Episode 84- Rich Helppie and Dr. Roseanne Paglia
Brian Kruger:
Welcome to Richard Helppie’s Common Bridge. The fiercely nonpartisan discussion that seeks policy solutions to issues of the day. Rich is a successful entrepreneur in the technology health and finance space. He and his wife, Leslie, are also philanthropists with interest in civic and artistic endeavors with a primary focus on medically and educationally under-served children.
And welcome to the Common Bridge. Today Rich is talking with Ascension Michigan Pharmacy clinical specialist, Dr. Roseanne Paglia about the COVID-19 vaccine roll-out and the logistics surrounding that implementation. We go now to Rich and Dr. Paglia in conversation.
Rich Helppie:
And with us today is Dr. Roseanne Paglia. Dr. Paglia is a Pharm-D, as the industry refers to her, she has a very large responsibility for the distribution of vaccines. Dr. Paglia, welcome to the Common Bridge.
Dr. Paglia:
Thank you. Thank you for having me today.
Rich Helppie:
Most of the people that listen to the Common Bridge are unfamiliar with the design of the healthcare system. Do you mind giving maybe a little thumbnail of what your current professional responsibilities are, and then maybe a little bit about what your responsibilities are as it pertains to distribution of the COVID-19 vaccines?
Dr. Paglia:
Sure. So within my organization, my role is really quite multi-factorial. My training of course, is as a pharmacist, but my role is somewhat non-traditional. So in the capacity for my daily activities, I am often assigned to things such as quality management programs, information and training regarding new drugs and new therapies, working with provider groups to establish guidelines for use of specific medications and how to make all of this clear and understandable for large groups of people. And then specifically as it relates to the COVID vaccination protocol, just like all the other organizations that are in our area in Michigan, we began vaccinating and coming up with vaccination deployment plans in December. We started using the information available to us through the CDC to create pods and groupings of individuals who would be offered the vaccination as priority groups. And then extended that over time as the availability of the vaccine increased and our ability to vaccinate more people also expanded.
Rich Helppie:
How is the distribution supposed to work? There’s been so much news reporting about the manufacturer and then the federal government had a logistics plan. And I know that I’m getting notices from my providers and such. Can you give us an overview? How was this distribution supposed to work? And because it’s my understanding that we’re significantly behind plan as a nation now.
Dr. Paglia:
And the way I believe it really was supposed to work was to really target first those groups, those healthcare providers, those long-term care residents. And again, as the list extends to other individuals like first responders in the community, et cetera, I think it was initially intended to target those people immediately with the assumption that the individual organizations, provider groups and community groups would already be prepared to launch that effort immediately. Not to say that we weren’t prepared, but the complexity of receiving and distributing and documenting and transmitting data was new to all of us. So things we did plan for were how to test new systems for data management that were going to help us track who’s been offered the vaccine, who received the vaccine, how to plan for a second dose, things like that, that we had to create as part of this process. It wasn’t something that was already pre-established. And then how to correct errors quickly and move forward without abandoning the project, because we all run into errors, we all run into pitfalls problems, et cetera, and we just have to keep moving forward. And that has been a bit of a challenge for us.
Rich Helppie:
Dr. Paglia, we’ve had other guests on the Common Bridge, myself included, that have said our healthcare delivery system is not designed for a major public health event and particularly a pandemic. And just from what you’ve described, it seems like that’s coming to the fore. If we don’t know where to find people, how to identify them, invite them, prioritize them, and then schedule them for their follow-up-it just seems like there’s a lot of hands. How are you doing as far as coordinating with other healthcare delivery systems and public health agencies and other sponsors of the vaccine? That to me seems a monumental task. Am I wrong about that?
Dr. Paglia:
No, you’re not wrong about that at all. And one thing I do want to mention, and this started with just the identification of the pandemic, how to manage patients-months prior to the availability of the vaccine is that I think what we’re seeing here is a nice collaboration among health systems, among public health officials and providers all over the state. That instead of reacting in a competitive way, we are very much behaving in a collaborative way and we’re learning from each other. And as we’ve come up with workflows that have been helpful specifically for the vaccine, such as identifying the right person, getting that person prioritized for the vaccine administration, et cetera, we are all sharing our experiences. So from something that I have not seen in the past is we are more united across the state of Michigan than separate.
