine. Teva Pharmaceuticals also has discontinued production of the drug and does not expect to resume it until late 2016, according to the ASHP site.

Dr. Papadakos, a member of the editorial board of Anesthesiology News, called the current frequency of drug shortages “ridiculous,” and said the FDA’s response has been inadequate. “The silence from Washington is deafening.”

No comments:

Post a Comment