COVID-19 VACCINATION / THERAPEUTIC INFORMATION
1) VACCINE ADMINISTRATION AUTHORIZATION
THURSDAY, SEPTEMBER 23, 2021
FDA AMENDS PFIZER COVID-19 BOOSTER SHOT EMERGENCY USE AUTHORIZATION. On September 22, 2021, FDA amended its Pfizer COVID-19 booster shot emergency use authorization to allow for a single booster dose, administered at least six months after the primary series, in: (1) patients age 65 or older; (2) patients age 18 to 64 at high risk of severe COVID-19; and (3) patients age 18 to 64 whose frequent institutional or occupational exposure to the SARS-CoV-2 virus puts them at high risk of serious complications of COVID-19 (including severe COVID-19 disease). More information here: https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations?utm_medium=email&utm_source=govdelivery.
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.
THURSDAY, AUGUST 19, 2021
*UPDATE* STATE HEALTH DIRECTOR BETSEY TILSON PROVIDES ADDITIONAL GUIDANCE ON OPERATIONALIZING ADMINISTRATION OF THIRD DOSES OF THE PFIZER AND MODERNA COVID-19 VACCINES TO CERTAIN IMMUNOCOMPROMISED PATIENTS. Building on guidance issued Monday, August 16, 2021, State Health Director Betsey Tilson has issued more guidance on third COVID-19 vaccine dose administration. This guidance includes an updated standing order, as well as instructions for documenting third doses in the CVMS system.
Additional Dose for people with moderate to severe immunocompromise.
An additional dose of a vaccine is administered when the immune response following a primary vaccine series is likely to be insufficient. An additional mRNA COVID-19 vaccine dose has already been authorized by the FDA and recommended by the CDC for moderately to severely immunocompromised people after an initial 2-dose primary mRNA vaccine series. You may administer an additional dose to patients who self-attest to being moderately to severely immunocompromised. Providers can reference vaccineinfo communications from August 17 for detailed operational guidance.
Updated Standing Order
The Statewide Standing Order for FDA Authorized Pfizer and Moderna COVID-19 Vaccine Administration has been updated to reflect the approval of additional doses of COVID-19 vaccine for moderately and severely immunocompromised people. You can view this order on the NCDHHS website’s Guidance section as linked below:
- Statewide Standing Order for FDA Authorized Pfizer and Moderna COVID-19 Vaccine Administration (August 16, 2021)
Patient may self-attest to their moderately or severely immunocompromised status. This should be documented by providers within CVMS or their system of record.
- Providers can utilize the free-form “Notes” field on the Vaccine Administration page in CVMS when administering the vaccine or a comparable section in an alternative system of record being used.
To document an ADDITIONAL DOSE in the COVID-19 Vaccine Management System (CVMS):
- Connect to the Provider Portal at https://covid-vaccine-provider-portal.ncdhhs.gov
- Click on NCID and enter your username and password
- From the HOME tab, search for the recipient in the APPOINTMENT WALK-IN TOOL (note that an ADDITIONAL DOSE cannot be scheduled using the CVMS Scheduling feature)
- Select the appropriate recipient, and click the APPOINTMENT BOOKING button
- Click the recipient’s name under TODAY’S APPOINTMENTS on the Home Tab
- Document the vaccine administration details, and select the ADDITIONAL DOSE button to indicate the dose (note that doses that have already been logged will appear grayed out)
- Complete the documentation of the vaccine administration
Booster Shots Anticipated for General Population
A booster dose is administered when the initial sufficient immune response to a primary vaccine series is likely to have waned over time or the circulating variants. The White House announced today that planning is underway to support booster shots for the general population who received the Pfizer or Moderna vaccines. Boosters will be available pending authorization by the Food and Drug Administration (FDA) and recommendations from the Centers for Disease Control and Prevention (CDC). NCDHHS is preparing for boosters and will be ready once given the go-ahead from the FDA and CDC. No booster doses are authorized or recommended at this time, until further guidance is provided by the FDA and CDC.
Please see the full statement from US HHS, indicating preparation to offer booster shots for the general population beginning potentially as early as the week of September 20 and likely starting eight months after an individual’s second dose pending FDA authorization and CDC recommendations.
Why COVID-19 Vaccine Booster Shots?
The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Although we continue to see stable and highly effective protection against hospitalizations and severe outcomes for people who are fully vaccinated, we are seeing a decrease in vaccine effectiveness against infection.
