COVID-19 UPDATES AND RESOURCES
Board staff have consolidated COVID-19 related items posted on our homepage and organized them below by topic. Select a topic to be taken to that section:
2) Temporary Pharmacy Closures and Relocations
3) COVID-19 Drug Preservation Rule
4) Board of Pharmacy Waivers and Guidance Documents
6) Licensure/Registration/Volunteer Resources
8) Guidance From other State/Local Agencies
**FOLLOW THIS LINK FOR COVID-19 VACCINATION UPDATES AND RESOURCES**
1) EMERGENCY DECLARATIONS
WEDNESDAY, AUGUST 3, 2022
NORTH CAROLINA COVID-19 STATE OF EMERGENCY ENDS AUGUST 15, 2022 – HOW DOES THIS AFFECT PHARMACISTS? As has been widely reported, the North Carolina COVID-19 state of emergency sunsets on August 15, 2022. Overall, the end of the North Carolina state of emergency will have relatively little effect on pharmacy practice. Here are details:
- Board of Pharmacy Waivers. The Board of Pharmacy’s waiver authority is keyed by a state of emergency. So, on August 15, the Board’s waiver authority will expire. This will, however, have a negligible effect on pharmacy practice:
- Inter- and Intra-Pharmacy Remote Operations. The Board withdrew the March 17, 2020 expanded emergency services waiver authorizing remote operations effective July 1, 2022, when it began enforcing amended Rule .1816 and new Rule .2515 which authorize and govern inter- and intra-pharmacy remote operations, respectively. See http://www.ncbop.org/PDF/GuideToInterPharmacyRMOP.pdf and http://www.ncbop.org/PDF/GuidanceForIntraPharmacyRMOPServices.pdf.
- Cross-Jurisdictional Practice. Effective December 31, 2020, the Board withdrew the March 10, 2020 emergency services waiver allowing pharmacists and certified technicians in good standing in another state to practice in North Carolina under certain conditions.
- Temporary Relocation. The portion of the March 10, 2020 emergency services waiver allowing temporary pharmacy relocations without re-permitting will expire on August 15, 2022 when the state of emergency sunsets.
- Waiver and Clarification Concerning Pharmacy Intern Status. The Board’s June 16, 2020 waiver and clarification that 2020 pharmacy school graduates retained internship status through December 31, 2020 expired on its own terms on that date. And, in all events, intern status (including that of pharmacy school graduates) is now governed by amended Rule. 1503: http://www.ncbop.org/NewsItems/PharmacyInternRegistration.html.
- CPR Certification for Immunizers. The Executive Director’s exercise of authority under the March 10, 2020 emergency services waiver to waive enforcement of the requirement that an immunizing pharmacist hold a current provider level cardiopulmonary resuscitation certification will end on August 15, 2022 when the state of emergency sunsets.
- Supervision of Immunizing Pharmacy Technicians. The Executive Director’s December 8, 2020 exercise of authority under the March 10, 2020 emergency services waiver to broaden the definition of “supervision” for immunizing pharmacy technicians was superseded by amended Rule .2507, which incorporated that same supervision standard: The technician “[e]ither (i) has an Immunizing Pharmacist on site and readily available to assist as needed, or (ii) has another licensed health care provider authorized to administer vaccines on site and readily available to assist asneeded and has a supervising pharmacist readily available by phone or other telecommunications method for consultation as needed.” 21 NCAC 46.2507(c)(5) (effective July 1, 2022)
- State Health Director’s Standing Orders. Throughout the COVID-19 state of emergency, State Health Director Tilson has issued a number of COVID-19 related standing orders: https://www.dph.ncdhhs.gov/HDSO-pharmacists.htm. Those standing orders remain in effect after the August 15 sunset. In S.L. 2022-74, the General Assembly continued Dr. Tilson’s authority to issue statewide standing orders to facilitate the administration of COVID-19 vaccinations, diagnostic tests, or other treatments until rescinded.
- PREP Act Declarations. Federal Department of Health and Human Services’ PREP Act declarations granting pharmacists and pharmacy technicians various authorities remain in effect after the August 15 sunset. The PREP Act declarations are keyed to the federal declaration of public health emergency, which does not sunset on August 15.
