 Daniel S. Streetman, PharmD, MS, discussed the effects of the COVID-19 pandemic on patients with immunocompromised conditions and the importance of vaccinations. His background as a pharmacist and research experience in clinical pharmacology and pharmacogenomics extends to his interest in understanding why certain drugs do not affect patients the way they are expected to.

Immunocompromised patients can be defined in two categories, Streetman explained:

Patients who have a particular medical condition or disease state that affects their immune system, such as patients with cancer and patients with HIV.

Patients who are taking a drug that can impair the immune system, including those with certain cancers.

But this is not an all-inclusive list, according to Streetman. “I certainly have seen some of the other ways that some of the COVID issues have impacted these patients,” he said. “Pre-vaccine, you saw a lot of greater concern, fear, anxiety, amongst patients…where they're taking not only the recommendations about distancing or masking or avoidance and following those but to an even greater degree…out of an abundance of caution and desire to stay away from it.”

Additionally, Streetman explained the continuing concern patients have and the possible mistrust some may be feeling about getting vaccinated for COVID-19. He noted that patients are asking questions about ongoing precautions they may consider taking, including getting extra vaccine doses. Patients are also sometimes confused about contact and social distancing parameters moving forward. However, it’s not only immunocompromised patients who are struggling with these kinds of questions; their families, friends, and others in close contact are also asking questions about how to minimize their likelihood of contracting COVID-19 and passing the virus to individuals at increased risk for worse outcomes.

The immune system defends the body against infections, such as the COVID-19 infection. Without a normally functioning immune system it is easier for COVID-19 to take hold; and, once someone is exposed, it is more likely to lead to a clinically relevant, clinically important infection, according to Streetman. This is where vaccination can make a difference.

When looking at influenza or new pneumococcal vaccines that are widely recommended for immunocompromised patients, there is evidence that supports the findings with COVID-19 responses. Streeman explained that there are medications that have a large impact, such as a drug called rituximab, which knocks the B cells out of the bloodstream. However, he emphasized that although immunocompromised patients who take immunosuppressants may have a poorer response to vaccination, they should still get vaccinated.

The more intense the immunosuppressive therapy, the greater the likelihood that somebody is going to have a lower antibody response. This has key implications, according to Streetman: the greater number of immunosuppressants that somebody is on or the higher the dose of immunosuppressants that patients are using, the more likely there is to be a concern about antibody response.

However, this doesn't mean that patients taking these drugs wouldn't potentially benefit from getting vaccinated against COVID-19 - only that their antibody response may be lower. There are many other considerations when evaluating vaccination responses, cellular immunity being one example. “That type of response has not been looked at nearly as much as measuring antibody levels after vaccination,” said Streetman.

“The key takeaways are that, according to all the evidence that's out there, [COVID-19 vaccines] seem both safe and beneficial,” Streetman highlighted. “NET [Neuroendocrine tumor cancer] patients still stand to benefit from it, even if the antibody responses diminished somewhat.”

“If I could give a second piece of advice, and more specific to health care providers, it would be to understand or be aware that a number of immunosuppressive medications may need to be altered as far as their timing around the time that someone gets a COVID vaccine. And so, it's important that pharmacists either learn those things and become aware of them, or more realistically that they find a trusted resource that they can consult,” he concluded.

Articles

Drug Topics® sat down with Dr. Daniel Streetman, PharmD, to discuss patients with compromised immune systems and reported responses to COVID-19 vaccines and others.

Immunocompromised Patients, COVID-19 Vaccine Responses


Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource 

, and now serves as the main digital news writer for 

. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Updated outcomes from the ongoing phase 1/2 GO40554 trial (NCT03677154) show that mosunetuzumab monotherapy demonstrated promising efficacy and a tolerable safety for elderly/unfit patients with previously untreated first-line diffuse large B-cell lymphoma (DLBCL).1

In the 39 patients evaluable for efficacy, the overall response rate was 61.5% (n = 24), which included a 41.9% (n = 17) complete response (CR) rate. Of the 17 patients with CR, 8 (20.5%) have maintained a complete remission with a follow-up of at least 12 months from the start of therapy. The median duration of follow-up for the overall population was 9.4 months (range, 0.2–22.7).

In terms of safety, 72.9% of 48 patients in the safety cohort had at least 1 adverse event (AE) that investigators categorized as treatment related. The most common AEs were chronic rhinosinusitis (29.2%; n = 14), fatigue (18.8%; n = 9), and abdominal pain (14.6%; n = 7).

Grade 3 febrile neutropenia was observed in only 1 patient. The most common grade 3/4 AE was neutropenia (10.4%; n = 5). One patient discontinued treatment because of renal failure and disease progression and 1 grade 5 AE of sudden death due to natural causes was reported.

Elderly/unfit patients with DLBCL ineligible for standard are first-line chemoimmunotherapy because of frailty and comorbidities often receive reduced-dose rituximab (Rituxan) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), or therapies such as rituximab plus cyclophosphamide, vincristine sulfate, or prednisone and rituximab plus bendamustine.

R-CHOP is considered the standard of care for this patient population; however, real-world data suggest that since most elderly patients (≥ 80 years) receive an attenuated dose, it may be unsuitable because of its inferior efficacy performance.2-3

Better tolerated and more efficacious treatments are needed for this patient population, according to Adam Olszewski, MD, hematologist, oncologist, and researcher with Lifespan Cancer Institute at Rhode Island Hospital and The Miriam Hospital in Providence.

“This is a population which needs improved approaches because of the inability to deliver aggressive, full-strength chemotherapy because of their medical status or age,” said Olszewski in a presentation at the 2021 Pan Pacific Lymphoma Conference.

The multicenter GO40554 trial is currently assessing the potentially promising efficacy and manageable toxicity of mosunetuzumab, a bispecific antibody targeting both CD20 and CD3, as a monotherapy for elderly and/or unfit patients with previously untreated DLBCL considered unsuitable for standard R-CHOP therapy.

