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The CDC confirmed another human bird flu case, marking the first instance of the virus in a human without occupational exposure to infected birds or dairy cattle during the 2024 outbreak.

First Human Bird Flu Case Without Exposure to Infected Animal Discovered in Missouri

Whereby gastroparesis can hinder the absorption of oral medications in the stomach, Tonix Pharmaceuticals is promoting alternative migraine treatments that bypass the digestive system. 

Tonix Pharmaceuticals Launches Campaign Promoting Non-Oral Medications for Gastroparesis, Migraine

LEO Pharma presented data from 2 of the largest multinational real-world studies on the prevalence, severity and treatment of chronic hand eczema at the European Society of Contact Dermatitis congress.

Chronic Hand Eczema Studies Show Condition is Common, Burdensome

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Now Trending: Simplified HIV Treatments, Lesser-Known Social Detriments of Health

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What pharmacists need to consider before selling CBD in their stores.

Use This Checklist To Select Your CBD Product 

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

With Medicare open enrollment fast approaching for the 2025 plan year, the National Community Pharmacists Association (NCPA) addressed the Centers for Medicare & Medicaid Services (CMS), urging them to create guardrails for independent pharmacies to stay protected against predatory pharmacy benefit manager (PBM) contracts. With Medicare Part D plans constituting a significant portion of community pharmacies’ businesses, NCPA prompted CMS to establish fair protections for the upcoming year, preventing PBMs from locking independent pharmacies into unfair, long-lasting contracts.

“To alleviate the crisis that pharmacies are facing in Medicare Part D, NCPA asks CMS to provide regulations outlining Part D pharmacy contracting guardrails to ensure fair and common-sense contracting between Part D plans/PBMs and pharmacies. This is essential to eliminate abuses in contracting practices and processes from Part D plans and PBMs, and to ensure patient access to accurate information to select their pharmacy of choice,” wrote B. Douglas Hoey, RPh, MBA, CEO of NCPA, in a letter to CMS Administrator Chiquita Brooks-LaSure and Meena Seshamani, MD, PhD, CMS deputy administrator and director of the Center for Medicare.

On average, 36% of a community pharmacy’s revenue consists of Medicare Part D plans.

 With such a high proportion of independent pharmacy businesses relying on Part D reimbursements, NCPA’s goal is to convince CMS to mediate the relationships between PBMs and independents. Since declining reimbursements and unfair contracting are 2 significant issues in the fight between PBMs and community pharmacies, CMS has an important role to play regarding Medicare benefits come the start of the 2025 plan year this coming January.

Medicare open enrollment—officially known as the Medicare Annual Enrollment Period (AEP)—starts on October 15 and ends on December 7, with benefits going into effect on January 1 the following year. Before AEP begins on the 15th, insurers update their Medicare coverage plans on October 1 every year. Beneficiaries then have until December 7 to reassess their Medicare coverage prior to being locked into the next year’s coverage plan.

Drug Companies to Pay Medicare Rebates if Prices Rise Faster Than Inflation

Ahead of AEP starting next month, NCPA has attempted to garner the attention of CMS in multiple areas of Part D plans. While there is not much time for all opinions to be considered, NCPA is simply proposing a better-leveled playing field between PBMs, insurers, pharmacies, and the millions of plan beneficiaries across the US.

But most importantly, in the eyes of NCPA, their recent letter to CMS is urging Medicare Part D to prioritize independent pharmacies, their contracts with PBMs, and their much-needed Part D profits.

“Among other things, NCPA is urging CMS to require Part D plans/PBMs to notify pharmacies or their contracting entities about the pharmacies’ network status for the upcoming plan year, and that the contracts themselves must be opt-in, signed, and finalized prior to October 1 each year; require plans/PBMs to make their standard contracts available upon request from interested pharmacies no later than the first week of June of each year when Part D bids are due to give pharmacies and their contracting entities enough time to adequately analyze and negotiate a PBM contract; require that contracts be offered anew every year, with payments and networks that cannot be changed without further negotiation and consent of all parties to the contracts; and require that plans/PBMs cannot ‘bundle’ or ‘tie’ participation in one network to another non-Medicare Part D network,” wrote NCPA in a recent news release.

