Board News and Announcements

JANUARY 2022 NCBOP/NABP NEWSLETTER

 

 

** THE 2022 RENEWAL PERIOD ENDED ON DECEMBER 31, 2021, ALTHOUGH THE NCBOP ALLOWS A 60-DAY GRACE PERIOD TO RENEW. LOG IN TO THE BOARD'S LICENSURE GATEWAY NOW TO RENEW YOUR LICENSE, PERMIT, OR REGISTRATION FOR 2022. **


 

NC BOARD OF PHARMACY STAFF HAVE CONSOLIDATED AND ORGANIZED BY TOPIC ALL COVID-19 UPDATES AS FOLLOWS:



 

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2022 LICENSE / PERMIT / REGISTRATION RENEWAL - GRACE PERIOD JANUARY 1, 2022 THROUGH MARCH 1, 2022

If you have not yet renewed your pharmacist license, technician registration, NP/PA or
dispensing physician registration, DME or pharmacy permit for 2022, you may do so between now and March 1, 2022 with no penalty. Log in to the licensure gateway to complete your renewal.

North Carolina pharmacists are reminded that the Board is holding an election for both the Northern and Western Districts. Click on the voting tile once you log into your pharmacist profile to read about the candidates and cast your votes. It only takes a minute!

 


 

NCDHHS COVID RESPONSE

NC DHHS COVID-19 VACCINATION INFORMATION FOR PROVIDERS: https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.

 

 


 

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 As a result, and as already reported by Board staff, State Health Director Elizabeth Tilson has rescinded the statewide standing orders for these treatments.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:

These Statewide Standing Orders were rescinded due to the high prevalence of the Omicron variant of SARS-CoV-2 virus in North Carolina for which these therapies are not an effective treatment.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.

 

Companion Document for Intravenous Administration of Sotrovimab Monoclonal Antibodies Revised January 5, 2022

 


 

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:

Provided below is a table containing booster qualification details and the CDC recommended age for each vaccine product type:

Booster Guidance

 

 


 

FRIDAY, JANUARY 7, 2022

PHARMACIST ROLE IN PAXLOVID AND MOLNUPIRAVIR THERAPY FOR COVID-19.  The FDA has issued emergency authorizations for two oral antivirals to treat COVID-19, Pfizer’s Paxlovid and Merck Sharp & Dohme’s Molnupiravir.  See Paxlovid Emergency Use Authorization and Molnupiravir Emergency Use Authorization.

Board staff have received questions concerning pharmacists’ authority to order Paxlovid and Molnupiravir for COVID-19 patients.  Unfortunately, pharmacists do not have any authority to order these products.

The EUAs for both products specify that they may only be prescribed by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which the two drugs belong (i.e., anti-infectives). 

It is true that the Ninth Amendment to the US DHHS PREP Act declaration authorizes pharmacists to “order and administer” oral COVID-19 therapies.  But that declaration also specifies that ordering must comply with the terms of any FDA EUA or approval.  See http://www.ncbop.org/PDF/PREPActExpandingAccesstoCOVIDTherapeuticsSept2021.pdf.

US DHHS has emphasized that “[i]f the Emergency Use Authorization includes a condition that the product may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which the belongs, the Ninth Amendment to the Secretary’s PREP Act Declaration would not permit pharmacists to order the product.”  See PREP Act Q&As.

A number of pharmacy organizations have expressed disappointment that the FDA’s EUA for these products excludes pharmacists as prescribers.  See https://www.ashp.org/News/2021/12/22/fdas-decision-to-block-pharmacists-from-ordering-covid19-oral-antivirals?loginreturnUrl=SSOCheckOnly. But the terms of the EUAs and the PREP Act declaration are clear.  Board staff will, of course, promptly advise of any change to either or both the EUAs or the PREP Act declaration.

 


 

TUESDAY, DECEMBER 14, 2021

*SECOND UPDATE* FDA TEMPORARILY SUSPENDS NEW CLOZAPINE REMS SYSTEM.  In July, FDA approved a modification to the Clozapine REMS system.  The modification became effective November 15, 2021.  FDA has announced, however, that it is temporarily suspending the new Clozapine REMS system due to “problems with implementation and the potential impact to patient care.”  Accordingly, FDA states that “pharmacists may dispense clozapine without a REMS dispense authorization.”   FDA “encourage[s] pharmacists and prescribers to continue working with the Clozapine REMS to complete certification and patient enrollment.  More detail on FDA’s suspension is here:  https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-suspending-certain-clozapine-rems-program-requirements-ensure-continuity-care.