The CDC released three Morbidity and Mortality Weekly Reports (MMWR) today that reinforced the high level of stable protection and vaccine effectiveness against hospitalization, but did show a decreased vaccine effectiveness preventing infection.Those reports are available on the CDC’s website: https://www.cdc.gov/mmwr/index.html.
We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. Only after a thorough review of the evidence will CDC’s independent advisory committee make recommendations on the use of boosters for the public.
MONDAY, AUGUST 16, 2021
STATE HEALTH DIRECTOR BETSEY TILSON PROVIDES GUIDANCE ON ADMINISTRATION OF THIRD DOSES OF THE PFIZER AND MODERNA COVID-19 VACCINES TO CERTAIN IMMUNOCOMPROMISED PATIENTS.
On August 12, 2021 FDA modified the Emergency Use Authorizations (EUAs) for Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine to allow for administration of an additional dose (i.e., a third dose) of an mRNA COVID-19 vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series for certain immunocompromised people (i.e., people who have undergone solid organ transplantation or have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise). The age groups authorized to receive the additional dose are unchanged from those authorized to receive the primary vaccination series:
- Pfizer-BioNTech: aged ≥12 years
- Moderna: aged ≥18 years
On August 13, 2021, ACIP met and reviewed the data for use of an additional dose of mRNA COVID-19 vaccine for immunocompromised people within the Evidence to Recommendation Framework. ACIP made an interim recommendation for use of an additional dose of Pfizer-BioNTech COVID-19 vaccine (for persons aged ≥12 years) or Moderna COVID-19 vaccine (for persons aged ≥18 years) after an initial 2-dose primary mRNA COVID-19 vaccine series for moderately to severely immunocompromised people. Following the ACIP meeting, the CDC endorsed the use of an additional dose of mRNA COVID-19 vaccine to people with moderate to severely compromised immune systems after an initial two-dose vaccine series.
Vaccine providers may begin administering an additional dose of mRNA COVID-19 vaccine to people with moderate to severely compromised immune systems after an initial two-dose vaccine series.
Healthcare professionals and public health officials should consider the following for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series for moderately to severely immunocompromised people:
- The currently FDA-authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered to immunocompromised people.
- Studies indicate some immunocompromised people have a reduced immune response following a primary COVID-19 vaccine series compared to vaccine recipients who are not immunocompromised.
- Studies have further demonstrated that including an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series in some immunocompromised populations may enhance immune response.
- The clinical benefit of an additional mRNA vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series for immunocompromised people is not precisely known. However, for people with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments, the potential to increase immune response coupled with an acceptable safety profile, support the recommendation for an additional mRNA vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series.
- The additional dose should be administered at least 28 days after the completion of the initial mRNA COVID-19 vaccine series.
- The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses.
Conditions and treatments associated with moderate and severe immune compromise include but are not limited to:
- Active treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ transplant and taking immunosuppressive therapy
- Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
- Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
Patient may self-attest to their medical condition. More details on that process is forthcoming. An updated Standing Order is also forthcoming.
The clinical considerations for use of an additional dose of an mRNA COVID-19 vaccine apply only to people who are moderately or severely immunocompromised.
Currently there are insufficient data to support the use of an additional mRNA COVID-19 vaccine dose after a single-dose Janssen COVID-19 vaccination series in immunocompromised people. FDA and CDC are actively working to provide guidance on this issue.
Please see the updated Interim Clinical Considerations for use of COVID-19 Vaccines Currently Authorized in the United States for more details.
Other resources and links:
Pfizer Health Care Provider Fact Sheet
Pfizer Fact Sheet for Recipients
WEDNESDAY, MAY 19, 2021
REVISED GUIDANCE FOR COVID-19 VACCINE PROVIDERS AND UPDATED STANDING ORDERS FROM THE STATE HEALTH DIRECTOR. The Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) revised their clinical recommendations yesterday and North Carolina's State Health Director has updated the Standing Orders for both the Pfizer/Moderna and Johnson and Johnson COVID-19 vaccines.
Updated Standing Orders:
Johnson and Johnson: https://covid19.ncdhhs.gov/media/2250/open
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 or directly linked here:
- Statewide Standing Order for FDA Authorized Pfizer and Moderna COVID-19 Vaccine Administration
- Statewide Standing Order for FDA Authorized Johnson and Johnson (Janssen) COVID-19 Vaccine Administration
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.
