Board News and Announcements

OCTOBER 2021 NCBOP/NABP NEWSLETTER

 

 

** THE 2022 RENEWAL PERIOD BEGAN ON NOVEMBER 1 AND RUNS THROUGH DECEMBER 31. 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 RENEWAL PERIOD BEGINS NOVEMBER 1

Now is the time to renew your pharmacist license, technician registration, NP/PA or
dispensing physician registration, DME or pharmacy permit for 2022. Log in to the licensure gateway to complete your renewal.

 


 

TUESDAY, DECEMBER 7, 2021

*UPDATE* FDA EXPANDS EMERGENCY USE AUTHORIZATION OF BAMLANIVIMAB AND ETESEVIMAB FOR TREATMENT AND POST-EXPOSURE PREVENTION OF COVID-19.  FDA has expanded the EUA for bamlanivimab and etsevimab for treatment and post-exposure prevention of COVID-19 to all pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19.  More information here:  https://www.fda.gov/news-events/press-announcements/fda-expands-authorization-two-monoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19.  State Health Director Betsey Tilson has updated the state standing order to reflect the expanded EUA:  Standing Order.

 


 

THURSDAY, DECEMBER 2, 2021

*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.

 


 

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.

 


 

WEDNESDAY, DECEMBER 1, 2021 - CONTINUING EDUCATION OPPORTUNITY THROUGH FDA

FDA’s Division of Drug Information is presenting a series of continuing education (CE) webinars targeting the needs of health care professionals.

Tuesday, December 14, 2021 - FDA Drug Topics: Overview of Expanded Access (EA) Program and EA eRequest Site 1:00 PM – 2:00 PM (ET)

Program details and registration available 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.

 


 

MONDAY, NOVEMBER 22, 2021

FDA AUTHORIZES AND CDC RECOMMENDS COVID-19 BOOSTERS FOR ALL PATIENTS AGE 18 OR OLDER.  The Food and Drug Administration (FDA) has authorized and the Centers for Disease Control (CDC) has recommended booster vaccine shots for all adults 18 and older to help strengthen and extend protections against COVID-19. Patients who received the Pfizer or Moderna COVID-19 vaccine can get a booster six months after their second shot. Patients who received the Johnson & Johnson vaccine can get a booster two months after their first shot.  

Anyone patient over 50 or at high risk, as well as those 18 or older who were vaccinated more than two months ago with the Johnson & Johnson vaccine, should get a booster dose now.

Additionally, fully vaccinated patients who received their first COVID-19 vaccine outside of the U.S. or in clinical trials with a brand not currently authorized can now receive a Pfizer booster shot when they are eligible. 

State Health Director Betsey Tilson has updated the North Carolina COVID-19 vaccine standing orders to reflect this change.

Patients can receive any brand of COVID-19 vaccine for their booster shot. Some patients may prefer the vaccine type that they originally received; others may prefer to get a different booster. Limited preliminary evidence suggests that booster doses of one of the two mRNA vaccines—Moderna or Pfizer-BioNTech—more effectively raise antibody levels than a booster dose of the Johnson & Johnson vaccine.  

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED DECEMBER 1, 2021.)

 


 

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.

 


 

*UPDATE* THURSDAY, NOVEMBER 4, 2021

FDA AND CDC AUTHORIZE PFIZER-BioNTech COVID-19 VACCINE FOR PATIENTS AGE 5 TO 11 YEARS.  On October 29, the Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for patients age 5 to 11 years -- https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age.  On November 2, the Centers for Disease Control endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that patients age 5 to 11 years be vaccinated against COVID-19 with the Pfizer-BioNTech vaccine.  The vaccine formulation for the 5-11 age group will come in orange-capped multi-dose vials with orange bordered labeling.  After dilution, the multi-dose vials will contain 0.2 mL doses, each containing 10 micrograms of modRNA.  Full product description is available here:  https://www.fda.gov/media/150386/download. CDC announced that distribution of the pediatric vaccine began this week, and scale up to full capacity will occur the week of November 8.

