VerifiedRx

505b2 Pathway: Ghost Generics

The 1984 Hatch-Waxman Act codified the 505(b)(2) drug approval pathway and allowed the use of studies from a previously approved drug. To be clear, medications approved via this pathway are not generic molecules of the reference listed drug. They may have similar clinical effects and roles in therapy, but they also bring challenges. Dr. Tyler Wood, System Director of Pharmacy Oncology and Biosimilars, and Pharmacy Executive Director, Carolyn Liptak at Vizient, join Gretchen Brummel, Pharmacy Executive Director in the Vizient Center for Pharmacy Practice Excellence and your program host to give an early look.
 
Guest speakers: Tyler Wood, PharmD, BCBBSSystem Director, Pharmacy Oncology and Biosimilars Providence St. Joseph Health
 
Carolyn Liptak, MBA, BSPharmPharmacy Executive Director Vizient 
 
Host: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence
 
Show Notes: 
[00:55-01:34] Dr. Tyler Wood background information 
[01:35-03:09] How the 505(b)(2) pathway is intended to work
[03:10-04:32] Comparisons can we draw from the biologics approval process
[04:33-05:53] What the FDA says about which pathway to use
[05:54-07:05] What's changed recently in the approval process
[07:06-08:09] Can a 505(b)(2) product be rated as a generic equivalent?
[08:10 -09:07] How CMS changes are impacting management
[09:08-11:23] What our providers can do to plan and act to address these issues
[11:24-12:27] What’s most concerning moving forward
 
Links | Resources: 
Applications Covered by 505(b)(2)
Hospital Outpatient Prospective Payment System: January 2024 Update
MLN Matters® Articles Sign-up
CMS.gov ASP Pricing Files
CMS.gov What's a MAC
Drugs@FDA: FDA-Approved Drugs
FDA: Overview of the 505(b)(2) Regulatory Pathway for New Drug Applications
HCPCS Level II Coding for 505(b)(2)-Approved Drugs or Biologicals – Frequently Asked Questions
 
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What’s pneu part 2: pneumococcal vaccines update

Pneumococcal vaccines have been instrumental in decreasing invasive disease since their introduction in the 1980s. 2021 brought regulatory changes and recent ACIP recommendations were published in the Morbidity and Mortality Weekly Report, also known as MMWR. Dr. John Schoen, Senior Clinical Manager of Evidence-Based Medicine and Drug Information shares his insights on these changes with host Gretchen Brummel.
 
Guest speaker:  John Schoen, PharmD, BCPSSenior Clinical Manager of Evidence-Based Medicine and Drug Information Vizient Center for Pharmacy Practice Excellence    Host:  Gretchen Brummel, PharmD, BCPS  Pharmacy Executive Director  Vizient Center for Pharmacy Practice Excellence  
 
Show Notes:  
Recorded in the Fall of 2023
[01:00-03:34] What’s new since March 2022 with pneumococcal vaccines 
[03:35-06:51] Changes with the adult recommendations
[06:52-13:10] New recommendations from CDC as well as published recommendations for adults
[13:11-19:05] Recommendations for Pneumococcal vaccines in pediatrics
[19:06-21:46] The area of biggest risk moving forward
[21:47-24:07] What we are looking at for the future
 
Links | Resources:  
Vizient pneumococcal vaccine side-by-side comparison Click Here
ACIP pneumococcal vaccine recommendations Click Here
 
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Vizient Pharmacy Market Outlook – Winter 2024

Vizient publishes our Pharmacy Market Outlook twice a year. The outlook features drug price projections and key market insights to help support members' strategic planning. Drs. Jeni Hayes and Amanda Frick, both Senior Clinical Managers for Market Intelligence, join Gretchen Brummel, Pharmacy Executive Director in the Vizient Center for Pharmacy Practice Excellence and your program host to give an early look.
 
