PQS Senior Manager of Pharmacy Accounts, Nick Dorich, PharmD, talks with Parth Shah, PharmD, PhD, Assistant Professor, Hutchinson Institute for Cancer Outcomes Research, about the COVID-19 Prevention Network. Shah describes his current role and explains how pharmacists have the ability to encourage patients to take part in the COVID-19 prevention network.
On the podcast, Shah also discusses collaborative efforts needed to combat COVID-19. Listen to the full episode, “What is the COVID-19 Prevention Network?” below or read the full transcript further down.
To volunteer please visit The Coronavirus Clinical Studies COVID-19 Prevention Network.
LinkedIn: Parth Shah, PharmD, PhD
Welcome to the Pharmacy Quality Solutions Quality Corner Show, where we talk quality of healthcare and explore what that actually means. Let’s dig into performance measurements, the EQuIPP® platform, pharmacy goals, and personal goals. We will also occasionally cover topical healthcare news and maybe throw into the conversation a few of our own nerdy, passions and hobbies. So turn us up. The Quality Corner Show starts now.
Nick Dorich, PharmD (00:33):
Hello, Quality Corner show listeners. This is your host, Nick Dorich, and we welcome you to the next episode of the Quality Corner show. Let’s address another COVID topic for today, but rather than talking about updates for the disease, it’s management, or how your pharmacy can adjust, let’s talk about how you can help share information and possibly change the world. Am I being hyperbolic? I don’t think so. And this line did get approved in our script review. So we’re going to run with it. The topic of discussion today is related to COVID vaccine testing and registry signup. Fortunately, we have a great guest for today’s show who will help explain the process of enrolling patients into the COVID-19 vaccine trials here in the United States. Many of our listeners are pharmacists or others in the healthcare sector. So we won’t go into all the nitty gritty details of vaccine development.
Nick Dorich, PharmD (01:25):
There’s plenty of other resources that can cover that for you. However, we do currently face a challenge with the phase three trial efforts to find an efficacious COVID vaccine. While I could go into those details, I would prefer to let our expert cover those topics for us. Please allow me to introduce Parth Shaw, PharmD, PhD to the Quality Corner Show. Parth welcome to the PQS Quality Corner Show.
Parth Shah, PharmD, PhD (01:52):
Thanks for having me on, Nick.
Nick Dorich, PharmD (01:54):
Before we get into our questions with Parth our guest, we must provide some context to our listening audience. So Parth, do you mind giving us some information about your background, where you currently work and then perhaps most importantly, how has your role changed due to COVID-19? Sure.
Parth Shah, PharmD, PhD (02:11):
Yeah, I’d be happy to. So as you mentioned, I’m a pharmacist by training by, research background is in behavioral and implementation science. So what that essentially means is I study how to bring, um, evidence-based practices into new contexts, new settings. And as you can imagine, my area of research is bringing evidence based practices into pharmacies. So a large portion of my work is improving vaccine delivery and pharmacies, but I also do a lot of work, related to other types of preventative services.Where I work, where I’m a researcher is out the Fred Hutchinson cancer research center and in Seattle, Washington. So a lot of my work is related to cancer prevention, but as I mentioned, because I do work around vaccinations, I have also been working pretty closely around implementation of COVID-19 vaccination, at least starting to think through what preparations we need to make within our different clinical settings, including pharmacies for vaccination next year. And that’s, that’s actually been a pretty significant pivot towards my work over the past few months, really thinking through those implementation challenges. And that’s how I got, joined, or rather roped into, the coronavirus vaccine trials.
Nick Dorich, PharmD (03:41):
Thanks Parth. As a science nerd, myself, your current work sounds pretty amazing to say the least for months COVID has dominated the discussions globally. And much of the talk has included when we can begin to reduce restrictions, start to gather in person again, and when we can start to have some aspects of normal life, as opposed to what we’ve seen here for most of 2020. For many public health experts, and for many people that are health conscious, the availability of a vaccine would be considered the prerequisite to opening things back again. That’s why this project is necessary for us to see appropriate development. At this point, I would like to provide our audience more about the development and so that we can learn how pharmacies and pharmacists can assist with that gargantuan effort.
Nick Dorich, PharmD (04:28):
So Parth, you’ve already given us a little bit of background to your work and the efforts that you’re doing, but I think our questions will further tease out how the pharmacies can assist in these efforts. So, would you like to go ahead and start with our questions for this episode of the show?
Parth Shah, PharmD, PhD (04:45):
Sure. Yeah. Let’s, let’s go for it.