At baseline, the median age range of patients was 83 (range, 65-100); 75% of patients were 80 years or older (n = 36/48). All patients had an ECOG performance status score of 0 to 2.Of the 12 patients younger than 80 years, 5 had impaired renal function, 2 had impaired cardiac function with or without impairment in at least 1 activity of daily living (ADL) and/or instrumental ADL (IADL), and 5 had impairment in at least 1 ADL and/or IADL only.

At the data cut-off April 12, 2021, 48 patients received mosunetuzumab monotherapy. Two safety-evaluation cohorts were assessed—mosunetuzumab 13.5 mg (n = 8) and 30 mg (n = 7). An expansion cohort was added and included 33 patients treated with mosunetuzumab at the 30-mg dose.

Twenty-one patients received optional pretreatment with prednisone with or without vincristine, followed by intravenous mosunetuzumab administered in step-up doses on days 1 (1 mg), 8 (2 mg), and 15 (full dose, 13.5/30 mg) of cycle 1; the full dose of mosunetuzumab was administered on day 1 of each subsequent 21-day cycle.

Patients with a CR stopped mosunetuzumab after 8 cycles. Patients with a partial response (PR) or stable disease continued mosunetuzumab for a total of 17 cycles. The median number of mosunetuzumab cycles received was 7 (range, 0-16).

For patients in the 13.5-mg cohort, the ORR was 75%, which included a CR rate of 50% and a PR rate of 25%. In the 30-mg cohort, the ORR was 58.1%, comprising a 41.9% CR rate and 16.1% PR rate. Follow-up for patients in the expansion cohort was limited.

Chronic rhinosinusitis was grade 1 or grade 2 and occurred only during cycle 1 of mosunetuzumab. The most frequent chronic rhinosinusitis effects were pyrexia (78.6%; n = 11/14) and chills (42.9%; n = 6/14). Grade 2 chronic rhinosinusitis events (n = 4/14) were treated with supportive care in all patients and steroids in all patients and steroids in 1 patient. No pressors or tocilizumab were used, and no treatment in the intensive care unit was required.

Pharmacodynamic changes in peripheral blood in cycle 1, including T-cell activation and cytokine production, were similar between elderly/unfit patients with previously untreated DLBCL who received mosunetuzumab monotherapy in the current study and fit patients with previously untreated DLBCL who received mosunetuzumab-CHOP in an ongoing phase 1b/2 trial (NCT03677141).

Olszewski concluded that mosunetuzumab monotherapy should be further evaluated as a chemotherapy-free backbone for patients unable to tolerate standard chemoimmunotherapy.

“These data suggest a potential future role for mosunetuzumab, as monotherapy or in chemotherapy-free or chemotherapy-light combinations, in older and/or unfit patients with previously untreated DLBCL who are considered unsuitable for standard R-CHOP therapy,” Olszewski wrote in a poster of the data presented.

Olszewski A, Avigdor A, Babu S, et al. Mosunetuzumab (Mosun) monotherapy for elderly/unfit patients (pts) with first-line diffuse large B-cell lymphoma (DLBCL) continues to show promising safety and efficacy with durable complete responses. Presented at: 2021 Pan Pacific Lymphoma Conference; August 9-13, 2021; Big Island, HI.

Tilly H, Gomes da Silva M, Vitolo U, ESMO Guidelines Committee, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. 

. 2015;26(suppl 5):116-125. doi:10.1093/annonc/mdv304

Shewade A, Olszewski AJ, Pace N, et al. Unmet medical need among patients with previously untreated DLBCL characterized using real-world data in the United States. 

 2020;136(suppl 1):6-8. doi:10.1182/blood-2020-136271

Updated outcomes from the ongoing phase 1/2 GO40554 trial show that mosunetuzumab monotherapy demonstrated promising efficacy and a tolerable safety for elderly/unfit patients with previously untreated first-line diffuse large B-cell lymphoma.

Mosunetuzumab Evokes Strong Response in Elderly Population With DLBCL 

 Hello and thanks for listening to Over the Counter, the podcast from 

This podcast series was created in partnership with AmerisourceBergen and Good Neighbor Pharmacy (GNP), as part of 

 coverage of the 2021 ThoughtSpot conference and trade show, hosted by GNP. 

For more exclusive coverage of ThoughtSpot 2021, including more podcast episodes, go to DrugTopics.com.

In this episode, special guest Lonie Haynes, senior vice president and chief diversity and inclusion officer at AmerisourceBergen, will be hosting and leading the conversation on reducing health disparities and caring for underserved communities. He’ll be speaking with Ryan Marable, president of the National Pharmaceutical Association (NPhA), and Chichi Ilonzo-Momah, owner and pharmacy manager of Springfield Pharmacy.

Hello, everyone. Thank you for tuning into today's discussion in partnership with Drug Topics. I'm Dr. Lonie Haynes, senior vice president and chief diversity and inclusion officer at AmerisourceBergen. 

I'm joined today by Dr. Ryan Marable, president of the National Pharmaceutical Association, and Dr. Chichi Ilonzo Momah, owner and pharmacy manager of Springfield Pharmacy in Springfield, Pennsylvania, which is part of our Good Neighbor Pharmacy network. 

Thank you both for being here. I'm excited to have the opportunity to speak with these 2 leaders in the pharmacy community on an important topic that has been exacerbated by the COVID-19 pandemic: health care disparities.

Discussions like these are critical, and they're important to AmerisourceBergen's ongoing commitment to diversity, equity and inclusion, as well as our purpose, which is creating healthier futures. 

Before we dive into the conversation, I'd like to pass over the mic to Dr. Marable and Dr. Chic

hi to briefly introduce themselves. Dr. Marable, please take some time and introduce yourself to the audience.

 Hi everyone, my name is Dr. Ryan Marable. I am a pharmacist with the drug information and medical communications team. Definitely excited to be here. 

