 Another topic that’s is important for us to talk about is what is an interchangeable product? This is because many people are saying, “If you’re telling us that this compound is very similar, if it’s highly similar to the originator biologic product and meets all the FDA requirements, can I interchange?”

An interchangeable product is a biosimilar that meets additional requirements outlined by the Biologics Price Competition and Innovation Act. Part of fulfilling these additional requirements means that information is needed to show that a product is specifically interchangeable. It should produce the exact same clinical result as the reference product for any given patient. Also, for these products that are administered to more than 1 patient, we need to make sure the safety and efficacy of switching back-and-forth has been established, so interchangeable products may be substituted for the reference biologic product without involvement from the prescriber. That’s where it starts to get different because interchangeability status for biosimilar hasn’t been set; it’s something that we’re looking for. It’s something that’s going to be innovative. In the current state, we treat these as separate products, and we need the provider approval or some type of collaborative practice agreement or P&T [pharmacy and therapeutics] policy to switch out these products. This isn’t something that can be done independently without any prescriber input or any organizational policy put in place. So it’s important that we start on those fundamental building blocks, that biosimilar, highly similar focus on the manufacture process. I really want to get to a place where I can call it that interchangeability status.

 Thank you for that extensive summary and interpretation. It’s a great point to talk about interchangeability because there’s definitely this perception that interchangeability is this higher designation that a biosimilar has, right? Brandon or Tim, do you guys have any perspective? Does that actually matter to your practice in adopting a biosimilar based on its interchangeability status?

 I can speak to my practice and community. I don’t think it would matter a whole lot. At this point, as we said, there is no interchangeable status for a biosimilar.

 For my other question, is that basically considered inferior to the reference product because you don’t have interchangeability status with any of the biosimilars?

 I don’t think so. I don’t think it impacts our practice that way because there are data. The amount of data that’s required to get that interchangeable status is a lot. It also costs a lot. That’s why I would assume it’s not been done by anyone doing a biosimilar. If the biosimilar that’s not interchangeable is already in practice guidelines, and in many cases has the same FDA label, is there a huge incentive? We have a P&T committee, at least at my previous organization, that can determine if it’s worth it. But I don’t think it would make a huge difference, at least in my setting.

 To bring it back with regard to a standalone cancer institute, it similarly does not have much of a bearing for our incorporation of biosimilars. Our incorporation of biosimilars, which I’m sure we’ll touch on later, in the hospital network setting, we’re essentially treating the biosimilar to its biologic reference product as “interchangeable” within our institution with pharmacy substitution anyway. Bhavesh can probably speak to this, but my understanding is similar to Brandon’s. I don’t believe any manufacturers have attempted this because it also seems like it curtails and defeats some of the purpose of the biosimilar process, which is to cut developmental costs. Then we’re going to proceed to this additional very likely financial-burdensome process.

 Sure. I absolutely agree. We don’t want to belabor this anymore. We established that it does not give it a higher designation, and I don’t think many manufacturers would be pursuing that because I don’t see a value into that.

Videos

A discussion on what it means for a biosimilar to have “interchangeability” status and its potential impact on biosimilar adoption in clinical practice.

Interchangeability of Biosimilars

One of the other things that is a key challenge is that management might be slightly different depending on where the primary tumor is rising, whether it is from the GI [gastrointestinal] tract, the pancreas, or the lungs.

Cecilia, have you noticed any challenges in the management between the various sites of neuroendocrine tumors as well?

 As you said, the disease characteristics can be different depending on the site of disease. Some sites are more prone to be functional [compared with] others and [to treat] indolent disease vs the more aggressive disease. Even in the most aggressive cases or patients with very bulky disease, they may need chemotherapy either during or even before somatostatin analogues are started. Chemotherapy regimens are oftentimes tailored after the small cell cancer regimens, so we have to consider whether patients can tolerate those regimens, and we also need to work with insurance to make sure they are properly authorized.

Have there been any issues from your experience? We can take the example of something like a pancreatic neuroendocrine tumor where we might use oral chemotherapy with some of the alkylating agents. Have there been any issues in terms of getting oral chemotherapy as first-line treatment compared with traditionally somatostatin analogue therapy as first-line treatment for those types of neuroendocrine tumors?

