COVID-19 (Coronavirus) 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:

1) Emergency Declarations

2) Temporary Pharmacy Closures and Relocations

3) Emergency Rules to Mitigate Certain Drug Shortages

4) Board of Pharmacy Waivers and Guidance Documents

5) NC DHHS Resources

6) Licensure/Registration/Volunteer Resources

7) Federal Guidance

8) Guidance From other State/Local Agencies

 


 

 

 

1) EMERGENCY DECLARATIONS

 

WEDNESDAY, MAY 6, 2020

COVID-19 RECOVERY ACT AND IDENTIFICATION FOR CONTROLLED SUBSTANCE DISPENSING.  The General Assembly passed, and Governor Cooper signed into law, the COVID-19 Recovery Act on Monday, May 4, 2020.  Among many other things, this statute "extend[s] for a period of five months the validity of [a drivers license] that expired on or after March 1, 2020, and before August 1, 2020.  A [drivers license] extended under this section shall expire five months from the date it otherwise expires . . . ."  Accordingly, when a pharmacy is reviewing an ID as required for dispensing certain controlled substances (see http://www.ncbop.org/faqs/PhotoIDFAQ.pdf and the paragraph immediately below), a North Carolina license whose expiration has been extended by this statute is "current" and acceptable. 

Pharmacists should also be aware that the COVID-19 Recovery Act lessens ID check requirements in certain respects "for the duration of the COVID-19 emergency." Pharmacists "may confirm the identity of an individual seeking dispensation of a prescription by the visual inspection of any form of government-issued photo identification.  If the individual seeking dispensation is a known customer, the pharmacist may confirm the individual's identity by referencing existing records, including the controlled substance reporting system."  The statute further states that "nothing in this section shall be construed to relieve a pharmacist of the obligation to review information in the controlled substances reporting system in accordance with [the STOP Act]."  A STOP Act FAQ may be found here:  http://www.ncbop.org/PDF/GuidanceImplementationSTOPACTJuly2017.pdf

-----------------------------------------------

 

THURSDAY, APRIL 9, 2020

GOVERNOR COOPER ISSUES EXECUTIVE ORDER THAT PLACES OCCUPANCY LIMITATIONS ON RETAIL ESTABLISHMENTS -- INCLUDING PHARMACIES.   Governor Cooper today issued Executive Order 131 as part of the state's continuing response to the COVID-19 pandemic.  An FAQ summarizing the order is available here. E.O. 131 applies to "any business in which customers enter to purchase goods or services, including . . . pharmacies."  Retail establishments are limited to no more than 20 percent of the business's stated fire capacity or five customers for every one thousand square feet of the location's total square footage.  Retail establishments must clear mark six feet of spacing in lines at cash registers and in other high-volume areas to ensure proper social distancing, and must perform frequent cleaning of high-touch areas.   Beyond these requirements, E.O. 131 recommends implementation of a number of other actions designed to decrease risk of COVID-19 transmission in the establishment, and those are outlined in the E.O. 131 FAQ.  Pharmacists-managers should review E.O. 131 immediately and ensure that its requirements are being met. 

-----------------------------------------------

 

STATEWIDE SHELTER-IN-PLACE ORDER EFFECTIVE MONDAY, MARCH 30, 5 PMGovernor Cooper has announced a state-wide shelter-in-place order that takes effect Monday, March 30, at 5 pm.  The Order permits pharmacies to remain open as essential businesses.  The Order does not require employees of an essential business to have documentation to report to work under the Order. See this FAQ on the Order.

Any pharmacist or pharmacy technician who nonetheless wishes to carry documentation may print additional copies of their annual license/renewal certificate, which may prove useful if some form of documentation is necessary to report to a pharmacy.  To do that:

    1.       Log in to your personal profile in the Board’s Licensure Gateway (https://portal.ncbop.org/) with your username and password.

    2.       If you've forgotten your username or password, please use the retrieval tools on the Licensure Gateway home page.

    3.       Once logged in, scroll down the bottom of your page, and click on the tile under Licenses/Certificates.

    4.       On the next page, click the PRINT ANNUAL CERTIFICATE button.  That will produce a savable, printable PDF file of your annual renewal certificate and license pocket card.

-----------------------------------------------

GOVERNOR COOPER DECLARES STATE OF EMERGENCY TO COORDINATE RESPONSE AND PROTECTIVE ACTIONS TO PREVENT THE SPREAD OF COVID-19 On March 10, 2020, Governor Cooper declared a state-wide state of emergency to coordinate response to the COVID-19 (coronavirus) outbreak:  http://www.ncbop.org/PDF/NCEO116StateOfEmergencyCOVID19_031020.pdf.

