COVID-19 Resources
July 6, 2022 - FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations
Today, the U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.
When testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area. While this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations as described below, community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer this service to patients.
Patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:
- Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s health care provider.
- A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function.
- Sufficient information is not available to assess for a potential drug interaction.
- Modification of other medications is needed due to a potential drug interaction.
- Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
- Coronavirus Treatment Acceleration Program (CTAP)
- Test to Treat Locator
- COVID-19 Therapeutics Locator
We invite you to join us on this Friday, July 8th from 12:00 – 1:00 PM ET for the HHS/ASPR Weekly Therapeutics Clinical Rounds webinar to learn more about this update and to receive additional information regarding the current COVID-19 therapeutics landscape.
What: HHS/ASPR COVID-19 Therapeutics Clinical Rounds Webinar
When: Friday, July 8th (12:00 – 1:00 PM ET)
Dial-In Link (Zoom): https://hhsasproea.zoomgov.com/j/1617536991?pwd=NjFMcnJOUENuSFhtRFFtaWltejYzZz09
Webinar ID: 161 753 6991 | Passcode: 113212
Should you have questions regarding this update, you may also email COVID19Therapeutics@hhs.gov.
April 15, 2022 - U.S. Department of Health and Human Services: New Paxlovid dose pack authorized by FDA
The U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for the COVID-19 oral antiviral therapeutic Paxlovid to authorize an additional dose pack presentation with appropriate dosing for patients with moderate renal impairment within the scope of the EUA. As a result, Paxlovid will soon be available in two package presentations:
- The standard packaging that is currently in distribution: 300 mg nirmatrelvir;100 mg ritonavir - Each carton contains 30 tablets divided in 5 daily-dose blister cards. Each blister card contains 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each). Nirmatrelvir tablets and ritonavir tablets are supplied in separate blister cavities within the same child-resistant blister card.
- The new packaging option that will be in distribution later this month: 150 mg nirmatrelvir; 100 mg ritonavir - Each carton contains 20 tablets divided in 5 daily-dose blister cards. Each blister card contains 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each). Nirmatrelvir tablets and ritonavir tablets are supplied in separate blister cavities within the same child-resistant blister card.
The updated provider Fact Sheet, Letter of Authorization, and Dear Healthcare Provider Letter are available for your reference. More information regarding the additional dose pack presentation for Paxlovid and timing for when this option will be included in allocations for ordering and distribution will be provided during the COVID-19 Therapeutics Update Call on Wednesday, April 20.
December 1, 2021 - U.S. Department of Health and Human Services: Updated Distribution and Administration of COVID-19 Therapeutics
The Office of Assistant Secretary for Preparedness and Response has released the updated Distribution and Administration of COVID-19 Therapeutics report....
November 17, 2021 - U.S. Department of Health and Human Services: Updated Distribution and Administration of COVID-19 Therapeutics
The Office of Assistant Secretary for Preparedness and Response has released the updated Distribution and Administration of COVID-19 Therapeutics report....
October 14, 2021 - Regen-cov Update
Important information regarding packaging, labeling, and storage of COVID-19 monoclonal antibody therapeutic...
October 6, 2021 - U.S. Department of Health and Human Services: Updated Distribution and Administration of COVID-19 Therapeutics
The Office of Assistant Secretary for Preparedness and Response has released the updated Distribution and Administration of COVID-19 Therapeutics report....
September 14, 2021 - Health and Human Services Update: Update to mAb Distribution System
As of Monday, September 13, HHS transitioned from the direct ordering process to a state/territory-coordinated distribution system, similar to that used from November 2020 – February 2021. We fully recognize that state/territorial health departments know best where product is needed in their areas. Transitioning to a state/territory-coordinated distribution system will give health departments maximum flexibility to get these critical drugs where they are needed most.
The federal government will determine the weekly amount of mAb products each state and territory receives based on COVID-19 case burden and mAb utilization. State and territorial health departments subsequently identify which sites in their respective jurisdictions receive product as well as the amount each site receives.
As of Monday, September 13, 2021:
- Administration sites no longer order directly from AmerisourceBergen.
- Weekly distribution amounts for each state/territory will be determined by HHS based on weekly reports of new COVID-19 cases and hospitalizations in addition to data on inventories and use submitted in HHSProtect.
- State/Territorial Health Departments will determine where product goes in their jurisdictions.