I'm currently the president of NPhA, which is the oldest Black pharmacist association with an overall mission to provide service to underserved and underrepresented populations throughout this country. So, definitely excited to be here for this very, very important topic on health inequities and health disparities and looking forward to a great discussion.

And Dr. Chichi, if you would, share a little bit about yourself. 

My name is Chichi Ilonzo-Momah. I am a clinical pharmacist and also the owner of Springfield Pharmacy, located here in Pennsylvania. 

I have been practicing as a pharmacist for over 15 years now. I started off with the pharmaceutical industry. And for the last 10 and a half years, I have been running Springfield Pharmacy. I have a passion for helping the underserved population, and thank you for having us here.

 Thank you for those introductions. To get started, we know that community pharmacies are uniquely positioned as trusted and accessible providers with long standing community connections to create opportunities for quality care, increase prescription adherence, and, of course, reduce health disparities.

But before we start, I really want to unpack the term health disparities. We know clinically it means a difference or an outcome differentiated between different groups of people. I'd like to hear from you, Dr. Marable, your thoughts around the term health disparities, and can you discuss some of the causes and complexities in that space, from your perspective at the NPhA?

 Absolutely, so, the term health disparities, it is definitely a very complex subject, but just trying to simplify it as best as possible and just get a basic understanding of what health disparities are, really in its essence, it's a situation where groups or populations of individuals have a disproportionate effect as it relates to their outcomes of their care.

You have situations where groups of individuals may experience negative outcomes as it relates to their overall health and wellness that can't necessarily be just explained by the level of care that they're receiving. So, typically, these are systematic approaches - so it's not an individualized situation where someone is experiencing a negative outcome, but you have to think about the bigger picture.

One of the main areas as it relates to health disparities can be impacted by groups of individuals, their overall socioeconomic status. You can have gender disparities; you can have disabilities as it relates to sexual orientation; you have situations where access and availability to care and medications can create impact. And there's so many different areas that can lead to health disparities. 

But I feel like some of the more important ways, as pharmacists who are interfacing with these with patients, and other health providers in the community, is to just take time throughout your professional journey and to educate yourself, because things do continue to change, sometimes for good, sometimes for bad. But at the essence of it all, as long as you're continuing to educate yourself, that's one way that we can continue to address these health disparities and try to break down some of those barriers that we just mentioned previously.

 Thank you, Dr. Marable. Dr. Momah, you have that unique position of not only being a clinician, but also a practitioner with boots on the ground. And you support many different patient populations in Springfield, PA and throughout the Delaware County. Can you describe some of the disparities that you experience and those barriers that you've seen in the patient population you happen to serve?

 Absolutely. We are fortunate and blessed to be located in Springfield, where it's almost like in the middle of Delaware County, where we can reach the underserved, as well as a lot of people that are experiencing health care disparities.

One of the major things that I've noticed is accessibility. A lot of patients are not able to have access to a certain level of care that should be easy to get. And most of them are due to, some people might say ignorance, some people might say hesitancy, but it comes down to education and communication.

And I've seen a lot of language barriers, where people, we just assume people understand English or can read English, but because they can't understand or read, they're not able to be served what they need.

And we've also noticed fear. A lot of people are afraid to ask questions. A lot of people are afraid to admit that they don't know some information. And that causes a lot of gaps in our system. And as pharmacists on the front line, we are the liaison between other providers and these patients, so we have to be able to - some people might say dumb it down - but it is what it is. We have to be able to speak the language that they understand and meet them where they are to explain it to them better.

And being able to empathize with this patient and be approachable. Being able to be accessible to them is important and the pharmacy is the place where you can walk in without really making an appointment. We are training our staff to be more empathetic, so that when the patient sees you, they're not afraid to even talk.

We’ve had situations where patients can come in with a problem, but are afraid to even voice out the problem because of fear of being judged, fear of not being understood, or the fact that they don't see anybody that look like them in the pharmacies.

I am very passionate about patients I serve. I'm going to give you an example. We ran a COVID-19 clinic, where everybody there spoke Spanish and I do not speak Spanish. Being able to have an interpreter say some of these medical terms in Spanish, but in a very easy and understandable way, so I can communicate with this patient and tell them, ‘You're going to be okay. Are you having any symptoms?’ Explaining it to them in their language so that they can feel comfortable in their own skin to express how they feel.

 Excellent. As you were speaking, Dr. Momah, I did think about what is coined as cultural competency. Being able to, to your point, speak the language for those patients, whether it is a different language, whether it's sign language, if you're dealing with deaf individuals, or whether, as you said earlier, the LGBTQ population. Race, ethnicity, gender - all these are critical when engaging with patients.

And Dr. Marable, I wanted to ask you if you could describe some actionable ways that pharmacists can address these disparities, and also how to best engage with a diverse patient population and within their own communities?

 Yes. With pharmacists, we're uniquely positioned to really create positive change and to interact with patients from diverse backgrounds, communities, and socioeconomic backgrounds. I always am a champion of pharmacists to be able to really put our best foot forward and to try to address these various barriers and try to break them down.

So just a few unique ways to accomplish that is to try to engage with other like-minded organizations in your area to try to create unique partnerships and to build off of each other. You have various organizations in whatever respective community that you're in: you have religious organizations, you have public health and public safety organizations. It will be in your best interest, as a health care professional and leader within the community, to really try to align with them and see what services that they offer that could assist you and how you interact with your patients, and vice versa, because you have a professional level of service - from immunizations, to medication counseling, point of care (POC) testing - all of these different services you already have readily available, but you may not have that unique connection with those patients.

And by aligning with those organizations, that can help facilitate those relationships. Really being able to build relationships with the individuals within your community, that is more than half of the battle. And if you can accomplish that, that will help you in delivering the best level of care that you can and create those positive outcomes in the health and wellness lives of the patients that you serve.

 Dr. Marable, you mentioned some great points. And as you were discussing that, I thought of one of the most challenging populations that we're facing as a country and when it comes to health care and would like if you could expound a bit on our elderly population, especially in urban communities.