Now, another thing that I think that was part of some of our misconception with launching the vaccine deployment program was even though we somewhat surveyed our employees regarding who might be interested in the vaccine and who’s potentially going to defer the vaccine, we’re pretty surprised at the number of individuals that have declined getting vaccinated, at least at this time. And tracking those people is very different than tracking somebody who has accepted the vaccine in the system, ready for their second dose, et cetera. So understanding are we ready to move on to another group also includes an understanding of who we’ve missed and why we’re missing people. So again as we collaborate with other organizations, groups that to get more clarity regarding why there’s reluctance for vaccination has been very eye-opening.
Rich Helppie:
I was going to be asking you about that-is that we’ve got stories about people trying to kind of elbow their way to the front of the line and get the vaccine early versus waiting their turn. I know that some of my healthcare contacts, particularly in the western states, they have the opposite problem of not having enough vaccine. And then I was going to ask you also about people declining or avoiding, opting out if you will, why are they telling you they don’t want to get a vaccine?
Dr. Paglia:
There are a variety of different reasons that have been shared regarding this. Some of it is just a feeling of it’s too new, and just a reluctance to accept a therapy that is too new. When they hear the words messenger RNA, there’s a misconception that it’s integrating into human DNA and changing our DNA as humans. So there’s some of that. The novel mechanism of the vaccine is one of the true benefits as to our being able to access this option as quickly as we have, but it comes with a little bit of an unknown. So without having widespread use of this delivery system in past vaccines, there are people that are uncomfortable with accepting this type of product.
Rich Helppie:
Are you hearing much about adverse reactions or side effects?
Dr. Paglia:
Yes, they tend to be somewhat rare, but we have a good understanding of who might be more at risk than others. So individuals who have had vaccine related reactions and specific allergic reactions to vaccines tend to be those individuals that we spend a little bit more time screening to make sure that we better understand their past reactions and anticipate what their needs might be following the COVID vaccination. So every day new information is published and again, shared, about how the experiences have evolved over these last several weeks. So without years and years of experience, we’re just getting case reports on a regular basis. And even today, as an example, information regarding contraindications to the COVID vaccination effort has been shared from the CDC. Types of additives to the vaccine product are recognized as potentially being more problematic in certain individuals than others. So again, this is an evolving understanding, but the vaccine related adverse reactions are in general, pretty mild and rare, but there have been some severe reports. So we’re looking into those very, very carefully.
Rich Helppie:
So when you think about reactions that are maybe not so troubling, this is things like arm pain or feeling a little ill for a day. Am I right about that?
Dr. Paglia:
Those are the more, the most common ones-arm pain, maybe a little achiness, body aches, fatigue, maybe a mild fever. Those are things that are very short-lived and considered to be mild.
Rich Helppie:
And what are some of the bigger adverse reactions that have been documented?
Dr. Paglia:
The more significant adverse reactions, which again are much more rare, are things that are very allergic in nature. So it could be the development of a skin type of reaction such as hives. It could be as severe as something as anaphylaxis, and the anaphylaxis cases again…
Rich Helppie:
Would you mind giving a lay definition of anaphylaxis please?
Dr. Paglia:
So anaphylaxis is what probably you would consider to be the most severe type of complication of any treatment. That’s when the immune system has recognized the substance as foreign and the body is reacting, and generally it’s causing significant respiratory distress. Maybe their breathing is compromised and they need respiratory support and medication to reverse that reaction, to get things under control. So those types of reactions happen quickly. They typically happen within the first 15 to 30 minutes after a vaccine has been administered. And you know when they’re going to have that because they are generally within that window that you are observing them following their vaccine. The other types of reactions, the mild side effects-the arm pain, as you mentioned, maybe achiness, et cetera., those tend to start a little later, maybe that night after you received the vaccine, then following day, and those will typically happen or take place for one to three days. So the timing of when the event takes place is very important for us to understanding whether or not it’s a side effect, which is somewhat not severe, versus a true allergic, serious allergic reaction, which would be very immediate in nature.
