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The supplemental new drug application for roflumilast (Zoryve) is approved for adult and pediatric patients 12 years and older.

FDA Approves Roflumilast Foam For Plaque Psoriasis of Scalp, Body

Approval comes from positive results in the MATINEE and METREX phase III trials, with data showing a significant reduction in annual rates of COPD exacerbations among patients.

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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

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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 

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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

Luke Turnock, PhD, MSc, has done extensive research on prescription drug markets and how these products have been promoted on social media in recent history. He’s specifically versed in the promotion of weight-loss medications, testosterone replacement therapy (TRT), and sexual enhancement products. Throughout his research, he and his colleagues have uncovered an alarming normalization of these products that can potentially lead to poor outcomes for many consumers globally.

We had a chance to catch up with Turnock, who began his discussion touching on glucagon-like peptide-1 (GLP-1) drugs for weight loss.

“The [weight-loss drugs] people are buying [are] semaglutide, which is Ozempic and Wegovy; tirzepatide, which is Mounjaro; and liraglutide, which is Saxenda,” said Turnock. “Those tend to be the ones that are getting promoted and those have been approved as prescription-only medicines that you can access through your doctor if you need them for weight-loss purposes. It's designed for those who need that type of drug to control that weight. What we've seen since about 2021-2022 is just an explosion of interest from people who don't fit within those categories."

In part 1 of our interview with Turnock, he dove deep into insights he and his colleagues provided in their article titled “Semaglutide, testosterone, and sildenafil advertising on social media: the normalization of lifestyle enhancement drugs.” He discussed the normalization of GLP-1s, TRT, and sexual enhancement drugs like sildenafil and tadalafil.

Semaglutide, TRT Advertising Contributing to Normalization of Use

: With your expertise in enhancement drugs, as well as your work on published articles like “Semaglutide, testosterone, and sildenafil advertising on social media: the normalization of lifestyle enhancement drugs,” what exactly is going on right now regarding these drugs and their circulation throughout social media?

Starting with the GLP-1 medicines, so semaglutide, tirzepatide. Those obviously started off as they were prescribed for treating diabetes, and there's been a recent shift, as we've understood, these are very good for weight loss. In the UK, a couple of them were approved for weight loss. There [are] others that aren't yet approved, like retatrutide, but the ones people are buying [are] semaglutide, which is Ozempic and Wegovy; tirzepatide, which is Mounjaro; and liraglutide, which is Saxenda. Those tend to be the ones that are getting promoted and those have been approved as prescription-only medicines that you can access through your doctor if you need them for weight-loss purposes. That's for people on prescription with a high BMI. I think it's 30 off the top of my head, but it's designed, obviously, for those who need that type of drug to control that weight.

What we've seen since about 2021-2022 is just an explosion of interest from people who don't fit within those categories. And of course, this is prior to them being approved for weight loss. Them being approved for weight loss came about a year after this explosion where there was a trend on a lot of social media sites, particularly TikTok, where people were coming to the realization these were really effective for weight management. A lot of the people who were promoting these were not people who would fall in that high level of BMI. They were people who just perceived themselves as slightly overweight or wanted to get in better shape for summer or whatever. There was just this explosion. You probably remember some of the articles around that time saying there's been shortage of diabetes medicines because so many people have started seeking them out because of social media.

That's kind of the background to this explosion. As this awareness of these drugs got everywhere, we then saw a rise in advertising. There are so many companies in that article, I listed a few of them. They are promising and they're putting out paid advertisements on places like YouTube and Facebook saying, ‘We sell this for X amount of money.’ Now, technically a prescription medicine in the UK, you can't say ‘You can buy this from us for this amount.’ That's not how prescription works, but these companies are doing it. And then for the influencer culture, there's a lot of beauty pages, fitness pages, this sort of thing. They often are sponsored by more of illicit company to sell. These peptide sellers and so on will have influencers who they give free product to and they perhaps have a referral link; you click their link and they get a kickback. Those are essentially selling potentially quite sketchy products when you buy from them because they're often not actual prescription medicines. Even if they appear to be, they're very likely produced in China in powder form, not necessarily the highest quality. Ashraf and colleagues did some research on this, checking, ordering semaglutide over the internet, and they found quite a big degree of variation in what's underdosed, what's overdosed. Some of it was as much as 39% overdosed, which, of course, presents a risk. And that's being shipped to, for instance, the UK, where it's often then being drawn up into insulin syringes, after being reconstituted and just sent out in an insulin syringe with perhaps handwritten instructions on this is the doses you should be using, which, of course, has a lot of potential for harm.

