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Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic, discusses key benefits of incorporating biosimilars into a health system's formulary.

Benefits of Incorporating Biosimilars Into Health System Formularies

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Karissa Kim, PharmD, BCPS, BCACP, discusses the main challenges pharmacists face in assessing and addressing patients’ health literacy levels.

Q&A: Challenges Pharmacists Face in Assessing, Addressing Health Literacy

The prevalence of high blood pressure is highest in Mississippi at 40.2% compared with the lowest in Colorado at 24.6%.

Heart Disease Remains Leading Cause of Death in US

Researchers conducted a population-based study of women in Korea to analyze the association between age at menopause and incidence of type 2 diabetes.

Premature, Early Menopause Associated with Increased Risk of T2D

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Racemic substitutions for single-enantiomer drugs offer new opportunities for savings.

Generics of Older Drugs Could Have Saved Medicare Billions, Study Says

journal explores issues within pharmacy, from the impact advocacy can have in community pharmacies to staffing shortages across multiple sectors within pharmacy. This month’s issue also explored the importance of disease awareness months and how they are opportunities to maximize valued care. Check out a preview of this month’s issue here.

download the PDF of the Total Pharmacy August 2024 issue here

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In This Issue: Total Pharmacy August 2024

Combining sodium glucose co-transporter 2 inhibitors (SGLT2is) with glucagon-like peptide-1 receptor agonists (GLP-1RAs) may offer additional protection against cardiovascular and kidney disease in patients with type 2 diabetes (T2D), according to the results of a new meta-analysis published in 

 and presented at the 61st European Renal Association Congress in Stockholm, Sweden.

Separately, SGLT2is and GLP-1RAs have demonstrated cardiovascular benefits. However, little clinical literature has focused on outcomes associated with using the medicines together. Due to the growing prevalence of GLP-1RAs in the 

 and obesity landscape, accelerated by an increasing number of indications for the agent class, this is a crucial area for further study.

The SGLT2 Inhibitor Meta-analysis Cardio-Renal Trialists’ Consortium (SMART-C) is the largest assessment of outcomes for the combined therapeutic use of SGLT2is and GLP-1RAs. The study gathered data from 12 large-scale, placebo-controlled trials of SGLT2is involving 73,238 patients with diabetes. Of these, 3065 were already receiving GLP-1RAs.

Overall, SGLT2is lowered the risk of major adverse cardiovascular events by 11% and hospitalization for heart failure or cardiovascular death by 23% compared to placebo. Notably, this benefit was seen regardless of whether patients were also taking GLP-1RAs.

When used together with GLP-1RAs, SGLT2is reduced the risk of chronic kidney disease progression by 33% and slowed the annual loss of kidney function by nearly 60%.

The study found no additional safety concerns when SGLT2is were used in combination with GLP-1RAs.

Study Reveals Robust Benefits of Semaglutide in Protecting Against Kidney, CV Events in Patients With T2D

Current meta-analysis results build off positive results of the landmark FLOW trial (

). Published earlier in May, results of the international, double-blind, randomized, placebo-controlled phase 3 trial spotlighted semaglutide’s effectiveness in lowering the risk of kidney failure, decelerating worsening kidney function, and protecting against the risk of cardiovascular events and death, in patients with T2D.

“SGLT2 inhibitors have clear protective effects against heart failure and chronic kidney disease, while GLP-1 receptor agonists can reduce the risk of heart attack, stroke, and also kidney disease—as recently demonstrated in the landmark FLOW trial,” said Brendon Neuen, lead author, clinical associate professor, senior research fellow at The George Institute for Global Health, and director of kidney trials at Sydney’s Royal North Shore Hospital, in a news release.

 “Our findings support using this combination to further improve outcomes in patients with type 2 diabetes who meet guideline recommendations for both therapies.”

Elevated glucose from diabetes can damage blood vessels in the heart and kidneys, increasing the risk of 

 and kidney disease. In fact, diabetes is the most common cause of chronic kidney disease.

Moreover, estimates predicting that T2D prevalence will more than double in the next 30 years, surpassing 1 billion global cases by 2050, further strengthen the need for research into diabetes care.

 According to Neuen in an interview with 

 conducted over email, the current study offers valuable insights for developing global treatment strategies for the condition.

"These findings, which represent the largest and most comprehensive evaluation of the combined use of SGLT2i and GLP-1RA, provides the clearest evidence yet that combined use of both medicines can further reduce cardiovascular and kidney disease," said Neuen. "We anticipate that these findings will inform how people with diabetes are treated worldwide, including influencing major clinical practice guidelines.