For more information on the temporarily suspended Clozapine REMS system, see this document.

On December 14, 2021, FDA issued additional information for pharmacies concerning this matter.  See http://www.ncbop.org/PDF/FinalClozapineLettertoStateMedicalandPharmacyBoards121421.pdf.

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JANUARY 25, 2022.)

 


 

FRIDAY, DECEMBER 10, 2021

BE ALERT! FRAUDULENT RECALL NOTICES ARE BEING CREATED AND ISSUED TO DIVERT PRESCRIPTION MEDICATIONS. The North Carolina Department of Agriculture notified Board staff that fraudulent recall notices are being sent to wholesalers in an attempt to divert prescription medication from the wholesalers.  The fraudulent recall notices are being sent to the wholesalers using the manufacturers’ logos.  The drugs mentioned on the fraudulent recall notices include Xarelto, Invega, Invokana, Saxenda, Victoza, and Ozempic.  In some instances, a fraudulent recall notice was issued and a courier was sent to collect the prescription medications.  Pharmacists and Pharmacies should be alert when receiving and reviewing recall notices.  Please notify Board staff if you receive any fraudulent recall notices, (919) 246-1050.

 


 

WEDNESDAY, DECEMBER 1, 2021

BOARD REVISES PROCESS FOR APPROVAL OF PHARMACIST:TECHNICIAN RATIO REQUESTS.  The North Carolina Pharmacy Practice Act provides that “a pharmacist may not supervise more than two pharmacy technicians unless the pharmacist-manager 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.”  G.S. 90-85.15A(c)).  In light of changes to the North Carolina Pharmacy Practice Act granting qualified pharmacy technicians the authority to administer certain vaccines under pharmacist supervision, and (effective February 1, 2022) expansion of pharmacist’s ability to initiate and modify certain drug therapies, the Board has modified its process for reviewing and approving pharmacist:technician ratio requests.

A pharmacist-manager’s request for a 1:3, 1:4, or 1:5 pharmacist:technician ratio may be allowed by Board staff without formal Board action as long as the pharmacist-manager demonstrates that the pharmacy employs a sufficient number certified technicians to meet the ratio.  A pharmacist-manager’s request for a 1:6 or higher pharmacist:technician ratio must be considered by the full Board.

More detail on the Board’s revised process, as well as instructions on how to submit a pharmacist:technician ratio request, is found here.

 


 

MONDAY, NOVEMBER 29, 2021

DEA ISSUES NOTICE OF PROPOSED RULEMAKING CONCERNING TRANSFERS OF ELECTRONIC PRESCRIPTIONS FOR SCHEDULE II – V CONTROLLED SUBSTANCES BETWEEN PHARMACIES FOR INITIAL FILLING.  Pharmacists may recall that, in 2017, then-DEA Associate Section Chief Loren Miller stated in an email that unfilled prescriptions for controlled substances of any schedule could not be transferred among pharmacies for initial dispensing.  That email stated a DEA policy that an unfilled electronic prescription for a controlled substance could be “forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy.”  The email, however, provided no guidance as to how a unfilled electronic prescription should be “forwarded” or what documentation was required.  DEA’s policy-by-email announcement also created a number of other practical problems.  More detail available here:  http://www.ncbop.org/faqs/Pharmacist/faq_TransferringRXs.htm.

On November 19, 2021, DEA published a proposed rule governing the transfer of electronic prescriptions for Schedules II-V controlled substances between pharmacies for initial filling: http://www.ncbop.org/pdf/DEAProposedRuleECPSTransferNov2021.pdf. In it, DEA acknowledges some of the challenges its 2017 statement created for patients, prescribers, and pharmacists – including the potential for duplication of controlled substance prescriptions and significant procedural burdens on patients and pharmacies. 

