 at the Sixth International Cancer immunotherapy Conference (CICON) 2022, Yvonne Chen, PhD and Associate Professor at the University of California, Los Angeles, also breaks down the latest research from her laboratory, where she is engineering CAR proteins that can “wake up” the immune system.

Have these next-generation CAR T-cells proven beneficial to targeting specific treatments?

 I think in recent months, we finally started seeing positive signal in solid tumors. So a very encouraging study had been published by a group at Stanford with Michelle Monje and Crystal Mackell, where they treated pediatric patients with the IPG diffuse midline glioma. They really have seen remarkable clinical response from the patients.

There's also emerging data on CAR T-cells targeting cloud in 6, cloud in 18.2. I think again, the responses are not quite as dramatic as we have seen in B-cell malignancies. But given that we're finally starting to see positive signals, I think there's a lot of room for both optimism and improvement.

I think some of the strategies that we have mentioned so far, as trying to improve T-cell effectiveness or effector function stemness, as well as ability to overcome immunosuppression, can likely be applied in combination so that we can engineer products that that can really be sufficiently potent to make a difference for our patients.

I think as we develop these different strategies, we tend to focus on one thing at a time, right? We develop CAR T-cells, and another group may decide to knock out, or knock in, this specific gene. But provided that one can implement these during the manufacturing process, there’s no reason why you couldn't combine these different strategies.

Of course, I think from a safety perspective, during clinical translation, we may have to do it one step at a time. But one can easily imagine the situation where you can combine a strategy that overcomes immunosuppression together with another strategy that promotes stemness and then generate a product, one that is both more capable of remaining functional in the tumor microenvironment as well as sustaining a prolonged, durable response.

I think it is important to keep in mind that a lot of these pathways are not fully orthogonal, as in they could have crosstalk and they could influence how each other functions. And so a combination is not always a straightforward thing like you know, like 1 plus 1 is 2. Sometimes they actually influence each other, sometimes synergistically sometimes in opposition. So I think the combination strategy requires a detailed investigation— but I imagine that will eventually be the path forward.

 Following the pandemic, what are you currently working on at your lab (Chen Laboratory)?

 My lab is, so far, primarily focused on CAR T-cell engineering, where my life is mostly biomolecular engineers. We really think about what's currently limiting the safety and/or efficacy of the CAR T-cell therapy, and what can we do to overcome these challenges.

A lot of our earlier efforts is focused on rational protein design on the CAR protein itself. We've engineered bispecific CARs that can hopefully reduce the probability of antigen escape because it can recognize two different antigens on the tumor. We focus on engineering CARs that can respond to soluble antigens like transforming growth factor beta (TGF beta). And now we're moving on to trying to find ways to engineer T-cells so that they don't have to do all the work themselves.

We talked about the problem of heterogeneity— tumor cells oftentimes don't uniformly express an antigen. And even though we can build bispecific CAR T-cells, one can even build trispecifics, or quads…I think these hardwired antigen specificities ultimately have a limit. And when you have highly heterogeneous tumors, I think the way to go is to engineer T-cells that can not only attack tumors themselves, but also engage endogenous immunity. And the idea is the T-cells go in, they do the frontline attack, but then at the same time send signals that pull in reinforcements from the endogenous immune system.

Now, the endogenous immune system naturally has a wide antigen repertoire. And the idea is if your T- cells can trigger the immune system to react against the tumor, we will have a better chance of attacking these highly heterogeneous tumors that are not all recognizable to our engineer T-cells. A lot of our ongoing effort is focused on figuring out how to engineer our T-cells to productively interact with endogenous immune.

CAR T-cells themselves still have limited antigen specificity. As I mentioned, we can build bispecifics, maybe even trispecifics and quads. But that's still 2 to 4 antigen recognition capabilities.

What we want to do is engineer these T-cells, even though they themselves have limited antigen specificity. Once they go into the patient, we want them to be able to induce immune response from the naturally occurring immune cells that we did not engineer.

The idea is you want to pull in this naturally occurring immune response with a much wider range of antigen specificities in order to make them reactive against the tumor. So, in a sense it’s waking the immune system up against a target that they don't normally recognize for a number of different reasons.

Videos

Yvonne Chen, PhD, discusses some of the strategies that researchers are using to improve T-cell effectiveness and overcome immunosuppression in CAR T-cell therapy. 

