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Episode 110: PERSPECTIVES - Dr Brian Gilbert & Dr Katie Qualls

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Episode 110: PERSPECTIVES - Dr Brian Gilbert & Dr Katie Qualls

Contributors

  • Katie Qualls, PharmD

  • Brian Gilbert, PharmD, BCPS, BCCCP

    Dr. Gilbert is an emergency medicine clinical pharmacy specialist at Wesley Medical Center in Wichita KS. He received his Doctorate of Pharmacy from the University of Florida and went on to complete his PGY-1 at Jackson Memorial Hospital in Miami FL then a PGY-2 in critical care at Wesley Medical Center.

  • Lauren Koffman DO, MS

    Assistant Professor, Clinical Neurology, Lewis Katz School of Medicine at Temple University

  1. Hi, and welcome back to the Ncs Podcast
  2. perspective Series, This is Laura
  3. Kaufman, M a neuro intensivist at
  4. Temple University in Philadelphia, and
  5. today I'd like to welcome onto the
  6. podcast, Authors of the recent Ncs
  7. Currents article, transitioning alter
  8. place to connect a place for acute
  9. ischemic stroke, so today I'd like to
  10. welcome to pharmacists. We have Brian
  11. Gilbert, who is an emergency medicine
  12. pharmacist in Katy Qualls, is a neuro
  13. critical care pharmacist both practice
  14. at Wesley Medical Center in Wichita,
  15. Kansas. Hi, thanks for joining.
  16. Thank you for having us. Yeah, thanks,
  17. so you know before we get into the nitty
  18. gritty of you know why we need to
  19. consider transitioning over the more
  20. practical aspects How to hospitals do it
  21. can When he would just explain really
  22. briefly like hottest, an act of police
  23. work, And why the different from Tp. A.
  24. Yeah, I can talk about that, so
  25. tonight to place is a thrombolytic agent.
  26. It binds to fibrin rich clots, and then
  27. cleaves your. In the plasmin, a jinja
  28. form plasmin and then plasmid, in turn
  29. degrades the fibrin rich matrix of the
  30. thrombus, and then one of the couple of
  31. the biggest differences between to
  32. nectar place, and all places, strict
  33. place as a higher affinity for the
  34. fibrin, when compared to alter place,
  35. and then the other one that we really
  36. like to talk about is the longer half
  37. -life which gives you the ability to
  38. give it as a push dose versus
  39. traditional altar place dosing over an
  40. hour. Okay, Yeah, I mean, I, that
  41. makes things a lot easier for us when
  42. our residents are in the emergency room
  43. and scrambling and having to hang things,
  44. and then they get moved from one unit to
  45. another. You know things get lost in
  46. transitions are having a push doses
  47. great, So now we know how it works.
  48. You know the past couple of years,
  49. we've had a few different trials that
  50. have given evidence as to why we should
  51. consider using Connect a place for acute
  52. ischemic stroke patients. Could you
  53. just summarize some of the landmark
  54. trials?
  55. Yeah, some of the ones that I like to
  56. think about our. In two thousand and
  57. fifteen, you had the test trial that
  58. looked at all to place standard dose
  59. versus point, two, five milligrams per
  60. kilogram up to next place, and that was
  61. kind of one of the first ones. I showed
  62. us that there's no difference in
  63. radiological outcomes of those, and
  64. then you follow that up with your two
  65. different, nor test studies that have
  66. just been completed, and then also the
  67. Extend I A and case studies, the first
  68. nor test study looked at point four
  69. milligrams of ten Acta place vs the
  70. place, and that's the one that showed
  71. us that there was similar rate of
  72. improvement, and the complication rate
  73. was also the same in mild, strict,
  74. milder, severe stroke, More recently,
  75. you had the nor test to trial, which
  76. showed the point four milligrams per
  77. kilo yielded a worse safety and
  78. functional outcomes, and so kind of
  79. when we come to the current dose that we
  80. use the point, two five milligrams per
  81. kilo was really shown prevent, in the
  82. extent I a trial that showed that it was
  83. not inferior to all the place. And then
  84. when you look at the extend, I a T Nk
  85. trial, though number two, that was
  86. done in twenty nineteen, it still
  87. showed no difference between Tnk doses.
  88. When you look at point four, vs point
  89. two, five, so kind of to round that
  90. all out, based on those studies.
  91. That's where we got our point. Two five
  92. milligrams per kilogram dose of ten
  93. active place, that's most likely used
  94. at facilities, Okay, so I mean you
  95. just summarized a few kind of key trials
  96. for us, based on that you think we have
  97. enough evidence or data to kind of
  98. convince people that it's time to make
  99. the change,
  100. so I'll take that one I think we do at
  101. this point when you consider the amount
  102. of patients that have been in Brooklyn a
  103. lot of trials. It's going to be a lot
  104. more robust than other critical care
  105. subtypes were patient types That we
  106. really see it. So. In this setting, I
  107. think we do we obviously having every
  108. single phenotype of stroke that presents
  109. to the jar in the studies, but you know
  110. we're off to combating this against