The Governor's emergency declaration also triggers operation of the Board's Emergency Services Waiver order: http://www.ncbop.org/PDF/NCBOPEmergencyServicesWaiver.pdf.  That waiver speaks specifically to pharmacists and nationally-certified technicians who are not licensed in North Carolina providing services in North Carolina during the declared emergency and to pharmacies that need to temporarily relocate as a result of the declared emergency.   All pharmacists are encouraged to review the waiver.

Back to Index/top of page

 

 

 

2) TEMPORARY PHARMACY CLOSURES AND RELOCATIONS

Follow this link for daily updates on North Carolina pharmacies that have temporarily closed, relocated, and/or reopened during the COVID-19 pandemic. (Last updated 5/8/20.)

Back to Index/top of page

 

 

 

3) EMERGENCY RULES TO MITIGATE CERTAIN DRUG SHORTAGES

    

NC BOARD OF PHARMACY CONVENED AN EMERGENCY MEETING BY CONFERENCE CALL ON TUESDAY, MARCH 24, 2020, 4 PM AUDIO FILE OF THE MEETING MAY BE FOUND HERE.

---------------------------------

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.  On March 24, 2020, the North Carolina Secretary of Health and Human Services and the State Health Director requested that the Medical Board and the Board of Pharmacy adopt the COVID-19 Drug Preservation Rule in order to alleviate shortages and ensure that these drugs are available to patients who need them. The Pharmacy Board’s emergency rule is found here.

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, oseltamivir, darunavir, and azithromycyin.

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

---------------------------------

NOTICE OF EMERGENCY RULEMAKING TEMPORARY RULE 21 NCAC 46 .1819

A public hearing will be held on May 8, 2020 at 10AM by teleconference. Dial-in number is 408-215-9377; access code is 829 609 515#

Comments from the public shall be directed to: Jay Campbell, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517; fax 919-246-1056; email jcampbell@ncbop.org. Comment period begins March 24 and runs through May 1, 2020.

Emergency Rule-Making Findings of Need

Notice of Text / Proposed Temporary Rule

---------------------------------

PRESCRIPTIONS FOR HYDROXYCHLOROQUINE, CHLOROQUINE, AZITHROMYCIN, KALETRA, AND OTHER MEDICATIONS.   Board staff and public health officials at the North Carolina Department of Health and Human Services are aware of numerous reports from pharmacists across the state concerning new prescriptions for hydroxychloroquine, chloroquine, azithromycin, Kaletra, and potentially other medications – often in large quantities with a high number of refills -- to respond to the COVID-19 pandemic.  Reports include these prescriptions being issued by prescribers for themselves and family members, and for persons who have not been exposed to or infected by the COVID-19 virus.  Board staff and public health officials are aware that some prescription drug wholesalers are reporting shortages of these drugs.  Board staff are aware that at least three other state boards of pharmacies have passed emergency rules limiting the circumstances under which these drugs may be dispensed, and their quantities. 
 
All health care providers are reminded that, while these drugs are being investigated as potential COVID-19 treatments, there is at this date only anecdotal evidence of their potential usefulness.  Public health authorities are working to obtain better data on their potential  -- and most appropriate -- use in the pandemic.
 
Pharmacists are reminded of their ability to refuse to fill prescriptions that, in the pharmacist’s professional judgment, are not clinically appropriate.  And exercising that professional judgment may include setting reasonable policies designed to ensure that prescription drugs are available for all patients, including by use of partial fills of limited days’ supply and otherwise ensuring that patients taking these medications for established, and approved, indications do not have their drug therapy interrupted.  21 NCAC 46.1801.   
 
Public health officials at the North Carolina Department of Health and Human Services are working with appropriate stakeholders, including the Board of Pharmacy, to issue guidance and take actions on this issue that are designed to best protect the public health and safety.  Please continue to monitor the Board of Pharmacy website for updates on this, and other, issues. 

Back to Index/top of page

 

 

 

4) BOARD OF PHARMACY WAIVERS AND GUIDANCE DOCUMENTS

 

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, .

---------------------------------

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.

