The Food and Drug Administration has taken yet another step in a bid to reduce a shortage of medicines needed for Covid-19 patients on ventilators, this time by allowing small compound pharmacies to temporarily fill the void.
The agency will permit these compounders, which fill individual prescriptions, to supply hospitals unable to purchase medicines from the usual manufacturers or larger compound pharmacies. Also known as outsourcing facilities, the bigger compounders make and sell large quantities of medicines without requiring patient prescriptions. Last week, the FDA also began allowing outsourcing facilities to sell to hospitals.
As noted previously, the decision comes as hospitals are having difficulty receiving orders for more than a dozen sedatives, anesthetics, painkillers, and muscle relaxants, which have been in short supply. The drugs are used to help manage pain and comfort levels while a patient is on mechanical ventilation. But orders are being filled and shipped to hospitals only 53% of the time, down from 72% last month.
The shortages have been growing worse this month. Overall demand for these drugs jumped notably, rising 87% from January to March, and increased by 213% from January to April, according to recent data from Vizient, a group purchasing organization that negotiates contracts for medicines on behalf of about 3,000 hospitals and health care facilities in the U.S.
“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 wrote in a guidance.
The move by the agency, which will allow smaller compounders to produce the same medicines as outsourcing facilities, comes after years of efforts to increase oversight of compounders ever since a 2012 outbreak of fungal meningitis killed dozens of people. More than 60 deaths around the U.S. were attributed to a quality control breakdown at the now-defunct New England Compounding Center.
As a result, Congress created two classes of compounders in 2013. One is the 503B compounder, or outsourcing facility, which can ship large quantities out of state and is overseen by the FDA. The other is a 503A, or more traditional compounder, which is overseen by state boards of pharmacy. But safety and oversight remained controversial for several years, in part due to varying state inspection policies.
The temporary change in policy has been met with mixed reactions, however.
The decision was praised by Scott Brunner, who heads the Alliance for Pharmacy Compounding, which has been lobbying the FDA to allow smaller compounders to supply hospitals with medicines that are being used to treat Covid-19 patients.
These compounders “are more nimble,” he told us. “They have to meet state boards of pharmacy standards and USP standards (the U.S. Pharmacopeia, an independent organization that publishes standards for manufacturing medicines). But they don’t have to adhere to good manufacturing standards, as the outsourcing facilities do.”
He added that not all outsourcing facilities, which are already required to register with the FDA and follow accepted manufacturing practices, may be inclined to invest in order to supply hospitals. One reason is that after shipping 1,000 units, an outsourcing facility will have to conduct sterility testing, which can take two weeks or more. This is also crucial time for hospitals that urgently need medicines.
But Liz Richardson, director of the health care products project at Pew Charitable Trusts, expressed reservations.
Smaller compounders “don’t need to meet good manufacturing requirements, and this guidance would remove the requirement that (they) compound only in response to a patient-specific prescription, provided that they are compounding one of the products on the (FDA) list and provided certain other conditions are met,” she wrote us.
“The prescription requirement was the key mechanism that limited large scale compounding by (these) pharmacies, so removing that requirement comes with some risks. I think the agency is still trying to do what it can to get the benefit-risk balance right and get drugs in shortage to hospitals that need them. But it’s hard to predict what will happen as a result of these changes.”
Meanwhile, Lee Rosebush, who represents the Outsourcing Facility Association, a trade group, argued the latest FDA move could hurt larger compounders and may open the public to harm if smaller compounders are not held to sufficient standards.
“This decision is as shocking as it is dangerous,” he wrote us. “At a time when American citizens are expecting the FDA to help protect them during this crisis, they just put them at higher risk.”