Updates as of October 3, 2023:

• Updates to available resources and response to surges.
  

Lagevrio (molnupiravir) and Paxlovid (nirmatrelvir/ritonavir) are oral antiviral drugs that are highly effective for preventing hospitalization and death in patients with mild to moderate COVID-19 infection who are at risk for severe disease. Multiple factors are involved to ensure timely administration of oral antivirals, including adequate drug supply and distribution, acceptance of the therapy by health care providers and the public, and patient access to testing, prescriptions, and drug dispensing sites.

The California Department of Public Health (CDPH) has been made aware of occasions where pharmacists have turned away patient prescriptions for COVID-19 oral antiv​​iral therapy due to misinformation or a lack of information. This document provides recommendations to clarify what information is necessary to dispense these therapeutics.  It is intended to aid pharmacies serving as dispensing sites for these critical medications. For more information on COVID-19 therapeutics and California's efforts to increase accessibility, please see the COVID-19 Treatment Resources for Healthcare Providers.

In all situations, clinical concerns about inappropriate prescriptions or inappropriate dosing should be weighed against the clinical consequences of delaying or denying treatment that prevents severe illness from COVID-19, which has caused more than 100,000 deaths in California as of September 29, 2023. There is also early and increasing evidence that COVD-19 treatment reduces the risk of developing long COVID symptoms.

As we are likely to continue to see periodic surges of COVID-19 cases, it is important to remain up-to-date on the latest clinical guidance to ensure patients receive appropriate and timely access to highly effective COVID-19 treatment. Pharmacies and pharmacists should be aware they may see a rise in prescriptions for COVID-19 medications for a number of reasons including:

• All Facility Letter (AFL) for Skilled Nursing facility (SNF) residents AFL 23-29 that provides guidance and resources for evaluating, prescribing, and obtaining COVID-19 therapeutics for SNF residents. AFL 23-29 supersedes AFL 22-20.
• All other AFLS including those relating to COVID-19 therapeutics may be accessed at the All Facilities Letters – Library. CDPH health advisories related to respiratory viruses including COVID-19,  can be found in the health advisories page.
• CDPH is conducting an ongoing campaign via TV, radio, and social media to promote the use of COVID-19 oral antiviral therapeutics. Find shareable content on the CDPH COVID-19 Treatments page.
• After November 11, 2023, most insurance plans will cover COVID-19 treatment. Persons who do not have a healthcare provider should use the COVID-19 Test-to-Treat-Locator.​
  

While treatments are an important tool in the fight against COVID-19, vaccines are also a critical component of mitigating the spread and impact of COVID-19. All individuals are recommended to stay up to date with COVID-19 vaccinations, which increase protection against severe COVID-19. Learn more about vaccines at the CDPH Vaccines Site. 

The following information is intended to clarify topics that pharmacies and pharmacy staff may need to prevent delayed access to critical COVID-19 treatment:​

Pharmacies ​and pharmacy staff should be aware that most insured patients continue to have a right to free, low-cost, and/or reimbursable over-the-counter COVID-19 tests despite the end of the State and Federal Emergencies.

• Ensure all staff are knowledgeable about patients' benefits for COVID-19 tests:
• Pharmacists should order and/or dispense allotted test kits for Medi-Cal beneficiaries at the point-of-sale in accordance with the following: CDPH COVID-19 Medical Coverage Changes (PDF).
• After November 11, 2023, most insurance plans will cover COVID-19 at-home tests. If you do not have an at-home test, testing locations can be found at Find a testing site (ca.gov) or No-Cost COVID-19 Testing (cdc.gov). Refer to the DMHC Know Your Health Care Rights Fact Sheet (PDF) for information on commercial plans.​
• ​Refer to this webpage for Medicare recipients and to the COVID-19 Medical Coverage Changes (PDF) table for a summary of COVID-19 health care benefits after the end of the Public Health Emergency. ​
• For insurance plans that allow patients to pick up tests at pharmacies within their network free of charge, including Medi-Cal, pharmacists should write an order for the COVID-19 tests and submit the claim as a pharmacy benefit. 
• If tests are not covered by insurance at point of sale in the pharmacy, patients may elect to pay at the counter and submit a claim for reimbursement from their insurance company directly.

The number of free test kits varies by health planin network benefits. Uninsured patients can get information on testing at the: CDC No-Cost COVID-19 Testing Locator.​ 

Pharmacies should maintain an adequate supply of COVID-19 oral antivirals during seasonal surges.

CDPH has learned of several pharmacies that are notifying patients that they are out of stock of COVID-19 oral antivirals and have not replenished their supply. This puts the public at risk for not receiving treatment quickly. 