Guest speakers: 
Jeni Hayes, PharmD, MSPharm, BCPS
Senior Clinical Manager, Market Intelligence
Vizient 
 
Amanda Frick, PharmD, BCPS
Senior Clinical Manager, Market Intelligence
Vizient 
 
Host: 
Gretchen Brummel, PharmD, BCPS 
Pharmacy Executive Director 
Vizient Center for Pharmacy Practice Excellence 
  
Show Notes: 
[00:42-03:08] Areas of focus 2024 highlighted in this Pharmacy Market Outlook 
[03:09-05:35] The table of new and noteworthy approvals and some of the approvals that you were most excited to see
[05:36-07:05] Some drugs that you're looking forward to seeing approved in 2024
[07:06-08:25] What are you hearing from our members on their experiences and challenges with cellular and gene therapies?
[08:26-10:57] What else is going on in the specialty space
[10:58-12:14] Specialty pharmacy sustained growth that we've seen for patients in the acute care space
[12:15 -14:39] What's the projection for this edition
[14:40-14:24] Where listeners go if they want more detailed information on the outlook
 
Links | Resources: 
Vizient Pharmacy Market Outlook provider link: Click Here
Vizient Pharmacy Market Outlook highlights public version: Click Here
 
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“Standardized” Stewardship – Navigating the new TJC Standards for Antimicrobial Stewardship

Anti-Microbial Stewardship Programs are critical to optimizing utilization, mitigating resistance, and improving patient outcomes. These programs are continuously refined, and recent updates to The Joint Commission standards provide an opportunity to enhance our approach. Dr. Ripal Jariwala, Infectious Diseases Clinical Pharmacist, and Assistant Clinical Professor at the University of California San Francisco, and Dr. Ethan A. Smith, Clinical Infectious Diseases Specialist at Ronald Reagan UCLA Medical Center, join host Gretchen Brummel to discuss the revised standards and implications for pharmacy.
 
Guest speakers: 
Dr. Ripal Jariwala, PharmD, BCIDP, AAHIVP
Infectious Diseases Clinical Pharmacist, and Assistant Clinical Professor UCSF 
 
Dr. Ethan A. Smith, PharmD., BCIDP
Clinical Infectious Diseases Specialist
Ronald Reagan UCLA Medical Center
 
Host: 
Gretchen Brummel, PharmD, BCPS 
Pharmacy Executive Director 
Vizient Center for Pharmacy Practice Excellence
 
Show Notes: 
[01:01-01:47] The guests background 
[01:48-02:58] Brief update of the recent changes to Antimicrobrial Stewardship
[02:59-07:35] Interpreting the new EP-10 Joint Commission standard about financial and IT resources
[07:36-11:23] The current landscape on FTEs to support antimicrobial stewardship
[11:24-15:13] EP15 on evidence-based use of antibiotics considerations
[15:14-18:27] How do you approach meeting the revised standard on data collection analysis and recording for EP20
[18:28 -21:23] Other standards besides the joint commission standards that people need to be aware of
[21:24-23:34] Other related work going on in this space
[23:35-26:54] More information or other resources to find those items about antimicrobial stewardship
 
Links | Resources:
Knowledge on the Go Podcast: Updates for Antimicrobial Stewardship Standards
VHA directive 1031: Click here
CDC Updates on Antibiotic Stewardship and Required Antimicrobial Use and Resistance Reporting – On Demand: CDC Updates OnDemand2023 document and Click here to play recording
 
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DSCSA “Go”

The Drug Supply Chain Security Act was designed to ensure the safety and integrity of our nation’s drug supply and prevent counterfeit medications from entering the market.  In this third of a four-part series, Carolyn Liptak and Dwight deVera share their insights on FDA final DSCSA guidance with host Gretchen Brummel and how member providers can be ready.  
 
Guest speakers: Carolyn Liptak, MBA, BSPharm Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence 
Dwight deVeraVP of Healthcare Intelligence Inmar
Host: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence 
 
Show Notes: 
[00:44-01:14] Dwight’s background 
[01:15-02:20] What Carolyn and Dwight are hearing in the market
[02:21-03:39] Carolyn and Dwight’s thoughts on taking that stabilization period as an opportunity to wait
[03:40-05:22] Meeting the deadline on GLN’s
[05:23-06:59] Issue with having duplicate GLNs for a single site
[07:00-07:43] How Dwight is advising clarity on a timeline with the quarantine process
[07:44-09:23] Other tools our members need to know about if they have a suspect product investigation
[09:24-10:30] Comments and advice from Dwight and Carolyn
 
Links | Resources: 
Drug Supply Chain Security Act (DSCSA) portal
FDA Requests Feedback on Enhanced Drug Distribution Security Implementation Progress
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA)
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies
 
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Rollout Strategy Vexing: Pediatric RSV prevention strategy implementation challenges