 Yeah, absolutely. During this COVID-19 pandemic, I feel like this has been an exposing moment for everyone that's involved, most specifically with our elderly patients.

Having a background and working in community pharmacy and interacting with patients who come from that elderly population - it can be situations where they have limited access to come into your pharmacy, they may have situations where they may not understand their full regimen of their medications.

The benefit previously, before the pandemic, was you would be able to communicate with them in person and to be able to interact with them face to face. But now, we're in a situation where those opportunities can be few and far between.

So, being able to utilize resources that you have at your disposal is going to be critical. Not only using them for yourself, but also ensuring that those patients have the understanding and ability to use those as well, because if they're not engaged in their health, and they don't have that interaction with their health professionals, with their physicians, with their nurse practitioners, then the likelihood of them disengaging and not fully understanding their care increases.

That puts them in the position where they're already a part of a vulnerable population, and that makes the situation compounded to be even worse. As pharmacists, we have the ability to utilize technology and our resources to best interact with our patients who come from that elderly population to make sure that their care is kept that priority number 1.

 Thanks for that, Dr. Marable. Dr. Ilonzo-Momah, can you share with the audience things you're doing within your pharmacy to better understand the patients? And if you could describe some recent experiences during COVID-19, during George Floyd, where that engagement and interaction really stood out?

 Absolutely. So, in our pharmacy, like I said earlier, we have a diverse population in our area. So, employing a diverse staff is something that I was very intentional about in the last few years because you want the customer to walk in and see somebody that does look like them.

And like Dr. Marable was talking about the elderly patients, for example, we have to start an adherence program where we put it in blatant packaging for the elderly. And they don't pay for it. It's free. But we noticed that some of them can't even read the label to know how many medications you're supposed to take at a given time, so we put it in these packages, and all they have to do is pop one in the morning and pop one at nighttime, and we explain it to them.

And then we COVID as well, we increase our delivery radius to give people more access to their care because of a pandemic. They're not able to maybe take public transportation or get somebody else to pick it up or bring them to the pharmacy.

Other things that we're doing - we are visiting the patient more often. Especially during COVID, most of the patients are not able to come to our pharmacy to get their vaccines. So, we do home calls for a lot of elderly patients or home-bound patients. Or it might just be a mom that had 4 kids that she can’t bring out with her to come pick up a prescription, so we take it to them. These are little things that we do in the pharmacy.

And for example, you brought up George Floyd. During the George Floyd incident - it was a very emotional time in our pharmacy, because some places might not address the situation, but in our pharmacy, I said we have to talk about it. We have to talk about how the staff is feeling about it.

Because if you talk about how you feel, and everybody talks about what they think about the situation, a lot of people will get educated on what is going on. Because a patient might come in, and is Black, and has a family member that is going through what is going on in the media. When my staff doesn’t understand the why - they don't understand why the Black Lives Matter, or why there's a movement going on now, they will not be able to understand the pain that the patient is feeling. They will not be able to empathize with a patient. They will not be able to serve the patient better. They will not be able to meet the patient where the patient currently is at that moment emotionally.

 That's great. Thank you for that. And I know, as part of our discussion, we've talked about the challenges that you face on the ground and how to best address some of those. I'm curious, and as we go into the last part of this, would love to hear your thoughts about how we as an organization at Amerisourcebergen, our Good Neighbor Pharmacies, and how the National Pharmaceutical Association, how we both can increase diverse representation within the pharmacy space.

I would love to hear your thoughts around that, first Dr. Marable, and then, of course, Dr. Ilonzo-Momah, I'd love to hear your thoughts, especially, again, as a practitioner on the ground.

 Yes, so the National Pharmaceutical Association, our mission, of course, is service to the underserved. But one of our main aims and values is upholding the highest level of standards within the practice of pharmacy.

One area that we continually address is developing our students that are within the student National Pharmaceutical Association. We have over 5000 students nationwide, chapters present on pretty much every campus around this country, and some of our main focuses even on just African American students in the colleges of pharmacy, but all students who have a desire to provide service to the underserved.

Not only are we performing ongoing leadership development, but we also have a scholarship program in which we have an endowment that has been established. And we have been able to deliver over $35,000 in the form of scholarships to students since the year 2001.

It's been an amazing journey to see the development of our students, who will then go on to transition as pharmacists and will be able to serve within communities from coast to coast. It's an amazing situation for all parties involved. Many of the funds are raised privately by our members, but we also have many corporate partners, one being AmerisourceBergen, so that's something that we are very excited about that we just connected with this past year. It's something that we are looking forward to as it relates to developing the next generation of pharmacists who are looking to address and break down those barriers of those health disparities, so definitely an exciting point.

 Thanks, Dr. Marable. And Dr. Ilonzo-Momah, as I said, you have boots on the ground, you're there on at the front line. And I think as you mentioned earlier, you're the first face that patients see when they arrive in the pharmacy when trying to get prescriptions filled or just wanting advice or consultation from a clinician. Can you please share your thoughts and perspective on how we can best increase diverse representation in the profession?

 Sure. Just over the last year or 2, we partnered with local colleges to give a chance to some of the minority students that attend pharmacy school.

And another example that I have is that we got a grant from the Pennsylvania Pharmacy Association to hire an intern for about 10 to 12 weeks this summer, just to give them the opportunity to grow in the practice of pharmacy. And we were able to pick a student from the student National Pharmacy Association from Temple University.

And this kid, he's very smart. But he would have been able to fall through the cracks, and nobody would have been able to give him this opportunity to learn, to network, and to grow and see other sides of pharmacy.

He was able to work with people in government this summer. He was able to work with other local universities and colleges, and it really empowered him. This is what we would love for, not just my pharmacy to continue, but other pharmacies and other organizations to empower these young, brilliant minds from these historically Black colleges and universities (HBCU) and give them access to be able to bridge the gap and help drive awareness to their communities. In African American communities, in Latinx communities, whatever it is, just to be able to drive awareness in these communities.

