Helene Relief and Recovery Updates for Pharmacies


Latest News, Thursday, October 3:

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.

*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.

*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.

This information, and other Helene response updates, are being compiled on the BOP’s website here: https://www.ncbop.org/heleneaftermath.html

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.

Tuesday, October 1, 2024

To our Pharmacy Community:

Board members and staff support your efforts to ensure that patient needs are being met in the areas devastated by Helene. Board members and staff support you, and know that you will use your compassion and good judgment to deal with the crisis. Board staff are constantly updating this website with information. Some particularly important notifications are repeated below. Board staff are available by phone at any time – 919-246-1050.



BOARD STAFF COMPILING AND PUBLISHING A LIST OF PHARMACIES THAT ARE OPEN IN HELENE-AFFECTED COUNTIES. To assist patients and emergency response coordinators, Board staff are compiling a list of pharmacies in Helene-affected counties that have reported they are able to provide patient services. Any pharmacy that is open in these counties is encouraged to send in a notice. A short, fillable form requesting basic information is found here. Please save the form after completing and email to: emergency@ncbop.org. The list of responding pharmacies is found here.



EMERGENCY REFILL AUTHORIZATION. 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 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.



EMERGENCY RELIEF EFFORT VOLUNTEERING. Pharmacists and pharmacy technicians wishing to volunteer for relief and recovery operations should notify the NCDHHS Division of Public Health, and Public Health Preparedness. Please use the following link to sign up: https://nc.readyop.com/fs/4efP/11ea5584. Deployment for at least 3 consecutive days is preferred. Please use the comments section on the linked form to provide details about your availability. Questions about the form or operations should be submitted by email to OEMSSupportCell@dhhs.nc.gov.



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.



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.