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The event will focus on clinical practice expansion for community pharmacies and how to make them a revenue-generating health care destination.

Register Today: March 2025 Total Pharmacy Solutions Summit

Coalition for Epidemic Preparedness Innovations experts warned of the potential for bird flu to become a pandemic event if officials don’t prepare quickly.

Experts Warn Public to Prepare for Potential Bird Flu Pandemic

The ADjoin long-term extensive study is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.

Lebrikizumab Demonstrates Sustained Response for Atopic Dermatitis at 3 Years

Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years and older whose symptoms are not well controlled with inhaled corticosteroids.

FDA Approves Omalizumab-Igec as First Interchangeable Biosimilar to Xolair

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On January 6, 2023, the FDA granted lecanemab-irmb (Leqembi) accelerated approval for treating mild cognitive impairment and mild dementia in patients with Alzheimer disease.

Lecanemab-irmb Approved for Alzheimer Disease

Overall median survival was higher in participants taking quizartinib, according to results from QuANTUM-First trial.

Quizartinib Approved for Newly Diagnosed AML in Patients with ITD

Mavacamten improves functional capacity and symptoms in adults with New York Heart Association class II-III obstructive HCM.

First-in-Class Treatment for Obstructive Hypertrophic Cardiomyopathy Is Approved by FDA

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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See what’s trending in pharmacy with a preview of the Total Pharmacy August issue.

Total Pharmacy

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.

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our 

 and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

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

The FDA approved omalizumab-igec (Omlyclo) as the first interchangeable biosimilar referencing omalizumab (Xolair). This also marks the first respiratory biosimilar in the United States.

Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years of age and older whose symptoms are not well controlled with inhaled corticosteroids, chronic rhinosinusitis with nasal polyps for patients older than 18 years old, and food allergy for individuals aged 1 year and older to reduce allergic reactions triggered by eating 1 or more foods that the patient is allergic to. It was approved in 2 dosage forms: a 75 mg/0.5 mL injection and a 150 mg/mL injection, which can be administered via single-dose prefilled syringes subcutaneously.

Adverse reactions can include injection site reactions, fever, headache, dizziness, and arthralgia. Furthermore, the FDA issued a boxed warning for anaphylaxis based on pre- and postmarketing reports of anaphylaxis after administration.

The biologics license application for the drug, previously known as CT-P39, was based on data from a global phase 3 clinical trial (

) that evaluated the efficacy, safety, and pharmacokinetics of CT-P39 compared to the reference product. Investigators analyzed data from the drug for patients with chronic spontaneous urticaria for up to 40 weeks, according to a company news release. The primary outcome included the equivalence of the efficacy and the potency between both drugs at 12 weeks. The secondary end point included dose response by Weekly Itch Severity Score at week 8 and week 24, Urticaria Activity Score at week 8, 12, and 24, Hives Severity Score at week 8, 12, and 24, pharmacokinetics, quality of life, and safety, including adverse events.

Investigators of the study found that there was equivalent efficacy between the drugs as well as comparable safety. There were 619 patients, with 204 receiving the biosimilar in the 300 mg dosage, 205 receiving the reference product in the 300 mg dosage, 107 receiving the biosimilar in the 150 mg dosage, and 103 receiving the reference product in the 150 mg dosage.

The mean change between the 300 mg products was evident for ISS7 at 12 weeks (treatment difference 0.77, 95% CI -0.37 to 1.90; US analysis: treatment difference 0.70, 90% CI -0.22 to 1.63). The trial also had comparable efficacy between the groups at both dose levels, with no impacts on switching. For safety, the adverse events were also comparable, according to the study authors.

This approval comes after the biosimilar’s approval in Canada, which came in December 2024. Like most biosimilars, this marks a cost-effective option for these patient populations.

1. Omalizumab-igec (Omlyclo). [package insert]. Celltrion; 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf. Accessed March 7, 2025.

2. Jeremias S. FDA Approves First Omalizumab Biosimilar. 

. March 7, 2025. Accessed March 7, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-omalizumab-biosimilar

3. Celltrion Usa completes submission of biologics license application (BLA) to US FDA for CT-P39, an interchangeable biosimilar candidate for Xolair (omalizumab). News release. Celltrion. March 10, 2024. Accessed March 7, 2025. https://www.prnewswire.com/news-releases/celltrion-usa-completes-submission-of-biologics-license-application-bla-to-us-fda-for-ct-p39-an-interchangeable-biosimilar-candidate-of-xolair-omalizumab-302084902.html

4. To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (omalizumab). ClinicalTrials.gov identification: NCT04426890. Updated June 22, 2023. Accessed March 7, 2025. https://clinicaltrials.gov/study/NCT04426890

5. Saini SS, Maurer M, Dytyatkovska Y, et al. CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. 

. Published online January 9, 2025. doi:10.1111/all.16446

The discussion covers the benefits and risks of using continuous glucose monitoring (CGM) systems with smartphones.

