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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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MINDing our Residents: Helping them from the Inside Out

Pharmacy residents can experience burnout during their training, and as preceptors, it is our responsibility to work to prevent this. Practicing Mindfulness can help. Glenn Kuz, Clinical Pharmacist at UW Medicine and certified mindfulness meditation practitioner joins Gretchen Brummel to discuss a formal training program he developed for the residents at UW Medicine, providing a safe patient care environment and improving their own wellbeing.
 
Guest speakers:Glenn Kuz, PharmDClinical Pharmacist UW Medicine
Moderator:Gretchen Brummel, PharmD, BCPSPharmacy Executive DirectorVizient Center for Pharmacy Practice Excellence
 
Show Notes:
[00:49 - 01:37] Glenn’s background
[01:38 - 3:50] How Glenn got interested in using Mindfulness Practice to help pharmacy residents during their training
[3:51 - 5:48] Glenn’s training program
[5:49 - 8:54] Literature that supports Glenn’s program
[8:55 - 10:51] The impact of the program
[10:52 - 12:22] Future plans
[12:23 - 13:13] Glenn’s recommendations for other pharmacy programs looking to start a similar program
 
Links | Resources:
https://www.rickhanson.net/
Resilient by Rick Hanson, PhD
gkuw@uw.edu
 
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Insights Into Oncology Drug Shortages

Vizient recently published a paper on the impact of oncology drug shortages for patients and provider members. Drs. Carina Dolan and Jeni Hayes share their insights of the causes and how to improve things moving forward with host Gretchen Brummel.  
 
Guest speakers: Carina Dolan, PharmD, MS, BCOPAVP of Market Intelligence Vizient Pharmacy Solutions 
Jeni Hayes, PharmD, MSPharm, BCPS Senior Clinical Manager, Market IntelligenceVizient Pharmacy Solutions  
Host: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence 
 
Show Notes: 
[00:48-01:52] Drugs included in shortage of cancer drugs report
[01:53-02:58] How we define drug shortages
[02:59-04:03] Specific event that precipitated the oncology drug shortage
[04:04- 05:39] Overall impact on the sales for these medications
[05:40-07:25] What demand are we seeing for these medications
[07:26-08:23] How Vizient Pharmacy Program participants have been affected
[08:24-09:59] Looking at the shortage severity and its impact on Vizient Pharmacy Program participants
[10:06-12:13] How we improve things moving forward
[12:14-13:49] What front line pharmacy staff should know about these shortages
 
Links | Resources: 
Evaluating the impact of the oncology drug shortage white paper
Evaluating the impact of the oncology drug shortage fact sheet
Vizient: Lack of Information Across Supply Chain Exacerbating Oncology Drug Shortage press release
Webinar: Oncology insights: new therapies and drug shortages
Drug shortage: Oncology agents mitigation strategy
 
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DSCSA “Ready”

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.  Carolyn Liptak shares her insights on DSCSA 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 
Host: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence 
 
Show Notes: 
[01:01-02:32] The DSCSA at its core 
[02:33-06:25] The different responsibilities of manufacturers, repackagers, wholesalers, and distributors
[06:26-08:47] What things should have been taken care of already
[08:48-10:34] What is a GLN? How do I get one, who needs one?
[10:35-11:39] What Vizient has done to help our provider members get ready for this
[11:40-14:26] What happens on November 27th, 2023
[14:27-16:11] The impact of the recent FDA announcement
 
Links | Resources: 
Vizient DSCSA page  - Click Here
How to obtain GLNs - Click Here
DSCSA SBS - Click Here
 
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