Bulletin Today
APhA staff
Early data suggest 2024–2025 COVID-19 vaccinations reduced hospitalizations
Preliminary data suggest that CDC’s recommendation that all qualified persons 6 months and older receive a 2024–2025 COVID-19 vaccination was an effective move. Early calculations suggested the vaccine was 33% effective against COVID-19–associated visits to the emergency department or urgent care facilities for adults. For adults over 65 years, compared with nonrecipients, the vaccine was 40% to 46% effective against COVID-19 hospitalizations, depending on immune system status.
The interim data were based on data from the Virtual SARS-CoV-2, Influenza and Other Respiratory Viruses Network (VISION) and the Investigating Respiratory Viruses in the Acutely Ill (IVY) network. The data from VISION encompasses EHRs from 373 emergency departments and urgent care facilities. IVY collects inpatient data from 26 hospitals across 20 states.
The surveillance data indicate that the 2024–2025 COVID-19 vaccination “provided additional protection against COVID-19–associated [emergency department/urgent care] encounters and hospitalizations among adults with and without immunocompromising conditions, compared with not receiving a 2024–2025 COVID-19 vaccine dose,” CDC concluded. ■
Some patients unable to afford insulin despite price caps, assistance programs
Some patients with insulin-dependent diabetes cannot afford or have trouble obtaining the medication, even though federal legislation limits prices and manufacturers have financial assistance programs in place. Advocates have pointed out flaws in the manufacturer coupons, saying they are useless for some patients because the insulin products covered by them are not the ones that work best for them or because they do not qualify for the aid.
The complexity of formularies and other aspects of the U.S. health care system also contribute to the problem, according to Kasia Lipska, MD, Yale School of Medicine endocrinologist. Lipska was the primary investigator of a widely cited 2018 study reporting that one in four insulin users resort to rationing.
“The Inflation Reduction Act just capped [insulin prices] for Medicare but not for commercially insured patients,” she said. Additionally, the $35 month ceiling is doubled if a patient requires two different types of insulin, including all patients with T1D who use multiple daily injections rather than a pump. “I think price caps are a Band-Aid solution,” Lipska added. “In and of themselves, they don’t fix our system. I would like to see bigger system-level changes in terms of how we regulate pricing and access to medications.”
Advocacy groups have accused the three major manufacturers of insulin—Novo Nordisk, Eli Lilly and Co, and Sanofi—of engaging in “monopolistic control, price gouging, and patent manipulation.” The manufacturers deny the accusations. ■
Illegal ingredients for GLP-1s entering U.S. market could endanger patients
A report from the Partnership for Safe Medicines (PSM) said that suspicious, unauthorized, and illegal ingredients for diabetes and weight loss drugs are flooding into the United States. A total of 239 shipments of semaglutide and tirzepatide between September 2023 and January 2025 failed to register their facilities with FDA—a legal requirement to ensure the safety of the U.S. drug supply. FDA blocked entry for 44 suspicious loads, allowing 195 illegal shipments into the U.S. market, where they were likely used in knockoff products. The shipments contained nonsterile and other potentially harmful active ingredients.
“Use of compounded versions of GLP-1 medications has surged, with telehealth companies and compounding pharmacies aggressively marketing them to consumers,” said Shabbir Safdar, PSM executive director. “Consumers remain largely unaware that, unlike prescription medicines, these knockoffs are not FDA-approved, and they’re not generics. Our report reveals these knockoff GLP-1s may contain active ingredients from unregulated, overseas manufacturers that are not be suitable for human use.”
PSM urged FDA to refuse entry to any drugs that appear to be misbranded or otherwise unapproved. Additionally, FDA is advised to flag future shipments from suspect manufacturers and to work with state boards of pharmacy to prioritize inspections of compounders complicit in these shipments.
“Under the law, the FDA is required to block shipments of pharmaceutical ingredients from unregistered manufacturing facilities at the border,” said George Karavetsos, former director of the FDA’s Office of Criminal Investigations and federal prosecutor. “Yet this report shows dangerous, unchecked drug ingredients are entering the U.S. in large numbers bound for use in compounded and counterfeit products. U.S. law enforcement and regulators must ensure Americans are not exposed to the dangers of illegal drug ingredients from foreign sources.” ■
FDA issues changing label language of testosterone products
FDA has announced labeling changes for testosterone products to update the language including a warning about the potential for increased BP. This comes after a review of clinical trial data and postmarket ambulatory blood pressure (ABPM) monitoring studies. The updated language will include findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men study on all testosterone products; retain “Limitation of Use” language for age-related hypogonadism; and remove language from the boxed warning related to an increased risk of adverse cardiovascular outcomes.
Other label language changes that FDA will require include adding product-specific information on increased BP for testosterone products with completed ABPM studies and adding a new warning about increased BP for testosterone products that currently do not have such a warning in their labeling.
Testosterone is approved only for use in men who lack or have low testosterone levels due to a medical condition. Current FDA-approved testosterone formulations include oral, topical gel, transdermal patch, buccal system, and injection. FDA had previously warned of reported risks of stroke, heart attack, and death in men taking FDA-approved testosterone products. ■