Counseling Patinets on CGM and Smartphone Use

FDA issued an alert to patients of potential safety concerns for diabetes devices

, including continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, specifically those that rely on a smartphone to deliver safety alerts. The agency received reports in which users said the safety alerts are not being delivered or heard, even in cases where the user thought they set the alerts to be delivered. The FDA reported that some cases of missing alerts contributed to events such as severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, and even death. Currently, the FDA is working with manufacturers to ensure that smartphone alerts are carefully evaluated prior to use by patients.

In the interview, Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, endocrine clinical pharmacy specialist, director of education & training in diabetes technology at the Cleveland Clinic Endocrinology & Metabolism Institute, discussed the benefits and risks of using continuous glucose monitoring (CGM) systems with smartphones. She discussed the recent alert by the FDA, alerting of potential missed notifications for Bluetooth devices. Further, Isaacs talked about preventing compatibility issues and how to counsel patients who are concerned.

What are your initial thoughts on the FDA's alert about potential missed safety notifications with smartphone-compatible diabetes devices?

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP: 

Well, I have a lot of thoughts about this. On one hand, I'm disappointed that we need to have this FDA alert and that we don't have technology that is just perfect, and we can trust the alerts all of the time. But I am happy that the FDA put out this alert because this is a reality with our current smartphones that there can be just issues that cause an alert to not be received, and I think it's really important that patients know about that so that they really can double check their glucose They can rely more on their symptoms versus only relying on an alert from a device. So I do think the FDA certainly did the right thing by putting this alert out.

: What are the potential consequences of missed safety notifications for patients with diabetes?

It can be quite serious. I mean worst-case scenario is if a person is having an urgent low glucose and doesn't receive an alert and therefore does not take action by eating, drinking, or treating their low; I mean, they can pass out. It could lead to death in the worst-case scenario. Now, fortunately, a lot of people will feel symptoms, and they can take action, and so usually that doesn't happen, but certainly there is that risk of that happening.

The FDA recommends that patients periodically check smartphone settings to ensure safety alerts are being delivered. How do you counsel patients on the best practices for checking these settings and confirming device functionality?

I think this is a really important point for anyone that works with patients in CGM. So generally, we discourage the automatic updates where you go to the latest operating system because it takes a little bit of time for these mobile apps to be tested and be compatible with the latest update, and so we actually train patients to toggle that off so it's not automatically updating, and that's one way to hopefully prevent that compatibility issue. The other thing I'd say is just periodically testing it. Now, most will know because they'll get a higher, they'll get a low, and they'll hear it go off. But I would say that if someone hasn't noticed an alert in a while, go ahead and check the system and make sure that it's still working, perhaps adjusting it to something they're more likely to reach with their number, and just confirming that it truly is going off; it's making a sound and everything.

What are some practical tips you can share with patients to ensure they receive critical alerts from their diabetes devices?

I would just say making sure that it's not automatically updating, going ahead and checking like they could change your high alert to like 140 if you want, and a person should hit that anytime they eat, so that doing those types of things can just double check that it truly is working. I'd also say it's important to remember that technology is not perfect all the time. So we want to back up. We really want people to still feel the symptoms of low glucose levels and not lose sight of what those are. Then also, I'd say, having a backup meter, just in case, because the instructions for all of them are, if a person has symptoms that don't line up with what the number is saying on the CGM device, they really should confirm with a finger stick. I think just remembering that technology, it's just not perfect 100% of the time.

Do you believe that the benefits of smartphone-compatible diabetes devices outweigh the risks associated with potential missed notifications?

No, I think 100%, the benefits are worth this risk. So I want to highlight that this is not a super common occurrence where the alerts aren't going off. I would say it's not something that happens to many people, so it is certainly not a common occurrence in terms of benefits of it being on the smartphone. There are so many, it makes it much easier to share data with the health care team. So through the Bluetooth and the data going into the cloud, we can see it. We don't have to download a device. We don't have to bring a patient into clinic. We can do a virtual visit, a phone visit. We can do remote monitoring with that data. So that makes it super useful, and then the other thing with smartphones is that all the CGMS have a follow app that you can use when it's on the smartphone versus if you're just using a separate reader or receiver, you can't use those follow apps. Then the other thing I'd say is that it's just a whole lot more convenient to carry 1 device instead of 2. So asking a person to have a separate reader or receiver and their phone, they're more likely leave it somewhere, or forget about it, or lose it, and then they're not going to get any alerts if that happens. So I think definitely the benefits outweigh the risks.