THURSDAY, FEBRUARY 25, 2021
STATE HEALTH DIRECTOR TILSON ISSUES REVISED STANDING ORDER FOR COVID-19 VACCINE ADMINISTRATION. State Health Director Betsey Tilson has issued a revised state standing order for COVID-19 vaccine administration. The revised order (found here: https://files.nc.gov/covid/documents/guidance/vaccinations/Statewide-COVID-19-Vaccine-Standing-Order.pdf) specifically includes “covered person[s] under the federal PREP Act” who are functioning as vaccinators. Accordingly, pharmacists exercising authority conferred by US DHHS PREP Act declarations may use the state standing order to administer COVID-19 vaccines. And pharmacists may supervise PREP Act-authorized qualified pharmacy technicians administering COVID-19 vaccines when using the state standing order. Board of Pharmacy staff are grateful to NC DHHS staff for issuing this revised standing order, which clarifies and simplifies COVID-19 vaccine administration authority.
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.
TUESDAY, DECEMBER 29, 2020
STATE HEALTH DIRECTOR SIGNS STANDING ORDER AUTHORIZING IMMUNIZING PHARMACISTS IN NC TO ADMINISTER COVID-19 VACCINES. North Carolina State Health Director, Dr. Elizabeth Tilson, signed a standing order authorizing immunizing pharmacists in NC to administer the COVID-19 vaccines in order to reduce the morbidity and mortality of COVID-19. This standing order authorizes pharmacists licensed by the North Carolina Board of Pharmacy and practicing in North Carolina to administer FDA-authorized or FDA-licensed COVID-19 vaccines to eligible recipients. The standing order spells out the eligible recipients, proper procedure, and reporting requirements: http://www.ncbop.org/pdf/COVID19StatewideStandingImmunizingPharmacists12_27_20signed.pdf.
Immunizing pharmacists must meet the qualifications listed in N.C.G.S. 90-85.3:
-completion of an immunization certification course
-current provider-level CPR
-immunization specific continuing education
-training on how to participate in the North Carolina Immunization Registry
- NC Pharmacy COVID-19 Vaccine Protocol
- A screening questionnaire / PreVaccination checklist to be used by immunizing pharmacists in North Carolina who administer the COVID-19 vaccines.
This statewide standing order is state law, and it is an authorization for pharmacists to administer the COVID-19 vaccines in addition to the Federal DHHS’ Declarations under the PREP ACT authorizing administration of COVID-19 vaccines by pharmacists, pharmacy technicians, and pharmacy student interns. http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf.
TUESDAY, DECEMBER 8, 2020
SUPERVISION OF PHARMACY INTERNS AND QUALIFIED PHARMACY TECHNICIANS ADMINISTERING VACCINES OR ASSISTING WITH VACCINATION EFFORTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. As pharmacists know, under North Carolina law pharmacy interns may administer vaccines under the supervision of a pharmacist. 21 NCAC 46. 2507. Under the United States Department of Health and Human Services’ PREP Act declarations, pharmacy interns and qualified pharmacy technicians may administer vaccines under the supervision of a pharmacist. http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf; http://www.ncbop.org/PDF/PREPActCOVIDVaccination090920.pdf; http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf.
Board staff have received a number of inquiries concerning what constitutes proper supervision of a pharmacy intern or qualified pharmacy technician who is administering vaccines or otherwise assisting with a vaccination effort. To facilitate the safe, rapid deployment of pharmacy personnel to administer vaccines during the COVID-19 public health emergency, the Board’s Executive Director has exercised authority delegated to him in the Board’s Emergency Services Waiver to waive enforcement of Rule .2507’s requirement that supervision be “direct [and] in-person,” and that the supervision be provided only by a pharmacist. However, pharmacy interns and qualified pharmacy technicians must be supervised by a pharmacist or certain other health care providers who are present at the same facility and available to assist, and ultimate supervision must be provided by a pharmacist who is responsible for the administration.
Accordingly, a waiver is granted as follows: Supervision of a pharmacy intern or qualified pharmacy technician who is administering vaccines or otherwise assisting with a vaccination effort shall be deemed adequate if either: (a) a supervising pharmacist is on site and readily available to assist as needed; or (b) another licensed health care provider authorized to administer vaccines is on site and readily available to assist as needed, and a supervising pharmacist is readily available by phone or other telecommunications method for consultation as needed.
The decision whether and how to implement a supervision alternative described above lies with the responsible pharmacist-manager.
WEDNESDAY, NOVEMBER 18, 2020
QUALIFIED PHARMACY TECHNICIANS MAY ADMINISTER ACIP-RECOMMENDED PEDIATRIC VACCINES AND COVID-19 VACCINES UNDER PHARMACIST SUPERVISION REGARDLESS OF WHO ORDERED THE VACCINE. Pharmacists are aware that US DHHS 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.
