COVID-19 VACCINATION / THERAPEUTIC INFORMATION
Board staff have consolidated COVID-19 vaccine related items posted on our homepage and organized them below by topic. Select a topic to be taken to that section:
1) Vaccine / Therapeutics Administration Authorization
2) NC DHHS's COVID-19 Vaccine Management System (CVMS) Provider Enrollment Portal
4) Other Vaccine Related Resources for Pharmacy Practitioners
NC DHHS COVID-19 VACCINATION INFORMATION FOR PROVIDERS: https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.
1) VACCINE ADMINISTRATION AUTHORIZATION
MONDAY, OCTOBER 17, 2022
STATE HEALTH DIRECTOR BETSEY TILSON ISSUES STATEWIDE STANDING ORDERS FOR PEDIATRIC BIVALENT COVID BOOSTERS. Standing orders for pharmacist administration of the bivalent COVID booster vaccine for pediatric patients age 5 or older have been issued and links are below. These standing orders also are, or will soon be, added to the NCDHHS’ pharmacist standing order compilation here: https://www.dph.ncdhhs.gov/HDSO-pharmacists.htm.
- NC State Health Director’s Statewide Standing Order for monovalent Primary Series Pfizer-BioNTech mRNA COVID-19 Vaccine Administration in Patients Ages 5-11 Years; October 12, 2022
- NC State Health Director's Statewide Standing Order for Pfizer-BioNTech mRNA COVID-19 Bivalent (Original and Omicron BA.4/ BA.5 B) Booster Vaccine Administration in Patients Ages 5-11 Years;
October 12, 2022
- NC State Health Director's Statewide Standing Order for monovalent Moderna mRNA COVID-19 Primary Series Vaccine Administration for individuals 6 years through 11 years of age; Revised: October 12, 2022
- NC State Health Director’s Statewide Standing Order for
Administration of Moderna COVID-19 Vaccine Bivalent Booster Original and Omicron BA.4 /BA. 5 in Individuals
6 Years of Age and Older;
September 2, 2022; Revised October 12, 2022
TUESDAY, SEPTEMBER 6, 2022
STATE HEALTH DIRECTOR TILSON PUBLISHED STATEWIDE STANDING ORDERS FOR PFIZER AND MODERNA BIVALENT COVID-19 BOOSTER VACCINES. On August 31, 2022, the Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize single booster dose bivalent formulations. More information is available here: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use?utm_medium=email&utm_source=govdelivery
State Health Director Betsey Tilson has issued statewide standing orders for the bivalent boosters, along with provider updates:
The Statewide Standing Order FDA EUA Moderna Bivalent Booster (18+) and Pfizer Bivalent Booster (12+) are now published online and available.
- Statewide Standing Order for FDA Authorized bivalent (original and Omicron BA.4/BA.5) Pfizer-BioNTech COVID-19 Vaccine Administration in Patients 12 Years and Older (Sept. 2, 2022)
- Statewide Standing Order for FDA Authorized bivalent (original and Omicron BA.4/BA.5) Moderna COVID-19 Vaccine Administration in Patients 18 Years and Older (Sept. 2, 2022)
All current SWSOs are available on the NCDHHS site on the following pages: https://publichealth.nc.gov/HDSO-pharmacists.htm and https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.
Please read and review the Fact Sheet for Healthcare Providers:
- Moderna: Moderna Recipients 18+
- Pfizer: Pfizer Recipients 12+
FRIDAY, JULY 22, 2022
NOVAVAX COVID-19 VACCINE AUTHORIZED AND RECOMMENDED FOR ADULTS 18 AND OLDER. The Food and Drug Administration and the Centers for Disease Control and Prevention have announced that the Novavax COVID-19 vaccine can be used as an additional vaccine option for adults ages 18 years and older.
The Novavax COVID-19 vaccine is the latest authorized and recommended vaccine to prevent severe illness, hospitalization and death caused by the virus. The Novavax COVID-19 vaccine provides a more familiar type of protein-based vaccine technology that has been used for more than 30 years in shots that help prevent diseases like shingles, hepatitis B, the flu and other illnesses.
The Novavax vaccine will be made available in the coming weeks to North Carolinians over the age of 18 who are not yet vaccinated. It is given in a two-dose primary series, with a second dose administered between three-to-eight weeks after the first.
For more information about COVID-19 vaccines, testing and treatments, visit MySpot.nc.gov or contact the North Carolina COVID-19 Vaccine Help Center by phone at 1-888-675-4567.
UPDATED THURSDAY, JULY 7, 2022 TO INCLUDE NOTICE FROM NC MEDICAID - SEE BELOW
JULY 6, 2022 *UPDATE* PHARMACIST ROLE IN PAXLOVID THERAPY FOR COVID-19. As pharmacists know, the FDA has issued emergency authorization (“EUA”) for Pfizer’s Paxlovid, an oral antiviral, for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients.
