Experts Provide an Institutional Perspective on the Safe Handling of Immunotherapy Treatments

As safety considerations for immunotherapy agents continue to be investigated, institutions have been developing safe handling approaches based on perspectives and anecdotal experience, according to representatives from Allegheny Health Network Seon Jo Park, PharmD, BCOP; and Heather Kennihan, MSN, RN, OCN.

“There’s a difference between traditional chemotherapy compared with checkpoint inhibitors,” Park said. “The checkpoint inhibitors are a more recent development, they started coming out approximately 7 or 8 years ago, and [more] keep coming out.”

For many institutions, standard procedures for administering chemotherapy have been adapted for immunotherapy drugs out of caution.

In an interview with Oncology Nursing News®, Kennihan, a professional development specialist with the AHN Cancer Institute, and Park, an oncology faculty member in the Department of Pharmacy Management and Clinical Specialists at AHN, highlighted the safety precautions used in their experience, the challenges with at-home infusions, and notable toxicities to keep in mind when using these agents.

Oncology Nursing News®: How do immune checkpoint inhibitors compare with chemotherapy in terms of risk when administering these agents?

Kennihan: [When] immune checkpoint inhibitors and these new medications started coming out, we treated them just like we did regular anticancer therapy, regular chemotherapies. There was a lot of discussion of are these hazardous agents, do they pose risks for our staff?

[At AHN], we still err on the side of caution for our nursing staff, our mixers, and our pharmacy staff. They still apply PPE [personal protective equipment] just like they would for chemotherapy. We educate [our staff on] safe handling precautions. Is there more risk for hazardous precautions if the patient is only [receiving] immunotherapy vs combination therapy? I don’t think so. However, we do still treat them the same. We handle the medications the same way [and] we educate the patients similarly on safe handling precautions.

Park: The way the checkpoint inhibitors work is a little bit different than traditional chemotherapy, [which] binds to the patient’s DNA and then [essentially] damages their DNA. Checkpoint inhibitors [interact with the patient’s] immune systems and boosts it. In terms of hazardous drugs, one of the institutions that looks at [the category of] hazardous drugs is called the National Institute for Occupational Safety and Health [NIOSH]. That organization, with ASHP [American Society of Health-System Pharmacists], looked at checkpoint inhibitors and did not see all those hazardous components. The definition of hazardous characteristics [include] carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity, and genome toxicity. [NIOSH and ASHP] didn’t see many of the [toxicities] with checkpoint inhibitors, so they didn’t list them under their hazardous drug list.

That’s the difference, [but] how should we handle them? According to the [determination by NIOSH and ASHP]: they’re not harmful, they’re not hazardous. But at the same time, because immune checkpoint inhibitors are a recent development, we believe that [limited] research has been done. There’s some animal data on reproductive toxicity and teratogenicity of checkpoint inhibitors, so if you look at the package insert of, [for example,] pembrolizumab [Keytruda] and nivolumab [Opdivo], it does have a warning that the animal data showed some reproductive toxicity. A lot of institutions want to be a little more cautious when they handle these drugs just because there’s not much data compared with chemotherapy just yet.

At AHN, do you allow visitors to be with patients in the infusion room during immunotherapy infusion? Are there special precautions?

Kennihan: As far as having a visitor or a family member or caregiver at chairside when [patients are] getting infusions, we absolutely allow that in most of our facilities where space allows.

We’re covering all the bases; we still [perform] all the safe handling precautions that we do for standard chemotherapy. We educate the patients [and] provide them with written instructions. [For example,] we ensure that pregnant women aren’t handling their excretions for a couple of days after they’ve had treatment and those types of things.

Some centers and institutions have been exploring options for at-home infusions. What risk do at-home infusions potentially pose for individuals? Where do you think the field is headed?

Park: I don't think that’s a very central issue. We administer immunotherapy and checkpoint inhibitors in satellite cancer centers. That has been going on ever since they came out. For home infusion, [there are] a lot of different issues that come with it. Not only that we need to train the home infusion nurses on the safety for the hazardous drugs, but we also have to coordinate when patients are going to see an oncologist and how health care staff are going to assess the patient when they’re at home and how often.

Storage of the medication [is another issue] because checkpoint inhibitors have expiration times. They have to be refrigerated, ones that [require] mixing can only be used within certain hours. How about the exposure at home? Who are the [patients] living with? [We need to consider] insurance coverage as well: are agencies going to cover home administration vs when a patient comes into the institution?

There’s a lot of different questions that we have to answer before we start doing this. I’m not sure about in the US but I know some home infusion has already started in Europe. I think that’s a little bit easier because their insurance system is different than in the US and they had pretty good success coordinating with the oncologist doing assessment. But it all depends on the patient’s specific environment. As long as we can coordinate all different pieces and the insurance issues, I think it is possible, but I don't think it’s going to be anytime soon for our own institution just yet.

Kennihan: I completely agree with Seon Jo on that. One good factor about immunotherapy is [the patient’s] risk for reactions is lower, so that’s a positive for at-home infusion. There needs to be a lot of coordination, assessments need to be done on these patients. It’s not like you can go in and say, “How are you feeling today? Are you okay to get your medication and hang [the IV bag]?” We have lots of questions and assessments we need to do, and it needs to be [an individual] who’s trained and skilled in doing that.

Park: In terms of infusion reactions, we have so many different patients who are on checkpoint inhibitors and I saw maybe a handful—approximately 5 patients or less—who had an [infusion-related] reaction over the past 7 years. The reaction risk is definitely lower, but the scary thing about this reaction is that this can happen at any point. For some of the agents, it’s more a risk to have an infusion reaction with their first dose and once they don’t react from the first dose, you can relax, it’s not going to happen. But with an immunotherapy reaction—what I’ve seen in my experience is that— it can happen at any point. It happened with 1 patient in cycle 40, which was so random. I don’t think we have enough data about checkpoint inhibitor reactions either.

What does proper storage look like with immunotherapy? Are there any safety precautions you would like to highlight?

Park: Because [immunotherapy drugs are not on the] hazardous drug list, you can store them in a nonhazardous section, just like with any other nonchemotherapy agent. At AHN, they store them with the hazardous for workflow, and they take all the precautions just as the chemotherapy. Most of our checkpoint inhibitors must be refrigerated.

Kennihan: I think it’s important to make sure your staff are educated on the medications and the reasons why they’re getting the safe handling. Educating the patient is important to keep them informed of what’s going on and why they’re getting the medications that they are.

Park: One thing that I wanted to point out is if you look at all [immunotherapy] labels and their package insert, they all have a warning for pregnancy. If patients are receiving these agents, they must use contraception during therapy and for at least 4 to 8 months after the treatment to make sure that they’re not getting pregnant. I think that’s one thing that a lot of staff forget to mention with the immunotherapy checkpoint inhibitors, but those are the official recommendations as of right now.

Reference

Wiley K. What Safe Handling and Administration Requirements Apply to Immunotherapy? Oncology Nursing Society. June 27, 2017. Accessed September 9, 2022. https://bit.ly/3d1eorj