There are quite a few difficulties with just the prevalence of this. And also, do consumers necessarily know what is legitimate pharmaceutical product versus, ‘Oh, this is sold by this beauty page’ and they have no idea that actually that [may] not [be] safe to use. Even if it is, does the dosing information being given by that seller even reflect what the clinical dosing protocols should be, because you're meant to titrate up GLP-1 medicines. Whether users know that, we've certainly got examples. The 

 have reports on some examples where people have been hospitalized, have been put into hyperglycemic comas from using these drugs. So that's kind of the background to the GLP medicines.

In terms of testosterone. Again, it's kind of two-fold in that you have this illicit market and you have the TRT market. You've long had bodybuilders and so on use testosterone and use steroids. With the rise in gym and fitness accounts and fitness influencers, quite a few of these are either directly selling or they're showing links to people who are selling illicit testosterone, being a scheduled drug, a Class C drug in Britain, obviously higher classification in the US. Those are premised around getting big, getting ripped, getting shredded, and it's mostly these male fitness influencers. What we're also seeing is the rise of these TRT services, where some of that is by fitness-type influencers, but some of it is more general advertising that's going out everywhere, on Instagram, TikTok, Facebook, YouTube, even. That's for the ‘check your testosterone levels,’ ‘buy our home testing kit.’ They'll generally list a range of symptoms and things that they say could be associated with low testosterone to encourage people to try their testing kits and then hopefully be paying them for prescription tests.

So obviously, TRT, testosterone replacement therapy, that traditionally has been for older men, when your natural testosterone levels start to decline. Potentially, as they say about the male menopause, it can be used as a treatment for that. It might also be used for men with hypogonadism or specific medical conditions. But with these recent trends in advertising, a lot of them seem to be targeting a younger demographic. If you look at some of the men in the adverts, they'll be using guys in their late ‘20s, for instance—not traditionally a market who particularly needs TRT. They should—unless they have a specific medical condition, or maybe if they messed around with a lot of steroids when younger and tank their testosterone levels—they shouldn't really be the market for this. But some of the language that's used to promote it, there's some posts about ‘Testosterone levels are declining worldwide, your grandfather [had] much higher testosterone levels than you do, get your levels checked.’ Some of it's to do with if you're feeling down, if you're feeling fatigued, if you struggle to concentrate, you probably have low testosterone. And some of it is also based around libido and sexual performance, which I'll probably come to in a second because that ties in with the third example I want to use of the sexual enhancers.

All these claims very much frame it around if you have this condition or you have this concern, or potentially even in that kind of broader masculinity, testosterone levels are declining population wide. It's all very much targeted to your problems now are the result of low testosterone, so you need to get on this. As I said, the men they're primarily marketing to are not the men who most need TRT. So with the low-libido adverts, there's one example we used in the article that said, ‘Sex isn't everything, said the man with low testosterone.’ It's playing on this idea that you need testosterone for sexual performance, and if you don't have peak sexual performance, it's probably because you have low testosterone and you should buy our kits, get tested, get a prescription.

Now, Andrew Richardson's done some interesting work around this area. Essentially, what's happening, very much as with the gym and fitness culture, everything's moving towards this enhanced idea of these guys on steroids are setting the norm for sex. It seems to be that the porn consumption is so prevalent that a lot of guys are looking at that thinking that's what sex is supposed to look like. ‘If I don't have porn star performance, that means there's something wrong with me.’ And so, companies advertising testosterone prey on that, but so potentially do the ones that are selling these sexual enhancers.

Drugs like tadalafil (Cialis), sildenafil (Viagra), those are being promoted again to young men, not the population who medically tends to need them. It's generally older men who suffer from clinical erectile dysfunction, but they're being promoted as these more recreational drugs. Blue Chew was like the big one that I remember several years ago, back in 2018, and various podcasts have promoted it. You've got a bunch of guys in their late ‘20s, early ‘30s, saying about, ‘Oh, Blue Chew is so good. It helps with your sexual performance.’ A range of influencers [are] promoting it, and obviously, mainly targeting men in their ‘20s. Now, again, with advertisements, the problem is, if you're promoting these drugs to people who wouldn't necessarily clinically need them, but you're leading them to believe you need them because you don't have this porn star sexual performance, the problem is, you can create psychological dependency from using these drugs. That’s being sold as this recreational thing, and just have more fun sex, and your sex will be better using this. Obviously, that can then lead to actual erectile dysfunction occurring once they become dependent psychologically on them.