Rich Helppie:
I see. I’ve done a little bit of work looking into how the antigens are supposed to work, whether they’re stimulated by a vaccine or from a natural infection. And if I’m quoting him correctly, Dr. James Baker said that the natural antigens for people that have gotten infected with the COVID-19 virus, that as far as they could study it, because it’s only been about six months, that those are an effective vaccine of a natural type. If I have that right, would it make any sense at all, to test people for the antigens prior to giving them a very precious supply of that vaccine?
Dr. Paglia:
That’s a great question. I’m not sure I’m the right person to answer it, but this is our approach to that particular scenario. Number one, we know that a lot of people, especially healthcare providers that I work with, have had a COVID 19 infection. Many of them had it many, many months ago. Some of them have had it more recently. So it’s not typical for us to test antibodies in those individuals, but sometimes they are tested. It could have been that they were tested because they weren’t sure at the time if they actually had COVID, and maybe also at the time that they had COVID testing for COVID itself wasn’t even as abundant as it is today. So having antibody testing available to guide the distribution of vaccines, perhaps is something we think about how to ration the supply at this point. It could be part of an important strategy. The way we’re dealing with this is we are offering it to the priority individuals, whether or not they have experienced COVID in the past. However, what we are telling them is that if you had COVID recently, you may want to delay receiving the COVID vaccination to give somebody else that priority dose, because your antibody levels are most likely protecting you from a second infection. Again, I’m probably not qualified to make further statements regarding this, but it makes sense to have maybe a COVID naive person, especially somebody with risk factors, to receive the vaccine in more of a priority fashion, even within the same groupings that we’re talking about-healthcare providers, first responders, et cetera.
Rich Helppie:
It’s a strange situation we’re in. We have a limited supply of the vaccine worldwide. We have a general understanding of the prioritization. We have people anxious or eager to get the vaccine and want to exercise influence to jump the line. And you would think we’d be running out of the vaccine. And instead the American Hospital Association, estimated that 1.8 million people need to be vaccinated every day, starting now until the end of May, if we’re going to get herd immunity by the summer. But we’re running over a million people per day below that. It just doesn’t seem to make sense that we’re not getting everything we’ve got distributed and the issue isn’t a supply problem, what the heck is going on?
Dr. Paglia:
So when we first started giving vaccines at each site that we developed, what is called a pod or a vaccination center, we looked at each of those processes at that specific site, very individualized. So for example, on the first day that vaccines were going to be provided that the schedule was very, very minimal so that we could test to make sure the processes were working correctly at that site. So things that are probably somewhat unique to this one is that the tracking of this vaccine is so important. That’s probably aside from screening to make sure the person is a good candidate for the vaccine, actually getting the vaccine administered, but the tracking component, you can’t get that wrong. You have to get that right, right away. And you have to do that immediately, that we took our time initially to make sure that we had all of those systems in place.
So for our organization, in addition to documenting into our own system to track it, we of course also documented into the Michigan registry for vaccines, which is MCIR, and made sure that there were no errors with any of those submissions. So getting the group together to have all of those processes connect to assure that there were no problems was somewhat of a rate limiting step. So again, for each site, they started slow, worked through their bugs and ramped up as they could as quickly as possible. So now we’re at the point where starting this week, we are preparing to extend our vaccine administration efforts into the community. So aside from having a very finite controllable group, we’re now launching into the community and we’re expecting additional issues related to that. So we’ve learned a lot from what we experienced with our first sampling, I would say, but we are anticipating a whole lot more problems as we launch into our next phase.
So one of the things that we just spent nearly two hours discussing prior to this call today, was scheduling vaccines for patients 65 years and older. And so there’s a new scheduling system that our organization is using that these individuals haven’t accessed in the past. We’re going to ask them to use new technology. We’re going to ask them to schedule, we’re going to ask them to figure out parking at a new place. We’re going to ask them to trust us that we’ve got all their information there on site and we’ll be able to get all that documentation in place so that each person is counted the way we need to count them. And it’s so detailed regarding how this has to work. Again, we want to get to the point where each of our sites is administering a minimum of 800 shots a day. We’re probably not going to get there for the first several days.
