COVID-19 has flooded media headlines and health care practices for the past year, but diabetes has not taken a pandemic holiday. Professional groups continue to publish and update practice guidelines and the FDA continues to work on new diabetes drug applications. During a virtual session titled 

New and Approved: Your Annual Diabetes Update

 at the American Pharmacists Association Annual Meeting and Exposition, which was held March 12-15, Jennifer D. Smith, PharmD, BCACP, BC-ADM, CDCES, a clinical pharmacy specialist for the US Department of Veterans Affairs, provided an update on treatment advances in the type 2 diabetes (T2D) space.

The FDA has approved continuous glucose monitoring (CGM) for ambulatory care, but pandemic pressures are spurring the use of CGM in all practice settings, especially inpatient.

“You are going to see more CGM in the hospital setting,” said Smith during her presentation.

The FDA has not approved CGM for inpatient use, Smith noted. But a growing number of institutions are using CGM to reduce patient contact and consumption of personal protective equipment during the pandemic. As health system practices and procedures increasingly promote CGM, pharmacists should remember that CGM is not appropriate for intensive care or other critically ill patients, Smith said. All CGM use should be supervised to ensure that appropriate adjustments to insulin doses can be made in a timely manner.

 The American Diabetes Association (ADA) guideline goal for CGM is to maintain patients within their target glucose range at least 70% of the time, she noted.

 It is also important to individualize glucose targets, according to Smith. The ADA’s global glycated hemoglobin (A1C) target is less than 7%. New 2021 guidelines target from less than 7% to less than 7.5% for healthy adults aged 55 years or older. Patients with complex cases might do better with an A1C target of less than 8%. However, in very complex cases, targeting A1C goals may not be helpful. 

“Instead, let’s keep our patients comfortable and avoid glycemic extremes,” Smith said. “The goal is to avoid all hypoglycemia and any symptomatic hyperglycemia.”

The Kidney Disease: Improving Global Outcomes Diabetes Work Group issued its first-ever practice guidelines for diabetes management in chronic kidney disease (CKD) in late 2020.

Angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blockade treatment should be initiated for patients with diabetes, hypertension, and albuminuria. Titrate medications to the highest tolerated dose.

A1C is the appropriate measure of glycemic control, but A1C accuracy and precision declines with advanced CKD, in dialysis, or when using erythropoietin-stimulating agents. Individualize A1C targets from less 6.5% to less 8.0% based on comorbidities. A glucose management indicator derived from CGM may be useful for glycemic assessment, especially in patients for whom A1C is not accurate because of declining kidney function, dialysis, or other treatment factors.

Metformin plus a sodium-glucose cotransporter 2 inhibitor (SGLT2i) can be used as a first-line treatment for T2D in CKD. Avoid SGLT2i treatment if the patient has an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2 and stop SGLT2i in dialysis. The preferred agents for patients with a low eGFR are a dipeptidyl peptidase 4 inhibitor, insulin, or a thiazolidinedione. The preferred add-on agent for all patients is a long acting glucagon-like peptide-1 (GLP-1) receptor agonist.

The ADA takes a different approach. For patients with CKD and no albuminuria, the ADA recommends a GLP-1 receptor agonist or SGLT2i with proven cardiovascular disease benefit. For patients with CKD and albuminuria, use a SGLT2i with a documented reduction in CKD progression. For patients who cannot use a SGLT2i, a GLP-1 receptor agonist is acceptable.

 The American Association of Endocrinology (AACE) and the American College of Endocrinology (ACE) published a new algorithm for the comprehensive management of dyslipidemia and prevention of cardiovascular disease in late 2020. Lifestyle changes remain the primary management tool, but treatment recommendations have been updated since AACE/ACE last addressed dyslipidemia in 2017.

The low-density lipoprotein cholesterol (LDL-C) goal for high-risk patients with diabetes and no other risk factors is 100 mg/dL. The triglycerides (TG) goal is less than 150 mg/dL. Recommended treatment is a moderate- to high-intensity statin as needed. Major risk factors include advancing age, elevated nonhigh-density lipoprotein cholesterol (HDL-C), elevated LDL-C, reduced HDL-C, diabetes, hypertension, CKD, cigarette use, or family history of atherosclerotic cardiovascular disease (ASCVD).

