[Updated] Access to Pharmacies and Prescription Refills after Hurricane Helene
Update 10/4/2024:
This post was updated on October 4 to include information about an exception authorized by the United States Drug Enforcement Agency (DEA) that enables pharmacists to use rule 21 N.C.A.C. 46 .1815 to to create and dispense emergency refills of Schedule III, IV, and V drugs for a limited period of time. This includes buprenorphine, a Schedule III drug that is widely used in the treatment of opioid use disorders. Please see the updated section titled “Update: Dispensing Controlled Substances” below.
Update 10/2/2024:
This post was updated on October 2 to include additional information about the dispensing of certain controlled substances in an emergency. Please see the updated section titled “Update: Dispensing Controlled Substances” below.
Introduction
Late last week, the remnants of Hurricane Helene moved through North Carolina and neighboring states, causing widespread destruction throughout western and parts of eastern North Carolina. It is nearly impossible to describe the full scope of the devastation caused by Helene, in part because some communities are still without electricity or cell service and are physically isolated due to collapsed or flooded roads and bridges. The AP reports that across the southeastern United States and as of October 1, over 150 people have been confirmed dead and hundreds more are missing. Many of those who survived the storm have lost their homes, businesses, and important belongings- including important prescription medications. This blog post explains how those impacted by Helene here in North Carolina can locate open pharmacies and access emergency refills of their prescription medications.
The State of Emergency
This blog post describes state insurance laws and North Carolina Board of Pharmacy (BOP) waivers that apply only in areas covered by an emergency declaration and for the duration of the declared emergency. The state of emergency declared by Governor Cooper on September 25, 2024 (Executive Order No. 315) applies statewide and the relevant portions of the declaration are in effect for 30 days, unless terminated sooner. Any future extensions of the emergency declaration and other emergency response actions taken via executive order will be documented here on the governor’s official website.
List of Pharmacies Open in Western North Carolina
The BOP is maintaining this list of pharmacies in western North Carolina that are open and serving patients. Pharmacies that want to be added to the list can notify the BOP via email at emergency@ncbop.org. The BOP has an online form that pharmacies can download, fill out, and email to the BOP as part of this process of notifying the BOP that the pharmacy is open.
Obtaining Prescription Refills
Emergency Refills
The BOP has promulgated two administrative rules that apply to emergency prescription refills: 21 N.C.A.C. 46 .1809 and 21 N.C.A.C. 46 .1815. Both rules allow one-time emergency supplies of prescription medications to be dispensed when the medication is essential to the maintenance of life or continuation of therapy in a chronic condition and certain other conditions are met. Under 21 N.C.A.C. 46 .1809, if a patient asks a pharmacist for a prescription refill and the pharmacist cannot obtain a refill authorization from the patient’s prescribing provider, the pharmacist may (but is not required to) dispense a one-time refill for up to a 30-day supply of the medication. Under 21 N.C.A.C. 46 .1815, a pharmacist may (but is not required to) dispense a one-time emergency supply of up to 90 days of a prescribed medication if the pharmacist cannot readily obtain a refill authorization from the patient’s prescribing provider because the prescribing provider is unable to provide medical services to the patient. These emergency refill procedures may not, however, be used to fill prescriptions for Schedule II controlled substances.
What does this look like in practice? Under these rules, a patient whose usual pharmacy or primary care provider is not available due to a natural disaster or death of the prescribing provider could go to a pharmacy elsewhere in North Carolina that they have never used before and obtain an emergency refill of a prescription medication. The patient can obtain an emergency refill this way even if there are no refills remaining on the current prescription.[1] Pharmacists may rely on the label on a patient’s medication bottle as presentation of a current valid prescription.[2]
Pharmacists that dispense emergency refills of medications under 21 N.C.A.C. 46 .1809 and .1815 should be aware of the rules’ requirements, including determinations about the necessity of the medication that must be made using the pharmacist’s professional judgment, documentation of the medications that are dispensed, and notice that must be given (or attempted to be given) to the original prescribing provider.
Insurance Coverage and “Early” Refills
On September 25, 2024, the North Carolina Department of Insurance (DOI) issued this bulletin reminding health insurance plans that are licensed to operate in the state of their legal responsibilities under G.S. 58-3-228. This statute says that insurers must allow and cover prescriptions that are otherwise being filled “too early” by people who reside in an area that is subject to an emergency declaration for 29 days following the issuance of the DOI bulletin, unless this time period is further extended by the DOI Commissioner.