We can sit here and talk about it, but we have to do something about it. Empowering these kids through internship, and I know Dr. Marable’s organization helps these students to be able to form organizations and network, but we have to be able to help give them access so that they can pass on the torch to the next generation.

 Wonderful. I just want to thank you both for taking time to really delve into this topic, and for our audience to understand the importance of health disparities, having the ability to address health disparities with a diverse patients in their communities.

And this should not only be viewed as altruism or something that is the right thing to do. There's a good business sense of this. And if the audience is aware that in the next 25 years, this will be a majority minority country, where you’ll have diversity in rural areas and urban areas, small towns and big cities. And it's critical that we as an organization, as we strive to create healthier futures for everyone, understand health disparity.

So, I want to thank the 2 of you again for sharing your time sharing your perspective, and we look forward to continued partnership to create healthier futures for everyone.

Thanks so much to Lonie, Ryan, and Chichi for taking the time to have a conversation about this important topic, and thank you to AmerisourceBergen and Good Neighbor Pharmacy for partnering with 

And thank you for listening to Over the Counter, we hope you enjoyed this episode. If you did, take a minute to subscribe and share with your pharmacy friends. We’ll see you next time at the counter.

Podcasts

As part of our ThoughtSpot 2021 podcast series, guest host Dr. Lonie Haynes leads the conversation with diversity experts on how pharmacists can work to reduce health disparities. 

ThoughtSpot 2021 Series: Reducing Health Disparities

Knowing your customer is one of the best methods to prioritize innovation and achieve success in your pharmacy. In a session from the 2021 National Association of Chain Drug Stores (NACDS) Total Store Expo (TSE), Wendy Liebmann, chief executive officer and chief shopper, WSL Strategic Retail, offered her exceptional insights. She delved into how retailers can meet and exceed the demands of their shoppers to stay relevant in today’s fast-paced retail market.

Liebmann is one of the leading innovators of shopper insights, according to Steven C. Anderson, FASAE, CAE, IOM, president, chief executive officer, NACDS. Her presentation amassed the latest research, direct consumer feedback, and current revolutions. Through this research she provided context for the latest trends in the retailer space, as well as what we can expect to see going forward.

The notion of boosting online shopping came to fruition during the COVID-19 pandemic, when shopping online became the norm to keep consumers and employees safe. Now, retailers can use online shopping to respond to current consumer demands more effectively. “The pandemic changed the shape of retailing,” Anderson noted. “Shopping occurred in a completely different environment. How and when a shopper decided to shop and how a retailer attracted and provided for the shopper evolved at supersonic speed,” he added.

Retailers and manufacturers alike have taken pandemic challenges by the reigns and maximized opportunities to bring cutting-edge experiences to shoppers, Liebmann explained, but the work doesn’t stop there. “Now, we’ve got to ramp up the way we think about innovating…through the shopper’s lens,” she said.

She shared her inspiring insights on the contemporary shopper, including their growing expectations from retailers. “[Shoppers] are very clear about what they want to achieve in their lives in the future,” she said. “An easier, meaningful, well life. It began to develop pre-pandemic and the pandemic has just ramped it all up,” Leibmann added.

The presentation incorporated interviews from real consumers, highlighting convenience and saving time as key factors in determining a quality retail experience. These elements allow consumers to spend more time pursuing a life that is meaningful to them, as Liebmann stated. “This urgency [of not feeling like] I have enough time…that’s actually not new news,” she explained. “We saw as far back as 2017 shoppers really talking to us differently about shopping,” she added.

Generation Z and millennials are particularly aligned with these notions of saving time and money through the use of technology. But these values don’t start and end with convenience. Liebmann also pointed to stress, which has been particularly relevant during the pandemic, but was a widespread issue prior to 2020. “This notion of stress, even as early as 2014-2015 – we were seeing shoppers tell us…that stress was the number 1 barrier to living a healthy life,” she said. This is especially true for Hispanic and African American shoppers, who experience higher rates of stress, Liebmann explained, as well as systemic disparities in their health care.

ThoughtSpot 2021 podcast series dives into how pharmacists can reduce health disparities through their practice

Retailers can answer consumer calls for a more efficient, safer and easier shopping experience in several ways, according to Liebmann. Adding more checkout counters and self-checkouts, contactless pay, offering essential products in a convenient location, and curbside pickup, are a few options. “It’s not just these things, it’s everything from virtual reality to payment systems - all the ways people can make their shopping fast, safer and easier,” Liebmann said.

“If you follow the shopper, you will see the future,” Liebmann highlighted.

on Drug Topics for part 2 of this article as part of our continuing coverage of TSE 2021.

Anderson SC, Liebmann W, Long D, et al. Business Program II. National Association of Chain Drug Stores Total Store Expo 2021; August 23-25, 2021; online. August 24, 2021.

“If you follow the shopper, you will see the future,” said Wendy Liebmann, CEO and chief shopper at WSL Strategic Retail, during a session at the 2021 NACDS Total Store Expo. 

Part 1: Tune into Consumer Demands to Achieve Success in Your Pharmacy

Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

A prescription for opioids is not uncommon for children who are recovering from surgery and dental care and require pain management. However, as many as half of those prescriptions are high risk due to the potential for adverse outcomes, according to a 

. The study looked at nearly 4 million opioid prescriptions written for children and young adults aged younger than 21 years. Prescriptions were classified as high risk if they either exceeded a recommended supply or dose or included a drug that is not recommended for children.

The most common high-risk prescriptions were for treatment of acute pain and had doses that went beyond 7 days. According to the Centers for Disease Control and Prevent, a 3-day supply is often enough to manage acute pain and prescriptions that contain more than 7 days of medication are rarely required. One in 6 of the prescriptions for children aged 0 to 11 contained either codeine or tramadol, despite a warning from the US Food and Drug Administration to not use either drug in young children as a result of reports of fatal overdose. Among adolescent and young adult patients, roughly 12% of the prescriptions were high risk because they exceeded recommended daily dosage. Five percent overlapped with benzodiazepines, which can significantly increase the risk of overdose in this population.