On July 6, 2022, the FDA amended the Paxlovid EUA to state:
PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:
O Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and
hepatic function; and
O Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to
obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.
FDA’s July 6, 2022 announcement is found here: 6 July 2022 FDA Statement. The full, revised Paxlovid EUA is found here: Paxlovid Emergency Use Authorization.
The Ninth Amendment to the US DHHS PREP Act declaration (found here: PREP Act Declaration Ninth Amendment) authorizes pharmacists to “order and administer” oral COVID-19 therapies. The Ninth Amendment specifies that such ordering must comply with the terms of any FDA EUA or approval. See also Board of Pharmacy Guidance to PREP Act Declaration Ninth Amendment.
Accordingly, under the terms of the PREP Act Declaration Ninth Amendment and the newly revised Paxlovid EUA, pharmacists may “order and administer” Paxlovid therapy for COVID-19. Pharmacists ordering and administering Paxlovid therapy must follow the conditions described in the revised EUA, which are summarized in the FDA’s 6 July 2022 FDA Statement. The Paxlovid Emergency Use Authorization, at pages 9 to 11, provides more detail on requirements for health care providers administering Paxlovid – including directives on provider and patient education, tracking and reporting of adverse events and medication errors, drug storage, and dispensing record creation and maintenance.
Pharmacists are reminded that Paxlovid contains 100 mg ritonavir in each dose. Ritonavir is a CYP3A4 inhibitor and may affect the hepatic metabolism of various drugs. Therefore, it is important to understand that coadministration of Paxlovid with several classes of drugs could result in potentially serious drug-drug interaction mediated adverse reactions. The Paxlovid FDA EUA Fact Sheet for Health Care Providers contains a list of established and potentially significant drug interactions (see Section 7.3). It is critical when dispensing Paxlovid to inquire about a patient’s medication therapy. Standard drug interaction software is not a substitute for patient-specific screening. And pharmacists should specifically inquire if the patient has received an organ transplant, as Paxlovid interactions with anti-rejection drugs have been documented. All potential drug-drug interactions should, of course, be evaluated and, where appropriate, discussed with the patient’s transplant care or primary care providers.
Additional resources:
Paxlovid FDA EUA Fact Sheet for Health Care Providers
Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treament of COVID-19
FDA Updates on Paxlovid for Health Care Providers
NIH COVID-19 Treatment Guidelines Panel’s Statement on Potential DDI’s between Paxlovid and Concomitant Medications
University of Liverpool COVID-19 Drug Interaction Checker
IDSA Statement on Considerations for Use of Paxlovid in Treatment of COVID-19 for Patient’s with HIV and Hep C
*****************************************************************************************
JULY 7, 2022 UPDATE FROM NC MEDICAID: NC Medicaid Pharmacy POS Billing for Pharmacist Prescribed Paxlovid:
The July 6, 2022 FDA Statement authorizes state licensed pharmacists to prescribe Paxlovid. It is the responsibility of the pharmacist to prescribe Paxlovid in accordance with conditions of the FDA’s July 6th guidance.
Only CPP credentialed pharmacists are enrolled as NC Medicaid providers. This means non-CPP pharmacists prescribing Paxlovid must use the pharmacy NPI as the prescriber on POS pharmacy claims submitted to NC Medicaid. Using the pharmacy NPI will avoid denials for non-enrolled provider. A State standing order will not be issued for Paxlovid.
In addition to the above, the following is applicable to Paxlovid POS claims.
- Reimbursement is the ingredient cost (currently free) plus the professional dispensing fee.
- No copay applies because Paxlovid is for treatment of COVID19.
- Pharmacist must enter the COVID19 diagnosis on the claim.
This pharmacy POS billing guidance is effective July 6, 2022. NCTracks system readiness for claims processing is anticipated by July 18, 2022. After claims processing is active, retro billing back to the July 6, 2022, start date can be done.
WEDNESDAY, JULY 6, 2022
GUIDANCE FROM NC DHHS ON HOW PHARMACIES IN NORTH CAROLINA CAN GAIN ACCESS TO FREE COVID-19 THERAPIES. To ensure efficient and equitable distribution, COVID-19 therapeutics such as Paxlovid, Lagevrio and Evusheld are currently purchased by the federal government from their manufacturers and are not available on the commercial market.
If your pharmacy is not currently receiving allocations of COVID-19 therapeutics, you may submit a
request to the North Carolina Department of Health and Human Services (NC DHHS) to receive COVID-19 oral antivirals and/or Evusheld by following the steps outlined in this guidance.