With a specific focus on PBM contracts and how they are distributed to participating pharmacies, NCPA’s requests are all regarding contract terms and are designed to create more transparency between independents and PBMs for the upcoming Medicare plan year. One specific highlight among these requests is the suggested regulation to have contracts be offered anew each year, giving pharmacies more leverage to negotiate their contracts with PBMs as well as opportunities to seek out other options for Medicare Part D coverage.

While CMS has yet to make an official statement regarding NCPA’s letter, information regarding Medicare Part D plans and AEP for 2025 is expected to be released in the next few weeks as important enrollment dates approach.

“If contracts are for more than 1 year, pharmacies find themselves in a relationship with plans/PBMs similar to the Eagles’ ‘Hotel California,’ which they can never leave. We believe that plans/PBMs are attempting to lock our members into multiple-year contracts to game CMS’ pharmacy access standards in Medicare Part D,” concluded Hoey.

Simulation Highlights Substantial Medicare Savings Due to IRA Drug Price Negotiation

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1. Hoey BD. Regulating fair and common-sense contracting guardrails between Part D plans/PBMs, and pharmacies. NCPA. September 4, 2024. Accessed September 5, 2024. 

https://ncpa.org/sites/default/files/2024-09/9.4.2024-NCPAtoCMS-ContractGuardrails.pdf

2. NCPA Pushes CMS for Regulations Outlining PBM Contracting Guardrails. News Release. NCPA. September 4, 2024. Accessed September 5, 2024. 

https://ncpa.org/newsroom/news-releases/2024/09/04/ncpa-pushes-cms-regulations-outlining-pbm-contracting-guardrails

3. Renneke A. Medicare annual enrollment period guide 2025. 

https://www.healthpartners.com/blog/medicare-open-annual-enrollment-period-aep/

As Medicare open enrollment begins, the NCPA is urging CMS to facilitate appropriate PBM contracting for pharmacies in the upcoming plan year.

NCPA Calls on CMS to Establish PBM Protection for Independent Pharmacies

Traditionally cast in roles of strength and resilience, men frequently underreport or delay treatment for pain. Unlike women, who are more likely to seek medical attention, men often downplay their symptoms or suffer in silence. This reluctance to seek help has serious consequences, contributing to higher rates of cancer, heart attack, and stroke among men.

However, this isn't entirely a matter of personal choice.

"There's a lot of societal perceived norms that certainly come into play," said Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, professor at WVU School of Pharmacy, host of the Pain Pod, and alternatively known as the Pain Guy. Namely, phrases like "man up," "tough it out," or "don't be a baby" perpetuate ideas that men should be able to endure pain without complaint. "Depending on how far it gets drummed into our brains, [it] will dictate how we proceed and how we roll with [pain] going forward, of course."

, Garofoli delves deeper into the challenges men face when it comes to acknowledging 

, underscoring the critical need to dismantle the surrounding stigma. By openly discussing their experiences, men can provide support to one another and inspire others to seek appropriate medical attention.

According to Garofoli, bringing it up in conversation may make all the difference.

"Don’t worry about being that guy," says Garofoli. "If you have a group of 10 people and they're your friends and you bring something up, and they're like, 'Yeah, that was weird,' but 1 of them then goes and gets care that they wouldn't have gotten, well go home and feel good."

1. Improving men’s health. News Release. USA Gov. May 23, 2024. Accessed August 7, 2024. 

https://www.usa.gov/features/improving-mens-health

Mark Garofoli delves deeper into the challenges men face when it comes to acknowledging pain, underscoring the critical need to dismantle the surrounding stigma.