  111. twenty plus years of autoplay data. and
  112. so over time I believe we're going to
  113. see a lot of those subsequent database
  114. trials are essentially come out and
  115. improve overall that there is likely no
  116. difference in outcomes they're even
  117. slightly maybe been beneficial in other
  118. phenotypes so I think at this point we
  119. certainly do so I don't i don't know in
  120. terms of efficacy wise if there should
  121. be any hesitation for making this switch
  122. at this point okay so thanks you just to
  123. kind of cover why we should believe it
  124. works and we test a little bit about
  125. adverse events but obviously it's a
  126. thrombolytic you know most people would
  127. be concerned about symptomatic
  128. hemorrhage so what are your thoughts on
  129. that Yeah I mean safety profile wise
  130. they do appear to be similar when you're
  131. evaluating the zero point two five
  132. milligram per kilo does the zero point
  133. four I would say at this point has been
  134. established to be somewhat more harmful
  135. than the zero point nine milligrams per
  136. kilo to play so I think at this point I
  137. don't foresee a lot of centers utilizing
  138. the zero point two, five, the aura
  139. that a zero point four milligram per
  140. kilo dosing, and so yeah, symptomatic
  141. hemorrhage rates are slightly different
  142. Are with those two dosing schemes, but
  143. the one that's gonna be utilized should
  144. be about the same On the question
  145. becomes is how do you manage it,
  146. especially with a longer half -life
  147. medication and I, you know, obviously
  148. that if there's not enough data out
  149. there right now to essentially treat
  150. them differently, I think for the most
  151. part most sinners would utilize the same
  152. protocol that they would use for all to
  153. place, but if you look at that dataset
  154. a lotta that is not very robust as it is,
  155. and so we don't have a great handle on
  156. how to manage that as it is, so
  157. probably at this point, we're still
  158. going to treat for fibrinogen levels
  159. greater than one hundred and fifty to
  160. two hundred, depending on who you speak
  161. with a plus, minus the use of antiviral
  162. analytics, like Thc or vehicle broke
  163. acid, and you know transfusion of
  164. platelets of patient has
  165. thrombocytopenia. And so is certainly a
  166. lot of data to cover or ways to describe
  167. management of Teen K, associated bleeds,
  168. and that needs to occur over the next
  169. few years, Thanks and then I knew at
  170. our institution, we essentially have
  171. the same reversal protocol for the
  172. tonight to place that we were using for
  173. outta place. Is it are you doing the
  174. same practice? I'm not sure we've had a
  175. t and cases or switch. I, I'm not sure
  176. we've had a teen care so suitably get,
  177. but for for all intents and purposes,
  178. we were treated the same, Just stop
  179. speaking with our intensive, as then
  180. our emergency medicine physicians. I
  181. think that's what we would do and you
  182. know you kind of get stuck in those know
  183. me Atlanta. Where you have this bleeds
  184. that are four to six hours out, and you
  185. wonder if there's any associated hyper
  186. fibrinolytic activity still occurring,
  187. so I've always been a proponent of
  188. utilizing probably less biography to
  189. check and see before we erroneous lie to
  190. give anti fibrinolytic sending,
  191. Obviously, we have fairly well robots.
  192. thresholds for fiber energy values. But
  193. yeah, it's certainly a conversation
  194. that we, or data sets that we need. So
  195. if people have this data, we need to
  196. make sure that we're publishing that so
  197. that we can try to develop the best
  198. protocols. Yeah, that's a really great
  199. opportunity for us to keep eyes open for
  200. in the future. So you mentioned you've
  201. been using this. We recently switched
  202. over a few months ago. When did your
  203. institution make the change? And are
  204. there any learning points you guys have
  205. had through your experience?
  206. Yeah, we decided to make the change in
  207. August of 2022. So we've been doing it
  208. for a little bit over a year here at
  209. Wesley. And I think one of our biggest
  210. things, learning points that we learned
  211. before we started was really getting
  212. everybody on board. I think that that's
  213. one of the most important things is to
  214. make sure that all your stakeholders are
  215. available and willing to make the change
  216. I think getting all of our providers and
  217. our. whether that's emergency medicine,
  218. neuro-intensivist, or our neurology
  219. providers, all kind of together to know,
  220. hey, we're making this change, but
  221. then also thinking through how are we
  222. going to educate all of our nursing
  223. colleagues and anybody that's gonna take
  224. care of these patients that's kind of
  225. outside of that realm. I think that was
  226. one of our biggest areas that we kind of,
  227. when we made the change, was making
  228. sure that we had thorough education to
  229. anybody that's gonna be involved in the
  230. process because it is different dosing,
  231. and when you look at fiber analytics,
  232. you have different indications for