Although current results suggest that using SGLT2is and GLP-1RAs in tandem may offer robust protection against cardiovascular and kidney disease, further research is needed to fully understand the long-term effects of the combination therapy.

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1. Apperloo E, Neuen BL et al. Efficacy and safety of sodium glucose co-transporter 2 inhibitors with and without glucagon-like peptide-1 receptor agonists: A SMART-C collaborative meta-analysis of randomised controlled trials. 

. 2024. doi: 10.1016/S2213-8587(24)00183-9

2. Massaro L. Study reveals robust benefits of semaglutide in protecting against kidney, CV events in patients with T2D. 

https://www.drugtopics.com/view/study-reveals-robust-benefits-of-semaglutide-in-protecting-against-kidney-cv-events-in-patients-with-t2d

3. Combining popular diabetes drugs offers complementary heart and kidney benefits. News release. The George Institute for Global Health. July 9, 2024. Accessed July 10, 2024. 

https://www.georgeinstitute.org/media-releases/combining-popular-diabetes-drugs-offers-complementary-heart-and-kidney-benefits

4. Mayo Clinic Staff. Chronic kidney disease. Fact sheet. Accessed July 8, 2024. 

https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/symptoms-causes/syc-20354521

5. Klein HE. Diabetes prevalence expected to double globally by 2050. 

https://www.ajmc.com/view/diabetes-prevalence-expected-to-double-globally-by-2050

When used together, sodium glucose co-transporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) were able to lower the risk of major adverse cardiovascular events and kidney disease by 11% and 33%, respectively.

Clinical

SGLT2i, GLP-1RA Combination Therapy Offers Robust Protection Against Cardiovascular, Kidney Disease

Discover effective solutions to tackle the growing issue of drug shortages with our comprehensive white paper. In the first quarter of 2023, the number of active ongoing drug shortages reached a record peak of 301, according to the American Society of Health-System Pharmacists. Even a single missed dispensation can disrupt patient care and erode confidence in their local pharmacy.

This white paper explores four key strategies for optimizing procurement processes and managing inventory through a unified solution. By adopting smarter purchasing practices, pharmacies can maintain high-quality patient care and safeguard their business’s success despite rising drug shortages.

Discover effective solutions to tackle the growing issue of drug shortages with our comprehensive white paper.

Health System

The 2024 Smarter Purchasing Report

Between their expertise in medications and an ever-increasing gap in the primary care workforce, pharmacists are specifically positioned to assist prescription regimentation and be key members of a primary care team. With real-world evidence showing pharmacists’ accelerated capabilities within prescription drugs, health systems can utilize pharmacist expertise to alleviate primary care gaps and improve patient outcomes.

“We're seeing that…outcomes are superior when we have pharmacists involved in designing and optimizing the medication regimens. We really see that that leads to superior outcomes, and it makes sense. As the medication specialists, they just have more expertise on what the implications are, what needs to be added, what needs to be reduced,” said Jonathan Watanabe, PharmD, MS, PhD, BCGP.

Watanabe co-authored “Addressing the Gap in Primary Care,” a subsection of the American Society of Health-System Pharmacists (ASHP) 2025 Pharmacy Forecast. He joined us to explore the pharmacists’ role in addressing primary care gaps and their unique expertise that sets them apart as providers. In 

 with him, Watanabe discussed how providers have identified primary care gaps and the potential legislation that could address those gaps.

Q&A: The Importance of ASHP’s 2025 Pharmacy Forecast

Stay tuned for more Drug Topics interviews regarding the ASHP 2025 Pharmacy Forecast. As we meet with authors and industry leaders that contributed to the report, we will discuss some of its main sections.

: How can a collaborative care program address gaps within pharmacy?

That's going to be a key component. Think what we've learned through outcomes. Basically, team-based care translates to better outcomes, if we could just really find ways to make it more efficient in terms of teaming the partners where they can have superior outcomes, where it plays to their expertise. We can shore up gaps so more people can have the appropriate time, whether it's the primary care physician as sort of the quarterback for the team. But that shores up time if you can have the pharmacist more involved in managing [and] designing the medication regimen. That alleviates pressure on other members of the health care team to do what's best in their expertise.

I think we're seeing that more and more in the data that outcomes are superior when we have pharmacists involved in designing and optimizing the medication regimens. We really see that that leads to superior outcomes, and it makes sense. As the medication specialists, they just have more expertise on what the implications are, what needs to be added, what needs to be reduced. How do we make regimens less complex? What are the moments where we do need to add medications? Oftentimes, that's what we're seeing as well. It's not always just a case of deprescribing. I think we're seeing that there's more and more situations where gradual dose reduction [and] deprescribing could be had. But there's plenty of realms now, particularly with the advances we're seeing in medications, where there's medications that are missing and only a pharmacist can be involved in that. [It’s] really just finding ways to better organize the team so we can have superior outcomes.

