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Articles

Cologuard Plus is approved for adults aged 45 years and older who are at average risk for the disease.

FDA Approves New Non-Invasive Colorectal Cancer Screening Test

Social pressures, physiological changes, mental health challenges, and burnout all complicate diabetes management among adolescents.

Beyond Blood Glucose: Addressing Adolescent Diabetes Challenges

Researchers aimed to determine whether or not opioids were appropriate for treating adolescents experiencing chronic pain.

Multimodal Approach Suggested for Treating Pain Amongst Adolescents

Check out important updates from the FDA for the week of September 30.

FDA Roundup: Biosimilar Approval, Hereditary Angioedema Treatment Receives Orphan Drug Designation

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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

Don’t get left behind: Sign up today for our 

 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

Steven C. Anderson, FASAE, CAE, IOM, president and CEO of the National Association of Chain Drug Stores (NACDS), sat down with 

 during the 2024 NACDS Total Store Expo to discuss the challenges of pharmacy benefit managers (PBMs) in the current market and the importance of grassroots advocacy in powering Congressional reform.

Drug Topics: How can PBMs and their practices be regulated to ensure fair competition and transparency in the industry?

They don't have transparency now; they don't they don't foster competition. It's a highly consolidated market, with the “Big 3” PBMs controlling about 90% of the business.

We've been very active at the federal and state level on this. We've helped enact 150 new laws over the last 3 years. We're working on Capitol Hill on this issue, and at the regulatory [level]. The 

 has been investigating PBMs for 2 years. They issued an interim report last month [in July 2024], and we're hoping that the final report will come out and in [the report] there will be certain recommendations that they're suggesting to make the market more competitive.

At the same time, [PBMs are] forcing pharmacies to accept these contracts that are untenable; it's not sustainable. PBMs have been hiding behind this complexity—the opaqueness—of the industry, of people not understanding it, and now people are beginning to understand. We've got bipartisan support in a 

. We have Republicans and Democrats fully understanding PBMs, where in the past they really didn't understand it. It was complicated… Try to tell a member of Congress what a direct and indirect or remuneration fee…is, and what a PBM is… Now they get it. As their understanding deepens, their voices rise, their eyes kind of light up, saying, ‘We're going to fix this, because it's not good for our country.’

New Report Scrutinizes PBM Spread Pricing Practice

Drug Topics: How can pharmacies leverage their collective voice to maintain momentum and pressure congress to act on PBM reforms?

There's a strength in the power of the voters. [As] we’re coming into this election year…we find members of Congress being much more responsive when they're on the ballot, right? You have the whole House of Representatives up for reelection this year, and about one-third of the Senate.

We have mobilized an incredible grassroots network of people within pharmacy to contact their members of Congress. We do congressional pharmacy tours; we get the Senators and we get the House members into the pharmacies, so they can actually get behind the pharmacy counter and see [not only] what the pharmacist does from a broader health and wellness issue in addition to dispensing drugs, but also about the potential of, they could do much, much more that they're currently not allowed to do, or are not getting paid for.

When they get in there, members of Congress realize, on the PBM issue, that PBMs hurt their constituents, our [pharmacist’s] patients. They hurt employers; they raise costs for employers, not cut costs for employers, and they're destroying communities. They're forcing pharmacies to close and having people drive very long distances to get their prescriptions filled by a pharmacist. That 

 is really one of our great powers at NACDS. It's really a superpower, I guess I would call it.

The 2024 NACDS Total Store Expo was held August 17 to August 19, 2024, in Boston, Massachusetts. 

The National Association of Chain Drug Stores is active at both the federal and state levels in advocating for PBM reform. 

Q&A: NACDS President and CEO on PBM Reform and Grassroots Advocacy

More than 50% of Americans are living with at least 1 chronic health condition. Spending around these conditions continues to grow, including upwards of $100 billion per year on excess hospitalization and $528 billion on the misuse, underuse, and overuse of medications per year. The solution, proposed Jon Easter, lies with pharmacists.

In a presentation at the 2024 National Association of Chain Drug Stores (NACDS) Total Store Expo, held August 17 to August 19, 2024 in Boston, Massachusetts,

 Easter—a professor of practice, the vice chair of practice advancement, PACE division, and associate faculty director at the University of North Carolina Center for the Business of Health—highlighted the crucial role of community pharmacists in a research project-turned-real–world program that has both improved patient outcomes and allowed pharmacists to be paid for their clinical work.

