FDA to take steps to ease shortages of drugs for COVID-19 patients on ventilators
pharmafile | April 21, 2020 | News story | Manufacturing and Production | COVID-19, Ventilators, coronavirus
The FDA is to allow small compound pharmacies to fill the shortages of medicines needed for patients with COVID-19 who are on ventilators.
The decision was taken as hospitals are struggling to acquire individual prescriptions and purchase medicines from their traditional suppliers. These include painkillers, muscle relaxants, sedatives and anesthetics.
These shortages have increased drastically since the pandemic reached America. From January to March, the shortages of these drugs rose 87%, and between January and April it increased by 213% according to Vizient.
In its new guidance, the FDA said: “In light of unprecedented disruptions to, and demands on, the global pharmaceutical supply chain as a result of the Covid-19 pandemic, and in order to respond to evolving regional conditions, additional flexibility is temporarily needed to ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with Covid-19.”
These types of compound pharmacies became controversial when in 2012 an outbreak of fungal meningitis killed dozens of people. It is felt that 60 of these deaths were due to a quality control breakdown at the now-defunct New England Compounding Center.
In the aftermath, Congress created two classes of compounders in The Drug Quality and Security Act. One is the 503B compounder which ships large quantities out of state overseen by the FDA, and the 503B compounder which is overseen by state boards of pharmacy.
Conor Kavanagh
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