From new drug approvals to at-home vaccine administration, 2025 was filled with a variety of notable medication therapy management (MTM) updates and medication safety changes from the FDA. Pharmacists play a vital role in educating patients and health care professionals about these MTM updates.
FluMist Home Administration
FluMist (AstraZeneca) is a live, attenuated influenza nasal spray vaccine that was FDA approved for caregiver administration or self-administration in September 2024.1 It is approved for patients aged 2 to 49 years. Individuals aged 18 to 49 years can self-administer FluMist, but individuals aged 2 to 17 years should receive FluMist through caregiver administration.1
In August 2025, FluMist launched for at-home delivery.2 Licensed health care professionals review the information online through Asembia Specialty Pharmacy Network Pharmacies to determine whether the patient is eligible, and Polaris Pharmacy Services dispenses and ships FluMist in temperature-controlled packages.2 Pharmacists can educate eligible patients about this new vaccine option.
MTM Spotlight
In an email interview with Pharmacy Times, Charity Reid, PharmD, a pharmacist at Costco, discussed MTM trends she has seen in her practice.
“Some of these therapies aren’t unconventional or new, but the uptick in prescribing is interesting. Before we had seen some of these things once in a blue moon, and now we are seeing it on a weekly basis,” Reid said.
She added that budesonide/formoterol (Symbicort; AstraZeneca) is being used more often as a rescue inhaler. Research shows single maintenance and reliever therapy (SMART) is effective at preventing asthma attacks.6 SMART therapy uses 1 inhaler, such as budesonide/formoterol, as both a maintenance and rescue inhaler for asthma.
Reid provided additional updates, which include ending the clozapine REMS program and an increase in the prescribing of propranolol for anxiety. Additionally, Reid has seen more hormone therapy prescriptions for testosterone therapy in women and progesterone for men. Oral minoxidil is also being prescribed more often to treat hair loss in women.
Opioid Labeling Changes
In June 2025, the FDA removed the risk evaluation and mitigation strategy (REMS) program for the antipsychotic medication clozapine (Clozaril; HLS Therapeutics) to improve access.3 The REMS program had previously required prescribers, pharmacies, and patients to enroll in a restricted program that required them to report the absolute neutrophil count (ANC) due to the risk of severe neutropenia.3 The FDA determined that the REMS was no longer needed based on the program reevaluation and the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee.3 Because there is still a risk of neutropenia, prescribers should monitor patients’ ANC before beginning clozapine and throughout their treatment.3 However, pharmacists are no longer required to verify the ANC before dispensing clozapine.
In July 2025, the FDA announced safety changes to opioid pain medication labeling (Table4). The recommendations are based on a public advisory committee meeting held in May 2025 that reviewed data showing serious risks of long-term opioid use such as misuse, addiction, and overdoses.4 Additionally, the FDA is requiring another clinical study that evaluates the benefits and risks of long-term opioid therapy.4 Pharmacists can review this important safety information during MTM consultations with patients taking opioid medications.
Gepotidacin for Urinary Tract Infection
Gepotidacin (Blujepa; GSK) is a novel medication for urinary tract infections (UTIs) approved by the FDA in March 2025.5 Gepotidacin treats uncomplicated UTIs in women and female pediatric patients 12 years or older with weight of at least 40 kg.5 Additionally, gepotidacin is the first in a new class of triazaacenaphthylene antibiotics for uncomplicated UTIs that has been approved in almost 30 years.5 Gepotidacin has a unique mechanism of action that inhibits 2 different type II topoisomerase enzymes. This unique mechanism of action may help prevent antibiotic resistance.5
Gepotidacin is an oral antibiotic, and the recommended dosage is 1500 mg (two 750-mg tablets) twice daily for 5 days. Patients should separate their doses by approximately 12 hours. Gepotidacin is expected to launch in the second half of 2025.5
MTM Spotlight
In an email interview with Pharmacy Times, Charity Reid, PharmD, a pharmacist at Costco, discussed MTM trends she has seen in her practice.
“Some of these therapies aren’t unconventional or new, but the uptick in prescribing is interesting. Before, we had seen some of these things once in a blue moon, and now we are seeing it on a weekly basis,” Reid said.
She added that budesonide/formoterol (Symbicort; AstraZeneca) is being used more often as a rescue inhaler. Research shows single maintenance and reliever therapy (SMART) is effective at preventing asthma attacks.6 SMART uses one inhaler, such as budesonide/formoterol, as both a maintenance and rescue inhaler for asthma.
Reid provided additional updates, which include ending the clozapine REMS program and an increase in prescribing of propranolol for anxiety. Additionally, Reid has seen more hormone therapy prescriptions for testosterone therapy in women and progesterone for men. Oral minoxidil is also being prescribed more often to treat hair loss in women.
About the Author
Jennifer Gershman, PharmD, CPh, PACS, is a drug information pharmacist and Pharmacy Times contributor who resides in South Florida.
REFERENCES
6. Sobieraj DM, Weeda ER, Nguyen E, et al. Association of inhaled corticosteroids and long-acting β-agonists as controller and quick relief therapy with exacerbations and symptom control in persistent asthma: a systematic review and meta-analysis. JAMA. 2018;319(14):1485-1496. doi:10.1001/jama.2018.2769
