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While the new guidelines are reserved for critical care pharmacists in the ICU, they can be applied to other practice areas, highlighting the crucial role pharmacists play in health care.

What New ICU Guidelines Mean for the Pharmacist Profession

Articles

Due to an increased risk of vaccine-preventable diseases, researchers explore pneumococcal, COVID-19, and influenza vaccine coverage among people living with HIV in Belgium.

Suboptimal Pneumococcal, Flu Vaccine Rates Persist Among People with HIV

As part of the guidance, the FDA emphasizes drug development, specifically with trial design, patient populations, and outcomes such as reducing the need for opioids.

FDA Issues New Guidance to Accelerate Development of Safe, Effective Nonopioid Pain Treatments

Laura is the vice president of content of Drug Topics

 since 2022 and has been with the publication's parent company, MJH Life Sciences

, since 2011. She has an MA in business and economic reporting from New York University.

As the 2025-2026 respiratory season approaches, the CDC’s Advisory Committee on Immunization Practices has not met and voted on guidelines for COVID-19 vaccines.

HHS and American Academy of Pediatrics Differ on COVID-19 Vaccine Recommendation

Drug Topics connects pharmacists across retail, health system, and specialty practice with clinical updates, pharmacy trends, and regulatory news.

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FDA approves apalutamide for castration-resistant prostate cancer.

Apalutimide for Prostate Cancer: What to Know

CVS and Walgreens will limit their offerings for the COVID-19 vaccine, even for those who meet the new criteria from the FDA, according to 

 The new criteria limit who can receive a COVID-19 vaccine, with 4 different vaccines having different indications on who can receive the immunization.

CVS will now offer COVID-19 vaccines in 13 of 16 states and the District of Columbia to those who have a prescription from their physician or other medical provider. The states include Arizona, Colorado, Florida, Georgia, Kentucky, Louisiana, Maine, North Carolina, New York, Pennsylvania, Utah, Virginia, and West Virginia. CVS will not offer COVID-19 vaccines in Massachusetts, Nevada, and New Mexico. According to 

, CVS will offer updated COVID-19 vaccines in the remaining states pending Advisory Committee on Immunization Practice (ACIP) guidelines. For Walgreens, patients need prescriptions for 16 states but not all of them overlap with CVS, and it is unclear which states include these 16, according to 

The FDA recently approved 4 updated COVID-19 vaccines: Pfizer and BioNTech’s Comirnaty, Novavax’s Nuvaxovid, and Moderna’s Spikevax and mNexspike. All have been approved for adults 65 years and older to prevent COVID-19. Other indications include

Nuvaxovid: for patients aged 12 years through 64 with at high risk of severe disease with least 1 underlying condition

Spikevax: for patients 6 months through 64 years at high risk of severe disease with at least 1 underlying condition

mNexspike: for patients aged 12 through 64 years at high risk of severe disease with at least 1 underlying condition

Comirnaty: for patients aged 5 through 64 years at high risk for severe disease with at least 1 underlying condition

Guidance and information on the upcoming 2025-2026 respiratory season have been met with confusion. Recommendations, which were once aligned across organizations, are now conflicting, which included government organizations, such as the CDC, as well as the health care organizations, such as the American Academy of Pediatrics (AAP). Pregnancy has been removed from the adult schedule, even though some health care providers consider it an underlying condition leading to severe disease.

“We need to take the politics out of immunizations and rely on medical experts with years of education, the experience, and the knowledge to interpret that data to provide evidence-based recommendations," Laura Knockel, PharmD, BCACP, clinical associate professor at the University of Iowa College of Pharmacy, said.

AAP published its annual immunization schedule, which covers guidance for influenza, respiratory syncytial virus, and COVID-19. Although recommendations from the organization typically follow ACIP guidelines, this year the schedule differs from the recent recommendations from the committee.

“[Patients are] understandably confused. The space around vaccines is changing so rapidly,” Knockel said.