• Even pharmacies that have not dispensed many oral COVID-19 antivirals in the past are recommended to be prepared for potential incoming patients and ensure on-shelf availability during seasonal surges. Seasonal COVID-19 surges can be tracked at the CDPH COVID-19 Tracking webpage.
• There is adequate supply for pharmacies in the Federal Retail Pharmacy Therapeutics Program.
• Pharmacies receiving their supply from their local health department (LHD) should continue to request from these channels. The LHD may allow larger than usual order requests if feasible.
• Pharmacies should monitor expiration dates to retain stock and not discard product that potentially has not expired. HHS/ASPR shelf-life extensions are issued frequently. A full list of HHS/ASPR's updates related to oral antiviral shelf-life extensions are available here:
• Shelf-Life Extension for Specific Lots of Paxlovid | HHS/ASPR
• Shelf-Life Extension Evaluation of Lagevrio | HHS/ASPR
• Pharmacies that are temporarily out of stock are recommended to aid the patient in finding COVID-19 therapeutics using the COVID-19 Therapeutics Locator (arcgis.com).  ​
  

There are several ways patients can be eva​​luated for COVID-19 treatment.

Phar​macists may prescribe COVID-19 therapeutics with certain conditions. Note: Paxlovid is now FDA approved in adults but remains under EUA for ages 12 years old to 17 years old.

• ​The State Board of Pharmacy is encouraging interested persons to evaluate the Public Readiness and Emergency Preparedness (PREP) Act with an attorney, if necessary, to determine eligibility for pharmacists to continue independently initiating and furnishing Paxlovid to individual patients.
  
• Direct p​atient inquiries for information on ass​​essment and treatment to the State's COVID-19 Hotline at 1-833-422-4255 or treatment website. This hotline and website can also help patients get free access to telehealth providers who can prescribe oral antivirals for COVID-19 when appropriate.
  
• Pharmacy staff may also find additional ass​​essment and treatment information at COVID19.ca.gov.
• If a pharmacy has any additional methods f or access, those should also be shared with patients.​​

Pharmacies should accept all valid hard copy prescriptions; they do not need to be sent electronically.

• The California Business and Professions Code (BPC) section 688(i) states pharmacists are not required to ​verify that a written, oral, or faxed prescription falls under one of the exceptions of the e-prescription law.
• BPC section 688(i) also states pharmacists may continue to dispense medications from legally valid written, oral, or faxed prescriptions pursuant to law. When deciding whether to refuse to dispense an​ otherwise legally valid written, oral, or faxed prescription solely because it was not transmitted electronically, a pharmacist should consider the impact on the patient and continuity of care.​
• This is also addressed in Question 3 of the BPC's Electronic Data Transmission Prescriptions – Frequently A​​​sked Questions.
  

Pharmacies should accept uninsured pati​ents and not charge patients for a COVID-19 oral antiviral.

• Organizations must not sell or seek ​reimbursement for publicly funded COVID-19 therapeutics that the federal government provides at no cost to an organization.
• ​Uninsured patients in California are encouraged to read this​​ Fact Sheet: HHS Announces 'HHS Bridge Access Program for COVID-19 Vaccines and Treatments' to Maintain Access to COVID-19 Care for the Uninsured for guidance on obtaining coverage as a pathway to no cost vaccines and treatment.​
• For information on free assessment and treatment options for uninsured patients, direct inquiries to the State's COVID-19 Hotline at 1-833-422-4255 or  treatment website.

Pharmacists should NOT reject COVID-19 prescriptions solely due to the absence of renal function and liver function test results​.

• The Paxlovid EUA indicates that these tests are only required for pharmacists when pharmacists are prescribing the medication. These labs are generally not required when dispensing.
• According to ASPR-HHS under “Are lab results required before a patient can be prescribed Paxlovid? - Licensed physicians and advanced practice providers are not required to perform additional laboratory testing when prescribing Paxlovid. Providers should use clinical judgement to determine if labs are necessary." Typically lab results are not necessary. 
  
• In making a r​easonable attempt to clarify any concerns with the provider and/or patient, pharmacists should use clinical judgement and consider the impact of delayed COVID-19 treatment. Treatment must be started within 5 days of symptom onset.​​

Pharmacists should NOT ​​​​reject COVID-19 prescriptions due to the absence of a “positive test" date or “symptom onset" date written on the prescription.

​​These items are not required to be written on the prescription and patients can self-attest to the symptom onset dates.

• The FDA revised its emergency use authorizations on Paxlovid and Lagevrio on February 1, 2023, to no longer require positive results of direct SARS-CoV-2 viral testing before a provider can prescribe them. Additional testing is not required.
• Paxlovid received full FDA approval on May 25, 2023, for the treatment of mild to moderate COVID-19 in adults who are at risk for progression to severe COVID-19, including hospitalization or death. There is no mentio​​n of the requirement of a positive test.​
  

Pharmacists should not reject COVI​D-19 prescriptions due to the presence of only mild symptoms.

• Patients with mild symptoms are, in fact, included​ in criteria for outpatient treatment according to the FDA EUA and National Institutes of Health recommendations.

This information should be shared with stores and facilities staff to ensure correct information and the best possible patient experience are provided.

The State's COVID-19 Hotline (1-833-422-4255) should also be shared as hotline staff are available to respond to all questions related to COVID-19. Additional information can also be found at COVID-19 Treatment page.

Additional information for staff and clinicians can be found at  COVID-19 Treatment Resources for Healthcare Providers.​

​*​Tracking COVID-19 in California - COVID-19 Response​