---------------------------------

BOARD ANNOUNCES NEW PROCESS FOR OUT-OF-STATE PHARMACISTS AND OUT-OF-STATE CERTIFIED TECHNICIANS TO OBTAIN AUTHORIZATION TO PRACTICE IN NORTH CAROLINA DURING THE DECLARED STATE OF EMERGENCY.   When Governor Cooper declared a state-wide emergency on March 10, 2020 to coordinate response to the COVID-19, that triggered operation of the Board’s Emergency Services Waiver.  The Emergency Services Waiver allows a pharmacist or nationally-certified technician who has a license and registration in good standing in another state to practice in North Carolina during the declared emergency without being licensed or registered with the Board, provided the pharmacist and pharmacist-technician is pre-cleared to do so. 

Effective immediately, out-of-state pharmacists and out-of-state certified technicians who wish to practice in North Carolina during the declared state of emergency must obtain an NABP Passport to do so.  The NABP Passport is a license verification process administered by the National Association of Boards of Pharmacy to assist in the pandemic response.

Individuals can obtain an NABP Passport at no cost by following these steps (screenshot instructions are available here.)

  1.  Navigate to NABP’s e-Profile system at https://dashboard.nabp.pharmacy/Login/Splash
  2. Click the  "Customers" tile.
  3. Enter your e-profile ID and Password.
  4. Click on the "My e-Profile" tile.
  5. Click on the tile labeled: “NABP Passport/COVID-19 Emergency”.   Note:  Your license information, including expiration date and license status must be current to access this tile.  If it is not current, please follow the instructions for updating.
  6. Follow the "Add a State” instructions on this page.  Check the attestation, and then click "Submit"
  7. NABP will verify your information and eligibility for a Passport.
  8. Once the NABP Passport for North Carolina is approved, you will be notified.  The North Carolina Board of Pharmacy will be notified as well, and you will then be eligible to practice in North Carolina during the state of emergency.

---------------------------------

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. 

---------------------------------

PHARMACIST-ADMINISTERED VACCINES.  State public health officials recommend:

  1. Pharmacists continue to administer routine immunizations to non-symptomatic patients using ordinary precautions. 
  2. 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

---------------------------------

BOARD STAFF UPDATES GUIDANCE ON HAND SANITIZER PREPARATION Recognizing dwindling availability of USP-grade alcohol to prepare hand sanitizer, the United States Pharmacopeia has updated its guidance to pharmacies with best practices on substitution.  FDA has also issued guidance to industry on ethanol manufacturing for inclusion in hand sanitizer products (found here.)  Board staff updated its garb- and sanitizer shortage document to reflect the new USP and FDA guidance. The updated guidance is found here.

---------------------------------

NABP CORONAVIRUS RESOURCE PAGE: https://nabp.pharmacy/coronavirus-updates/

Back to Index/top of page

 

 

 

 

5) NC DEPARTMENT OF HEALTH & HUMAN SERVICES RESOURCES

 

 

TUESDAY, APRIL 28, 2020 - CAROLINA COMMUNITY TRACING COLLABORATIVE FORMED

NCDHHS announces the formation of the Carolina Community Tracing Collaborative, a new partnership with Community Care of North Carolina and the North Carolina Area Health Education Centers to expand contact tracing.

Contact tracing is the process of supporting patients and notifying contacts of exposure in order to stop chains of transmission.  Our local health departments are North Carolina’s experts in this essential detective work.  The new Collaborative will hire and train staff that will support local health department’s contact tracing efforts.  This will allow North Carolina to meet the goal of doubling the number of contact tracers.

Recruitment will start immediately; interested applicants should visit the Collaborative’s webpage. Special consideration will be given to those who are unemployed, have community engagement experience and live in the communities that they will serve.

Read more in yesterday’s press release.

In addition, we have the following COVID-19 updates to share.

Follow this link to read more.

 

---------------------------------

 

Comprehensive COVID-19 Information and Resources: https://www.ncdhhs.gov/divisions/public-health/coronavirus-disease-2019-covid-19-response-north-carolina

 

Back to Index/top of page

 

 

 

 

6) LICENSURE/REGISTRATION/VOLUNTEER RESOURCES

 

OUT-OF-STATE PHARMACISTS AND CERTIFIED TECHNICIANS HOLDING AN NABP PASSPORT TO PRACTICE IN NORTH CAROLINA DURING THE STATE OF EMERGENCY - updated 5/21/2020

 

---------------------------------

 

MONDAY, MAY 4, 2020

IMPORTANT INFORMATION FOR CANDIDATES FOR PHARMACIST LICENSURE BY EXAMINATION.  During the declared state of emergency to respond to the COVID-19 pandemic, the North Carolina Board of Pharmacy will not require licensure by exam applicants to submit a Certificate of Graduation with an affixed school seal.  Moreover, licensure by exam applicants may submit the certificate of graduation electronically, by uploading it to their application through the BOP Portal.  Applicants with questions about this process should contact Board licensing staff. 