 Personally, I have not had too much difficulty [at City of Hope]. For the most part, most insurance requires an authorization, but it is fairly straightforward. It is more of a co-pay issue. For 1 of the more commonly used regimens, capecitabine and temozolomide, those drugs are generic. If the patient has a high co-pay, there may not be as much patient assistance available, unlike for some of our branded drugs, where the drug company has co-pay cards to help offset the patient’s portion of the drug charges. For generic drugs, that avenue is quite limited, so that can be a little difficult for our patients.

Megan, similarly in terms of lung neuroendocrine tumors, there are less data on neuroendocrine tumors even with the use of agents like somatostatin analogues. There have not necessarily been large studies looking at somatostatin analogues and lung neuroendocrine tumors. Taking lung neuroendocrine tumors, have you had any difficulty in accessing any types of treatments that we use for other neuroendocrine tumors, specifically for lung neuroendocrine tumors given the limited data that are available?

 Yeah. That is a great question because you are right: We are extrapolating some data from the small cell lung cancer data that is out there. For us [at Baptist Health Lexington], we have had some denials, but we were able to either do a peer-to-peer with the insurance and get it approved or also write appeal letters. In the end, we have been able to treat our patients with what we wanted by providing the data that are available, looking at national guidelines, and submitting that to the insurance. We are then able to get it approved in order to treat the patient.

That is absolutely wonderful. These are going to be continued challenges as more treatment options become available for patients with neuroendocrine tumors. It is good to highlight some of the challenges that we might already encounter for the current treatments that are available because that is going to help us in terms of how we plan for further treatments as they become available.

A panel of experts in neuroendocrine tumors review the challenges in the management of patients based on the site of the tumor.

Practice Pearl 3 Challenges in the Management Among the Various Sites of NETs

Theresa Mallick-Searle, MS, RN-BC, ANP-BC: 

There are 2 groups of individuals that we are looking at. There are our patients using the opiates appropriately, who need to be trained so they are in a safe environment, but then there is also the community. I would really like to see a bigger attempt made in getting naloxone—and I’m hearing this from Joshua and I’m also hearing this from Jeffrey—into the communities with the social workers and educating those folks on the streets who need it as well.

I’m taking a step back, but when you look at the whole 2016 CDC guidelines on the opiate crisis, where does this start? What is the reality of it? The reality of it, and why we started using it, is because people were dying. Patients were dying or people using opiates were dying. That is what has given a lot of fuel to this effort to make naloxone more accessible, and this is why the government has paid attention to it.

Now we have the widespread availability of an antidote, and to not use it or to not know about it is mind-boggling. It’s baffling that we would not take this and run with it.

There is another big gorilla in the room—a lot of gorillas—and that is the payers or the insurance companies. They could play a huge role if every time they paid for CVS care—I don’t want to mention anyone specifically, but in all the pharmacy benefit programs, when they filled and paid for a prescription, there would be an automatic discussion. It could be along the lines of, “Have you prescribed naloxone? We would like you to prescribe naloxone. We suggest that you prescribe it.” They could say whatever is legal and legitimate—but they need to play an active role. The reality is that they are filling the prescription, and they could play a huge role in normalizing this as well.

Chain pharmacies have done that. The same EMR [electronic medical record] alert that Dr Salgo mentioned exists at some major pharmacies to recommend naloxone. That is our state because we recommend coprescribing, something that can also be found in Vermont and Virginia. New York has a wonderful naloxone co-pay program, so we know that from data that people will not pay more than $10 or so for naloxone. They may be convinced by the pharmacists or their primary care physician that they need this, and they will go, and they pick it up and when they’re told, “It’s $20,” they’re like, “No, thank you.” They understood everything. New York says we’ll pay up to $40, but it is still 0, and it’s been very successful. I would go even farther than that.

How about this: If you want to get really annoying—and why not? It’s in the EMR, which in my definition is annoying—why don’t you have an opt-out as opposed to an opt-in? That is, you’d say, “We are going to go prescribe naloxone unless you specifically uncheck this box. By doing so you’ve got to provide a reason.”