  233. different medications, so really making
  234. sure that you know what you're using to
  235. neck to place for, and if you're
  236. keeping all to place on formulary, what
  237. that's gonna be used for as well. Okay,
  238. so you mentioned education, what's one
  239. thing to consider when transitioning,
  240. but I think there are also some kind of
  241. financial implications as well. Yes,
  242. when thinking about the financial
  243. implications, The cost of connective
  244. place is lower than that of all to place.
  245. And so that was one of the other driving
  246. factors is looking at the cost reduction
  247. that you can do with it as well. When
  248. you look at the extent I a T Nk trial.
  249. I thought it was pretty interesting that
  250. they had a secondary analysis. I
  251. believe that looked at the cost per
  252. hospitalization, and so when you use
  253. the connector place versus all to place,
  254. your connected place, hospitalization
  255. was twenty two thousand dollars around,
  256. versus you're also place was twenty nine
  257. thousand, so while there may be people
  258. may not think that that is that
  259. significant for some hospital systems,
  260. and when you're looking at the number of
  261. cases, that can be a very substantial
  262. number, for sure, am so kind of
  263. following up on the education that you
  264. said that is needed. That is really
  265. interesting, and your current article.
  266. You disgust like you know. Considering
  267. having a stroke kit available, Would
  268. one of you just walk us through What's
  269. in that kit.
  270. Yeah, I'd be happy to. I just used to
  271. probably an hour ago, so the reason
  272. that we utilize. A physical stroke kit
  273. is that for those who haven't actually
  274. laid eyes on the TK box is that it
  275. actually comes in a box that has
  276. myocardial infarction dosing in it. So
  277. try to mitigate any adverse effects or
  278. dosing errors. We physically removed
  279. the product and the deal with it itself
  280. away from the package itself So we
  281. developed this kit as a way to one, you
  282. know, prevent those errors from
  283. occurring, but then also to have
  284. everything that a pharmacist, a nurse,
  285. a physician, or whoever is admixing the
  286. medication
  287. to have it ready. So our kits actually
  288. have the drug, the diluent, any of the
  289. subsequent supplies that you would need,
  290. like needle levels, alcohol swabs, and
  291. syringes available The other thing that
  292. we developed was essentially a dosing
  293. sheet and dosing card, which is also,
  294. I believe, available on that current's
  295. article. Just as a way to make, again,
  296. that dosing easier and to have
  297. essentially two sets of eyes evaluate so
  298. that we don't end up with any of those
  299. errors. And so it's been really
  300. valuable for us as a center that's still
  301. utilizing all the place for pulmonary
  302. embolism as a way to try to, again,
  303. mitigate those adverse events and while
  304. also maintaining appropriate door to
  305. needle times. Okay, thank you. So now
  306. I know we keep referring to your current
  307. article. There is a super helpful
  308. checklist that you have included in it.
  309. We will include a link to this in the
  310. show notes, but are there any key or
  311. most important points you kind of want
  312. to highlight from that checklist for the
  313. listeners?
  314. One thing I thought was key when you're
  315. doing this and going through is making
  316. sure you have all the parties available
  317. that are going to be mitigating the
  318. change. When it comes to safety, I
  319. think A lot of our agents, when we use
  320. thrombolytics, are in our automated
  321. dispensing cabinets. And so really
  322. assessing who can get to what. I know
  323. sometimes in different emergency
  324. departments, your level of override
  325. capabilities can be different. So who
  326. is going to be able to override these
  327. user accesses or access? And then also
  328. making sure whoever is accessing it have
  329. they had the appropriate education
  330. regarding how you dilute it and mix it
  331. and dose it And then other things to
  332. consider is unlike all to place, to
  333. neck to place is a push dose. So once
  334. you give it, it's in. So really making
  335. sure that your blood pressure parameters
  336. and those things are also being quickly
  337. monitored after and during the push
  338. where you're making sure that you're
  339. looking at that and making sure our
  340. nursing colleagues are really helping
  341. assist that as well as talking to
  342. providers. And then we've kind of
  343. talked about our kit and our operational
  344. and preparation of that and how that's
  345. important and then other things to
  346. consider is. looking at the cost and
  347. the billing practices within the finance
  348. department. So really reviewing that to
  349. make sure that when you make the switch,
  350. you are getting the most advantageous
  351. for that. And then making sure that
  352. it's built appropriately in your
  353. electronic medical record system to
  354. appropriately bill in different
  355. instances. Great, so now, I mean,
  356. you guys have kind of explained why it
  357. works, how it works, and why there can