There's been several studies that have shown that that benefits other members of the health care team, particularly the physicians. That's translated to a reduced work burden, potentially improving patient satisfaction, reducing burnout. Those are aspects that a pharmacist can assist with. But the caveat is, we just have to make sure that that's done almost always with the wellness of the pharmacist in mind. When we really think about the provider, the pharmacist [should] not [be] left out of that dialog, because we saw that also during the pandemic. Pharmacists took on this heroic role, but that role, that emotional toll, the time, and the fatigue, those components weighed heavily. We have to be really strategic about incorporating that, otherwise the gains that we're going to have, potentially for pharmacists being involved, are going to be short lived. We just have to be really mindful of how we can do this in the long game to make sure that it leads to long-term population-level gains.

Finally, we have to be wise about how we make this sustainable, and that means economically sustainable. All this can't be done without finding ways that we reimburse for those activities, whether it's global payment, value-based arrangements. How do we make sure that we make pharmacists whole for these contributions that they're making to primary care? I think a lot of that really needs to be looked at and there's groups that are doing it, but I think we need to enhance that.

: How exactly are pharmacists positioned to address gaps within primary care?

I think some of those are still being really delineated. Really, I think we're just getting more and more information. We've been doing it for a long time in so many different settings. Think about what we do in the [Veterans Affairs], or some of the roles for clinics like Kaiser Permanente. These have been long-standing, where pharmacists have been charged with running clinics. But in many settings outside of that, beyond vertically integrated systems, that's still sort of being developed. In academic health systems, oftentimes, you see these pharmacist-led clinics that are very successful with demonstrated outcomes, but there's a lot of variability. If you've got rural settings, other settings that are less robustly situated, that are not a part of large health systems, how do we organize there? How do we make sure that these gains can be deployed in different settings. Protocolizing [and] coming up with how we right-size these for different clinics and different settings still needs to be developed. I think we see that there's success from almost anywhere we've looked when we have pharmacists involved in looking at the medication regimens. There's been opportunities for improvement in outcomes. That's sort of always been there.

I think, in some hospital settings recently, they looked at trials [that] didn’t improve some of the mortality outcomes. Even when those ones weren't statistically significant, they still saw an improvement in terms of reduction in inappropriate medications. So, there's almost always gains, but how do we deploy those in such a way that it makes sense for the setting, for the care team, given that we have seen a reduction in people entering pharmacy school? All these things, I think, make it really important that we're deliberate about how we're going to approach it. This can't be done in a cookie-cutter way. I think we're getting better at understanding how collaborative practice agreements can be best developed to maximize. I think it's almost the implementation science of it is now becoming very important. We know that it works, but how to do it in a way that's going to meet the needs of the setting, of the population, that we could show the benefit, that we can make it sustainable even when the grant that's supporting it dries up. I think all those things become more and more relevant as we understand this.

I was a part of a committee that looked at medications for opioid use disorder, and that was from the White House Office of National Drug Control Policy. It was a physician that spurred that effort. But when I was looking on the 4 items, the second or third item was ‘How can we better integrate pharmacists and pharmacies in alleviating the opioid use disorder crisis?’ So, people know that pharmacists are going to be the best tool, [in] many ways, to try to address these problems, but how to do that in a way that makes the most sense? How do patients, if they want to see a pharmacist and they're at a rural setting, how do they do that? I think that those are questions that still need to be better delineated, understood, and then addressed.

Stay tuned for more from our conversation with Watanabe and other ASHP 2025 Pharmacy Forecast authors. Drug Topics will be posting weekly podcast episodes from our conversations with forecast panelists, all available on our 

 platform with new episodes coming out every Thursday.

Jonathan Watanabe, PharmD, MS, PhD, BCGP, joined Drug Topics to discuss how pharmacists can facilitate improved patient outcomes through collaborative care.

Q&A: Pharmacists’ Play Key Role in Alleviating Primary Care Gap

Discover effective solutions to tackle the growing issue of drug shortages with our comprehensive white paper. 