 That is coprescribing. For coprescribing in Rhode Island, you have to have a reason not to do it. The only downside is that sometimes people show up to their pharmacy postsurgery or postinpatient visit, and the pharmacist says, “I filled this naloxone,” and the patient responds, “My doctor never told me about it. Why didn’t he?” 

These same barriers are here. They do not want to talk about it; they are meeting the law. We are dispensing more naloxone per capita than anywhere in the nation, but we are still having those disconnects. If the pharmacist says, “Let me tell you about it; we do this all the time” like in the EMR and in surgery, what do we do in medicine? We practice, and then we keep practicing. Do we ever master anything? We always practice everything, but we have to do things over and over to make it normal for us, to normalize those conversations. As a pharmacist—you probably know—if you say something to the patient and then the pharmacist says something to the patient, they are more likely to do it, to stay adherent to their regimen, to monitor their blood sugar, to do those exercises, to maintain their appointments, to see their counselor. It is a 2-step process.

Frankly, the EMR allows you to send messages to the pharmacist as you prescribe, and you can work together.

In the community, if every time Mr or Mrs Jones hears about 1 of his or her friends who gets an opioid and every 1 of them got Narcan [naloxone], it’s a normal thing at that point. It is not something extraordinary; it is not about you or about the expectations that you are going to have a problem, it is the expectation that this drug requires Narcan [naloxone] to be prescribed with it.

 Just a quick note on the EMR—we noticed that we had a lot of naloxone from the Health Department sitting on the shelves of the pharmacy or sitting in the Pyxis system, and it was not being moved. It was just sitting there. We went into the order sets and rewrote the order set for painful condition discharges, the order set for overdose in the ED [emergency department], and the order set for altered mental status. We prechecked opiate overdose kits, which used to be kits in little bags that you had to assemble with the atomizers; now they just consist of the nasal spray. Having it prechecked pings the nurse to pull it out of the Pyxis system and put it in the patient’s room. Now the patient has it. They did not have to ask; there was not a long discussion about it, and they had the opportunity walk out of the hospital with it in their hand. We think this is 1 step easier. Although it’s not practical in all circumstances, it has worked fairly well.

Experts address barriers to overcome regarding naloxone prescribing, dispensing, and utilization that they have seen in the community.

Barriers to Naloxone Prescribing, Dispensing, and Utilization

I want to come back to a basic idea. If naloxone is available over the counter without a prescription—which, by the way, is a great idea—then more people need to know about this. 

People know, but there is a difference between buying a pregnancy test, buying condoms, and buying whatever you’re buying—diapers, adult diapers, things that people don’t want to buy in a pharmacy. You can buy them, but you have to then deal with the front desk and go. For nicotine replacement therapy, you still have to talk to a pharmacist or a pharmacy tech, and in our research, some are extremely good about recommending naloxone for all those higher-risk prescription opioids or opioid-benzodiazepine combinations. Some have that same, as Theresa said, that same perception of “I don’t want to recommend naloxone.” You have probably heard this from your patients who take opioids appropriately; they do not want to hear they have naloxone. The pharmacist says, “No, I don’t want to give it to you,” so we’re educating pharmacists to say everyone gets it. Our research shows that universal offers work well, and that is what pharmacists and primary care [providers] need to say. Just offer it to everybody.

 I’m sorry for jumping again, but an endocrinologist teaching someone how to use insulin would educate the family and people about the signs of hyperglycemia, the signs of hypoglycemia, and what to do or how to have a plan. That is normalized. This is such a biased area of medical care. More people are affected by chronic pain than the combination of heart disease, cancer, and diabetes combined, yet we have so many people biased against simply saying, “I am prescribing this for you to help you. Here are the risk benefits: the good, the bad, the ugly, and here is how you keep safe.” The prescribers are not comfortable with that language.

This speaks to the need for a multimodality public health campaign. It is not only about making the patients feel comfortable walking into the pharmacy but also making the pharmacist feel comfortable offering it at the point of dispensing, or even about the doctors or the APPs [advanced practice providers] giving or offering it when they write a prescription.