Dentists and surgeons wrote 61% of the prescriptions. However, opioids aren’t always needed for procedures, such as tooth extraction and tonsillectomies, which can be managed with ibuprofen. The investigators in the study found that a small group of prescribers, just 5.2% of the pool, is responsible for half of all pediatric opioid prescriptions and half of those that are considered high risk. Surgeons and dentists make up a sizeable portion of the group and there are a disproportionate number who practice in the South. More judicious prescribing of opioids in pediatrics would not only reduce the risk of overdose and misuse, but also the risk of common side effects from opioids such as constipation and vomiting.

Many pediatric opioid prescriptions are high risk and leave children at risk of overdose and side effects like constipation.

Half of Pediatric Opioid Prescriptions are High Risk

The National Association of Chain Drug Stores (NACDS) 2021 Total Store Expo (TSE) kicked off virtually on Monday. In Session I, NACDS leadership and an economic expert discussed key industry issues, NACDS initiatives, and future economic opportunities.

Steven C. Anderson, FASAE, CAE, IOM, president and chief executive officer of NACDS, along with NACDS Chair Colleen Lindholz, president of Kroger Health, The Kroger Co, and Mark Zandi, chief economist and cofounder of Moody’s Analytics, offered their valuable insights on current economic issues and successes that have influenced pharmacies over the course of 2020 and 2021.

Just prior to the pandemic, in 2019, NACDS board of directors and staff were at work shaping a “bold new approach to public policy issues,” Anderson recalled. "And then in 2020, of course, COVID-19 turned everything on its head. That became the focus, and you answered the call,” he said to the pharmacist attendees. “At the same time, suppliers ramped up, moved product, got creative, gave us continuity and collaborated with retailers to serve consumers and communities," he added.

Thinking differently became key in tackling many of the issues that arose during the last 20 or so months, Anderson noted. Some of the issues that are now being addressed include direct and indirect remuneration (DIR) fees for elderly patients and fair reimbursement for pharmacies. “So far in 2021, we have seen over 60 individual improvements in state laws and how pharmacy teams can serve people,” Anderson said. 

Anderson discussed several successes as a result of NACDS partnerships with like-minded industry stakeholders. “We already have been met with the success on these issues this year. Just a few examples: NACDS, the National Community Pharmacists Association (NCPA), and the Washington State Pharmacy Association (WSPA), won a major legal fight in July. The Supreme Court upheld an important Arkansas law last year in a case that NACDS weighed in on when we filed a brief...that has created a ripple effect of new state laws like the Arkansas law that the Supreme Court upheld. These new laws would regulate pharmacy benefit managers (PBMs),” Anderson explained. 

The indispensable support of pharmacies during national crises is not a new trend, Anderson noted. “Looking back through the years, we've been through some things together as an industry,” he said. “Responses to other public health issues like HIV, and 2 natural disasters, earthquakes, floods, wildfires, hurricanes, tornadoes; serving as part of the solution to opioid abuse; shaping the Affordable Care Act, the government's biggest health care reform in decades; pioneering electronic prescribing; engaging on game-changing retailer and CPG issues like mobile and digital -  and that's just to name a few,” he said.

Anderson also mentioned the numerous external dynamics and factors that influence the work of pharmacists, such as the economy, politics, and social change. “The economic turmoil of 2008, international and domestic terrorism, contentious presidential and congressional elections that have flipped control of the government, and back again and back again and back again,” he said. “Times described as upheaval, unpredictable, volatile, angry, and chaotic...still, these most recent years have really ramped up the volatility, speed, and scope of change.”

In the face of a crisis as unpredictable as the COVID-19 pandemic, the enhanced role of the pharmacist continues to gain momentum, Anderson explained, noting President Biden’s recent announcement of his plan to offer Americans COVID-19 vaccine booster shots, potentially starting in September. “We said that when the need for additional shots was upon us, pharmacies would be the ones that are still here at the ready. And true to form, here we are,” Anderson said. “It is critical that NACDS brings together the front-line experience of pharmacies, so we can speak clearly to the government about what is needed.”

Lindholz spoke about the achievements and strides pharmacies have made across the country throughout the pandemic and during vaccine and technology rollouts. Lindholz’s discussion centered on the importance of collaboration in leading the successes of pharmacies and communities.

Pharmacies have been underpaid, under-recognized, and under-reimbursed for many of the services offered prior to and during the pandemic, Lindholz asserted. Pharmacies have been established as the face of health care and COVID-19 vaccination; and they have introduced self-care, prevention, and well-being as integral parts of medicine during non-crisis times. 

“These are complex issues, yet one common factor is that a personal and local approach to connecting with patients is absolutely the key," Lindholz said. "We have seen studies that have shown us what pharmacies in the neighborhood can do to help increase vaccination rates, enhance medication adherence, boost the management of chronic disease, and more. We need to turn these studies into new standards for how we approach health and wellness,” she explained.

COVID-19 shined a light on the valuable care provided by retail pharmacies, Lindholz added. Retailers have been meeting customers where they are on their health care journey, providing COVID-19 vaccinations, and addressing vaccine hesitancy. Pharmacists have established themselves as trusted health care professionals at the front doors of health care, according to Lindholz.

The connections between retailers, suppliers, and health care providers are vital during crises to bolster economic and health care progress, Lindholz explained. “I mentioned that NACDS is simultaneously focused on bringing together chains and suppliers, while also fighting for public policy. Pro-patient, pro-pharmacy policy based on everything that we've talked about here - it's possible that bringing together chains and suppliers, and advocating for sound policies are more aligned than ever before,” she said.

Economist Zandi provided the wide lens on the legislation trends that would boost job growth and competition, noting that policies related to infrastructure, immigration reform, and those supporting low-middle class income families, such as childcare, would improve the economy and in turn bolster pharmacies and manufacturers.

