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Check out these important FDA updates from the month of July 2024.

FDA Roundup: Agency Highlights from July 2024

Researchers aimed to address the associations between prenatal cannabis use and maternal health outcomes over a 9-year period.

Prenatal Cannabis Use and Maternal Health Outcomes

Slideshows

The American College of Allergy, Asthma, and Immunology (ACAAI) recently released its 5 tips to help children and their parents stay educated on asthma peak month.

Slideshow: Managing The Peak of Asthma Season

Galderma said the FDA has accepted the company’s Biologics License Application for the therapy based on data from the trials.

Nemolizumab for Atopic Dermatitis Shows Positive Results in Phase 3 Trials

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The novel drug elranatamab-bcmm (Elrexfio) received accelerated FDA approval on August 14, 2023, for treating adults with relapsed or refractory multiple myeloma.

Elranatamab-bcmm Approved for Adult Patients With Relapsed or Refractory Multiple Myeloma

Relyvrio is intended to slow the disease progression of amyotrophic lateral sclerosis.

Relyvrio: A New FDA-Approved Treatment for Patients With ALS

Acid sphingomyelinase deficiency is a rare, progressive genetic disease associated with significant morbidity and mortality.

FDA Approves Olipudase Alfa-rpcp for Acid Sphingomyelinase Deficiency

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

Rite Aid Addresses Cyberattack: 2.2 Million Customers’ Data Breached

On July 16, 2024, Rite Aid reported a cybersecurity breach that occurred last month on June 6. Although the company maintains that Social Security and financial information were not breached—just data from the purchase or attempted purchase products—up to 2.2 million customers’ data may have been affected.

Chronic Hand Eczema Treatment Shows Positive Results in Phase 3 Trials

Positive results from two phase 3 trials evaluating the safety and efficacy of twice-daily delgocitinib cream for the treatment of adult patients with moderate to severe chronic hand eczema have been announced, according to a release from LEO Pharmaceuticals. Results from the DELTA 1 (

) trials showed that twice-daily delgocitinib cream met its primary endpoint of an Investigator’s Global Assessment for chronic hand eczema treatment success score of 0 or 1.

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

, Steve Postal, JD, Director of Policy and Regulatory Affairs at the National Community Pharmacists Association (NCPA), sat down with 

 to discuss his organization’s work to introduce pharmacy benefit manager reform. From resources made available for its members to class-action lawsuits and several legislative bills in the works, read about the NCPA’s fight to reclaim revenue for community pharmacists.

Emporos, InterLink AI Partnership to Revolutionize POS in the Pharmacy

Combining a point of sale (POS) system with scripClip’s lighted pharmacy will-call system, the newly announced partnership between Emporos and InterLink AI will allow pharmacists to streamline tasks, free up their time around the pharmacy, and—crucially—improve patient care with swift yet valued care and services. “Our partnership with Emporos reinforces the vision we share: to make the pharmacy experience more efficient and safer, for the health of pharmacies and their patients everywhere,” said Dan Gordon, InterLink AI President and CEO.

The Girls Are Back: One Pharmacist’s Journey to Save His Community Pharmacy

“Ever since I was a child,” Mayank Amin, PharmD, RPh, MBA, owner and chief patient advocate of Skippack Pharmacy, recalls, “I always wanted to do something that could make a big impact in the lives of those around me.” This wish would guide his career.
A must-listen for any pharmacist struggling to find positivity in the profession, Amin—also known as the Superman Pharmacist—sat down with 

 to share his experiences transforming a shuttered independent pharmacy into a thriving community hub.

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

In case you missed it, this week we had news about cybersecurity breaches at Rite Aid, advancements in chronic hand eczema treatment, the Superman Pharmacist, and more.

Weekend ICYMI: July 15 to July 19

With no prior experience in independent pharmacy, Mayank Amin, PharmD, RPh, MBA, was a stranger to the world of mom-and-pop drugstores. That all changed when he witnessed the heartbreaking closure of a local pharmacy at the hands of a large chain.