  358. be financial incentives to make the
  359. transition. So why do you think some
  360. centers are still hesitant to kind of
  361. make the transition over from all to
  362. place to connect to place?
  363. I think there's probably a lot of
  364. factors that go into that decision. And,
  365. you know, we really didn't have a lot
  366. of hesitancy at first, where I wouldn't
  367. say we were an early adopter, but I
  368. would say we're somewhere in between the
  369. middle and early adopting, you know,
  370. some of the things that we were
  371. concerned about was obviously with that
  372. longer half-life is as soon as you push
  373. that medication, There, there's no
  374. getting it back, so we wanted to make
  375. sure we had our ducks in a row in terms
  376. of the safety protocols, but also the
  377. safety data that was available, we will
  378. want to be surprised with a safety
  379. outcome that came out later with some of
  380. these larger trials that Katie had
  381. recently quoted, so that I think that
  382. was one of the biggest issues we were
  383. considering at first was the safety
  384. aspect. Another would be some of the
  385. operational consideration. So one thing
  386. we haven't really touched on today was
  387. that ten k itself if you're not able to
  388. pre -mixed this medication. Currently
  389. at the time of this recording, an
  390. insect does not allow for vile
  391. replacement of this once it has been
  392. mixed if it's not used, and so I know
  393. that as a practice that occurs with
  394. water sinners to try to reduce toward a
  395. needle times, but you know when you
  396. look at the other operational factors
  397. have on T K, and you know being able to
  398. just push them out and give it right
  399. away, certainly doesn't slow down. A
  400. lot of time in so that pre mixing
  401. process, really, I think is negated by
  402. the ability to push and not need a pump
  403. and set everything up, and then I think
  404. you know the other thing would be just
  405. hesitancy. Have we have twenty plus
  406. years of data with Ultra place, and so
  407. some of that hasn't see, and at anytime
  408. there's a big change or any sort of
  409. practice, that
  410. is is going to be new and and from sort
  411. of the dogma of what we've had for neuro
  412. critical care, it's going to be met
  413. with some resistance at first, and so I
  414. think that was probably some of the
  415. issues we had and trying to identify if
  416. I Tnk should be used for all strokes are
  417. just certain phenotypes, and I think
  418. now we have enough data as we previously
  419. discussed how to make the switch over
  420. for all, but I can see that being some
  421. of the hesitancy think so. I guess I'd
  422. like to ask if there's any last pieces
  423. of advice, especially if you're trying
  424. to convince someone to make the
  425. transition.
  426. Katie, you or me or you can go first up
  427. paint. I think, initially, I think
  428. having a initial meeting with all
  429. parties that would be involved and then
  430. breaking out into groups instead of
  431. having really like a large meeting for
  432. every single process change, I think
  433. that if you divide and conquer on, it
  434. becomes a lot easier especially for a
  435. large institution that is going to have
  436. a lot of different opinions on it. I
  437. think for your moderate size institution
  438. or community based institutions. It may
  439. be slightly easier because there's only
  440. going to probably be a few parties
  441. involved that as opposed to a plethora
  442. at an academic center, but I think that
  443. was be something I would consider first
  444. is one big meaning to start, but then
  445. breaking up into sub groups and making
  446. sure that there is a one distinct leader
  447. that is sort of pushing the process
  448. through and finding those updates.
  449. I think that's good at at facility level.
  450. I think one other thing that I didn't
  451. really consider in the beginning that I
  452. wish that I would thought about Moore
  453. was, And if you are a large referral
  454. center is what are the facilities around
  455. you doing? Because I think that we talk
  456. when you when you talk to different
  457. facilities. Especially as providers.
  458. It's well. What are you doing. We're
  459. doing this and kind of really getting
  460. them on the same page and I think that
  461. that helps coordinate care, especially
  462. when we have so many transfers, and
  463. then had gotten thrombolytic therapy,
  464. so maybe reaching out and having those
  465. relationships and those conversations
  466. early, and especially with I know,
  467. there's a lot of little or facilities
  468. that are out there that are going to
  469. start only using maybe one thrombolytic
  470. agent and have one available, so
  471. knowing that, and knowing how to best
  472. you know, guide them in their in their
  473. quest before the patient gets get to you
  474. as their final destination or whatnot I
  475. will, Thanks so much. I appreciate you
  476. joining. We'll include a link to the
  477. article in the show notes, but to check
  478. out this or other currents content,
  479. please go to
  480. currentsneurocriticalcareorg. As a
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