VerifiedRx

A periop love story: sugamma-next? Or stay with your (neo) ex?

The debate on whether to use sugammadex or neostigmine has heated up dramatically in recent years. Two industry experts, Eric Johnson, perioperative critical care pharmacist at UK HealthCare, and Stacy Lauderdale, senior director for drug information at Vizient, discuss the many considerations involved in choosing between the two agents.
 
Guest speakers:
Eric Johnson, PharmD, BCCCP
Perioperative Critical Care Pharmacist
UK HealthCare
 
Stacy Lauderdale, PharmD, BCPS
Senior Director, Drug Information
Vizient
 
Moderator:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
 
Show Notes:
[01:11] Neuromuscular blockers play two main roles in the perioperative setting. 
[01:52] The ability to reverse neuromuscular blockade is important for prevention or decreased incidence of adverse effects.   
[03:07] In 2013, neostigmine received FDA approval, eliminating all other non-FDA-approved versions from the market.
[03:32] The sole supplier of neostigmine raised the cost ~450%.
[03:52] In 2015, sugammadex received FDA approval and hit the market at a cost similar to neostigmine.
[04:13] Neostigmine’s cost has dropped since 2015, causing member hospitals to question the added value of sugammadex.
[04:37] One institutional use was 90% sugammadex vs. 10% neostigmine.    
[05:07] Via Pharmacy Market Outlook, Vizient has found that sugammadex is the number-three top-spend drug in the acute care setting.
[06:01] One benefit of sugammadex is its ability to reverse at a deeper level.
[06:24] Another benefit of sugammadex is its lack of cardiovascular effects.
[06:55] Sugammadex displays more optimal pharmacokinetics.
[07:58] Important safety and quality factors to consider.
[08:53] Studies cannot conclusively determine if sugammadex reduces postoperative respiratory complications.
[09:10] The cost difference between sugammadex and neostigmine continues to grow.
[09:50] Vizient assembled an expert panel of 12 multidisciplinary specialists to review the comparative effectiveness of sugammadex vs. neostigmine.
[10:32] The focus of the panel was to look at outcomes that have a measurable impact on patient quality, safety and cost.
[11:45] The panel used the Institute for Clinical and Economic Review Matrix to rate the comparative effectiveness of sugammadex and neostigmine.
[12:21] The ICER Matrix assisted the panel in determining the magnitude of difference between the two therapies. 
[14:46] Anesthesiologists’ concern about the lack of resident training with neostigmine
[15:39] Final report, that will include many more findings, to be published in the fourth quarter of 2021.
[16:08] Importance of train-of-four monitoring
 
Links | Resources:
National Library of Medicine, “Sugammadex versus Neostigmine for Reversal of Neuromuscular Blockade and Postoperative Pulmonary Complications (STRONGER): A Multicenter Matched Cohort Analysis,” Anesthesiology, 2020 June 1 Click here
National Library of Medicine, “Postoperative Pulmonary Complications' Association with Sugammadex versus Neostigmine: A Retrospective Registry Analysis,” Anesthesiology, 2021 June 1 Click here
 
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Enhanced Recovery After Colorectal Surgery

Historically there have been countless paths to recovery following colorectal surgery. However, having a well-rounded, evidence-based enhanced recovery program is critical to patient success. Two Vizient experts, Mark Ninno and Karen Smethers discuss the details and the power of these programs.
 
 Guest speakers:
Mark Ninno, PharmD
Senior Consulting Solutions Director
Vizient
 
Karen Smethers, PharmD, BCOP
MSS Pharmacy Network
Senior Director
Vizient Pharmacy Member Services
 
Moderator:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
 
Show Notes:
[01:21] Enhanced recovery programs are specific programs designed to help patients after surgery
[01:59] Strong recovery programs involve four pillars to achieve its goal of patient discharge: patient-centered, multi-modal, multidisciplinary and evidence-based approaches
[03:29] Vizient observes that health systems have a wide variety of practices following colorectal surgery
[03:56] Vizient gathered a panel of experts to assess and evaluate recovery programs
[04:16] The expert panel focused on two specific domains: literature review and expert opinion    
[05:33] Vizient evidence review includes pharmacological and non-pharmacological interventions
[06:09] Early introduction of oral feeding proved to have the strongest support in recovery
[06:24] Studies involving alvimopan contain many factors that hinders its application in an enhanced recovery program
[07:10] Vizient found many systems are supporting alvimopan use in minimally invasive surgery even though the evidence may not fully support this practice
[07:46] Non-drug regiments such as chewing gum and caffeine have been handed down for many years, yet these therapies have minimal benefits
[08:33] It’s critical for front line pharmacists to collaborate with all health care professionals
[08:59] Education of prescribers, patients and family members provide many benefits
 