What does this look like in practice? Let’s say that in the course of an emergency evacuation, someone lost their prescription medication or accidentally left it behind. The prescription is for a 30-day supply and has refills remaining, but the patient just filled their prescription last week- which means it would typically be too early to obtain a refill that would be covered by the patient’s health insurance. Under G.S. 58-3-228, if the patient is in or from an area covered by the emergency declaration (and as reminder, the current emergency declaration applies statewide) then the patient should be able to obtain a refill of their prescription and have it covered by their insurance, even if the prescription is otherwise being refilled early.
Non-Patient Picking Up Refills
What if someone other than the patient needs to pick up a refill? For most prescriptions, this may be done readily. However, under G.S. 90-106.1, the photo ID of the person for whom the prescription has been written must be presented before a Schedule II and certain Schedule III controlled substances can be dispensed. Someone other than the patient (e.g., a relative or a friend) can still pick up the prescription for the patient if they can present a valid copy of the patient’s ID.[3]
Many pharmacists may be subject to the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and its implementing regulations, which govern the privacy of health information. Because having a person other than the patient pick up a prescription inherently involves the sharing of that patient’s health information, pharmacists and other health professionals may wonder whether having someone else pick up a prescription creates an issue under HIPAA. The United States Department of Health and Human Services (HHS) has addressed this question on their website. According to HHS, pharmacists should use their best judgement but are generally permitted under 45 C.F.R. 164.510(b) to make disclosures of health information in these situations. This means that allowing someone other than the patient to pick up a patient’s prescription- to the extent it is permissible under other applicable law- does not likely create an issue under HIPAA.
Update: Dispensing Controlled Substances
DEA Exception Letter for Schedule III, IV, and V Controlled Substances, Including Buprenorphine
This section was added to the blog post on October 4, 2024. Please see the BOP’s webpage dedicated to Hurricane Helene updates for more information.
The DEA has issued an exception letter clarifying that 21 N.C.A.C. 46 .1815, North Carolina’s administrative rule governing emergency prescription refills when medical services are interrupted, may be used to create and dispense one-time, 90-day supply emergency refills of Schedule III, Schedule IV, and Schedule V controlled substances. This is particularly important for patients with a prescription for buprenorphine, which is a Schedule III drug that is used in the treatment of opioid use disorders. This exception is in effect for 30 days (until November 3, 2024) unless the DEA issues an extension. Pharmacists with questions about the implementation of this exception should contact the BOP.
The North Carolina STOP Act and Schedule II Controlled Substances
This section was added to the blog post on October 2, 2024 and is comprised of information copied directly from the BOP’s October 1, 2024 website publication regarding Hurricane Helene, which is available here.
From the BOP website:
“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.”
Emergency Related Waivers
Out-of-State Pharmacist and Pharmacy Technician Volunteers
Pursuant to its authority under G.S. 90-85.25(a), the BOP has authorized a waiver of specific provisions of the Pharmacy Practice Act (G.S. 90, Article 4A) and related regulations. The waiver allows pharmacists and nationally-certified pharmacy technicians who are licensed and have a registration in good standing in another state to provide services in parts of North Carolina that are subject to a declared state of emergency for the duration of that emergency declaration.
Pharmacists and nationally-certified pharmacy technicians coming into North Carolina from another state must give notice to the BOP before they begin providing services in North Carolina. More information about the BOP’s waiver and requirements for out-of-state professionals is available here. Pharmacists and pharmacy technicians can find more information about volunteering with the North Carolina Office of Emergency Medical Services on the BOP website.
Operation of a Pharmacy in a Temporary Location
The BOP’s waiver also allows permit holders (pharmacies) that are unable to operate in their permitted location to operate in a temporary location, subject to certain limitations and only for the duration of the declared emergency. Permit holders seeking to operate in a temporary location must first give notice to the BOP and may be required to obtain permission from the Executive Director of the BOP if the permit holder plans to operate more than 10 miles from their regularly permitted location. More information about the BOP waiver and specific requirements for permit holders seeking to operate in a temporary location is available here.
Additional Resources
Updates from NCDHHS and NCDPS
The North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Public Safety (NCDPS) are providing important updates on their websites, including information about waivers and regulatory flexibilities.
Licensed Health Care Professionals
The BOP has set up a webpage dedicated to Helene updates, which can be found here. Other licensed health care professionals should visit the websites for their respective licensing boards for information about any waivers or other updates that those licensing agencies may have issued.