Driven by a desire to help those affected, and with a vision that extended far beyond the bottom line, Amin took on the task of reopening Skippack Pharmacy to the public. With the community by his side, he steered Skippack through the COVID-19 pandemic, filling critical health care gaps and providing support to residents facing unprecedented uncertainty.

This dedication to care would soon earn him a heroic reputation.

, Amin discusses how he redefined the role of a pharmacy at Skippack Pharmacy. Check out part 1 of the conversation 

 I happened to go by that pharmacy the next day. I was sitting in the parking lot watching a lot of these seniors pull up to the window, because there's not too much of an announcement when a pharmacy closes. One day it’s there, the next day, lights are out, phones are redirected to whatever pharmacy purchased [it], and the patients [are] kind of left floundering. And that's exactly what had happened here.

Patients were coming to the door trying to open it up. There were red signs in the window that said, "Your prescriptions have been transferred up the street to CVS," who had purchased their files. And I took nothing of it, but I saw that there were seniors absolutely destroyed by this. It was almost like I was watching a funeral happen. Something so meaningful to these patients, something that they were so passionate about—some of these people might have come to this pharmacy on their horse 50 years ago, and here they were sitting in a parking lot, all looking and talking, saying, “What actually happened here? How did we lose something that means so much to us?”

I happened to be born and raised in that town, like 5 miles away from this pharmacy, so I was like, maybe I could start up something here and create a different experience. And that's what I did. I reached out to a few of the providers that I knew, because I knew a lot of people in the town, and I asked them, “Do you think it would be wise for me to reopen this pharmacy?” I knew it would require a lot of work because CVS has already bought all the files. I would start with 0 patients. I'd have to bring everybody back in. 

So, the thing I love doing—marketing—I'd have to market the heck out of this place and find a unique way to bring people back. But I didn't just want to bring people back into the pharmacy. I wanted them to have an experience like they've never had before in pharmacy. So, it's 1 thing just to open a pharmacy and have people come to pick up prescriptions. But why not transform the way that people view a pharmacy and change the way that they actually think? Instead of just coming in to pick up a prescription, they could be coming in, and even if they feel terrible on the way in, they would feel great on the way out. And that's kind of what happened, is that we reopened this pharmacy from ground 0. 

I ended up hiring some of the original employees of the pharmacy. So, some of the ladies that had been working there for 50 years who were mostly all 75 plus years old at that time. I rented a billboard down the street from the pharmacy and the billboard said, “The Girls Are Back.” with a picture of the 3 women who were the original employees, and the town got very excited that the girls were back—the pharmacy [was] back.

It almost felt like a party in the town. I've never seen people have this much excitement towards a business, but we've had patients, when we first opened, roll down the aisles, because it felt like their home was back. We had people asking me for yard signs. Now, I didn't even have a yard sign in my own yard that said, “Skippack Pharmacy is back,” but these patients had these yard signs that I bought that said, “Skippack Pharmacy is back.” They had bumper stickers that they asked me to get that said, “Skippack Pharmacy has my back,” so, you see cars roaming around town [with that message]. It was like a huge reunion for everybody. And I was so excited.

But then, as I started doing the business side of things, I was like, “This is great. It's like a party, everyone's so happy.” [But] as I started running prescriptions, I started seeing red lines on the screen. And when I started seeing red lines—red lines don't usually mean positive things in any world. So, when I started seeing the red, I was like, “This is not good," because it looks like I'm losing money filling a lot of prescriptions. I didn't know you could actually lose money filling prescriptions. Here I was at Walgreens thinking that the more prescriptions you fill, the more money your pharmacy makes. And it was the complete opposite. 

