VerifiedRx

Reversal Revisited: Agents for the Management of Factor Xa Inhibitor-Associated Bleeding

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, MSInvestigator, Blood Research Institute, Versiti Associate Professor of Hematology and Oncology, Medical College of WisconsinMedical Director, Antithrombotic Therapy Management Program at Froedtert Health
 
Host: Kerry Schwarz, Pharm.D, MPHSenior Clinical Manager of Evidence-Based Medicine and Outcomes Vizient Center for Pharmacy Practice Excellence
 
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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Dose of data: Drug shortage KPIs

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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What's pneu part 3: pneumococcal vaccines update

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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No pain, much gain?

Prescription opioids continue to be the most frequently misused prescription drugs in the United States, having caused nearly 300,000 deaths over the past two decades. Signed into law in 2022, the No Pain Act expands Medicare reimbursement for specific non-opioid pain management options. Carolyn Liptak, Pharmacy Executive Director in the Vizient Center for Pharmacy Practice Excellence, and Dr. Phil Mentler, Senior Consulting Director at Vizient join Program Host Stacy Lauderdale to discuss the implications of the No Pain Act, which took effect on January 1, 2025.
 
Guest speakers: 
Carolyn Liptak, MBA, RPh
Pharmacy Executive Director
Vizient
 
Phillipe Mentler, Pharm.D, BCPS
Senior Consulting Director
Vizient
 
Host: 
Stacy Lauderdale, Pharm.D, BCPS
Associate Vice President
Vizient
  
Show Notes: 
[01:49-03:48] Background on the No Pain Act
[03:49-05:03] What is new as of January 1, 2025
[05:04-05:37] The difference between a hospital outpatient department versus an ambulatory surgical center
[05:38-06:30] Other drugs and or devices that are on the list other than Exparel
[06:31-07:42] What specifically prevents multi modal drugs and therapy from being added to the list
[07:43-08:24] Specific language that needs to be included in the FDA labeling for non-opioids to be considered for reimbursement under the Act
[08:25-10:50] Reimbursement basics of the NO PAIN Act
[14:32-15:44] Reimbursement
[15:45-17:04] The importance of opioids in pain management
 
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Winter Spend Management Outlook

Historically, Vizient has published the Pharmacy Market Outlook biannually. This year, we are introducing the Spend Management Outlook, which integrates the comprehensive insights from the Pharmacy Market Outlook with the Vizient Budget Impact Report. This new report enhances strategic planning by aligning pricing projections across the healthcare supply chain and providing key market insights. Dr. Carina Dolan, Associate Vice President of Clinical Oncology, Pharmacoeconomics, & Market Insights, and Jeff King, Director of Research and Intelligence at Vizient, join Program Host Carolyn Liptak to discuss the unique features and critical importance of the new Spend Management Outlook.
 
Guest speakers: 
Carina Dolan, Pharm. D., MS Pharm, BCOP
Associate Vice President, Clinical Oncology, Pharmacoeconomics and Market Insights
Vizient
 
Jeff King
Research and Intelligence Director
Vizient
 
Host:
Carolyn Liptak, MBA, BS Pharm
Vizient
 
Show Notes: 
[01:06-01:56] Jeff’s background and role
[01:57-02:50] The transition from Pharmacy Market Outlook and Budget Impact Report to Spend Management Outlook
[02:51-03:28] Defining spend management
[03:29-04:43] Key insights into spend management categories med-surg and laboratory
[04:44-06:01] Key insights into spend management categories Capital equipment and physician preferences insights
[06:02-07:23] Enhancements to pharmacy projections of this edition
[07:24-08:39] Spend management projection methodology
[08:40-09:34] The spend management projections
 
Links | Resources:
Spend Management Outlook
 
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The Administrations, they are a-changing!

We anticipate there will be some policy changes and important issues to watch with the inauguration of the 47th president of the United States. Vizient’s office of public policy and government relations monitors, educates and advocates on key items of interest. They share informative updates, comment on proposed rules from agencies like the Centers for Medicare and Medicaid Services and work with Congress on legislative priorities. Jenna Stern, Associate Vice President of Regulatory Affairs and Public Policy at Vizient joins Program Host Carolyn Liptak to discuss the change over.
 
Guest speakers: 
Jenna Stern
Associate Vice President of Regulatory Affairs and Public Policy
Vizient
 
Host:
Carolyn Liptak, MBA, RPh
Vizient
  
Show Notes: 
[00:56-01:15] Jenna’s background 
[01:16-02:38] Anticipation in DC since November
[02:39-04:26] What we should anticipate with the new Congress
[04:27-08:10] Trade and Tariffs
[08:11-10:37] What we should anticipate with the Executive Branch
[10:38-12:48] Policies to watch during transition
[12:48-13:34] Where listeners go for more information
[13:34-16:12] What issues are important to the new Congress
 
Links | Resources: 
Vizient Public Policy and Government Relations 
Vizient advocacy letters and Congressional statements 
Legislative and regulatory summaries 
China Tariffs document
 
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Rabies - You don't know what you know

Human rabies cases are fortunately rare in the US. Access to pre- and post-exposure prophylaxis, and domestic animal vaccination programs, drive this public health success. This comes at a financial and human resources cost. Dr. Kyle Weant, clinical assistant professor and an emergency medical clinical pharmacy specialist at the University of South Carolina College of Pharmacy and Dr. Philippe Mentler, senior consulting director, join host Gretchen Brummel to discuss the use of rabies immune globulin and rabies vaccine in patients who have been exposed and provide treatment pearls for frontline pharmacy practioners.
 