“Affordability of health care is difficult now, and becoming more difficult,” said Easter. “It’s also impacting our country.” As national debt increases, the high health care spend—anticipated to make up nearly 20% of the US gross domestic product by 2030—“will continue to have an impact on our debt, as well as [on the United States] as a competitive country.”

Transforming Diabetes Interventions Into Sustainable Programs for Pharmacy

Much of that spend, Easter noted, goes to hospital care. By the time patients require that level of health care, they very well may have already experienced acute exacerbations, inadequate treatment, and other issues due to chronic diseases. “We’re not doing a very good job as a country on prevention and treating proactively,” Easter noted.

According to the most recent CDC data from 2021,

 an estimated 11.6% of the US population, or 38.4 million people, had diabetes, including 14.7% or 38.1 million US adults. Within this group, 8.7 million individuals were undiagnosed. In 2022, the total cost of diagnosed diabetes reached $412 billion in both direct and indirect medical costs in 2022. According to the American Diabetes Association, after adjustments were made for population age and sex differences, the “average medical expenditures among people with diagnosed diabetes were 2.6 times higher than what expenditures would be in the absence of diabetes.”

Unfortunately for North Carolinians living in one of the 70 of 100 North Carolina counties classified as rural, 

 remains a significant challenge. “We have access issues,” Easter said. “We have worse outcomes when it comes to diabetes and economic conditions. We have health equity issues, social determinants that are more prevalent. As a state…health care is a huge challenge. But it’s also an incredible opportunity for pharmacy to solve a problem.”

It was with that backdrop that Easter and his colleagues, including the NACDS Foundation, who provided funding for the project, began working to address the high costs of diabetes care in the state.

The 3-step program included steps for patient identification, screening and pharmacist consultation to identify at-risk patients, and provider communication to refer at-risk patients and patients with diabetes with an HbA1c level greater than 8% for intervention. The intervention itself consisted of 6 sessions, focused on different aspects of 

: general diabetes education, nutrition and exercise education, blood sugar education, heart disease, blood pressure, and cholesterol education, self-care education, and a health education session review. Sessions were conducted either over the phone or in person in a community pharmacy setting.

A total of 21 sites across 5 states participated in the research project, including small and large independent chains and large grocers in both rural and urban areas. This variety in project sites, Easter noted, was important to make sure that the intervention implementation “could be flexible based on which environment we were in, which gives us a better shot at repeating it sustainably and scaling it up at the end.”

Implementation itself was focused on 3 core areas: replication, sustainability, and success. “It’s starts with a useful intervention,” Easter said. “You have to have a defined intervention; what is it that you’re actually going to do?” Crucially, it must also be measurable: clinical metrics “[are] the currency by which our payers and providers and others want to see what pharmacy contributes to an overall project. What is the pharmacist contributing that is an addition to what a provider, case manager, [or other provider] can contribute?” These metrics—HbA1c, blood pressure control, the Patient Health Questionnaire-9—can be directly tied to the work that pharmacists are doing.

Overall, the outcomes of Easter’s project were positive: Throughout the research period, HbA1c reduced by a half-point, from 9.5% to 9%; pre- and post-intervention measures of disease state education knowledge improved in all 5 areas, as did patient quality of life. And although patient satisfaction wasn’t measured before the intervention, 100% of participants indicated at the conclusion of the program that they were satisfied with the education they had received.

Evaluation of pharmacist satisfaction, however, painted a slightly different picture. Intervention acceptability increased slightly and appropriateness remained flat, but when asked about feasibility and intent to sustain, interest in the intervention declined. Part of the feasibility issue, Easter explained, “was [that] we were still in the midst of coming out of COVID-19, and these pharmacists were reworking their workflows to incorporate this project. What they shared with us was, ‘We’re getting paid for our vaccinations; we’re not getting paid for this project.’”

That’s where Jasmine Perry, PharmD, CPHQ, and Blue Cross and Blue Shield of North Carolina come in. Perry is a senior clinical pharmacist at Blue Cross and Blue Shield of North Carolina, and has worked to develop 

, a partnership with North Carolina community pharmacies “to leverage free, enhanced services provided by pharmacists” as a means to increase access to high-quality health care for members of Blue Cross and Blue Shield North Carolina living with chronic health conditions.