I didn't ask too many pharmacy owners about any of these practices, about the difficulties they were facing. I didn't look at news stories, literally nothing, I just jumped in thinking that this is the best idea for me. And I'm actually glad that I did that, because if I would have looked into this further—most people aren't opening pharmacies right now, because they're scared of all of those things that they see that are negative, including the poor reimbursements. But I realized that okay, as with anything in life, there's challenges that come up. But you have to find ways around it. 

And that's what I did, is that, the things that we were losing money on, I realized that it's not okay just to have a business and keep losing money. Because, like what's happening today, 1 pharmacy is closing in this country every single day. That is not okay. And I don't want to be a number that contributes to that increasing in our country of pharmacies closing down. So, I put my creative thinking hat on [and] said, “We're going to do whatever it takes to not fill those prescriptions where we lose money.” Because if you have a problem, you don't continue doing things that will add on to the problem. You have to plug it. And that's what we did.

We tried to find ways [to redirect] the prescriptions that we [were losing] money on. We [didn't] directly fill them at our pharmacy, or we [tried to] get the patient set up for mail order, [we saw] if they [could] pick that prescription up at CVS, or Walgreens, or somewhere else where that pharmacy might not lose money filling it. And yes, there is something called PBMs [pharmacy benefit managers] and spread pricing. I could lose $50 on that prescription at my pharmacy, and meanwhile, a chain pharmacy down the street who owns a PBM could be making $500 on that prescription.

I started learning a lot more. It's like going back to elementary school and you're learning your ABCs, your numbers. I was learning about all this every single day, about how this system works. And a lot of things that came to mind—I was like, “How is this legal?” Those questions came to my mind often. How are people allowed to do this in America? My family is from India, there's things that I question the legalities of when I'm over there. But I'm like, I know this happens in India. But how is it legal here in America, where we have so many rules, so many systems of checks and balances? 

But I've realized that things happen. And then once they do happen, if it grows, like how an insurance company and a pharmacy can own each other, how [they] can be vertically integrated, and how that same person is the 1 that's paying the independent pharmacy. So if you want to get that thorn out of your foot, and you're a PBM, or a chain pharmacy that owns a PBM, you just under pay that independent pharmacy, and eventually, if they bleed long enough, that independent pharmacy owner is going to be like, “Actually, I don't want to keep this place open because I can't survive, just losing money every day.”

But once again, I didn't want to be a stat. So, I said, “I understand this is happening, I can't change it. But I'm going to make sure our voice, our community's voice is heard. So, I'll reach out to all our legislators, I'll do whatever is required—sign me up for every organization—and I'm going to try to change the way that things are happening, at least in my pharmacy.”

While I was doing all this, [the COVID-19 pandemic] hits. [The] first case of COVID [happens in] our county, and at that point, I was like, “Okay, you cannot lose money doing COVID supplies, because you're not going to buy a mask or a glove or sanitizers at a specific cost and then sell it at a loss.” Yes, we donated literally hundreds of thousands of products. But when everybody else was sleeping, we were up and awake, driving to New York, driving to Maryland, driving hours away to find ways to make sure that our community had tests, masks, sanitizers, all the things that people were urgently needing, including toilet paper. 

We literally had an entire truck of toilet paper come to our pharmacy, and we were the supplier of toilet paper in our town for a while when that shortage happened. But it was finding those urgent needs of our community and being able to help them. That's what I realized was the best part of what we can do, is while we might not be the best place for you to fill your prescriptions every single day, or to fill that brand name injectable, or your brand name diabetes medication, we can fill gaps that others cannot.

That's what I ended up doing, is that myself and my team, my community, we came together. At my grand opening, I mentioned to the community, saying “One day, if I ever need your help, I'm going to ask you for it. I've opened this pharmacy for you guys. So, if I ever ask for help, I hope you guys come back and help me.” And that time came literally within a year and a half of me opening when it was COVID, and I was like, I can't do this myself. If an entire truck comes to the store, I only have 2 employees and we have all this stuff that needs to happen. I need the community's help. 