For very high-risk patients who have diabetes with 1 or more risk factors, the LDL-C goal is less than 70 mg/dL and the TG goal is less than 150 mg/dL. Add ezetimibe, a PCKS9 inhibitor, colesevelam, or bempedoic acid, depending on LDL needs.

For extreme risk patients with established clinical ASCVD and diabetes, the LDL-C goal is less than 55 mg/dL and the TG goal is less than 150 mg/dL. Add a PCKS9 inhibitor, ezetimibe, colesevelam, or bempedoic acid, depending on LDL needs. For patients with diabetes, 2 or more risk factors and TG 135-499 mg/dL, add icosapent ethyl.

 For patients with heart failure with reduced ejection fraction (HFrEF), left ventricle ejection fraction less than 45%, the ADA recommends a SGLT2i with proven heart failure benefits. Prescribers have multiple choices, according to Smith.

 Two agents, dapagliflozin and empagliflozin, have primary heart failure outcome data.

 Three agents––empagliflozin, canagliflozin, and dapagliflozin––have shown reduction in heart failure and reduction of 

CKD progression in cardiovascular outcome trials.

 The 2021 ADA guidelines introduced a new concept: overbasalization, which is characterized as an excessive basal dose of insulin. Too much basal insulin can overcorrect fasting glucose levels, which then rebound to excessive levels, Smith explained. Typical examples of overbasalization are an elevated bedtime-morning glucose differential, greater than 50 mg/dL, an elevated post-preprandial differential, hypoglycemia, and high glucose variability.

Guidelines noted overbasalization is a potential concern anytime the basal dose exceeds 0.5 units/kg/d, Smith said. Any indication of overbasalization should prompt reevaluation of insulin dosing to reduce glucose variability.

 High-dose glucocorticoids can increase the need for insulin. Patients with diabetes who start high-dose prednisone for an asthma flare, for example, need a corresponding increase in insulin. Neutral protamine Hagedorn insulin protocol is the standard approach for once daily or twice daily steroids, Smith said.

 Insulin formulation and dose should match the steroid. A long-acting steroid needs a long-acting insulin and increasing doses of steroids need increasing doses of basal, prandial, and correctional insulin. The ADA recommends an increase of 0.1 IU/kg of insulin for each 10 mg/d of prednisone to a maximum of 0.4 IU/kg for 40 mg or more of prednisone.

Jennifer D. Smith, PharmD, BCACP, BC-ADM, CDCES, a clinical pharmacy specialist for the US Department of Veterans Affairs, highlighted recent safety changes for diabetes treatments that pharmacists should know:

Canagliflozin has lost its black box warning for lower-limb amputation. However, an increased risk of lower-limb amputation remains in the label warning and precautions section.

An FDA safety communication recommends stopping canagliflozin, dapagliflozin, and empagliflozin at least 3 days prior to scheduled therapy. Ertugliflozin should be stopped at least 4 days before surgery. All 4 agents can be restarted after surgery.

New data also suggest stopping sodium-glucose cotransporter 2 inhibitor therapy before scheduled surgery to lessen the risk for ketoacidosis.

At least 4 new agents are in the pipeline, Smith reported.

, a once-weekly “twincretin” combination of a GLP-1 receptor agonist and a glucose-dependent insulinotropic polypeptide, showed solid phase 3 data in T2D. A cardiovascular outcomes trial is ongoing.

 a nonsteroidal selective mineralocorticoid receptor antagonist, reduced the risk of composite cardiovascular outcomes in patients with CKD and T2D in the FIDELIO-DKD trial (NCT02540993). The agent’s application has been submitted to the FDA, she said, and a decision is expected sometime this summer.

, a prefilled rescue pen for severe hypoglycemia, is under review by the FDA.

, a once-weekly basal insulin, showed efficacy and safety profiles similar to once-daily insulin glargine U100 in T2D.

“Even with all these changes, we cannot underscore more the benefits of lifestyle and nutrition management,” Smith said. “Whole-food, plant-based, Mediterranean, and DASH [dietary approaches to stop hypertension] diets remain the bedrock of therapy for diabetes and ASCVD risk reduction. Physical activity is key, and treatment must be tailored to the patient.”

Smith JD. New and approved: your annual diabetes update. Presented at: American Pharmacists Association 2021 Annual Meeting and Exposition; March 12-15, 2021; virtual. Accessed March 12, 2021. 

Articles

APhA

A session held during the American Pharmacists Association 2021 Annual Meeting and Exposition provided an update on diabetes practice changes and new treatments. 