Links | Resources:
American Association of Nurse Anesthesiology (AANA): Enhanced Recovery after Surgery Click here
Scott MJ, Baldini G, Fearon KCH, et al. Enhanced Recovery After Surgery (ERAS®) for gastrointestinal surgery, part 1: pathophysiological considerations. Act Anaesthesiol Scand. 201559(10):1212-1231 Click here
Gustafsson UO, Scott MJ, Hubner M, Et al, Guidelines for perioperative care in elective colorectal surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations: 2018. World J Surg. 2019 ;43(3):659-695 Click here
 
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The Unknowns of Anti-factor Xa Reversal: The Experts Weigh In

The ability to chronically anticoagulate a patient has prevented significant morbidity and mortality from thromboembolic events. Over time, our anticoagulation choices for oral use have evolved, but the need for reversal agents still persist. Two Vizient pharmaceutical experts weigh in on the clinical implications and latest standings of reversal agents. 
 
Guest speaker:
Stacy Lauderdale, PharmD, BCPS
Senior Director, Drug Information
Vizient
 
David Reardon, PharmD, BCPS
Senior Director, Pharmacy Networks
Northeast Purchasing Coalition (NPC)
Pharmacy Member Services
Vizient
 
Moderator:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
 
Show Notes:
[01:15] Warfarin has been the cornerstone of oral anticoagulant therapy since the 1950s but has many limitations including causing bleeding and thrombosis if not managed properly.
[01:45] In 2011, a new class of oral factor 10a inhibitors was approved which drastically changed the oral anticoagulant landscape.  
[01:45] Most common:  apixaban and rivaroxaban.  They have fewer drug-drug interactions and fewer drug-food interactions than Warfarin.  
[02:26] In May 2018, FDA approved andexanet alfa. It has an accelerated biologic license conditional approval based on some surrogate markers in the trials. Clinical trials are underway.
[03:41] In January 2021, Vizient published a consensus-based document regarding the expert task force’s findings on how to manage the pharmacological reversal agents for factor 10a inhibitor-related bleeding. 
[05:27] What the literature says regarding the factor 10a inhibitors
[06:53] Task force compared the clinical effectiveness of andexanet versus pro-hemostatic agents using the ICER Evidence rating Matrix tool.  
[08:37] Task force recommends that institutions have an anticoagulation reversal policy.  The Joint Commission National Patient Safety Goal for anticoagulation therapy provides guidance for that organizations should have on hand.
[09:06] Policy should address standard of care, radiographical and laboratory studies, as well as appropriate pharmacological interventions. Anticoagulation reversal agents will not correct hemodynamic instability, so you’ll need to start other therapies.
[09:35] Pharmacists can drive the protocols and adoption of prothrombin complex concentrates
[10:43] Expert panel is in consensus that use of pro-hemostatic agents for reversal of a factor 10a inhibitor-related bleed is ethically and legally justified, despite the fact that andexanet is FDA approved for it.
[12:42] Budgetary considerations with the two agents, the prothrombin complex concentrates or PCCs and andexanet alfa
 
Links | Resources:
Consensus statement on use of reversal agents for factor Xa inhibitor – related bleeding, December 2020, Vizient Click here
 
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Vizient Pharmacy Market Outlook Summer 2021

Vizient publishes the Pharmacy Market Outlook twice a year to project drug prices and key market trends for the next 18-months.  Pharmacists use this information to budget and project their supply needs.  Carina Dolan, Senior Director for Clinical Oncology and Pharmaceutical Outcomes at Vizient shares details revealed in the summer 2021 edition of the Pharmacy Market Outlook. 
 
Guest speaker:
Carina Dolan, PharmD, MS, BCOP
Senior Director for Clinical Oncology and Pharmaceutical Outcomes
Pharmacy Solutions
Vizient
 