MONDAY, JUNE 27, 2022
ADMINISTRATION OF COVID-19 VACCINE TO PATIENTS UNDER THREE YEARS OF AGE. The Food and Drug Administration has approved Pfizer and Moderna COVID-19 vaccines for patients as young as six months. Pharmacists have inquired of Board staff about their authority to administer COVID-19 vaccines to these pediatric patients. Still-in-effect PREP Act declarations issued by the United States Department of Health and Human Services authorize qualified pharmacists to administer COVID-19 vaccines to patients age three or older. North Carolina law authorizes qualified immunizing pharmacists to administer COVID-19 vaccines to patients age 10 or older pursuant to protocol, and 6 or older pursuant to a patient-specific prescription. While the PREP Act declaration remains in place, pharmacists may exercise the broader authority to administer COVID-19 vaccine to patients age 3 or older. There is no authority under PREP Act declaration or North Carolina law for pharmacists to administer COVID-19 to a patient younger than 3 years of age.
Updated statewide standing orders and fact sheets are found here:
- Statewide Standing Order for Pfizer-BioNTech mRNA COVID-19 Vaccine Administration in Patients 6 Months to 4 Years (June 20, 2022)
- Statewide Standing Order for Moderna COVID-19 Vaccine Administration in Patients 6 Months to 5 Years (June 20, 2022)
Fact sheets for Healthcare Providers:
- Moderna: Moderna Recipients FS 6m-5y 06172022 (fda.gov)
- Pfizer: Pfizer Recipient FS 6m-4y Maroon 06172022 (fda.gov)
All current statewide standing orders are available on the NCDHHS site on the following pages: https://publichealth.nc.gov/HDSO-pharmacists.htm and https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers
FRIDAY, JUNE 24, 2022
CDC BROADENS RECOMMENDATION OF COVID-19 VACCINES FOR INDIVIDUALS 6 THROUGH 17 YEARS OF AGE TO INCLUDE THE MODERNA COVID-19 VACCINE PRODUCT.
Following the FDA authorization, the Centers for Disease Control and Prevention (CDC) broadened their recommendation of COVID-19 vaccines for individuals 6 through 17 years to include the Moderna COVID-19 vaccine product.
PROVIDER COMMUNICATION FROM THE NC DEPARTMENT OF HEALTH AND HUMAN SERVICES IS FOUND HERE.
The Statewide Standing Order FDA EUA Moderna 6y-11y and Moderna 12+ are now published online and available:
- Statewide Standing Order for Moderna mRNA COVID-19 Vaccine Administration in Patients 6 Years through 11 Years (June 23, 2022)
- Statewide Standing Order for FDA Authorized Moderna COVID-19 Vaccine Administration in Patients 12 Years and Older (June 23, 2022)
All current SWSOs are available on the NCDHHS site on the following pages: https://publichealth.nc.gov/HDSO-pharmacists.htm and https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.
Please read and review the Fact Sheet for Healthcare Providers:
- Moderna: Moderna Recipients 6y-11y
- Moderna: Moderna Recipients 12+
- Moderna: Product Guide
MONDAY, JUNE 13, 2022
NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES UPDATES GUIDANCE TO PROVIDERS FOR OUTPATIENT TREATMENT AND PREVENTION OF COVID-19. State Health Director Tilson has issued updated guidance to providers concerning outpatient COVID-19 treatment. Key updates include: (1) Statement on limited bebtelovimab availability and expected NC supply to be depleted in August 2022; (2) Information regarding COVID-19 rebound; and (3) Updated overview of Veklury (remdesivir) since gaining full FDA approval. The full update is linked here. Broader guidance for providers is found here: Therapeutics Information for Providers Page.
FRIDAY, MAY 20, 2022
STATEWIDE STANDING ORDER FOR FDA AUTHORIZED PFIZER/COMIRNATY COVID-19 VACCINE ADMINISTRATION IN PATIENTS AGES 5-11 YEARS. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 5 years of age and older.
The Statewide Standing Order for Pfizer 5-11 has been revised due to updated FDA authorization and CDC recommendations.
Please read the Pfizer 5-11 Fact Sheet for Healthcare Providers.
This (and all current SWSO) revised Statewide Standing Order for FDA authorized Pfizer/COMIRNATY COVID-19 Vaccine Administration in Patients Ages 5-11 Years is available on the NCDHHS site on the following pages: https://publichealth.nc.gov/HDSO-pharmacists.htm and https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.
THURSDAY, MARCH 31, 2022
STATE HEALTH DIRECTOR UPDATES MODERNA AND PFIZER COVID-19 VACCINE STANDING ORDERS. State Health Director Betsey Tilson has updated the state standing orders to reflect FDA’s authorization of a second booster for certain patient populations. The updated standing orders are found here:
They are also found here (along with all other state standing orders for pharmacists): https://ncpublichealth.info/HDSO-pharmacists.htm.
