Can't use Ivermectin but can now use Regen-CoV Monoclonal Antibody therapy

 

To: WAMT Acute & Ambulatory CMO’s, Pharmacy Directors and Infection Prevention Director

 

From: WAMT Medical and Pharmacy Leadership

 

 

Please distribute to all appropriate WAMT providers, IP professionals and pharmacists

 

 

Position: PSJH’s Ivermectin use for the treatment or prevention of COVID-19: See Attached SBAR

 

 

Situation:

 

Ivermectin, for use in the treatment and/or prevention of COVID-19, is not FDA approved or authorized. Clarity on the appropriateness of use for this indication was requested of our PSJH infectious disease and antimicrobial stewardship teams.

 

Background:

 

Growing Public demand and subsequent COVID-19 related prescribing of ivermectin has caused ongoing and increased safety concerns. The FDA, CDC, WA DOH, AMA, APhA and ASHP have all released warning statements (see below) about ivermectin’s use for COVID indications, as it lacks any FDA indication or authorization or sufficient safety or efficacy data to support its use or approval for any COVID related indication.

 

Assessment:

 

The PSJH Joint Clinical Council has provided the attached SBAR, recommending that “Providence facilities and providers should not use ivermectin for the prevention or treatment of COVID-19”.

 

Request:

 

WAMT Medical and Pharmacy Leadership request immediate distribution of the attached SBAR to all appropriate providers and pharmacy teams. WAMT Medical staff and pharmacy leadership will assist local team in supporting this position as needed.

 

 

Additional Supportive Information:

 

FDA: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 | FDA

CDC/HAN: HAN Archive - 00449 | Health Alert Network (HAN) (cdc.gov)

WA DOH: Ivermectin should not be used to prevent or treat COVID-19 Washington State Department of Health

AMA-APhA-ASHP Joint Statement: 090121 - Joint Ivermectin Statement -Marcom (magnetmail.net)

 

Thank You,

 

Sent: Tuesday, September 7, 2021 5:13:47 PM

Subject: Regen-CoV Monoclonal Antibodies for Kadlec FSED & UC Patients

 

Dear Kadlec Employed Providers & Core Leaders,

 

 

We are excited to announce that Kadlec Free Standing ED & Kadlec Urgent Care Providers may start referring high risk COVID(+) patients for Regen-CoV Monoclonal Antibody therapy beginning Wednesday, 9/8/21.

 

 

We only have a small supply of monoclonal antibodies, and the ordering process was just changed by the Federal Government, so we need to temporarily delay opening this referral service to all Kadlec Providers.

 

 

I want to highlight several key points:

 

Please read and save the attached COVID-19 MAb Practice Alert – it has the detailed workflow instructions

You must follow the attached instructions & strictly adhere to MAb inclusion & exclusion criteria

This is only for high-risk COVID(+) patients with symptoms for less than 10 days

Patients with 3 or more risk factors are the most likely to benefit from treatment (see the slide deck)

Access is by referral only and is limited to patients seen at Kadlec FSED or Kadlec UC to start

Our clinic team will schedule these patients when they receive the referral

We only have access for 6 patients per day Monday-Friday to start, but we hope to expand access quickly

NNT (number needed to treat) to prevent one hospitalization is 8-20

This service is FREE to patients currently, but that is subject to change in the future