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Panelists review the dispensing process including storage requirements.
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Luigi Brunetti, PharmD, MPH: Of course, once patients are out, and let’s say you transition from the HTC [hemophilia treatment center] administration and they are back home, what is the dispensing process typically for either a factor VIII or emicizumab, Hemlibra?
Robert F. Sidonio, Jr, MD: You’re closer to that than I am.
Giles Slocum, PharmD: Surprisingly I’m not that close to it on the inpatient side. But specialty pharmacy is going to be the workhorse for this dispensing component. And again, another hat tipped to HTCs. They’re fully equipped. They have the nurses, the social workers, and everybody to help with that transition and to help with making sure prior authorizations are filled out and appropriately submitted. As we’ll talk about, some of the complications in being discharged from the hospital are, are we going to even have factor VIII available for them at home? Or what’s the next step? So this is an important question, and really HTCs are equipped for helping with this transition.
Robert F. Sidonio, Jr, MD: Prior authorizations are really key and trying to communicate with the nurses. If they’re going home, they may or may not need a nurse to come out and finish this, because we have to remember, with some of the older patients, they may have had joint bleeds in their elbows and they just can’t physically infuse themselves. And so these things can lead to prolonged delays or longer stays than they need to be. So really good coordination is critical. And of course, these always happen on Friday afternoons, and so it’s really important to have the nurses be able to get this and call the specialty pharmacies and rush out factor VIII to their house, those kinds of things, because obviously we want to get our patients home when they’re ready to go home.
Luigi Brunetti, PharmD, MPH: Product storage could also be a burden as well. Any tidbits on how we can ensure that patients store their products correctly? Of course, we’re always going to recommend that you refer back to the manufacturer for instructions because every product is a little bit different and there are some nuances, but do you have any suggestions or recommendations for that?
Giles Slocum, PharmD: I’d be interested to hear what you have to say. Refrigerated, obviously, is the way that the package insert is labeled. A lot of them do have language where it can be out for 7 days or so, as long as it gets either used at that point or put back into a refrigerator.
Luigi Brunetti, PharmD, MPH: The factor VIII products.
Giles Slocum, PharmD: Correct, it’s for factor VIII products, thank you. Those are the big things that we try to keep track of.
Robert F. Sidonio, Jr, MD: And it’s important for traveling. We all traveled to come to this, and you forget that they have to pack all those things in their bag. And we often will send them with a letter telling people at the TSA [Transportation Security Administration] to leave it alone: “Don’t open these packages.” Once you open it, that’s an expensive inspection. Because it looks unusual that they’re carrying a bunch of needles and supplies. And families used to joke about this, they’d have to bring an extra bag just for their factor VIII products.
It’s important to know that it can be outside, but we don’t want them to leave it in their glove compartment box. We don’t want to leave it in random locations. And it’s also important for them to understand this issue about stockpiling, which used to happen more often and now our pharmacists call them and ask, “How much do you have left,” because we obviously don’t want a bunch of factor VIII to expire in their refrigerator, even if it’s been there a long time. So have those discussions.
Some of the products have reports where they can be out at higher temperatures. That could be a selling point for some patients if they live in hotter climates. It’s not a huge selling point I think for most patients. But sometimes that little difference matters. Patients care about the delivery device and things like that that don’t really affect me in any way, but if they don’t like the way it’s delivered, they may not even choose that product. So it’s important that our pharmacist goes over some of these things, and we’ll often bring in some of these sample versions and dummy devices to show them because they do have that option. And sometimes those things matter to them when they may not seem to matter to us.
Luigi Brunetti, PharmD, MPH: One of my pet peeves is actually the storage of these products. And you can recommend patients put it in the refrigerator, but probably putting it in the door of the refrigerator, where they’re opening and closing it, is not a good place for it. I generally say, if you’re going to put it in the fridge, tuck it away maybe in the center of the fridge. Put it in a plastic bag. Take it out of the box, which can grow mold on it. It can be pretty gross, so you don’t want patients to do that. So those are some general, simple things. And the temperature excursions I think are really important because with some of the products when they’re at room temperature, with factor products we mentioned they’re good for 7 days. I think Hemlibra is 3 months, if I’m not mistaken.
Robert F. Sidonio, Jr, MD: Yes.
Luigi Brunetti, PharmD, MPH: But I live in a neighborhood where I lose power pretty often. So it is important for patients to not get too nervous about that, and to know. And if they don’t know, contact their pharmacist, contact their provider and ask, “Hey, what should I do with this product?” Because what we don’t want is them to end up with a product that has lost its potency, and when they need it, it’s not going to work. I think that’s important.
Robert F. Sidonio, Jr, MD: Having just enough is important, and obviously you want them to have enough to feel comfortable over a weekend, over a long trip. We encourage people to travel with that and then when you get to your room to refrigerate it, and not just to leave it in the room or somewhere where it could get hot.
Luigi Brunetti, PharmD, MPH: Sure. And we already mentioned this as well, other instructions. We provide the storage instructions, administration instructions; these demo models might be important. You mentioned travel and the importance of providing patients with instructions on travel. Maybe providing them a letter, so when they go through the airport they’re not hassled. Is there anything else that we missed here?
Robert F. Sidonio, Jr, MD: Those are the big things. We often recommend a MedicAlert bracelet of some sort. It doesn’t have to be that brand, it can be any emergency bracelet. But we often provide, and I know that they do at your center as well, they provide an emergency letter such that if they’re traveling somewhere else, they know who to call, they know what the risks are. Ours has a pretty long statement about Hemlibra because it’s important to know it interferes with different assays and that could really confuse doctors who have little experience, particularly in the emergency department where they may not have the assay that we need to measure whatever has been infused.