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Stimulant medications are the first-line pharmacologic therapy for ADHD,
but many of these medications are currently in short supply. 

Navigating Pediatric ADHD Medication Shortages

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

The FDA has granted emergency use authorization (EUA) to an updated COVID-19 vaccine from Novavax to prevent the disease in individuals aged 12 years and older, the company announced in a release.

 Novavax said the vaccine will be available in thousands of pharmacies and grocers across the United States after batches are released by the Center for Biologics Evaluation and Research.

The protein-based vaccine, called NVX-CoV2705, is an updated 2024-2025 formula that includes a monovalent component corresponding to the Omicron variant JN.1 strain. The EUA was based on non-clinical data that showed the vaccine provides cross-reactivity against JN.1 and lineage viruses, including numerous variants that are currently circulating. The most common adverse reactions associated with the vaccine include headache, nausea, vomiting, muscle and joint pain, injection site tenderness or pain, fatigue, and malaise.

Q&A: How Health Care Providers Can Help Increase COVID-19 Vaccine Uptake

"[This] authorization enables Novavax to launch our updated COVID-19 vaccine in the US in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide," John C. Jacobs, president and CEO of Novavax, said in a release.

 "Our updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1."

According to data from the CDC, COVID-19 infections are growing or likely growing in 20 states and are stable or uncertain in 18.

 The increased viral activity in many parts of the country is due largely to the KP.3.1.1 Omicron variant, which is the only major variant increasing in proportion nationally. KP.3.1.1 is now the predominant variant circulating in the country after overtaking the KP.3 and KP.2 variants.

 For the 2 week period ending August 17, the variant accounts for 31% to 43% of COVID-19 clinical specimens.

The CDC recommends that all people aged 6 months and older get vaccinated against COVID-19 to protect against serious illness. The agency said that individuals who are considering getting a 2023-2024 COVID-19 vaccine formula should talk with their health care provider to determine if it would delay their ability to get the updated 2024-2025 vaccines. Data has shown that those who are up to date on COVID-19 vaccines have lower risk of severe illness, hospitalization, and death compared to unvaccinated individuals.

The EUA for Novavax’s updated COVID-19 vaccine comes shortly after 

 approval to updated shots from Pfizer and Moderna. Pfizer’s Comirnaty and Moderna’s Spikevax, which are based on mRNA technology, include a monovalent component that corresponds to the Omicron variant KP.2 strain and are approved for use in individuals aged 12 years and older. The Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine also are authorized for emergency use in individuals aged 6 months through 11 years.

“The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a release.

 “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. [This] authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

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.

1. Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. News Release. Novavax. August 30, 2024. Accessed September 3, 2024. 

https://ir.novavax.com/press-releases/2024-08-30-Novavax-2024-2025-Formula-COVID-19-Vaccine-Now-Authorized-and-Recommended-for-Use-in-the-U-S

2. Current Epidemic Growth Status for States. Report. CDC. August 23, 2024. Accessed September 3, 2024. 

https://www.cdc.gov/cfa-modeling-and-forecasting/rt-estimates/index.html

3. KP.3.1.1 is the Predominant Variant as COVID-19 Activity Increases. News Release. CDC. August 19, 2024. Accessed September 3, 2024. 

https://www.cdc.gov/ncird/whats-new/kp-3-1-1-is-the-predominant-variant.html

4. FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants. News Release. FDA. August 30, 2024. Accessed September 3, 2024. 

https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-better-protect-against-currently-circulating

The protein-based vaccine includes a monovalent component corresponding to the Omicron variant JN.1 strain.

FDA Approves Updated Novavax COVID-19 Vaccine

Oral contraceptives, pioneered in the 1950s, were the first drugs explicitly designed to serve a social purpose—a departure from traditional medicine focused on treating illness.

This innovation was met with resistance, even from the 

, which initially hesitated to approve the drug for contraceptive use. Although eventually greenlit by the agency, the discomfort surrounding birth control has persisted.

For some women, this shame and stigma is enough to deter them from seeking the necessary medication. The bureaucratic process to obtain a prescription adds more challenges, as women must often navigate insurance hurdles, find a reliable health care provider, and deal with logistical issues such as transportation and wait times. This is particularly concerning given the reproductive backdrop of the nation, as more than half of the states in the US have banned abortion in its entirety.

However, in the 6 decades since approval of the first birth control, contraceptive medicine has progressed rapidly. Last year, a major milestone was achieved with FDA approval of the first over-the-counter (OTC) birth control pill, Opill. The decision was supported by a study demonstrating that women could determine their suitability for contraception without a health care provider. Now, Opill is available on pharmacy shelves nationwide without a prescription.

Developers of Opill hope that its availability in pharmacies will help reduce the 

 surrounding the medicine. According to Stephanie Sober, MD, MSHP, global director of medical affairs for women's health at Perrigo and investigator on the pivotal research that supported the prescription-to-OTC switch of Opill, in an interview with 

, the science is simple. "The more [contraceptive] options [people] have and the easier access [people] have, the more likely people are to find something that works for them and to be able to continue it," she said.

How Pharmacists Are Expanding Reproductive Care Access

 Can you tell us about the study that supported OTC FDA approval of Opill? Specifically, how did the study demonstrate that women can effectively determine their suitability for Opill without consulting a doctor?

