Pharmacists increasingly are being asked to make drugs in bulk for hospitals that are in short supply, and they’re even beginning to make chemotherapies. But some in the industry worry about the unintended consequences of over reliance.
Hospitals’ reliance on pharmacist-made drugs, a practice called compounding, has risen in step with worsening drug shortages.
When the American Society of Health-System Pharmacists surveyed its members this past summer, 59% said they increased purchases from compounders because of drug shortages.
Premier, which buys drugs for about 4,400 hospitals, purchased 41% more drugs from compounding facilities in 2022 than in 2021. The rise in compounding business from drug shortages was first reported by the Wall Street Journal.
Some compounders are even beginning to make chemotherapies, which are much more complicated to manufacture than other sterile injectable generics.
But compounding is supposed to offer temporary relief during drug shortages and was never intended to replace generic drug manufacturers, said Kalah Auchincloss, executive vice president of regulatory compliance at the FDA regulatory consulting firm Greenleaf Health.
“You’re not fixing the underlying problem, which is an economic one,” Auchincloss said. It’s “like patching a hole.”
Two different pathways
Bulk compounders take generic drugs, approved by the Food and Drug Administration, and make them into ready-to-use products, such as pre-filled syringes. When drugs are on the FDA shortage list, they’re also allowed to make drugs from the bulk ingredients.
It’s cheaper and faster for compounders to respond to drug shortages than generics makers, because compounders don’t need to undertake the expensive and lengthy process of getting drugs approved by the FDA. They also often do not use manufacturing processes that are as safe as generic drug makers.
Eric Kastango, founder of the compounding consulting firm Kastango Consulting Group and training firm Critical Point, said bulk compounders are an important backstop to shortages.
However, bulk compounding is a young industry and many compounders still have more to learn. In 2012, contaminated drugs made by the New England Compounding Center infected nearly 800 people and resulted in 64 deaths. In the aftermath, Congress created higher standards for bulk compounders. Those bulk compounders have come to be known as 503B facilities, so named after the new section of law that created them. Pharmacists that compound drugs for individual patients in response to prescriptions are known as 503As and are not subject to the same rigorous standards.
Bulk compounders typically use less rigorous, and far cheaper, sterilization processes than those employed by generic drugmakers, Kastango said. That’s why FDA typically gives compounded drugs shelf lives no longer than half a year, so that in the event of minor contamination, bacteria doesn’t have much time to grow. Generic drugs typically expire two to three years after they’re made.
In addition to manufacturing-quality concerns, Auchincloss worries that bulk compounding might undermine incentives for drugmakers. The decision by some generic drugmakers, such as Hikma Pharmaceuticals, to open compounding facilities is evidence that’s happening. It’s expensive to get FDA approval of generic drugs, and it takes much longer to undergo the approval process than it does to start compounding drugs in bulk.
“Why would I face competition from the 503Bs who don’t have that extra expense of having to get approval?” she said, referring to bulk compounders by the section of law that created them.
The generic drug lobbying group Association for Accessible Medicines declined to speak to STAT for this article.
Generics, however, have a couple major advantages over compounded drugs.
“From a buyer’s perspective, I would much rather buy from a commercial manufacturer because it’s going to be fairly significantly cheaper,” said Michael Ganio, director of pharmacy practice and quality for the American Society of Health-System Pharmacists.
Also, generics can extinguish the market for compounders, and compounders have no control over that. Once enough generics come on line to end a shortage, compounders are no longer allowed to make drugs from bulk substances.
Compounders are at times the only option
Laura Bray, founder of Angels for Change, a nonprofit that helps patients get drugs that are in short supply, started a program to help compounders plan for shortages. Compounders are only allowed to compound drugs once they’ve been added to the FDA drug shortage list. Despite being more nimble than generic drug manufacturers, it still takes at least half of a year to get a compounded drug on the market.
Bray works with the U.S. Pharmacopeia and the American Society of Health-System Pharmacists to predict drugs that might go into shortage. Then her organization provides small grants to compounders that prepare in advance to compound those drugs. Last year was her first year running the program. The two drugs that Angels for Change funded did indeed experience shortage, and 700,000 patients had access to compounded drugs soon thereafter thanks to the advance planning. This year Bray’s foundation has provided grants for five drugs that could soon be in short supply, and she hopes to fund two more.
STAQ Pharma is one of the compounders working with Angels for Change. STAQ CEO Joe Bagan said his company plans to make chemotherapies. Many of STAQ’s investors are hospitals, including pediatric hospitals that have had a particularly difficult time getting chemotherapies that are in short supply. Cancer drugs are themselves hazardous materials, so the process of compounding them is much more difficult and expensive than other drugs.
However, compounders could play a bigger role in chemotherapies because the market for them is much smaller than most of the other more than 300 drugs experiencing shortages right now.
“This is a perfect application of 503B because I can make enough to actually help the country out,” Bagan said.
Kastango said compounders can help generics identify markets. Figuring out which drugs to make can be an expensive proposition for generics, he said. Being able to count the number of compounders in a market makes those decisions easier.
David Rochefort, director of government affairs for the compounder Revelation Pharma, said he has witnessed that phenomenon first hand. Generic drugmakers have taken the market back from compounders on several occasions over the years, he said. Compounders simply move on to other drugs in short supply when that happens.
“There’s a symbiotic relationship between the generic and compounding industries,” Rochefort said. “It’s not our objective to take over the generic drug market but to provide drugs when there’s a shortage.”
By John Wilkerson
Wilkerson, John, “Pharmacists can make shortage drugs, but at what cost?” STAT News, 10/20/23
https://www.statnews.com/2023/10/20/pharmacists-drug-shortages/ 2/5 10/20/23, 5:41 AM Pharmacists can make shortage drugs, but at what cost? - STAT