So, I started reaching out on Facebook, saying, “If anyone can come help me, we're getting sanitizer, and I need people to help me compound sanitizer in the back of our room if you're available.” People just started showing up in numbers. That's when the community also realized that this pharmacy wasn't Mak’s pharmacy. It was their own pharmacy all over again, like they've always experienced in the last 50 years. And that's what made me very excited and happy to continue to keep moving forward. Because there would be days that I'd walk into the pharmacy, and somebody would have a vacuum in their hand vacuuming our store—and it was a patient. You don't ever see that happen in a business where you walk into a building, and you see a customer cleaning the shelves or the aisle or bringing the boxes off of a truck and putting them on your shelf. 

And that's when I realized that they were right: This is not Mak’s pharmacy, this is their pharmacy, I'm going to do whatever possible to make sure that our community is taken care of.

And then, time flew, and it was time for the vaccines to come. Just like I did at Pfizer, never be afraid to reach out to whoever you know, because your voice can be heard. I knew the vaccines were coming from the government. So, for me to reach out to local stores, it made no sense. For me to reach out to our wholesaler, didn't matter, they weren't going to supply those vaccines. There was 1 source, it was the government. So, at that point, I reached out to everyone I knew in government, and I happened to be on a state chat. They were discussing the vaccine rollout in Pennsylvania, and I saw one of our state representatives on that chat. 

So, I messaged him on the side, I was like, “Hey rep, you know that we have the bandwidth to literally handle any kind of emergency, as you've seen with all the other shortage crises that we've had, and how we've helped so many people in our community. If you get me vaccines somehow, we're going to crush it in this town and every vaccine is going to get into arms as fast as possible. And we have an army of volunteers that are ready to help.” And he said, “Mak, let me see what I can do.”

So, there wasn't any back door that they reached out to. They simply gathered a few other state representatives from our area, and they wrote a very nice letter to the Department of Health, just saying that they have someone in this town that's willing to make a difference. If it's possible to move our application up and to give us some vaccines, they can make it happen. And that's what actually happened. After we shook some trees through our representatives, the vaccines came flowing, and we got our first 1000 doses of Pfizer vaccine.

Those 1000 doses were administered in less than 8 hours. Imagine a store that has 2 employees, 8 hours those 1000 vaccines were administered, and our story became viral at that point. The story of Superman begins at that point where we got our COVID vaccines.

Check out part 3 of our conversation with Amin 

In part 2 of his interview with Drug Topics featured on Over the Counter, Mayank Amin, PharmD, RPh, MBA, discusses how he redefined the role of a pharmacy at Skippack Pharmacy.

Q&A: How This Heroic Pharmacist Redefined Community Pharmacy

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.

Man of Heal: The Story of the Superman Pharmacist

“Ever since I was a child,” Mayank Amin, PharmD, RPh, MBA, owner and chief patient advocate of Skippack Pharmacy, recalls, “I always wanted to do something that could make a big impact in the lives of those around me.”

After graduating from pharmacy school, Amin held various non-traditional pharmacy roles, including acting as a stand-in for a Hollywood film and directing a wedding planning company. But while exploring these passions, and working part-time at Walgreens, Amin learned about an independent pharmacy that had been shuttered in his community.

“I saw that there were seniors absolutely destroyed by this. It was almost like I was watching a funeral,” says Amin. “Some of these people might have come to this pharmacy on their horse 50 years ago. And here they were sitting in [the pharmacy’s] parking lot, all looking and talking, saying, ‘What actually happened here? How did we lose something that means so much to us?’”

Moved by the devastation, Amin took it upon himself to reopen Skippack Pharmacy to the community—with a focus on creating a unique patient experience.

Mayank Amin, PharmD, RPh, MBA, sat down with Drug Topics on part 1 of an episode of Over the Counter to share his experiences transforming a shuttered independent pharmacy into a thriving community hub.

Kevin W. Chamberlin, PharmD, FASCP

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