Sepsis drug shortage linked to increase in patient deaths: 7 study findings

Septic shock patients treated at a hospital with an insufficient supply of the drug norepinephrine were more likely to die than those treated at a hospital not experiencing the effects of the 2011 norepinephrine drug shortage, according to a study published in the Journal of the American Medical Association.

Here are seven things to know.

1. The Food and Drug Administration announced a severe shortage of the drug — which raises blood pressure by activating blood vessels to constrict — in February 2011. The shortage lasted a year and stemmed from production issues at three manufacturing sites.

2. For the study, researchers examined data on 27,835 septic shock patients treated at 26 hospitals between 2008 and 2013.

3. Prior to the shortage, about 60 percent of the hospitals used norepinephrine to treat septic shock. Researchers defined any hospital whose use of the drug decreased more than 20 percent in three months as experiencing a shortage.

4. Researchers found norepinephrine was used in about 77 percent of septic shock patients at the hospitals included in the study. By the second quarter of 2011, usage dropped to about 56 percent, according to the report.

5. Septic shock patients had about a 40 percent risk of death during the shortage. Individuals treated at a hospital not experiencing a shortage only had a 36 percent risk. Researchers believe this four-percentage point difference accounts for hundreds of additional deaths among patients with septic shock.

6. While researchers could not confidently conclude why a risk of death was related to the drug shortage, they said it might be related to the drugs physicians used as a replacement for norepinephrine. Furthermore, some patients who were treated with norepinephrine during the shortage may have had to wait longer to receive it.

"You can’t come to the firm conclusion that the alternative vasopressor was the problem, but it does point to problems in the system when there are shortages of medications like that," senior author Hannah Wunsch, MD, of Sunnybrook Health Sciences Center in Toronto, told Reuters.

7. Julie Donohue, PhD, and Derek Angus, MD, researchers at the University of Pittsburgh discussed the shortage and share five broad solutions to stopping drug shortages in an accompanying editorial. Their suggestions included establishing early warning systems, implementing professional guidelines about drug alternatives and requiring drug manufacturers to produce specific volumes of drugs after they are approved by the FDA.

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