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May 7 (posted viaProZ.com): Just finished the last of the interview focused on "health advocates" in the US. Pretty interesting initiative, especially for Latinos in California. ...more »
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Sample translations submitted: 1
Spanish to English: Interview with HCP General field: Medical Detailed field: Medical (general)
Source text - Spanish Recording, in Spanish.
Translation - English M: Perfect, thank you. And today we're going to be talking about three rare diseases. Specifically, we have generalised myasthenia Gravis in urology, which I'm going to shorten to GMG If that's okay with you. So GMG and then we've got two haematology conditions, and that's atypical hemolytic uremic syndrome. So atypical HUS and also PNH paroxysmal nocturnal hemoglobinuria. Are you familiar with all those conditions and the abbreviations?
R: Yes, I am.
M: Lovely. So if we start with GMG, could you just approximate for me, you know, how many patients with GMG are managed at your institution?
R: Well, we probably have around 25 patients or so.
M: Yeah. And then for PNH, which is paroxysmal nocturnal...
R: it's probably around 8 or so.
M: Yeah. And then finally, atypical HUS.
R: Similarly, so probably under double digits. So I would say the same thing.
M: Okay. Perfect. Are there any restrictions on which healthcare professionals are able to prescribe biologics or other high-cost medications for these particular rare conditions?
R: So a lot of these have to be done maybe possibly outpatient in their outpatient infusion centres. It might have to be done by you know, neurology or it might need to be done by vascular or haematology. You know, maybe even nephrology can do some of these, possibly.
M: Okay, that makes sense. And then can you briefly talk me through the involvement that you and your team have in the management and the provision of medication for these conditions? So you know, you mentioned you're on the PMT committee.
R: essentially, what happens is, you know, for any medication, you need to go through the formula review process. So the way it works is a prescriber would you know, request something via our intranet web form, that will get reviewed by our pharmacy residents, and we would come up with all the collected data from the clinical trials, see what else is available, maybe, you know, research from other institutions across the country, what they're doing, this gets presented a PNT for either approval or, you know, we deny it, or we try to see if there's any restrictions we need to place on this product, or is there a particular setting, it's better suited for? And is this more of an outpatient drug? is it supposed to be inpatient? So we've kind of come up with his working guidelines of how to use this particular product.
M: And then, are you involved in, if the decision is made, to accept a product are you involved in incorporating that into practice?
R: Exactly so once something is approved, the whole downstream process where we need to create our EMR screens, our epic screens have to be correctly coordinated, we have to put in a ticket for that, to make sure it reflects the dosing appropriately if something's weight-based or does it round to the nearest vial, dispense correctly, then we have to put in as well as in terms of ordering, is it something that we're going to order per patient? Or is it something that we need to keep a particular par level on? So there's different you know, nuances that kind of go into it? Nothing, you know, impossible or insurmountable. It's usually, you know, getting our formula takes about maybe a month to 45 days to kind of have it up and running efficiently.
M: Yeah. And then do you educate or provide guidance to the prescribers?
R: You know, most of the prescribers who are going to be using a particular medication are already knowledgeable, you know, they go to different conferences, they're already aware of clinical trials that are happening. So they're fairly knowledgeable about their disease and their practice. So, the main, you know, the knowledge that what we try to do is, we have our limitations in our EMR system, in our epic, so we would have, you know, blocks there, where they wouldn't be able to order it if they weren't a certain prescriber, or there are dose restrictions, or we may have some verbiage at the bottom of how to order this or what to monitor.
M: Okay. And, you know, I'm aware for these rare conditions that medications and biologics can be quite high cost. Are you involved in any negotiations on the medicines and procuring the medicines?
R: Not so much in terms of contracting and that. We do have a GPO as well. So we're using... one of our sites was a 340 b. So there definitely is another level of contracting where that occurs, because I'm more on the clinical side of things.
M: Yeah. Got it.
R: But a lot of these are also outpatient, we can sometimes write... We have more favourable dynamics in terms of reimbursement.
M: Okay, yeah. Lovely. And with the European Committee, is there a separate or a special committee for rare disease drugs or is everything in the same... Just one committee that covers all drugs?
R: We have one centralised PNC.
M: One centralised? Yeah.
R: yeah.
M: Got it. Are there any unique steps or anything specific about when you're looking at a rare disease drug? Or does it tend to follow the same process?
R: In the same process, sometimes with rare diseases, we also look at kind of the cost, but also look at the total number at the end, the total number of patients, and the annual budgetary impact. So something like a heart failure medication may not be that expensive, but if we're using it in 3000 patients, it would definitely add up. So it really feels like something that's more of a niche or kind of a low-volume drug in a way, it's kind of easy to review because we can definitely manage it better, I feel like.
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Born into a family where English and Spanish flowed as freely as water, I've always been a bit of a wanderer, curious about the world beyond my hometown. Growing up, my bilingual superpower opened doors to adventures, new friends, and more projects. I've spent the last seven years as a translator, something that has allowed me to experience different cultures and parts of the world.
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