With recent surges in popularity, FDA guidance, and state legislation within the landscape of cannabis-derived compounds, pharmacies are increasingly supplying cannabidiol (CBD) products.

Of note, CBD is only 1 of the compounds found within the cannabis plant and has no psychoactive effects; delta-9-tetrahydrocannabidiol (THC) is a different compound that does produce psychoactive effects, and marijuana is a type of cannabis plant that possesses multiple naturally occurring compounds, including CBD and THC.

Study investigators Leticia Shea, PharmD, BCACP, Anna Carnazzo, PharmD candidate, and Janelle Matura, PharmD candidate, from the Rueckert-Hartman College for Health Professions at Regis University in Denver, Colorado, documented the OTC products currently being offered by pharmacies across Colorado. The findings were presented in a poster during the Association of Health-System Pharmacists (ASHP) 2020 Midyear Clinical Meeting and Exhibition.

Survey Identifies Need for CBD Education Among Community Pharmacists

Although there are myriad CBD products marketed and sold with medical claims, there is currently only 1 CBD product that has been evaluated and approved by the FDA for safety and efficacy.

As the CBD sphere of influence expands, pharmacists should “recognize the discrepancy between these CBD products and CBD approved by the FDA,” the researchers wrote. Importantly, pharmacists should also be prepared to effectively counsel patients on the use of untested CBD products that are available in their stores.

Of the 35 pharmacies included in the study, 18 (51%) sold at least 1 CBD product. Investigators took inventory of the CBD products at the 18 chain and independent pharmacies across the state of Colorado, located in both urban and rural regions. A total of 60 CBD products were recorded.

The majority of products took the form of oral drops/pumps, balms/salves, or creams/ointments. Other CBD product forms included topical oils, bath products, gummies, lotions, patches, and pet salves and balms.

Depending on the product form – oral, topicals, or transdermal – concentrations of compounds varied. In oral products, CBD concentrations varied from 10 to 60 mg/mL, with 13 (87%) labeled as “full spectrum” and therefore likely contained active cannabinoids other than CBD. In topical products, concentration ranged from 30 mg CBD/15 mL to 1000 mg CBD. Most topical products also contained other ingredients; among these products, 32% contained menthol, 17% contained camphor, 10% willow bark extract, and 10% contained peppermint, among other ingredients. The single transdermal product offered a 20mg CBD/24h dose, according to researchers.

Researchers reported that additional studies are needed to determine the safety and efficacy of these products in regard to the formulations themselves, as well as dosing.

“The impact of drug-interactions for topically applied CBD is currently unknown as no studies have evaluated [only CBD] topical formulations in humans,” investigators wrote. “The OTC CBD market is growing, and will be important for pharmacists to be cognizant of the variety of products being sold.”

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. FDA. Last updated March 5, 2020. Accessed January 25, 2021. 

https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

Carnazzo A, Matura J, Shea L. Cannabidiol (CBD) products found over-the-counter in Colorado. Presented at: American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition. December 6-10, 2020; virtual.

Articles

ASHP

Results of a study presented in a poster presentation during ASHP Midyear collected data of the available OTC CBD products being sold in Colorado pharmacies. 

OTC CBD Products Currently Available in Pharmacies 

Last year proved momentous for health care professionals, including pharmacists. 

During the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition in 2020, several ASHP officials provided an update on key policy issues poised to effect change in the industry.

Pharmacist Recognition and Scope of Practice

“Pharmacist recognition has been a huge priority for us at ASHP,” Doug Huynh, JD, director of federal legislative affairs, said during the virtual session. However, he added that the scope of pharmacist recognition as providers was narrowed during the coronavirus disease 2019 (COVID-19) pandemic to tailor advocacy efforts toward the COVID-19 response.

The most notable expansion of authority from the federal level occurred in the arena of vaccinations. The recent federal designation allowing licensed pharmacists to order and administer vaccines to any patients 3 years and older, as well as the ability to administer future COVID-19 vaccines, represents a big win.

“In broad strokes, this is really dramatic recognition by the [US Department of Health & Human Services] of the role pharmacists play in COVID-19 response,” Tom Kraus, JD, MHS, JD, vice president of government relations, added. He noted that gaps around reimbursement remain, because the current requirements allow reimbursement only for the vaccine but not necessarily for related services, such as specimen collection or patient counseling.

Jillanne Schulte Wall, JD, senior director of health and regulatory policy, discussed some of the payment changes made by the Centers for Medicare & Medicaid Services (CMS), particularly in the Physician Fee Schedule.

During the pandemic, CMS clarified that pharmacists providing telehealth or incident-to services, such as medication management services, do not need the same level of supervision required for in-person services. According to CMS, pharmacists can provide these services under virtual supervision until at least 2021.

“One of the things we’ve been pushing them on is the idea of simplifying incident-to billing and making sure that the billing that is being done for pharmacists’ services is actually reflective of the value that is provided,” she said.

Wall noted that ASHP hopes to push CMS to make this change permanent and ensure that pharmacists can be reimbursed at the same level as other providers.

In continuation of the 340B Drug Pricing Program reimbursement cuts, CMS proposes 2 options: the payment of average sales price (ASP) minus 22.5%, the cut initially proposed, or an even steeper cut of ASP minus 34.7% plus an overhead-and-handling payment of 6%, which equals ASP minus 28.7%.