 

---------------------------------

 

MONDAY, MARCH 30, 2020

MUTUAL DRUG COMPILING A LIST OF PHARMACISTS AND PHARMACY PERSONNEL TO ASSIST SHORT-STAFFED PHARMACIES DURING STATE OF EMERGENCY.  To mitigate any possible pharmacy staffing shortages during the COVID-19 outbreak, Mutual Drug is compiling a list of pharmacists, technicians, delivery drivers, and other pharmacy personnel who may be able to assist if a pharmacy becomes short-staffed. Please note that this resource will be made available to all pharmacies who may have a need. If you are willing to step in to assist a local pharmacy please complete the form below. Please contact Patrick Brown with any questions at pbrown@mutualdrug.com or 919-598-4970.

NC Backup Pharmacy Staffing Survey

 

---------------------------------

 

FRIDAY, MARCH 27, 2020 - BOARD ANNOUNCES NEW PROCESS FOR OUT-OF-STATE PHARMACISTS AND OUT-OF-STATE CERTIFIED TECHNICIANS TO OBTAIN AUTHORIZATION TO PRACTICE IN NORTH CAROLINA DURING THE DECLARED STATE OF EMERGENCY.   When Governor Cooper declared a state-wide emergency on March 10, 2020 to coordinate response to the COVID-19, that triggered operation of the Board’s Emergency Services Waiver.  The Emergency Services Waiver allows a pharmacist or nationally-certified technician who has a license and registration in good standing in another state to practice in North Carolina during the declared emergency without being licensed or registered with the Board, provided the pharmacist and pharmacist-technician is pre-cleared to do so. 

Effective immediately, out-of-state pharmacists and out-of-state certified technicians who wish to practice in North Carolina during the declared state of emergency must obtain an NABP Passport to do so.  The NABP Passport is a license verification process administered by the National Association of Boards of Pharmacy to assist in the pandemic response.

Individuals can obtain an NABP Passport at no cost by following these steps (screenshot instructions are available here.)

  1.  Navigate to NABP’s e-Profile system at https://dashboard.nabp.pharmacy/Login/Splash
  2. Click the  "Customers" tile.
  3. Enter your e-profile ID and Password.
  4. Click on the "My e-Profile" tile.
  5. Click on the tile labeled: “NABP Passport/COVID-19 Emergency”.   Note:  Your license information, including expiration date and license status must be current to access this tile.  If it is not current, please follow the instructions for updating.
  6. Follow the "Add a State” instructions on this page.  Check the attestation, and then click "Submit"
  7. NABP will verify your information and eligibility for a Passport.
  8. Once the NABP Passport for North Carolina is approved, you will be notified.  The North Carolina Board of Pharmacy will be notified as well, and you will then be eligible to practice in North Carolina during the state of emergency.

---------------------------------

 

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.

 

---------------------------------

 

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.
 

---------------------------------

FRIDAY, MARCH 20, 2020 - NORTH CAROLINA DEPARTMENT OF HEALTH & HUMAN SERVICES CALLS FOR HEALTH CARE VOLUNTEERS.

DHHS Secretary Mandy Cohen issued this call for volunteers today (March 20, 2020):

As you know we are facing an unprecedented crisis from COVID-19 that has already had devastating consequences internationally. With the virus now spreading in North Carolina, we need to bolster our health care system to ensure we can care for those impacted by the virus. A crucial component is recruiting volunteers to supplement our health care workforce. I am writing today to ask you to register as a volunteer.

We are working through our State Medical Response System (SMRS), to recruit and manage volunteers in the following areas:

If you are able to volunteer, please register though the NC Training, Exercise, and Response Management System (NC TERMS). That system can be accessed through: https://terms.ncem.org/TRS/. We are also asking volunteers to provide medical supplies if they are able, including personal protective equipment.

A letter from NCDHHS Secretary Mandy Cohen with additional information is found here.

A guide for the NC TERMS system is found here.

The response to COVID-19 will require action at every level of government. As a health care professional you are critical to helping us make sure our health care system is prepared and ready to respond to this unprecedented challenge.