Executive Orders
Executive orders issued by Governor Cooper, including orders related to the current state of emergency and Helene, will be documented and available on the governor’s official website here.
School of Government Resources
The School of Government has set up a webpage with information that may be useful to local governments during the Helene emergency response. This includes links to recent blog posts, a list of faculty areas of expertise, and information about upcoming Zoom office hours where local government officials can drop in and ask our faculty experts questions related to emergency response work. Additional materials, including templates and information about emergency procurement, debris removal, data sharing, and more, can also be found on the School’s emergency management microsite. The School will continue to update and add information and resources to both webpages over the coming days and weeks.
UNC Resources
The Carolina Center for Public Service is serving as the coordinating group for UNC-Chapel Hill’s Helene response work. For more information, please visit their website.
Disclaimers
The information provided in this blog post does not constitute legal or medical advice. The situation following a major natural disaster like Helene is constantly evolving. Legal requirements, licensing board guidance, and other standards may change over the coming weeks and months to address the ongoing emergency response. The author will do her best to make updates to this post as such changes occur.
Notes
[1] For additional information, see the North Carolina Board of Pharmacy’s “Pharmacy Related FAQs” website, and specifically the section titled “Prescriptions” and subsection titled “Refills”: https://www.ncbop.org/faqs/general-pharmacy-faqs.html. See also the section titled “Prescriber Retirement, Death, or Loss of License.”
[2] Personal correspondence between UNC School of Government faculty member Kirsten Leloudis and North Carolina Board of Pharmacy staff, on file with the author. North Carolina and federal law govern the minimum information that must be included on all prescription labels. See 21 U.S.C. 353(b)(2), G.S. 90-85.29, G.S. 106-134.1(b), and 21 N.C.A.C. 46 .1818.
[3] G.S. 90-106.1(c). See also North Carolina Board of Pharmacy, “Frequently Asked Questions about S.L. 2011-349, An Act to Direct Pharmacies to Require Photo Identification Prior to Dispensing Certain Controlled Substances,” https://www.ncbop.org/downloads/PhotoIDControlledSubstancesFAQ.pdf.
1
Coates’ Canons NC Local Government Law
[Updated] Access to Pharmacies and Prescription Refills after Hurricane Helene
Published: 10/01/24
Last-Revised: October 2, 2024
Author Name: Kirsten Leloudis
Update 10/4/2024:
This post was updated on October 4 to include information about an exception authorized by the United States Drug Enforcement Agency (DEA) that enables pharmacists to use rule 21 N.C.A.C. 46 .1815 to to create and dispense emergency refills of Schedule III, IV, and V drugs for a limited period of time. This includes buprenorphine, a Schedule III drug that is widely used in the treatment of opioid use disorders. Please see the updated section titled “Update: Dispensing Controlled Substances” below.
Update 10/2/2024:
This post was updated on October 2 to include additional information about the dispensing of certain controlled substances in an emergency. Please see the updated section titled “Update: Dispensing Controlled Substances” below.
Introduction
Late last week, the remnants of Hurricane Helene moved through North Carolina and neighboring states, causing widespread destruction throughout western and parts of eastern North Carolina. It is nearly impossible to describe the full scope of the devastation caused by Helene, in part because some communities are still without electricity or cell service and are physically isolated due to collapsed or flooded roads and bridges. The AP reports that across the southeastern United States and as of October 1, over 150 people have been confirmed dead and hundreds more are missing. Many of those who survived the storm have lost their homes, businesses, and important belongings- including important prescription medications. This blog post explains how those impacted by Helene here in North Carolina can locate open pharmacies and access emergency refills of their prescription medications.
The State of Emergency
This blog post describes state insurance laws and North Carolina Board of Pharmacy (BOP) waivers that apply only in areas covered by an emergency declaration and for the duration of the declared emergency. The state of emergency declared by Governor Cooper on September 25, 2024 (Executive Order No. 315) applies statewide and the relevant portions of the declaration are in effect for 30 days, unless terminated sooner. Any future extensions of the emergency declaration and other emergency response actions taken via executive order will be documented here on the governor’s official website.
List of Pharmacies Open in Western North Carolina
The BOP is maintaining this list of pharmacies in western North Carolina that are open and serving patients. Pharmacies that want to be added to the list can notify the BOP via email at emergency@ncbop.org. The BOP has an online form that pharmacies can download, fill out, and email to the BOP as part of this process of notifying the BOP that the pharmacy is open.
