A Difficult Pill to Swallow

In June 2023, study findings published by the National Comprehensive Cancer Network (NCCN) showed that approximately 93% of responding cancer centers (n = 27) were experiencing a shortage of carboplatin. When centers (n = 25) were asked to respond about whether they were able to treat all their patients currently receiving a carboplatin-containing regimen according to the intended dose and schedule, 60% responded yes, 16% answered no, and 20% said that they could treat some patients but not all. Investigators received comments such as, “We have developed a mitigation strategy to allow for switches to equivalent regimens when possible,” and “We are staying ahead of need but using conservative measures.” Other responders said that they were leveraging clinically appropriate dose reductions to avoid stopping treatment.¹

In some cases, the changes in treatment led to treatment delays. For example, among 19 responding centers, 16% shared that the act of reobtaining prior authorizations due to the shortage resulted in treatment delays. Although cases of delays were few, many respondents noted that the full impacts were still largely unrealized because the shortage began the week of May 22 and these responses were published in June. Of note, as of mid-June, only 40% of these centers had received word from their suppliers about when they would be receiving readily available carboplatin.¹

Cisplatin is also in short supply. In the same survey (n=27), 70% of centers shared that they were experiencing a shortage of cisplatin. Fortunately, at the time of the survey, all the respondents shared that they were able to treat their patients with their cisplatin-containing regimens in accordance with the intended dose and schedule. However, as with the carboplatin, only 39% of centers shared that their suppliers had informed them of when cisplatin would once again be readily available. Other drugs in shortage, according to the respondents, included methotrexate (67%), fluorouracil (26%), fludarabine (11%), paclitaxel (4%), and hydrocortisone (4%).¹

There has been little to no movement from most local legislatures regarding the shortage: 41% of respondents stated that their local legislature was aware of the shortage, 4% stated that their officials were unaware of the situation, and 55% were not sure either way. Regardless, those who believed their officials knew of the situation were not optimistic about their ability to intervene. Respondents wrote that their officials were “attempting to be helpful” but noted that they do not have the capacity to address acute shortages. Some respondents shared that they planned to partner with local officials soon.¹

Behind the Numbers

Clinicians have had to alert patients to a startling reality. Jovonne Owens, DNP, FNP-BC, has been an oncology nursing professional for the past 17 years and has worked as a nurse practitioner for the past 7 years. She works in the outpatient setting and primarily cares for patients with multiple solid tumors in the Division of Hematology & Oncology at the University of Illinois Health in Chicago. In an interview with Oncology Nursing News, she discussed patient and provider perceptions of the shortage.

Jovonne Owens, DNP, FNP-BC

“There are more than 20 chemotherapy drugs [in] shortage,” Owens said, noting that the drugs in low supply are generic and frequently used across multiple disease states. She also shared that communication with suppliers has been difficult.

“We do not get the information as quickly as we would like,” she said, noting that notifications from manufacturers alerting institutions of delays have consistently offered very short notice. In her experience, notifications have left institutions with less than a month to prepare, leaving clinicians “scrambling” to come up with a game plan.

Although patients have been less cognizant of the broader implications of the market failure compared with clinicians, over the past couple of months, she has had more patients ask her questions about what is happening and whether it will affect their care. “They see the drug shortages from other medications; now they are starting to hear that these oncology drugs are [affected],” she said. “They want to know: ‘Does this [affect] me? Does this [affect] my particular cancer?’ ”

She shared an example of a patient who was receiving treatment for curative intent. The center was low on the platinum therapy medication that this patient needed, so they were delaying starting her therapy by 2 weeks.

“That was very anxiety-provoking for her,” Owens recalled. “She came into the office, we were having this conversation, and she was understandably shaken [and] tearful because she just wanted to get on treatment. She wanted to start the thing that was going to take care of her cancer. I understood.”

