Drug Topics®: Hi, I'm Gabrielle Ientile with Drug Topics® and here's the latest pharmacy-related news from DrugTopics.com.
Johnson & Johnson has submitted an emergency use authorization (EUA) to the FDA for its single dose vaccine candidate for coronavirus disease 2019 (COVID-19). The EUA submission is based on the company's phase 3 randomized, double blind, placebo-controlled ENSEMBLE clinical trial, which met all primary and key secondary endpoints.
Overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19. In a recent White House briefing, Biden's COVID-19 response team announced that the FDA has received the request, and its advisory committee will be meeting in 3 weeks.
That's the latest news from DrugTopics.com. Now, here's my interview with Lee RoseBush of BakerHostetler his law firm.
Hello, I'm Gabrielle Ientile with Drug Topics®. So today I'm speaking with Lee Rosebush of Baker Hostetler law firm about their interactive state-by-state COVID-19 vaccination rollout guide and the issues of regulation and compliance within pharmacies amid the pandemic. Lee, thank you so much for joining me today.
Rosebush: Thank you for having me, really appreciate it.
Drug Topics®: So before we get into our topic today, can you give us a little bit of your professional background in pharmacy and your areas of expertise?
Rosebush: Sure. I went to school way too long. My background includes being a Doctor of Pharmacy, or PharmD, from Purdue University. I'm a registered pharmacist in multiple states still today. I have a degree from Case Western Reserve University in Cleveland, Ohio, and I also have an MBA and master’s in finance from Indiana University Kelley School of Business.
In the pharmacy world, I’ve done everything from working and stocking shelves at CVS and Walgreens, to working in hospital pharmacies, and all the way up in the regulatory department, including spending some time at the FDA.
Drug Topics®: Great, thank you for that background. So today we're talking about the interactive map that your law firm has created for pharmacies looking for guidance, so I wanted to ask you the process of creating this map. How long did it take and when was it first launched?
Rosebush: Sure. So at BakerHostetler, we have an entire team that's dedicated to the pharmacy and reimbursement areas, and in fact we have multiple attorneys who are also pharmacists, and so one of the things that we wanted to do is put together an interactive resource for pharmacies and pharmacists, for those who are wanting to help out especially in this COVID time.
And so we spent a couple of weeks actually compiling information from each of the state plans. And we've tried to put it into an interactive map for no cost. Those who are interested in understanding, 1, where they can actually go to obtain, so in other words, which pharmacies could actually administer the vaccines, to is who is actually eligible to receive the vaccine.
One of the things that a lot of folks ask is, “I'm a healthcare worker, am I eligible?” or “I have an elderly parent, are they eligible?” for example. And so we tried to lay out each of the state plans as to who could actually receive and where we're at at that point.
And then we also provided information on who can actually administer the vaccine themselves. For example, could it be a pharmacist, a pharmacy intern, a clerk, a technician, a licensed practical nurse (LPN), registered nurse (RN), etc. We've tried to lay that all out there in this interactive map.
So you could go to, for example, the state of New York or Oklahoma, click on your plan and see what actually is eligible and where things are at, at the moment.
Drug Topics®: So I'm interested to hear the feedback that you've had from pharmacies and pharmacists, what has been their reaction to this map?
Rosebush: You know, we've actually had a lot of positive press and a lot of reach-out from individuals, especially for those that work in academic medical centers, or they're trying to move into the independent pharmacy area and trying to help out.
The biggest push we've had is for people that are afraid. For example, in the state of New York, Governor Cuomo not to knock anybody, but has actually threatened criminal prosecution if you administer a vaccine into an individual who wasn't eligible. And so now all of a sudden, we have a lot of questions that are coming in from pharmacies and pharmacists saying, “Can I actually administer this vaccine to a patient x? And if I have somebody who comes in who's 16, but they volunteer in a medical clinic, are they eligible?,” for example.
And so we've tried to give a little bit of a peace of mind. So that way, those who are actually administering the vaccine, understand who is eligible, and to help them in proceeding, 1, from a negative PR, because we're here to try to help, but to also to protect themselves, especially in the licensure area, to make sure that they're going down the right pathway.
Drug Topics®: And how often does the map need to be updated?
Rosebush: We try and update it on a daily or weekly basis, depending on the state and those that reach out to us. Obviously, we give the caveat that things could change at a moment's basis, especially during the COVID situation. In certain states like Ohio, where I'm actually personally licensed, they do a great job - they send out an email when things are updated, but they are updating things fairly quickly to their credit.
And so it is one of the areas where we say, look, we try and keep up to date as much as we can. We personally take on the responsibility of trying to do it daily and weekly. But it is something that those who are really nervous in this area need to make sure they keep monitoring is their state plan to make sure that they are up to date.
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