The proposed rule would allow pharmacies a one-time transfer of an unfilled electronic prescription to another pharmacy for initial dispensing.  The proposal’s preamble claims that there is no concern where paper prescriptions are concerned because a pharmacy may return the paper prescription to the patient for dispensing at another pharmacy.  The proposal is silent as to transfer of valid, unfilled verbal prescriptions for controlled substances, even though the concerns DEA identifies with its current policy as applied to electronic prescriptions – i.e., the patient has no physical copy of the prescription and therefore cannot take it to another pharmacy for filling; risk of duplicate controlled substance prescriptions at multiple pharmacies; procedural burdens on patients and pharmacies – are precisely the same. 

The proposed rule states that the prescription “must be transferred from one retail pharmacy to another retail pharmacy in its electronic form” and that “[a]t no time may an intermediary convert an electronic prescription to another form (e.g., facsimile) for transmission.”  It further warns that “any change to the content during transfer, including truncation or removal of data, will render the electronic prescription invalid.”  Board staff is concerned that these requirements may be achievable when an electronic prescription is transferred among pharmacies sharing a common, real-time database, but will be impossible to meet when a transfer among pharmacies that do not share such a database is contemplated (which is likely to be a substantial portion of transfers).

The proposed rule requires that transfers be “communicated directly between two licensed pharmacists” and specifies various information that must be recorded in the electronic prescription record by the transferring and recipient pharmacists.

DEA is accepting written and electronic comments on the proposed rule on or before January 18, 2022.  The notice of rulemaking provides instructions on comment submission.  Pharmacists are strongly encouraged to review the proposal and provide comments to DEA.

 


 

TUESDAY, NOVEMBER 23, 2021

STATE HEALTH DIRECTOR TILSON UPDATES STATEWIDE STANDING ORDER FOR COVID-19 DIAGNOSTIC TESTING.  Dr. Tilson has issued a revised statewide standing order for COVID-19 diagnostic testing.  The revised order is found here: http://www.ncbop.org/PDF/COVID19NCDHHSSWSOTestingFinalSigned112221.pdf.  Most revisions are minor in nature.  This companion document - http://www.ncbop.org/PDF/COVID19NCDHHSSWSOCompanionDocument112221.pdf - highlights updates and additions in yellow.  The revised standing order is also available here: https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.

 


 

THURSDAY, NOVEMBER 11, 2021

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- FEBRUARY 8, 2022 -- ON THE FOLLOWING PROPOSED ACTIONS:

Details about this public hearing and the rules being considered may be found here.

 


 

BOARD ELECTIONS OPEN NOVEMBER 1 THROUGH MARCH 1.

The North Carolina Board of Pharmacy is conducting an election to fill two positions, the northern and western districts. North Carolina pharmacists may vote anytime between now and March 1, 2022. Log in to your pharmacist profile through the Licensure Gateway and select the yellow ELECTION - NORTHERN & WESTERN DISTRICTS tile. There you may read about the candidates before casting your votes.

All pharmacists actively licensed and living in North Carolina as of October 31, 2021 are eligible to vote. The winners of this election will begin their terms on May 1, 2022.

Northern District Candidates

Western District Candidates

Questions about the election should be directed to Jay Campbell or Kristin Moore.

 


 

THURSDAY, OCTOBER 28, 2021

NEW RULES GOVERNING LIMITED SERVICE PERMITS EFFECTIVE NOVEMBER 1.  New rules clarifying when a pharmacy is eligible to obtain a limited service permit, as well as a pharmacist-manager’s responsibilities for a limited service permit are effective November 1, 2021.  Pharmacist-managers of limited-service permit pharmacies are strongly encouraged to review this FAQ document for details. 

 


 

TUESDAY, OCTOBER 26, 2021 - HOPE4HEALERS HELPLINE, (919) 226-2002

The NC Department of Health and Human Services, in conjunction with the North Carolina Psychological Foundation, created Hope4Healers, a large volunteer force of licensed mental health professionals providing pro bono, confidential mental health support for healthcare workers who are on the front lines of the coronavirus pandemic and their families. Pharmacists are working at the heart of this crisis in high stress environments as they provide vaccines, testing and treatments for COVID-19. Our aim is to support these individuals and their families in a timely, accessible manner. 

The Hope4Healers Helpline number is 919-226-2002.

Hope4Healers is also available 24 hours per day, seven days a week for people to reach out for support from a licensed mental health professional.

 


 

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. 

 


 

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).

 


 

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.

 


 

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.

 


 

Health Advisories (last updated September 15, 2021) - 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.


 

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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.



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