Diabetes Treatment Guidelines, Practices Advance Despite COVID-19 Focus in Health Care

The preliminary results of a recent survey showed that independent community pharmacies may be better positioned to implement COVID-19 point-of-care (POC) than chains, although strategies across the board could be improved.

The findings were presented during a poster presentation at the American Pharmacists Association (APhA) 2021 Annual Meeting and Exposition, which was held virtually March 12-15. Carrie Lynch, PharmD, PGY1 community-based pharmacy resident with the University of South Carolina College of Pharmacy and corresponding author of the poster, reported preliminary results of a survey conducted at a variety of pharmacies within the state of South Carolina.

Improve Your Pharmacy's Workflow With Expanded Technician Roles

“Community pharmacies, and community pharmacists, are positioned perfectly to be sites and providers for point-of-care (POC) testing, as they are accessible and very trusted within the public eye,” Lynch said.

The poster highlighted a systematic review that showed the “lack of widespread availability of POC testing in pharmacies and hesitation to implement can delegitimize efforts in the eyes of other healthcare stakeholders,” according to the authors.

Researchers aimed to gain insight into independent community pharmacists’ attitudes toward POC testing in the pharmacy setting, as well as identify strategies for and perceived barriers to implementing a COVID-19 POC testing service in the pharmacy.

The ongoing study included 80 pharmacists in various settings—national chain, regional chain, supermarket, multi-store independent, and single-store independent—practicing in South Carolina who completed a 44-item survey over a 10-week timeline. The survey is a component of a larger study that is taking place at the University of South Carolina.

Of the survey respondents, 22 (21.2%) were single-store independent pharmacists and 17 (16.3%) owned multiple stores. The majority of respondents -- 37 or 35.6% -- have been practicing for more than 20 years; another 25 (24%) have been practicing between 10 and 19 years. Of the national chains, 2 possessed a Clinical Laboratory Improvement Amendments (CLIA) waiver, whereas 5 single-store independents and another 5 multi-store independents possessed CLIA waivers, according to the survey.

Investigators additionally determined pharmacists’ willingness to implement a COVID-19 POC testing program by analyzing perceptions on patient-related factors, testing follow-up, and operations-related factors. The study combined this information with whether the pharmacy could be considered to have “enhanced pharmacy status.” This was accomplished by confirming the presence of the Community Pharmacy Enhanced Services Network’s required services, which include:

The study investigators used the Pearson correlation against these 2 variables to deduce a statistically significant correlation between the patient-related factors and testing follow-up categories of analysis.

Based on the survey data, the researchers outlined necessary considerations, duty allocations, and courses of action for the successful implementation of COVID-19 POC testing. Some of the most pertinent considerations pharmacists had were related to staff and patient safety and potential disruption to their existing workflows. As for duty allocations, pharmacists pointed to technicians, who would be responsible for marketing the service, screening and obtaining consent, and billing. Survey respondents also added that POC testing would require more responsibilities following the POC itself, such as contacting the patient and their primary care provider.

“Independent pharmacies do seem more equipped to conduct POC testing when compared to chain pharmacies based on CLIA waiver status alone,” Lynch said. “However, there is need to improve status across all practice settings.”

Furthermore, Lynch asserted the need for more effective strategies to implement COVID-19 POC testing in a way that does not impede normal workflow and encroach on pharmacists’ day-to-day responsibilities. “This was the biggest concern for pharmacists within this study,” Lynch concluded.

brought to you by Drug Topics®, for resources related to the practice of independent pharmacy.

Lynch CL, Fabel PH, Hasting TJ, et al. Pharmacist perceptions and willingness to initiate COVID-19 point-of-care testing in an independent, community pharmacy setting. Presented at: APhA2021 Annual Meeting & Exposition; virtual. March 12-15, 2021. Accessed March 18, 2021.

Survey results suggest independent pharmacies may be better positioned than chains to offer COVID-19 POC testing to their patients. 

Community Pharmacies Well Equipped for COVID-19 POC Testing, But Barriers Remain

A session presented at the American Pharmacists Association (APhA) 2021 Annual Meeting and Exposition on March 12 offered pharmacist-centered guidance on the current cannabidiol (CBD) landscape, and methods of counseling on CBD products.