According to Wall, CMS based the new proposals on hospital surveys sent out earlier in 2020. “We asked them not to do this during a pandemic.…This was really the wrong time if they wanted a lot of information from hospitals,” Wall said. “I don’t think they got a very good cross section at all of how hospitals are using this program.” Wall noted that ASHP continues to push for protecting the 340B program.

According to Huynh, the Coronavirus Aid, Relief, and Economic Security Act, passed in March 2020, featured many of ASHP’s key policy priorities related to mitigating drug shortages. These included requirements for manufacturers to provide the FDA with more information about the causes of shortages and expected duration, requirements to establish contingency plans, and incentives to encourage manufacturers to produce drugs in shortage.

In response to COVID-19, the FDA initiated a number of regulatory flexibilities around compounding. Notably, the agency announced that it will not enforce the 1-mile radius requirement from the hospital and health-system draft guidance. The FDA also allowed flexibility around compounding products in short supply and revising beyond-use dates for certain products compounded for patients with COVID-19. However, many of these policies are temporary.

Walls also discussed how the DEA worked with ASHP and other stakeholders to quickly increase allocation of annual production quotes for CIIs used for mechanical ventilation. The agency also allowed hospitals to send CIIs to temporary expansion sites.

“We’re a long way from resolving drug shortages; that’s a perennial issue,” Kraus said. However, he said that ASHP hopes to continue working with these agencies to address impending drug shortages.

Kraus T, Schulte Wall J, Huynh D, Robb K. Key policy issues impacting health-system pharmacy 2020. Presented at: American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition; December 6-10, 2020; virtual.

Several key regulatory changes made over the past year affect health-system pharmacists. 

ASHP Officials Provide Year-End Review of New Policy Issues

 from the National Pharmaceutical Association. 

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

In this special episode, Brian Nightengale from AmerisourceBergen, returns to speak with Dr. Lakesha Butler, immediate past president of the National Pharmaceutical Association (NPhA), and Dr. Ryan Marable, current president of NPhA.

The topic is closing the healthcare gap, where experts will tackle the social determinants of health (SDOH), improving access to care and the pharmacist role in addressing these disparities in health care to improve care for diverse populations.

 Hello, everyone, and thank you for tuning in to our ThoughtSpot 2020 podcast in partnership with 

 I'm Brian Nightingale, president of Good Neighbor Pharmacy (GNP) and today I am joined by Dr. Ryan Marable, president of NPhA and Dr. Lakesha Butler, immediate past president of NPhA. Thank you both for joining me today. Really appreciate your time and very much looking forward to the conversation.

 Absolutely. I'm really excited to have the opportunity to learn from both of you really and to discuss the important role that pharmacists in organizations like NPhA and others can play in increasing awareness and addressing the historical and cultural barriers of under resourced communities. And certainly to promote racial and health equity, and hopefully advance the standards of pharmaceutical care amongst all practitioners for the communities that we serve.

So again, really excited for this important conversation today. And I appreciate you joining. But really, before we dive into the key topics at hand, perhaps both of you can share a little bit about your background, your current position, and certainly the important mission of NPhA. So Dr. Butler, let's start with you.

 Sure. I wanted to start off and say I really appreciated the use of the word under resourced and we'll tap into that a little bit later because we don't use that very often. But it's the idea of being under resourced.

And so NPhA was founded in 1947 by Chauncey Cooper. During this time NPhA was, unfortunately, members such as African Americans, who were not accepted into majority organizations. And so this was a time where this type of organization was needed.

The mission we're committed to is serving underserved and under resourced areas. We represent the views of minority pharmacists on critical issues affecting health care and pharmacy. We promote racial and health equity, as you've mentioned, as well as advancing pharmaceutical care amongst all.

I'm a lifetime member of NPhA and began my journey of involvement as a pharmacy student. I was a member of the student National Pharmaceutical Association at Mercer University. And that was where I found my passion.

As a pharmacy student, I decided to get involved in an organization that mission was serving the underserved because I knew that's what I had a liking for. And honestly, during that time, I was able to really find myself through the service and serving others.

And I realized that I wanted to go into ambulatory care, academia, but want it to be in communities that really were under resourced, and that needed additional education. And so after graduating from Mercer, I completed a pharmacy PGY-1 residency in ambulatory care specialty at University of Illinois at Chicago. And within this time of my residency, once again, getting greater exposure to academia and knew right off the bat after that I wanted to pursue a career in teaching and so went on board at Southern Illinois University, Edwardsville as a clinical assistant professor and then moved through the ranks of becoming a full professor at SIUE.

In addition, my title as well is director of diversity, equity inclusion. During my teaching, I have once again found that the area that I'm most passionate about is equity, in addition to diversity and inclusion, and so, all parts of my job, whether it's teaching, service, scholarship, is blended around that topic of diversity, equity and inclusion.

So that that's kind of my pathway. As I have gone through the ranks in my career, I have found ways to serve the community, but also serving in greater capacities, and hence the previous service as president of NPhA. I do believe that serving is where you can make great impact; that that serving it doesn't have to be in a leadership role, but oftentimes, we can have a greater level of impact as leaders. That was my desire, to have a greater impact through leadership.

 That's great. Thanks for sharing that wonderful background. And I look forward to to hearing more. So. Dr. Marable, how about you?

: Absolutely. So just to pick up right where Dr. Butler left off as far as providing some context for the NPhA.