RSV infections are not new and have devastating impacts. The recent advent of new prevention strategies has renewed the focus on the disease with a hopeful outlook. For the last 25 years, the only FDA approved product preventing RSV, lower respiratory tract disease, was palivizumab or Synagis, a monoclonal antibody indicated for use in high risk infants children and administered intramuscularly monthly throughout the RSV season.
In May, the first ever RSV vaccines were approved, Arexvy and Abrysvo. These two new RSV vaccines were approved for use in adults greater than or equal to 60 years of age. In August this year, one of the RSV vaccines, Abrysvo, also received approval for expanded use for maternal vaccination to prevent RSV lower respiratory tract disease in infants.
Nirsevimab or Beyfortus, a new long-acting monoclonal antibody, was approved in July for prevention of RSV lower respiratory tract disease in infants and children. Compared with palivizumab, nirsevimab is indicated for a much broader patient population including recommended use in all infants less than eight months of age, born during or entering their first RSV season.
The rollout of nirsevimab has proved challenging due to supply shortages, among other factors. Today we discuss the new RSV prevention strategies, focusing on the pediatric patient population, as well as the recent shortages with nirsevimab. Dr. Deb Bondi, Dr. Nikolai Dahl, as well as Dr. Kyle Hoelting from Vizient join guest host Vizient’s John Schoen for today's podcast.
 
Guest speakers: 
Deb Bondi, PharmD, FCCP, BCPS, BCPPS
Pediatric Clinical Coordinator, NICU Clinical Pharmacy Specialist, and PGY2 Pediatric Pharmacy Residency Program Director
UChicago Medicine, Comer Children's Hospital
 
Nikolai Dahl, PharmD
Utilization and Formulary Program Manager
John Muir Health
 
Kyle Hoelting, PharmD, BCPS
Senior Clinical Manager of Drug Shortages and Drug Information
Vizient Center for Pharmacy Practice Excellence 
 
Host: 
John Schoen, PharmD, BCPS 
Senior Clinical Manager of Evidence-Based Medicine and Drug Information
Vizient Center for Pharmacy Practice Excellence
 
Show Notes: 
[02:39-04:09] Update on where everything currently stands with the Nirsevimab supply and what led to the shortage
[04:10-05:01] Information on whether or not there's going to be additional supply of either the 50 mg or 100 mg syringes later this season
[05:02-06:01] Resources related to mitigating this nirsevimab shortages
[06:02-10:29] What University of Chicago and John Muir Health are doing with these new RSV vaccines and the new monoclonal antibody, Beyfortus
[10:30-13:15] Formulary decisions University of Chicago and John Muir Health make around nirsevimab and palivizumab
[13:16-15:24] Organizational preference for the maternal RSV vaccine or nirsevimab
[15:25-20:33] Other logistical issues with either nirsevimab or the maternal RSV vaccines, such us scope of practice consideration, stocking of the VFC product in patient education, et cetera
[20:34-22:01] Payment of billing issues either University of Chicago or John Muir Health experienced for either nirsevimab or the maternal RSV vaccine
[22:02-24:57] Clinical pearls or advice related to these new prevention strategies
 
Links | Resources:
Vizient member RSV resources
RSV vaccines in adults side-by-side comparison
RSV monoclonal antibodies in pediatrics side-by-side comparison
FAQ pediatric RSV prevention strategies
Minute Market Insight on nirsevimab shortage
Mitigation strategy on nirsevimab shortage
 
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Flex your Pharmacy

With healthcare complexity and workforce challenges increasing across the board, there's opportunity for pharmacies to take on new roles to improve patient care. Dr. Jill Michaud, system director of pharmacy at Aspirus Health, joins us to share their innovative approach to expanding pharmacy services with host Gretchen Brummel.  
 
Guest speakers: Jill Michaud, PharmD, MS-HASystem Director of PharmacyAspirus Health
Host: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence 
 
Show Notes: 
[00:49-01:55] Aspirus and Jill’s role there
[01:56-04:27] Activities that Jill’s staff is doing
[04:28-06:48] Work they are doing in the oncology space
[06:49-07:27] Making Aspirus Health’s approach to public relations and marketing activities with regards pharmacy a priority.
[07:28-09:17] Is that included in residency recruitment, or more of a surprise when they get there
[09:18-11:37] Advice do you have for other pharmacies who may be faced with challenges
 
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DSCSA “Set”

The Drug Supply Chain Security Act was designed to ensure the safety and integrity of our nation’s drug supply and prevent counterfeit medications from entering the market.  In this second of a four-part series, Carolyn Liptak, Eric Marshall, and Josh Bolin share their insights on FDA final DSCSA guidance with host Gretchen Brummel and how member providers can be ready.  
 