 One of the key things to understand here is a little bit about the FDA process for prescription-to-OTC switches. It’s a fairly standardized and quite rigorous process especially for a first-in-class switch, which was the case with Opill, since there was no other OTC birth control pill available prior to this. We had to do all the steps, which is not necessarily the case when other products that are similar to OTC products are coming onto the market.

But there are a few key steps in that process. The first is that you need to develop a label. Any OTC medication you're probably familiar with, if you look at the back, it has that standard 

 label template on it. You need to figure out how to get all the key information that consumers need to use the product appropriately into that little template. That piece of the process is actually a big chunk of it and involves numerous studies. 

It’s really an iterative process where you test the template with consumers—test a draft—and then go back and see the places where they maybe didn't understand quite as well. Then, you try to make it more easily understandable and go back and test it again. You keep doing that and honing the label until you get to the point where you feel as though it is well understood by the consumers that you're trying to target.

Once the label has been developed, you then take it a step further and do what's called a self-selection study, where now you are going to consumers and no longer asking them hypothetical questions about another person. For example, in a label-comprehension study, you would ask somebody something like, “Sally is pregnant. Is this product appropriate or not appropriate for Sally to use?” But now, with the self-selection study, you're asking about the person themselves, and so they are taking their own medical history into account. So now they're thinking, “Do I want to use this, and is it appropriate for me based on my own medical history?”

Once you do the self-selection part, then you do what's called an actual use trial, where the folks who have decided that the medicine is appropriate for them and they want to try it, then take the product home and use it using only that 

 label. So, no involvement of a health care provider.

Then you monitor it in some way. In the case of our study, we had folks record in a diary whether they took their pill each day, whether they had sex that day, and if they missed a pill, whether they took appropriate actions based on that. What we found, as you might imagine, since the directions for taking Opill are not all that complicated—they’re just to take 1 pill at the same time every day—we found that people really were able to do this and use the product appropriately without the involvement of a health care provider. People did it actually really, really well. 

In our self-selection study, 99% of people were able to appropriately choose whether the product was right for them. And then in the actual use trial, on 97% of the days in the trial, folks either appropriately took their pill or took appropriate mitigating action if they missed their pill. So, we found—not all that surprisingly—people can do this on their own. That data was part of the package we submitted to the FDA that led to the ultimate approval of the switch.

 How has Opill changed the dynamic between patients and health care providers? Do you believe it has opened new avenues for patient education and empowerment?

 This is a tremendous achievement, and a game changer. I think it definitely opens up new access and new avenues for empowerment and increased options and increased choice. 

In terms of the relationship between patients and health care providers, though, I think we may see lots of different things. For people who do have access to the health care system and have a provider that they want to see, this doesn't change that. They can still see their provider if they want to have a conversation about contraceptive options. 

The important thing that this does, though, is for folks who don't have ready access to a health care provider. This opens the door for them to have access to a more highly effective contraceptive option than what was previously available OTC. Because, you know, when you think back to what was previously available, it’s things like condoms and spermicides, and those unfortunately fall into the less effective contraceptive methods. So now we're giving folks who don't have that access to the health care system increased options and freedom to choose a new option.

One important thing to note is that there are many folks in this country who live in what are called contraceptive deserts. The number is around 19 million women who live in these areas. To be deemed a contraceptive desert, there has to be a lack of access to the full range of birth control options. That’s quite a large number of folks who, depending on where they live, wouldn't have access. And so, this really does open opportunities for them to access a more highly effective method of contraception.

 Historically, birth control has faced significant stigma and shame. How do you think the availability of OTC birth control can help destigmatize reproductive health care and encourage open conversations about contraception?

 This is extremely important, and hopefully the availability of Opill, and raising awareness about Opill and providing education about it in a stigma- and shame-free way, can really help to open lines of communication about contraception more generally. 

Getting birth control should never be a process that involves shame or stigma. But as it was previously, having to jump through hoops and navigate barriers—certainly some of that has come into play. We hear stories from folks who feel that they haven't had a positive process acquiring contraception. So, hopefully by providing them a new option where they can avoid some of those barriers, but also trying to promote people getting educated about their reproductive health and contraception more generally, we can help to tamp down some of that stigma that does exist.

 What are the potential benefits of OTC birth control in terms of improving access to contraception, particularly for marginalized populations who may face barriers to health care?

 The impetus for this switch was an unmet need in this country for access to contraception. We know that even with all of the contraception methods that were previously available, almost half of the 6 million pregnancies that occur in the US each year are unintended. Some of that is because folks either don't have access to contraception or have barriers to accessing contraception. And we know that even folks who are getting their prescription from their doctor, if there's some interruption in that care that causes them to be in need—all those things were really part of the reason why this was such an important and groundbreaking achievement.

I still work clinically, part time at this point, but those of us who prescribe contraception and do this as part of our clinical work know that the more options you have and the easier access you have, the more likely people are to find something that works for them and to be able to continue it. Even folks who want to have children at some point in their life can spend over 30 years trying to prevent getting pregnant. And what they need and what they want can change, and that's fine, but this certainly can fill in the gaps for those who can't get access in other ways, or who just don't want to have to deal with the health care system and want a highly effective and safe method of birth control.

 Looking ahead, what are the potential implications of OTC birth control for the future of reproductive health care? Do you see any opportunities for further innovations or advancements in this area?

Stephanie Sober, MD, MSHP, investigator on the pivotal research that supported the prescription-to-OTC switch of Opill, shares insights on how the medicine is reshaping the reproductive landscape.

Luz Rosario, PharmD candidate

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