In Buffalo, New York, we have tried many ways to educate the public, including billboards saying that you can get naloxone at the pharmacy without a prescription. We also have stickers on the window of Walgreens when you walk in the door that say, “Naloxone is available without a prescription—just ask the pharmacist.” We are also putting it either in emergency department discharge papers or on little signs in triage at a patient’s eye level when they are sitting in the triage chair getting screened. There is not 1 way to fix this but making it normal will take probably a generation.

Back to the point of saying patients are ashamed or nervous—either when they’re on opioids or when they have naloxone, I know of many examples, but 1 particular patient stands out. When we were going through her medication history, she was talking about the antihypertensive drugs she takes. She is smiling when she says she is on lisinopril or other things, but she puts her head down when she says that she’s on suboxone [buprenorphine and naloxone]. This is me, a nurse, and a patient in a closed room with no audience or family members. This is how deeply rooted the stigma of looking at the drug user is, and this patient wasn’t even a drug user. This patient had to be on suboxone because there were a whole bunch of problems in the past. It is an internal stigma. Even the patient is embarrassed about it. These are deep-rooted things that require approaches from all different angles to change anything.

There is also a significant way that naloxone has been framed that has interfered with its utilization and uptick. Going back to the example of an EpiPen, there is this idea that it is an antidote for bee sting anaphylaxis. If you use that analogy, then the essence of the issue is that we are prescribing bee stings with our opioids and giving them the antidote with naloxone, which does not make a lot of sense. Just stop giving the opioid, and they do not need the naloxone. That is the mindset. Therefore, if they’re so at risk that you have to prescribe naloxone, then why are you prescribing in the first place?

I’ve completely reframed how I discuss naloxone with patients. That is, I say having an opioid in the home increases the risk of an accidental overdose. That may not be because somebody is doing something inappropriate; they may take a dose, forget they took it, and take it again. They may take it thinking they took something else. We know from the diversion data that most misusers get it without a prescription from a patient who has a prescription. Our patient may become the rescuer. I use the example of placing a fire extinguisher in a kitchen. You do not put your fire extinguisher there because you plan to build a bonfire on your stove. You put it there in case there is an accident. This is about risk prevention; the more naloxone is out, the more it will likely be where it is needed. It is not that your patient is doing something inappropriate or wrong when you offer them a naloxone.

The way health care and community need to think about this has to be repositioned and reframed to see its utilization in this space and to create normalization.

Theresa Mallick-Searle, MS, RN-BC, ANP-BC:

There is also, it seems to me, some wishful thinking among practitioners—

“That is other people’s patient population. Not mine. I have the good patients, and my patients do not need naloxone.” Nothing could be further from the truth. Drugs are drugs; overdoses are overdoses, inadvertent or otherwise. Naloxone is lifesaving, period. Isn’t that the message? It is very simple.

Multidisciplinary expert panel share perspectives on stigmatization and normalization of the conversation about naloxone between clinicians and patients.

Normalizing the Conversation about Naloxone with the Public

When they launched the Let’s Pharmonize podcast in early 2020, High Point University pharmacy students Cal Vandergrift and Shane Garrettson did not expect it to gain the number of followers that it has. With their content ranging from pharmacy references in pop culture to more clinical discussions of specific drugs, Vandergrift and Garrettson have learned to balance the rigors of school with their biweekly podcast.

In a recent interview, Vandergrift and Garrettson said they do not entirely remember how the idea for a podcast came about, although Vandergrift said they both had a unique presentation style in classes. Balancing schoolwork with the podcast has kept them busy, but Garrettson said their audience has been understanding when there’s an occasional schedule change.

Because they started by telling their classmates about the podcast, Vandergrift said their audience mostly consisted of pharmacy students at first, but it has quickly grown to encompass professionals in all areas. Although the COVID-19 pandemic limited their ability to travel and meet their audience, Vandergrift said he’s hopeful that they will get to interact with audience members soon at various pharmacy and podcasting events.

When asked where they see the podcast going, Vandergrift said “Hopefully the sky’s the limit on that one.”

With their content ranging from pharmacy references in pop culture to more clinical discussions of specific drugs, the Let's Pharmonize podcast hosts have learned to balance the rigors of school with their biweekly podcast.