2) TEMPORARY PHARMACY CLOSURES AND RELOCATIONS
Follow this link for updates on North Carolina pharmacies that have temporarily closed, relocated, and/or reopened during the COVID-19 pandemic. Last updated 1/20/22.
3) COVID-19 DRUG PRESERVATION RULE (WHICH REMOVES OSELTAMIVIR AND AZITHROMYCIN FROM THE ORIGINAL DRUG PRESERVATION RULE)
BOARD PASSES EMERGENCY RULES TO MITIGATE CERTAIN DRUG SHORTAGES. On March 10, 2020, the Governor of North Carolina, by issuing Executive Order No. 116, declared a state of emergency to coordinate a response and enact protective measures to help prevent the spread of COVID-19. COVID-19 is respiratory disease that can result in serious illness or death. The search for potential treatments for COVID-19 has caused shortages and threatens to cause further shortages in certain drugs.
A permanent rule went into effect on February 1, 2021 which removes oseltamivir and azithromycin from the restricted drugs list because the State Health Director has determined that North Carolina is unlikely to suffer future shortages of these drugs because of the COVID-19 pandemic. The other provisions of the temporary COVID-19 Drug Preservation Rule will continue to be enforced. The North Carolina Medical Board is taking the same position with respect to the prescriber-side COVID-19 Drug Preservation Rule. Click here to read the rule language.
An overview of the rule:
1 What drugs does the emergency rule apply to? The rule creates a list of “restricted drugs”: hydroxychloroquine, chloroquine, lopinavir-ritonavir, ribavirin, and darunavir.
2. What restrictions does the rule apply to dispensing any of the Restricted Drugs? A pharmacist shall fill or refill a prescription for a Restricted Drug only if that prescription bears a written diagnosis from the prescriber. The diagnosis must be included in any electronic prescription as well. A prescription for a Restricted Drug may be phoned in by a prescriber or a prescriber’s agent, but all of the information required by this rule must be recorded by the pharmacy, as well as the identity of the prescriber or prescriber’s agent transmitting the prescription.
3. What if the diagnosis is COVID-19? In that case, a pharmacist may dispense no more than a 14-day supply. And that prescription may not be refilled. Only a new prescription meeting the requirements of the rule may be filled. No emergency refill may be provided for a Restricted Drug prescribed for a COVID-19 diagnosis.
4. May a Restricted Drug be dispensed for prevention of, or in anticipation of, a COVID-19 infection? No. No prescription for a Restricted Drug may be dispensed to prevent on in anticipation of a COVID-19 infection.
5. What if a patient was already taking a Restricted Drug for something other than COVID-19 prior to this rule? The rule does not apply to prescriptions for a Restricted Drug for a patient previously established on that particular Restricted Drug on or before March 10, 2020.
6. Does the emergency rule affect dispensing to in-patients at health-care facilities? No. Orders to administer a Restricted Drug to an inpatient of a health-are facility are not affected by this rule.
7. Are prescribers governed by similar restrictions? Yes. The Medical Board has passed emergency rules that apply identical restrictions to prescribers:
http://www.ncbop.org/LawsRules/EmergencyRulemakingFindingsofNeedNCMedBoard21NCAC32B.1709_032720.pdf
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4) BOARD OF PHARMACY WAIVERS AND GUIDANCE DOCUMENTS
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.
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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.
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TUESDAY, JUNE 16, 2020
BOARD ISSUES WAIVER AND CLARIFICATION CONCERNING PHARMACY INTERN STATUS FOR 2020 PHARMACY SCHOOL GRADUATES. Today, exercising authority granted by G.S. 90-85.25, the Board of Pharmacy waived -- for 2020 graduates of an ACPE-approved school of pharmacy who have applied for licensure in North Carolina -- language limiting status as a "pharmacy intern" to students "enrolled in approved academic internship programs." The waiver ensures that 2020 pharmacy school graduates retain intern status -- and therefore the ability to perform all acts constituting the practice pharmacy while under supervision by a North Carolina licensed pharmacist -- through the end of the year while completing the licensure process. The waiver also clarifies the meaning of "under supervision." The full waiver is found here.
