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“Reducing abdominal adiposity may be considered a target for chronic pain management, particularly in those with pain in multiple sites and widespread pain,” wrote investigators.

Excess Abdominal Fat May Contribute to Chronic Musculoskeletal Pain

Researchers looked for a better understanding of medical debt and what type of role the US government plays in lessening the burden on patients and their health care costs.

Understanding Medical Debt, Complexity of US Health Care System 

Viridian Therapeutics also said it has completed enrollment for a second phase 3 trial of veligrotug, THRIVE-2, and expects topline data to be available by the end of this year.

Thyroid Eye Disease Treatment Shows Positive Results in Phase 3 Trial

Researchers explored an alternative pharmacist education intervention as a way of improving pharmacist-patient conversations and decreasing vaccine hesitancy among patients.

Community Pharmacist Education to Combat Vaccine Hesitancy

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A compounding leader takes issue with FDA's position that compounding is the production of a new drug that needs to be approved.

FDA's stand on compounding is bad for R.Ph.s and patients

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 the avian influenza (H5 bird flu) outbreak persisting amongst US dairy cattle and poultry farms, the CDC reported last week the first known human case of the virus existing in an individual who had no contact with infected animals. The patient, who had underlying health conditions, was hospitalized in Missouri, treated with antiviral medications, and eventually discharged, making a full recovery.

Despite the CDC’s messaging that a bird flu outbreak among humans is unlikely, as well as the patient’s ability to recover, it is a major concern for the CDC that the virus is morphing to infect humans.

“This is the 14th human case of H5 reported in the US during 2024 and the first case of H5 without a known occupational exposure to sick or infected animals. H5 outbreaks in cattle have not been reported in Missouri, but outbreaks of H5 have been reported in commercial and backyard poultry flocks in 2024. H5N1 bird flu has been detected in wild birds in that state in the past,” wrote the CDC in a news release.

With no bird flu outbreak among Missouri dairy cattle and the patient not coming into contact with infected animals, it is uncertain how exactly the patient contracted the virus. As the CDC and other government agencies continue to monitor samples of the virus and its overall spread, they still claim that risks of it infecting mass amounts of humans “remains low.”

According to the CDC, there has been a total of 14 patients who have reported a positive case of the bird flu since 2022. Further portraying its containment efforts, the CDC has also monitored over 4800 individuals exposed to infected animals and tested over 240 individuals who have reported exposure.

“Bird flu has been on the rise among cows in the US this year. An outbreak was first reported in March and cattle in 14 states had been affected as of September 3,” wrote Kayla Epstein for 

Bird Flu Infects Second Human as Outbreak Continues

The CDC and US government have been working together since March—when just the second ever bird flu case was reported in a human in the US—to curb the spread of bird flu among dairy cattle and poultry farms across the Midwest. However, despite concerted efforts from a slew of organizations, the outbreak has continued and is now affecting humans; an occurrence that the CDC is continuing to mark as “unlikely.”

According to the CDC’s current data, 100,713,651 poultry have been infected with the bird flu and the virus remains prominent in 196 dairy herds across 14 states.

 While monitoring humans, dairy cattle, and poultry across the country remains of equal importance to the CDC, the bird flu issue has negatively persisted under the watch of the US government.

One specific way the CDC is monitoring individuals, and the reason they were able to detect the virus in a patient with zero occupational exposures, is through various influenza surveillance systems.

“CDC continues to closely monitor available data from influenza surveillance systems, particularly in affected states, and there has been no sign of unusual influenza activity in people, including in Missouri,” continued the CDC.

While this recent news and ongoing monitoring continues, it is important for the general public to understand that a bird flu infection is highly unlikely but certainly not impossible. With only 14 known human cases and a bulk of the virus persisting predominantly in dairy cattle and poultry farms in the Midwest, a national bird flu emergency is far from necessary as human outbreaks remain unlikely.

However, the virus still remains an issue and as the CDC and other government agencies attempt to stop the spread and keep it away from humans, the potential eradication of the bird flu remains an uphill battle. And with this being the first non-occupational exposure to the virus, further investigations are still necessary for experts to gain a better understanding of the H5 bird flu.

“The results of this investigation will be particularly important in light of the current lack of an obvious animal exposure. It is important to note that, while rare, there have been novel influenza A cases where an animal source cannot be identified. The main concern in these situations is that no onward transmission is occurring. Findings from the ongoing investigation will inform whether guidance changes are needed,” concluded the CDC.

To stay caught up on Drug Topics’ news regarding the 2024 bird flu outbreak, be sure to check out our 

1. CDC confirms human H5 bird flu case in Missouri. News Release. CDC. September 6, 2024. Accessed September 9, 2024. 

https://www.cdc.gov/media/releases/2024/s0906-birdflu-case-missouri.html

2. H5N1 bird flu: current situation. CDC. Accessed September 9, 2024. 

https://www.cdc.gov/bird-flu/situation-summary/index.html

3. Epstein K. US confirms first case of bird flu with no known animal exposure. BBC News. September 7, 2024. Accessed September 9, 2024. 

https://www.bbc.com/news/articles/cy0rzqwxp7jo

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

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

Are you ready to elevate your pharmacy practice? Sign up today for our 

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.

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.

L.D. King

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