NPhA is one of the oldest predominantly Black professional pharmacy organizations established for pharmacists and other pharmacy professionals here in America. And our members, what makes us unique – yes, we are predominantly Black organization; however, our members are not only serving within these communities, but we're active participants.

We live, we invest, we work, we play, and we represent people nationwide amongst the people. I thought that was a very unique aspect of our group, is that not only do we work professionally within these areas, but we're a part of them, and we're active in them, so it's something that's very important.

But just a little bit about myself. I am a recent, relatively recent, graduate from the James L. Winkle College of Pharmacy at the University of Cincinnati in 2013. But just to kind of take it back a few steps. My first experience, which led to my passion in life, was within a small, independent pharmacy. It was a father and son team, the son was the manager and developer of the location. And the father, who was also a pharmacist, they work side by side. And I just thought that that was just such a concept because it was in an under resourced and underserved area within Dayton, Ohio, where I'm from.

Just seeing the level of rapport that those pharmacists have with the patients, and the level of respect that they each received, based in the fact that they were providing a service and care for the people within their area, I just thought that that was something that I could perform, or something that I could do because it was a model of behavior, or action that I felt like I could achieve and it somewhat lit a flame in me to move forward with.

That drove me toward the University of Cincinnati. And because of that experience within a community pharmacy setting, I was full speed ahead to become a community pharmacist.

For the first 7 years of my career, I was in the community pharmacy space as a staff pharmacist. I also spent 2 years as a direct patient care pharmacist, working with the diet, diabetes and hypertension coaching program within Kroger pharmacy, which is here in Cincinnati.

Then recently transitioned over to management and served as a manager for 2 years, which was a very enriching experience, it was actually pretty much the end goal for me. However, I would say after that 2-year experience, I felt a little boxed in, so I wanted to do something that would expand my horizon as far as my impact with people.

That transitioned over to my current role within the industry space. I'm currently a drug information associate with Eversana within their medical communications department, so it's very been very enriching.

How did I get involved as far as being an advocate for the profession? I would say my journey is very similar to many pharmacists from around the country. Just from the day-to-day tasks and in providing service during your workday, there can be times where you can feel burnt out. In order to prevent that, I felt that it was very important to remain engaged within the profession and networking with other individuals who have goals similar to mine as far as addressing barriers to care and access amongst the most vulnerable people within our various populations.

And that is what drove me to NPhA. It initially started off with my experience with the student affiliate during my time at the University of Cincinnati, and then that transitioned over on the professional side with NPhA. So it's been a very awesome 7 years as a pharmacist, and just looking forward to continuing that precedent during my time with NPhA as President.

 That's great. And now you've got the gavel, so looking forward to that.

First of all, great to get to know more about you, thank you and for sharing. You both talked a lot about communities and communities that you serve. And of course, that's what the profession is all about.

So let's dive into, certainly the patients in the communities that we serve, and, in particular, the role of SDOH in access to care.

There's a lot of diverse communities - our GNP network, we have over 5000 of those independent community pharmacies really across a broad geography in the US: rural settings, urban settings, certainly suburban settings as well. And, of course, they serve patients across a very broad socioeconomic and demographic spectrum.

And so, one of the things that we sometimes struggle with when we're developing programs to support these pharmacies is really the role that the various SDOH play in how care is provided, and also importantly, how care is received across various geographies and communities. And ultimately how that impacts patient outcomes within these diverse communities.

So Dr. Marable, how does NPhA, view the role of SDOH and why do you think they're so important for pharmacists to have a better understanding of?

 Thank you, Brian, for laying that question like that.

I feel like it's definitely something that you have to take a step back and view from a wider angle. The term, SDOH, just to provide some additional context, are conditions in the places where people live, learn, work, and play, that affect a wide range of health risks and outcomes.

So just in general, we often associate, as pharmacy professionals and healthcare professional in general, we often view an individual's behavior as the major driver behind how their health outcomes will be determined. However, that's typically only about 10% of how that person or that individual, their health will actually really play out.

So you'd have to think about what is that other 90%? What is actually creating a much more significant impact on their health. And that's where those social determinants come into play. It's those things that individuals, those things that groups of people and various populations, that they can't control. So those things can present themselves in a number of different ways.

That could be educational access, and quality of that education. That could be an individual's particular neighborhood or their actual environment. So you have to think, if you're an individual living in an area, if you have poor infrastructure, if you don't have access to transportation, it can be difficult for you to access your actual primary care physician. Or you have difficulty getting to a pharmacy or there may not be a pharmacy within 15 or 20 minutes. You could have the strongest intentions in taking care of yourself and addressing the health needs that you may have. But if, for any particular reason, you don't have that access based on your community's infrastructure, you're going to be behind, and that can greatly impact your overall health.

Also, this is one area that I never really thought about until diving a little bit more deeply into the topic was the social and community context. So how does an individual's ability to be included within their overall community, how can that impact their feeling in their perception of how their health should be played out?

You often see this in the forms of civic participation, levels of discrimination, mass incarceration. This is often evident in the topics of criminal justice reform. You also have areas of workplace conditions. If you have poor workplace conditions, that can even spill over into one's treatment or their overall care.

And then of course, you have economic stability. So if you have individuals who have employment issues, or food insecurity, or housing stability, these are all just different areas that as individuals, we just don't have as much control over. And that can ultimately play into your health.