Thank you for your commitment to protecting the health and wellbeing of all North Carolinians.

Back to Index/top of page

 

 

 

 

7) FEDERAL GUIDANCE

 

MONDAY, MAY 4, 2020

FDA CLARIFIES THAT NO COVID-19 ANTIBODY TESTS HAVE BEEN AUTHORIZED FOR ADMINISTRATION AT THE POINT-OF-CARE OR IN CLIA-WAIVED LABORATORIES .  Today (May 4, 2020), the FDA announced revisions to its March 16, 2020 policy concerning COVID-19 antibody tests.  As many pharmacists know, on March 16, the FDA announced a policy of "not objecting" to the introduction of certain COVID-19 antibody tests into the market prior to FDA review of those tests.  Since that time, "FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the  NIH."  Accordingly, FDA has clarified its guidance:   "Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing."  FDA’s updated guidance is found here:  https://www.fda.gov/media/135659/download 

In a statement accompanying the updated guidance (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy), FDA emphasized that its original guidance was:

intended to limit antibody testing laboratories certified under [CLIA] by [CMS] to perform testing in high-complexity and point-of-care settings when covered by such certificates – that is, labs with special clinical and technical expertise – as long the tests were properly validated and labeled as outlined in our policy, and the developer notified the FDA.  Under CLIA, only those laboratories are allowed to perform tests that have not been FDA authorized. . . . [I]t is not accurate for developers to claim their test was authorized by the FDA if an EUA was not granted for the tests, nor should they be distributing their test if it has not been properly validated.

Board staff have received several inquiries from pharmacies who have received marketing materials for point-of-care COVID-19 antibody tests claiming that they are “FDA authorized.”  They are not.  At present FDA has not issued an EUA for any COVID-19 antibody test to be administered in a laboratory holding a CLIA waiver.  See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#ivdnote1  

Pharmacies that receive marketing pitches for these non-FDA-authorized antibody tests are encouraged to report them to the North Carolina Attorney General’s office:  https://ncdoj.gov/covid19/

 

---------------------------------

 

WEDNESDAY, APRIL 22, 2020

CDC UPDATES COVID-19 TRANSMISSION PREVENTION GUIDANCE FOR PHARMACIES.  The CDC has updated its guidance for pharmacies to mitigate COVID-19 transmission risks.  Key updates:

The full guidance document is found here: https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html

Pharmacist-managers are reminded:

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. 

---------------------------------

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/.

---------------------------------

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:

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.

---------------------------------

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.

---------------------------------

THURSDAY, APRIL 9, 2020

FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES GUIDANCE FOR PHARMACISTS TO ORDER AND ADMINISTER COVID-19 TESTS.  HHS' Office of the Assistant Secretary for Health has issued guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to order and administer COVID-19 tests including serology tests that FDA has authorizedhttps://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf  Some questions likely to arise:

                1.  What COVID-19 tests has FDA authorized?  FDA has authorized certain in vitro diagnostics for detection and/or diagnosis of COVID-19.  More information is found here:  https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

                2.  Does North Carolina law prohibit a pharmacist from ordering and administering COVID-19 tests as authorized by HHS?  No.  As long reported by Board staff, North Carolina law does not prevent pharmacists practicing  from administering CLIA-waived tests (http://www.ncbop.org/faqs/Pharmacist/faq_CLIAwaivedTests.htm)  A COVID-19 test that has received an emergency use authorization (EUA) for use by health care providers at the point of care is deemed to be a CLIA-waived test and “for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver or Certificate of Compliance.”   https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#5e81a899c3e46

                3.  Who should receive COVID-19 tests under this authorization? HHS' guidance reminds all health care providers that Priority 1 for testing is hospitalized patients and healthcare facility workers with symptoms.  Priority 2 for testing are symptomatic patients in long-term facilities; symptomatic patients over age 65; symptomatic patients with underlying health conditions; and symptomatic first responders.  Priority 3 for is testing individuals in the surrounding community of rapidly increasing hospital cases to decrease community spread and ensure health of essential workers -- symptomatic critical infrastructure patients; other symptomatic individuals; healthcare facility workers and first responders; mildly symptomatic individuals in communities experiencing high numbers of COVID-19 hospitalizations.   Asymptomatic individuals are a non-priority.   More information is found here:  https://www.cdc.gov/coronavirus/2019-ncov/downloads/priority-testing-patients.pdf