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FRIDAY, MARCH 13, 2020 - BOARD OF PHARMACY OFFICE CLOSED TO THE PUBLIC UNTIL FURTHER NOTICE. Consistent with recommendations from public health authorities and Governor Cooper’s declared state of emergency responding to the COVID-19 pandemic, the Board of Pharmacy office is closed to the public until further notice. Each of the Board’s application and other processes are available to our regulated community and the public through the Board’s website and by contacting Board staff, who remain available by phone and by e-mail. Board staff will continue to provide updates on the Board’s website and through the Board’s Twitter account, Follow @NCBOPNews.
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TUESDAY, MARCH 17, 2020 - BOARD OF PHARMACY EXPANDS EMERGENCY SERVICES WAIVER TO ADDRESS USE OF REMOTE OPERATIONS AND ALTERATIONS TO IN-PHARMACY WORKFLOWS. Today (March 17, 2020), the Board of Pharmacy expanded its Emergency Services Waiver to authorize the use of certain remote operations as means of reducing the risk of person-to-person coronavirus transmission and to preserve pharmacists' ability to provide patient care. The expanded waiver also provides support and encouragement for pharmacies seeking to adjust work flows and processes within a pharmacy to reduce the risk of person-to-person coronavirus transmission.
The expanded Emergency Services Waiver is found here.
The baseline Emergency Services Waiver is found here.
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BOARD ISSUES ADDITIONAL GUIDANCE TO PHARMACIST-MANAGERS TAKING IN-PHARMACY MEASURES TO REDUCE THE RISK OF COVID-19 TRANSMISSION. North Carolina law requires that a pharmacy, among other things, be "kept in a clean, orderly, and sanitary condition." 21 NCAC 46.1601. "Sanitary" conditions plainly include conditions sufficient to minimize the risk of transmission of communicable disease within a pharmacy.
Under North Carolina law, the pharmacist-manager is the person to whom the Board issues a pharmacy permit (NCGS 90-85.21) and is, therefore, "the person who accepts responsibility for the operation of a pharmacy in conformance with all statutes and rules pertinent to the practice of pharmacy." 21 NCAC 46.1317(27).
The Board’s Expanded Emergency Services Waiver issued on March 17, 2020 stated, in part:
The Board strongly supports efforts by pharmacies and pharmacists to adjust work flows and processes within a pharmacy to reduce the risk of person-to-person coronavirus transmission. Such efforts might include, but are not limited to: not physically handling patient identifications at the point of dispensing; not requiring a physical signature for pick-up of a prescription; increasing use of prescription delivery service; limiting the number of patients physically entering a pharmacy; enforcing social distancing within a pharmacy.The Board emphasizes that the pharmacist-manager is the person authorized by law to ensure compliance with these standards. Improper interference with a pharmacist-manager’s carrying out these duties and responsibilities subjects a pharmacy permit to potential disciplinary action, up to and including revocation. Likewise, a person licensed by, or registered with, the Board who improperly interferes with a pharmacist-manager’s carrying out these duties and responsibilities is subject to potential disciplinary action, up to and including revocation.
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PHARMACIST-ADMINISTERED VACCINES. State public health officials recommend:
- Pharmacists continue to administer routine immunizations to non-symptomatic patients using ordinary precautions.
- Pharmacists not administer immunizations to symptomatic patients. Information on COVID-19 symptoms is found here: https://www.ncdhhs.gov/covid-19/faq
Some immunizing pharmacists have inquired whether they may continue to administer vaccines if their provider-level CPR certification expires during the declared state of emergency. In order to preserve the public safety, health, and welfare, the Executive Director has exercised authority delegated to him in the Board’s Emergency Services waiver to waive enforcement of the requirement than an immunizing pharmacist “hold a current provider level cardiopulmonary resuscitation certification issued by the American Heart Association or the American Red Cross, or an equivalent certification” (N.C.G.S. 90-85.3(i1)) for the duration of the declared state of emergency
The full text of the March 17, 2020 Expanded Emergency Services Waiver is found here: http://www.ncbop.org/PDF/NCBOPEmergencyServicesWaiverRemoteOperationsAddition031720.pdf
The Board’s baseline Emergency Services Waiver is found here: http://www.ncbop.org/PDF/NCBOPEmergencyServicesWaiver.pdf
North Carolina DHHS is constantly updating information here: https://www.ncdhhs.gov/divisions/public-health/coronavirus-disease-2019-covid-19-response-north-carolina
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NABP CORONAVIRUS RESOURCE PAGE: https://nabp.pharmacy/coronavirus-updates/
5) NC DEPARTMENT OF HEALTH & HUMAN SERVICES RESOURCES
NC STATE HEALTH DIRECTOR STANDING ORDERS FOUND HERE.