TUESDAY, FEBRUARY 1, 2022
*UPDATE* GUIDANCE TO S.L. 2021-110: AN ACT TO AUTHORIZE IMMUNIZING PHARMACISTS TO DISPENSE, DELIVER, AND ADMINISTER CERTAIN TREATMENT AND MEDICATIONS. On August 19, 2021 Governor Cooper signed S.L. 2021-110, which expands practice authority for certain pharmacists and pharmacy technicians. This guidance document reviews the granted authorities, timelines and conditions for implementation, and how existing US DHHS PREP Act declarations intersect with (and in some cases supersede) this authority. As this guidance details, full implementation of S.L. 2021-110 requires a number of actions over a number of different timelines. Board staff will update this guidance document regularly as those processes go forward: http://www.ncbop.org/PDF/SL2021110GuidanceAug2021.pdf. *UPDATE* As detailed in the linked guidance document, portions of the statute authorizing pharmacists to initiate certain drug therapies – including hormonal contraceptives -- are effective February 1, 2022. However, these new authorities will not be implemented until the State Health Director issues standing orders to do so. Stakeholders have been working diligently together to craft the standing orders. When the State Health Director issues the standing orders, Board staff will publicize them. A number of press reports stated that pharmacists’ ability to initiate hormonal contraceptive therapy was in place today. But, again, this will not become operational until the State Health Director issues a standing order.
FRIDAY, JANUARY 28, 2022
PHARMACISTS REMINDED TO BE VIGILANT IN SCREENING FOR DRUG INTERACTIONS WHEN PROVIDING COVID-19 THERAPY WITH PAXLOVID. As pharmacists know, the Food and Drug Administration has issued an Emergency Use Authorization for Paxlovid™(nirmatrelvir tablets/ritonavir tablets) to treat COVID-19 infection. Paxlovid™ contains 100 mg ritonavir in each dose. Ritonavir is a CYP3A4 inhibitor and may affect the hepatic metabolism of various drugs. Therefore, it is important to understand that coadministration of Paxlovid™ with several classes of drugs could result in potentially serious drug-drug interaction mediated adverse reactions. The Paxlovid FDA EUA Fact Sheet for Health Care Providers contains a list of established and potentially significant drug interactions (see Section 7.3).
It is critical when dispensing Paxlovid™ to inquire about a patient’s medication therapy. Standard drug interaction software is not a substitute for patient-specific screening. And pharmacists should specifically inquire if the patient has received an organ transplant, as Paxlovid™ interactions with anti-rejection drugs have been documented. All potential drug-drug interactions should, of course, be evaluated and, where appropriate, discussed with the patient’s transplant care or primary care providers.
Additional resources:
Paxlovid FDA EUA Fact Sheet for Health Care Providers
NIH COVID-19 Treatment Guidelines Panel’s Statement on Potential DDI’s between Paxlovid and Concomitant Medications
University of Liverpool COVID-19 Drug Interaction Checker
IDSA Statement on Considerations for Use of Paxlovid in Treatment of COVID-19 for Patient’s with HIV and Hep C
TUESDAY, JANUARY 25, 2022
FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant. On January 24, 2022, the FDA announced revisions to the emergency use authorizations for bamlanivimab/etesevimab and REGEN-COV. Data show that these treatments are highly unlikely to be effective against the omicron variant of the COVID-19 virus, which now accounts for more than 99% of US COVID-19 cases. Accordingly, these two treatments are no longer authorized for use in the United States, its territories, or jurisdictions at this time. More information here: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron. As a result, and as already reported by Board staff, State Health Director Elizabeth Tilson has rescinded the statewide standing orders for these treatments.
MONDAY, JANUARY 24, 2022 *UPDATE*
RECISSION OF STATEWIDE STANDING ORDERS FOR BAM/ETE AND REGEN-COV MONOCLONAL ANTIBODIES. State Health Director Dr. Elizabeth Tilson has issued recissions for the following statewide standing orders:
- Statewide Standing Order for Subcutaneous Administration of Casirivimab/ Imdevimab (REGEN-COV) Monoclonal Antibodies (recission)
- Statewide Standing Order for Intravenous Administration of Casirivimab/ Imdevimab (REGEN-COV) Monoclonal Antibodies (recission)
- Statewide Standing Order for Intravenous Administration of Bamlanivimab/ Etesevimab Monoclonal Antibodies (recission)
These Statewide Standing Orders were rescinded due to the high prevalence of the Omicron variant of SARS-CoV-2 virus in North Carolina for which these therapies are not an effective treatment.
The recission orders can be accessed here: https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.