Rich Helppie:
Well, to add to the complexity there’s that second dose that has to go in. And that means scheduling people. And I don’t know if you have a population of over 65s and the answer lies in them using a new technology. That seems like a hurdle, unless they have grandchildren, because that’s the way you get things done.
Dr. Paglia, we’re recording this on a Sunday and you are seven days a week on making sure that the vaccines can get to the people that need them from the manufacturer, through the government processes, through your healthcare system, and then to those that need them. And I know that you’re due on yet another call in just minutes. So let’s wrap up and I just have two questions for you, and I’ll ask them at the same time. From where you sit, what does success look like? And second, what should the public know about vaccinations and how to get one?
Dr. Paglia:
I envision a successful program to be flawless in its implementation and reaches as many people as possible as quickly as possible. I would think that a successful program would provide the assurances that the community expects to make sure they’re getting quality products in a safe way, and that they can feel confident when they receive this type of vaccine. That caring healthcare providers who are looking at them as people are going to be making sure that they’re getting the right product that is designated for them. We are very concerned in our organization to make sure that the deployment of the vaccine is done in a socially just manner. So I think a successful program would emphasize that that is part of our mission. And I would think that any individual who meets the criteria would feel-regardless of who they are, where they come from-as prioritized as anybody else. So I think those are some of the key elements in a successful vaccination program.
Regarding how to get the vaccine, the process for that is-patients from our system anyway, are being invited to receive the vaccine. So we have databases which identify individuals and stratifies them according to age, according to the complexity of their medical status. So we have the ability to risk stratify patients if we need to, to get patients that are probably have higher risk factors than others. So when we invite them to receive the vaccine, maybe if the are somewhat reluctant, there’s conversations that take place to make sure they understand why it would be a really good idea for them specifically to get it. And for people that haven’t had an appointment, or maybe a relationship with a healthcare provider at this point, as we are targeting patients 65 years and older this week, let’s say there are some people that are very healthy and haven’t seen a doctor in three years. That certainly could be a possibility. They may actually miss our initial outreach. So as we are planning who we are inviting to schedule appointments, we’re outreaching to people that we know fit the criteria. So over time as the availability extends to other people in the community, all adults, et cetera, et cetera., those people we’ll find them, but it might take a while. And they may find that they’re reaching out to other venues to get their vaccine as opposed to a healthcare organization. So one thing to keep in mind is that it’s important to be patient during this time because we’re moving forward. We’re not moving forward perfectly, but we are moving forward. So there are going to be misses along the way, but we’re going to correct them as quickly as we can fix it and then learn from our mistakes.
Rich Helppie:
I think you just made the case for a more robust public health system in that that’s where the messaging, the prioritization could go regardless of someone’s interaction with the healthcare system.
Dr. Paglia you’ve been very generous with your time, and I know that our listeners are going to appreciate all this information. Before we sign off today what didn’t we cover today that perhaps we should have?
Dr. Paglia
I think that certainly in my career, this entire pandemic from the beginning up to where we are at this point has been a remarkable learning experience. And everything that we’ve discovered along the way regarding how to prevent transmission, how to treat infections, how to influence your immune system with different therapies, and now how to prevent future spread using a vaccine. This has all been a remarkable opportunity for all of us. We of course have had a lot of tragedy along the way. And in many ways it’s been frustrating to everyday have to learn something new, but the opportunities that we’ve built upon and the collaboration and the relationships that have been developed during this time are really once in a lifetime thing. So I guess the last thing I’d like to emphasize is that for those that are really anxious to get their vaccine product, please be patient because every effort is being made to make sure you get your vaccine, you get it in a safe way, and you get it in a way where it’s going to be meaningful for all aspects of what you’re looking for with that product. So thank you for inviting me to the podcast today. I very much enjoyed this.
Rich Helppie:
Well, thank you for putting some of your time, that is at a premium today, into educating the public. And I hope everybody heard that there are protocols for people that have had adverse reactions to other vaccines, that it’s not a forced march. And also if you believe that you’re at risk, that there’s avenues to make sure you can access the vaccines. We wanted to thank our guest today, Dr. Roseanne Paglia for informing us from the front lines about vaccine distribution on COVID-19. This is Rich Helppie signing off on today’s Common Bridge.
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