Pharmacy Expert Discusses Chemo Shortage Challenges, Mitigation Strategies

Michael Ganio, PharmD, MS, BCPS, FASHP

American Society of Health-System Pharmacists

Communication among practitioners, pharmacists, nurses, and patients is “paramount” for managing cancer care during the ongoing chemotherapy shortage across the United States, according to Michael Ganio, PharmD, MS, BCPS, FASHP.

In an interview with CancerNetwork^®, Ganio, senior director of Pharmacy Practice and Quality at the American Society of Health-System Pharmacists, described the cause of the carboplatin and cisplatin shortages that are impacting cancer care in the United States, and how the FDA is working to mitigate the situation by collaborating with Chinese manufacturers to import these chemotherapy agents.¹ He also discussed several details practitioners should keep in mind when working with these imported agents, including the possibility of non-functioning barcodes or the national drug code (NDC) number missing.

Ganio emphasized that practitioners should be open with patients during the shortage and inform them of the ongoing situation during treatment. In particular, he indicated that all members of the care team, from nurses to pharmacists, should be engaged in conversations about drug administration to help prevent critical errors.

“Shortages are not new; this has been going on for 20 years,” Ganio said. “The oncology world in particular has been hit several times in the past 5 to 10 years with shortages. Advocacy is needed. Our policymakers need to know that these shortages are having a real-world impact, and that they need to be addressed.”

CancerNetwork^®: Could you detail the cause of the current cisplatin and carboplatin shortage in the United States?

Ganio: Cisplatin and carboplatin have been in short supply for a couple of months, now. The triggering event was an FDA inspection of a facility in India that is a manufacturer of the product for the United States, and that inspection did not go well. There were some concerning findings from the FDA, and they've been working with that manufacturer to resolve those findings. In the meantime, they've been slowly releasing some of the product that had already been manufactured. But the manufacturing has not resumed, so what's been released from that manufacturer has undergone additional testing to make sure it's of suitable quality.

But as of the last time I heard, production has not resumed. That's not good news in the longer term for both of these shortages. The manufacturer had about half of the market for cisplatin and about 20% of the market for carboplatin. Unfortunately, we're now seeing the side effects of that inspection and the product that had not been released. There was a survey of the National Comprehensive Cancer Network that found that almost all the organizations that responded were experiencing a carboplatin shortage.² Although 20% of the market doesn't seem like a lot, it's probably the first thing that clinicians would go to as an alternative to the cisplatin shortage. Between the 2 drugs, it's making it very difficult to give patients the regimens that are either first-line or second-line for their cancer depending on which treatment they would normally receive.

How is the FDA working with Chinese manufacturers to bring cisplatin and carboplatin to the United States?

As I mentioned with the concerning inspection, they are trying to expedite getting that product that had already been manufactured released and also getting manufacturing up and going again to help address the underlying cause of the shortage. In the meantime, they have authorized importation of cisplatin from a Chinese manufacturer.¹ It's a facility that didn't normally have the product registered with the FDA, but that company does have FDA-approved products.

It's a matter of the FDA going through some steps to make sure that product is of suitable quality. It's probably not going to be enough to meet the market demand, but what it should do is give clinicians an opportunity to implement their strategies for managing the shortage, whether that's prioritizing certain patients over other patients or scheduling patients differently to make sure there's less waste from the vials. There are several strategies that can be used, and that additional supply can help stretch the amount that they have on hand that much further.

Are there any concerns or challenges with this importation strategy?

As far as the product itself, there's not really any concern. The one thing that we've seen in the past is product that has been manufactured overseas doesn't always contain the pharmaceutical label that we expect on our products. For example, cisplatin is one of the medications that's recommended to have capitalized letters to call out the distinction between cisplatin and carboplatin; the imported product doesn't have that. Barcodes may not work. The label does state cisplatin and the concentration in English, but most of the other writing is in Chinese, so clinicians should know that the product is going to look different.

They can find the prescribing information that they would normally find in the labeling on the FDA website. But, again, [clinicians should] recognize that barcodes may not work and that there may not be an NDC number, which can make billing difficult. Not that these are expensive products, but I'm sure clinicians who are using them still would like to be reimbursed for them. It may take a couple of extra steps when adding these products to a formulary or into a clinic where they're going to be used.

How long can practitioners anticipate this shortage lasting? What do you suspect will be the long-term impact of the shortage?

That is a tough question because we don't really know; it depends on how quickly that plant can get up and running again [for] all those underlying concerns to be addressed. One of the things that we have found in previous shortages is that there there'll be continued research on outcomes with this, which is good—it's one of the things that the oncology community does well—as opposed to some of the other shortages we see where we just switch the patient to an alternative.

In oncology, we tend to do a much better job of following up, so there'll be some retrospective studies looking back and seeing what the overall survival was like, and what the response rates were like to different regimens. I think this is going to last a while. But one of the things that should come out of this is a little bit more information on which patients may benefit most from some of these regimens.

What advice do you have for practitioners during this shortage? What should they keep in mind?

Keep an eye on professional organization websites. For example, ASCO, the American Society of Clinical Oncology, has put out some recommendations,³ as has the Society for Gynecologic Oncology (SGO),⁴ on managing the shortages and helping to find ways for clinicians to prioritize which treatments should go to which patients. Engage all the disciplines in your organization, including your ethics committee if you have one, your pharmacist, nurses, and anyone else who's administering medications. They might be administering something they're a little less familiar with, so make sure every member of the health care team is engaged.

Include your informatics team, too. Changing the way regimens might be built in whatever electronic health record is being used is important, too, to prevent errors. We're talking high-risk medications as far as dosing. Most chemotherapy is considered high risk, so making sure the dose is correct, the patient gets the right medication, and the medication goes to the right patient [is important]. There are a couple of different layers where there can be errors with chemotherapy, and they have dire consequences, so communication is paramount.

Involve the patient in that conversation, too. It seems obvious, but we sometimes take for granted managing a shortage without even telling a patient; they may get a different antibiotic without even knowing it was the second line. Patients in this instance have the absolute right to know, and they should be aware that these shortages exist. Every member of the team, including the patient, should know that there are some discussions in Congress right now to try to address the problem.Reach out to your representatives, and make sure that they know that this is having a real-world impact so that we can bring them into these shortages.

References

1. Temporary importation of CISplatin injection with non-U.S. labeling to address drug shortage. FDA. May 24, 2023. Accessed July 27, 2023. https://shorturl.at/eiPQZ
2. NCCN releases statement addressing ongoing chemotherapy shortages; shares survey results finding more than 90% of cancer centers are impacted. News release. National Comprehensive Cancer Network. June 7, 2023. Accessed July 27, 2023. https://shorturl.at/ERY27
3. Clinical guidance. American Society of Clinical Oncology. Accessed July 27, 2023. https://shorturl.at/hNUVY
4. SGO statement: carboplatin and cisplatin shortages. News release. Society of Gynecologic Oncology. April 21, 2023. Accessed July 27, 2023. https://tinyurl.com/y3dcmdk4