Guest speakers:
Kyle Weant, PharmD, BCPS, BCCCP, FCCP
Clinical Assistant Professor and an Emergency Medical Clinical Pharmacy Specialist
University of South Carolina College of Pharmacy
 
Philippe Mentler, PharmD, BCPS
Senior Consulting Director
Vizient
 
Host: 
Gretchen Brummel, PharmD, BCPS
VerifiedRx Host
 
Show Notes: 
[00:54-01:17] Kyle’s background information 
[01:18-03:31] Rabies as a disease
[03:32-05:13] Public Awareness
[05:14-07:06] Options right now for post-exposure prophylaxis
[07:07-10:01] Thoughts on dose rounding
[10:02-10:13] Is rabies immunoglobulin considered an essential medication that everyone should stock in their hospital pharmacy
[10:14-11:30] Who should be administering these drugs? And who's ensuring follow up of these patients?
[11:31-14:31] Potential pitfalls in patient management
[14:32-18:12] What should our frontline pharmacy staff know about post-exposure prophylaxis
 
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Proceed by Number – Data Approaches to Drug Shortages

Data dominate nearly every sector and drug shortages are an area to leverage data solutions. Stephen Colvill, Senior Policy Advisor for Medical Supply Chains, The White House Domestic Policy Council and Dr Nikola Markoski, Vizient Manager of Pharmacy Analytics and Clinical Insights, join host Gretchen Brummel to explore novel approaches and future implications for data use cases in drug shortages.
 
Guest speakers: 
Stephen Colvill
Senior Policy Advisor for Medical Supply Chains, Domestic Policy Council The White House, Domestic Policy Council
This podcast was recorded in December 2023 prior to Stephen joining the federal government. The opinions expressed are the author’s own and do not necessarily reflect the views of  the United States government or any agency thereof.
At the time of recording, Stephen was Executive Director of RISCS and Assistant Research Director at the Duke-Margolis Institute for Health Policy.
 
Nikola Markoski, PharmD, MBA, DPLA
Manager of Pharmacy Analytics and Clinical Insights
Vizient
 
VerifiedRx Host: 
Gretchen Brummel, PharmD, BCPS
 
Show Notes: 
[00:36-02:23] Guest’s background information 
[02:24-05:44] How using data can change the discussion of drug shortages
[05:45-09:23] Approaches that have been attempted so far in the data space
[09:24-12:01] Where things are going in the future
[12:02-15:23] How we get everybody on the same page
 
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Cha Ching Chemotherapy - Untangling the Cost of Cancer Treatment

Chemotherapy is a vital treatment for cancer patients, but high medication prices often cause issues and may even prompt patients to skip therapy. Various factors influence the cost of chemotherapy drugs, including research and development, manufacturing complexity, and regulatory compliance. Limited use implications further complicate the market. Dr. Michele Rice, Senior Pharmacy Executive with Vizient Pharmacy Advisory Solutions, joins us today to discuss these factors in depth.
 
Guest speaker: Michele Rice, PharmD, MSSenior Consulting Solutions Director Vizient Pharmacy Advisory Solutions
 
VerifiedRx Host: Gretchen Brummel, PharmD, BCPS 
Show Notes: [00:47-01:31] Guest’s background information 
[01:32-03:41 ] What’s happening in the industry now
[03:42-05:15] How this ultimately affects patients
[05:20-06:26] How pharmacists can assist patients with this difficult to navigate scenario or situation
[06:27-07:35] What patients should know about this issue
[07:36-08:09] How to improve the system
[08:10-08:44] What does the future hold
 
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Helene Aftermath - Baxter Production Shortage

Baxter's Intravenous Fluids North Cove Plant was impacted in September by Hurricane Helene. Although Baxter implemented a hurricane preparedness plan, a levy breach and bridge collapse forced a complete shutdown. Intravenous fluids are now on allocation as the plant remains shuttered. Multiple actions by the FDA and Baxter are in effect to improve supply for these fluids. Vizient colleagues Katie Korte, VP Assurance and Continuity Team and Kyle Hoelting, Senior Clinical Manager of Drug Information and Shortages join Stacy Lauderdale, Associate Vice president of Evidence-based Medicine today to discuss lessons learned from this and past supply disruptions, ongoing efforts by the FDA to improve supplies and the supply outlook for the next four to eight weeks
 
Guest speakers: 
Katie Korte, PharmD, MHA
VP Assurance and Continuity Team
Vizient
 
Kyle Holting, PharmD, BCPS
Senior Clinical Manager of Drug Information and Shortages
Vizient Center for Pharmacy Practice Excellence
 
Host: 
Stacy Lauderdale, PharmD, BCPS
Associate Vice president of Evidence-based Medicine
Vizient Center for Pharmacy Practice Excellence 
 
Show Notes: 
[00:57-01:27] Guest’s background information 
[01:28-04:33] Recent supply disruptions
[04:34-05:54] What Vizient has learned from past disruptions
[05:55-09:30] What providers have learned from these shortages
[09:31-13:42] What the FDA is doing to assist with this shortage
[13:43-18:23] What the trajectory of this shortage looks like over the next four to eight weeks
[18:24-19:45] Most important thing to emphasize to our listeners as they continue to handle this fluid shortage
 
Links | Resources: 
Vizient’s IV push list: Click here
Vizient’s IV fluid conservation strategies: Click here
Baxter’s North Cove facility website: Click here
FDA’s Baxter North Cove facility website: Click here
 
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