 “There's so much misinformation and disinformation out there, so I really think the first step is to acknowledge that concern, and again, coming from the point of they want to do what's best for their child.”

Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our

1. Astor M, Blum D. CDC uncertainty upends COVID vaccine access at CVS and Walgreens. 

. August 28, 2025. Accessed September 2, 2025. https://www.nytimes.com/2025/08/28/well/cvs-pharmacy-covid-vaccine-16-states.html

2. Levy S. CVS, Walgreens limiting offerings of new COVID-19 vaccines. 

. September 2, 2025. Accessed September 2, 2025. https://drugstorenews.com/cvs-walgreens-limiting-offerings-new-covid-19-vaccines

3. Gallagher A. FDA approves COVID-19 vaccines for patients 65 years and older. 

. August 23, 2025. Accessed September 2, 2025. https://www.drugtopics.com/view/fda-approves-covid-19-vaccines-for-patients-65-years-and-older

4. Gallagher A. New COVID-19 vaccine recommendations cause confusion among public, health care providers. 

. June 10, 2025. Accessed September 2, 2025. https://www.drugtopics.com/view/new-covid-19-vaccine-recommendations-cause-confusion-among-public-health-care-providers

5. Gallagher A, Knockel L. Q&A: pharmacist advocates for evidence-based immunization guidelines for COVID-19 vaccines. 

. September 1, 2025. Accessed September 2, 2025. https://www.drugtopics.com/view/q-a-pharmacist-advocates-for-evidence-based-immunization-guidelines-for-covid-19-vaccines

6. Gallagher A. FDA approves updated 2025-2026 COVID-19 vaccine for patients 65 years and older. 

. August 27, 2025. Accessed September 2, 2025. https://www.drugtopics.com/view/fda-approves-updated-2025-2026-covid-19-vaccine-for-patients-65-years-and-older

CVS will not offer COVID-19 vaccines in Massachusetts, Nevada, and New Mexico.

Clinical

CVS, Walgreens Will Limit COVID-19 Vaccine Offerings in 16 States

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.

SGLT2i, GLP-1RA Combination Therapy Offers Robust Protection Against Cardiovascular, Kidney Disease

In January 2025, the FDA approved the first and only nonopioid analgesic, suzetrigine (Journavx), to treat moderate to severe acute pain in adults. Suzetrigine reduces pain by targeting pain-signaling pathways before pain signals reach the brain, according to the FDA.

“Any pain management treatment option that is not an opioid is typically well received these days, as not only [does] the sensationalized anti-opioid hysteria continue its reign, [but] also the realistic desire of clinicians to provide actual safe and effective patient care for those in pain remains,” Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, director of experiential learning at West Virginia University School of Pharmacy and clinical pain and addiction pharmacist at West Virginia University Medicine, said. “Suzetrigine is FDA approved for moderate to severe—numerical pain scale range of 4 to 10—acute pain in adults, leaving patient care opportunities rather wide open.”

This approval marks the first in a new class of pain management medications and is aimed at developing nonopioid analgesics for acute pain.

It is unclear how the new approval will affect the opioid pandemic. However, in an interview, Madison Irwin, PharmD, BCPS, a clinical pharmacist specialist in palliative care at the University of Michigan Health and a clinical assistant professor at the University of Michigan College of Pharmacy, discussed how insurance coverage could influence the impact of the approval.

“Vertex [Pharmaceuticals Incorporated], which is [suzetrigine’s manufacturer], is reporting they’ve established a wholesale acquisition cost of $15.50 per 15-mg tablet, and so, per their recommended dosing and the label dosing, [that] would be around $30 a day,” Irwin said. “It’s also not astronomically high, so I don’t know if that will be as much of a limiting factor as with some other drugs, but it certainly will have an impact.”

A HISTORY OF OPIOIDS IN THE UNITED STATES

Opioids have been separated into 3 categories: natural, semisynthetic, and synthetic. Natural opioids, also referred to as opiates, include morphine, and synthetic opioids include methadone and fentanyl, which are wholly made in a laboratory. Semisynthetic opioids include many of the prescription pain medications, including oxycodone and hydrocodone, which are synthesized from morphine and codeine.