              NC DHHS provider guidance emphasizes:  testing is not recommended for asymptomatic persons; patients in non-congregate settings with mild illness that does not progress do not need testing; and patients with clinical COVID-19 infection, in general, do NOT need a negative COVID-19 test result to document recovery.   NC DHHS also advises:

“Patients undergoing testing will be considered a person under investigation (PUI). Providers should give the Person Under Investigation Guidance (Spanish) to all patients undergoing testing and ensure patients are aware that they are expected to stay in isolation until results are back and longer if they are positive. Submitters should establish a clear plan with patients to inform them of their results. If the result is positive, further isolation may be required in coordination with the local health department. Providers are no longer being asked to fill out and submit a PUI form to the local health department for every patient for whom testing is ordered. Physicians and laboratories are still required to report suspected or confirmed cases of novel coronavirus infection to the state or local public health department via telephone or facsimile with basic contact information of the case. This is particularly important in high-risk settings such as congregate living facilities.”

More information here:  https://files.nc.gov/ncdhhs/documents/files/covid-19/COVID-19-Provider-Guidance-Final.pdf

               Critical to appropriate management of the pandemic is consistency in the who, what, when, where, and how of testing among health care providers.  Pharmacists must follow NC DHHS guidance and policies, and should frequently check NC DHHS’ COVID-19 resource page for updates:  https://www.ncdhhs.gov/divisions/public-health/covid19/covid-19-guidance

                4.  To whom should a pharmacist administering COVID-19 tests report results?  Pharmacists must report COVID-19 test results to the patient and the patient’s health care provider.  Board staff will update this FAQ with any additional reporting requirements from DHHS or other public health authorities.

                5.  What precautions must a pharmacist administering COVID-19 tests take?  As is true for any health care worker, pharmacists administering COVID-19 tests must use “appropriate combinations of engineering and administrative controls, safe work practices, and personal protective equipment (PPE) to prevent worker exposures.”  More information is found here:    https://files.nc.gov/ncdhhs/documents/files/covid-19/NC-DPH-Respiratory-Protection-Guidance-March-2020.pdf  and here:  https://www.osha.gov/SLTC/covid-19/controlprevention.html

                Furthermore, pharmacists-managers are reminded of their authority and responsibility to manage infection transmission risk in a pharmacy:  http://www.ncbop.org/COVID19.html#BOPWGD

                *     *     *

Pharmacists are encouraged to return to this guidance periodically, as it is a potentially fast-changing area.

 

---------------------------------

CDC COVID-19 Information and Resources: https://www.cdc.gov/coronavirus/2019-ncov/index.html

---------------------------------

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.

 

---------------------------------

SATURDAY, MARCH 14, 2020 - FDA ISSUES GUIDANCE TO INDUSTRY ON PREPARATION OF ALCOHOL-BASED HAND SANITIZER PRODUCTS DURING THE PUBLIC HEALTH EMERGENCY. The federal Food and Drug Administration issued guidance to pharmacies today on the preparation of alcohol-based hand sanitizer products during the public health emergency.  Board staff have fielded a number of calls and emails from pharmacies prior to this guidance and have consistently advised that pharmacies should exercise professional judgment and follow best practices in preparing hand sanitizer products during the COVID-19 pandemic response.  Today’s guidance from the FDA establishes those best practices.

---------------------------------

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

Back to Index/top of page

 

 

 

8) GUIDANCE FROM OTHER STATE/LOCAL AGENCIES

 

WEDNESDAY, APRIL 15, 2020

WHAT SHOULD PHARMACIES DO IF THEY SUSPECT THAT A SUPPLIER IS PRICE GOUGING?  Board staff have received messages from some pharmacists concerned about offers for sale of medication or supplies (including, especially, personal protective equipment (PPE)) at prices that beggar belief.  Crises bring out the absolute best in a lot of folks. Unfortunately, there are always folks who are less, let's say, public-minded in time of crisis.  Other adjectives come to mind, but you get the point.  North Carolina has a strong price-gouging statute that operates during emergency declarations.  Attorney General Josh Stein is aggressively enforcing it.  Effective enforcement, though, depends on reporting from those suspicious of price gouging behavior.  The Attorney General's COVID-19 resource page includes information on how to report suspected price gouging -- https://ncdoj.gov/covid19/. Any pharmacy, pharmacist, or DME supplier who suspects this behavior is strongly encouraged to contact the Attorney General's office. 

---------------------------------

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. 

---------------------------------

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.

Back to Index/top of page