MONDAY, JANUARY 10, 2022
REVISED STATEWIDE STANDING ORDERS FOR JANSSEN, PFIZER, AND MODERNA COVID-19 VACCINES; ADJUSTED RECOMMENDATIONS FOR WHEN PEOPLE CAN RECEIVE BOOSTERS.
CDC has adjusted the recommendation for when people can receive a booster shotThe FDA now authorizes and the Centers for Disease Control and Prevention recommends individuals who received the Moderna COVID-19 vaccine get a booster dose after five months. This announcement from federal agencies comes just three days after the announcement of a shortened wait time for a booster from six months to five months for individuals who received the Pfizer vaccine.
Current recommendation for COVID-19 boosters is:
• Those who received the Moderna or Pfizer vaccine should get a booster five months after their last dose.
• Those who received the Johnson & Johnson vaccine should get a booster two months after their initial dose.
Adults may receive any brand of the COVID-19 vaccine for their booster, while children 12 to 17 can only receive Pfizer. NCDHHS encourages individuals to speak with a doctor, nurse or pharmacist if they have questions about what booster is right for them.
Anyone ages 12 and older should receive a booster.
The Statewide Standing Orders have been revised to reflect this latest guidance:
- Statewide Standing Order for FDA Approved Pfizer/COMIRNATY COVID-19 Vaccine Administration in Patients Ages 5-11 Years (revised 1/6/2022)
- Statewide Standing Order for FDA Approved Pfizer/COMIRNATY COVID-19 Vaccine Administration in Patients Ages 12 Years and Older (revised 1/6/2022)
- Statewide Standing Order for Janssen COVID-19 Vaccine Administration revised 1/7/2022
Companion document for Janssen SWSO found here.
- Statewide Standing Order for Pfizer/COMIRNATY COVID-19 Vaccine Administration revised 1/7/2022
Companion document for Pfizer SWSO found here.
- Statewide Standing Order for Moderna COVID-19 Vaccine Administration revised 1/7/2022
Companion document for Moderna SWSO found here.
Provided below is a table containing booster qualification details and the CDC recommended age for each vaccine product type:
FRIDAY, SEPTEMBER 10, 2021
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICS ISSUES DECLARATION UNDER THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS (“PREP”) ACT AUTHORIZING PHARMACISTS TO ORDER AND ADMINISTER, AND QUALIFIED PHARMACY TECHNICIANS TO ADMINISTER, CERTAIN COVID-19 THERAPEUTICS. On September 9, 2021 the U.S. Department of Health and Human Services (“US DHHS”) issued a declaration under the PREP Act authorizing pharmacists “to order and administer,” and qualified pharmacy technicians and interns “to administer” select COVID-19 therapeutics to patient populations authorized by the FDA. Board staff have created a guidance document, which is found here: http://www.ncbop.org/PDF/PREPActExpandingAccesstoCOVIDTherapeuticsSept2021.pdf.
**************************************************************
MONDAY, AUGUST 23, 2021
FDA APPROVES FIRST COVID-19 VACCINE. Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. More at https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine?utm_medium=email&utm_source=govdelivery.
MONDAY, APRIL 12, 2021
COVID-19 STATEWIDE STANDING ORDERS UPDATED TO INCLUDE PHARMACISTS AS MEDICAL PROVIDERS. The COVID-19 Vaccine Statewide Standing Orders have been updated to include Pharmacists as medical providers. The relevant portion of the revised standing order now reads:
A medical provider, defined as a physician, physician assistant, nurse practitioner, or a pharmacist authorized to order COVID-19 vaccines by the PREP Act must be accessible to provide medical supervision of the vaccination site/service, to assess and evaluate individuals who present with precautions to vaccination, and to answer questions or address problems with carrying out this standing order.
You can find the updated standing order on the NC DHHS COVID-19 Guidance page under Vaccines > Vaccination Info for Providers.
THURSDAY, MARCH 18, 2021
US DEPARTMENT OF HEALTH AND HUMAN SERVICES CREATES WEBSITE DETAILING PREP ACT AUTHORIZATIONS FOR COVID-19 VACCINE PROVIDERS
As COVID-19 vaccine availability ramps up, the Biden Administration has taken steps to expand
vaccine locations and the workforce of vaccinators. The March 12, 2021 (Seventh) Amendment to the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act, added pharmacists, pharmacy interns and pharmacy technicians, whose licenses have expired (within the last 5 years) to the list of qualified persons who can administer COVID-19 vaccines in any jurisdiction.These individuals can administer vaccines if their license or certificate was active and in good standing prior to the date it became inactive, expired, or lapsed and was not otherwise suspended or revoked by the licensing authority or they were on the List of Excluded Individuals/Entities maintained by the Office of the Inspector General. In addition, these individuals must adhere to training and supervision requirements that are detailed in this PREP Act Fact Sheet on expanding the COVID-19 vaccination workforce.