In looking at economic projections and the business model for health care and beyond, Zandi pointed to shifting employment rates. While there is a sense of optimism that unemployment and the real estate market will return to their pre-pandemic levels, the economy is also facing significant changes, including the retirement of baby boomers and therefore shifts in the job market. Zandi additionally touched on the current inflation spike, which is showing an increase in demand and surge in prices; however, supply is on a downturn, which can negatively influence hospitality and retail industries, he said. On the other hand, the inflation spike is temporary and Zandi reported that there have also been recent improvements in productivity and growth.

2020 and the national pandemic response have posed yet another challenge to pharmacy retailers, but NACDS leadership is confident that COVID-19 has been a launchpad for the industry and a testament to what pharmacies can achieve. “What we have achieved is an inspiration, not a destination," Anderson said. "And NACDS is committed to nothing short of a complete rethinking, again, of how we fight for this industry and for the consumers that you serve,” he concluded.

Anderson SC, Lindholz C, Zandi M. Business Program I. Presented at: National Association of Chain Drug Stores Total Store Expo 2021; August 23-25, 2021; online. Accessed August 23, 2021.

NACDS Total Store Expo 2021 proved to be a success, with speakers covering key issues related to the pandemic, vaccine rollout, the changing health care landscape, and opportunities for growth.

NACDS Total Store Expo 2021 Highlights Pandemic Successes, the Future of Pharmacy 

Delivering clinical services doesn’t start with the patient walking into the pharmacy or talking with the pharmacist. Clinical care begins long before. Existing programs such as medication synchronization and Medicare Part D’s Medication Therapy Management (MTM) can help. Medication synchronization serves 2 purposes. Enrolling 30% to 50% of chronic patients in an appointment-based refill program frees up a significant amount of pharmacist time compared with walk-in refills, according to Cody Clifton, PharmD, director of clinical services at Duvall Family Drugs in Duvall, Washington, and director of practice transformation and clinical programs for Community Pharmacy Enhanced Services Network (CPESN).

Regular, scheduled follow-ups then pave the way for other clinical services. “Reaching out to patients 7 to 10 days in advance of every refill lets you take services to the next level by asking straightforward questions about medication changes, changes in health, vaccinations, testing, and all the other ways we can help,” Clifton said.

Many independent pharmacies use Outcomes MTM’s standalone Part D MTM program. The program boosts nondispensing cash flow and can help identify patients who need more than a compre- hensive medication review (CMR). “We sometimes use that CMR to identify patients [who] could benefit from other services,” said Tripp Logan, PharmD, vice president of SEMO Rx Pharmacies, which has pharmacies across 3 counties in southeast Missouri.“From a value standpoint, we don’t see a ton of clinical value in 1 visit because these patients are complex enough that they need more than 1 intervention a year. That CMR is an identify clinical needs. The payer or network can forward patient contacts or selection criteria directly.

“Our program identifies patients who are part of a certain health plan, have disease states within certain date ranges, or [have] other criteria,” explained Farah Madhat, PharmD, executive vice president at PrescribeWellness.“We try to empower community pharmacies to run their own clinical programs. And once you’ve identified that population through software, you can send out singular communications to only those select patients.”

Read the rest of the article on Totalpharmacy.com

Medication synchronization and Medicare Part D’s Medication Therapy Management (MTM) can help deliver clinical care to patients.

Synchronization, Communication, Staff Participation Boost Sales and Help Patients

The first COVID-19 vaccine has been fully approved by the FDA, according to an announcement made by the agency on Monday.

The Pfizer-BioNTech vaccine, BNT162b2, will be renamed Comirnaty and will be available to all individuals 16 years of age and older. The vaccine will also remain available for those 12 to 15 years under the emergency use authorization (EUA), as well as for the administration of a third dose, according to the FDA.

Pfizer and BioNTech began the approval process for their COVID-19 vaccine in early May 2021 after submitting a Biologics License Application (BLA), supported by data submitted on a rolling basis. On May 10, the FDA expanded the Pfizer-BioNTech EUA to include adolescents 12 through 15 years of age.

According to topline results from an analysis through March 13, the vaccine has shown to be 91.3% effective against SARS-CoV-2 for up to 6 months after the second dose. Several recent analyses have demonstrated that a third dose of the Pfizer-BioNTech vaccine may reduce the risk of COVID-19 infection among individuals aged 60 years and older, according to a 

The CDC estimates that 73% of US adults – or around 201 million – have received at least 1 vaccine for COVID-19, with just over 51% of the population fully vaccinated against the virus.

 The Pfizer-BioNTech vaccine accounts for more than 204 million jabs in the United States alone.

The FDA and health officials hope that the full approval will impart confidence in Americans who have delayed getting their COVID-19 shots due to vaccine hesitancy. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Janet Woodcock, MD, acting commissioner, FDA, in a 

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Woodcock said. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

FDA Approves First COVID-19 Vaccine. News Release. FDA; August 23, 2021. Accessed August 23, 2021. 

https://content.govdelivery.com/accounts/USFDA/bulletins/2edf3f5

Israel finds COVID-19 vaccine booster significantly lowers infection risk. Reuters. August 23, 2021. Accessed August 23, 2021. 

https://www.reuters.com/world/middle-east/israel-finds-covid-19-vaccine-booster-significantly-lowers-infection-risk-2021-08-22/

The FDA EUA for the COVID-19 vaccine will remain in effect for those 12 to 15 years of age and for the administration of a third dose. 