Nick Dorich, PharmD (04:46):
Excellent. So our first question, and you had already mentioned the COVID-19 prevention network. Obvious question: So what is this, who’s involved with this work, and perhaps most importantly for our audience, why is it important for pharmacists, for pharmacies and for health plans to consider promoting efforts of the prevention network?
Parth Shah, PharmD, PhD (05:09):
Yeah, yeah. Okay. So, um, a quick little like history lesson. The COVID-19 or coronavirus prevention network, or as we call it the CoVPN. So the CoVPN is actually based off of an existing infectious disease network that was set up by the National Institutes of Health or NIH. And the specific Institute that set it up is NIAID, the National Institute for Allergy and Infectious Diseases. So it was actually a Tony Fauci, Dr. Tony Fauci, who said that we need a prevention network that brings together our infectious disease experts, our research institutions and our private partners to develop important vaccines against infectious diseases that not only are prevalent within the United States, but globally. So this prevention network has been in existence for about 20 years and originally the network was focused on HIV vaccines, developing and testing HIV vaccines, as well as influenza, and malaria vaccines. But earlier this year as Coronavirus hit shores in the United States and in North America, NIH and the federal government, that not only made a mandate, but, increased funding funding for this prevention network to begin, doing studies related to finding a viable vaccine to actually prevent COVID-19 disease. So this prevention network has brought together disease expertise from all over the country and globally, to develop out, a viable coronavirus vaccines.
Nick Dorich, PharmD (07:04):
Parth, when hearing your response, a couple of key things that came to mind for me about COVID-19, and just the response that we’ve seen so much of the conversation has been around, what information is shared, what could be misinformation that’s out there, and how updates and guidelines may change. Certainly as it goes to vaccine development, vaccine efficacy, that’s going to be an important part, but from your background and description here, it sounds like with the prevention network, while COVID is a new disease, excuse me, we’ve certainly had experience with vaccine development education for patients. And that seems like that’s really a key driver for this organization and the involvement, would that be correct?
Parth Shah, PharmD, PhD (07:45):
Yeah. Yeah. So, it’s, it’s not just conducting the phase three trials, right? So it’s not just about doing the science should bring a safe and effective vaccine or multiple vaccines to the American public. It’s also being able to relay important information about COVID-19. So, we provide information about the vaccines that are being developed, but we also provide information about the disease and what the disease is, who it’s affecting, what can we do to prevent it. So this, this prevention network, is far reaching in terms of where it touches along the variety of different research and public health initiatives that are plaguing our healthcare system and in the United States right now.
Nick Dorich, PharmD (08:38):
Yeah, it really makes me think of a great, great, very important line that’s often referenced from an eighties classic that being GI Joe, and that “knowing is half the battle.” That is the key part here, how we know what we know is important, but how we implement is going to be what really makes the difference, but we can’t there unless we already know and have that information. It’s not just the scientists or the pharmacists, the healthcare providers, it’s the patients, it’s the public, having confidence that the vaccine that is developed is safe and efficacious. So, yeah, and actually the prevention network, I mean, it’s really funny that you’ve referenced GI Joe, but I mean, it is that knowing is half the battle, right? And, and implementation is a really important key. And that was sort of the role that I was brought on to help with is to really think through the implementation challenges of bringing these really massive efficacy trials up and running. And one of the important aspects of the Coronavirus Prevention Network is that we’re not just relying on disease expertise too, like we’ve, we have some of the world renowned expertise working on bringing vaccines and antibodies that can work against COVID-19 disease. But we’re also working with community members. We have expert panels of community members of patients, lay individuals who aren’t scientists, but they know their communities really well. And they know the devastation that this disease is having within their communities. And we’re listening to them. We’re partnering with them to understand what are their concerns about the vaccine? What are the things that they are finding challenging for enrolling themselves into the vaccine trial? So this is a true partnership in every sense of the word that this isn’t just completely driven by the disease experts. We’re also going back to our communities and learning about what impact this disease is having on them and prioritizing how we can help them.
