Prothrombin complex concentrates (PCCs) are frequently used off label for the management of factor Xa inhibitor-associated major bleeding.

In 2018, accelerated approval was granted for andexanet alfa, a specific factor Xa inhibitor reversal agent, for reversal of apixaban and rivaroxaban in the setting of life-threatening or uncontrolled bleeding.

Following accelerated approval, some clinical practice guidelines were updated to include recommendations for andexanet alfa preferentially over PCCs for reversal of life-threatening or uncontrolled bleeding due to rivaroxaban or apixaban. Other guidelines stated no preference of andexanet alfa over PCC.

In 2020, Vizient convened an expert panel to critically appraise the literature and provide consensus-based, expert opinions on the utilization of pharmacological reversal agents for factor Xa-related major bleeding. Since then, the body of literature evaluating these agents has expanded to include a randomized controlled trial, ANNEXa-I, the results of which were submitted to the US Food and Drug Administration to convert the approval of andexanet alfa from accelerated to full approval.

Dr. Lisa Baumann-Kreuziger, Associate Professor of Hematology and Oncology, Medical College of Wisconsin and medical director of the Antithrombotic Therapy Management Program at Froedtert Health discusses the current status of management of factor Xa inhibitor-associated major bleeding with Dr. Kerry Schwarz, Senior Clinical Manager of Evidence-Based Medicine and Outcomes with the Vizient Center for Pharmacy Practice Excellence, and your program host.

Guest speakers: Liza Baumann-Kreuziger, MD, MS Investigator, Blood Research Institute, Versiti Associate Professor of Hematology and Oncology, Medical College of Wisconsin Medical Director, Antithrombotic Therapy Management Program at Froedtert Health

Host: Kerry Schwarz, Pharm.D, MPH Senior Clinical Manager of Evidence-Based Medicine and Outcomes Vizient Center for Pharmacy Practice Excellence Verified Rx Host

Show Notes:

[02:25-04:26] The current state of hemostatic management in the setting of factor Xa inhibitor-related major bleeding

[04:27- 05:35] Limitations of available evidence making clinical practice and formulary decision making so challenging

[05:35 – 10:52] Publication of the first randomized controlled trial, ANNEXa-I, comparing andexanet alfa to usual care

[10:52-14:49] Meeting of the FDA advisory committee and subsequent complete response letter

[14:50-16:45] How we can approach clinical management of patients and formulary decision-making in the current state

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Drug shortages continue to pose significant challenges for hospitals and health systems. While they gained national attention during the COVID-19 pandemic, pharmacy departments have managed them for decades. During high-profile shortages, institutions must rapidly establish command centers, engage stakeholders, and implement plans for frontline staff. Once resolved, shortages often recede from immediate focus until the next crisis emerges. However, pharmacy departments consistently manage shortages on a daily basis, often without recognition.

Dr. Kyle Hoelting, Sr. Clinical Manager of Drug Information and Drug Shortages at Vizient, Dr. Heather Warhurst, Director of Drug Use Policy, Quality Initiative and Regulatory at IU Health, and Dr. Chris Nagy, Medication Sourcing and Supply Pharmacist at Intermountain Health join us to discuss a Vizient workgroup project designed to measure the impact of drug shortages and highlight the crucial role of pharmacists in their management.

Guest speakers:

Heather Warhurst, Pharm.D, MHA

Director of Drug Use Policy, Quality Initiative and Regulatory

IU Health

Chris Nagy, Pharm.D, BCPS

Medication Sourcing and Supply Pharmacist

Intermountain Health

Kyle Holting, Pharm.D, BCPS

Senior Clinical Manager of Drug Information

Vizient Center for Pharmacy Practice Excellence

Host:

Stacy Lauderdale, Pharm.D, BCPS

Associate Vice President

Vizient Center for Pharmacy Practice Excellence

Show Notes:

[01:18-02:29] Heather and Chris introductions

[02:30-04:00] Vizient drug shortage key performance indicators (KPI) workgroup series

[04:01-10:04] Labor and Inventory drug shortage KPIs

[07:50-16:56] Patient Safety and Stress to Front Line Staff drug shortage KPIs

[16:57-18:32] Call to Action

Links | Resources:

Key performance indicators for the management of drug shortages

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The widespread use of pneumococcal conjugate vaccine (PCV) in children has dramatically lowered the incidence of pneumococcal disease through direct and indirect effects. Despite this progress, pneumococcal pneumonia still leads to more than 200,000 adult hospitalizations annually in the United States. Older adults, individuals with underlying health conditions, and certain racial groups continue to experience higher rates of pneumococcal disease. Dr. John Schoen, Senior Clinical Manager of Drug Information at the Vizient Center for Pharmacy Practice Excellence, joins Program Host Stacy Lauderdale to discuss the newest adult pneumococcal vaccine, PCV21, and recent updates to age-based pneumococcal vaccine recommendations.

Guest speakers:

John Schoen, Pharm.D, BCPS

Senior Clinical Manager of Drug Information

Vizient Center for Pharmacy Practice Excellence

Host:

Stacy Lauderdale, Pharm.D, BCPS

Associate Vice President

Vizient Center for Pharmacy Practice Excellence

Show Notes:

[01:25-02:53] Background on PCV21

[02:54-07:56] Difference between PCV20 and PCV21

[07:57-16:15] Discussing the new ACIP recommendation to move the universal age for pneumococcal vaccination from 65 years of age down to 50 years of age and older

[08:31-16:15] Why a healthy 50-year-old who has no risk factors for invasive pneumococcal disease should get a pneumococcal vaccination

[16:16-17:57] Summary of other changes in the most recent MMWR

[17:58-19:34] What organizations consider when selecting specific pneumococcal vaccines

[19:35-21:18] What’s in the pipeline for pneumococcal vaccines

Links | Resources:

Publicly available resources

Previous VerifiedRx podcasts on pneumococcal vaccines:

• What’s pneu with pneumococcal vaccines? – March 29, 2022
• What’s pneu part 2: pneumococcal vaccines update – February 13, 2024

January 2024 MMWR - ACIP recommendations for the use of PCV in adults ≥ 50 years of age

Vizient client exclusive resources

2025 pneumococcal vaccines side-by-side comparison

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