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Shortage of Norepinephrine for Septic Shock Linked to Mortality Increases

TORONTO – Drug shortages have plagued emergency departments and hospitals for years, but a new study demonstrates how dangerous they can be.

A study published online by JAMA notes a higher mortality risk for patients with septic shock admitted to hospitals affected by the 2011 drug shortage of norepinephrine. In February 2011, the U.S. Food and Drug Administration (FDA) announced a severe nationwide shortage of norepinephrine, which persisted for a year and was attributed to production interruptions at three drug manufacturers.

The problem is that norepinephrine is recommended as the first-line vasopressor for treatment of hypotension due to septic shock.

Led by the Sunnybrook Health Sciences Centre, the study is being released to coincide with its presentation at the 37th International Symposium on Intensive Care and Emergency Medicine. Researchers focused on changes to patient care and outcomes associated with the 2011 shortage of norepinephrine.

Included were 26 U.S. hospitals with a baseline rate of norepinephrine use of at least 60% for patients with septic shock. The study group consisted of 27,835 adults with septic shock admitted to study hospitals between July 2008 and June 2013. The study defined hospital-level norepinephrine shortage as any quarter in 2011 during which the hospital rate of norepinephrine use decreased by more than 20% from baseline.

Results indicate that hospitals used norepinephrine with 77% of patients before the shortage and that figure declined to a low of 56% in the second quarter of 2011. During that time, phenylephrine was the most frequently used alternative vasopressor, but inability to access norepinephrine apparently was not without consequence.

The study finds that, compared with hospital admission with septic shock during quarters of normal use, hospital admission during quarters of shortage was associated with a 3.7% increased rate of in-hospital mortality. The figures were 9,283 deaths out of 25,874 patients, or 35.9%, during normal use vs. 777 deaths out of 1,961 patients, or 39.6% during shortage quarters.

The authors posit that other specific vasopressors selected to replace norepinephrine might have resulted in worse outcomes for patients with septic shock. They also question, however, whether the observable decreases in norepinephrine use during shortage periods could be a marker of related unmeasured factors that affected patient outcomes, such as the absence of a dedicated shortage pharmacist to optimize distribution of limited supplies, delayed administration of vasopressors, or lack of clinician familiarity with dosing of alternative vasopressor agents.