The US Department of Health and Human Services is directing volunteers to its web page so that individuals can find their relevant state or territorial website to sign up to administer vaccines in their communities.
Additionally, this digital toolkit has been created to assist entities in promoting the effort to increase the vaccine workforce.
FRIDAY, JANUARY 29, 2021
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES NEW PREP ACT DECLARATION AUTHORIZING QUALIFIED HEALTHCARE PROVIDERS TO PRESCRIBE, DISPENSE, OR ADMINISTER COVID-19 VACCINES IN ANY STATE. On January 28, 2021, US DHHS issued the latest in a series of declarations under the PREP Act. This latest declaration (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID-Amendment5.aspx) authorizes “any healthcare professional . . . who holds an active license or certification permitting the person to prescribe, dispense, and/or administer vaccines under the law of any State” to “prescribe, dispense or and/or administer COVID-19 vaccines in any State” as “long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General.”
Accordingly, pharmacists, qualified pharmacy interns, and qualified pharmacy technicians licensed or certified in other states – and whose licenses or certifications are not suspended, restricted, or surrendered – may prescribe or dispense (in the case of pharmacists) or administer (in the case of pharmacists, qualified interns, and qualified technicians) COVID-19 vaccines in North Carolina. Conversely, North Carolina pharmacists, qualified interns, and qualified pharmacy technicians may do so in other states.
Scroll down below for more information on the training requirements for vaccinating pharmacists, interns, and technicians – as well as more information on appropriate supervision of vaccinating interns and technicians.
Regarding previous editions of the PREP act, the following is still accurate for the pharmacy workforce:
1. Proper supervision of a pharmacy intern or qualified pharmacy technician who is administering vaccines or assisting with a vaccination effort can include supervision by a pharmacist or certain other health care providers who are present at the same facility, and ultimate supervision must be provided by a pharmacist who is responsible for the administration.
2. A qualified pharmacy technician and pharmacy intern can administer vaccines under the PREP Act as long as a valid order for the vaccine exists - by way of a pharmacist order, physician order, state-authorized standing order, or other legal order.
3. The PREP Act has authorized pharmacists, pharmacy interns, and qualified pharmacy technicians to administer ACIP-recommended vaccines to patients ages three (3) to eighteen (18) and FDA-approved COVID-19 vaccines to patients ages three (3) years or older.
2) NC DEPARTMENT OF HEALTH & HUMAN SERVICES COVID-19 VACCINE MANAGEMENT SYSTEM (CVMS) PROVIDER ENROLLMENT PORTAL
FRIDAY, JANUARY 15, 2021
FROM THE NC DEPARTMENT OF HEALTH & HUMAN SERVICES: COVID-19 VACCINE MANAGEMENT SYSTEM (CVMS) PROVIDER ENROLLMENT PORTAL
We have received an influx of applications since the COVID-19 Vaccine Management System (CVMS) Provider Enrollment Portal opened to providers on January 11, 2021 and thank you for your enthusiasm around COVID-19 vaccine administration. Given the number of applicants, we want to provide insight into how providers are currently being approved for enrollment.
Please understand that while qualified providers are welcome to enroll, applications will be reviewed in an order aligned with the prioritization phases, and the timeline for approval will vary. The table below highlights the six prioritization groups as well as target timing for enrollment decisions.
Provider Type |
Target Approval Timing |
(1) Hospitals, Health Systems, LHDs |
November / December |
(2) FQHCs, LTC Pharmacies, LHD Identified Partners, Correction Health, Mass Vaccinators |
December / January |
(3) Family Medicine/Internal Medicine, Medical Directors SNF, Occupational Health |
January / February |
(4) Retail Pharmacy, Pediatric Primary Care, Independent Practice Specialty |
February / March |
(5) Other Providers (e.g. Dental, Optometry) |
TBD pending executive authorization to administer COVID-19 vaccines |
(6) Other Entities (e.g. Labs, Colleges, Universities) |
TBD |
We ask for your patience as we review the thousands of provider applications. Please also remember that provider enrollment approval does not guarantee vaccine allocation. We will update you as we receive more information on the timing and prioritization of enrollment applications.
Thank you for your continued support,
NC Immunization Branch
MONDAY, JANUARY 11, 2021
From the NC Department of Health and Human Services:
We are writing to inform you that starting today (1/11/21), North Carolina’s COVID-19 Vaccine Management System (CVMS) Provider Enrollment Portal is open. Please share this message with any providers you are aware are eligible and interested in administering the COVID-19 vaccine.
