Local pharmacies are well aware of the continuing shortages of hydroxychloroquine, chloroquine, albuterol and fluticasone inhalers, and azithromycin and the challenges facing their community patients who depend on the medications. 

The shortages now extend far beyond those commonly prescribed drugs, however, to include a range of medications used to treat pain, provide anesthesia, prepare IV drugs, and battle bacterial infections in hospitalized patients. Increasingly, even large hospitals and healthcare systems cannot find critical medications through their usual channels or outsourcing facilities. 

STATnews reported that hospitals are receiving their orders for sedatives, anesthetics, painkillers, and muscle relaxants used for patients on ventilators just over half the time, and often they get only a fraction of the quantity they’ve ordered. At the same time, demand for the medications has more than tripled since January.

Typically, that wouldn’t affect independent pharmacies, but extraordinary times require extraordinary measures. In that spirit, the FDA has turned to small compounding pharmacies that are not registered with the FDA as outsourcing facilities to ask for their help in supplying hospitals. 

“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,” the FDA said.

Since 2013, small compounders have been required to have a patient-specific prescription in hand to compound a drug. They have also been barred in most instances from essentially duplicating a commercially available medication. The loosened guidance removes those restrictions if the pharmacy is compounding one of the drugs on the FDA list. 

“FDA does not intend to take action against a pharmacy for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription” during the public health emergency related to COVID-19 or until further notice, according to the new guidance. 

The compounded drugs must be on the list attached to the guidance, which will be updated regularly. Currently, the list names 15 drugs, including epinephrine, fentanyl, hydromorphone, ketamine, lorazepam, morphine, and vancomycin, among others. 

Generally, the drugs are also on the FDA’s national shortage list, and hospitals must make every attempt to source them from more traditional suppliers first. 

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