Board News and Announcements
NC BOARD OF PHARMACY STAFF HAVE CONSOLIDATED AND ORGANIZED BY TOPIC ALL COVID-19 UPDATES AS FOLLOWS:
THURSDAY, OCTOBER 21, 2021
The next National Prescription Drug Take Back Day is this Saturday, October 23. Follow this link for details and to locate a collection site near you: https://takebackday.dea.gov/.
TUESDAY, OCTOBER 19, 2021
CANDIDATES FOR THE BOARD'S WESTERN AND NORTHERN DISTRICT SEATS. The next Board of Pharmacy election is scheduled to begin November 1, 2021 and North Carolina pharmacists will vote to fill two positions.
Three pharmacists from the Western District submitted petitions to appear on the ballot:
Four pharmacists from the Northern District submitted petitions to appear on the ballot:
Read more about the seven candidates ahead of the November 1 election by clicking on the links below:
Voting coincides with the license renewal period and will run from November 1, 2021 through March 1, 2022. All pharmacists actively licensed and living in North Carolina at the start of the election will be eligible to vote. The winners of this election will begin their terms on May 1, 2022.
WEDNESDAY, OCTOBER 13, 2021
FDA WITHDRAWS TEMPORARY GUIDANCE FOR ALCOHOL-BASED HAND SANITIZERS. On October 12, the Food and Drug Administration announced that it intends to withdraw, effective Dec. 31, 2021, guidances originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency. Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements. Manufacturers who no longer plan to produce these products are able to deregister by following the instructions on the Electronic Drug Registration and Listing Instructions page. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances must no longer be sold to wholesalers or retailers by March 31, 2022. More information available here: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers.
THURSDAY, OCTOBER 7, 2021
FDA ISSUES REVISED DRAFT GUIDANCE ON HOSPITAL AND HEALTH SYSTEM COMPOUNDING. On October 6, 2021, the FDA issued a revised draft compounding guidance document for hospitals and health systems. This latest draft follows commentary received on a 2016 draft guidance on the same topic, specifically concerning hospital and health system distribution of compounded human drug product among commonly owned facilities. A fuller statement, and a link to the latest draft guidance is found here: https://www.fda.gov/news-events/press-announcements/fda-revises-hospital-and-health-system-compounding-guidance-help-preserve-patient-access-compounded. Instructions for submitting comments to FDA are included in the linked draft guidance document.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED OCTOBER 15, 2021.)
FRIDAY, OCTOBER 1, 2021
UPDATED GUIDANCE TO PHARMACIST ADMINISTRATION OF LONG-ACTING INJECTABLES. The North Carolina General Assembly has passed, and Governor Cooper has signed into law, legislation that authorizes qualified immunizing pharmacists to administer long-acting injectable medications to patients age 18 and older pursuant to prescription. This new authority becomes effective on October 1, 2021. Board staff has prepared a guidance document that summarizes the new authority and how pharmacists may exercise it: http://www.ncbop.org/PDF/LAIAdministrationGuidance.pdf.
FRIDAY, OCTOBER 1, 2021
The NC Board of Pharmacy has an opening for an Inspector/Investigator. The available position is in Central North Carolina covering the counties of: Alamance, Chatham, Durham, Guilford, Lee, Moore, Orange, Randolph, Rockingham, and Western Wake. It is recommended that applicants live within the area in which they will be working.
The salary range for this position is $45,000 - $55,000 annually.
All applicants should submit a cover letter of interest along with a resume to Rhonda Jones, Director of Finance and Human Resources, firstname.lastname@example.org.
FRIDAY, SEPTEMBER 24, 2021
PHARMACIST ADMINISTRATION OF BOOSTER PFIZER COVID-19 VACCINE DOSES. FDA has updated the Pfizer-BioNTEch’s COVID-19 third-dose EUA to allow a single booster dose, administered at least six months after the primary series, for certain patients: https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations.
Yesterday, CDC’s Advisory Committee on Immunization Practices (ACIP) and the CDC Director recommended (https://www.cdc.gov/media/releases/2021/p0924-booster-recommendations-.html) as follows:
• People 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer- BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series;
• People aged 50 to 64 with certain underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series;
• People 18 to 49 who are at high risk for severe COVID-19 due to certain underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks; and
• People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.
Pharmacists may exercise authority to administer booster doses to these populations under any of the following:
- State standing order. State Health Director Tilson has updated the state standing order to incorporate Pfizer-BioNTech booster dosing: https://covid19.ncdhhs.gov/media/1517/download. NC DHHS overall guidance for vaccine providers is found here: https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.
- PREP Act Declarations. PREP Act declarations authorize pharmacists to order and administer – and qualified pharmacy technicians to administer – COVID-19 vaccinations: http://www.ncbop.org/PDF/PREPActCOVIDVaccination090920.pdf ; http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf. Pharmacists may administer booster doses to the CDC-recommended populations above under these declarations. (Some pharmacists have noted that ACIP’s recommendation was more narrow than CDC’s final guidance. No matter. CDC has confirmed that the final guidance should be treated as the ACIP recommendation for PREP Act declaration purposes.)
