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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:
[00:54] A quarter of all snakebites are dry bites
[01:24] Venomous snakes are everywhere in the United States except in Alaska and Hawaii
[01:24] Most common venomous snakes in North America are pit vipers (rattlesnakes, copperheads, cottonmouths)
[02:00] Clinical manifestations of snakebites
[02:40] In 2019, American poison control reported more than 4,000 pit viper snakebites
[02:55] History of antivenins
[03:50] The development of a new antivenin, CroFab
[04:55] In 2019, FDA approved Anavip for North American Rattlesnakes, and in April 2021 FDA updated its approval for all North American pit vipers
[05:26] Variances between antivenins Anavip and CroFab
[06:13] Clinical trials focusing on blood dyscrasias for Anavip and CroFab
[07:15] 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
[07:58] 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
[08:45] Should a hospital carry both products?  
[09:25] 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): Click here
CroFab crotalidae polyvalent immune fab (ovine): 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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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:
[01:25] Four mechanisms used by FDA to expedite approval of medications: Fast Track, Breakthrough, Accelerated Approval and Priority Review
[01:54] Fast track and breakthrough help drug developers increase communications with the FDA to make approval process flow smoothly
[02:14] The “Fast Track” designation
[2:42] A “Breakthrough” designation – FDA will talk to you more, give advice  
[3:18] Example of an Accelerated Approval
[4:00] Accelerated Approval looks at a surrogate indicator of a disease state’s ultimate outcome
[4:33] “Priority Review” – FDA reviews drug within six months
[5:19] Three reasons why pharmacists need to be aware of the approval programs
[6:07] Expedited approvals are used for serious diseases
[6:15] Analysis: In 2018, 81% of new molecular entities took advantage of at least one expedited program
[6:38] Drugs that use expedited programs have fewer clinical studies and a smaller profile of how they work
[7:20] Survey: 3/4th physicians didn’t know what Breakthrough Therapy meant
[7:57] Analysis of “Accelerated Approval” between 1992 - 2017
[8:44] 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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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:
[01:20] Patients accessing drugs through clinical trials
[02:29] Pharmacists should familiarize themselves with the inclusion and exclusion criteria of clinical trials in order to help clinicians identify good patients candidates
[03:00] ClinicalTrials.gov
[3:17] Patients that don’t qualify for a clinical trial can apply for access through an Expanded Access Program (EAP)  
[3:35] What Pharmacists need to know about Expanded Access Programs (EAPs)
[4:26] Goal of the EAP is to get the drug to the patient
[5:03] Step by step process for accessing a drug under the Expanded Access Program (EAP)
[5:42] Investigational New Drug (IND) application
[6:30] Four stakeholders: manufacturer, FDA, patient and Institutional Revenue Board (IRB)
[6:50] Getting access to the FDA by using Form 3926
[7:54] Timing for submitting an EAP
[9:00] How Emergency Use Authorizations (EUAs) differ from Expanded Access Programs (EAPs) 
[10:00] How long an EUA lasts
[10:41] When an Emergency Use Authorization (EUA) is issued, it does not mean the drug is approved
[11:15] Why apply for an EUA, instead of a biologics license
[12:07] 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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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:
[01:31] Demand for Propofol for COVID ventilated patients skyrocketed to 272%
[01:52] Private label programs provides resiliency to the market
[02:41] How to strengthen pharmacy supply chain
[03:55] Drug shortage task force objectives
[06:00] Essential Medication Lists
[06:57] Labor cost for managing drug shortages
[08:10] Prioritize Essential Medication List and educate others   
[08:35] Elevate the transparency, accountability and resiliency of the pharmaceutical supply chain  
[10:08] Frontline pharmacist advocacy plays a huge role
[10:45] 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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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:
[01:37] Home life turned upside down for staff
[02:20] COVID cases continue to increase
[02:50] Listen to staff and identify their stressors
[04:08] Daily huddles to check in with staff
[05:02] It’s turning from stress to burnout
[05:55] Resiliency and the ability to adapt helps
[06:18] Rewards to help staff cope 
[07:12] The four A’s: Acknowledge, Appreciate, Acceptance, Accommodate 
[07:47] Employee assistance programs
[09:30] 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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