Pharmacy Students Explore Podcasting to Educate, Entertain 

interviewed Ted Karkus, CEO of ProPhase Labs, on the differences between saliva COVID-19 tests and nasal swab COVID-19 tests and their different applications in clinical practice. ProPhase Labs recently began investigating aspects of saliva testing for COVID-19 and the variants of the virus.

During the discussion, Karkus addresses whether any of the saliva COVID-19 tests that have received emergency use authorizations from the FDA have been able to detect the COVID-19 variants, and what settings specifically benefit from saliva tests versus nasal swab tests.

Karkus explained that in professional environments, even if staff are vaccinated against COVID-19, testing will remain important since the potential to spread the disease may still be possible following vaccination.

“While vaccinations are growing both in popularity and in distribution, that doesn't mean don't wear a mask, and it doesn't mean don't get tested,” Karkus said. “If you're 75 or 80 years old and you're sitting in a room with somebody and you only get to ask one question, do you want to ask the question are you vaccinated or do you have COVID-19? It's more important to know that you don't have COVID-19.”

The saliva test is also highly effective for providing people with the opportunity to take a COVID-19 test at home, which allows tests to be more broadly accessible as an OTC product at pharmacies.

“Saliva is so easy. You just spit in a tube, you seal it, and you ship it off. So, at the end of the day, at-home testing is the wave of the future. The FDA is starting to approve various tests for at-home testing, and saliva is definitely the way to go.”

Karkus also discussed how the saliva COVID-19 tests may be used going forward beyond 2021, whether COVID-19 tests will continue to have a role in health care after much of the global population has been vaccinated, and what the value of the pharmacist is in conducting COVID-19 tests in communities.

Ted Karkus, CEO of ProPhase Labs, discusses the differences between saliva COVID-19 tests and nasal swab COVID-19 tests and their different uses in clinical practice.

Differences Between Saliva COVID-19 Tests, Nasal Swab COVID-19 Tests

: Esty, one of the questions I wanted to ask you was, barcoding practices changed during COVID-19, and I’m sure for you Michael, especially when we created the pumps. Having to bring the pumps out of the room and trying to protect the nurses with the PPE [personal protective equipment] shortage so they didn’t have to go in and out of the room. Talk about the barcoding that we normally would do by the bedside, how did that change during COVID-19 in your institutions?

: When we went to the pump outside of the room, we found there were a lot of titrations for these patients, and nurses would be going into the ICU [intensive care unit] often. Multiple times the nurse would be going in and out of the room to barcode scan the patient with each titration. When we looked at this and at the patient loads for our nurses, we deviated from our usual process of barcode scanning at bedside to having a duplicate armband with a double check at the door in our ICU. That was during the height of our surge, and it was only allowed in our ICU unit. That’s where we deviated from usual practice. Then there were a lot of things that came out from New York from ECRI [the Emergency Care Research Institute] and from some of the ISMP [Institute for Safe Medication Practices] reports about the challenges during this crisis mode, saying it is beneficial to continue to use barcode scanning at the bedside.

Now that our [COVID-19] numbers are coming down, we’ve reverted back to having barcode scanning at bedside and those titrations, even though the pumps are outside of the room. So there was some deviation from our usual process of barcode scanning in those early times in relation to any drip that is titratable in the ICU.

: What about you Michael? How were the barcoding challenges in your institution?

 When it comes to barcoding, we have been hardwiring the need to scan barcodes over the years. When we originally rolled out barcode scanning for patient wristbands and barcode scan on the medication, the initial numbers were in the 60th or 70th percentile. And now we are continuously close to 100%. We didn’t want to roll back on that at all, and so our barcode scanning requirements and process did not change during that time. We did make sure that our nurses had appropriate PPE to go into the patient rooms, and we have computers in the nursing units and in each of the patient rooms. The barcode scanning continued as before. We really didn’t make any adjustments to that. We felt that we could sustain barcode scanning, and it was important to keep some things consistent since we were dealing with so many other challenges.