Existing PREP Act declarations authorize immunizing pharmacists to order and administer COVID-19 vaccines to this patient population (http://www.ncbop.org/PDF/PREPActCOVIDVaccination090920.pdf) and qualified pharmacy technicians to administer COVID-19 vaccines to this patient population (http://www.ncbop.org/PDF/PREPActTechnicianVaccination102220.pdf).

State Health Director Tilson has issued an updated statewide standing order for administration of the Pfizer-BioNTech vaccine to patients 12 and older, found here: http://www.ncbop.org/PDF/SWSOPfizerCOMIRNATY_12AndUpRev11032021signed.pdf.

Dr. Tilson has also issued a new statewide standing order for administration of the Pfizer-BioNTech vaccine to patients age 5 to 11, found here: http://www.ncbop.org/PDF/SWSOPfizerPEDS_5to11yrs11032021FinalSigned.pdf.

 


 

TUESDAY, NOVEMBER 2, 2021

STATEWIDE STANDING ORDER FOR SUBCUTANEOUS ADMINISTRATION OF REGEN-COV MONOCLONAL ANTIBODIES.  On September 9, US DHHS issued a PREP Act declaration authorizing pharmacists to “order and administer” certain COVID-19 therapeutics by subcutaneous, intramuscular, or oral route.  Complete information here:  http://www.ncbop.org/PDF/PREPActExpandingAccesstoCOVIDTherapeuticsSept2021.pdf. State Health Director Betsey Tilson has also issued a statewide standing order for subcutaneous administration of REGEN-COV monoclonal antibodies that may be employed by “a covered person under the PREP Act” – https://covid19.ncdhhs.gov/media/3372/download 

 


 

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.

 


 

*UPDATE* OCTOBER 29, 2021

NORTH CAROLINIANS FULLY VACCINATED WITH MODERNA AND J&J VACCINES MAY BE ELIGIBLE TO RECEIVE A BOOSTER DOSE. The Food and Drug Administration (FDA) and Centers for Disease Control (CDC) have authorized and recommended "booster" vaccine shots to provide continued protection.

ModernaIf you were vaccinated more than 6 months ago with the Moderna COVID-19 shot, boosters are now available for people: 

  
The Moderna booster is a smaller dose than what is given in the first two shots. Be sure to let your provider know you want the booster. 

Johnson & Johnson: It is recommended that anyone 18 or older who was vaccinated more than 2 months ago with the Johnson & Johnson vaccine should get a booster dose.

Pfizer:  Pfizer-BioNTech (COMIRNATY) booster shots continue to be available to anyone at high risk for serious illness or exposure, and who received their second dose at least six months ago.  
The North Carolina Department of Health and Human Services has now authorized the distribution of Moderna and Johnson & Johnson boosters in addition to Pfizer COVID-19 boosters. Not all vaccines may be available at every vaccine location.

To find a COVID-19 booster visit MySpot.nc.gov to search vaccine locations near you.

Additionally, individuals are now able to receive any brand of COVID-19 vaccine for their booster shot. Some people may have a preference for the vaccine type that they originally received and others may prefer to get a different booster. Limited preliminary evidence suggests that booster doses of one of the two mRNA vaccines—Moderna or Pfizer-BioNTech—more effectively raise antibody levels than a booster dose of the Johnson and Johnson vaccine. NC DHHS encourages you to speak with a doctor, nurse or pharmacist if you have questions about what booster is right for you.

Have questions about whether your personal medical conditions or job might make you eligible? Talk to a doctor, pharmacist or nurse about whether you should get a booster.

IMMUNIZING PHARMACISTS:  UPDATED state standing orders reflecting booster eligibility, as well as the ability to provide mRNA vaccines to boost recipients of the J&J vaccine, found here: 

 


 

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. 

 


 

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.

Follow this link for a detailed job description.

All applicants should submit a cover letter of interest along with a resume to Rhonda Jones, Director of Finance and Human Resources, rjones@ncbop.org.

 


 

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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