5 episodes

Delivering short doses of insight for hospitals’ frontline pharmacists, Vizient pharmacy leader Gretchen Brummel brings together experts to verify best practices for navigating today’s pharmacy practice challenges and accelerating career growth. It’s a prescription for success, delivered by the Vizient Center for Pharmacy Practice Excellence.

VerifiedRx Vizient Center for Pharmacy Practice Excellence

    • Health & Fitness
    • 5.0 • 4 Ratings

Delivering short doses of insight for hospitals’ frontline pharmacists, Vizient pharmacy leader Gretchen Brummel brings together experts to verify best practices for navigating today’s pharmacy practice challenges and accelerating career growth. It’s a prescription for success, delivered by the Vizient Center for Pharmacy Practice Excellence.

    Rattlesnakes, copperheads, cottonmouths, oh my! The antivenins for crotalid envenomation

    Rattlesnakes, copperheads, cottonmouths, oh my! The antivenins for crotalid envenomation

    Summertime means snakebite time, and with it comes the critical decisions pharmacists and clinicians are faced with when choosing antivenins. In this episode, we will look at the differences and similarities between the two latest antivenins for snakebites.


     


    Guest speaker:


    Philippe Mentler, PharmD, BCPS


    Consulting Director, Pharmacy


    Vizient


     


    Moderator:


    Gretchen Brummel, PharmD, BCPS


    Pharmacy Executive Director


    Vizient Center for Pharmacy Practice Excellence


     


    Show Notes:


    [00:45] A quarter of all snakebites are dry bites


    [01:13] Venomous snakes are everywhere in the United States except in Alaska and Hawaii


    [01:13] Most common venomous snakes in North America are pit vipers (rattlesnakes, copperheads, cottonmouths)


    [01:51] Clinical manifestations of snakebites


    [02:30] In 2019, American poison control reported more than 4,000 pit viper snakebites


    [02:46] History of antivenins


    [03:40] The development of a new antivenin, CroFab


    [04:45] In 2019, FDA approved Anavip for North American Rattlesnakes, and in April 2021 FDA updated its approval for all North American pit vipers


    [05:16] Variances between antivenins Anavip and CroFab


    [06:03] Clinical trials focusing on blood dyscrasias for Anavip and CroFab


    [07:05] The original approval for Anavip was exclusively in rattlesnakes and did not consider copperheads and cottonmouths because of the limited incidence of blood dyscrasias in those species in the trial


    [07:47] Cottonmouths and copperheads typically don’t cause blood dyscrasias and tissue injury. This was not specifically addressed in the original study. Now, Anavip updated their information to the FDA, and with that the FDA approved antivenin for all pit viper snakes


    [08:37] Should a hospital carry both products?  


    [09:16] There’s no national guidelines for antivenins. The American Academy of Emergency Medicine published a clinical statement about antivenin drugs, but that’s obsolete now that the FDA has updated its antivenin approval


     


    Links | Resources:


    ANAVIP, crotalidae immune F(ab)2 (Equine): “Venom Has Met Its Match” Click here


    CroFab crotalidae polyvalent immune fab (ovine): “Time is her tissue Why risk it?” Click here


    American Association of Poison Control Centers: National Poison Data System Click here


    NCBI: Rattle Snake Toxicity Click here


    USDA, Forest Service: “Snakes” Click here


    Centers for Disease Control and Prevention, The National Institute for Occupational Safety and Health: “Venomous Snakes” Click here


    Alaska Department of Fish and Game: “No snakes in Alaska” Click here


     


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    • 10 min
    Expedited drug reviews in the time of COVID-19 (Part 2)

    Expedited drug reviews in the time of COVID-19 (Part 2)

    The Coronavirus pandemic has put a spotlight on drug supply and the approval process for new medications. In this episode, we will define the different expedited drug approval processes, and take a closer look at how successful these programs are in identifying drug efficacy.


     


    Guest speaker:


    Steven Lucio, PharmD, BCPS


    Senior Principal, Pharmacy Solutions


    Vizient


     


    Moderator:


    Gretchen Brummel, PharmD, BCPS


    Pharmacy Executive Director


    Vizient Center for Pharmacy Practice Excellence


     


    Show Notes:


    [01:19] Four mechanisms used by FDA to expedite approval of medications: Fast Track, Breakthrough, Accelerated Approval and Priority Review


    [01:48] Fast track and breakthrough help drug developers increase communications with the FDA to make approval process flow smoothly


    [02:07] The “Fast Track” designation


    [2:35] A “Breakthrough” designation – FDA will talk to you more, give advice  


    [3:12] Example of an Accelerated Approval


    [3:55] Accelerated Approval looks at a surrogate indicator of a disease state’s ultimate outcome


    [4:26] “Priority Review” – FDA reviews drug within six months


    [5:12] Three reasons why pharmacists need to be aware of the approval programs


    [6:00] Expedited approvals are used for serious diseases


    [6:08] Analysis: In 2018, 81% of new molecular entities took advantage of at least one expedited program


    [6:32] Drugs that use expedited programs have fewer clinical studies and a smaller profile of how they work


    [7:14] Survey: 3/4th physicians didn’t know what Breakthrough Therapy meant


    [7:50] Analysis of “Accelerated Approval” between 1992 - 2017


    [8:38] Why you should know about the expedited drug approval processes


     


    Links | Resources:


    JAMA Network: FDA Approval and Regulation of Pharmaceuticals, 1983 – 2018, Click Here


    JAMA Network: Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation, Click Here


    JAMA Network: Assessment of the Clinical Benefit of Cancer Drug Receiving Accelerated Approval, Click Here


     


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    • 9 min
    Expedited drug reviews in the time of COVID-19 (Part 1)

    Expedited drug reviews in the time of COVID-19 (Part 1)

    The Coronavirus pandemic has put a spotlight on drug supply and the approval process of new medications. In this episode, we will discuss what frontline pharmacists need to know to about the drug approval process. 