We do have a medications safety committee that reviews barcode scanning rates and any gaps or issues with medications that don’t scan. We review that information monthly, and we did not see any decline in barcode scanning, which made me very happy because we were using new medications and moving patients around depending on their isolation status. And so, I felt that barcode scanning had to remain in place as a second layer of protection and the final double check. We didn’t make any changes; that was one of the few things that remained the same.

Estela Trimino, PharmD, BCPS, leads a discussion on changes in barcoding practices to address infection control challenges caused by COVID-19.

Practice Pearl 2: Infection Control Challenges Due to COVID-19—Barcoding Practices

: One example of a challenge during COVID-19 was that lot of medications get returned to pharmacy, and we were trying to deal with infection control issues of these COVID-19 floors, where you had to wipe down, sequester medications, and were not able to put them into inventory. It was a constant, challenging time, for pharmacy. Michael, that was going to be a question for you, then Esty, you can answer the same question. What were some of the other challenges pertaining to infection control caused by COVID-19? For example, PPE [personal protective equipment] policies and procedures that we had to change and do on the fly, the long tubing that Esty talked about. What were some of the things at [Medical City Dallas Hospital] that you all had to do?

There were similar challenges. I would say we were fortunate, we have always had enough PPE. But we implemented more monitoring and rationing. One example would be, we’re a high-volume oncology hospital, and we make 50 to 70 chemotherapy preparations a day. Chemotherapy gowns, at one point, went into shortage because when the regular gowns weren’t available, all of a sudden everybody started buying chemotherapy gowns, even though they didn’t really need the protection. As a result, we had a hard time procuring enough chemotherapy gowns. So we took that over from the supply chain, and pharmacy would supply gowns for a nurse to use with every chemotherapy medication we delivered. That way we were assured that the nurse had a chemotherapy gown to protect themselves while administering chemotherapy, and we prevented someone from taking those precious gowns and using them for some other reason.

Those are some of the creative ways where pharmacy took on more work and initiative to help with appropriate distribution and conservation of PPE. That one stands out to me; we never saw ourselves as distributors of gloves and gowns and other PPE. But sometimes we had to step it up and take that additional responsibility so that we were very rational and regimented in our approach to make sure that those employees who needed appropriate PPE had it available to them and that it wasn’t used inappropriately, therefore, depriving others from it.

We’ve done a good job and adjusted quickly because we could always tell what the inventory stock levels were so we could ration what we needed, and it worked out well. And of course, we had to reach out to and find new suppliers of these products because we couldn’t get enough through our regular channels.

Michael Epshteyn, PharmD, MSM, discusses some of the infection control challenges caused by COVID-19, such as the procurement of personal protective equipment (PPE).

Practice Pearl 2: Infection Control Challenges Due to COVID-19—PPE

: Usually you are a pharmacy that does a lot of one thing; either you’re compounding a lot, or you do some premix, or try to throw everything at nursing while they’re trying to navigate with these patients. What have you seen in your organization, Esty? I’m talking about the utilization of premixed IV [intravenous] solutions, the drug reconstitution systems that Michael just discussed, and how does that compare to trying to compound the IV products in house? Can you discuss the impact on patient safety, from a safety officer perspective, and the impact on quality of each of the different IV products?

: Thank you. That was one of our hardest implementations; traditionally we had things…either premixed or made by pharmacy. It’s a balance. When you’re looking at what you’re going to put on the floor versus what you have in the pharmacy, you have to take an assessment and say, from a safety perspective, “Can I put this medication on the floor safely, and a nurse can attach it,” and you have the drug readily available. The way we worked with nursing is, pharmacy is working very diligently to get these medications to you. And again, staffing was a challenge with COVID-19, not only in our hospital, we saw it in our pharmacies. We had decreases in production, per se, in the pharmacy team. Having those products with connectors available for nursing is good for pharmacy as well as for nursing because it puts those medications up there. You’re not waiting for it to be delivered by pharmacy. We evaluated which products were going to be used with the connectors andcould be used with the connectors. Now, there were challenges with the connectors during COVID-19 because some of these products were not available, so you might have had multiple types of adapters. From pharmacy, we get them and we have them there. But from a nursing point of view, the challenge would be education of, can we roll these out in enough time that all our nursing staff, which is more than pharmacy, would know how to do these and have them available?