Moderator:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
 
Show Notes:
[1:16] The Pharmacy Market Outlook is a bi-annual report that projects drug prices for 18 months, and reviews the trends of the various market segments.
[2:08] How the report is calculated
[2:45] Purchases made through 340B program and direct or outsourced purchases made by hospitals are not included in the Pharmacy Market Outlook.
[3:02] Prediction of the drug price inflation rate for January – December 2022
[3:38] How the Vizient Pharmacy Market Outlook compares to other drug forecasting reports.
[4:01] The estimate drug price inflation rate for the upcoming calendar year is anticipated to have a moderate price increase.
[4:30] The largest contributor to drug price increases is at Adalimumab and will remain that way until 2023.
[4:49] The Vizient Drug Price Forecast Report in the Vizient Savings Actualyzer can help you with your budget. It pulls your wholesale purchase data and self-populates the projections of the report. It has the capability to use your institutes direct purchases.
[5:25] Closer Look features the different segments of the market including acute care, non-acute care, specialty pharmaceuticals and pediatrics.
[5:34] The report has a projected timeline graphic that shows investigational medications likely to be approved and other events likely to happen during the 18-month timeframe.  
[6:40] The current, high-priority advocacy topics include 340B pricing for contract pharmacies, white-bagging for provider-administered medications, the unapproved drugs initiative (UDI) and changes to the FDA enforcement of Action.
[7:25] Accelerated Approval Pathways
[7:25] Example: Aducanumab, brand name: Adulhelm, for the treatment of Alzheimer’s disease  
[9:10] New topic highlighted is therapeutic class (i.e. diabetes and related medications)
[9:52] Vizient members can access the report online through the website at Vizientinc.com/pharmacysolutions.com, then go to My Dashboard to access the Vizient Pharmacy Market Outlook report.
[10:06] Non-Vizient members can access a public version on the VizientInc.com
[10:15] The drug budget report may be accessed through the Vizient Savings Actualyzer Pharmacy.
[10:20] If you have issues accessing the report or other questions, please email PharmacyQuestions@Vizientinc.com
 
Links | Resources:
Vizient Pharmacy Market Outlook - member version Click here
Vizient Pharmacy Market Outlook highlights - public version Click here
 
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Show me the data! Updates on the evidence of thrombolytic use in ischemic strokes

Ischemic stroke is the leading cause of morbidity and mortality in the United States, taking the lives of 140,000 people each year.  Historically, the thrombolytic alteplase has been the mainstay of drug therapy, but now the FDA is looking at tenecteplase as a treatment option for ischemic strokes.
 
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:
[01:03] The treatment of ischemic strokes prior to alteplase
[01:46] Controversies in the original clinical trials of alteplase, including the 1995 NINDS trial
[02:45] The advances in imaging and patient care since the initial trials
[03:58] The difficulties of administering alteplase – including estimating a patient’s weight
[04:50] The consequences of under-dosing
[06:00] Tenecteplase: A potential alternative to alteplase
[06:47] Variances of tenecteplase and alteplase in clinical trials
[07:37] Determining the choice of one drug over the other
[08:41] Clinical outcomes of tenecteplase vs. alteplase
[10:37] Determining when to convert from alteplase to tenecteplase
[12:17] Anticipating tenecteplase will eventually get FDA approval
 
Links | Resources:
American Heart Association: Stroke, AHA/ASA Guideline, December 2019 Click here
AHA Journals, Tenecteplase Thrombolysis for Acute Ischemic Stroke: Click here
 
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The Drug Supply Chain Security Act: The road to patient safety

The Drug Supply Chain Security Act was enacted in 2013 to protect patients from counterfeit, stolen or contaminated medications. It allows for the detection and removal of these drugs from the marketplace. In this podcast, we explore how frontline pharmacy staff can support compliance.
 
Guest speaker:
Joseph Alessandrini, RPh, FASHP
Vice President, Clinical Services
Inspira Health Network
 
Moderator:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
 
Show Notes:
[1:03] Drug Supply Chain Security Act (DSCSA) was enacted on November 27th, 2013 as a patient safety measure to avoid contaminated medications from entering marketplace
[2:34] Pharmacists are the last defense in protecting the patients. After manufacturers and wholesalers
[3:10] Pharmacists must verify product, serial number, vendor and patient
[3:34] Check all avenues of distribution: inpatient, retail and specialty pharmacies, physician practices, Surgi-Centers, urgent care, paramedics
[5:00] Work with a software company to collect data in a repository that is retrievable within 24 – 48 hours.
[7:52] FDA delayed enforcement of a portion in 2020, but may start enforcing compliance anytime
[10:00] U.S. organizations are about 50% compliant.
[11:43] The future will be more technology using 2D barcodes to capture data
 
Links | Resources:
Pharmacy Times: “What are the Drug Supply Chain Security Act’s key provisions?” Click here
FDA: Drug Supply Chain Security Act (DSCSA) Click here
ADENTS: DSCSA: Serialization requirements and deadlines Click here
NCPA: DSCSA pharmacy checklist 2019 Click here
FDA: Pharmacists: Utilize DSCSA requirements to protect your patients Click here
FDA: Drug Supply Chain Security Act Law and Policies Click here
 
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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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