6) LICENSURE/REGISTRATION/VOLUNTEER RESOURCES
EMERGENCY AUTHORIZATION FOR OUT-OF-STATE PHARMACISTS AND OUT-OF-STATE CERTIFIED TECHNICIANS TO PRACTICE IN NORTH CAROLINA SUNSETS ON DECEMBER 31, 2020. On March 10, 2020, the Board of Pharmacy activated an emergency services waiver that authorized a pharmacist or nationally-certified pharmacy technician who has a license or registration in good standing in another state to practice in North Carolina without being licensed or registered by this Board. The waiver was made operational through the National Association of Boards of Pharmacy Passport program. The Board has determined that the waiver is no longer required to ensure the provision of pharmacy services in North Carolina. Accordingly, the waiver will sunset on December 31, 2020. Any out-of-state pharmacist or pharmacy technician who is providing services in North Carolina pursuant to this waiver, and who wishes to continue doing so after December 31, 2020, must obtain a North Carolina license to practice pharmacy or North Carolina technician registration. More information on the license/registration application process found here, http://www.ncbop.org/pharmacists_forms.htm, and here, http://www.ncbop.org/technicians_forms.htm.
OUT-OF-STATE PHARMACISTS AND CERTIFIED TECHNICIANS HOLDING AN NABP PASSPORT TO PRACTICE IN NORTH CAROLINA DURING THE STATE OF EMERGENCY - updated 11/02/2020
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FRIDAY, MARCH 20, 2020 - UPDATE ON TEMPORARY REACTIVATION OF LICENSE TO PRACTICE PHARMACY. Exercising its authority under NCGS 90-95.15(a) to waive provisions of the Pharmacy Practice Act and regulations during a declared emergency, the Board has created a pathway for the temporary reactivation of certain pharmacist licenses to provide patient care during the state of emergency.
Only for the duration of the state of emergency declared by Executive Order No. 116, a pharmacist meeting the following criteria my apply for temporary reactivation of an expired North Carolina license to practice pharmacy:
A. The license to practice pharmacy has been inactive for two years or less.
B. The license did not become inactive as a result of a Board disciplinary order, voluntary surrender, or agreement not to renew.
C. The pharmacist has not committed any act since the license became inactive that would be a basis for denying a license application under North Carolina General Statutes Section 90-85.38.
D. The pharmacist has been invited or engaged to provide services at a North Carolina licensed pharmacy to assist with COVID-19 containment and treatment efforts.
E. The pharmacist completes a temporary reactivation application (found here) and submits it to the Board at emergency@ncbop.org.
F. The pharmacist receives notification from the Board that the temporary reactivation application has been approved.
The Application for Temporary Reactivation of Pharmacist License is a fillable PDF document. Once you have completed the application: (1) Select “PRINT” from your Print Menu; (2) Select “SAVE AS PDF” option; (3) Email the completed application form to emergency@ncbop.org.
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INFORMATION CONCERNING BOARD OF PHARMACY PERMIT MEETINGS. Consistent with recommendations from public health authorities and Governor Cooper’s declared state of emergency responding to the COVID-19 pandemic, the Board of Pharmacy permit meeting scheduled for Monday, March 16, 2020 will not be held. And future biweekly permit meetings are cancelled until further notice.
The Governor's emergency declaration, however, also triggered operation of the Board's Emergency Services Waiver order. That order authorizes the Board's executive director to make case-by-case waivers of Pharmacy Practice Act requirements to preserve the public safety, health, and welfare during a state of emergency. Accordingly, the Board's Executive Director has waived 21 NCAC 46.1606, which requires that the pharmacist-manager of an applicant pharmacy or the person in charge of a facility applying for a device and medical equipment permit to appear personally at the Board office prior to issuing a permit.This waiver is limited to pharmacy or DME permit applicants that are notified by Board licensing staff of their eligibility to attend a permit meeting. Permit applicants eligible to attend the March 16, 2020 permit meeting have already been notified. Every two weeks, newly eligible permit applicants will be notified by e-mail. If you have a question concerning the status of your permit application, please call or email Board licensing staff. Do not travel to the Board office for the March 16 permit meeting or to inquire about application status. The Board office is closed to the public until further notice.
