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Articles

A recent systematic review and meta-analysis found that almost half of all patients with type 2 diabetes were deficient in multiple micronutrients.

Micronutrient Deficiencies Common Among Patients With Type 2 Diabetes

Natalie DiPietro Mager, PharmD, PhD, discusses the role of community pharmacy in maternal health.

Q&A: Raising Awareness About Maternity Care Deserts Among Community Pharmacists

Scott Nelson, PharmD, MS, FAMIA, ACHIP, discussed the increasingly crucial role artificial intelligence has played in streamlining pharmacy services.

Q&A: The Rise of AI in Alleviating Health Care Workforce Challenges

Researchers analyzed liveborn infant data from January 2020 to June 2024 to determine prevalence, cause, and treatment strategies for pain among preterm infants.

Gestational Age Associated with Pain Among Very Preterm Infants

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Scott Nelson, PharmD, MS, FAMIA, ACHIP, is a pharmacist and Associate Professor in the Department of Biomedical Informatics at Vanderbilt University Medical Center. Nelson is the Director of the Master of Science in Applied Clinical Informatics (MS-ACI) online program, and currently works in Medication Safety Informatics in HealthIT, with a focus on medication reconciliation, e-prescribing, artificial intelligence, and clinical decision support at Vanderbilt University Medical Center.

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.

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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 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.

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. 

. 2024;82(2). doi.org/10.1093/ajhp/zxae280

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

For a very small and rare proportion of the US population, treatments for rare diseases that cost upwards of $1 million have become an increasingly significant issue within health care because of their egregious costs but continued patient reliance. Highlighting a challenge between payers, patients, and providers to distribute and access rare medications, these drugs have since been defined by the American Society of Health-System Pharmacists (ASHP) as “ultra-high-cost drugs.”

“With the health care system that we have in the United States, with mostly commercial payers—but also [the] government being one of our largest payers—we end up in a situation where the payers decide if they're going to cover a specific, very, very high-cost treatment or not. In some cases, there are other treatments for these disease states as well. So that makes that coverage decision that much more difficult,” said Erin Fox, PharmD, MHA, BCPS, FASHP.

Fox helped co-author a section of the ASHP 2025 Pharmacy Forecast—an annual report detailing opportunities and challenges pharmacy leaders may face in their profession in the near future. She joined 

 to discuss her section of the report, titled “Managing Ultra-High-Cost Drugs,” and the complexities within US health care that allow these costs to persist.

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

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

: To begin your section of the report, you mention the ultra-high costs of gene and cell therapies because of their rare use within the market, accounting for just 0.8% of total pharmaceutical spending. Can you further explain why these drugs are so expensive and why payers have such a hard time accessing them?

When you think about a very rare disease and all of the work and effort that goes into making a treatment for that, when only a few people will actually ever need that treatment, we don't have the economies of scale that we get with other drug development. At the end of the day, these treatments end up being very high cost.

Then, with the health care system that we have in the United States, with mostly commercial payers—but also government being one of our largest payers—we kind of end up in a situation where the payers decide if they're going to cover a specific, very, very high-cost treatment or not. In some cases, there are other treatments for these disease states as well. So that makes that coverage decision that much more difficult.

: According to the report, one of the key issues leading to ultra-high-cost drugs is the absence of a sustainable payment model. Can you tell us what an improved payment model might look like? How would that model differ from previous structures that have contributed to higher-cost drugs?

Right now, many people switch insurance plans every year, in some cases. You have that open enrollment period, and then you can switch your payer. If you're on the payer side, you want to know that, if you're going to cover say a $3 million therapy that's going to last perhaps even a lifetime, that you want that patient to stay with you in your health plan. But we don't have any guarantees like that. I think we need to think of a different model for paying for these products that kind of gives a little bit of risk to all of the different parties. We have hospitals who would have to pay for the actual product.

We might get value-based contracts between a payer and a manufacturer where, let's say the patient doesn't get the full benefit of the treatment, then perhaps the manufacturer gives a rebate back to the payer. But what's forgotten in that value-based contracting step is what happens to the hospital that actually paid the $3 million in the first place and did all the work to administer the product to the patient. We need to make sure that we're including health systems in these value-based contracts that could provide a little bit more sustainability for these ultra-high-cost drugs.

: What is ethical allocation and how can it be utilized to benefit patients in need of ultra-high-cost drugs?

[It’s] such a tricky subject because I think, with the health care system that we have in the US, I'm not sure that we actually even have ethically available care. Not everybody has access to care. So, we're already dealing with an unethical situation where we have ‘haves’ and ‘have nots.’ But really, it's going to come down to, if you want to access one of these high-cost treatments, it really will depend on your insurance. Some people have more choices than other people.

And of course, folks that have more assets than others are going to have more opportunities to access these products as well, even things like having the resources available to maybe go to a different state that offers that treatment, or a different city, stay in a hotel, and all of those extra resources that add costs. Not every patient can afford that. I think it's really tricky to think about how we truly make sure that, of a group of 10 people who all could truly benefit from an ultra-high-cost drug, how do you decide if all 10 can access it, or how do you decide which patients are left behind?

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Erin Fox, PharmD, MHA, BCPS, FASHP, discussed the 2025 Pharmacy Forecast and its perspective on managing ultra-high-cost drugs.