According to a report from the Congressional Research Service, the 1990s brought more intense marketing for nearly reformulated prescription opioid medications, such as oxycodone hydrochloride (OxyContin), which was paired with a pain advocacy campaign, leading to the rise in opioid use in the US. From 1999 to 2010, opioid prescription sales quadrupled, and misuse and overdose-related deaths also increased. Between 1999 and 2020, approximately 565,000 Americans died from opioid-involved overdoses, leading federal, state, and local governments to respond to the epidemic.

Further, the COVID-19 pandemic may have exacerbated the impact of the opioid crisis, which showed significant increases in alcohol and substance misuse, according to the Federal Communications Commission. However, the CDC suggests that the increased use of telehealth for opioid use disorder (OUD)–related services was associated with a lowered likelihood of fatal drug overdoses for patients who had Medicare.

“The necessary isolation efforts and the general psychology of dealing with such a worldwide scenario propelled many to more drug utilization. Drug overdose deaths increased during the pandemic yet are thankfully slowly starting to decrease to prepandemic levels these days, a trend that many hope continues,” Garofoli said.

The opioid epidemic has been separated into 3 waves. The first wave began with the increased opioid prescriptions in the 1990s, with the marked increase starting around 1999. The second wave began in 2010, with increases in opioid deaths involving heroin specifically. The third wave began in 2013, with substantial increases in overdose deaths that involved synthetic opioids, particularly fentanyl or fentanyl analogues. Fentanyl is often found as a powder or pressed into counterfeit pills and can be mixed into other drugs. The CDC reports that many opioid deaths involve other drugs, with nearly 43% of drug overdose deaths in 2022 involving both opioids and stimulants.

Out health care system is so very complicated that one should take pause [at] the reality that it's rather hard to [obtain] a prescription pain medication these days. —Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS

“I think the important thing to remember with suzetrigine right now is that it has been studied in and is indicated for acute [pain], and so certainly it has the potential to reduce the use of opioids perioperatively, which is how it was studied,” Irwin said. “It remains to be seen what its place is going to be in the chronic pain space.”

SUZETRIGINE'S POTENTIAL ROLE IN THE OPIOID CRISIS

The approval of suzetrigine was evaluated in 2 randomized, double-blinded trials for acute surgical pain—one for abdominoplasty and the other for bunionectomy. Investigators found that at the highest dose, the drug reduced acute pain over 48 hours after either an abdominoplasty or bunionectomy.

In one study, investigators included patients who were scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy and internal fixation under regional anesthesia and were aged 18 to 75 years. The primary outcome included the time-weighted sum of pain intensity difference (SPID) recorded on a numeric pain rating scale (NPRS) of 0 to 48 hours an abdominoplasty without collateral procedures who were aged 18 to 75 years. The primary end point included time-weighted SPID recorded on an NPRS at 0 to 48 hours after the first dose of the study drug. Secondary end points included SPID at 0 to 24 hours after the first dose; the proportion of patients with 30%, 50%, and 70% or greater reduction in pain score at 48 hours; and the number of patients with treatment-related AEs and serious AEs.

In the bunionectomy trial, there were 274 patients, with 90.1% completing treatment; for the abdominoplasty trial, there were 303 patients, with 81.5% completing treatment. The least-squares mean difference between the high-dose drug and the placebo group was 36.8 and 37.8, respectively. For the lower dose, the results were similar to those of the placebo. Concerning safety, the most common AEs (at least 10%) included nausea, headache, constipation, dizziness, and vomiting for patients in the abdominoplasty trial and nausea and headache for those in the bunionectomy trial.

Pharmacists are well positioned to screen for diversion, monitor for opioid use disorder, and educate patients on opioid-related risks.

Stephanie Trexler, PharmD Candidate

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