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7) FEDERAL GUIDANCE
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.
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).
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THURSDAY, AUGUST 26, 2021
FDA AND CDC 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.
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.
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.
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THURSDAY, SEPTEMBER 10, 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 COVID-19 VACCINES TO PATIENTS AGED THREE YEARS AND OLDER DURING THE PUBLIC HEALTH EMERGENCY. On September 9, 2020 the U.S. Department of Health and Human Services issued a declaration (https://www.hhs.gov/sites/default/files/licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf) authorizing pharmacists "to order and administer," and a “supervised pharmacy intern acting under the supervision of [a] qualified pharmacist” “to administer” FDA-approved COVID-19 vaccines, when available, to patients ages three (3) years or older during the federally-declared public health emergency. 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/PREPActCOVIDVaccination090920.pdf.
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THURSDAY, JULY 16, 2020
FDA ADDS DEXAMETHASONE SODIUM PHOSPHATE TO LIST OF DRUGS THAT MAY BE COMPOUNDED TEMPORARILY DURING THE COVID-19 PANDEMIC. The federal Food and Drug Administration has added dexamethasone sodium phosphate to the lists of drugs for temporary compounding by outsourcing facilities and pharmacies during the COVID-19 public health emergency. These updates help address shortages and access concerns affecting some drugs urgently needed for hospitalized COVID-19 patients. The updated lists are referenced in the following guidances:
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry
The guidance for temporary compounding of certain drugs by outsourcing facilities during the COVID-19 public health emergency includes timely product reporting by outsourcing facilities compounding drugs covered by the guidance. Hospitals can use this information, which FDA posts on its website, to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19.
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TUESDAY, APRIL 21, 2020
CDC ISSUES GUIDANCE ON SPOTTING COUNTERFEIT RESPIRATORY PROTECTION EQUIPMENT. As pharmacists are well aware, acquiring adequate PPE during this pandemic is a challenge. Shortages of critical goods inevitably brings out bad actors looking to cash in. Reports of counterfeit or substandard PPE are emerging. The CDC has issued this guidance to assist health care workers to identify counterfeit respiratory equipment: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html. Pharmacists are also reminded that offers of PPE (or any other supplies) that appear to be counterfeit or to involve price gouging should be reported to the North Carolina Attorney General’s office: https://ncdoj.gov/covid19/.
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TUESDAY, APRIL 21, 2020
FDA ISSUES TEMPORARY POLICY FOR COMPOUNDING OF CERTAIN DRUGS FOR HOSPITALIZED PATIENTS BY PHARMACY COMPOUNDERS NOT REGISTERED AS OUTSOURCING FACILITIES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. The FDA has issued a guidance explaining a temporary policy regarding state-licensed pharmacies and federal facilities compounding certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance helps address reported issues with accessing certain FDA-approved drugs used for hospitalized patients with COVID-19.
FDA recognizes that during the COVID-19 public health emergency, even with the recent temporary regulatory flexibility provided to outsourcing facilities, the supply of FDA-approved drugs and drugs compounded by outsourcing facilities may not be sufficient to meet urgent needs for drugs used to treat hospitalized COVID-19 patients. As a temporary measure, with regard to drugs listed in Appendix A, FDA does not intend to take action against state-licensed pharmacies and federal facilities under the circumstances outlined in the guidance for:
- compounding a drug that is essentially a copy of a commercially available drug, or
- providing a drug to a hospital without first obtaining a patient-specific prescription
Hospitals that cannot obtain FDA-approved drugs and seek to use compounded drugs for their hospitalized patients should first contact outsourcing facilities that produce compounded drugs under more robust quality standards than those made by state- licensed pharmacies or federal facilities.
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THURSDAY, APRIL 16, 2020
USP ISSUES OPERATIONAL CONSIDERATIONS FOR STERILE COMPOUNDING DURING COVID-19 PANDEMIC. USP has issued guidance for sterile compounders during the COVID-19 pandemic designed to mitigate potential supply disruptions and shortages of drug products. The guidance focuses on assignment of beyond-use dates (BUDs), certification and recertification matters, and cleaning and disinfecting matters. The guidance is found here.