Q&A: Ultra-High-Cost Drugs Highlight Complex US Health Care System

The US health care system is facing a primary care physician shortage that is expected to reach 50,000 by the end of 2025. Compounded with an aging population in need of life-saving medications, as well as an increased prevalence of chronic conditions, health care experts are urging providers to play their role in addressing this gap.

“There are just fewer people that go into primary care, and [there are] challenges that arise because of that. There's been some positive signs with physician assistants, with nurse practitioners that are entering that area to shore up the primary care gap. But at the same time, while right now that looks fairly robust, there is still the concern that [it] also is going to start ticking towards specialty care, and we're going to wind up in the same place if we don't take a really close, hard, clear-eyed look at primary care as something we need to really focus on,” said Jonathan Watanabe, PharmD, MS, PhD, BCGP, co-author of the 2025 Pharmacy Forecast.

Watanabe co-authored a section titled “Addressing the Gap in Primary Care” from the American Society of Health-System Pharmacists (ASHP) 2025 Pharmacy Forecast—an annual report detailing opportunities and challenges pharmacy leaders may face in their profession in the near future. He sat down with 

 to discuss the factors leading to primary care gaps and what possible federal interventions industry leaders can be on the lookout for.

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.

: The pharmacy forecast owes the gap in primary care to an expanding shortage of primary care providers, an aging society, and an increased prevalence of chronic conditions. Are there other noticeable gaps in primary care, or are these the key factors that health systems are looking to tackle?

 I think you've covered most of them. I know that what we describe in the data, in terms of the impetus, is that 75 million people in the United States live in primary care health workforce shortage areas. The estimate of primary care physician shortage is expected to reach nearly 50,000 by this year. Every metric we see is that we've got an identifiable shortage of primary care access, particularly for physicians, and that's unexpected to continue. A lot of it is due to the reasons you mentioned: rapidly aging population that utilize more medications. Most people over 65 have 2 or more disease states, are on multiple medications. So those, in itself, with more than 12,000 older adults that turn 65 plus each day in the United States, we just have this exponential growth. We know that there's those key components, fewer primary care providers, the rapidly aging population, increased use of medications. A lot of these things are actually because we have advances in terms of the increase in medications.

But on top of that, to your question, I think there are other factors. It's that low reimbursement for primary care activities that I think we're going to really have to grapple with. There are just fewer people that go into primary care, and the challenges that arise because of that. There's been some positive signs with physician assistants, with nurse practitioners that are entering that area to shore up the primary care gap. But at the same time, while right now that looks fairly robust, there is still the concern that that also is going to start ticking towards specialty care, and we're going to wind up in the same place if we don't take a really close, hard, clear-eyed look at primary care as something we need to really focus on. I think that's a segue to the rest of our discussion; that’s a great place for pharmacists to have an increasing role, almost sadly. I think to some ways, they're going to have an increasing role whether we pharmacists choose it or not because more patients just go to their pharmacist, go to their pharmacy, as a place that I almost think is primary [to] primary care. They'll try to access their pharmacy, ask questions, get the vaccinations, testing when it's available. Many times, that's the option that they seek before they even reach out to their primary care provider. We witnessed that during the pandemic, and that's not going to be lost on society forever. That's informing more federal health policy. I think that these are the things that really resonate [and won’t] subside, at least anywhere in the near-term future with the way population level projections are heading.

: In many cases, when health care providers do not have the resources and tools to alleviate a nationwide issue, they look to the federal government to enact change. The report mentions federal efforts to address the gap in primary care and the government’s possible responses. Can you summarize what those responses might be and which you think may be enacted in the near future?

I think, based on the responses from the forecast itself, 60% [of forecast panelists] will declare a primary access crisis in the next 5 years. But whether there's going to be strong movement towards something specific, I think that was a lower percentage, if I remember correct. What could occur is calling it a primary care access crisis, which we've seen in other public health emergencies—opioid use disorder, pandemic. But I think the federal agencies have been nonspecific about what that's going to entail. I think it's been well stated. You can look on the websites and you can see that they're calling this an access issue. But, it's been very general about how that needs to be addressed. And I think that's because there is some level of uncertainty about what's going to be feasible, what's going to be palatable, what's going to be effective.

I think that simply making mandates hasn't been addressed yet, because I think that there probably materially is some concern about if it's going to be effective, if it's going to be feasible. Who are going to be the actors that are going to operationalize those things? I think those things are still undetermined. I certainly can't say exactly how that would manifest, and I think that's sort of what you're seeing. There’s a real acknowledgement that we have a crisis in terms of primary care access, which impacts so many things, including specialty. There's been studies that have shown that. How do we specifically develop mandates to address it? I think that still is TBD. But many systems, many settings, many regions, many states, they are taking action. What that group has also discussed is likely steps will be taken at the regional level, at the state level, if not federal. I think that [there is an] acknowledgement that it's an access crisis, but yet, we're not seeing necessarily federal interventions. That's not to say that things aren't going to be done. It just may be approached at something that's more provincial, if you will.

Jonathan Watanabe, PharmD, MS, PhD, BCGP, discussed a section of the ASHP 2025 Pharmacy Forecast that he co-authored titled “Addressing the Gap in Primary Care.”

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.”

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.

Scott Nelson, PharmD, MS, FAMIA, ACHIP

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