- Pharmacy Practice Act. Effective September 1, 2021, amendments to the Pharmacy Practice Act granted immunizing pharmacists authority to administer a “COVID-19 vaccine approved by” or “authorized under an emergency use authorization by” the FDA. For more detail, see this guidance document: http://www.ncbop.org/PDF/SL2021110GuidanceAug2021.pdf. Immunizing pharmacists using the protocol aspect of this authority must consult with their supervising physician(s) and make any needed adjustments to their protocol to cover COVID-19 vaccines. And immunizing pharmacists may administer a Pfizer-BioNTech booster (and, of course, primary COVID-19 vaccine sequences) pursuant to prescription.
Immunizing pharmacists should monitor CDC’s booster guidance page for updates: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html. ACIP will continue to meet to evaluate new data and may recommend booster shots for other populations and vaccine recipients soon. CDC and ACIP continue to emphasize that the populations most vulnerable to COVID-19 are those who are unvaccinated, and the nation’s priority should remain getting everyone fully vaccinated with their primary series.
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, SEPTEMBER 15, 2021
FDA AND CDC ISSUE WARNINGS REGARDING THE PROLIFIERATION OF DELTA 8 THC PRODUCTS. Pharmacists should be aware that on September 14, 2021, the FDA issued a consumer alert warning that delta-8 THC products have not been evaluated or approved by the FDA for any use. The FDA is particularly concerned by the proliferation of such products and their marketing for therapeutic or medical uses – which marketing and promotion is a violation of the federal Food, Drug & Cosmetic Act. FDA has also received a number of adverse event reports involving delta-8 THC products, including hallucinations and loss of consciousness. FDA also notes that the manufacturing processes for delta-8 THC products involve the use of unsafe household chemicals and may have harmful by-products as a result: https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc?utm_medium=email&utm_source=govdelivery
The CDC has likewise issued a health advisory alert to healthcare professionals emphasizing the same troubling developments: https://emergency.cdc.gov/han/2021/han00451.asp.
Pharmacists are urged to pay close attention to these warnings, and are reminded of their obligation to engage in neither negligent nor unprofessional conduct in the practice of pharmacy. G.S. 90-85.38(a)(9) and (a)(10).
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.
SUNDAY, AUGUST 22, 2021
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.
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.
TUESDAY, AUGUST 17, 2021
PHARMACIST: TECHNICIAN RATIO NON-COMPLIANCE
North Carolina General Statue 90-85.15A (c ) states that “a pharmacist may not supervise more than two pharmacy technicians unless the pharmacist manger receives written approval from the Board. The Board may not allow a pharmacist to supervise more than two pharmacy technicians unless the additional pharmacy technicians are certified pharmacy technicians.” Board Investigations and Inspections staff have found many pharmacies in violation and have worked hard to educate pharmacy staff on compliance. Compliance problems have continued despite this effort. Accordingly, when Board staff discover a violation, the pharmacy will be cited and a Corrective Action Plan (CAP) requested. A reinspection will determine whether the pharmacy has corrected the problem. If the pharmacy remains in violation, the pharmacy will be noticed for disciplinary action, including revocation of any previously granted ratio allowance.
Pharmacist Managers should ensure that their pharmacy is in compliance with G.S. 90-95.15A. If you need to submit a PT ratio increase application, please log into your pharmacy’s profile in the Board’s Licensure Gateway under the Facility Management Tab. You will then see a tile labeled PT Ratio Change. You may submit an application by clicking on that tile. Please keep in mind a ratio increase of 1:3 or 1:4 can be approved at Board staff level, but all PT ratio applications seeking a 1:5 or higher ratio must be presented to the full Board for approval. Guidance on presenting a 1:5 or higher ratio request is found here: http://www.ncbop.org/PDF/PT_Ratio_Guidance_5to1or_greater_Apr2021.pdf.
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
UPDATE - TUESDAY, AUGUST 10, 2021
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES PREP ACT DECLARATION AUTHORIZING PHARMACISTS TO ORDER AND ADMINISTER, AND QUALIFIED PHARMACY TECHNICIANS TO ADMINISTER, SEASONAL INFLUENZA VACCINE. On August 2, 2021, the United States Department of Health and Human Services issued an additional declaration under the federal PREP Act authorizing pharmacists to order and administer, and qualified pharmacy technicians to administer: (1) any vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule; or (2) seasonal influenza vaccine to persons aged 19 and older according to ACIP’s standard immunization schedule; or (3) FDA authorized or FDA licensed COVID -19 vaccines to persons ages three or older. See http://www.ncbop.org/PDF/PREPActFluVaccineAug2021.pdf. This authority is in addition to that granted pharmacists and qualified technicians under previous PREP Act declarations. This authority is in addition to existing authority for North Carolina pharmacists to administer influenza vaccine to patients age 10 or older by protocol, and patients age 6 or older by prescription.
