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Articles

Pharmacy law experts detailed the Drug Supply Chain Security Act, highlighting the role each entity within the supply chain plays in ensuring the safety and authenticity of US prescription drugs.

How DSCSA Serves as the Drug Supply Chain’s Lead Investigator | ASPL 2024

Lauren Biscaldi is the Managing Editor of Drug Topics. 

High copayments can be a structural barrier to medication therapy adherence. 

Copayment Burden Affects Medication Adherence in Chronic Conditions 

The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.

FDA Accepts BLA Resubmission for Epidermolysis Bullosa Gene Therapy

FDA experts gathered to discuss the DEA’s rescheduling of marijuana and how it will impact the pharmaceutical supply chain.

The Nuances of Marijuana’s Potential Rescheduling | ASPL 2024

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Natallia Mazina is a founding partner of the law firm Carman & Mazina, specializing in pharmacy law and assisting pharmacists and pharmacies with compliance, litigation, audits, and defense proceedings. E-mail her at nmazine@cmpharmlaw.com.

Some tips on what constitutes a QA and how to comply with pharmacy law when creating one.

Does your pharmacy comply with quality assurance requirements?

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

StreamCare improves your profitability by removing PBMs from the Workers' Comp reimbursement process.

StreamCare bills the responsible payers directly which results in significantly higher reimbursement. Our technology and experienced team uniquely position us to take on all the obstacles of the Workers Comp reimbursement process while improving your bottom line.

The Workers' Compensation Advantage Independent Pharmacies Need

Independent pharmacy owners must understand how the components of a wholesaler purchasing agreement are assessed and valued in order to make informed decisions.

In the second episode of our 3-part podcast series with American Associated Pharmacies (AAP), we dive into the various elements of a purchase agreement between an independent pharmacy and a pharmaceutical wholesale distributor.

Wayne Boese, vice president of sales at AAP, discusses how pharmacy owners can:

Identify the factors that can impact the total cost of goods and inventory buying costs.

Learn the value of buying flexibility, and dig deep into the percentages and what they mean for your pharmacy.

Identify the indicators of profitability.

In this world of shrinking margins, this topic should be at the topic of every independent pharmacist’s list. Listen to the podcast to learn more. 

This podcast episode is sponsored by American Associated Pharmacies.

In this world of shrinking margins, this topic should be at the topic of every independent pharmacist’s list.

Community Practice

Total Pharmacy Podcasts

An Essential Guide to Wholesaler Purchase Agreements

In December, the NCPA asked our members for their feedback on the issues of highest priority to them. Their input is invaluable. The 

 helps inform NCPA’s advocacy agenda and helps us push for a marketplace where community pharmacies and their patients can thrive.

What our members told us, loud and clear, is that the elimination of retroactive direct and indirect remuneration (DIR) fees in Medicare Part D plans is their highest priority. These fees are recouped from pharmacies by pharmacy benefit managers (PBMs) weeks or even months after seniors pick up their prescription. The uncertainty is maddening for community pharmacists. After all, how do you operate your business when you can’t predict cash flow? And, these fees are bad for seniors who pay the inflated price and are pushed more quickly into the Medicare Part D coverage gap.

Related article: Everything Pharmacists Need to Know About DIR Reform

Spurred by NCPA’s concerns, the Centers for Medicare and Medicaid Services (CMS) has expressed skepticism about the way DIR fees are applied. In January 2017, CMS warned that DIR fees increase costs for Medicare beneficiaries and the federal government. Then in April 2018, CMS issued a 

 asserting its statutory authority to require that some portion of rebates and pharmacy DIR fees be applied at point of sale. The final rule stops short of requiring such a change, instead stating that new requirements “would be proposed through notice and comment rule-making in the future."

The regulatory progress is one route, but NCPA is also advocating for passage of 

 in Congress, "The Improving Transparency and Accuracy in Medicare Part D Drug Spending Act,

 which would prohibit pharmacy DIR fees from being applied retroactively.

The second advocacy issue identified by NCPA members is the continued lack of transparency in how PBMs calculate reimbursement rates for generic drugs. PBMs use multiple maximum allowable cost (MAC) lists, which can under-reimburse pharmacies, yet they charge plan sponsors a higher price for the drug and profit from the spread. The take-it-or-leave-it PBM contracts that community pharmacies must sign enshrine this inequity.