Nick Dorich, PharmD (10:38):
Great. So Parth, I’m going to transition us for our next question. And we went pretty in depth with the background for the COVID-19 prevention network, and I think that’s necessary to understand the importance for it. Where does the group’s work currently stand? I think that for myself, in looking at social media, you’re seeing advertisements on even on TV, in between the many sports that I’m watching that are now back up and running to some degree, there’s been a lot of talk about one education, which we covered a little bit, but also the phase three clinical trials, and that patient enrollment is the perhaps the biggest need right now. So is that true in where does that exactly stand for practical purposes? Yeah. Yeah. So where we are right now, so as I mentioned, the, CoVPN, our network is in charge of conducting, essentially running all phase three trials within the United States. And a couple of them are also global trials too. So we’re in charge of that, right now two of the phase three trials. So two of the candidate vaccines have already begun their trials. The first one started back in at the end of July, and then the second one actually started last week. Their timetable went up by a few weeks, and then we’re expecting a third trial to begin next week. And then on deck are two more trials. So right now we are currently managing five trials, um, that could expand out, because I know Pfizer has begun development for their candidate vaccine. They’re doing a combined phase two/phase three trial. So it’s possible we may be managing that trial. And I know Merck has been in development of their own vaccine too. So potentially up to seven trials now with efficacy trials, one of the issues with being able to find efficacious vaccines is that you need enough participants in a vaccine trial, in order to actually see an effect, right? Won’t bore you with the statistics, I think a lot of your audience is gonna know that, you know, vaccine trials rely on really robust statistics for us to be able to conclusively say a vaccine is actually having a positive effect in reducing disease. So each of these trials are massive massive trials. Each of them has a minimum of 30,000 participants that need to be enrolled. So and with a couple of them much larger because they are taking it place internationally. One of them is actually enrolling up to 60,000 participants. So that means that our prevention network is in charge of ensuring that we can find at least 150,000 eligible candidates to be enrolled into these vaccine trials. And what that means is that we actually then need to talk to a much larger number of people to actually be able to screen out and identify those individuals. And typically an efficacy trials we use really use a 10 to one or 20 to one rule, which is for every 10 people that we talk to and screen for, for eligibility about one person is going to be eligible to actually be a candidate into the vaccine trials. So backing that number up, if we have to enroll 150,000 people by the end of the year, that means we have to register into our database, at least 1.5, probably around 3 million people. That’s a huge number of people to be enrolling in just the next three months. And so this is, this is going to require a Herculean effort, not just from our prevention network, but from a variety of different community partners, from different businesses and organizations and our prevention network has been working with a lot of different companies to do that. We’ve been working with Amazon, we’ve been working with Walmart to bring some of that awareness out to essential to their consumers. And this is… one of the strategies that we’re looking at is actually talking to healthcare providers. So pharmacies, pharmacy, organization, and healthcare plans.
Nick Dorich, PharmD (15:02):
Parth, one key question here, and thank you for doing the math for me on that part of it. You know, as well as I do pharmacists, we’re used to counting by fives that would have taken me a while to get to that, to that number, doing out the math. The cancer center that you’re at, that’s working with this located in Seattle, Washington, but the opportunity that’s here and with the trials, this is nationwide, right? So whether, whether you’re in Seattle, whether you’re in the new England area, whether you’re in Florida or Arizona, or somewhere in the middle in the Midwest, these vaccine trials are going to be enrolling patients on a pretty much a national basis. Is that correct?
Parth Shah, PharmD, PhD (15:38):
Yeah, that’s correct. So right now I believe, so as, as more vaccine trials come online, there’s going to be more and more enrollment sites. And what I mean by enrollment sites is that these are the actual medical sites that are going to be delivering the vaccines. Either the placebo or the vaccine candidate. This is a randomized control trial, the gold standard when it comes to clinical trials. So right now we have, I think around a hundred sites nationally that are enrolling patients. And by the end of the year that I think that number is going to be anywhere between 500 to 600 sites nationally. So this is truly a national effort that even though the coordinating center, the headquarter is in Seattle, we’re working with the broader prevention networks. So we’re working with sites out in Georgia and Maryland and all the way up through the New England coastline through you know, the Midwest, Southeast South Southern parts of the United States. So, truly, truly, a truly national effort to enroll these individuals and getting these trials done.
Nick Dorich, PharmD (16:51):
Great, thanks Parth. I want to get to our final question for the series that’s here is because we’ve talked about the background for the network. We’ve talked about what the ask is. Let’s get to the call to action. Why you’re here, why you’re working on this outreach with pharmacies. Because to me, it sounds like we’ve got an opportunity where pharmacists as frontline healthcare providers, that they have the touch points, they have the power to have these conversations with patients and get patients enrolled to get to that 1.5 to 3 million patients that we need to enroll to see if they can be eligible. So you’re here today. What’s your ask, what’s your message. What can pharmacies do here, right here right now, to help out?