Researchers Are Developing Bispecific CAR Proteins to “Wake Up” the Immune Systems of Cancer Patients

 As we shift gears, we’re going to think about another product, called SER-109. This product differs from RBX2660 because it’s a capsule formulation, but it’s a narrow consortium. As opposed to RBX2660, which has spore- and non-spore-forming bacteria and a broader group of microorganisms, SER-109 is made up of firmicutes spores. It’s dosed as 4 capsules daily for 3 days, following the standard-of-care antimicrobial. Within this clinical trial, patients who had at least 2 recurrences of 

, and received fidaxomicin or vancomycin, had a brief washout period. They received a magnesium citrate bowel lavage, then were randomized to receive SER-109 or placebo.

They were followed for 8 weeks for occurrence, 24 weeks, or 6 months for safety. Overall efficacy within this treatment cohort was 88% for SER-109, vs 60% in the placebo arm, a statistically significant difference, and form fit function once again. Specifically, there were decreases in the proinflammatory 

 and increases in the firmicutes, specifically 

. Once again, we see that supplementation of the deficiencies helping the microbiota give that spore phase a specific knockout punch. RBX2660 and SER-109 have both finished phase 3 trials, but there are 2 products in phase 2 trials: CP101 and VE303. Bincy, can you walk us through those products and their data?

Sure. CP101 was a randomized, double blinded placebo-controlled trial. There’s going to be a phase 3 trial looking at CP101, which is a fecal matter transplant as a single oral dose, to look at prevention of recurrent 

 infection. The study is called PRISM4, so look out for that when you’re looking at abstracts in the future. They’re similar to all the other studies. This will be given after completing the standard-of-care antibiotics, after their most recent 

 recurrence. They’ll be randomized to get this vs placebo. The plan for the study is to evaluate 

 recurrence and safety up to week 8 as their primary end point. But we also want to look further out, to about week 24. That’s the goal of the study.

CP101 is an interesting product because it’s a broad consortium in a capsule form. It’s given as 10 capsules on a single day following the standard of care, vs VE303, which is a little different. VE303 is what we call a defined consortium, and it has 8 specific bacterial species. It also reported encouraging data at the major national conference in San Diego in May. That will also probably proceed to a phase 3 trial.

Drs Abraham and Feuerstadt share recent data with emerging live biotherapeutic products, SER-109, CP101, and VE303, for treatment of recurrent C difficile infection (rCDI).

SER-109, CP101, VE303 for Treatment of Recurrent C. difficile Infection (rCDI)

With that fundamental concept in mind, let’s talk about RBX2660 and what it is. RBX2660 is what we call a broad consortium, meaning it includes broad range of microorganisms, including both spore- and non-spore-forming bacteria. It’s rectally instilled as a onetime dose. It’s phase 3 data have been presented in abstract form at a major national conference. But to understand the phase 3 data, we have to understand the phase 2 data. The phase 2 study structure included patients with at least 2 recurrences of 

. They were all given a standard-of-care antimicrobial and then randomized to either 2 doses of placebo a week apart—a dose of RBX2660, followed a week later by placebo—or 2 doses of RBX2660. They were then followed for 8 weeks for recurrence and for 2 years for safety. As a result of that clinical trial, a single dose of RBX2660 was proceeded ahead to the phase 3 trial because of its efficacy. Within the phase 3 trial, patients with a single recurrence of 

 all received standard-of-care antimicrobial. Then they were randomized to receive a placebo, or a single rectal installation of RBX2660, followed for 8 weeks for recurrence and 24 weeks for safety.

Essentially, the phase 3 and phase 2 trials had very similar designs, the same product, and the same diagnostics. As a result, it was decided that something called a Bayesian analysis would be used for this. A Bayesian analysis leverages data across 2 studies to create a larger data set. Essentially, they look at the signal of efficacy of the placebo arm and of the intervention arm to see if they’re similar in both trials. If they are, then you can leverage the data. That was the case with RBX2660: the overall efficacy was 70.4% for 2660 vs 58.1% in the placebo arm. The posterior probability of superiority was 0.986, achieving statistical significance. These are very exciting data for this product.

Several abstracts have been presented about this product. Bincy, at a major national conference in May 2022 in San Diego, California, 2 specific abstracts were presented. One was a subgroup analysis, and the other was an assessment of the Kaplan-Meier curve time to recurrence. Can you walk us through some of those data?