And outside of that, once an individual is placed in those types of situations where these areas are gone unchecked, that could put an individual in a position to where they're basically going from being in a position to thrive, and then they're forced into survival mode.

Often what is seen in an individual or a group of individuals, they're just basically trying to make the best out of a situation. It comes into play of identifying the most nutritional based foods. If they can't afford that, or if they can't identify the quickest way to get it, they're going to do whatever they have to do just to survive. And that just puts an individual in a position where their health could be put in jeopardy.

 Yeah, so it sounds like what you're saying is when we as pharmacists are caring for a patient, in many instances, what's in that patient profile or in that chart represents only about 10-15% of what actually you need to know to be able to understand their healthcare environment and some of the barriers to appropriate care.

And that's a pretty startling number when you think about the lack of information that a caregiver and a pharmacist have in front of them. So, Dr. Butler, maybe you can transition that into education and are pharmacy students starting to learn more about the importance of those factors. And is there a role for the pharmacist in capturing that information and making care plans accordingly?

 Absolutely, Brian. Dr. Marable did a great job of setting up the foundation of the importance with SDOH and factors that contribute to it. Ironically, I am, and this is the honest truth, I'm teaching this tomorrow to my students where we are discussing SDOH, and specifically how that plays with systemic racism.

I know we'll talk a little bit more about that later, but I think it's important to reiterate what Dr. Marable said about this iceberg: that we only see the surface when we are interacting with patients or when we're looking in their charts and coming up with health care plans for them.

And so, yes, the importance of relationship with the patient becomes critical in order to understand and have a better sense of how these factors are contributing to their health outcomes. I oftentimes think of some of my real patients that I take care of and many of them, because of where they live - I serve predominantly African American patients that live in under resourced areas - so when it comes to finding places that, for instance, grocery stores, those are limited in the areas that they live. However, fast food restaurants are in high demand and in high numbers that exist in those areas.

This idea of problem patients that aren't showing up for their appointments, or they're not getting their prescriptions filled. We may view them as problem patients, but digging deeper to understand why. Anytime I see a patient who's not taking their medications how they should be taking it, I know that there's a much deeper story on why they're not taking it.

As Dr. Marable mentioned, survival mode makes you create priorities. So sometimes healthcare is not necessarily a priority when you have to pay bills and you're concerned about medical bills that you may incur from going to the hospital and so not going to the hospital just seems like the easiest thing to do. So, therefore, healthcare may not be the priority.

Also transportation. Dr. Marable talked about that. But I see that very often. If you're depending on public transportation and if you missed your stop, that could actually delay you, or get you completely off track with getting to work on time. And that can snowball into lower performance at work and potentially affecting employment rates.

Also, we talked about housing. Housing, depending on where you are, there may not be sidewalks. We know that with healthcare, physical activity is important to decrease our risk for disease states such as cardiovascular disease, diabetes, and if there aren't sidewalks to walk on, or if you don't feel safe to go out and walk, then that can contribute as well to a decreased level of physical activity. And so finding optional ways or other ways, alternatives, to increase physical activity - I oftentimes will say, well go up and down the stairs in your home; going down into your basement and maybe doing some exercise there; parking further away when you're at certain places - that takes time. And that takes a genuine interest in your patient, a genuine relationship building with the patient in order to uncover this huge iceberg that's contributing to what we're seeing on the surface.

 Those are great points. I think you're talking about structural and societal barriers and things that that can create issues that show up at the point of care that the care provider has no idea about. And then I can imagine that lack of awareness of what happened from the time that person left their home to try to get to their appointment or the pharmacy, and that, again, due to just either outright racism or unconscious bias, the automatic thought might be, well, they just must not care. So why should I care? Right?

 To kind of tie into the pharmacy, your role in this a little bit. I've been in other conversations, where there's a whole conversation around trust and mistrust.

How can care providers or pharmacists that are white and that may not understand or be aware of a lot of the challenges and issues that we're talking about – what should we do to better build that trust so that we can create that better relationship that you're talking about?

 Absolutely. I think the first step is that interpersonal work: truly finding ways to educate ourselves on what might be contributing factors to these decreased health outcomes. It does take a deep dive into historical context. And we know that we're here today because of history. And there have been hundreds of years of marginalization of underrepresented, marginalized or minoritized communities.

And because of that, we have biases. We all have biases, because of what we've been taught, what we've been told, what we see in the media, and specifically, when we think about our white colleagues, because of the historical context in our country, there is an innate feeling of negative bias against individuals that are of color.

And so because of that, oftentimes, biases are considered to be unconscious most often, especially in the healthcare field. But we have to take a deeper dive and really understand and self-reflect on what is our socialization? How were we socialized, as individuals, when we grew up in our home; what were some messages that we received, about minority patients that we take care of?

Those socializations really stick with us until we decide to disrupt the cycle. We continue to stay in that socialized cycle based on what messages we received internally and inside our home and externally, until we decide to educate ourselves. And that's why I say that interpersonal work is so important.

I think the other piece is listening and seeking to understand your patient. So those open-ended questions, and I like to use the term cultural humility instead of cultural competence, because cultural humility says that I'm coming as a pharmacist to the table, certainly with knowledge in in medications, disease state management, but that patient is also coming to the table with knowledge about themselves. And so I'm here to also learn from them about what factors, or that, once again, that iceberg that we need to uncover, to understand the patient at a deeper level.