Any provider enrolling through the portal will be reviewed and considered for approval by the NC Immunization Branch to administer the COVID-19 vaccine. Enrollment can be initiated here: https://covid-enroll.ncdhhs.gov/s/login/?ec=302&startURL=%2Fs%2F.
As a reminder, COVID-19 vaccine providers must be qualified under the CDC agreement to prescribe COVID-19 vaccines and authorized under the appropriate NC licensing authority. Enrolled COVID-19 vaccine providers must be credentialed/licensed in North Carolina. Please understand that while currently qualified providers are welcome to enroll, requests will be addressed in an order aligned with the prioritization phases and the timeline for approval will vary. The State will continuously reassess enrollment prioritization based on needs.
Please visit the North Carolina Immunization Branch COVID-19 training website for Provider Enrollment Portal training content: https://immunize.nc.gov/providers/covid-19training.htm. The available modules are captured in the screenshot below.
Additional trainings related to CVMS can also be found on https://immunize.nc.gov/providers/covid-19training.htm. Please note, any trainings you elect to review at this time are subject to be refreshed by the time you become an approved provider. You may need to revisit trainings depending on approval timelines.Thank you for your continued support,
NC Immunization Branch
3) COVID-19 VACCINATION TRAINING OPPORTUNITIES FOR PHARMACISTS AND TECHNICIANS
Free Monoclonal Antibody Assessment & Administration CE. APhA has released a new and free training program to help meet the 9th Amendment of the PREP Act requirements! Coupled with the APhA Immunization Certificate, these activities meet the requirements of all PREP Act amendments thus far to order and administer COVID-19 Immunizations and Therapeutics.
The training program covers the clinical evaluation of indications and contraindications of COVID-19 therapeutics, adverse events, and the specifics related to the FDA approval, authorization, clearance, or licensing of COVID-19 therapeutics. You can find the training here: COVID-19 Monoclonal Antibody Assessment & Administration.
****************************************
COVID-19 Vaccination in North Carolina Parts 1 and 2 on-demand videos are now available on our website https://cmetracker.net/CAMPBELL/Catalog
Follow the instructions provided at registration to view the videos. Be sure to record the activity code and claim credit at the following link.
HOW TO CLAIM CE CREDIT:
The activity code to claim credit is provided at the end of the presentation. Record the code and sign in here: https://cmetracker.net/CAMPBELL/Catalog
Credit Instructions: https://cmetracker.net/CAMPBELL/Files/EventMaterials/3239.pdf
Slides: https://cmetracker.net/CAMPBELL/Files/EventMaterials/3211.pdfContact: Samantha Clinton, CPhT, CQEP, HMCC
Assistant Director of Continuing Professional Education
Campbell University College of Pharmacy & Health Sciences
910.814.4784 | clintons@campbell.edu
Description: This two-part continuing pharmacy education course has been developed in partnership with the North Carolina Board of Pharmacy to provide education and guidance for pharmacists and pharmacy technicians on the novel COVID-19 virus, COVID- 19 vaccines in development and currently available, COVID-19 vaccine distribution plans in North Carolina, vaccine administration strategy, and federal and state regulatory issues governing pharmacist, pharmacy intern, and pharmacy technician administration of COVID-19 vaccines.
*************************************
4) OTHER VACCINE RELATED TOPICS AND RESOURCES FOR PRACTITIONERS
WEDNESDAY, SEPTEMBER 15, 2021
FDA, CDC, AND NC DHHS CONTINUE TO WARN AGAINST THE USE OF IVERMECTIN FOR PREVENTION OR TREATMENT OF COVID-19. Pharmacists have reported receiving increased numbers of prescriptions for ivermectin, as well as hostile and abusive communications concerning the same from some prescribers and patients.
The United States Food and Drug Administration has re-emphasized that ivermectin is not approved for the treatment or prevention of COVID-19. It is approved for the treatment of intestinal conditions caused by certain parasitic worms and, in topical formulation, certain external parasites. Veterinary formulations are approved to treat certain internal and external parasites – but not to treat any condition in humans. FDA emphasizes that taking large doses of ivermectin is dangerous. And no reliable studies support the safety or efficacy of ivermectin in the treatment or prevention of COVID-19. More information from FDA is found here: https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19.
The United States Centers for Disease Control issued an alert on August 26, 2021 noting a sharp rise in serious illness associated with ingestion of ivermectin products (human and veterinary) for purported treatment or prevention of COVID-19. Severe gastrointestinal and neurotoxic effects are being reported. Like the FDA, the CDC emphasizes that ivermectin is not approved for the treatment or prevention of COVID-19, no reliable studies support its use in the treatment or prevention of COVID-19, and improper use is dangerous. More information from CDC is found here: https://emergency.cdc.gov/han/2021/han00449.asp.