We will continue to monitor product utilization rates, COVID-19 case burden, and overall availability of mAbs to determine when a shift back to the normal direct ordering process may be possible. In the meantime, your cooperation in this effort will help ensure that, to the extent feasible, current and future patients receive monoclonal antibodies as needed.
We encourage you to join this week’s stakeholder call and the office hour sessions to learn more about the state/territory-coordinated distribution system. Should you have questions regarding this update or need instructions for dialing into the calls/sessions please email the Federal COVID-19 Response Team at COVID19therapeutics@hhs.gov.
September 22, 2021 - Health and Human Services Update: Update to mAb Distribution System
The Office of Assistant Secretary for Preparedness and Response has released the udpated Distribution and Administration of COVID-19 Therapeutics report....
September 3, 2021 - Health and Human Services Update: Distribution and Administration of COVID-19 Monoclonal Antibody Therapeutics
As you are likely aware, the recent increase in the prevalence of the Delta variant of COVID-19 has caused a substantial surge in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates. It is our goal to ensure continued availability of these drugs for current and future patients. As such, we are immediately implementing the following changes to help promote optimal and equitable use of the available supply of monoclonal antibodies while we continue efforts to procure additional product:
- Limiting immediate orders and shipment only to administration sites with HHSProtect accounts and current utilization reporting
- Reviewing all orders for alignment with utilization, currently estimated at 70% of orders
Please note that this is a temporary change. We will continue to monitor product utilization rates, variant prevalence, and overall availability of monoclonal antibody therapeutics to determine when we will shift back to the normal direct ordering process. In the meantime, your cooperation in this effort will help ensure that, to the extent feasible, current and future patients receive monoclonal antibodies as needed.
Should you have any questions regarding this update in ordering and distribution procedures, please email the Federal COVID-19 Response Team at COVID19therapeutics@hhs.gov. If a site needs to establish an HHSProtect account for weekly utilization reporting, please email hhs-protect@teletracking.com.
September 2, 2021 - U.S. Department of Health and Human Services: Updated Distribution and Administration of COVID-19 Therapeutics
The Office of Assistant Secretary for Preparedness and Response has released the udpated Distribution and Administration of COVID-19 Therapeutics report....
August 30, 2021 - Centers for Disease Control: Covid Data Tracker
Find maps and charts tracking cases, deaths, and trends of COVID-19 in the United States, updated daily by 8 pm ET....
August 25, 2021 - U.S. Department of Health and Human Services
The Office of Assistant Secretary for Preparedness and Response has released the udpated Distribution and Administration of COVID-19 Therapeutics report....
August 24, 2021 - Substance Abuse and Mental Health Services Association: Resources and Information
SAMHSA recognizes the challenges posed by COVID-19 and is providing the following guidance and resources to assist individuals, providers, communities and states. SAMHSA stands ready to assist in any manner possible....
August 23, 2021 - Centers for Medicare and Medicaid Services: Coronavirus (COVID-19) Partner Resources
The Centers for Medicare & Medicaid Services (CMS) is taking action to protect the health and safety of our nation’s patients and providers in the wake of the 2019 Coronavirus (COVID-19) outbreak. CMS has compiled these resources to help you stay informed on CMS, HHS CDC and other materials and resources available on the COVID-19 vaccine. Please share these materials, bookmark the page, and check back often for the most up-to-date information....
August 23, 2021 - ESRD Provider Telehealth and Telemedicine Tool Kit
This document contains electronic links to reliable sources of information regarding telehealth and
telemedicine. Most of the information is directed towards providers who may want to establish a
permanent telemedicine program. There are specific documents identified that will be useful in
choosing telemedicine vendors, initiating a telemedicine program, monitoring patients remotely, and
developing documentation tools. However, there is also information that will be useful for providers
who wish to care for patients through the virtual services that may be temporarily used during the
COVID-19 situation. The HIPAA waiver described above is particularly important during this time as it
allows the immediate utilization of commonly available programs such as FaceTime and Skype (in
addition to others), which are now a very low cost option for any provider in any setting....
August 20, 2021 - AUGUST IS NATIONAL IMMUNIZATION AWARENESS MONTH: THE PERFECT TIME FOR COVID-19 VACCINE EDUCATION, By Pat Stricker, RN, MEd
While reviewing a list of months for national healthcare observances I noticed that August has been designated as “National Immunization Awareness Month." The purpose of each month’s observance is to educate people about the importance, benefits and need for the given topic. Typically the goal for August is to discuss the need for childhood vaccines as children prepare to return to school. It is also a good time to remind adults about the vaccines they need, such as the annual flu vaccine, pneumonia vaccine, shingles vaccine, etc. However, it is especially pertinent this month to discuss the need for the COVID-19 vaccine, given what is currently happening here in the United States – the lower than anticipated overall vaccination rate that is causing a significant rise in COVID cases and deaths....