Related article: 10 Reasons Pharmacists Have It Tougher Than Anyone Else

So how is NCPA addressing this challenge? One way is by supporting 

, “The Prescription Drug Price Transparency Act,” which would provide clarity for how MAC prices are determined. The bill also creates an appeals process for contesting below-cost reimbursements and bans PBMs from requiring patients use mail order and specialty pharmacies where the PBM has an ownership interest. These changes would apply to Medicare Part D, TRICARE, and the Federal Employee Health Benefits programs.                                                                                             

The third advocacy issue identified by NCPA members was not among the top 

priorities for 2017, but is high on members’ radar now

. Community pharmacies across the nation have started seeing dramatic reimbursement cuts in Medicaid managed care plans, a serious financial blow to community pharmacies. The cuts may undermine a CMS directive that states must establish time and distance network adequacy standards for providers, including pharmacies, under managed care contracts and ensure continuity of care for beneficiaries on or after July 1, 2018. Community pharmacies ability to participate In Medicaid is endangered by these unsustainable cuts.

Because Medicaid is largely a state function, NCPA is working with state partners to ensure CMS’ network adequacy standards are being met. Managed care organizations should reimburse pharmacies at fee-for-service Medicaid pharmacy reimbursement rates. PBMs are currently running these tax payer-funded plans like commercial plans, where transparency and accountability are lacking. That must change. NCPA will continue to engage with CMS and other stakeholders to ensure pressure is applied to right this hardship.

Related article: Four Ways Trump's Drug Pricing Plan Impacts Pharmacists

In addition, NCPA is supporting states identifying savings in state Medicaid contracting. For example, West Virginia’s state Medicaid agency carved the prescription drug benefit out of Medicaid managed care last year. They did this based on a study that showed Medicaid could save $30 million annually by administering the benefit directly, which would also put $34 million back into local economies in the form of pharmacy reimbursements.

NCPA’s sole focus is on community pharmacy owners. They have told us what’s on their minds and we’re carrying that message-and potential solutions-to Capitol Hill and beyond.

Dave Smith, RPh, is president of the NCPA. 

NCPA found three things that pharmacists desperately want changed. Here’s how they’re going to do it.

Associations News

What Community Pharmacists Want-And How You Can Get It

A conversation with Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP.

Insulin Icodec Represents A Promising Option for Managing Diabetes, Improving Quality of Life

In the United States, about 38 million people have diabetes and more than 1 in 3 Americans have prediabetes but are unaware of it.

 The prevalence of the disease in the country is also expected to continue increasing, with some research estimating that more than 54 million people will have diabetes by 2030.

 As diabetes represents a major health crisis in the US, increasing awareness and improving disease management are crucial.

Insulin is an essential diabetes management therapy in the US, with 12.3% of adults estimated to initiate insulin therapy within their first year of a diabetes diagnosis. Adherence to insulin is crucial to achieving good glycemic control in patients with diabetes. However, adherence rates remain low due to several factors, including social stigma, impact of its use on daily life, and fear of side effects.

Insulin icodec, a human insulin analog formulation administered subcutaneously once weekly, is a promising therapy for patients with diabetes that may help increase adherence. Sold under the brand name Awiqli by Novo Nordisk, insulin icodec is approved to treat type 1 and type 2 diabetes in the European Union, Canada, Australia, Japan and Switzerland. But in July 2024, the FDA declined to approve insulin icodec in the US due to issues related to the manufacturing process and the type 1 diabetes indication.

In a recent met-analysis, investigators evaluated the efficacy, safety, and clinical implications of insulin icodec. For the study, a literature search was performed on PubMed, Google Scholar, Embase, and ClinicalTrials.gov up to August 26, 2024. The study concluded that insulin icodec could potentially improve treatment adherence and quality of life for patients with diabetes and that it represents a “significant innovation in insulin therapy.”

Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, lead author on the study and a professor of pharmacy practice at Massachusetts College of Pharmacy and Health Sciences, recently sat down with 

 to discuss how insulin icodec differs from existing daily basal insulins, important findings from the study, if the FDA’s decision will negatively impact patients with diabetes, and key things pharmacists need to know about the therapy.

1. A Report Card: Diabetes in the United States Infographic. Report. CDC. May 15, 2024. Accessed November 6, 2024 

https://www.cdc.gov/diabetes/communication-resources/diabetes-statistics.html

2. Rowley WR, Bezold C, Arikan Y, et al. Diabetes 2030: Insights from Yesterday, Today, and Future Trends. 

. 2017 Feb;20(1):6-12. doi: 10.1089/pop.2015.0181. Epub 2016 Apr 28. PMID: 27124621; PMCID: PMC5278808.

3. Skriver LKL, Nielsen MW, Walther S, et al. Factors associated with adherence or nonadherence to insulin therapy among adults with type 2 diabetes mellitus: A scoping review. 

 2023 Oct;37(10):108596. doi: 10.1016/j.jdiacomp.2023.108596. Epub 2023 Aug 22. PMID: 37651772.

Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, discusses how insulin icodec differs from existing daily basal insulins and key things pharmacists need to know about the medication.

Natallia Mazina, JD

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