Sure, Paul. The first abstract looking into the subgroup analysis of this was yours, which you presented, so I’m honored to present your data. This subgroup analysis looked at a pool rate of treatment success. This was defined as recurrence free of 

 infection for 8 weeks post-treatment. You found that in the RBX treatment arm, this recurrence-free rate was 68.3%, compared with 55% with the placebo group. All these patients did get initial antibiotic treatment, but with the addition of the RBX, it was 68% recurrence-free. This was statistically significant, with a 

Another abstract looked at time to recurrence of infection using a Kaplan-Meier curve estimate. We looked at the 20% percentile of this. When they compared RBX with placebo, the time to recurrence was 14 days for placebo vs 30 days for the RBX group. This separation between the placebo and RBX was sustained through 6 months of assessment…. This was very similar to the phase 2 trial that they found.

In effect, what we’re seeing across those 2 abstracts is that 2660 seems to have efficacy across multiple subgroups, regardless of risk factor for 

. Even patients who received RBX2660 are still with that supplementation with some delayed recurrence, meaning there was some benefit there. There were a couple of other abstracts presented at the same conference. One looked at the metabolomics: what was happening metabolically as a result of RBX2660. The other looked at sick patients, those with multiple medical comorbidities. Teena, can you walk us through those abstracts?

Sure. At DDW [Digestive Disease Week], Ken Blount presented studies that looked at more than 600 clinical trial participants for reducing recurrent 

. The study reported both microbiome and metabolic analysis of participants in these three trials of RBX2660. The end point in these studies was no 

 at 8 weeks, and they looked at something called MHI, the Microbiome Health Index, which is a microbiome marker of postantibiotic dysbiosis and restoration. In all 3 trials, the MHI was restored from dysbiotic to healthy levels, which was amazing. That’s what the end point of the study was, and that’s what the real end point for our patients is. Clinical response to RBX2660 was associated with restoration of not only the microbiome but also the secondary bile acids. We talked about how the secondary bile acids are good for us because they inhibit the growth of 

. Both microbiome and bile acid restoration were in these big trials with more than 600 participants.

What about comorbidities? There was an interesting abstract that looked at comorbidities and the Charlson Comorbidity Index.

That was done by Dr Glenn Tillotson, and it also showed treatment success of RBX2660 in a randomized 2:1 trial. RBX2660 and placebo were used, and they showed a reduction of recurrent 

 in patients but underlying comorbidities. These were anti-CD3 trials, so it was considered a success if there was no recurrence at 8 weeks. They looked at the mITT [intent to treat] population, and there were about 262 participants. Across all comorbidity scores, including the Charlton Comorbidity Index, the patients who got RBX2660 showed consistent and greater treatment success compared with placebo, so it was both safe as well as efficacious.

With RBX2660, we’re seeing that the form fits function, and that the metabolomic effect that you’d want to see with microbiota replacement therapy with a live biotherapeutic product seems to work, regardless of your medical comorbidities. In fact, the group that had moderate vs severe comorbidities had very similar efficacy. That speaks to the fact that supplementing this deficiency can go a long way in reducing future recurrence.

Drs Feuerstadt, Abraham, and Chopra discuss clinical trial data for RBX2660, a live biotherapeutic product, in treatment of recurrent C difficile infection (rCDI), as well as data with RBX2660 that were presented at DDW 2022.

RBX2660 for Treatment of Recurrent C. difficile Infection (rCDI)

® at the National Community Pharmacists Association (NCPA) Annual Convention, Lisa Schwartz, PharmD, RPh, senior director of Professional Affairs at NCPA, discusses the Drug Supply Chain Security Act and why it was updated for the distribution of naloxone.

What is the Drug Supply Chain Security Act?

The drug supply chain insecurity act, and I'll probably say DSCSA, but I’ll try touse the full thing and not the acronym all the time, was passed back in 2013 to address some supply chain security issues, but also to make sure that there was a federal standard way to do this and that states weren't doing things individually. You can imagine the state-by-state supply chain security process would be kind of a nightmare, probably even for pharmacies as well as wholesale distributors. It's really intended to introduce an additional level of security into how drugs move through the supply chain, so between manufacturer to a distributor possibly to a secondary distributor, and then ultimately, they use the phrase dispenser, but of course dispenser most of them are pharmacies.

At the end of September, the DSCSA was updated for the distribution of Naloxone. What is this change and why is it important?

 The FDA issued some guidance really to clarify and make it really plain for the industry that the opioid emergency, the opioid public health emergency, has really created a situation where we need to make it as easy as possible for people to get naloxone. They've clarified that because this is a public health emergency, that the emergency exemption or exclusion to the DSCSA is in effect, and that some of the requirements for exchanging transaction data doesn't apply when a supplier is providing naloxone to either a harm reduction program or harm reduction supplier, which of course, the suppliers supply harm reduction programs.

What other changes does this act make to pharmacies, and when do they go into effect?