The Rise in Direct-to-Consumer Advertising of Prescription Drugs

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Hirst M, Turnock LA. Semaglutide, testosterone and sildenafil advertising on social media: the normalisation of lifestyle enhancement drugs. 

https://doi.org/10.1016/j.peh.2024.100303

Luke Turnock, PhD, MSc, discussed current trends in the promotion of lifestyle enhancement drugs for populations they are not approved for.

Q&A: Expert on Social Media’s Normalization of Lifestyle Drugs

As Rite Aid has filed its second Chapter 11 bankruptcy with plans to close or sell all of its locations, what will the impact be on independent pharmacies? According to a previous survey from the National Community Pharmacists Association (NCPA), 43% of respondents said they are located near a chain pharmacy that has been impacted by closures and nearly 90% said they would be able to absorb patients who were receiving care there. However, many said low reimbursement and not enough staff or resources would make it difficult.

® sat down with Douglas Hoey, RPh, MBA, CEO of NCPA. In the conversation, we talked about how Rite Aid closures will impact independent pharmacies across the country, what independent pharmacies can do to effectively handle an influx of patients, and what Rite Aid’s situation means for the pharmacy landscape.

Rite Aid’s Closure is a Call to Action to Address Pharmacy Payment Model

: How will the closure of Rite Aid stores across the country impact independent pharmacies? Is this an opportunity or a serious problem?

: It's both an opportunity and a serious problem. It's a serious problem because pharmacies are closing throughout America. Here's another almost 1300 stores that are closing. There's been more than 7000 pharmacies that have closed over the last 7 years. There's been a net contraction, which is an even more important number. There's 7000 fewer pharmacy choices for consumers since 2017. Just in that short amount of time, there's 7000 fewer choices. Now, here's 1200 fewer choices from Rite Aid. Walgreens has announced they're going to close 1200 pharmacies. They announced that 6 months ago, and there will be more closures in addition to those. That's a problem.

It could be an opportunity for independent pharmacies, because those patients need to go somewhere, those patients need to land somewhere. It could be an opportunity to attract more business. However, not all business is created equally, and unfortunately, not all patient insurance plans are created equally. If those patients’ insurance plans are poor pain insurance plans, the pharmacy may be in a position where they don't want to accept that patient. Just like doctors and dentists don't accept all patients’ insurance plans, some pharmacies may be in a position where they have to say, “I'm not going to accept you as a patient because your mix of drugs or your payer is so bad it's going to force me to lose money.” It's an opportunity to have more business, but it's not like it was 10 years ago where all business was good business. Unfortunately, now not all business is good business. Pharmacies have to be really discerning how many of these patients they take on.

Frankly, it may put some patients in some tough positions, which we don't want to see. We don't want to see any patient do without or suffer. Period. Exclamation point. With that said, it may take some patients to scream to their employer, scream to the government, to say, “No pharmacy will take me. You've got to do something about our messed up payment system for pharmacies.”

: What can independent pharmacies do to effectively handle an influx of patients?

: That's the second problem that our members are facing, is having enough staffing and qualified staffing. One thing that we've seen is that certified technicians stay in the job longer, on average, so there's less turnover, which is less of a problem for our independent pharmacies than with the chains. We know that certified technicians, like through [the Pharmacy Technician Certification Board], will stay with the pharmacy longer, and are often able to take on more responsibilities. Making sure you have enough staffing is very important. But with the delicate balance of profit and loss in pharmacies, not having too much is also important.

Use of technology. Any pharmacies that aren't fully taking advantage of technology, this is the time to make that investment, to look into those new tools that can help you be more efficient, have your staff more efficient. Really creating systems where that pharmacist is involved in the checking, making sure before that prescription gets in the hands of the patient that a pharmacist has looked at it, checked it, verified it, validated it, is important. That filling process may be up to that point you can have some of our best operators have a technician that do most of that physical filling of the prescription. For operators who aren't already doing that, which many of them are, now's the time to take that leap to implement more workflow efficiencies, technology efficiencies, and then also the training of your staff to help them help you even more.