Owens went on to describe that the patient came with her family and was very distraught. “It is gut-wrenching as a clinician to have these difficult conversations with patients, but we were able to help her understand that although it [was] a delay, fortunately, it would not [affect] her overall survival outcome because she was still within the period where we [would] want to start treatment. But for her to hear that the medication that she needed was not available now was a very difficult pill to swallow,” she said.

Owens also shared that another patient, whose disease was metastatic, had been receiving medication for a long time, and her disease was stable. However, after the shortage, there was a week when the institution did not have enough medication for the recommended weekly dose.

“She was so fearful because she [had] been on this medication for approximately 6 months and [was] doing very well,” Owens recounted. “She wanted to know: What [if] her cancer started growing because she could not get the medication that she was on? She was understandably upset because we had to do something different when what she had was working.”

A New Normal?

According to Lee Wilke, MD, FACS, author of the NCCN study, this shortage is more significant than other ones in recent years. Wilke is professor of surgery and senior medical director of clinical cancer services at the University of Wisconsin-Madison.

“Drug shortages have become commonplace over the past several years for everything from anesthetic agents to IV [intravenous] fluids,” Wilke said in an interview with Oncology Nursing News. “We have seen chemotherapy or oncologic treatment shortages in the past several years but none to the degree we’re seeing right now.”

Lee Wilke, MD, FACS

Wilke went on to emphasize that carboplatin and cisplatin are frequently used to manage lung, breast, and gynecologic cancers and that they are the backbone of both curative and life-prolonging therapies. According to Wilke, although there have been shortages in the past, oncologists have usually not needed to create mitigation efforts to avoid running out of curative therapies.

There are some reasons that this shortage has been more acute. As mentioned, the frequency of these drugs’ use has augmented the extent to which their absence is felt. Furthermore, the United States has a much larger aging population currently than it has had historically. As the number of baby boomers has increased, cases of lung cancer, breast cancer, and gynecological cancers have increased because of population density. These are the cancers that often require platinum-based treatments.

The good news, according to Wilke, is that certain strategies that many institutions are adopting in light of the shortage are ones that are supposed to be standard practice. Mitigation efforts, which use slightly smaller but still effective doses, are an important tactic to ensure that drugs are not wasted. Lengthening times between treatments, although not ideal, is not necessarily associated with worse long-term outcomes, she added.

Unfortunately, some patients will need to change regimens during this time. Although Wilke noted that the efficacy of the new regimen will be the same for many patients, they will have different adverse effects that they will need to learn to manage.

“We recognize that patients may be getting an equivalent drug, but they are getting a drug [that’s new] to them that may have different adverse effects,” Wilke said. “Helping the patients talk through potential different adverse effects [is key].”

“Adverse effects are a big concern because they may be changing to a medication that has a different adverse effect profile or the adverse effects may be a little more severe,” Owens said. “We talk about [how] we manage those potential adverse effects if they were to happen to allay any anxieties that may come with changing treatment plans.”

Changing patient regimens also requires solid interdepartmental communications. “It was such an interdepartmental effort to make sure that the appropriate patients received what they needed,” Cristina Estipona, RN, OCN, said. Estipona, who has been an oncology nurse for the past 13 years, is a clinical nurse manager at the Florida Cancer Specialists & Research Institute (FCS), in Tampa. “FCS’s procurement and pharmacy operations team works tirelessly to procure these drugs where they can and provides the providers and leaders the update on availability continuously.”

Cristina Estipona, RN, OCN

Furthermore, the constant shift in appointments hurt patient satisfaction and put extra pressure on nursing staff. “With all the customized regimens, we, as clinical nurse managers, had to continuously communicate between the providers and the financial navigators to get drugs approved and switched appropriately in the orders,” Estipona told Oncology Nursing News. “Patients were constantly rescheduled. It affected patient satisfaction, acuity, and staffing needs. It was extremely challenging for many of us. It increased demands of our time to monitor it in addition to our routine clinical duties.”

