The Oregon Board of Pharmacy adopted the following Temporary Rule, effective February 10. 

The Emergency Use Authorization (EUA) for each product has been updated. The updated EUA for Paxlovid now differs from the approved statewide drug therapy management protocol which necessitates the protocol’s suspension. REGEN-COV is not authorized for use in any US region which also necessitates this protocol’s suspension. 

  • COVID-19 Monoclonal Antibody- REGEN-COV. EUA updated 1/24/2022. REGEN-COV (casirivimab and imdevimab) is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to REGEN-COV. Therefore, REGEN-COV may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the FDA.
  • COVID-19 Antiviral- Paxlovid. EUA updated 2/1/2023. The U.S. Food and Drug Administration has issued an EUA for the emergency use of PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death. 

Temporarily suspends the statewide drug therapy management protocols for COVID-19 Monoclonal Antibody and COVID-19 Antiviral due to: 

  • COVID-19 Monoclonal Antibody- REGEN-COV. REGEN-COV (casirivimab and imdevimab) is not currently authorized in any U.S. region. 
  • COVID-19 Antiviral- Paxlovid. Under Oregon state laws, pharmacists cannot diagnose. The current Paxlovid EUA requires a diagnosis to prescribe Paxlovid, which is not required in the Board’s Paxlovid protocol (based on the EUA dated 10/27/2022) and appears to be preempted by federal law. 

The FDA has stated that EUAs preempt any differing requirements under states’ laws. As a result, the Oregon Board of Pharmacy will not take disciplinary action against persons who act in accordance an EUA, as a result of the FDA’s position that state law is preempted. If a complaint is received relating to activities covered under an EUA, the Board will expect the licensee to provide documentation of full compliance with the EUA. Failure to do so may result in disciplinary action. 

Also in Oregon, the Board of Pharmacy permanently adopted the following rules at the February 2023 Board Meeting: 

Also in Oregon, the Board of Pharmacy is seeking subject matter experts (SMEs), including pharmacists, to serve on the Public Health & Pharmacy Formulary Advisory Committee (PHPFAC). The board utilizes SMEs to develop and revised protocols in the Protocol Compendium. If you would like to serve as a SME for the PHPFAC please complete the online form by March 1. Individuals selected will receive confirmation by March 15. Email SME related inquiries to pharmacy.formulary@bop.oregon.gov. 

Also in Oregon, the Board of Pharmacy posted the agenda for the Compounding Workgroup meeting on February 21. 

Also in Oregon, the Board of Pharmacy posted the agenda for the Interns Workgroup meeting on February 22. 

Finally in Oregon, the Oregon Health Authority (OHA) will resume health coverage renewals on April 1 for Oregon Health Plan (OHP) members. OHA is required to review eligibility for all 1.47 million OHP members by June 2024. Anyone who no longer qualifies for OHP coverage still have affordable health coverage options. The Oregon Health Insurance Marketplace (OHIM) will send information to people who are no longer eligible for OHP benefits and advise of potential coverage options and financial help through the Marketplace. The Marketplace Transition Help Center will help people understand their options, how to transition to the Marketplace, and to find help from local health coverage experts.  

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.