Patient Management of CDK4/6 Inhibitors

Kate Jeffers, PharmD: In our clinic, once the provider has decided on a treatment plan, they enter the orders into our oncology module of our medical record, and they sign those orders unless there are questions potentially about dosing for different liver function, renal function, etc. So they’ll sign those orders. That chart then comes to the pharmacist to review. After we’ve reviewed the orders, made sure everything is appropriate, that medication is released to the pharmacy. All of our prescriptions typically go through our in-house pharmacy and then they’ll triage out if needed or if appropriate, based on the patient’s insurance.

The pharmacy then does their processing, in terms of prior authorizations or dispense count limits or any other kind of overrides that need to happen. Our in-house pharmacy has also pursued URAC accreditation, which is one of the higher standards for a specialty pharmacy or dispensing pharmacy, showing that they are really seeking after quality and patient care. And so, they actually will give the patient a phone call as well to do some initial assessments. They will send out any manufacturer patient kits, if possible, and those kinds of things when they’re doing dispensing. And I know a lot of the other specialty pharmacies have similar accreditations or similar things like that.

Once the medication is dispensed or processed by the pharmacy, typically they’re mailed overnight to the patient at no charge, again kind of depending on that pharmacy or where they’re able to pick it up. Meanwhile, while all of this is happening, after that initial plan is placed, we have patients come in for a chemotherapy teaching, which is probably not the best term anymore since we have so many new terms like immunotherapy and targeted therapy and all of these different terms. But they come in for a teaching or an education session, which is one-on-one. So it’s a pharmacist and the patient and any family members, whoever it may be that they want to bring with them.

That visit lasts anywhere from 30 to 90 minutes or longer, depending on how many questions the patient has. And in those visits, we review not just the drug itself, but we review exercise recommendations, nutrition recommendations. We do talk about advanced directives with the patient regardless of their stage or diagnosis. And then we talk about the drug specifically. We talk about how they get the drug, really explaining this whole kind of specialty pharmacy—type process to the patient, that they can’t just go to their neighborhood pharmacy and pick it up. Sometimes they can, but not usually.

And then we talk through side effect management and what medications we’d recommend for them to have at home for side effect management. So for example, with abemaciclib, we do recommend that every patient has loperamide, and we will actually try to send that in as a prescription. Some insurances will pay for it and some won’t. If they won’t pay for it, we tell them to get it over-the-counter. If they will pay for it, then we have them do it through their insurance company. But these are things that we really think that they should have at home. These medications don’t cause significant amounts of nausea. It’s usually something that we’ll send a patient home with, a nausea prescription, and tell them to fill just in case, or I will occasionally give the patient the option and say, “Nausea is not very common with these medications, but if you would be more comfortable, I’ll send the prescription now. If you want to wait and see, I don’t want you to have another copay if you don’t need it. So if you want to wait and see, just give us a call and we’ll send it in, no questions asked if you do start having issues. Otherwise, let us know if there are any problems.”

So we go through all of the side effects with the patient, any side effect management. Ribociclib, we do make sure their EKGs are scheduled. We make sure orders are in place for their 2 week-after-starting EKG that we do just as a precaution and then really have patients let us know, really at any point of time, about any side effects. We give them all of the appropriate phone numbers to call, 24 hours a day. We have an 8:00 AM to 4:30 PM nursing option for the clinic. It goes directly to a nurse. After hours it would roll over to our on-call physician. And so, we are really making sure that they have all of that information and really understand when they should call. And then lastly, patients do sign a consent for all IV or oral chemotherapy at our institution.

For patients who have started on an oral oncolytic, we typically will try to schedule their appointment about 1 week to 2 weeks after they start therapy. The hard thing with oral oncolytics is you don’t know when they’re going to get the drug, and so in the best laid plans, we’ll schedule an appointment and we often have to change that appointment, just because they don’t get therapy quick enough or we’re struggling with a prior authorization or copay or whatever it is. And so, we do have a silent alert built in to our medical record where our nurses are alerted 10 days after the medication is released from our oncology module that the patient has started an oral oncolytic. And so our message kind of says, “Patient has started an oral cancer medication. Please call them to assess adherence and toxicity.”