In the session, which was titled “The ABCs of CBD Products and Practices,” presenter Danielle Fixon, PharmD, BCGP, BCPS, assistant professor, geriatric clinical pharmacist from the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, focused on how pharmacies can effectively develop a plan for helping patients who show signs of being good candidates for CBD and ensure the safe use of the product.

“Our patients are interested in CBD,” Fixon emphasized. According to a 2020 analysis of Google search trends, interest in CBD spiked closely after the Farm Bill was passed. As CBD increasingly piques the interest of the American public, pharmacists must be well-acquainted with the evidence supporting CBD use and the ways they can develop a plan of action for their patients interested in CBD therapy.

Fixon highlighted that much of the research surrounding CBD, as well as THC, are inconsistent in products and dosage, and as a result, the findings have been largely inconclusive.

“That’s one of the biggest downfalls, I would say, with a lot of the evidence that we have for CBD-base products, or even THC, is that it’s a lot of patients that are using non-specific doses,” Fixon explained. So, we really need more research on…what dose is appropriate, how many times a day should patients take it, and really look at the efficacy of one product.”

The limited studies mentioned by Fixon focused on conditions such as Crohn disease, chronic pain, insomnia, and ocular hypertension and glaucoma. Taking into consideration these pitfalls, Fixon does not recommend CBD for these disease states. 

Some studies have investigated the benefits that CBD may have on anxiety. Fixon noted that, to date, research has focused on alleviating anxiety through a 1-time dose. “Then [they] told patients to do public speaking for 2 to 4 minutes. They did find improvement in the patient’s anxiety, so, potentially, higher doses of CBD may be effective for anxiety-related to public speaking or social settings,” Fixon said. However, more research is still needed to gauge the potential benefits of long-term CBD use for anxiety.

Thus far, the CBD indication with the most supporting evidence is for pain. Overall, “CBD may decrease inflammation and pain. And in clinical practice, I would say I find that patients really have good benefit with using CBD for some of their pain syndromes,” Fixon said.

Assessing and Counseling Patients For CBD

Pharmacists should always start by recommending first-line therapies before CBD products, as current guidelines aren’t advocating the use of CBD or THC for first-line therapy. “They’re recommended for more of a rescue use,” Fixon explained.

Pharmacists should also review the patient’s current medications to weed out potential drug interactions, as well as discuss what route of administration––systemic or local––is best for that particular patient. Reviewing the patient’s medical history for disease-related concerns is also important, according to Fixon.

“If you decide that you are using a CBD product, our motto is start low, go slow. So, initiate at a low dose,” Fixon recommended. Another helpful tactic is to have the patient keep a cannabis log to examine what may be working, or, conversely, hindering progress. Fixon also recommended obtaining CBD products from a medical dispensary or state where CBD is legal.

Fixon additionally pointed to the following considerations when offering CBD products in your pharmacy:

Check the label of the product to ensure it lists the CBD dose.

As CBD products aren’t regulated, have patients ask for a Certificate of Analysis.

High-calorie and high-fat meals can increase the concentration fivefold.

Most common adverse effects include dry mouth, diarrhea, drowsiness, and fatigue.

Fixon concluded by stressing the importance of safety when recommending CBD products. “Medication assessment, including drug interactions, disease interactions, [are] really important before considering a cannabis product. Any of the products that are out there are not regulated by the FDA, so making sure patients are aware of that and report anything—any side effects or ill effects that occurs—is always good for us to know,” she said.

Fixon D. The ABCs of CBD products and practices. Presented at: American Pharmacists Association 2021 Annual Meeting & Exposition; virtual; March 12-15,2021. Accessed March 12, 2021.

In a presentation from APhA2021, clinical pharmacist Danielle Fixon, PharmD, BCGP, BCPS, offers counseling tips for CBD products. 

Develop a Plan for CBD Therapy 

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.

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.

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. 

Latest Conference Articles

Diabetes Treatment Guidelines, Practices Advance Despite COVID-19 Focus in Health Care

Community Pharmacies Well Equipped for COVID-19 POC Testing, But Barriers Remain

Develop a Plan for CBD Therapy

OTC CBD Products Currently Available in Pharmacies

ASHP Officials Provide Year-End Review of New Policy Issues

ThoughtSpot Series: Closing the Healthcare Gap

Survey Identifies Need for CBD Education Among Community Pharmacists

Fauci Address Pharmacists at ASHP Midyear

Understanding the COVID-19 Vaccine

Study: Mail Order Scripts Exposed to Unsafe Temperatures