For prior PREP Act authorization for qualified pharmacist technician administration (including the requirements for a qualified pharmacy technician), see here: http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf.
MONDAY, AUGUST 2, 2021
DEA ISSUES FINAL RULE CLARIFYING WHO MAY ENTER THE SUPPLIER’S DEA REGISTRATION NUMBER ON THE SINGLE SHEET DEA FORM 222. Drug Enforcement Administration (DEA) has issued a direct final rule to amend DEA regulations to clarify that either the purchaser or the supplier may enter a supplier’s DEA registration number on the single-sheet DEA Form 222, effective October 18, 2021.
UPDATE TO ITEM POSTED LATE LAST MONTH:
NC DHHS DRUG CONTROL UNIT ISSUES STATEMENT CONCERNING FULL IMPLEMENTATION OF CONTROLLED SUBSTANCE REPORTING SYSTEM. NC DHHS’ Drug Control Unit has announced that the Controlled Substance Reporting System (“CSRS”) will be fully implemented on July 7, 2021. See the statement here. Board staff’s broader FAQ on the STOP Act also covers this topic and a number of others: http://www.ncbop.org/PDF/GuidanceImplementationSTOPACTJuly2017.pdf.
*JULY 7, 2021 UPDATE* Some pharmacists have asked whether the DHHS statement describes pharmacists’ CSRS review obligation under the STOP Act differently than the Board’s FAQ on the same topic. DHHS staff have confirmed that it does “not have an interpretation of the statute that is different to the guidance set out by the Board of Pharmacy.” Question #12 of the Board’s FAQ (http://www.ncbop.org/PDF/GuidanceImplementationSTOPACTJuly2017.pdf) speaks to the issue:
12. Does the STOP Act require pharmacists to review CSRS information prior to dispensing a “targeted controlled substance”?
Yes, in some circumstances.
The STOP Act provides that a dispenser “shall review” a CSRS report on a patient “for the preceding 12-month period and document this review” when any of the following circumstances exist:
(1) The dispenser has a reasonable belief that the ultimate user may be seeking a targeted controlled substance for any reason other than the treatment of the ultimate user’s existing medical condition.
(2) The prescriber is located outside of the usual geographic area served by the dispenser.
(3) The ultimate user resides outside of the usual geographic area served by the dispenser.
(4) The ultimate user pays for the prescription with cash when the patient has prescription insurance on file with the dispenser.
(5) The ultimate user demonstrates potential misuse of a controlled substance by any one or more of the following:
(a) Over-utilization of the controlled substance.
(b) Requests for early refills.
(c) Utilization of multiple prescribers.
(d) An appearance of being overly sedated or intoxicated upon presenting a prescription.
(e) A request by an unfamiliar ultimate user for an opioid drug by a specific name, street name, color, or identifying marks.
Each of these circumstances is atypical “red flag” indicating potential misuse or abuse of a controlled substance. Additional resources are available here: http://www.ncbop.org/faqs/Pharmacist/faq_RedFlagsCS.html and http://www.ncbop.org/faqs/DrugDiversionPocketcard.pdf.
The STOP Act also provides that if a pharmacist “has reason to believe that a prescription for a targeted controlled substance is fraudulent or duplicative,” then the pharmacist “shall withhold delivery of the prescription until the [pharmacist] is able to contact the prescriber and verify that the prescription is medically appropriate.”
WEDNESDAY, MAY 19, 2021
UPDATED BUPRENORPHINE PRACTICE GUIDELINES – WHAT DO THEY MEAN FOR PHARMACISTS? On April 28, 2021, the United States Department of Health and Human Services issued revised Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (https://www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder) In brief, these new guidelines create an expedited pathway for certain practitioners to obtain an “X waiver” under DATA 2000 to prescribe buprenorphine for the treatment of opioid use disorder to 30 or few patients. The guidelines accomplish this by exempting certain practitioners from certification requirements related to training and the provision of psychosocial services.
What does this mean for dispensing pharmacies? In practical terms, very little. Prescriptions for buprenorphine to treat opioid use disorder must still come from a practitioner holding an “X” DEA under DATA 2000. There is simply a more rapid path available for some practitioners to obtain it.
More information here: https://www.samhsa.gov/medication-assisted-treatment/practitioner-resources/faqs.
Health Advisories (last updated June 4, 2020) - Check here regularly for the latest alerts and recall notices.
Medicare/Medicaid (last updated January 3, 2018) - Check here regularly for the latest updates regarding Medicare/Medicaid.
The North Carolina Board of Pharmacy's mission is to protect the public health, safety and welfare in pharmaceutical matters. The Board sets standards for academic and practical experience programs prior to licensure, issues permits to operate pharmacies and DME facilities, and annually renews licenses, permits and registrations.
For more information, please see About the NCBOP.
Copyright © 2006 North Carolina Board of Pharmacy
site design IV Design