: Is there anything else you wanted to say?

: Rite Aid is a brand name that is known to a lot of casual consumers. Walgreens, CVS, Rite Aid, that's the rundown of the big chains and Rite Aid is gone. I wouldn't say Walgreens is hanging by a thread, but to see what's happened to Walgreens in the last 10 years is shocking. Going from a $100 billion company to one that was just purchased for $10 billion by private equity. CVS has the cushion of its PBM to protect it, but its stock has not done very well compared to the S&P 500 over the last 10 years. So even it's gotten bruised a little bit despite having the anti-competitive advantage of its PBM. I think it's a real shot across the bow to any casual observer in the community pharmacy space to say, “What is going on here?” It's also a call to action for policy makers and for employers. Employers really need to pay attention to this and say, “You know what? It's going to be difficult for my employees to find a prescription which they need to be healthy, productive employees.”

One other thing I'll say is that some people say, “Well, Amazon mail order will solve this. They'll fill the gap.” If history is a guide, no, they won't. Patients don't prefer mail order, unless they're coerced into going into mail order. There's always some exceptions, but by and large, patients want a brick and mortar pharmacy, with a real pharmacist—not an 800 number with someone posing as a pharmacist—that they can talk to, that they can get medication from, get advice from.

Without payment reform, pharmacies as we know them are moving toward extinction—that won't happen—but again, it's a call to action for legislators who've been sitting on their hands and employers who have been unaware of the situation that they need to do something different. What they need to do differently is they need to pay pharmacies fairly. Cost plus, a fair dispensing fee, transparency, simplicity, [and] predictability is what is needed to fix this broken system.

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1. NCPA Survey: Chain Pharmacy Closures an Opportunity and a Threat for Independents. News Release. NCPA. September 28, 2023. Accessed May 8, 2025. 

https://ncpa.org/newsroom/news-releases/2023/09/28/ncpa-survey-chain-pharmacy-closures-opportunity-and-threat

Douglas Hoey, CEO of NCPA, discusses what independent pharmacies can do to handle an influx of patients and what the chain’s situation means for the pharmacy landscape.

Q&A: Douglas Hoey on How Rite Aid’s Closure Will Impact Independent Pharmacies

Disney sets the gold standard for customer service, mastering how to charge more while still leaving guests eager to return. While pharmacies face different challenges, such as managing controlled substances, insurance barriers, and low reimbursement, there’s much to learn from Disney’s model, says Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, clinical assistant professor and director of experiential learning at West Virginia University School of Pharmacy.

Pharmacy is, at its heart, a service profession. Garofoli emphasizes that personalized check-ins with patients can go much further than generic satisfaction surveys. Creating meaningful, consistent patient experiences can help foster loyalty and trust—just like the magic that keeps people coming back to Disney.

At the American Associated Pharmacies (AAP) Annual Conference, held April 10 to 12 in Austin, Texas, 

 sat down with Garofoli to discuss how Disney’s approach to customer service can be applied in a community pharmacy setting and what metrics or feedback methods can best evaluate the effectiveness of customer service initiatives.

Q&A: Balancing Patient Care, Compliance Amid Controlled Substance Challenges | AAP 2025

: How can Disney’s approach to customer service be applied in a community pharmacy setting?

Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS

: Disney, the entire entourage, has pretty much mastered customer service. There's very few entities on this planet, present self included, that can charge more for something, and people might have a little gripe, but will pay it and then ask, “Can I do that again?” That's not something we experience in pharmacy often, at least maybe, if ever. They have really recreated the game. There's other organizations that certainly specialize in customer service, guest satisfaction, really mastering the entire ballpark overall, but pharmacy being in service, obviously, patient care is service, there's opportunities along the way too. Is everything going to seamlessly fit right in? Mickey Mouse is not dealing with controlled substances, at least that we know of. It certainly is different. I think that has to be appreciated, because that's usually when eyebrows start going, “Oh, come on.” But there's opportunities, of course.

: What metrics or feedback methods can be used to evaluate the effectiveness of customer service initiatives in a pharmacy setting?

A conversation with Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, clinical assistant professor and director of experiential learning at West Virginia University School of Pharmacy, at AAP 2025.

Natalie Catalan, PharmD candidate

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