 The Act has required pharmacies to put some standard processes in place in their workflow to really address and make sure that when they're ordering from a new supplier that that new supplier is properly licensed, that it's a trading partner that they should be doing business with, that they're inspecting their order when they get the order to make sure it's actually what they ordered, and it's not something that was ever left the supply chain or was brought back in. Just to make sure that ultimately, the drugs that they're receiving and putting on their shelves are safe for patients.

The other aspect of this, there were some changes on the labeling. We've all seen 2D barcodes, or data matrixes. I think that phrase can be used interchangeably, but those 2D barcodes appear on labels, and that barcode contains more information than just the linear barcode. The linear barcode just had an NDC number in it, this data matrix has the serial number for that individual package. A lot more precision in the supply chain now, and we can trace figure out if that package was ever reported lost or stolen or, like in the case that it's a forged label, if it shouldn't exist at all.

How has the DSCSA improved patient safety?

 I think by making sure that the drugs that end up in a pharmacy are coming safely securely through the supply chain and are safe to give to patients.

 I do want to make sure pharmacies understand, that right now today, they have several obligations, several requirements to comply with the Drug Supply Chain Security Act. Those include making sure that you're only doing business with authorized trading partners. That's sort of the industry jargon for your wholesaler, I guess. So make sure that you buy from authorized trading partners, make sure that when your get your order that all of the pieces of the order have that 2D barcode on it, a compliant product identifier, making sure that the tracing data or the transaction data that you get from your wholesaler that you keep that or you have access to it for at least 6 years in case there's an investigation that needs to happen.

We anticipate at some point a regulator, such as FDA or your board of pharmacy, might ask you to demonstrate your compliance by being able to access your transaction data. If today you don't know how to do that, you really should get in touch with your wholesaler and make sure that you know how to find that transaction data.

Finally, you do need to make sure that you have a written procedure that is you know, tells you tells your employees what to do if you end up with a package, a bottle, a box, whatever it is that comes in a tote from somebody or in a box that you if it looks suspicious that you treat that as suspect product, do an investigation, quarantine it while you're doing your investigation just to really make sure that that product is safe to dispense to the patient. So of course if there are any questions about what those procedures should look like NCPA is very happy to help our members with that.

Lisa Schwartz, PharmD, RPh, senior director of Professional Affairs at NCPA, discusses the Drug Supply Chain Security Act and why it was updated for the distribution of naloxone.

Expert Discusses Changes to Drug Supply Chain Security Act

® at the National Community Pharmacists Association (NCPA) Annual Convention, Kurt Proctor, PhD, RPh, senior vice president of strategic initiatives at NCPA, discussed the importance of continue education for pharmacists.

NCPA has an objective of making immunizations a core competency of community pharmacy practice, and the NCPA Innovation Center has undertaken lots of different projects to help make that happen. We have lots of resources available to our members, we talk about it a lot, but we wanted to do something unique and present kind of a reality show approach to helping pharmacists get over whatever hurdles they're facing and expanding their vaccination program.

It may be a program that hasn't even started yet, or it may be one that's more fully developed, but yet they have some needs that they can use some help with. What we've done is we've sent in experienced peers who have very good robust vaccination programs into stores with pharmacies that have indicated to us that they wanted some help, and we're filming that. It's like, again, like a reality TV show type thing, and this is the first episode we were really, really happy with. So far, we've got some promo, early promos that are on 

 at this point., and we are hoping folks will see that.

We're planning a launch party for it later this month, but it all we believe many pharmacists will see themselves in the pharmacies that we've gone into film and help a lot of pharmacies experiencing the same kinds of problems, same kind of challenges, hurdles that they want to get over, and so hopefully they'll find nuggets of help. Just like the pharmacies that we visited got great help from their experience periods who visited them.

 What is the importance of continuing education for pharmacists, especially as their responsibilities grow?

Continuing education is clearly something that's been around with the profession forever. It's all health professions, it's an important part of what they do. It's important for pharmacists to kind of understand what they need in their practice, what do they need to learn, what might be newer information, things that they haven't been exposed to before. In our world at NCPA, we focus a lot on the services that pharmacies can be providing to patients, and that's an important part of it too, and their business. They need to be able to keep their business growing and profitable, so that they can be around to serve their community. So that's an important part of their continuing education as well that we focus on, but pharmacists get lots of CE and lots of whether it be on drugs and disease states. As new things come into the marketplace, it's important for pharmacists to understand the diseases that are being identified, and now where new treatments are coming out. It's just important for all health professionals to stay up to date on you know, on their practice, so they're serving their patients.