State Health Director Betsey Tilson has also issued a warning in light of spike in prescriptions, poison control calls, and emergency room visits. Dr. Tilson likewise reminds health care practitioners that ivermectin is neither approved nor authorized by FDA to treat or prevent COVID-19 – and that is not a substitute for COVID-19 vaccine or approved treatments for the disease. Dr. Tilson asks that all providers educate patients about the dangers of using ivermectin: http://www.ncbop.org/PDF/COVID19NCDHHSIvermectinRisksSept2021.pdf.
The North Carolina Medical Board has communicated these warnings to its licensees: https://www.ncmedboard.org/resources-information/professional-resources/publications/forum-newsletter/notice/cdc-warns-against-inappropriate-ivermectin-use. And the Federation of State Medical Boards has warned physicians that spreading COVID-19 misinformation risk disciplinary action by state medical boards, including suspension or revocation of license. https://www.fsmb.org/advocacy/news-releases/fsmb-spreading-covid-19-vaccine-misinformation-may-put-medical-license-at-risk/
Pharmacists are reminded that they have a right to refuse to fill or refill any prescription order if doing so would be contrary to their professional judgment. Moreover, a pharmacist shall not fill or refill a prescription order if, in the exercise of the pharmacist’s professional judgement, there is a question as to its safety for the patient. 21 NCAC 46.1801. As well, pharmacists have an obligation to engage in neither negligent nor unprofessional conduct in the practice of pharmacy. G.S. 90-85.38(a)(9) and (a)(10).
WEDNESDAY, JANUARY 27, 2021
PHARMACY TECHNICIANS QUALIFIED TO ADMINISTER VACCINES UNDER THE FEDERAL PREP ACT SHOULD UPDATE THEIR STATUS THROUGH THE BOARD’S LICENSING PORTAL. The U.S. Department of Health and Human Services has issued a declaration under the PREP Act authorizing qualified pharmacy technicians to administer ACIP-recommended pediatric vaccines and COVID-19 vaccines under the supervision of a qualified pharmacist: http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf Technicians who have completed the required training to administer vaccines under this declaration should log on to their profile through the Board’s Licensing Portal and update their status as vaccinators.
Once logged in to the technician’s profile, click on the “Pharmacy Technician” tile, then a “Vaccinator” tile will appear on the next page. A technician now qualified to administer vaccines should hover over that tile, note the attestation, and then click to turn the tile green and indicate vaccinator status.
Click on the Pharmacy Technician tile:
Then, click on the vaccinator tile to indicate a technician is vaccinating:
WEDNESDAY, NOVEMBER 18, 2020
IMMUNIZING PHARMACIST CONTINUING EDUCATION REQUIREMENTS UNDER THE US DHHS PREP ACT DECLARATION VERSUS REQUIREMENTS UNDER NORTH CAROLINA LAW. As pharmacists know, the US DHHS has issued declarations under the PREP Act authorizing pharmacists to order and administer ACIP-recommended pediatric vaccines and COVID vaccines: http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf; http://www.ncbop.org/PDF/PREPActCOVIDVaccination090920.pdf
Board staff have received questions about the immunizing pharmacist CE requirements under the federal authorization versus CE requirements under North Carolina law. Under the PREP Act declaration, the licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period (annually in North Carolina). This CE requirement differs somewhat from North Carolina law. North Carolina law requires an immunizing pharmacist to maintain “documentation of three hours of continuing education every two years, designed to maintain competency in the disease states, drugs, and vaccine administration.” G.S. §90-85.3(i1)(3). Any pharmacist exercising authority granted under the PREP Act must slightly increase his/her immunization-related CE and acquire two (2) hours in 2020 and two (2) hours in 2021 (assuming, as is likely, that the federally-declared COVID-19 public health emergency remains in effect into 2021).
More information about this requirement, and several others, is found in the two guidance documents linked above.
MONDAY, OCTOBER 12, 2020
PHARMACISTS UPDATING THEIR IMMUNIZER STATUS. Many Pharmacists are updating their immunizer status in order to administer vaccines.
Note: A pharmacist who completed an immunization certification course, but has not been administering vaccines does not need to retake the course. The immunizing pharmacist must have a current provider-level CPR certification prior to administering vaccines, must begin obtaining required biennial immunization-specific CE, and must obtain training to participate in North Carolina Immunization Registry as required by the immunizing pharmacist statute.
Here’s how to update the Board that you are a certified vaccinator:
- Log in on the Licensure Gateway page with your username and password
- Once logged in, scroll to the bottom of the page and click on the Pharmacist tile
- On the next page, under License Options, there is a tile for Vaccinator. If it’s white, then that means we don’t have you listed as a vaccinator in our database. If it’s green, then we do have you listed as a vaccinator. To change the color of the box, click on it.