In June 2023, a pharmacy advisory group, including Perry, Easter, the UNC Eshelman School of Pharmacy, CPESN, the North Carolina Association of Pharmacists, and technology vendor DocStation among others, came together to figure out how to extrapolate the data from Easter’s research into a real-world intervention.

“With this program, we’re closing a couple of gaps,” Perry explained. “The first is the gap of pharmacist reimbursement; we’re now incentivizing pharmacists to do the clinical work that they had been doing previously at no cost. We’re also closing clinical gaps: Improvement in HbA1c, improvement in blood pressure, and alignment with [Pharmacy Quality Alliance] quality metrics. And beyond that, we’re leveraging the work that independent pharmacies have done and giving that information to our members.”

Through continued collaboration, Perry hopes to see continued growth of More Than A Script, expanding beyond independent pharmacy to other types of pharmacy organizations while advancing clinical practice. The team is also working to standardize the work they’re doing, to create an approach that can be utilized by other states, tweaked to fit their specific populations. “Through partnerships, through the work that’s been done…we’ve been able to develop this innovative, value-based care program in a space where we hadn’t seen a program done like this before,” Perry said.

Ready to catch up on the rest of our conference coverage? 

 of the 2024 National Association of Chain Drug Stores Total Store Expo.

Easter J, Perry J. Leveraging diabetes care research to drive impact. Presented at: 2024 National Association of Chain Drug Stores Total Store Expo; August 17-19, 2024; Boston, MA.

National diabetes statistics report. CDC. May 15, 2024. Accessed August 19, 2024. 

https://www.cdc.gov/diabetes/php/data-research/index.html

Statistics about diabetes. American Diabetes Association. Updated November 2, 2023. Accessed August 19, 2024.

Trautman S. More Than a Script: Partnering with community pharmacists. Blue Cross and Blue Shield of North Carolina. Published July 23, 2024. Accessed August 19, 2024. 

https://www.bluecrossnc.com/blog/expert-takes/more-than-a-script

A collaboration with Blue Cross and Blue Shield of North Carolina focused on commercial populations has improved care and lowered costs in the state. 

A Diabetes Intervention in Community Pharmacy Drives Value-Based Health Care

Last month, 3 major drug distributors agreed to pay $300 million in a class action settlement, answering for each company’s role in fueling the US opioid epidemic. Despite not admitting wrongdoing, the companies are expected to facilitate the resolution upon judge’s approval, with McKesson, Cardinal Health, and Cencora taking responsibility for 38.1%, 30.9%, and 31% of the total $300 million lawsuit, respectively, 

 article, the recent $300 million lawsuit will be added on top of a 2022 agreement to settle $26 billion between multiple drug distributors and state and local governments. Along with McKesson, Cardinal Health, and Cencora, this settlement also included Johnson & Johnson.

With several lawsuits being settled as of late, federal and local governments are beginning to allocate responsibility to specific parties—mainly drug distributors—for the ongoing opioid epidemic in the US.

Regarding the August 2024 settlement, litigation support consultant Meredith Rosenthal, MD, Health and Policy Professor at Harvard University, played a significant role in identifying the reasoning behind drug distributors’ responsibility for issues fueling the epidemic. She further explained how distributors forced health benefit payors to back their patients into a corner regarding opioid prescriptions.

“A fixed settlement to compensate [third party payors (TPPs)] for overcharges related to opioid marketing should be allocated in a way that reflects the relative burden of opioid overuse borne by individual TPPs. This relative burden can be approximated by comparison of TPPs’ estimated spending on opioids and the health care sequelae of opioid addiction (e.g., emergency department visits for opioid overdose),” said Rosenthal, according to the court filing.

Unlike the 2022 agreement, resolved between distributors and local governments, this settlement involved the 3 drug distributors’ involvement with health insurers and benefit plans. Plaintiff lawyer Paul Geller further elaborated on how funds were “largely paid for the overprescribed and overmarketed pills and for the treatment required when their plan beneficiaries inevitably suffered opioid use disorder.”

McKesson, Cardinal Health, and Cencora will share the settlement payment, resolving claims that the companies were significantly involved in fueling the US opioid epidemic.

Caitlyn Bradford, PharmD

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