CSHP - California Society of Health-System Pharmacists

11/15/2025

FDA Approves New Treatment for Thymidine Kinase 2 Deficiency

The U.S. Food and Drug Administration (FDA) has approved a new treatment for thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. Doxecitine and doxribtimine (Kygevvi) is a combination of doxecitine and doxribtimine, both pyrimidine nucleosides, administered as a powder for oral solution.

The safety and efficacy of doxecitine and doxribtimine (Kygevvi) were evaluated in a prospective, open-label, single-arm study in pediatric and adult patients with genetically confirmed TK2d previously treated with pyrimidine nucleosides (Trial 1). Additional safety information was derived from retrospective chart review studies (Study 1, Study 2) and from an expanded access program.

Warning and precautions for doxecitine and doxribtimine (Kygevvi) include elevated liver transaminase levels and gastrointestinal adverse reactions. The most common adverse reactions (≥5%) to doxecitine and doxribtimine (Kygevvi) are diarrhea, abdominal pain (including upper abdominal pain), vomiting, alanine aminotransferase increased (ALT), and aspartate aminotransferase increased (AST).

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. Consumers are also encouraged to report adverse events to the FDA’s MedWatch site.

View the FDA’s announcement here:
https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

View doxecitine and doxribtimine (Kygevvi) package insert here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219792s000lbl.pdf

11/14/2025

📢 MAXIMIZING RURAL HEALTH: CSHP Urges CA to Include Pharmacists in CMS Rural Health Transformation Program!

Pharmacists are the most accessible healthcare professionals. Integrating them into care teams is critical to improving chronic disease outcomes, boosting medication safety, and ensuring grant dollars deliver maximum impact.

We must fully utilize the expertise of pharmacists to enhance patient care across California.

Read our full letter: https://bit.ly/47UBiZM

11/13/2025

Free CE from Medscape and MMWR: Underutilization of Influenza Antiviral Treatment Among Children and Adolescents at Higher Risk for Influenza-Associated Complications — United States, 2023-2024

Medscape will be hosting a free online CE activity to discuss a new study demonstrating the underutilization of antiviral treatment for pediatric outpatients and inpatients with influenza.

Upon completing this activity, participants will be able to distinguish the frequency of antiviral treatment among children and adolescents with influenza in the US in the hospital and outpatient setting, assess which age groups of children and adolescents are associated with lower influenza antiviral use, and compare trends of influenza antiviral treatment among pediatric inpatients over time.

Pharmacists are a part of the target audience for this activity.

Valid for credit through 10/01/2026.
Registration is not required.
This event offers 0.50 contact hours in pharmacy education.

View the Medscape Activity information here:

New study demonstrates disappointing application of antiviral treatment for pediatric outpatients and inpatients with influenza.

11/11/2025

IDSA’s New Guidelines for Vaccines for Seasonal Respiratory Viruses in the Immunocompromised

The Infectious Diseases Society of America (IDSA) released the 2025 guidelines for the use of U.S.-licensed vaccines for the prevention of seasonal COVID-19, influenza, and respiratory syncytial virus (RSV) infections in immunocompromised patients. These recommendations take into consideration patients who are immunopromised due to hematologic malignancy, primary immunodeficiency, autoimmune disease treated with immunosuppressants or biologics, or HIV with severe immunosuppression (CD4

11/10/2025

📣 Calling all Pharmacy Students! Join CSHP for our first-ever Student Town Hall on Thursday, November 20 at 6:00 pm!

Be part of an engaging and insightful Q&A session designed for students to connect directly with our CSHP leadership (President, Elaine Law, and CEO, Loriann De Martini), ask questions, and share ideas.

💡 We want to hear from you! What topics or questions would you like to see discussed? Share your ideas in the comments or message us directly — your voice matters.

Register ➡️ https://bit.ly/4hVFLAb

11/09/2025

⏰ TIME IS RUNNING OUT! ⏰

The deadline to submit your Poster Abstract for the Pacific Coast Patient Safety Conference 2026 is rapidly approaching on December 15, 2025!

Don't miss your final chance to share your research, practice innovations, or case vignettes with healthcare leaders in Monterey, CA. Submissions are for Residents, Practitioners, Students, and more!

Submit your abstract ➡️ https://www.cshp.org/PCPSC26_Posters

11/08/2025

FDA Approves New Treatment for Hot Flashes in Menopause

The U.S. Food and Drug Administration (FDA) has approved a new treatment for adults with moderate-to-severe vasomotor symptoms due to menopause. Elinzanetant (Lynkuet) is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist administered as an oral capsule. Elinzanetant (Lynkuet) is a nonhormonal treatment for the management of moderate-to-severe vasomotor symptoms due to menopause.