July 6, 2021 - Centers for Medicare and Medicaid Services: General Provider Telehealth and Telemedicine Tool Kit
Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from
one site to another through electronic communication to improve a patient’s health. Innovative uses of
this kind of technology in the provision of healthcare is increasing. And with the emergence of the virus
causing the disease COVID-19, there is an urgency to expand the use of technology to help people who
need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their
homes while maintaining access to the care they need. Limiting community spread of the virus, as well
as limiting the exposure to other patients and staff members will slow viral spread....
June 27, 2021 - Centers for Disease Control and Prevention: Coping with Stress
The COVID-19 pandemic has had a major effect on our lives. Many of us are facing challenges that can be stressful, overwhelming, and cause strong emotions in adults and children. Public health actions, such as social distancing, are necessary to reduce the spread of COVID-19, but they can make us feel isolated and lonely and can increase stress and anxiety. Learning to cope with stress in a healthy way will make you, the people you care about, and those around you become more resilient.
June 3, 2021 - Centers for Medicare and Medicaid Services: Coronavirus Waivers
In certain circumstances, the Secretary of the Department of Health and Human Services (HHS) using section 1135 of the Social Security Act (SSA) can temporarily modify or waive certain Medicare, Medicaid, CHIP, or HIPAA requirements, called 1135 waivers. There are different kinds of 1135 waivers, including Medicare blanket waivers. When there's an emergency, sections 1135 or 1812(f) of the SSA allow us to issue blanket waivers to help beneficiaries access care. When a blanket waiver is issued, providers don't have to apply for an individual 1135 waiver. When there's an emergency, we can also offer health care providers other flexibilities to make sure Americans continue to have access to the health care they need....
May 4, 2021 - National Council for Behavioral Health: Resources and Tools for Addressing Coronavirus (COVID-19)
For more than 50 years, we have been working to promote health and wellness among our staff, stakeholders, members and the communities they support. With recent news of the novel coronavirus (COVID-19) inviting a heightened sense of uncertainty and apprehension, that commitment has never been stronger. In this time of confusion, there is hope. And there is help....
April 22, 2021 - CARE FOR YOURCORONAVIRUS ANXIETY
Resources for anxiety and your mental health in a global climate of uncertainty....
April 20, 2021 - National Council for Mental Wellbeing: Mental Health First Aid
Mental Health First Aid is a skills-based training course that teaches participants about mental health and substance-use issues....
March 31, 2021 - Centers for Disease Control - Healthcare Workers: Information on COVID-19
Guidance for managing patients with COVID-19, including clinical guidance, home and hospital care, care for special populations, disease severity, and more....
February 22, 2021 - National Academy of Medicine: Clinician well-being is essential for safe, high-quality patient care.
Clinicians of all kinds, across all specialties and care settings, are experiencing alarming rates of burnout. Among the most telling of statistics, 35-54% of nurses and physicians as well as 45-60% of medical students and residents (“learners”) experience substantial symptoms of burnout. Burnout is a syndrome characterized by a high degree of emotional exhaustion and depersonalization (i.e., cynicism), and a low sense of personal accomplishment at work....
January 28, 2021 - National Association of Mental Illness COVID-19 Guide: COVID-19 Information and Resources
Click the link below to view NAMI's COVID-19 Information and Resources, The Effects Of COVID-19 Related Social Isolation On The Mental Health Of Racialized Communities, Public Service Announcements For AAPI Families Facing COVID-19 Discrimination, and more...
April 3, 2020 - Suicide Prevention Resource Center: Resources to Support Mental Health and Coping with the Coronavirus (COVID-19)
Looking for information on mental health and coping with the effects of COVID-19? Check out our compilation of resources for the general public, parents and caregivers, mental health professionals, community leaders, and tribal populations....
March 17, 2020 - Coronavirus-2019 (COVID-19): Information and Resources, Pat Stricker
As everyone is well aware, the novel coronavirus disease (COVID-19) pandemic is sweeping the globe. Since it was first reported in December 2019 to the World Health Organization by China, it has been reported in 159 counties worldwide, causing 184,976 reported cases and 7,529 deaths, according to the WHO website statistics of March 17, 2020. The U.S. has 3,536 reported cases with 58 deaths....