Breaking the Pain Barrier in Men's Health

At the National Community Pharmacists Association (NCPA), Steve Postal, JD, Director of Policy and Regulatory Affairs, helps independent pharmacies advocate for change in the pharmacy benefits space. While it’s no secret that pharmacy benefit managers (PBMs) hold an immense amount of power in influencing drug pricing, many legislative vehicles have been put into motion to give some of that power back to smaller pharmacies.

“Pharmacy benefit managers (PBMs) play a major role in the provision of pharmacy services by acting as the intermediary between pharmacies, plan sponsors (insurance companies and employers), pharmaceutical manufacturers, and drug wholesalers. Over the decades, PBMs have expanded their influence in the pharmaceutical supply chain and now handle claims processing, formularies, pharmacy networks, mail-order pharmacies, and contracting with wholesalers and manufacturers. As their role and visibility have increased, PBMs have come under increased scrutiny from policymakers,” wrote authors of a study published in 

In our chat with Postal, he discussed major changes in the PBM space regarding state legislation. While federal legislation that takes power away from PBMs is the ultimate goal, movement on the state level has been much more possible for local pharmacists and their state pharmacy associations.

“I think, on the state level, state advocacy can be much closer to the ground and there tends to be more grassroots involvement, which is a good thing. Pharmacy too is often typically more of a state-regulated issue,” Postal told 

Listen to the full-length version of our discussion with Postal on 

 and discover some incredible insights into what needs to be done to curb the growth and power PBMs have overtaken in recent decades.

Q&A: What the NCPA is Doing to Fight Back Against PBMs

1. Mattingly TJ, Hyman DA, Bai G. Pharmacy benefit managers: history, business practices, economics, and policy. 

. 2023;4(11):e233804. doi:10.1001/jamahealthforum.2023.3804

Steve Postal, JD, Director of Policy and Regulatory Affairs at the National Community Pharmacists Association (NCPA), sat down with Drug Topics to discuss Pharmacy Benefit Managers.

NCPA Representative Discusses Role in Influencing PBM Reform

A clearance Superman costume was the most valuable $20 that Mayank Amin, PharmD, RPh, MBA, has ever spent in his life.

The date was February 7, 2021. With COVID-19 vaccines newly available, people tired of following stay-at-home orders and mask mandates across the country were desperate to get shots in their arms. The Kansas City Chiefs were facing off against the Tampa Bay Buccaneers in the Super Bowl later that evening, and where Amin had planned a COVID-19 vaccination clinic, a blizzard swept through Montgomery County.

Employees and volunteers insisted that Amin cancel. But driven by his entrepreneurial spirit and commitment to help the community, he refused.

In the back of his store hung a Superman suit he had previously worn once to drop off medication at a resident’s doorstep. Remembering the look on the child’s face who had answered the door to an unexpected delivery from Superman, he weighed wearing it to administer vaccines.

“I asked [the volunteers], ‘Guys, what do you think if I just put this costume on and went to the firehouse where we’re having this clinic and just walked in dressed as Superman with the vaccines in hand?’” recounts Amin, owner and chief patient advocate at Skippack Pharmacy, on that cold Super Bowl Sunday. “They’re like, ‘Dr. Mak, that would be stupid if you didn’t wear it. Just put it on.’”

With the help of the community—and dressed as Superman—Amin vaccinated thousands of individuals. What started as a gag purchase became so much more to pandemic-weary residents.

“The amazing thing about our clinics is that they spread messages of love and positivity,” Amin says. “So, in a time of negativity, this costume fueled positivity.”

, Amin discusses his journey as the Superman Pharmacist and expresses hope for the future of community pharmacy. “We’re gonna get through this together,” he says.

Check out part 2 of our conversation with Amin

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

In part 2 of the latest episode of Over the Counter, Mayank Amin, PharmD, RPh, MBA, discusses his journey as the Superman Pharmacist and expresses hope for the future of community pharmacy.

Tim Gregorius, RPh

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