During the stock shortage period, phenylephrine was the most frequently used alternative vasopressor.
According to an editorial, there are important caveats to this study. The diagnosis of septic shock relied on claims and medication data rather than on prospective clinical adjudication. Also the analyses generated associations between periods of shortage and outcomes, but not causal estimates of the lack of access to a drug on outcomes. Even if mortality was increased by the shortage, the mechanism is complex, requiring consideration of not only the absence of noradrenaline but also the choices made regarding alternative treatments.
It notes that the majority of drugs prone to shortage are, like noradrenaline, generic sterile injectable drugs with a short shelf life, i.e. shortages occur for drugs with low profit margins that require specialised production operations and high storage costs. It alludes to other drug shortages in US during 2016 and 2017 including multiple intravenous antibiotics (aminoglycosides, ciprofloxacin, extended-spectrum penicillins, third-generation cephalosporins, and vancomycin), inotropes and vasopressors (dobutamine and dopamine), chemotherapy agents (bleomycin, cisplatin, doxorubicin, etoposide, and methotrexate), and miscellaneous drugs used in the intensive care unit, such as calcium, sodium bicarbonate, short-acting muscle relaxants, fentanyl, and morphine. It questions why the US, which accounts for nearly half of global pharmaceutical sales and is home to some of the world’s largest pharmaceutical companies, has shortages of more than 100 drugs each year. According to the FDA, most shortages for sterile injectable drugs are due to quality problems during manufacturing, leading to a slowdown or halt in production.
The editorial suggests at least 5 broad solutions for addressing and preventing drug shortages:
• Early Warning System
• Rapid Changes to Clinical Guidelines
• Quality Seal of Approval
• Expand the Stockpile
• Require Production