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ADI-001 is an investigation allogeneic gamma delta chimeric antigen receptor T cell therapy that targets CD20 for the treatment of a variety of autoimmune diseases.

FDA Grants ADI-001 Fast Track Designation as Treatment of Refractory Systemic Lupus Erythematosus

Primary hyperoxaluria type 1 (PH1) is a rare genetic condition that affects the kidney, bladder, or urinary tract, and indicates high levels of oxalates in the urine. 

FDA Grants ABO-101 Orphan Drug, Rare Pediatric Disease Designations for PH1

Scott Nelson, PharmD, MS, FAMIA, ACHIP, joined Drug Topics to discuss the 2025 Pharmacy Forecast and AI’s role in the future of pharmacy practice.

Q&A: How Pharmacists Can Use AI to Humanize Care

Investigators also find that the proportion of patients that were admitted to the intensive care unit after hospital admission was much higher for Black rural patients.

Black Rural Patients Experience Higher Mortality Risk for Health Care-Associated Infection

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Decades ago, when there were no pharmacy benefit managers and pharmacists were fondly called Doc and sold only medication, pharmacists were respected for the tireless care they gave patients. Over the past 20 years, PBMs working for insurance companies and government agencies have gradually disconnected the care from health, treating pharmacy like a commodity business. Because of PBMs' steady ratcheting down of reimbursements, pharmacists now barely make 1% to 2% profit margins on dispensing prescriptions for private and government plans.

Viewpoint: Can independents survive Part D?

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 

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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

With contracts and agreements serving as a shield against the impact of shortages, coupled with adherence to regulations such as the Drug Supply Chain Security Act (DSCSA), pharmacies must safeguard their operations and ensure patient safety. This white paper aims to delve deeper into the three pivotal strategies of driving purchasing compliance–contracts, agreements and regulations, providing insightful strategies and tools for navigating the pharmaceutical procurement process.


This white paper aims to delve deeper into the three pivotal strategies of driving purchasing compliance–contracts, agreements and regulations, providing insightful strategies and tools for navigating the pharmaceutical procurement process.


A Three Pronged Approach to Driving Purchasing Compliance Across Your Pharmacy Featuring CARE Pharmacies 

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.

Majority of Online GLP-1 Advertising Misinformed Potential Consumers

For the first time to researchers’ knowledge, they’ve found a link between pediatric obesity treatment and reduced mortality in the young adult population. With it also leading to a decrease in cardiometabolic morbidities in young adults, researchers saw the greatest reductions in health risks when patients experienced obesity remission in childhood, according to data published in 

“Childhood obesity has reached epidemic proportions in both developed and developing countries,” wrote authors of the study. “By 2035, the global prevalence of obesity in individuals aged 5 to 19 years is estimated to be 18% among girls and 20% among boys. Childhood obesity is associated with hypertension, steatotic liver disease, insulin resistance, and psychosocial issues, such as anxiety, depression, and stigma.”

Indeed, the obesity issue has persisted in recent history, with over 40% of the US adult population being diagnosed obese from 2021 to 2023.

 The persistence and steady increase of obesity in the US has led to pharmacotherapy options like glucagon-like peptide-1s (GLP-1s) to soar in demand for patients struggling to lose weight.

However, pharmacists and other providers need to be much more selective in counseling their younger patients with obesity because of the lack of approved weight-loss treatments for children and adolescents. Changing a child’s lifestyle and behavior is the standard option of treating pediatric obesity. According to the researchers, bariatric surgery and pharmacotherapy options are only suitable for children when lifestyle interventions are unsuccessful.

Highlighting the long-term effects of pediatric obesity treatment, researchers measured each participants’ treatment effectiveness and how that later impacted mortality and morbidity; hypertension, dyslipidemia, depression or anxiety, and bariatric surgery were all included as obesity-related events that led to childhood comorbidity. To measure treatment effectiveness, they found each patients’ change in body mass index (BMI).

“Included participants were children and adolescents with obesity according to the International Obesity Task Force, aged 6 to 17 years at treatment initiation, who received at least 1 year of obesity treatment before age 18 years, and were registered in BORIS [the Swedish Childhood Obesity Treatment Register] between 1996 and 2019,” they continued.

 “Outcomes were assessed from the date individuals turned 18 years until the disease outcome occurrence, bariatric surgery, death, emigration, age 30 years, or December 31, 2020, whichever occurred first.”

The study population included a total of 6713 adolescents (median age, 12.1; 56.3% boys; median BMI, 2.82). In order to measure participants’ long-term health outcomes and mortality, researchers needed to understand how pediatric obesity treatment impacted the population. While a majority of participants had intermediate responses (43.4%) to treatment, 15.9% exhibited what the researchers deemed “good” responses and even more patients (22.4%) reported obesity remission.