How can community pharmacists encourage their patients to get vaccinated?

It's important that pharmacists talk to patients about flu vaccine, about all vaccines, and kind of what their situation is what they may not have gotten yet that it's time in the series to get again, and, of course, flu being an annual vaccine. I think what a lot of pharmacists will be surprised at is how receptive patients are to their recommendation. I think, again, beyond just flu, they may not realize how many of their patients aren't up to date on their vaccines, and that when they do ask them about whatever it may be, they'll find that there's a real patient interest in getting those vaccines.

In fact, we discovered some of that even in the Show Me videos that we've filmed that a little surprise from the pharmacists in terms of the receptivity of the patients, so that was recommendations.

What are the biggest challenges community pharmacies are currently facing?

 That’s a big question, isn't it? Clearly, the economics around dispensing and product is first and foremost at the tip of everybody's mind, but they're coming off of a lot of success in serving their community with the COVID vaccines and COVID treatments and COVID testing and all that activity, which of course is now waning a little bit down. So, they are learning how to make that part of their core business, and it's not just about the pandemic and the public health emergency, but you're recognizing that they can be providing these services, can be charging for the services, can be billing for the services, and so there's a nice learning curve for them around that and how to maintain the service-based revenue that their business has enjoyed over these last couple of years as, again, they've served their community for COVID.

So we're focused on helping them understand those opportunities, understand the billing processes around those opportunities, but nothing at this point trumps the economics of dispensing and DIR concerns, etc. That gets a lot of attention, and it deserves it.

Kurt Proctor, PhD, RPh, senior vice president of strategic initiatives at NCPA, discussed the importance of continue education for pharmacists.

Continuing Education is Important for Pharmacists to Provide Best Care to Patients

 at the National Community Pharmacists Association Annual Convention, Carlie Traylor, director of Strategic Initiatives and Student Affairs at NCPA, discussed the growing roles of pharmacists and pharmacy technicians and how COVID-19 has changed the landscape of services offered in community pharmacies.

What are some key takeaways from the NCPA Innovation Center/CPESN Community Pharmacy Fellowship?

 Some key takeaways for the Innovation Center and the Community Pharmacy Fellowship is that our job is your success. We're trying to meet members where they're at and provide them with the resources and support they need to thrive. I like to use that phrase grow where you're planted. The fellowship program really does that where it creates a yearlong program that has the structure, the support, the accountability, in addition to all the expertise that you would need to be a success.

How is point of care testing growing, and how can pharmacies best utilize it?

 Point-of-care testing has been around for decades in community pharmacy, but it became absolutely vital during the COVID pandemic. For example, in our very first class, we had a pharmacy that you have to choose a capstone project. Their capstone project was already chosen. They called me in a panic in November asking if they could switch to point-of-care testing. Absolutely. The capstone project is meant to help the pharmacy. That pharmacist now funds her entire position through the revenue generated from that project. So that testify as to not only the value, but the reimbursement potential for that service.

How can pharmacies improve workflow to help take the burden off of pharmacists?

So I will quote, The Great Travis Wolf, so owner in Oklahoma, he likes to say when's the last time you went to the doctor's office and they were the ones that took your weight? Right. When you go to a pharmacy, you need to be that efficient. Pharmacists are the most community pharmacists are the most accessible health care providers, and we should remain that, but we should also have structure. Absolutely utilizing all of your different team members. I'm going to throw out something that I learned through the fellowship and our faculty members is actually collaborating with industrial engineers, specifically industrial engineering students because they're all required to have a capstone project, and pharmacy is absolutely perfect for that for analyzing workflow and you'll be shocked at the impact moving a bookcase 2 feet to the right can do.

 What are the pharmacy technicians' roles in pharmacy services as pharmacies continue to expand?

 Pharmacy technicians are absolutely vital as we expand these community services. The reason being as pharmacists become more educated and have more expanded roles, they need their technicians to do the same. I have story after story of how technicians have been interventionist. I just spoke with 1 recently, where I gave her a project that I had learned about that reimburse the pharmacy $200 per patient that was identified for diabetes prevention program. Within 2 hours, she had identified 3 patients. I never had to work with a pharmacist to make that happen in that pharmacy earn $700 by the efforts of that technician connecting patients to services that they needed.

How has COVID-19 changed the landscape for services offered within a community pharmacy, and do you think that these changes in services are here to stay post-pandemic?