Board staff have been asked whether, under the PREP Act declaration, a qualified pharmacy technician may only administer a vaccine that a qualified pharmacist has ordered. The answer is no. The PREP Act declaration permits a qualified pharmacy technician to administer these vaccines under the supervision of a qualified pharmacist. The authority is not conditioned on the identity of the health care provider who ordered or prescribed the vaccine. So long as a valid order for the vaccine exists – by way of pharmacist order, physician order, state-authorized standing order, or other legal order – and the qualified technician is supervised by a pharmacist, the technician may administer the vaccine.
More information about technician authority to administer these vaccines is found in the guidance document linked above.
THURSDAY, OCTOBER 22, 2020
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES DECLARATION UNDER PUBLIC READINESS AND EMERGENCY PREPAREDNESS ("PREP") ACT AUTHORIZING QUALIFIED PHARMACY TECHNICIANS TO ADMINISTER ACIP-RECOMMENDED VACCINES TO PEDIATRIC PATIENTS AND FDA-APPROVED COVID-19 VACCINES TO PATIENTS AGED THREE YEARS AND OLDER DURING THE PUBLIC HEALTH EMERGENCY. On October 21, 2020, USDHHS issued another declaration under the PREP Act authorizing “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 under the supervision of a qualified pharmacist. (https://www.hhs.gov/sites/default/files/prep-act-guidance.pdf) Note: This declaration also clarified the ability of qualified pharmacy interns to administer such vaccines, but, for purposes of North Carolina, those clarifications do not change pharmacy intern administration authority as discussed in the two Board guidance documents linked above. Board of Pharmacy guidance on implementing this declaration here: http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf.
For prior guidance on implementing USDHHS declarations authorizing pharmacists to order and administer ACIP-recommended pediatric vaccines and COVID-19 vaccines see there -- http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf -- and here --
WEDNESDAY, AUGUST 26, 2020
PHARMACISTS EXERCISING U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES-GRANTED AUTHORITY TO ORDER AND ADMINISTER PEDIATRIC VACCINES. As detailed in the August 20, 2020 Board of Pharmacy update, the U.S. Department of Health and Human Services issued a declaration under the PREP Act authorizing pharmacists to order and administer certain vaccines to patients ages three (3) to eighteen (18). More detail about that grant of authority and its intersection with North Carolina law is found here: http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf. Some pharmacists have asked, when ordering and administering vaccines under this grant of authority, who the documented prescriber should be. The answer is the pharmacist exercising this authority. Again, HHS authorized pharmacists to order and administer these vaccines, notwithstanding any state law to the contrary.
THURSDAY, AUGUST 20, 2020
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES DECLARATION UNDER PUBLIC READINESS AND EMERGENCY PREPAREDNESS ("PREP") ACT AUTHORIZING PHARMACISTS TO ORDER AND ADMINISTER VACCINES TO PATIENTS AGED THREE THROUGH 18 YEARS DURING THE COVID-19 HEALTH EMERGENCY. On August 19, 2020 the U.S. Department of Health and Human Services issued a declaration (https://www.hhs.gov/sites/default/files/third-amendment-declaration.pdf) authorizing pharmacists "to order and administer," and a “supervised pharmacy intern” “to administer” certain vaccines to patients ages three (3) to eighteen (18) during the federally-declared COVID-19 public health emergency. The purpose of this declaration is to mitigate a potential “decrease in rates of routine childhood vaccinations . . . due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.” This update describes the conditions under which pharmacists and pharmacy interns may exercise that authority, and how these conditions differ from existing North Carolina law: http://www.ncbop.org/PDF/COVID19PREPActVaccinationAug2020.pdf.
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.
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)
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
UPDATE SATURDAY, JANUARY 9, 2021 - CVMS OFFICE HOURS SCHEDULED DAILY. SEE BELOW FOR TIMES.
TRAINING ON USE OF THE COVID-19 VACCINE MANAGEMENT SYSTEM (CVMS). As further detailed in State Health Director Betsey Tilson’s standing order for pharmacist administration of COVID-19 vaccines -- http://www.ncbop.org/PDF/COVID19VaccineNCPharmacyProtocol122720.pdf -- after administration of a COVID-19 vaccine, the pharmacy must “record COVID-19 vaccination in the pharmacy record within 24 hours and record all required data elements in the COVID-19 Vaccine Management System.” NC DHHS has announced training sessions on CVMS use and office hours for questions:
Training Session Descriptions:
CVMS Office Hours
Description: Open hours to support CVMS. Subjects that can be covered:
- How to log in
- How to finalize enrollment
- How to onboard users to the CVMS Provider Portal
- How to receive inventory
- How to log a vaccine administration in the system
- How to upload a list of recipients
- How to register a recipient on their behalf
COVID-19 Vaccination Office Hours are scheduled and available for you to attend on Monday - Friday from 7:30AM – 5:00PM ET and Saturday and Sunday from 10:00AM – 12:00PM ET.