Another approach would be avoiding further marginalization when communicating, and that is verbally and non-verbally. So non-verbally, we don't want to stand up over a patient if we have an opportunity to be eye level with them. Sometimes, I recommend taking off the white coat if possible, because the white coat - we've heard of the white coat syndrome with high blood pressure - but that resonates across the board with many patients as a power dynamic. And this level of feeling like they're being judged.

The other piece is the terminology that we use. If we're stating that someone is at a greater risk for diabetes because of their race, that's not necessarily true. That's a level of marginalization. Because of the color of your skin, you're saying that you have this condition, that’s something that they could not control. And so that's a further marginalization when we're communicating to them. We want to avoid that.

Because honestly, race is a social construct that was made up. And we know that there are not many differences between individuals based on race. And so really, those differences or those disparities are due to those SDOH that we've talked about that stem from the systemic and structural racism that we've outlined.

Educating and empowering patients. So really taking the time, once again, I mentioned listening and seeking to understand, but educating them and empowering them on their disease state.

I have many patients that really don't understand why they're on a medication, and so sitting down, and helping them to understand that really goes a long way. That helps to build trust. Because first off, you're taking the time to educate, and you see them to be important enough to provide them with additional information and helping them to once again be their own advocate for their for their healthcare.

I think those are a few ways or approaches to help build trust among minoritized populations, certainly what we say and how we act, but also that interpersonal work is key.

 And that's such a great way to put it, I think that was great context. The takeaway for me, just from what you just said is, again, it's not the color of your skin that's raising your risk of a disease or an outcome, it's what's behind your life, right, and your SDOH, and that that's a great way to put it.

Dr. Marable, I think let's kind of continue that though, but not necessarily from the patient or the community perspective, but from the professional perspective.

What challenges or barriers do minority professionals face in their day-to-day practice and caring for patients? Whether it's a white patient or a white coworker or provider that you're working with? Does that play into this as well?

 Oh, absolutely. As a minority professional, I will have to draw back to my experience during my time as a direct patient care pharmacist.

So during that period of time, I was working more closely with the help of primary care physicians, and you would reach out to them and ask certain questions and elicit feedback from them. And there could be sometimes, if they have an idea that you may be Black or that you may be of a different ethnicity, that you could get some pushback.

But just some things that I just try to recommend for other minority professionals is just go into it, as far as just establishing who you are and what you're representing, you're here as a pharmacist, and the end goal is to represent the patient. I feel like just in general, to go back toward what Dr. Butler was mentioning, as far as the level of bias, I feel like we all have similar goals that we're working toward as healthcare professionals, but those biases are, they're just natural things that occur within us.

The only difference is that we all have a different perspective or a different lens that we're viewing the goals through. And that lens is produced through our life experiences. The things that we go through as individuals, the experiences that we may have seen friends and family go through growing up, cultural stories that you may have heard of growing up, that really shapes us, and it doesn't really go away. And if, once you become a working professional, you're a pharmacist and you're practicing within your respective field, if you don't address that, and if you don't acknowledge it, then it can get out of your control. And that can be manifested in your communication with other health professional.

If I had to make a point toward other healthcare professionals and pharmacists, specifically, I would just encourage each person to identify what their specific biases may be, do some level of self-inventory, and just try to make those changes.

And being committed to making those changes I think is very important, because as you're making these types of changes, as you're seeing that you have these levels of biases, and you see other individuals around you who may have similar biases, if you start to call individuals out, or if you voice your opinions, you will probably receive some pushback.

If you're committed to making that change and changing your environment and the individuals around you, there's going to be an even greater importance that you have a very strong foundation and knowledge and understanding of exactly what those biases are and how you can address those changes for other individuals as well.

Additionally, it's going to be important not to wait for someone else to educate you. For example, within your professional workplace, you may have a mandatory in-service or training event, but you cannot wait for those things to happen. You're going to have to do some legwork and go out there and really try to find those resources that can create that knowledge base for yourself.

NPhA, we have anti-racism resources on our website

Office of Minority Health has a tremendous amount of resources

. And even if you wanted to dive a little bit deeper and identify wealth inequalities and information, the 

Federal Reserve also has so many resources

 that'll allow you to paint a much wider picture. So if you are challenged, and you are, reaching out to members within the professional community and you're addressing those levels of biases in order to create that true change that you want, you'll have that knowledge base and you'll have the resources that not only prepare other individuals, but it also helps to keep you strong in your quest to commit to that change, and changing others.

 And I just wanted to piggyback on a couple of things Dr. Marable mentioned, which were great.

It's important to start the work, right? We have to understand that we all, as Dr. Marable mentioned, because of our life experiences, we all have a lens that we're looking through.

If we take the stance of being colorblind, that that's not going to solve the problem. If we take the stance that I'm just going to treat everyone the same, that is not going to solve the problem as well, because everyone is not the same. We've talked about how where we live, work, play, it varies, those social determinants of health, again, creeping back up. And that creates differences, disparities, and because of that, we cannot treat everyone the same because we won't see movement.

So, therefore, the work has to start and that has to be a desire for all pharmacists. We can go back to the oath of the pharmacist and how we are committed to serving all humanity and that includes everyone and so we have to start the work.

The all the other thing that I wanted to mention is that accountability partner. Once you do start the work and you're educating yourself, it's very easy to get complacent and say okay, I've read a couple of books. I think I'm good now. But there are going to be times that you may say certain things. For instance, you might state a microaggression, or you might minimize the work of a minority colleague and not even know it. Because once again, those biases are creeping up.