The COVID pandemic was trial by fire, and what I saw is that the best practices floated to the top. We've had adherence packaging, we've had delivery services, we've been advocating for pharmacies to do that. If you weren't doing them before the pandemic, you are absolutely doing them now, and while I don't think it necessarily expanded the number of services, I think those services existed, it increased the impact and the number of pharmacies participating. I am so grateful to be a part of a profession that was so on the frontline in supporting during the pandemic. I'm so proud of our members.

Carlie Traylor, PharmD, director of Strategic Initiatives and Student Affairs at NCPA discussed the growing roles of pharmacists and pharmacy technicians and how COVID-19 has changed the landscape of services offered in community pharmacies.

Expert: Best Community Pharmacy Practices "Floated to the Top" During COVID-19 Pandemic

Kyle McCormick, PharmD, owner of Blueberry Pharmacy, discusses the differences between a traditional pharmacy model and a cost-plus pharmacy model.

To start, what are some of the differences between a traditional pharmacy model and a cost-plus pharmacy?

At its core, the biggest difference is how we price medications, and we don't take insurance. Mainly because, we'll probably get into this a little bit, but these medications that we dispense, generic medications, are very inexpensive. When we think about what we buy insurance for, we buy insurance for high costs, unknown events, generic cholesterol medication that cost less than $3 a month is not high-cost or unpredictable. Since they're not insurable products, we don't take insurance. We like to do things cost plus because we believe the service that we provide is the same regardless of whether or not we're filling metformin, or lisinopril, or tecfidera, or imatinib. It doesn't matter the medication; we're using our same cognitive skills and services to provide to that patient. We should make the same amount on each prescription that we fill.

What patient populations benefit the most from a cost-plus model? How can pharmacists identify these populations?

In the long run, in theory, everybody benefits from the cost-plus model. Most of health care dollars is spent on administrative burden and middlemen. The whole cost-plus model removes the middlemen from that transaction. Everybody benefits in the end, payers, employers, taxpayers, until we get to that world where everything's cost plus, and everybody's benefiting.

We serve everybody. Our patient demographic is everybody except for patients with Medicaid. Honestly, we want to help patients with Medicaid because a lot of them need our help the most. The challenge is that copays are just so low that it's hard to convince somebody to do cost plus if they have a $0, $1 $3 copay because we're cost-plus 10, and so that means that nothing's cost less than $10. $0, $1, $2, $3 versus $10. It's an easy decision to make.

How can a cost-plus drug model help to address social determinants of health?

One of the social determinants of health is, and I’ll probably butcher it, but I know it has something to do with costs and access and affordability. In the current model, that's not at all true, there's little accessibility, there's high-cost burdens for patients. Patients are faced with the decision of paying for their medication or paying for their food.

In our model, we charge fair and transparent prices to everybody. We have patients who go from paying $300 a month for their insurance to getting the same exact drug for just $30. That's insurance, so they're paying a premium. That's their copay. In our model, they don't have any of that, and so that's $270 of savings every single month for those patients that can be redirected to better food choices, better health, other decisions around health, paying off debt, going to school, different things like that.

The model itself by lowering costs and increasing accessibility for medications, impacts many social determinants of health.

How has the staffing crisis affected cost-plus pharmacies? Has the impact been different from traditional pharmacy models?

Because we don't have the burden of interacting with insurance companies, one the staffing requirements a lot lower, so we don't spend 30% of our time troubleshooting insurance issues, we don't spend, how many hours a month, doing audits, we don't spend how many hours a month, shopping around to maximize our savings.

The cost of running a business is a lot lower, which means even fewer employees. That being said, because we don't have all those efficiencies, and we're just dealing directly with patients providing direct patient care. People love the model. I have pharmacists and technicians reaching out to me all the time that want to be hired. I just don't have the revenue to hire them quite yet, but there's no shortage of people that want to work for cost plus.

Much of our health care pharmacies specific problems can be solved by a cost-plus model, right now, we're being reimbursed pennies on the dollar for prescription drugs. We're solely volume driven, we're only making 20 cents on lisinopril, in order to pay a pharmacist just by filling lisinopril you'd have to fill, 100,000 no more than that, you’d have to fill a million prescriptions of lisinopril just to basically pay the pharmacist salary, right?

That's not healthy. There's no time. Pharmacists literally cannot fill out a million prescriptions. And so, in that model, there's no time for patient care. There's no time because there's no payment mechanism. In our cost-plus model, we set a floor for pricing, we say we're not going to accept below $10 per prescription because that's the value of our time. That's the value of our counseling a patient. That's the value of checking for drug interactions, making sure it's safe and effective for the patient. We're not going below that. That's our value. Once we recognize our value and charge for that, then patients see us as health care providers, they see us as providers of care. We're best able to work at the top of our license at that time.

