Helene Relief & Recovery Updates for Pharmacy Practitioners

FEDERAL RESOURCES / EMERGENCY PRESCRIPTION ASSISTANCE / USP RESPONDS

HHS SECRETARY BECERRA PROVIDES UPDATE ON EFFORTS UNDERWAY TO MITIGATE SUPPLY CHAIN DISRUPTIONS CAUSED BY BAXTER FACILITY DAMAGE

UPDATED 10/17/24 TO INCLUDE THIS UPDATE FROM US PHARMACOPEIA (USP): "USP, with input from our Compounding Expert Committee members and stakeholders, is providing the following resources intended to support healthcare practitioners and scientific professionals to address shortages of manufactured intravenous fluids resulting from the consequences of Hurricane Helene” (follow this link for details.)

UPDATED 10/15/24 TO INCLUDE THIS HEALTH ADVISORY FROM THE CDC: Disruptions in Availability of Peritoneal Dialysis and Intravenous Solutions from Baxter International Facility in North Carolina. Follow this link for details.

10/10/24 - Federal Department of Health and Human Services Secretary Becerra has issued a letter concerning federal efforts to mitigate sterile solutions supply chain disruptions attributable to significant damage to Baxter’s Marion, NC facility. FDA has established a continually updating information page here. Baxter has likewise established a continually updating information page here.

FEDERAL EMERGENCY PRESCRIPTION ASSISTANCE PROGRAM TO OPEN FOR CERTAIN HELENE-IMPACTED NORTH CAROLINA COUNTIES

The Emergency Prescription Assistance Program, or EPAP, helps people in a federally-identified disaster area who do not have health insurance get the prescription drugs, vaccinations, medical supplies, and equipment that they need. This program helps people and communities better cope with a disaster and reduces stress on the healthcare system. People who are eligible for EPAP can file a claim at more than 72,000 retail pharmacies across the United States and its territories for prescription items that were lost, stolen, or destroyed because of a disaster. EPAP is open for certain Helene-impacted North Carolina counties. Pharmacists and the public should monitor this site -- https://aspr.hhs.gov/EPAP/Pages/default.aspx - for developments.

Additional EPAP resources:
What You Need to Know about: The Emergency Prescription Assistance Program (hhs.gov)
Lo que debe saber sobre: El programa de asistencia para medicamentos en casos de emergencia (hhs.gov)
Emergency Prescription Assistance Program (EPAP) Fact Sheet (hhs.gov)
Hoja Informativa: Programa de Asistencia para Medicamentos de Emergencia (EPAP) (hhs.gov)

NC HEALTHCONNEX / NC HEALTH INFORMATION EXCHANGE

NC HEALTH CONNEX AND THE NC HEALTH INFORMATION EXCHANGE ACT (NC HIEA)

Dear North Carolina Health Care Provider Community,

The NC HealthConnex team is committed to supporting those most in need in western North Carolina impacted by Hurricane Helene. The NC HealthConnex Clinical Portal is a web-based application that allows providers to access critical clinical information such as medical history, medications and treatment plans for displaced patients.

Here are some steps you need to gain access based on your current participation status with the NC HIEA.

If you currently have a Full Participation Agreement:

• A Full Participation Agreement and login credentials are required to utilize this service.

• Current participants can request credentials by contacting the NC HealthConnex Help Desk at HIESupport@sas.com. For after hours or weekend support, please call 919-531-2700 for immediate assistance.

•Providers with credentials can access the portal from any web browser by visiting https://portal.nchealthconnex.net.

•After searching for a patient, you will need to click “Declare Patient Relationship” to look up patients with whom you do not have a previous treatment relationship. This action will attest that you have a reason to be accessing this patient’s information.

•To get started using the NC HealthConnex Clinical Portal, please see this Quick Start Reference Guide or view this demonstration video.

If you have a Submission Only Participation Agreement:

•You will need a Full Participation Agreement in order to gain access to the NC HealthConnex Clinical Portal. A Submission Only agreement is not sufficient.

•In order to switch to a Full Participation Agreement, please contact the NC HIEA Provider Relations team via email at hiea@nc.gov or via phone at 919-754-6912.

•In order to facilitate timely patient care, the provider relations team is prepared to expedite requests for affected providers.

If you do not have an agreement on file with the NC HIEA:

•The NC HIEA can expedite enrollment for new providers in the western part of the state and can provide training on the use of systems, etc. Please contact the NC HIEA Provider Relations team via email at hiea@nc.gov or via phone at 919-754-6912.

If you are a user of the NC HealthConnex Clinical Portal and experience any issues over the weekend, you will need to call the Help Desk at 919-531-2700.

