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Articles

Ozempic is now the most broadly indicated glucagon-like peptide-1 receptor agonist across the pharmaceutical drug market.

FDA Approves Ozempic for Improving CKD Outcomes in Adults with T2D

A supratherapeutic dose of 1000 ug cebranopadol was significantly less likeable compared to 40 mg oxycodone when crushed and taken intranasally.

Cebranopadol Shows Lower Abuse Potential Compared to Existing Pain Therapies

Researchers conducted a literature review of patients’ clinical experiences with using secukinumab to treat psoriatic arthritis.

Secukinumab Demonstrates Real-World Efficacy in Treating Psoriatic Arthritis

Researchers analyzed overall prescription stimulant dispensing trends among US children from 2017 to 2023.

Adderall Shortage Led to More Alternative Stimulant Prescriptions for US Children

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Authors

Stimulant medications are the first-line pharmacologic therapy for ADHD,
but many of these medications are currently in short supply. 

Navigating Pediatric ADHD Medication Shortages

GLP-1 receptor agonists, used to manage diabetes, are now being used for
obesity in children and adolescents.

Review of FDA Approvals for Pediatric Obesity Management

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

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

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.

: The aging population is a big theme in the pharmacy forecast. Do you expect that to change in the future, or do you think that the aging population is something that primary care providers need to get used to in the long-term future?

It's certainly something we need to get used to, and it's only going to get worse. A lot of problems that we have in the United States center around these issues. So even things like Social Security funding are under strain because of this aging population. We’re actually just sort of entering the early phases of this being a major challenge.

: The report goes right into market pressures on health systems’ infusion services and how injection and infusion services are key sources of income for health systems. What exactly are these market pressures and how have they impacted health-system services?

We talked earlier about organizations looking at different ways of controlling costs. The different payer groups are looking at infusions and they're seeing that this is a larger and larger portion of the expense that they have. As people come up with creative ways of navigating this, there's sometimes like an arbitrage, where people identify an opportunity and they try to push things in that direction. One of the things that we talk about in the paper is that there's this difference between out-of-pocket expense for medical benefits versus pharmacy benefits.

In general—so this is broadly speaking—patients have a higher out-of-pocket for pharmacy benefits than they do for medical benefits. A lot of this is because, if you run into a big problem with medical benefits, you hit maximum out of pocket. With pharmacy benefits, [it’s] a little bit less likely that you're going to hit those things. A lot of times, payers have found that if you push drugs that could go either direction towards the pharmacy benefit, the patient out of pocket is greater. And that means the employer contribution would be less; or the payer, the insurance contribution is less. So that is one of the big things that we talk about in the paper: Can they basically apply pharmacy benefit methodology to things that are being given by health care providers?

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.

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Pharmacy forecast. American Society of Health-System Pharmacists Foundation. December 9, 2024. Accessed January 17, 2025. 

https://www.ashpfoundation.org/research/pharmacy-forecast

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

Health System

Q&A: How Health Systems Must Navigate Pharmacy, Medical Benefits

Stemming from lessons learned during the COVID-19 pandemic, the National Community Pharmacists Association (NCPA) announced on Thursday the formation of the Independent Community Pharmacy Consortium for Government Engagement—a network designed to engage community pharmacies and other pertinent drug supply chain entities during future public health emergencies.

“[The Consortium] is bringing together pharmacy services administrative organizations, wholesale distributors, and pharmacy management system vendors to streamline the engagement of community pharmacies in public health initiatives,” read an NCPA news release. “Building on the vital role played during the COVID-19 pandemic, independent community pharmacies across the United States are taking proactive steps to enhance their readiness for future public health emergencies.”

Kurt Proctor, PhD, RPh, President of the Innovation Center and Senior Vice President of Strategic Initiatives at NCPA, recently joined 

“It's an effort to make it easier to include independents because that could be challenging,” he told us. “It could be challenging for those who don't understand how independents are organized and aggregated, and who serves them for what functions, etc. It's meant to be a one-stop-shop for engaging independents.”

Read on to learn more about the NCPA’s Independent Community Pharmacy Consortium for Government Engagement. Also, stay tuned for a full-length podcast version of our conversation with Proctor, touching on several themes highlighted by the NCPA Innovation Center’s brand-new initiative.

Community Pharmacy’s Future Hangs on Advocacy, Support From All Healthcare Professionals

: Can you start by discussing what the consortium is and how it came to be?

We worked with a number of entities as we went through the COVID-19 pandemic, and lots of them worked with each other and helped each other as we went through it. If you go back to the beginning, we learned quickly that we needed to help make including independents easier for government entities. They could call a chain and get whatever stores they have, but it's a different type of entity to engage the independents. As the experience came out of that, we spent a lot of time educating the government about independents—how they're aggregated, how they contract, etc—as we got into the pandemic. As we were winding down in the pandemic, we said, “Okay, we need to be even better prepared as we go forward to meet the needs of the public, independent community pharmacies’ customers, and the communities that they serve.” Therefore, we have to take yet another step forward in making it easy to do business with independents and easy for government entities to include independents in their response. I think independent pharmacies really proved to many that they reach very important populations and that they're a very integral part of an overall response to [an] emergency situation.