Differences Between Traditional Pharmacy, Cost-Plus Pharmacy

Tripp Logan, PharmD, vice president at SEMO Rx Pharmacies and Logan & Seiler Inc discusses how pharmacy staff and community health care workers can work together to address social determinants of health.

 What are some ways that you and your pharmacy network have targeted social determinants of health?

Social determinants of health are those situations that people deal with every day of their life that may impact their health, and so in our area, it's really no different than anybody else's area, what we do is we just look at local need. With our patients, locally, we just target the things that are of importance to them, and our approach has been to cross-train our pharmacy technicians as community health workers, so that always fall on the pharmacist, so that we can make sure that our staff is well equipped to fill the needs of the people in the community that we serve every day.

Can you discuss how social determinants of health have a significant impact on the health outcomes of underserved patient populations?

Social determinants of health have a big impact negatively on patients’ lives. It makes sense if you think about it because if you're if you've got a patient with diabetes, and hypertension, and heart failure, they may see their specialist a couple of hours a year, they may see their primary care a few hours a year, they may see my delivery driver a few hours a year, and that equals 10 total hours of the year that they've got access to health care professionals are their representatives.

That’s great. But every other hour of the year is life, and sometimes life gets in the way of health care. If you can't afford insulin, or your insulin gets warm, because you don't have a refrigerator that works properly or freezes your insulin, it's hard to do diabetes education, or expect somebody to have a reduction in their hemoglobin A1C.

So the first thing to solve a problem like that is to give them access to an appropriate refrigerator or insulin they can afford. All social determinants of health, not clinical. Each patient's journeys a little bit different and targeting social determinants of health means we just try to help them navigate not only their health, but make sure that life's not getting in the way of better health.

For pharmacists who want to address social determinants of health in their communities, what kind of organizations should they partner with to help?

In my experience, local public health, like if you feel like your community pharmacists like me, and you're on an island, some days you just feel like I'm out here by myself, then what you need to do is go down your local public health department and see like they're even on more of an island than you are.

So that's, that's what my number 1 recommendation is: if you don't know who the director is of the local Department of Health or who works down there, set an appointment, go talk about their needs and your needs, and it could be a cross referral destination. That's the first step. I think it's easy, and usually it's a welcome conversation because not every day, does local public health get somebody like a pharmacist coming in and saying, “Hey, how can I help you make your metrics better in the in the county and make the overall population health improve?” And that's something that pharmacy can often do with local public health departments.

How should pharmacists team up with community health care workers to address the gaps in patients’ social needs?

Community health workers are kind of like a hot topic, whether that's through the CDC or whether through state governments. What we found is that community health workers are local peer-to-peer liaisons that help people navigate the health care system locally. Peer-to-Peer, people that look like talk like come from the same neighborhood, so that white coat syndrome of dealing with a clinician or dealing with somebody from a call center that barriers let down.

So community health workers, in my experience, we have 9 on-staff technicians that are cross trained as community health workers, and their specialty is pharmacy and health care. The value they bring is when they're helping patients overcome barriers, they've got a pharmacist that's real close. Also, they work with community outreach, health workers, and health work community health workers that that work at nonprofits, who have specialty in maybe neighborhood or community organization or other things. It's really cool to see how the community health workers in the community often refer to the community health workers in the pharmacy because they have different skill sets.

 How can pharmacists work with underserved patient populations to address social determinants of health?

I usually start with quality metrics, and so if you look at a community and you see that it's a high tobacco use area, or the infant mortality rates high, or it's a high prevalence of diabetes, then there's obviously a need and so how can pharmacy fit that need and close those gaps and fill a void.

A lot of times there are state appropriated federal funds, or local public health funds, even health plan related dollars that are targeting those diabetes or whatever it is in that community. By pharmacy recognizing what the needs are in the community and having resources like maybe a community health worker or technician that's trained up on social determinants of health, how to identify and solve problems, it puts the pharmacy in a really good position to help support those and usually there's some sort of payment or funding to support the pharmacies effort help close those local gaps.

I would like to touch on one thing, which is just the value of the community health worker. This is my 21st year of community pharmacy practice, and I grew up in this watching my dad work in the community pharmacy and the most exciting and innovative thing that we've worked on is this community health worker project.

I've seen lives changed. I've seen lives saved by deploying community health workers to help vulnerable patients navigate the healthcare system. I really firmly believe that this is a solution to the small percentage of patients that have the poorest outcomes and cost the most money to the system. I think it's a unique solution to solve for that and to make people better in the local community, and it's a great service opportunity for service-driven pharmacies.