Sincerely,

The NC HIEA Team
Mail Service Center 4101
Raleigh, NC 27699-4101

STATE RESOURCES / UPDATES FROM NC DHHS / STATE HEALTH DIRECTOR’S STANDING ORDERS

HELENE STATE OF EMERGENCY EXTENDED THROUGH MARCH 1, 2025

On October 24, 2024, the General Assembly passed and Governor Cooper signed into law the Disaster Recovery Act of 2024 . Section 3.1 of the Act extends the Governor’s declared state of emergency through March 1, 2025. Accordingly, waivers issued by the Board of Pharmacy to facilitate Helene relief and recovery remain in effect through March 1, 2025 unless the Board acts to terminate them prior to that date.

STATE HEALTH DIRECTOR ISSUES STANDING ORDER FOR PHARMACISTS TO DISPENSE EPINEPHRINE AUTO-INJECTORS

To assist with Helene recovery, State Health Director Betsey Tilson has issued a standing order authorizing pharmacists licensed in North Carolina or practicing in North Carolina pursuant to the Board’s emergency waiver to dispense epinephrine auto-injectors to:

● Persons who request epinephrine auto injector for the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis

● Persons who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reaction

● Persons who voluntarily request epinephrine auto injector and are the caregiver, family member or friend of a person at risk of experiencing or have a history of an anaphylactic reaction

● Entities such as EMS agencies, disaster relief agencies, those operating Tropical Storm Helene shelters who voluntarily request epinephrine auto injectors and are in the position to assist a person at risk of experiencing an anaphylactic reaction.

The standing order is here.

EMERGENCY VERIFY CREDENTIAL

NABP ESTABLISHES EMERGENCY VERIFY CREDENTIAL FOR OUT-OF-STATE PHARMACISTS ASSISTING WITH HELENE RECOVERY EFFORTS

October 8, 2024: The Board of Pharmacy has exercised its authority under G.S. 90-85.25(a) to waive certain requirements of the North Carolina Pharmacy Practice Act to facilitate the provision of patient care during a declared emergency. The Board’s emergency waiver is now in effect and is found here. That waiver allows pharmacists who hold a license in good standing in another state to practice in North Carolina during the period of the declared emergency. NABP has established an emergency Verify credential that out-of-state pharmacists wishing to practice in North Carolina during the Helene emergency may obtain without cost. Instructions for obtaining an emergency Verify credential are found here.

An out-of-state pharmacist must obtain an emergency Verify credential to practicing during the emergency. Once obtained, no further communication with the Board is needed. The Board will maintain a list of out-of-state pharmacists holding the emergency Verify credential found here.

VOLUNTEER OPPORTUNITIES

EMERGENCY RELIEF EFFORT VOLUNTEERING

Thank you to all the pharmacists and pharmacy technicians who volunteered to support Helene response efforts in Western NC. At this time, NC DHHS is no longer seeking additional volunteers. NC DHHS will continue to utilize the list of individuals who have already volunteered to fulfill response missions as needed. The outpouring of support from the pharmacy community has been amazing. Thank you!

NC Department of Health and Human Services, Division of Public Health, Public Health Preparedness and Response Branch

NC BOARD OF PHARMACY WAIVERS / RULE REMINDERS / CS DISPENSING GUIDANCE / EMERGENCY PRESCRIPTION AUTHORITY

HELENE STATE OF EMERGENCY EXTENDED THROUGH MARCH 1, 2025

On October 24, 2024, the General Assembly passed and Governor Cooper signed into law the Disaster Recovery Act of 2024. Section 3.1 of the Act extends the Governor’s declared state of emergency through March 1, 2025. Accordingly, waivers issued by the Board of Pharmacy to facilitate Helene relief and recovery remain in effect through March 1, 2025 unless the Board acts to terminate them prior to that date.

BOARD EMERGENCY WAIVERS IN PLACE

The Board has exercised its authority under G.S. 90-85.25(a) to waive certain requirements of the North Carolina Pharmacy Practice Act to facilitate the provision of patient care during a declared emergency. The Board’s emergency waiver is now in effect and is found here. That waiver allows pharmacists and nationally-certified technicians who hold a license in good standing in another state to practice in North Carolina to assist during the period of the declared emergency. The waiver also authorizes relocations of pharmacies as needed to provide continuity of care. Certain notifications to the Board are required. The referenced notification email address – emergency@ncbop.org – is open. If a pharmacy needs to relocate to continue operations, once the notice is sent to emergency@ncbop.org, Board staff will reply to acknowledge receipt and approval. The pharmacy should then send that approval email to the DEA to request a waiver for a temporary location by email to natural.disaster2@dea.gov.