Having an accountability partner who you're not afraid of listening to, but also individuals that share with you that something you said just didn't sit well with them, or that was offensive, being open to receive that feedback, and reflecting and actually changing as well.

The other piece that I wanted to add is this idea of - we talk about the biases of our predominantly white colleagues, or pharmacists, it's also important to understand racial trauma. From a minority pharmacist perspective, as well.

I know that I've talked to many of our members, especially our Black male pharmacists. And just riding in their car, driving to work creates a level of fear because of what we have experienced, what we've seen happen in the in our community. And we're bringing that to work. And that can translate in a variety of ways where we're certainly more closed, or it affects our work.

And so we have to recognize that not only do we have, as Black pharmacists, have the life experiences that have been passed down from generation to generation, but right now we're dealing with racial trauma. I know for myself, during the summer, there were many instances that I just broke down and cried because of the effect of seeing so many of people that look like me being killed.

That's important. I want our white colleagues to understand the impact of that. I really think it's important, not only building relationships with our patients, but also one another. The importance of understanding and engaging with Black pharmacists, and other minoritized pharmacists as well.

 I was just going to provide a quick example. And it doesn't even have to be over the top. As far as checking in on someone, it could be as simple as, if there's a traumatic event that occurred, because they're going to occur clearly.

Just checking in on a colleague. Just ask them, "Hey, how you doing?". Simple things like that, literally could - sometimes the answer might not be what to expect, it could be an emotional outpour. But the fact that, as an individual who might not necessarily feel affected by that traumatic event, the fact that you're asking, like, "Hey, everything good, do you need anything?" Or "would you like to have lunch?", just something simple as that literally could change the tide and could create a whole new level within your professional work relationship, depending on what that is, like, it could be as simple as that.

I feel like in times, especially around these past, 10 to 12 months, it has it has really been difficult. And oftentimes we just like to think of what can we do? What significant action can we do as leaders that can make a difference in the lives of not only our patients but with other professionals? And sometimes it doesn't have to be such a significant event, it could be something as simple as just checking in on a colleague.

: That's a great point. And sometimes the fear of not knowing what to say, or the concern about feeling helpless, so I don't do anything, right? You make a great point, Dr. Butler, starting the work and sometimes that starting of the work is a discussion, it's a conversation. And sometimes that starting of work is simple outreach, like you mentioned, Dr. Marable.

So that's a great way to close out this part of the discussion. And again, these are incredibly important discussions to have. We must continue the dialogue. It can't just be when something happens that we get together and talk. It needs to be, in my opinion, a continued dialogue that turns into action, that then leads to positive change for patients that, quite frankly, deserve the best that our healthcare system has to offer, and they deserve the best that our profession has to offer.

So, love the conversation, really appreciate your openness, really appreciate your honesty. I've learned a lot and will continue to learn a lot. And look forward to continued conversations with you. And again, continued ideas and suggestions for our pharmacist colleagues to impact positive change. I really appreciate that.

And before we just wrap it up, I do want to ask you all to reflect a little bit on your tenure, and leadership within NPhA.

You passed the gavel on, Dr. Butler, to Dr. Marable. And as you pass that gavel, and reflect on your tenure, what are your insights? What are you most proud of with what you've accomplished? And, certainly, your involvement with the association will continue, but just reflect on this past year and what you're most proud of?

Podcasts

ThoughtSpot

Our final episode in our ThoughtSpot 2020 podcast series features NPhA president Dr. Ryan Marable and immediate past president Dr. Lakesha Butler, who share insights on health disparities and the social determinants of health. 

ThoughtSpot Series: Closing the Healthcare Gap

Many community pharmacists reported lacking knowledge of and confidence in non-prescription cannabidiol (CBD) products, according to a study presented at the American Society of Health-System Pharmacists (ASHP) 2020 Midyear Clinical Meeting and Exhibition.

Despite anecdotal reports of benefits for chronic pain, arthritis/joint pain, and anxiety, there is limited evidence to support the use of CBD. However, CBD product sales continue to soar, and pharmacists must be equipped with information needed to answer patient questions in the pharmacy.

To assess community pharmacists’ knowledge, experience, and confidence of these CBD products, a research team led by Shivani Patel, PharmD, surveyed a sample of those working at community pharmacies in the California Bay Area region. Pharmacists anonymously completed the 38-question pen-and-paper survey, which was divided in 4 sections: knowledge-based questions, participant’s experience, confidence-based questions, and demographics.

Twenty-five of the 128 pharmacists asked to participate in the survey declined to answer the questions. A total of 103 pharmacists completed the survey.

According to the findings, 80.6% of participants correctly answered the FDA-approved indications and 78.6% correctly answered the potential adverse effects (AEs) of CBD products. However, the majority were not knowledgeable about legality, metabolism, and psychoactive AEs.

Pharmacists had the most difficulty answering questions about the legality of CBD products, with only 6.8% of pharmacists who responded correctly. Additionally, only 39.8% of pharmacists correctly answered the questions about metabolism and psychoactive AEs. Overall, only 12.6% were able to answer 4 out of the 5 knowledge-based questions correctly and 4.9% were able to answer all 5 questions correctly.

Patel noted that pharmacists who reported formal training were more likely to answer more knowledge-based questions correctly compared with those who did not receive formal training.