4 Strategies to Mitigate Drug Shortages with Smarter Pharmacy Purchasing

Websites selling compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) misinformed customers by inaccurately promoting efficacy, safety, and FDA approval for available products, according to data published in 

“High global demand for [GLP-1 RAs] and dual gastric inhibitory polypeptide [GIP]/GLP-1s has exceeded manufacturers’ supply, leading to medication shortages that have persisted since 2022,” wrote authors of the study. “Medication shortages allow pharmacies to sell compounded versions of [FDA-approved] drugs, including GLP-1s.”

While avoiding medication shortages is a top priority for many parties within the pharmaceutical supply chain, if they are to arise, pharmacies are then able to sell compounded versions of the drug under shortage. With GLP-1 RAs under shortage for over 2 years, along with a spike in demand as more GLP-1 RA indications are approved, several online distributors have looked to cash in by selling non-FDA-approved, compounded versions of GLP-1 RAs like semaglutide (Ozempic), tirzepatide (Mounjaro), and liraglutide (Victoza).

“Compounding a copy of an FDA-approved product would ideally follow a U.S. Pharmacopoeia (USP) monograph or other standard to ensure product quality. However, USP monographs for most GLP-1 RAs and the dual GIP/GLP-1 RA therapies are currently unavailable to guide standard compounding,” wrote the American Diabetes Association.

Q&A: Factors Showing Tirzepatide is More Beneficial Than Semaglutide | ASHP Midyear

The act of compounding medications has shown to be a saving grace in times of manufacturer shortages and increased patient demand. Undermining FDA and USP guidelines, however, several online entities have since attempted to take advantage of this boom in demand for GLP-1 RAs.

Highlighting the need for appropriate advertising of compounded medications, researchers noted that 11% of all patients using GLP-1 RAs purchased them from an online website.

 Along with previously noted advertising that was misleading, researchers investigated advertising tactics of online compounded GLP-1 RA sellers and the extent in which consumers were misled when purchasing them.

Between July and September 2024, researchers conducted online searches of websites advertising the sale of compounded semaglutide, tirzepatide, and liraglutide. They searched by brand name and generic, and noted the location, medications sold and associated prices, compounding disclosures, efficacy and safety claims, use of brand names, and clinician involvement of each website’s products.

Before presenting advertising tactics, researchers found that all 79 websites included in the study sold compounded semaglutide, 57 (72.2%) sold compounded tirzepatide, and 3 (3.8%) sold compounded liraglutide. Furthermore, the median first-month price was $231 for semaglutide, $330 for tirzepatide, and $248 for liraglutide.

“Eleven websites (13.9%) did not disclose the GLP-1 RAs for sale were compounded, while 7 (8.9%) referred to compounded medications as generic. While 34 websites (43.0%) stated the compounded medications were not FDA approved, 29 (36.7%) stated or implied these drugs were FDA approved. Thirty-nine websites (49.4%) did not report adverse effects, warnings and precautions, and contraindications of compounded GLP-1 RAs, whereas 32 (40.5%) advertised an efficacy claim not in the authorized label of the FDA-approved branded GLP-1 RA,” continued the authors.

By exploring every existing website that sold compounded GLP-1 RAs during the study period, researchers uncovered a significant amount of misinformation being relayed to potential users of these medications. Across all notable data, at least 35% of all included websites disseminated some type of misinformation regarding GLP-1 RAs.

While the same websites partially advertised their products appropriately, these findings highlight the severe caution needed when purchasing GLP-1 RAs from online entities. But until these websites receive regulatory oversight and are forced to disseminate appropriate advertising, patients may have a hard time heeding the warnings of non-approved GLP-1 RAs because of their life-saving indications for diabetes, cardiovascular disease, and obesity.

“Enhanced regulatory guidance and oversight are needed to clarify criteria for ‘truthful, non-misleading, and accurate’ advertising to ensure consumers are informed of the risks and benefits of compounded GLP-1 RAs and other compounded medications. The FDA could require websites to explicitly disclose and define compounding, including lack of FDA approval; institute unique naming conventions for compounded medications; and be given greater authority to act against misleading compounded medication advertising,” concluded authors of the study.

Oral GLP-1 Shows Significant Weight Loss in Patients With Obesity

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1. Chetty AK, Chillakanti M, Ramachandran R, et al. Online advertising of compounded glucagon-like peptide-1 receptor agonists. 

. 2025;6(1):e245018. doi:10.1001/jamahealthforum.2024.5018

2. Neumiller JJ, Bajaj M, Bannuru RR, et al. Compounded GLP 1 and dual GIP/GLP 1 receptor agonists: A statement from the American Diabetes Association. 

Researchers wanted to better understand the accuracy of advertising practices behind websites selling compounded GLP-1 RAs.

Tricia Krizner

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