How do you address patient concerns about the reliability and safety of smartphone-compatible diabetes devices?

Using a smartphone that's been tested with the system is important. So there are a whole lot of different versions of smartphones, especially when it comes to Androids. I think there's a lot of different types, right? And on the respective CGM websites, you can get a list of the devices that are truly compatible along with the operating system. So it's important to use one that has been tested and true and everything, and then just going into the settings, making sure the critical alerts are on and everything. If there is any concern, all of them have a number, like a customer support number to call, to double check that it's working, it's compatible, and everything. So I think in doing those things generally, we can really trust the devices.

What is the role of that pharmacist in diabetes care for patients, especially with CGMs?

First of all, making sure patients know what the target ranges are and what all this data means, and I don't mean that the pharmacist needs to, like, go through and teach about glucose variability, and all of these like more complicated concepts. I just mean that we want a person to be able to see their number and understand, like, is this in range, or is this above, or are they having a low, and then what to do about it, and especially, I would say, treating low glucose levels, understanding that we generally consider, for most people under 70, to be a low, what to do about that, and then also setting alerts that are meaningful. Some people have the opposite problem, where they say their CGM is beeping and buzzing at them all the time, and even though they get all the alerts, they kind of ignore them because it's just alerting all the time, and so that's not good either. We want it to be meaningful alerts, and the pharmacist can have a great role in helping the person set a low that will be meaningful. For some people, that may be higher than 70, maybe that's going to be 80 or higher, and then setting a high alert that also is meaningful, or even turning it off for some people, and I think those are key things, and then also, I think it's great to go into the device turn off those automated updates for the operating system. That's a way to just prevent this kind of complication from coming up where they don't get any alerts.

Is there anything else you would like to add?

I think CGM systems are incredible, and when you think about how far we've come from blood glucose monitoring [(BGM)] devices to this growth of CGM where tons of people have access to it, and I know it's really annoying if someone should be getting alerts and they're not getting them. But think about the days of BGM, right? People aren't getting any alerts. If they don't say, in this moment, I'm going to check my glucose, I'm going to bring out my meter and poke my finger, right? They're not going to get an alert. So these devices are lifesaving, their life changing, and I'm really happy to see that more and more pharmacists are learning about these devices and bringing them to their patients and really supporting their use so that we can give the best outcomes for people with diabetes.

Recently, the FDA alerted users of missed notifications for continuous glucose monitoring devices and Bluetooth smartphone compatibility.

Counseling Patients on CGM, Smartphone Compatibility Usage

Artificial intelligence (AI) has made its way to health care and it is not leaving anytime soon. As with many new technologies, AI’s initial adoption has presented a variety of challenges and opportunities. But with its ability to serve as a tool for providers—rather than a replacement—AI may be the catalyst for a revolution in health care.

“AI is already here and already being used. It's being used a lot with drug discovery, research, purchasing, and inventory management; those kinds of things,” said Scott Nelson, PharmD, MS, FAMIA, ACHIP, Associate Professor in the Department of Biomedical Informatics at Vanderbilt University Medical Center. “Within the clinical context, it's also used in some decision support tools for identifying adverse drug events or even providing more context for alerts and drug information. So, there’re little pieces where it's being used.”

Already completing menial pharmacy tasks, Nelson believes that AI can humanize health care in the long-term by giving pharmacists time back to connect with patients and provide care of the utmost value. With almost an insurmountable number of notable challenges in the pharmacy industry today, AI may be a shining light at the end of the tunnel, as long as experts and providers work together to properly integrate it into health systems.

“I really hope that AI can humanize care again and address some significant issues like burnout and just bring back that human element into health care that it feels like we've lost over the years,” he continued.

Aside from his expertise in biomedical information, Nelson was also a contributing author of the American Society of Health-System Pharmacists (ASHP) 2025 Pharmacy Forecast. He co-authored a section of the report titled “Navigating Generative AI: Opportunity and Risk.” 

 caught up with him to further discuss his section of the report and explore the current and potential future roles of AI in the pharmacy profession.

Stay tuned for weekly podcast episodes on 

 every Thursday afternoon. Check out our previous episode with 

Eric Tichy, PharmD, MBA, BCPS, FCCP, FAST

, who was also a co-author of the ASHP 2025 Pharmacy Forecast. In our ongoing coverage of the forecast, Tichy discussed the business of health-system pharmacy and the challenges that often arise.

Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our 

DiPiro JT, Hoffman JM, Tichy E, et al. ASHP and ASHP Foundation Pharmacy Forecast 2025: Strategic planning guidance for pharmacy departments in hospitals and health systems. 

As artificial intelligence evolves from a novel technology to commonplace in health care, the pharmacy industry is adapting to its challenges and opportunities.

Kevin Chamberlain, PharmD, FASCP

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