     


    Guest speaker:


    Amanda Melton, PharmD, BCPS


    Senior Clinical Manager


    Center for Pharmacy Practice Excellence


    Vizient


     


    Moderator:


    Gretchen Brummel, PharmD, BCPS


    Pharmacy Executive Director


    Vizient Center for Pharmacy Practice Excellence


     


    Show Notes:


    [01:11] Patients accessing drugs through clinical trials


    [02:20] Pharmacists should familiarize themselves with the inclusion and exclusion criteria of clinical trials in order to help clinicians identify good patients candidates


    [02:55] ClinicalTrials.gov


    [3:08] Patients that don’t qualify for a clinical trial can apply for access through an Expanded Access Program (EAP)  


    [3:27] What Pharmacists need to know about Expanded Access Programs (EAPs)


    [4:17] Goal of the EAP is to get the drug to the patient


    [4:55] Step by step process for accessing a drug under the Expanded Access Program (EAP)


    [5:27] Investigational New Drug (IND) application


    [6:20] Four stakeholders: manufacturer, FDA, patient and Institutional Revenue Board (IRB)


    [6:48] Getting access to the FDA by using Form 3926


    [7:46] Timing for submitting an EAP


    [8:51] How Emergency Use Authorizations (EUAs) differ from Expanded Access Programs (EAPs) 


    [9:50] How long an EUA lasts


    [10:33] When an Emergency Use Authorization (EUA) is issued, it does not mean the drug is approved


    [11:06] Why apply for an EUA, instead of a biologics license


    [12:00] Issuance of an EUA for a product doesn’t preclude the manufacturer from seeing approval for the product


     


    Links | Resources:


    FDA: Emergency Use Authorization Click here


    FDA: Expanded Access Click here


    NIH U.S. Library of Medicine: ClinicalTrials.gov Click here


    Reagan-Udall Foundation for the FDA: COVID-19 Hub Click here


     


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    • 12 min
    Supply resiliency during unprecedented times

    Supply resiliency during unprecedented times

    The Coronavirus pandemic reveals how vulnerable the drug supply chain can be. In this episode, we will discuss what frontline pharmacists need to know to ensure essential medications are available and the drug supply remains resilient.


     


    Guest speakers:


    Doug Kucera


    Associate Vice President


    Contract Services, Pharmacy


    Vizient


     


    Mittal Sutaria, PharmD


    Vice President


    Contract and Program Services, Pharmacy


    Vizient


     


    Moderator:


    Gretchen Brummel, PharmD, BCPS


    Pharmacy Executive Director


    Vizient Center for Pharmacy Practice Excellence


     


    Show Notes:


    [01:21] Demand for Propofol for COVID ventilated patients skyrocketed to 272%


    [01:46] Private label programs provides resiliency to the market


    [02:31] How to strengthen pharmacy supply chain


    [03:45] Drug shortage task force objectives


    [05:51] Essential Medication Lists


    [06:47] Labor cost for managing drug shortages


    [08:03] Prioritize Essential Medication List and educate others   


    [08:26] Elevate the transparency, accountability and resiliency of the pharmaceutical supply chain  


    [09:59] Frontline pharmacist advocacy plays a huge role


    [10:36] Ask questions to make sure the solution is in the best interest for your pharmacy


     


    Links | Resources:


    Vizient’s Novaplus Enhanced Supply Program Enabled Access to 676,000 Additional Units of propofol as COVID-19 Cases Surged, Click here


    Essential Medications for Patient Care, Click here


    Drug shortages and labor costs: Measuring a hidden cost of drug shortages on U.S. hospitals, Click here


    Essential medications review (November 2020), Click here


    Vizient Identifies Essential Medications in Hospitals and Highlights Fragility of the Supply Chain, Click here


     


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    • 11 min
    Staying afloat in rising waters: Resiliency for frontline pharmacy workers

    Staying afloat in rising waters: Resiliency for frontline pharmacy workers

    The Coronavirus pandemic has taken a toll on clinicians across the country. As the surge persists, staff stressors increase, and the relentless pressure compounds the seriousness of the problem.  This episode reveals how the pharmacy director at Capital Health in New Jersey supports his staff and boosts their resiliency.  


     


    Guest speaker:


    Daniel T. Abazia, PharmD, BCPS, CPPS


    Director of Pharmacy


    Capital Health


     


    Moderator:


    Gretchen Brummel, PharmD, BCPS


    Pharmacy Executive Director


    Vizient


     


    Show Notes:


    [01:27] Home life turned upside down for staff


    [02:12] COVID cases continue to increase


    [02:44] Listen to staff and identify their stressors


    [04:02] Daily huddles to check in with staff


    [05:21] It’s turning from stress to burnout


    [05:58] Resiliency and the ability to adapt helps


    [06:16] Rewards to help staff cope 


    [07:14] The four A’s: Acknowledge, Appreciate, Acceptance, Accommodate  


    [07:50] Employee assistance programs


    [09:50] What to do at the system level


    [10:30] The future


     


    Links | Resources:


    American Psychological Association: Building your resilience Click here


    CDC: Stress & Coping Click here


    AMA Creating a resilient organization Click here


    American Academy of Pediatrics: TheResilienceProject - We can stop toxic stress Click here


    Harvard Medical School: Strengthening Resiliency in Health Care Providers During the COVID-19 Pandemic Click here


     


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    • 11 min

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