Furthermore, 68.6% of pharmacists reported having been asked about CBD products on a daily to quarterly basis. In the last year, 20.4% of participants have recommended the use of a CBD product to patients: 80.9% recommended a topical CBD product and 52.4% recommended an ingestible CBD product. Of the pharmacists who made recommendations, the majority indicated CBD products for pain (90.4%) followed by anxiety (38.1%), depression (28.6%), and insomnia (23.8%).

Between 41.7% and 75.5% of pharmacists were “not confident” in providing evidence-based recommendations, treatment recommendations, describing safety, describing warning and contraindications, and determining quality of the product.

Pharmacists younger than 55 years of age were more likely to report confidence in providing an evidence-based recommendation.

Pharmacists with formal training were more confident in providing evidence-based recommendations.

Sixty-six percent would like more educational resources on legal status and 75.7% would like more educational resources on the formulations and safety/efficacy.

According to Patel, the results of the study may not be generalizable to other parts of the country as the ethnicity of the sample is not representative of those in the US as a whole. Additionally, the sample size had a greater percentage of females and lower percentage of males compared with the national average. The results also may not be applicable to pharmacists working in other areas or to other health care providers.

ASHP Midyear 2020 Clinical Meeting and Exhibition was held virtually December 6-10, 2020.

Patel S, Doroudgar S, Ip E. Community pharmacists’ lack of knowledge and confidence of non-prescription cannabidiol products. Presented at: ASHP Midyear 2020 Clinical Meeting & Exhibition; December 7, 2020. Accessed January 4, 2020.

Survey results presented during the ASHP 2020 Midyear Clinical Meeting and Exhibition offered insight into community pharmacists’ knowledge and confidence of CBD products.  

Despite positive news around an effective vaccine, Americans should prepare for a difficult winter ahead amid the coronavirus disease 2019 (COVID-19) pandemic, warned Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), during a session at the ASHP Midyear 2020 Clinical Meeting & Exhibition.

While growing up, Fauci was first introduced to health care through his father, who owned a neighborhood pharmacy in Brooklyn, New York. Fauci would often help deliver prescriptions to patients by bicycle.

After launching into a successful career as a physician and scientist, Fauci initially aspired to ultimately return to New York as part of the teaching faculty at Weill Cornell Medicine. “I didn’t plan to be the director of a big infectious disease institute,” he quipped during the session. However, Fauci became interested with the concept of biomedical research and developed a broader interest in global health issues, and in 1981 he switched the direction of his research to focus on studying patients with the disease now known as HIV/AIDS. He was appointed director of NIAID in 1984.

“With that, my scope expanded considerably to include all infectious diseases, and particularly global health issues,” he said.

When asked about similarities between HIV/AIDS and the COVID-19 pandemic, Fauci noted that both diseases are unique in their own way. Although both emerged as brand new diseases during their respective times, the explosive nature of the COVID-19 pandemic is what really sets it apart from anything else.

“In that respect it’s very different from HIV,” Fauci said, recounting how the emergence of COVID-19 immobilized the entire world within a matter of months. One of the main differences with COVID-19 is that the entire population is susceptible.

“Of all the infections that I’ve dealt with in 36 years, I’ve never seen anything comparable to this,” Fauci said, in which 40-45% of individuals who are infected with virus are asymptomatic, approximately 80% of those with symptoms have mild disease, and 15-20% of individuals develop severe disease that can result in death. 

Fauci explained that, with such inconsistent messaging, it makes it difficult to convince the public, especially younger individuals, of the seriousness of the virus.

“The public health message is that we’re all in this together. You can’t operate in a vacuum,” he said. “What you want is to be a dead end for the virus, not a vehicle to spread to someone else.”

Minority communities, in particular, have been disproportionately affected by COVID-19. Fauci advised pharmacists to do their part in ensuring that the right message reaches these communities, while working to improve access to testing, counseling, and overall, more accessible health care services for this population.

“Minority communities, well before COVID-19, have always been in the compromised position of not having as much access to quality health care,” he said.

When asked about the pharmacists’ role in the pandemic, Fauci acknowledged their importance in upcoming vaccination efforts, as pharmacist buy in and cooperation is critical to the successful and equitable distribution of the vaccine. He pointed to the likelihood that, once the vaccine becomes available to the general public, patients will be able to visit their neighborhood pharmacy to receive their vaccination.

“Once you get to the general population, I believe it is going to be very similar to going to a pharmacy to get a flu shot,” he said.

Still, Fauci said that the country should heed warnings of the difficult journey ahead, especially during the winter months. “We have a precarious situation ahead of us,” he said, alluding to circumstances of holiday travel and gatherings that are likely to spread infection. He suspects that cases will continue to surge in the coming weeks. And even with an effective vaccine on the horizon, Fauci cautioned that “you cannot substitute a vaccine for public health measures.” Until a substantial portion of the population is immunized, other preventive measures, such as mask wearing and social distancing, will be crucial to mitigating the spread.

In bracing themselves for the months ahead, Facui noted that pharmacists should remember that their role is critical to addressing this outbreak.

“[Pharmacists] should be proud of the fact that they belong to a group of heroes,” he said.

Fauci A. Wednesday Wisdom with Dr. Anthony Fauci. Presented at: ASHP Midyear 2020 Clinical Meeting & Exhibition; virtual; December 9, 2020.

In a session held during ASHP Midyear 2020 Clinical Meeting & Exhibition, Anthony Fauci, MD, warned pharmacists of challenging months ahead amid the COVID-19 pandemic. 