Parth Shah, PharmD, PhD (17:28):
Yeah, so I think like the call to action. I mean, there’s a few, there’s a few reasons why pharmacies, pharmacists, healthcare plans should really consider partnering with us and become strategic partners with us. So there’s the public health aspect, right? I mean, the sooner we’re able to enroll these numbers, right? The sooner we can get these vaccine trials going, which means that we have efficacious data, we have efficacy data sooner, which ultimately means that a vaccine is able to come to the public at a much quicker rate, right? So there’s an imperative from, as us, as healthcare providers to kind of uphold that social contract that we really want to make sure that we have a safe and effective vaccine as quickly as possible. So that’s sort of the public health standpoint. There’s also a health equity standpoint. There are certain populations that have been disproportionately affected by COVID-19 and pharmacies are uniquely positioned within the United States to support and help those individuals. While, you know, a lot of primary care clinics have had to shut down or go to different hours during lockdowns, during the shutdowns, pharmacies have stayed open, they continue to remain the most important access point for healthcare and they, they continue, they’re going to continue to be. So you know, if there’s an opportunity for a pharmacy staff member to talk about the Coronavirus Prevention Network, to talk about these vaccine trials and to encourage their patients to enroll, that’s a huge, that’s gonna end up drawing a massive footprint, because, you know, millions of people go through pharmacies on a weekly basis. Now, I think there’s also an incentive for pharmacies to get involved. So there’s the publicity incentive, right? You know, pharmacies and health plans have an opportunity to actually say we are part of the solution to bringing a vaccine to the public.
Parth Shah, PharmD, PhD (19:37):
I think that’s a really powerful message that signals to the community that as healthcare providers, as healthcare institutions, we are committed to this public health crisis. And also there’s a financial incentive too. You can imagine the windfall that will happen because of economic productivity, going back to normal, that people being able to live the lives that they have been able to, that, that ends up saving a lot of money to the healthcare system. But also, I mean, pharmacies are going to be one of the key places where vaccines are going to be delivered. So that means feet through the doors. That that actually means that patients are gonna get vaccines from pharmacists. That’s an opportunity for reimbursement. That’s an opportunity for compensation. There’s also indirect benefits too, because while patients are at the pharmacy, they could be shopping around getting other things. So I think this is a win, win situation, where if, if they choose to partner with us, theyll be doing us and themselves a huge public health service, but down the road, they’re going to have a huge windfall of the good relationship building with the NIH, with the federal government and with their communities.
Nick Dorich, PharmD (20:52):
Parth, that’s a great point and you cover a lot of topics, this is one of those situations in 2020 has been different than any of us had expected. Normally, it’s always a conversation that any professional has. Well, if we’re going to do something, what do we get out of it? But as you made reference to, there is a payment aspect, there’s definitely a part of it right now with COVID that we, as, as a community, as a nation, definitely have an interest to help out those around us so that we can have, help return to some, some normalcy, Parth, I won’t hold you to any specifics about vaccine development. I know there’s a lot of people out there interested in, “Hey, when, when are they going to actually see it?” Where patients may be getting it as it happened, as soon as November, I won’t make you answer any of those questions on this podcast, put you on the spot like that. But I do think it’s worthwhile for us to continue the conversation, perhaps future episodes around the development and how pharmacies can continue to work with and have an impact on COVID-19. Certainly whether it’s from yourself or from others, with the CoVPN, that you’re going to be a great resource and something that hopefully pharmacies, and when I say pharmacies here, I mean, all of those healthcare professionals that are working in a pharmacy location that they’re going to be involved with. So, Parth for the sake of time, I’ll, I’m going to move us to our closing, and for today, but this has really been some, some great information and simple steps can go a long way, especially when we face chaos. And that’s, that’s probably chaos is probably the motto of 2020. If we’re being honest with ourselves, that the pandemic has certainly thrown our world into disarray, and we’ve seen so many great people step up to face the challenge head on in this time of strife. We face, we have seen numerous stories including on this podcast about how pharmacists and their team members are helping to keep their patients safe, how they’ve provided clarity and education based on the information that was described by Parth today, we’ve got a new call to action. We’ve got another step that we can take to help get our communities back on track, a new method, which we can participate to help create that response to COVID-19. I know that each and every one of us looks forward to putting COVID behind us, or at the very least being in a state where it’s being managed. This is the clearest action item that I’ve seen, where we can make a choice to help address COVID-19. So Parth, it’s been greatly appreciated that you’ve joined to share your information with us today. And I would also point out that while this is a great opportunity for us to help, we need to get some engagement. My part here at the end of the podcast is usually pretty scripted. And Parth already said a lot of the words that I had to have had considered in here, right? We need to get pharmacy involved. The more involvement and more forward pharmacy is, that can be tied to COVID testing, COVID immunizations. When there’s been a lot of consideration about provider status for pharmacists, with the treatment management of COVID, that only starts to happen the more that we are forward with our patients, with our legislators about those topics. So let’s continue to push, make ourselves known and, and let others know that we are in here for the fight against COVID. So with that, I do want to get us moving here to the end, before we close out the Quality Corner show, we always like to have some kind of fun and final message from our guests that being today, Parth Shah here. Our question is usually personalized for their guests, for the guests, something based on their interest or where they’re particularly maybe a hobby of their, something like that. And I believe I’ve got the perfect question lined up for Parth today. So Parth for you, If there is one college football team fight song that fully captures how we should be thinking about COVID, what would it be?