Board staff have updated the overall BOP COVID-19 compounding guidance document to incorporate the latest USP guidance.
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CDC COVID-19 Information and Resources: https://www.cdc.gov/coronavirus/2019-ncov/index.html
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MONDAY, MARCH 23, 2020
FDA ISSUES GUIDANCE CONCERNING REMS REQUIREMENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. The Food and Drug Administration (FDA) has issued guidance to health care professionals concerning REMS adherence during the COVID-19 public health emergency. That guidance is found here. In its most pertinent part, that guidance states:
For a limited number of drugs that are subject to a REMS with ETASU, the REMS requires laboratory testing ( e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging) under sections 505-1(f)(3)(d) or (e) of the FD&C Act (21 U.S.C. 355-1 (f)(3)(d) or (e)).
FDA recognizes that during the COVID-19 PHE, completion of REMS-required laboratory testing or imaging studies may be difficult because patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Under these circumstances, undergoing laboratory testing or imaging studies in order to obtain a drug subject to a REMS can put patients and others at risk for transmission of the coronavirus.
For drugs subject to these REMS with laboratory testing or imaging requirements, health care providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during the PHE, and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies. Health care providers should also communicate with their patients regarding these judgments, including the risks associated with it.
Although all REMS requirements remain in effect, FDA does not intend to take enforcement action against sponsors or others for accommodations made regarding laboratory testing or imaging study requirements imposed under sections 505-1(f)(3)(d) or (e) of the FD&C Act (21 U.S.C. 355-1 (f)(3)(d) or (e)) during the PHE declared by the Secretary of HHS on January 31, 2020, provided that such accommodations were made based on the judgment of a health care professional. Manufacturers should document and summarize in their next REMS Assessment Report steps that were taken to accommodate patient access to these REMS drugs during this COVID-19 PHE.
*UPDATE* The Journal of Psychiatry & Neuroscience has published guidance on the use of clozapine during the COVID-19 pandemic, which is described as "not intended as a definitive treatment strategy but as a suggested approach for clinicians treating patients with similar histories." The guidance is found here.
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FRIDAY, MARCH 20, 2020 - DRUG ENFORCEMENT ADMINISTRATION (DEA) POSTS COVID-19 RESPONSE GUIDANCE TO HEALTH CARE PRACTITIONERS. DEA has issued the following statement and guidance information to practitioners:
The mission of Drug Enforcement Administrations (DEA), Diversion Control Division is to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.
During this National Emergency the Diversion Control Division will continue to work with our Federal partners, DEA registrants, and their representative association to assure that there is an adequate supply of controlled substances in the United States. The DEA will also work to assure that patients will have access to controlled substances.
On March 16, 2020, the DEA published a COVID-19 Information Page (https://www.deadiversion.usdoj.gov/coronavirus.html) on the Diversion Control Divisions Web Site (https://www.deadiversion.usdoj.gov/index.html). This page contains important guidance concerning COVID-19 and the national drug supply, electronic prescribing of controlled substances, telemedicine, medicated assisted treatment, and other important federal and state information. This site will be updated frequently as new information and guidance is issued. Please check back frequently for further information.
Please continue to direct all policy questions concerning COVID-19 to the Policy email box at Natural.Disaster@usdoj.gov
8) GUIDANCE FROM OTHER STATE/LOCAL AGENCIES
THURSDAY, MARCH 12, 2020 - NORTH CAROLINA DEPARTMENT OF INSURANCE ISSUES BULLETIN CONCERNING INSURER RESPONSIBILITIES FOR EMERGENCY REFILL PAYMENT DURING STATE OF EMERGENCY. Pharmacists and pharmacies should review this memo from the North Carolina Department of Insurance reminding insurers of their responsibilities to cover emergency prescription refills during a declared state of emergency: http://www.ncbop.org/PDF/EmergencyDeclarationBulletinDeptofInsurance031220.pdf.
Pharmacists are reminded that Board Rules .1809 and .1815 provide authority to issue 30- and 90-day emergency refills, respectively, depending on the particular circumstances in your area.
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SUNDAY, MARCH 15, 2020 - Information for providers from Wake County Medical Director, Dr. Kim McDonald regarding recognizing and testing patients for COVID-19. Memo with important information for providers and links to other resources; and FAQs available here.