RUTHFULLY YOURS

https://www.axios.com/2023/03/21/drug-shortages-upend-cancer-treatments

Supplies of some essential drugs used in hospitals are hitting 10-year lows, forcing rationing and pharmacy workarounds.

Driving the news: Drug shortages are the worst they’ve been in a decade, according to the American Society of Health-System Pharmacists — a sign of how much we rely on low-margin manufacturers with limited capacity for basics like the inhalation drug albuterol and some common cancer treatments.

What they’re saying: Quality control issues, selected plant closures and other manufacturing woes have added up, Michael Ganio, senior director of pharmacy, practice and quality at ASHP told Axios.

Between the lines: Oncology drugs have been hit particularly hard in recent months, putting experts on high alert.

• Those in short supply include methotrexate, an injectable chemotherapy drug, and one of several generics produced by Illinois-based Akorn Pharmaceuticals, which shuttered operations last month due to bankruptcy.
• Manufacturing delays and increased demand have also led to shortages of the cancer treatments cisplatin, and fluorouracil, per ASHP.
• Pluvicto — used to extend survival among patients with metastatic prostate cancer — will take months to be made available to patients again, the Wall Street Journal reports.
• “People will die from this shortage, for sure,” Jonathan McConathy, director of the division of molecular imaging and therapeutics at the University of Alabama, told WSJ.
• A survey of health systems conducted by the group End Drug Shortages Alliance found the injectable Bacillus Calmette-Guerin (BCG), used for treating bladder cancer, was being rationed or was not available for use at all.
• “This is a terrible crisis. We should be doing everything we can to give every single one of these patients the best chance of survival,” Laura Bray, a board member of the alliance, told CNN.

Between the lines: Manufacturing delays and quality problems are blamed for the shortages. But that’s often because there aren’t many alternative sites to pick up the slack in the system due to the challenging economics of the market, experts say.

“These are really low-margin businesses. These companies, particularly the ones that are making some of these sterile products relied upon so heavily by hospitals, really have little play in the supply they are able to offer,” Hilary Marston, the FDA’s chief medical officer told Axios.

• The agency works with manufacturers as much as it can, such as quickly approving acceptable workarounds, she said. “But the underlying reality of this market remains what it is,” Marston said.

When it comes to oncology drugs, the FDA said it is doing what it can to help companies meet the demand, but it has special challenges.

• “Those are absolutely critical. They need to be made on very specialized manufacturing lines due to the nature of the manufacturing,” Valerie Jensen, associate director of the FDA’s Drug Shortage Staff, told Axios.

• “We’re working with those companies to not only increase production but also working with them qualify additional suppliers and sites and anything else they can do to increase supply.”

Be smart: In most cases, health system pharmacists can find a workaround by either compounding or repacking medications into different doses.

• “We’ll MacGyver a way to get the right dose to the right patient,” Ganio said.
• However, as he points out, that’s far from ideal, particularly as it adds to the workload in a workforce environment where burnout is already high. It can also increase the risk of a medication error, he said.
• A 2019 study by group purchaser Vizient found managing drug shortages cost U.S. hospitals about $360 million a year.

The big picture: These problems within America’s drug supply chain are also impacting consumer access at the pharmacy counter — most notably with the ADHD medication Adderall, as well as its generic alternatives.

• The FDA told the Washington Post the problem started with manufacturing delays but is now being driven by consumer demand.

The bottom line: For Ganio, the overall lackluster response to Akorn’s closure should be more on par with the collective national worry over Silicon Valley Bank’s failure.

“We have life-saving drugs being produced by this manufacturer,” Ganio said. “We certainly need to take that kind of look at our health care infrastructure and treat the drug supply chain as critical infrastructure.”