Owens added that patients who switch regimens will usually receive a drug in the same drug class. For example, some patients receiving an IV agent may switch to an oral treatment and some patients receiving oral treatments may switch to IV treatment. However, for some patients, the first-line treatment would be preferred because it is the most effective or has fewer adverse events.

Wilke also acknowledged that in some centers, changing regimens led to treatment delays. “[In these] centers, 20% had delays because the insurance companies had to reauthorize these new drugs. So there was a small group of patients that probably did get delays in their care, which is not what we want to see,” she said.

“Patients are worried if their treatment is delayed. Will that [affect] their survival? Will that [affect] their overall treatment plan? And it is hard to know,” Owens said.

Moving forward, Wilke underscored the urgency of fixing the quality problems with the [drug manufacturing] plants and restoring the regular supply chain. In her opinion, better regulation is needed to ensure that patients will not need to face an uncertain supply chain in the future. “We hope now with the public awareness and patient advocacy groups that we can start to influence and support increased regulation associated with maintaining an adequate supply of generic chemotherapy agents,” she said.

According to Estipona, there is no good reason for these treatment interruptions, and redirecting market forces to ensure this is not a recurrent problem should be a priority for all health care workers. “With our technology nowadays, we should have the capability to continue to produce these lifesaving drugs with no interruption,” she said. “Our company leadership team was very vocal and active with FLASCO [Florida Society of Clinical Oncology], COA [Community Oncology Alliance], [and] NCODA [National Community Oncology Dispensing Association] to help end the crisis and come to an agreement.”

Owens expressed similar views. “I hope that the root causes of these shortages are addressed urgently,” she said. “This is a public health crisis. If we do not get to the root causes of these things, then these shortages will continue to happen. We do not want to lose lives.”

What Is the Nurse’s Role?

“It’s a team effort,” Estipona said. “Providing the patients with up-to-date [information] makes them part of the team. I am proud of my nursing team for pushing through the challenges.”

Estipona noted that at the beginning of the crisis, administrators had to briefly choose to give available drugs to patients eligible for curative treatment and delay treatment for those in the palliative setting. “Many of these patients who have been responding [well] on [the] palliative approach missed several cycles of their treatment,” she said. “Patients and caregivers are under a lot of stress and worry. We, as oncology nurses, help them in managing their symptoms, understanding the process, and working with their treatment schedule. We are responsible to [ensure] the patient understands what they are receiving each time they receive their treatment, and we have to make them aware when they will not be receiving [their treatment] at a particular time.”

“Nurses play a huge role,” Owens said. “It can cause psychological distress to hear that lifesaving medications may be in shortage or are not available. That can feel like a crisis for [patients], especially if they know that it’s a drug that they need for their cancer.”

Because nurses are on the front line, they are often the ones to listen to patient stories, to allow the patient to express their emotions, and to help them better understand the modifications being made to their treatment. In Owens’ experience, many patients feel distress imagining the what-if scenarios. They wonder whether alternatives will work or whether different medications will be as effective. They also wonder whether they will be able to manage the new adverse events, especially if they have grown accustomed to a specific regimen.

“We do a lot of hand-holding because it is very anxiety-provoking. I have patients who are [in] tears because they don’t understand. They don’t know what led to this. They just know that they may not be getting something that is lifesaving for them,” Owens said.

Owens’ best advice to peers during this time is to be empathetic. “It is a difficult conversation [for] a clinician to have, and it is hard for the patients to hear. Put yourself in that patient’s shoes. These are lifesaving drugs. It is very unfortunate that in some cases they are not able to get what they need. Be present, listen, and talk about alternatives that may be available at your institution,” she said.

Reference

National Comprehensive Cancer Network. NCCN Best Practices Committee Carboplatin & Cisplatin Shortage Survey Results. National Comprehensive Cancer Network; 2023. June 7, 2023. Accessed July 12, 2023. https://bit.ly/3rhr2cs