“This nationwide prospective cohort study demonstrated the association between beneficial pediatric obesity treatment response and a reduced risk of obesity-related events in young adulthood, except for depression or anxiety. Particularly, a marked decrease in the risk of [type 2 diabetes], dyslipidemia, and premature mortality was observed, with greater risk reduction seen in groups with better response in pediatric obesity treatment,” wrote authors of the study.

Real-world evidence has shown that childhood obesity leads to detrimental health outcomes, including diabetes, risk of cardiovascular disease, various cancers, and mental health complications. While new weight-loss options are available for adults, combating obesity during a patient’s early development is much more beneficial than decreasing BMI later in life. Prior to the researchers’ study, there was lacking evidence showing that obesity remission during childhood led to better health and a longer life.

The study findings were presented in order to further inform pharmacists, clinicians, and any health care provider working closely with children experiencing obesity. With the long-term health benefits pediatric obesity treatment highlights, researchers believe achieving full obesity remission is the best predictor of a healthy adulthood for the younger, obese population. Future research may focus on furthering data for pediatric obesity treatment’s link to mental health.

“This nationwide study provides compelling evidence that beneficial response to pediatric obesity treatment in a real-world setting can lower risk of cardiometabolic morbidities in young adulthood,” concluded authors of the study.

 “The greatest risk reductions were demonstrated in those who experienced obesity remission during childhood. However, effective obesity treatment does not mitigate the long-term risk of depression or anxiety.”

1. Putri RR, Danielsson P, Ekström N, et al. Effect of pediatric obesity treatment on long-term health. 

. Published online January 21, 2025. doi:10.1001/jamapediatrics.2024.5552

2. Emmerich SD, Fryar CD, Stierman B, et al. Obesity and severe obesity prevalence in adults: United States, August 2021–August 2023. CDC. September 2024. Accessed January 23, 2025. 

https://www.cdc.gov/nchs/products/databriefs/db508.htm

3. Lasting impact: The long-term effects of childhood obesity. Cleveland Clinic. June 3, 2024. Accessed January 23, 2025. 

https://health.clevelandclinic.org/long-term-effects-of-childhood-obesity

To highlight the effectiveness of pediatric obesity treatment, researchers measured its impact on morbidity and mortality in young adulthood.

Pediatric Obesity Treatment Reduced Mortality, Long-Term Morbidity in Young Adults

With health systems uniquely positioned to witness the growth of both pharmacy and primary care, the pharmacists within health-systems pharmacies are too expected to understand the nuances of prescription drug and medical benefits amongst their setting.

“Health-system pharmacy has grown alongside the rapid growth of specialty pharmacy,” said Eric Tichy, PharmD, MBA, BCPS, FCCP, FAST, Mayo Clinic Division Chair and Associate Professor at the Mayo Clinic College of Medicine and Science. “Because of the high numbers of specialty medications that are generated out of health systems and the special care that goes into providing those medications, health systems have found that they play an important role in making sure patients get those medications.”

In part 1 of our interview with Tichy, he joined 

 to discuss the American Society of Health-System Pharmacists (ASHP) 2025 Pharmacy Forecast. More specifically, Tichy helped co-author a section of the report titled “The Business of Health Care: Strategic Challenges in Health-System Pharmacy.” He delved into health-systems’ growth in the past 5 years and the specific knowledge necessary to operate a successful health-system pharmacy.

Q&A: Identifying, Addressing Gaps in Primary Care

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 most important sections.

: This section of the report starts by detailing health-system pharmacy’s service growth in the past 5 years. Can you summarize that growth and explain exactly how health-system pharmacy has grown in the recent past?

Health-system pharmacy has grown alongside the rapid growth of specialty pharmacy. Because of the high numbers of specialty medications that are generated out of health systems and the special care that goes into providing those medications, health systems have found that they play an important role in making sure patients get those medications. Those 2 have kind of grown hand in hand, and this has become also an opportunity because of drug discount programs like the 340B program as well.

: Before getting into issues within the business of health systems—like market pressures on the industry that we’ll get to shortly—Can you describe the unique position health systems are in regarding reimbursements and overall financial stability needed to stay operating at a full capacity?

I think one of the big overall challenges in health care is that the cost continues to increase. A lot of that is because of the population demographics, with the age of citizens in the US skewing older and older. People are living longer. We have new emerging technologies that allow us to treat conditions that we didn't otherwise have treatments for. This is leading to some overall pressures on health care costs.

Different entities are trying to control their costs, so they're trying to lessen reimbursement. Some of that is government payers like Medicare and Medicaid, and then that's also commercial payers too, especially employers. For many employers, health care spending is their number 2 spend after salary. This is a big opportunity that a lot of entities are looking to and putting scrutiny on.

Eric Tichy, PharmD, MBA, BCPS, FCCP, FAST, sat down with Drug Topics to discuss challenges within the business behind health-system pharmacies.

Mike James, RPh

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