Guest speakers: 
Carolyn Liptak, MBA, BSPharm 
Pharmacy Executive Director 
Vizient Center for Pharmacy Practice Excellence 
 
Eric Marshall 
Principal at Leavitt Partners
Executive Director of the Partnership for DSCSA Governance
 
Josh Bolin 
Associate Executive Director, Government Affairs and Innovation
National Association of Boards of Pharmacy
 
Host: 
Gretchen Brummel, PharmD, BCPS 
Pharmacy Executive Director 
Vizient Center for Pharmacy Practice Excellence
 
Show Notes: 
[00:55-02:27] Josh and Eric’s backgrounds 
[02:28-03:36] What we need to know for DSCSA implementation on November 27th
[03:37-05:10] NABP view of FDA DSCSA guidance
[05:11-07:27] PDG view of FDA DSCSA guidance
[07:28-08:23] Next steps for DSCSA compliance that our members should be focusing on
[08:24-11:11] Why it is important to have documented policies and procedures to ensure compliance
[11:12-12:28] Where organizations that need help with creating those policies and procedures go
[12:29-15:24] How the 24-hour time frame is defined since medications are not traced within a hospital
[15:25-18:17] DSCSA regulatory responsibilities are shared between the FDA and state boards of pharmacy
[18:18-21:26] How we account for traceability across state lines and what should we expect in the future
[21:27-23:49] Some complexities here especially around 340B medications
[23:50-24:54] Where verification has to occur: data flowing from the manufacturer to the covered entity, but the product is flowing to the actual contracted pharmacy
[24:55-26:30] Last thoughts on how our members can be set for DSCSA
 
Links | Resources:
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA)
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies
NABP Links:
https://nabp.pharmacy
https://nabp.pharmacy/pulse  
 
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The nose knows: updates in intranasal pharmacology, Part 2

Intranasal administration of medications is on the rise for both on and off label uses. Dr. Mark Donaldson, Associate Principal and Dr. Philippe Mentler Senior Consulting Director, both at Vizient join host Gretchen Brummel for two episodes, sharing details on these drugs, their actions and indications.
 
Guest speakers:Mark Donaldson, BSP, RPH, PHARMD, FASHP, FACHEAssociate PrincipalVizient
Philippe Mentler, PHARMD, BCPSSenior Consulting DirectorVizient
Moderator:Gretchen Brummel, PharmD, BCPSPharmacy Executive DirectorVizient Center for Pharmacy Practice Excellence
 
Show Notes:
[00:33 - 02:50] Why you would choose intra-nasal administration of an agent over some of the other non-oral or non-IV routes
[02:51 - 6:05] Some practical considerations people should be aware of, particularly when not to use these agents
[6:06 - 7:12] Some of the implications for the pediatric population
[7:13 - 12:10] What we have to look forward to in the future in this space
[12:11 - 13:46] What our frontline pharmacy staff should know about these medications
 
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The nose knows: updates in intranasal pharmacology, Part 1

Intranasal administration of medications is on the rise for both on and off label uses. Dr. Mark Donaldson, Associate Principal and Dr. Philippe Mentler Senior Consulting Director, both at Vizient join host Gretchen Brummel for two episodes, sharing details on these drugs, their actions and indications.
 
Guest speakers:Mark Donaldson, BSP, RPH, PHARMD, FASHP, FACHEAssociate PrincipalVizient
Philippe Mentler, PHARMD, BCPSSenior Consulting DirectorVizient
Moderator:Gretchen Brummel, PharmD, BCPSPharmacy Executive DirectorVizient Center for Pharmacy Practice Excellence
 
Show Notes:
[01:16 - 03:46] Why the nose is a good target for medication administration
[03:47 - 5:49] Some things you need to consider when administering medications intra-nasally
[5:50 - 8:13] Some of the labeled and off-label intra-nasal medications and their indications
[8:14 - 9:15] What we should be thinking about in terms of safety
[9:16 - 10:06] Wrong route, have you seen that in your practice, or have there been reports of that in the literature
[10:07 - 15:10] How some of these drugs are used in dental medicine
 
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