Potential Future Shortages

As the pandemic wears on, what other products may be at risk for shortage in the near future?

“Fluids are a concern, for example, drugs such as saline and dextrose solution,” Dr Fox said. “The supply of these has been very tenuous, and they are necessary for all patients, but also for patients on chemotherapy.” 


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“One of the things that’s interesting about fluids and contrast dye, even though these are critical medications, and they are drugs, the way that they’re contracted for as a supply is almost as if they are Band-Aids,” she said. “But they’re not Band-Aids; they are really critical.” 

Dr Fox noted that, despite the critical need for a constant supply of these products, they are often managed by group purchasing organizations and staff, rather than specialist pharmacy personnel.

“We need to treat these products that have been treated as supplies… as the critical medications that they are because if we don’t have fluids, we can’t mix chemotherapy, we can’t offer hydration. Everything really comes to a standstill,” she said.

Preventing and Managing Shortages

Dr Lin said she has been contacted by physicians from other centers across the US to talk about how to navigate the shortage of fludarabine.

She and colleagues around the country have been scanning the literature and clinical trial results to come up with backup plans for lymphodepleting therapy for patients, should it become necessary. 

Dr Fox mentioned that the FDA recently issued a draft guidance for industry that is intended to help stakeholders develop and implement risk management plans to prevent shortages.5,6

“There really is no incentive currently for drug companies to avoid shortages,” Dr Fox said. “When you think of drug manufacturing as purely a business, especially for low-cost, cheap drugs like dexamethasone, why have a backup in place? But people’s lives are at stake when these shortages happen. It’s frustrating.” 

Dr Fox also noted that a committee she is on at the National Academies of Sciences, Engineering, and Medicine has proposed a scheme involving transparency about quality and supply whereby hospitals and health systems could choose to buy drugs from companies with good reputations in relation to their risk management plans to guarantee supply.7

“The idea is to improve that transparency around which companies are doing a good job and which companies, frankly, are not,” Dr Fox said. 

Ideally, this transparency would allow health systems to choose companies that have backup plans in place for shortages and therefore avoid putting patients at risk, Dr Fox added.

Disclosures: Dr Fox, Dr Lin, and Raghavendran have no relevant disclosures. 


References

1. Current and resolved drug shortages and discontinuations reported to FDA. FDA drug shortages. US Food and Drug Administration. Accessed August 18, 2022. 

2. Foti L. Patients face long delays for imaging of cancers and other diseases. New York Times. Published May 26, 2022. Accessed August 18, 2022.

3. Park B. GE Healthcare contrast media products in short supply. MPR. Published May 12, 2022. Accessed August 18, 2022.

4. Park B. FDA grants temporary import of contrast media agent to address shortage. MPR. Published July 27, 2022. Accessed August 18, 2022.

5. Risk management plans to mitigate the potential for drug shortages; draft guidance for industry; availability; agency information collection activities; proposed collection; comment request. Federal Register. US Food and Drug Administration. Published May 20, 2022. Accessed August 18, 2022. 

6. Risk management plans to mitigate the potential for drug shortages; draft guidance for industry; availability; agency information collection activities; proposed collection; extension of comment period. Federal Register. US Food and Drug Administration. Published July 12, 2022. Accessed August 18, 2022.

7. Security of America’s medical product supply chain. National Academies of Sciences, Engineering, and Medicine. Accessed August 18, 2022.