Parth Shah, PharmD, PhD (24:38):
Well obviously it’s my Alma Mater the University of Southern California, our fight song “Fight On,” right? It’s, it’s the perfect fight song for our situation, because we have to continue to persevere through any of these challenges and we don’t have the luxury to sit back and hope other people will take on the call. We are the frontline workers, and all I can say is, do you have to continue to fight on.
Nick Dorich, PharmD (25:10):
Yeah. Parth, I’m sure that you hated getting to reference USC there once again, something that I know that you’re, you are a big fan of. Before we close out for the show, Parth, do you mind walking us through for those that would be interested in hearing more reading more about the CoVPN, where can they look for more information and if they would like to contact you, how can they do so?
Parth Shah, PharmD, PhD (25:36):
Sure. Yeah. So we made this process as streamlined as possible for people to find out information about the CoVPN and the vaccine trials. You can go online to www.coronaviruspreventionnetwork.org, or you can just simply type in COVPN.org. And that will take you to our official website. There they can, people can find out information about the vaccine trials, the location of the trials and FAQ, and they can also register themselves or they can begin registering their own patients. That would be the easiest way. If a pharmacy or an individual wanted to work with me directly, they’d be more than happy to contact me. And of course they can go through PQS. If they’re already partnered with PQS or they can contact me directly. My email is PShah@fredhutch.org.
Nick Dorich, PharmD (26:37):
Great, thank you Parth again, this information very informative. And with our listeners, I think this is really a very great opportunity and appreciate getting to have you on the Quality Corner show. This is something that’s been a little bit different than what we typically tackle with the show, but our overall premise is that we talk about quality improvement. I think having a process to improve our response with COVID-19 certainly fits into the mold of what we’re looking to achieve with the show and that when it comes to healthcare providers, mainly pharmacist and pharmacy support staff, this is exactly what folks can be doing. So from that standpoint, Parth I thank you. You’re, you’re one of those pharmacists, much like myself that is in a very nontraditional role. But we also come from that background of knowing the great work that pharmacists do. So I appreciate you reaching out and connecting with us so that we can help share this message and that we can share it with our audience far and wide.
Nick Dorich, PharmD (27:34):
So Parth, in finality, here, thank you for your participation today. Any, any final words or final remarks that you would like to add?
Parth Shah, PharmD, PhD (27:43):
No. No, thank you for having me. This was a real pleasure to chat about the work we’re doing.
Nick Dorich, PharmD (27:48):
Excellent. Well, thank you again. This is a great opportunity, and hopefully it will inspire many of our listeners to get involved and to promote the signups in their community. This topic for today’s show wasn’t about quality measures, but it was about quality improvement. As I said, it’s certainly tied to improvement for our way of life and for our response to COVID-19. So for that reason, I hope you enjoyed this diversion from our usual topics. And I hope that our audience utilizes this opportunity to help us battle the COVID-19 pandemic. We thank you for listening to another episode of the Quality Corner Show.
Nick Dorich, PharmD Closing (28:23):
And with that, until next time, our team here at PQS has a couple of favors to ask of you our podcast listener. First, we encourage you to share this podcast with two friends, because if you share this with two friends and each of them shares it with two friends, it really helps us at a larger listening audience. Second, you also want to take a moment to remind you to subscribe to the podcast wherever you may find it. And then if you have any questions or topics you would like us to address, please contact us .The best way to do so is to email firstname.lastname@example.org. Let us know what is on your mind and what we can address so that you are fully informed. Our goal is to continuously improve our podcast content and to provide meaningful information to our listeners based on current topics in healthcare technology and quality measurement, we want to help you become as effective as possible in how you care for patients and improve public health outcomes. So until next time we wish you well.
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