Fauci Address Pharmacists at ASHP Midyear

The coronavirus disease 2019 (COVID-19) vaccine landscape is rapidly changing. As pharmacists prepare to eventually immunize the public, they should equip themselves with the knowledge necessary to accurately address patients’ questions and concerns.

In a virtual session at the American Society of Health-System Pharmacists 2020 Midyear Clinical Meeting and Exhibition, Litjen Tan, PhD, MS, chief strategy officer at Immunization Action Coalition in Saint Paul, Minnesota, and Mary S. Hayney, PharmD, MPH, FCCP, BCPS, professor of pharmacy at the University of Wisconsin–Madison School of Pharmacy, discussed the clinical considerations for ensuring the safety and efficacy of a COVID-19 vaccine, as well as opportunities to address vaccine hesitancy.

With COVID-19 vaccines moving through the development process at a much faster pace than other vaccines might, patients may be concerned about compromised safety and efficacy. However, there is no reason for worry, Tan explained in his overview of the clinical trial design process for COVID-19 vaccines. Although the process differs from that of traditional vaccine development, Tan reiterated that no steps are eliminated in the evaluation of safety and efficacy.

According to Tan, the process for traditional vaccines from the time of development to actual vaccine manufacturing and dissemination takes anywhere from 10 to 20 years. For COVID-19 vaccines, all the same development steps still apply; however, the phase 2 and phase 3 trials are instead conducted simultaneously to ensure an “exquisite balance of speed, safety, and efficacy,” for a target timeline of up to 12 months, Tan explained. 

“That is the reason why the development process of normally 8 years can be very, very quickly compressed to a rapid development process without sacrificing safety and efficacy,” Tan said.

This involves ensuring the safety and effectiveness in healthy human participants are studied in parallel while maintaining the trial size, quality, approval of regulatory trials, and ability to scale up. Additionally, incoming data can be used to modify the trial as it moves forward.

Tan used the Pfizer/BioNTech vaccine trials as an example of “how the clinical trials have been compressed so [manufacturers] can adapt as the data come,” he said.

Pfizer began with 4 vaccine candidates, Tan explained. In the phase 1 study, for each of those candidates, Pfizer started with a younger age group and multiple doses, conducting an internal safety review for each dose. Each dose that passed the safety review was then moved up to testing in older age groups. Pfizer used these data to select its best vaccine candidates to study in phase 2 and phase 3 trials.

“It was during phase 2 and phase 3 that they eventually whittled it down based on the first 360 participants of the [simultaneously conducted] phase 2/phase 3 trials,” Tan said. After the first 360 participants, Pfizer was able to unblind those to see which of the vaccine candidates was the best option to advance into the final, larger phase 3 trials. 

Although COVID-19 vaccines may receive Emergency Use Authorization (EUA) from the FDA, that designation does not mean they are fully approved, Tan noted. EUAs are not the same as actual approvals. “Generally, they are used only when there are no other adequate approved and available therapies,” he explained. Therefore, after the FDA issues an EUA, manufacturers must continue to seek regulatory approval for the vaccines.

Additionally, Tan assured that “there is actually harmonization for all the manufacturers…to get to the approval licensure or the EUA phase of the vaccine development process.”

The FDA issued a guidance noting minimal conditions that manufacturers must meet in the clinical trials for COVID-19 vaccines. For example, the primary end point for all manufacturers must be prevention of symptomatic COVID-19 by at least 50%.

“What is true for all vaccines, including vaccines that come out of the [EUA], is that all federal agencies that are involved in the process, along with private partners, will monitor safety after the public begins using that vaccine,” Tan added.

Hayney discussed how a COVID-19 vaccine released via EUA would be handled differently by clinicians. She said that health care providers and potential patients must be informed of:

an EUA authorized by the US Department of Health & Human Services secretary,

the extent to which benefits and risks of a vaccine are unknown,

the option to accept or refuse administration,

known and potential benefits and risks of a vaccine,

alternatives to the product and their benefits and risks, and

These notes will appear on a succinct fact sheet that providers must give to each potential recipient. Additionally, vaccinators are not required to collect signatures attesting that the recipient understands the information provided, Hayney added.

Tan discussed some of the foreseeable barriers to individuals accepting administration of a COVID-19 vaccine in the United States. “We do know that we are going to have challenges in getting people to take up the vaccine,” he said, noting that vaccinating adults in particular will be a road block. “We have a lot of data that show that we don’t vaccinate our adults well,” he added. For adults, vaccination tends to be a convenience factor, and individuals who do not have a regular 

health care provider may not receive recommendations.

However, according to Tan, lack of confidence in a vaccine is the biggest barrier to COVID-19 immunization uptake. In a poll conducted by The Associated Press-NORC Center of Public Affairs Research, only half of Americans reported a willingness to get vaccinated with a COVID-19 vaccine.

“There has been a considerable decline in COVID-19 vaccine acceptability in the past 4 months,” Tan said. Factors weighing on acceptance include concerns about adverse effects (AEs), efficacy, risk perception/need for vaccine, and associated costs. However, health care providers play an important role in fostering vaccine acceptance. “The provider recommendation to get vaccinated is one of the top reasons why a patient ends up getting vaccinated,” he added.

Pharmacists can prepare themselves to address patients’ questions and concerns about the COVID-19 vaccines. 

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