Pfizer-BioNTech Becomes First COVID-19 Vaccine to be Fully Approved by the FDA

Let’s be honest, pharmacist to pharmacist, we have parents coming in all the time with misconceptions about head lice. Some of those misconceptions make them too embarrassed to even talk about it without some gentle prompting—like the misconception that one gets lice from being unclean. In fact, that’s not true. Parasites do what they do, and lice don’t care if the host is clean or not. As pharmacists, we’re in the perfect position to rid patients of these misconceptions and to educate them about head lice, take away the stigma surrounding it, and help them manage it. So let’s make sure 

Head lice are common in preschool and elementary children between the ages of 3 and 11 years old. Up to 12 million children contract lice annually in the U.S and up to 24 million school days are lost due to head lice each year in the U.S.

The most common way head lice spreads is by direct head-to-head contact with someone already infested because lice do not hop, jump, or fly; they can only crawl, and they do so very quickly. Transmission may happen during sports activities, slumber parties, or even play time. Less commonly, people get head lice by wearing items, such as hats, scarves, or hair ribbons worn by someone with an active infestation; using infested combs, brushes or towels; or lying on a bed, couch, pillow, carpet, or stuffed animal that has 

been in contact with an infested person. It’s good to remind folks that getting the infestation under control quickly is important not only for them or their child but also for the people that they come into close contact with to prevent recurrence and spread.

A louse is a parasite called Pediculus humanus. Head lice are about the size of a sesame seed and tan to grayish-white in color. Lice need to have a blood meal every 12 to 24 hours, so they can’t survive away from a human head for longer than a day. Although people refer to an infestation as ‘having lice’, there are actually 3 stages in the lifecycle that any one bug can be in at any given time: the egg or nit, the nymph (an immature louse), and then the adult louse. It’s important to understand the stages because there is evidence to suggest that the stage at which you intervene can affect outcome. For example, studies have shown if you kill the eggs you get better outcomes, so recommend that patients intervene early and that they be thorough.

You can intervene at any stage, and as you’ll learn in the next video, intervening at one stage is often not enough to control the infestation and prevent it from recurring. If not treated appropriately, the cycle repeats itself approximately every 3 weeks. And get this, the legs on these parasites and the adhesive used to secure their eggs are specially adapted for clinging onto human hair strands. And they cling hard, making lice and their eggs really hard to get rid of.

Because head lice can move fast it may be easier to spot the nits. Nits can look like dandruff, but you can tell them apart because dandruff will come off easily, but nits will stay firmly attached to the hair. A lot of the times, nits can be found at the at the nape of the neck, however, it’s very easy to miss them.

People get embarrassed and are uncomfortable talking about head lice. And let’s admit it, there’s a lot to learn and do in order to manage it, and that can be overwhelming for folks. That makes having a conversation about head lice the perfect opportunity for pharmacists to increase awareness and education.

Videos

Education for pharmacists on the key aspects of head lice infestation, thus empowering pharmacists with the knowledge needed to rid patients of misconceptions, take away stigma, and help guide management.

Vital Information for Pharmacists to Increase Head Lice Awareness and Education

NACDS Total Store Expo Conference Coverage:

Stay tuned for 2021 coverage from the NACDS Total Store Expo

Attending NACDS Total Store Expo 2021? Here’s How to Maximize Your Experience

NACDS highlights tools designed to help you build relationships, discover the next industry trends, and get what you want out of this year’s Total Store Expo.

 will soon be available on DrugTopics.com. In this issue, you’ll find articles on flu point-of-care (POC) testing and vaccinations, psoriasis management, naloxone counseling, and more.

The final installment of this 3-part series on medication management services delves into the process of providing clinical care in the pharmacy.

Benefits of Pharmacogenetic Testing for Independent Pharmacists

A study conducted looked at pharmacists’ experiences delivering pharmacogenetic testing in independent community pharmacies.

 Study: Behavioral Health Problems Linked to Increased Risk of Opioid Use in Teens

Nonprescription opioid use can significantly increase the risk of opioid overdose, according to a recent study.

Here’s a preview of the featured content to watch for this week on Drug Topics®.





This Week on Drug Topics: August 23 to August 27

As of July 1, 2021, all states have adopted the EPA’s final rule on Hazardous Waste Pharmaceuticals, so it’s important to ensure that your pharmacy has policies in place to remain compliant. The “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” final rule (40 CFR Part 266 Subpart P) went into effect at a federal level in August 2019, but many states did not adopt the ruling at the time. According to the ruling, all states that did not require a statutory amendment had until July 1, 2021, to adopt Subpart P.

 (HWP), as defined by the ruling, is a pharmaceutical that is a solid waste, as defined in CFR 261.2, and exhibits one or more of the following characteristics: ignitability, corrosivity, reactivity, or toxicity. A pharmaceutical, over-the-counter pharmaceutical, dietary supplement, or homeopathic drug is not a hazardous waste pharmaceutical if it is legitimately used/reused or reclaimed or, excluding prescription pharmaceuticals, has a reasonable chance of legitimate reuse or reclamation. The EPA has categorized hazardous pharmaceuticals into three classes: 

 HWP has a reasonable expectation to receive manufacturer credit, is in the original manufacturer’s packaging (recalls excluded) and is unexpired or less than one year past the expiration date.

 HWPs consist of any prescription pharmaceutical that does not have a reasonable expectation of receiving manufacturer credit, and several conditions are included that could cause a product to fall into this category.

 HWPs are potentially creditable HWPs that have been evaluated by a reverse distributor to establish whether it is eligible for manufacturer credit.

A potentially creditable HWP may be returned to a reverse distributor, like Return Solutions; a non-creditable HWP may not be returned to a reverse distributor and must be handled at the healthcare facility as RCRA hazardous waste and sent to a Transportation, Storage, Disposal Facility (TSDF) licensed with EPA for the transportation, storage, and disposal of RCRA hazardous waste facility.

Is Your Pharmacy Compliant with the EPA’s Hazardous Waste Pharmaceuticals Rule?

IDSA Calls for Multi-Pronged Approach Against COVID-19 at Schools

NCPA Encourages DOJ and HHS to Defend Price Transparency Rule

This Week on Drug Topics: August 30 to September 3

News Roundup: Patient Vaccines, NACDS Total Store Expo Success