Dr. Amanda Fuller Moore will kick off the office hour session each weekday morning from 7:30-8:10AM ET. For general CVMS questions, the line will remain open weekdays until 5:00PM ET.
The purpose of the office hours is to give you the opportunity to ask questions on an open line with live help. You can join the office hours via Microsoft Teams or via the dial in provided below any time during the day.
Microsoft Teams Link
Microsoft Teams Dial In
Monday - Friday
7:30AM – 5:00PM ET
United States, Raleigh
Phone Conference ID: 871 816 988#
Saturday - Sunday
10:00AM – 12:00PM ET
United States, Raleigh
Phone Conference ID: 630 426 885#
3) COVID-19 VACCINATION TRAINING OPPORTUNITIES FOR PHARMACISTS AND TECHNICIANS
10/20/2021 – APhA/WSU PHARMACY-BASED IMMUNIZATION ADMINISTRATION BY PHARMACY TECHNICIANS
October 20, 2021
12:00 PM - 4:00 PM
ACPE Knowledge-based-Contact - 4.00
ACPE Knowledge-based-Non Contact - 2.00
Hosted by: Campbell University College of Pharmacy & Health Services in partnership with the North Carolina Association of Pharmacists (NCAP).
This training is for pharmacy technicians only. The live session will be in person at Campbell University.
Follow this link for details and to register: https://cmetracker.net/CAMPBELL/Publisher?page=pubOpen&nc=9714786513#/.
10/23/2021 – APhA PHARMACY-BASED IMMUNIZATION CERTIFICATE
October 23, 2021
In Person (at UNC Eshelman School of Pharmacy) and Online
ACPE Knowledge based contact: 20.0
This includes a 12 hour self-study, 6 hour live session with hands on injection assessment.
Follow this link for details and to register: https://pharmacy-ncu.learningexpressce.com/index.cfm
10/23/2021 – PHARMACY TECHNICIANS AND VACCINATIONS: AN ADVANCED TRAINING PROGRAM
October 23, 2021
In Person (at UNC Eshelman School of Pharmacy) and Online
ACPE Knowledge based contact: 4.5
This program includes a 1.5 hour home study, 3 hour live session with hands on injection assessment. This program meets PREP Acts standards for Pharmacy Technicians to provide approved vaccinations once completed.
Follow this link for details and to register: https://pharmacy-ncu.learningexpressce.com/index.cfm
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
Contact: Samantha Clinton, CPhT, CQEP, HMCC
Assistant Director of Continuing Professional Education
Campbell University College of Pharmacy & Health Sciences
910.814.4784 | email@example.com
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, 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:
MONDAY, JANUARY 4, 2021
NC DIVISION OF PUBLIC HEALTH SEEKING HELP WITH VACCINE COORDINATION. The North Carolina Division of Public Health has reached out to the Board of Pharmacy and is asking for personnel to help assist the Local Health Departments across North Carolina as they begin offering vaccinations to their community. Many of these Local Health Departments have well organized plans that they are preparing to execute in order to vaccinate their community while also continuing their critical daily duties and support ongoing COVID-19 pandemic responsibilities like contact tracing and outbreak identification.
NC pharmacists interested in an opportunity to volunteer and help North Carolinians protect themselves from COVID-19 should complete the survey below from North Carolina Division of Public Health. Their staffing team will reach out to you to match your willingness to serve with the Local Health Departments requesting assistance. This effort will be coordinated by state employees so please continue to monitor your e-mail for follow-up coordination from someone who will have an e-mail address (firstname.lastname)@dhhs.nc.gov .
Please complete this brief survey to indicate your availability/interest in helping—all data goes to North Carolina Division of Public Health staff and is not shared publicly: https://nc.readyop.com/fs/4d5I/ddb4
Questions, please contact:
Christine Mullarkey Campbell
Emergency Management Planner
Division of Public Health, Public Health Preparedness and Response
North Carolina Department of Health and Human Services
For additional information about North Carolina’s COVID-19 Vaccination Efforts, please follow this link.
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.