The safety and efficacy of elinzanetant (Lynkuet) were evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2, OASIS 3) in 1420 women. The primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to Weeks 4 and 12, including day and night HFs measured using the Hot Flash Daily Diary (HFDD)

Warning and precautions for elinzanetant (Lynkuet) include CNS depressant effect and daytime impairment, hepatic transaminase elevations, risk of pregnancy loss, and risk of seizures in patients with a history of seizures. The most common adverse reactions (≥5%) to elinzanetant (Lynkuet) were headache, fatigue, dizziness, and somnolence.

View the FDA’s announcement here:
https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

View elinzanetant (Lynkuet) package insert here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf

11/08/2025

The CSHP 2026 Election Bulletin is LIVE! 🗳️

It's time to meet the highly qualified candidates running for CSHP's 2026 leadership positions! These candidates will shape our profession's stance on key issues like legislative advocacy, workforce development, and innovation.

Official ballots will be sent on November 24th so be sure to review the candidate statements and biographies
➡️ https://www.cshp.org/Election_Bulletin2026

11/06/2025

FDA Announces Action to Accelerate Biosimilar Development and Lower Drug Costs

The U.S. Food and Drug Administration (FDA) announced its plan to accelerate the approval of biosimilar development, which will lower drug costs. Biosimilar medicines are the lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases.

The FDA proposes a major update in newly drafted guidance to simplify biosimilarity studies and reduce unnecessary clinical testing. Additionally, through a separate initiative, the FDA plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics. This change will help patients and pharmacists choose lower-cost options more easily.

FDA-approved biosimilars are as safe and effective as the branded drugs.
Currently, the FDA has approved 76 biosimilars, which is a small fraction of approved biologics. However, only about 10% of biologic drugs that are expected to lose patent protection in the next decade currently have a biosimilar in development.

View the FDA’s announcement here:
https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs

11/04/2025

ISMP Safety Recommendations for Wrong Dosage Strength Dispensed Due to Typing Error

The Institute for Safe Medication Practices (ISMP) prepared an article for the National Association of Boards of Pharmacy (NABP) regarding confusion caused by similar-looking characters in electronic prescriptions. An error occurred when pharmacy personnel mistook the lowercase letter ‘l’ in HCl for the numeral ‘1’ and processed the electronic prescription, resulting in the patient receiving a higher dose of medication.

ISMP recommends that to minimize the need for manual transcription of e-prescriptions into pharmacy systems, hospitals, medical offices, and clinics must ensure e-prescriptions are constructed and transmitted according to standards set by organizations such as the National Council for Prescription Drug Programs and Surescripts. It is recommended for pharmacies to routinely test and update their systems to ensure accurate processing and matching of e-prescription information.

View NABP’s news release with ISMP here:
https://nabp.pharmacy/news/blog/regulatory_news/ismp-safety-brief-wrong-dosage-strength-dispensed-after-confusing-l-for-1/

11/01/2025

FDA Approves New Treatment for Relapsed or Refractory Acute Myeloid Leukemia with A Susceptible NPM1 Mutation

The U.S. Food and Drug Administration (FDA) has approved a new treatment for adult and pediatric patients 1 year and older with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. Revumenib (Revuforj) is a menin inhibitor administered as an oral tablet.

The safety and efficacy of revumenib (Revuforj) were evaluated in a single-arm cohort of an open-label, multicenter trial. Patients enrolled had a susceptible mutation confirmed using next-generation sequencing or polymerase chain reaction of the last exon of NPM1. The main efficacy outcome measures were complete remission rate (CR), CR with partial hematological recovery (CRh), CR+CRh duration, and rate of conversion from transfusion dependence to transfusion independence.
Warnings and precautions for revumenib (Revuforj) include differentiation syndrome, QTc interval prolongation, Torsades de Pointes, and embryo-fetal toxicity.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

View the FDA’s announcement here:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation

11/01/2025

🤯 An absolute highlight from yesterday's !

A massive THANK YOU to the phenomenal Jessica Bejarano for her incredibly inspiring Keynote Presentation! Your powerful story and leadership resonate deeply. We are leaving motivated to apply your invaluable lessons to elevate patient care and leadership within the world of pharmacy!