BOARD AND DRUG CONTROL UNIT STAFF PROVIDE REASSURANCE ON PHOTO IDENTIFICATION REQUIREMENTS FOR DISPENSING CERTAIN CONTROLLED SUBSTANCES TO HELENE-AFFECTED PATIENTS

North Carolina law requires production of a photo identification prior to dispensing Schedule II controlled substances, and certain Schedule III controlled substances. More information on that requirement here. Board staff have conferred with staff at NCDHHS Drug Control Unit about this requirement in Helene-affected areas and for Helene-affected patients. If a patient impacted by Helene presents with a prescription that ordinarily requires identification, do the best you can. If the patient is known to you or has any form of identification, that’s acceptable. If the patient is not known to you and has no type of identification (which is likely to be the case for some folks displaced by Helene), use your best professional judgment. If, in the exercise of that judgment (which should include checking the CSRS if possible), the prescription is clinically appropriate and the patient (or person picking up for the patient) is the appropriate recipient, dispense without concern over identification.

DEA APPROVES USE OF BOARD RULE .1815 TO CREATE AND DISPENSE EMERGENCY REFILLS OF SCHEDULE 3, 4, AND 5 CONTROLLED SUBSTANCES

Board Rule .1815 authorizes pharmacists to provide a one-time emergency refill of up to a 90-day supply when the pharmacist is unable to obtain refill authorization from the prescriber due to the prescriber’s inability to provide medical services to the patient. This authority was specifically created for times of emergency like those in western North Carolina. Pharmacists are encouraged to use it to assist patients in affected counties. The DEA has issued an exception letter allowing Rule .1815 to be used to create and dispense emergency refills of Schedule 3, 4, and 5 substances (found here). This exception is in effect for 30 days (until November 3, 2024), though DEA states that it will consider a further extension if emergency conditions continue to exist at that time. Board staff thanks DEA Agent Stevie Ikner and DEA Assistant Administrator Tom Prevoznik for their quick response to this patient need.

EMERGENCY REFILL AUTHORIZATION

Board Rule .1815 authorizes pharmacists and DME providers to provide a one-time emergency refill of up to a 90-day supply when the pharmacist or DME provider is unable to obtain refill authorization from the prescriber due to the prescriber’s inability to provide medical services to the patient. This authority was specifically created for times of emergency like those in western North Carolina. Pharmacists and DME providers are encouraged to use it to assist patients in affected counties. The NC Department of Insurance has reminded health benefit plans of compliance requirements for operations under a state of emergency for purposes of obtaining extra prescriptions during a state of emergency or disaster.

*REMINDER* CONTROLLED SUBSTANCE PRESCRIPTION FORMATS

The North Carolina STOP Act requires that prescriptions for “targeted controlled substances” to be transmitted electronically unless an exception applies. One exception is “technical failure or other circumstance preventing electronic transmission.” For obvious reasons, transmission or receipt of electronic prescriptions in Helene-affected counties is likely to be problematic. Accordingly, the STOP Act’s electronic transmission provisions are not a reason to decline filling a controlled substance prescription issued for a legitimate medical purpose in the ordinary course of medical practice. More STOP Act information is found here.

Pharmacists are also reminded that, in the case of an “emergency situation,” federal law (21 CFR 1306.11(d)) allows a pharmacist to dispense a Schedule II controlled substance upon receiving oral authorization from the prescriber, provided that: (1) the amount is limited to that adequate to treat the patient during the emergency period; (2) the prescription is immediately reduced to writing by the pharmacist; (3) if the prescriber is not known to the pharmacist, the pharmacist makes a reasonable effort to determine the oral authorization came from a DEA-registered prescriber; and (4) within 7 days, the prescriber causes a written prescription to be delivered to the dispensing pharmacist.

*REMINDER* VERBAL SCHEDULE 2 PRESCRIPTIONS IN EMERGENCIES

Pharmacists are reminded that, in the case of an “emergency situation,” federal law (21 CFR 1306.11(d)) allows a pharmacist to dispense a Schedule II controlled substance upon receiving oral authorization from the prescriber, provided that: (1) the amount is limited to that adequate to treat the patient during the emergency period; (2) the prescription is immediately reduced to writing by the pharmacist; (3) if the prescriber is not known to the pharmacist, the pharmacist makes a reasonable effort to determine the oral authorization came from a DEA-registered prescriber; and (4) within 7 days, the prescriber causes a written prescription to be delivered to the dispensing pharmacist.

The Board continues to compile a resource listing pharmacies in Helene-affected counties that have resumed operation. The list is found here -- https://www.ncbop.org/emergencyoperatingpharmacieshelene.html -- and it includes a link for pharmacies to let the Board know that they are operational.





BOARD STAFF ARE HERE TO SUPPORT YOU AND WE’RE AVAILABLE AT (919) 246-1050 OR BY EMAIL.


10:30AM, 11/20/24