In the pandemic, we [didn’t] know what the next response [needed] to be. We started out the pandemic needing to contract and needing to figure out how we're going to engage. The federal government was putting together a federal retail pharmacy partner program. They had contracts that were written for chains and they weren't written for independents or aggregators of independents. We had to kind of educate them about what that was like, what these entities are like, what it takes to engage them, and what relationships exist between aggregators and independent pharmacies. We got over that hump and we [we're] doing the vaccinations. Then, all of a sudden, we had free masks to distribute. It became not a contracting issue as much as it was a physical distribution issue. We went beyond the partners that were in the federal partnership program, certainly included them, but we got the 6 regional wholesalers involved in distributing the free masks and connected them with the strategic national stockpile and arranged for those certain pharmacies who are served by those 6 regional wholesalers to participate and be able to reach their pharmacies and their pharmacies’ customers. Again, it's an effort to make it easier to include independents because that could be challenging. It could be challenging for those who don't understand how independents are organized and aggregated, and who serves them for what functions, etc. It's meant to be a one-stop-shop for engaging independents.

: Aside from the pandemic and independent pharmacies shining as a valuable resource for public health, is there another factor or event that spurred a need for this consortium?

No, I don't think so. Not anything specific. We go back in history to other pandemics, other responses, but it was really this one. One of the events that caught our attention quite strongly was, at the beginning of the pandemic, seeing just the big change represented in the White House Rose Garden ceremony. [We were] saying, “Okay, how are they not engaging independents in this?” Because, especially with the populations that they were most concerned about reaching, that's who our members and independent pharmacies serve to a great degree. It was that visualization from the rose garden that said, along with the others who were represented there from the big-box chains, we need to make sure that we have a way for government entities to engage independents more easily in mass.

The entities that were involved in the Federal Retail Pharmacy Partnership Program cooperated with each other quite a bit in terms of sharing things and talking about “How are you handling this? How are you doing that”—all for the good of the country and the good of the patients that we're serving. I think it demonstrated that there were times and there were topics where it made sense to work together and it made sense to put a common, singular face on independents. We also learned that it's tough to get folks who don't deal with pharmacies all the time to understand independents and understand how they're aggregated. There's such a big learning curve. Folks that had just incredibly large sets of responsibility, we would explain the same thing to them multiple, multiple times. You can't necessarily expect them to remember it all. So, [we’re] putting ourselves out there as the experts about how community pharmacies are organized, who they're affiliated with, how they're aggregated, so that the government doesn't have to try to understand that, because they never will, frankly. [It’s] just [letting] them know that here we are as the easy button again for independents.

: With its focus on bolstering public health, who would you say will benefit most from the consortium’s efforts? Would you say it’s patients, community pharmacies, NCPA partners, or just public health initiatives in general?

Well, we're not trying to replace anything that exists and that functions well today, in terms of the relationship between pharmacies, the business partners they have, and the folks who you can think of them being aggregated by. It's more to be there and to be ready when something happens and somebody needs to engage independents broadly. Again, we’re the easy button for them to do that. At this point, we don't have specific initiatives of our own to undertake other than readiness and making sure that, if the call comes, that we are able to respond to it, that we're able to engage the right people. Depending on what the need is—whether it's contracting, distribution, or dissemination of education and information—all of those things we can facilitate quite easily with a solid understanding of who the players are and how this marketplace works.

McKesson Amplify Initiative Secures Funding for State Pharmacy Associations

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Independent pharmacy partners form new consortium to bolster public health emergency preparedness and response. News Release. NCPA. January 16, 2025. Accessed January 21, 2025. 

https://ncpa.org/newsroom/news-releases/2025/01/16/ncpa-independent-pharmacy-partners-form-new-consortium-bolster

Kurt Proctor, PhD, RPh, President of the NCPA Innovation Center, discussed his organization’s efforts in launching the Independent Community Pharmacy Consortium for Government Engagement.

Q&A: NCPA Announces Independent Community Pharmacy Consortium for Government Engagement

Testosterone replacement therapy Azmiro is now available in the United States for use in male patients who have conditions that are associated with a deficiency or absence of endogenous testosterone, Azurity Pharmaceuticals announced in a release.

The therapy is the first and only prefilled testosterone cypionate injection approved by the FDA.

Azmiro comes as a 200 mg/mL single dose syringe and is intended for intramuscular use. This prefilled option provides greater accuracy and safety by reducing the potential for inadvertent needle sticks and exposure to products while drawing from a vial, as well as a reduced risk of microbial contamination. The safety and efficacy of Azmiro has not been established in men with age-related hypogonadism.

Patient Trust, Active Listening Key to Enhancing Men's Health Care

“Azurity’s purpose is to serve overlooked patients by developing innovative dose forms and formulations to serve unmet needs,” Richard Blackburn, CEO of Azurity, said in a release.

 “The commercial availability of Azmiro offers a convenient prefilled option for healthcare providers administering testosterone to patients.”

Testosterone deficiency, also known as hypogonadism, impacts between 20% to 50% of males in the US.

 The condition increases with age, with a particular rise in men aged 45 to 50 years. Low testosterone can also be caused by some conditions, including Klinefelter syndrome, mumps orchitis, and undescended testicles. Testosterone deficiency can lead to low energy, depression, poor concentration, low libido, and erectile dysfunction.

Testosterone replacement therapy has shown to improve the symptoms of hypogonadism and overall quality of life in patients with low serum testosterone.

Caitlyn Bradford, PharmD

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