ASHP leader: What the Adderall shortage means for drug supply visibility

After the FDA confirmed the nationwide Adderall shortage Oct. 12, Becker's spoke with Michael Ganio, PharmD, to discuss the shortage and what separates it from the other 260 drugs currently in short supply. 

Dr. Ganio is the senior director of pharmacy practice and quality of the American Society of Health-System Pharmacists. The ASHP tracks drug shortages, and its database is built on reports from healthcare providers and patients.

Reason for the shortage

The company responsible for most of the nation's supply of the generic, Teva Pharmaceuticals, has 10 products on back order. A Teva spokesperson told Becker's the issue is the result of a previous labor shortage but said the drugmaker is "fully committed to uninterrupted supply and continuing to manufacture and distribute as much product as possible each day."

The other drugmakers that have amphetamine mixed salts products on back order, including Amneal Pharmaceuticals and Novartis' Sandoz business, have not shared with the ASHP the reason for their shortage. 

"Some of them are more forthcoming than others with information. And it could just be a PR decision from the manufacturer not to respond to outside requests," Dr. Ganio said. "Not everyone complies or is willing to offer information."

This visibility issue isn't just on pharmaceutical companies reporting the reason for delays, he said.

"In general, there's been very little to address the root causes of the shortages, which more often than not are a quality issue with the manufacturing," Dr. Ganio told Becker's. "It's past time to see more transparency into the quality of the manufacturing facilities."

Why can't other Adderall generic manufacturers just ramp up their work?

Amphetamine is a Schedule IIN drug, meaning patients can't just get early refills or have a different pharmacy fill the prescription. If a location had enough in stock and a patient wanted to transfer pharmacies, they would have to receive a new written or electronic prescription. 

"That makes this particular shortage that much more complicated," Dr. Ganio said. 

Drug manufacturers usually don't have room to make more of a specific product since idle production lines are lost revenue, Dr. Ganio said. Asking a company to double or triple its output to offset another company's shortage could trigger a separate supply issue. 

Drugmakers can ask the FDA and the Drug Enforcement Administration to expand their production quotas, but there may not be any room in their warehouses to do so.

When to expect the supply to ease

When the ASHP first reported on the shortage in late August, Teva Pharmaceuticals said it expected supply levels to normalize in a few weeks. Most of the generic products are expected to return to normal supply in late October and early November, but the FDA said Teva's resupply timeline is now March 2023. 

"When you hear 'recovery by whatever month,' take that with a grain of salt because there could be further delays. There's also a difference [between] the time something is shipped out of the manufacturers' warehouses and the time it actually gets to a pharmacy and is able to be dispensed to a patient," Dr. Ganio said. "To me, the take-home message there is that the dates aren't always reliable."

Editor's Note: This story was updated Oct. 19 to include a response from Teva Pharmaceuticals.

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