VerifiedRx Vizient Center for Pharmacy Practice Excellence

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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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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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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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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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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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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