Pharmacy Staff, Community Health Care Workers Can Team Up to Address Social Determinants of Health 

Bri Morris, PharmD, senior director of Education and the Long-Term Care Division at the National Community Pharmacists Association (NCPA), discusses the importance of teamwork in the pharmacy.

 What is the importance of teamwork in the pharmacy?

 As we've seen over the last couple of years through COVID, it's very important. Pharmacies have been busier than they ever have, and they have been able to provide unprecedented service to their communities. They cannot do that without their teams. We're so excited this year at the NCPA Convention to welcome lots of support staff and teams who have really helped us get through the last few years.

How can pharmacies improve workflow and efficiencies to lighten their workload?

 Absolutely. Through working with their support staff and their other non-pharmacists team to take on new roles in the business and keeping that pharmacist role dedicated to things that you have to have a pharmacist for through their practice act.

How can technicians be effectively utilized to take over more responsibilities from pharmacists?

 Technicians have taken on so many different roles over the last few years, and you’ll see it here at the NCPA Convention, we have more support staff as speakers than we have ever had in the past. I was actually talking to one of our speakers the other day, who has a technician that is managing all of their immunizations, and they're giving 1000s and 1000s a year. She's to the point where now she's going to hire support staff for her support staff because they have grown so much. I think that the pharmacy team is a lot bigger than just the pharmacists that are working there, and I'm so excited about this kind of change that we have seen in the industry and how technicians and other support staff are really getting the recognition that they deserve.

How does technology help bridge the gap between increasing responsibilities and staffing challenges?

 Yeah, technology is very important in any industry, but we especially see it in pharmacy to be able to improve some of those workflow efficiencies, especially as we dive a little bit deeper into the service model and how pharmacists and their teams getting out from behind the counter to offer a lot more services. We really need technology to help tighten up that dispensing model and be able to help us out in that way.

What are some ways in which the business of pharmacy changed during the pandemic that you see sticking long term?

 During the pandemic, pharmacies had to adapt very quickly to meet the needs of their patients and their communities, so we saw things like curbside delivery COVID-19 testing, immunizations and immunizations by support staff when maybe you hadn't tried that before, large scale vaccination clinics, doing immunization clinics for your long-term care patients, which may not have been a sector that you had gotten into before. I think all of those different service opportunities will continue to stick around. I see point-of-care testing being a huge opportunity for pharmacies in the next decade. I think it'll become as important as immunizations has been to the profession, and we'll continue to see the role of both the pharmacist technician and other support staff just continue to evolve as we move into the future.

Bri Morris, PharmD, senior director of Education and the Long-Term Care Division at the National Community Pharmacists Association, discusses the importance of teamwork in the pharmacy.


Teamwork, Technology Helps to Strengthen Pharmacy Services

, students from the Daniel K. Inouye College of Pharmacy at the University of Hawaii at Hilo discussed their unique experiences. Thanks to its diverse patient population and unique culture, studying pharmacy in Hawaii provides interesting experiences with culturally competent care.

Taylor Eleola, second-year pharmacy student: 

I personally am hoping to work and serve my home community in the future. Hawaii is a very culturally diverse state that continues to grow and expand, and for these reasons, culturally competent care is something I hope to continue to learn and refine my skills in, in order to better serve my community and all the cultures that it encompasses.

Analeslie Martinez, fourth-year pharmacy student: 

So, the reason I actually became interested in health care in general was because I grew up in an underserved community. I grew up seeing and experiencing the holes in health care, and how many [people in] my community fell through those cracks. My family and I didn't know much about OTC medications or conditions that we were susceptible to, and how to prevent them. I saw a huge disconnect between the health care team and our community. But I do remember seeing mobile clinics come through and how helpful that was to my community. So, this is why culture and health care is so very important to me. I want to be able to bridge the pharmacy world to communities that may have reservations, you know, that may not necessarily trust us in the beginning. So, this is why having those firsthand experiences here in Hawaii, with so many different types of communities around the island, across the mainland, and also abroad, has been such a great experience.

Andrew Schuler, fourth-year pharmacy student: 

I will develop culturally sensitive questions and also listen to what the patient is telling me. I will acknowledge their views and opinions, even if there are some differences, and I will also share my suggestions. By doing this I will hopefully create trust and the needed attention from the patient. Doing so I will then be able to develop the right plan of care for them.

Thanks to its diverse patient population and unique culture, studying pharmacy in Hawaii provides interesting experiences with culturally competent care.