Patients with septic shock treated in hospitals during a 2011 shortage of norepinephrine, the recommended therapy, were more likely to die when the drug was unavailable, a study shows. The researchers, from multiple institutions, used a large nationally representative database of hospitalized patients in the United States to investigate associations between the norepinephrine shortage, use of alternative treatments—such as phenylephrine (used most often), dopamine, epinephrine, and vasopressin—and in-hospital mortality from septic shock.
The investigators noted that although drug shortages are an increasing problem that has received a lot of attention in the United States, the effects on patient outcomes and prescribing practices have had little research focus. Moreover, there is no national reporting system to monitor the impact of drug shortages at the level of individual hospitals and on patient care.
The cohort study of 27,835 patients with septic shock admitted to 26 hospitals found that in institutions with at least three months of the norepinephrine shortage, use of the drug dropped from 77% of septic shock patients before 2011 to 56% in the second quarter of that year. Compared with admissions of septic shock patients during times of normal norepinephrine use, admissions during times of drug unavailability were associated with a 4% absolute increase in septic shock deaths in the hospitals.
An accompanying editorial calls the situation “a case study of potential harm” and suggests five general solutions to address and prevent drug shortages: create an early warning system; make faster changes to clinical guidelines; create a quality “seal of approval”; mandate a stockpile of high-priority drugs; and change the generic drug approval process to require manufacturers of sterile injectable drugs (those most likely to have shortages) to include projections of demand and plans to meet them, and have backup penalties and inducements for companies.—Serena Stockwell
Vail E, et al JAMA
2017;317(14):1433-42; Donohue JM, Angus DC JAMA 2017 317 4 1415–7