In the beginning it was “Why nursing? We have so much going on, we have so many patients we’re taking care of. We can’t do an extra step,” versus once we have the product and the connectors. What we did in our system is we implemented pieces of it. We would go to 1 drug in the ICU, [intensive care unit], then we would go in house. Our strategy was it was easier in ICU, since our numbers were low on the medical-surgical floors, and the education was more isolated in those areas. Again, we went through premixes if they were available, in as many instances as we could. Now that some of our [COVID-19 case] numbers, at least at [Baptist Health] South Florida, have gone down we’re going to think about we optimize what we have in our machines because we don’t want to continue. You must balance the cost versus production and the safety as well.

Analyzing what products you’re doing the connectors with is going to be valuable. Definitely it’s time-saving for nursing as far as waiting for patients, having their medications available on the floor, after pharmacy verification, obviously. Then from the pharmacy workflow, it also frees up more IV items that need to be prepared with some of these COVID-19 newer therapies that are coming out that need to be mixed in pharmacy,

I know you asked a little about the quality of the IV products, so once they are there, we’re not attaching anything to these products, so these connectors are allowing the drug to sit there as part of inventory. Only when activated will that beyond-use dating start, and if expired, it has to go. This helped us a lot, Madeline, in our system because of the way when we started, a lesson learned from New York, the epicenter, was the quarantine of medication. The more things we mixed that would come down to pharmacy, we had to quarantine some of these medications for a couple of days. Then we eventually got more creative with the swabbing and cleaning of these products, and then just waiting minimal days for them to get back in stock. But imagine in the time where you have shortages and you’re trying to get these products back up, it freed some of those products to be available and decreased the quarantine time for those products in pharmacy.

Estela Trimino, PharmD, BCPS, discusses the use and impact of premixed IV solutions and drug reconstitution systems compared to compounded IV products.

Practice Pearl 2: Premixed IV Solutions & Drug Reconstitution Systems Use & Impact

Megan, have you encountered any potential challenges in terms of obtaining authorization for treatment for these patients, such as with any of the somatostatin analogues or with any treatment in general?

 With these agents, there are 2 types of authorizations to talk about. One is if the patient is getting the agent in our infusion center, getting those prior authorizations through the insurance. If we are sending a prescription home with the patient, like how Cecilia [Lau] was talking about using the injections at home and doing self-administration, then that is a different type of prior authorization that we are involved in.

If we are giving the agent at our institution [Baptist Health Lexington], we require insurance authorization prior to giving the medication. So up front, it is important to tell the patients that these are higher-costing medications and that it takes awhile for the insurance to approve the medication, and [to tell them] not to expect that, if the provider recommends it today, then they will get the medication today. For us, it usually takes at least 48 hours to get that approval before we can administer the medication. For the agents that we are sending home with the patient, that is going through their prescription insurance, so that is a different process of getting that prior authorization. I know that here, our pharmacy is involved in helping fill those forms out to get the authorization. Once a patient has authorization and we get the co-pay amount if they can afford it, then they can get the medication shipped to their house.

Another issue, though, is looking at funding. Is their co-pay too high after the insurance has approved it, or were we not able to get that prior approval through the insurance? Fortunately, there are a couple of options for our patients. A challenge that we have is the affordability, but there are some patient medication-assistant-support programs for these agents, which we are fortunate to have. There are 3 main types that we deal with. We have the manufacturer-provided patient assistance programs, or PAPs. We can also do medication funding through different charitable organizations where we can obtain foundation money for our patients. Some health care systems have charitable care funding. I know that here, we have a foundation that can help some patients afford their medications if there is a financial toxicity for them.

Depending on the patient’s eligibility, which would depend on which insurance they have and their annual income, patients can receive different medication access support programs through 1 of these avenues. For us, the important thing is getting the medication to the patient, so we will jump through all the hoops we have to in order to make that happen for them.

As a provider, I thank all my pharmacy colleagues. That is so helpful to me in terms of helping me understand and navigate through this complex process to make sure our patients get the care that I want them to get to provide the best treatment for them.

Megan May, PharmD, BCOP, reviews the authorization process for treatment options for the management of NETs.