The nurses call. They go through our standard flow sheets for adherence and toxicity, really trying to figure out (a) that they’ve got the medication and understand when they started it, so that we can appropriately schedule any lab work tests that need to happen, EKGs that need to happen, follow-ups that need to happen, making sure that those are timed appropriately. But it’s also talking about, “How are you doing so far? Are you taking your medication? If you’re not, why aren’t you? If you’re already having side effects, we need to bring you in sooner. Or if you are having side effects, what are you using to manage those and how can we make that better for you at home?” And that’s kind of our initial phone call to the patients.

Every time they come into the clinic subsequently, our medical assistant gets an alert in our medical record as well, saying, “This patient is on an oral cancer therapy. Please go get the nurse to assess adherence and toxicity.” And so they will go grab the nurse. The nurse will go through the same flow sheets so that we’re really able to track data over time and see if something is changing for patients. And then the physician or APP will come into the room to finish the office visit. We really work with our providers to say, “Before you go into the room, pull in that flow sheet information so that when you walk in the door, you already know what the patient is having issues with.”

So, instead of walking in and saying, “Oh, Miss So-and-So, how are you doing? Have you missed any doses?” Usually patients don’t want to tell their providers that they’re missing doses, and so the patient says, “Oh, I’m doing great.” This flow sheet really allows them to have a little bit more of a conversation with the nurse about why they’re missing doses. The nurse is able to document that, and then the provider is able to walk into the room and say, “You know, I see you’ve been missing doses for X, Y, and Z. Let’s talk about how we can make that better.” So our goal is that the provider visits are able to be more targeted and able to get the most out of them in the short amount of time that they really have scheduled with the patient.

That follow up goes on and these flow sheets go on for as long as they’re on the medication. For an AI, for example, that’s all 5 years or 10 years, whatever it may be, and then however often they come into the clinic. If that’s once a week, they’re asked once a week. If it’s every 3 months, it’s every 3 months.

In terms of monitoring for efficacy, it depends on the patient and how they present. So we will typically repeat scans at certain periods of time. We certainly follow blood work. That’s not always beneficial if the patient’s blood work isn’t elevated initially. If it does start to elevate on therapy, it could be a signal that something is going on. But if it is kind of lower at initiation of therapy and it stays low, there’s not always so much you can do with that. But we do use that, of course, to monitor for other side effects of the therapy, specifically neutropenia with palbociclib and ribociclib. We do check a CBC [complete blood count] and a CMP [comprehensive metabolic panel] every 2 weeks starting out on these agents and then monthly thereafter, after 2 to 3 cycles, so that we’re able to adjust as needed for patients.

But the providers … really the oncologist is really the driver of when scans will be repeated or what type of scan, if it’s an ultrasound or what have you. Certainly, when they come in to the office, they’ll do physical exams with the patients. Pain is always an assessment. If the patient is having pain initially and they start on therapy, your goal is that you see that pain starts to go away, especially if it’s being caused from the cancer, or if you’re starting to see new pain pop up, that could be the sign that something else is going on. And so, all of those are factors that we look at in terms of deciding if a medication is working or if we need to make any changes in therapy.

We have a couple of different mechanisms in place to ensure that staff are educated when new products come to market, if that’s IV or oral therapies. We do have a pharmacy residency program at my institution, and so we will utilize pharmacy residents or students to help make informational, educational handouts or presentations to nursing staff as well as our providers. When we do not have a resident or student available, it’s something that we try to send out the FDA [US Food and Drug Administration] updates, or HOPA is another one that I like to send out. It tends to give a little bit more information.

So the Hematology Oncology Pharmacists Association does something every Friday, basically an FDA update. So any changes that have happened over that week, they’ll send out. And so, I try to forward those out to staff as much as possible. Most of our providers also receive updates from ASCO [American Society of Clinical Oncology] or the FDA. And so our providers are fairly driven to stay up-to-date themselves, but it’s definitely something that we will provide any answers or questions to, as possible, and really try to use our residents and students to help encourage that education.

Our nursing staff will have clinical nurse educators come in from drug companies, especially if we’re talking about an IV agent, to help provide education to the nursing staff if there is anything special about how to administer that drug, and those kinds of things. But from an oral perspective, it typically falls back on the clinic, for us to provide the education within the clinic to our providers and to our nurses.