Obtaining Prescription Refills
Emergency Refills
The BOP has promulgated two administrative rules that apply to emergency prescription refills: 21 N.C.A.C. 46 .1809 and 21 N.C.A.C. 46 .1815. Both rules allow one-time emergency supplies of prescription medications to be dispensed when the medication is essential to the maintenance of life or continuation of therapy in a chronic condition and certain other conditions are met. Under 21 N.C.A.C. 46 .1809, if a patient asks a pharmacist for a prescription refill and the pharmacist cannot obtain a refill authorization from the patient’s prescribing provider, the pharmacist may (but is not required to) dispense a one-time refill for up to a 30-day supply of the medication. Under 21 N.C.A.C. 46 .1815, a pharmacist may (but is not required to) dispense a one-time emergency supply of up to 90 days of a prescribed medication if the pharmacist cannot readily obtain a refill authorization from the patient’s prescribing provider because the prescribing provider is unable to provide medical services to the patient. These emergency refill procedures may not, however, be used to fill prescriptions for Schedule II controlled substances.
What does this look like in practice? Under these rules, a patient whose usual pharmacy or primary care provider is not available due to a natural disaster or death of the prescribing provider could go to a pharmacy elsewhere in North Carolina that they have never used before and obtain an emergency refill of a prescription medication. The patient can obtain an emergency refill this way even if there are no refills remaining on the current prescription.[1] Pharmacists may rely on the label on a patient’s medication bottle as presentation of a current valid prescription.[2]
Pharmacists that dispense emergency refills of medications under 21 N.C.A.C. 46 .1809 and .1815 should be aware of the rules’ requirements, including determinations about the necessity of the medication that must be made using the pharmacist’s professional judgment, documentation of the medications that are dispensed, and notice that must be given (or attempted to be given) to the original prescribing provider.
Insurance Coverage and “Early” Refills
On September 25, 2024, the North Carolina Department of Insurance (DOI) issued this bulletin reminding health insurance plans that are licensed to operate in the state of their legal responsibilities under G.S. 58-3-228. This statute says that insurers must allow and cover prescriptions that are otherwise being filled “too early” by people who reside in an area that is subject to an emergency declaration for 29 days following the issuance of the DOI bulletin, unless this time period is further extended by the DOI Commissioner.
What does this look like in practice? Let’s say that in the course of an emergency evacuation, someone lost their prescription medication or accidentally left it behind. The prescription is for a 30-day supply and has refills remaining, but the patient just filled their prescription last week- which means it would typically be too early to obtain a refill that would be covered by the patient’s health insurance. Under G.S. 58-3-228, if the patient is in or from an area covered by the emergency declaration (and as reminder, the current emergency declaration applies statewide) then the patient should be able to obtain a refill of their prescription and have it covered by their insurance, even if the prescription is otherwise being refilled early.
Non-Patient Picking Up Refills
What if someone other than the patient needs to pick up a refill? For most prescriptions, this may be done readily. However, under G.S. 90-106.1, the photo ID of the person for whom the prescription has been written must be presented before a Schedule II and certain Schedule III controlled substances can be dispensed. Someone other than the patient (e.g., a relative or a friend) can still pick up the prescription for the patient if they can present a valid copy of the patient’s ID.[3]
Many pharmacists may be subject to the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and its implementing regulations, which govern the privacy of health information. Because having a person other than the patient pick up a prescription inherently involves the sharing of that patient’s health information, pharmacists and other health professionals may wonder whether having someone else pick up a prescription creates an issue under HIPAA. The United States Department of Health and Human Services (HHS) has addressed this question on their website. According to HHS, pharmacists should use their best judgement but are generally permitted under 45 C.F.R. 164.510(b) to make disclosures of health information in these situations. This means that allowing someone other than the patient to pick up a patient’s prescription- to the extent it is permissible under other applicable law- does not likely create an issue under HIPAA.
Update: Dispensing Controlled Substances
DEA Exception Letter for Schedule III, IV, and V Controlled Substances, Including Buprenorphine
This section was added to the blog post on October 4, 2024. Please see the BOP’s webpage dedicated to Hurricane Helene updates for more information.
The DEA has issued an exception letter clarifying that 21 N.C.A.C. 46 .1815, North Carolina’s administrative rule governing emergency prescription refills when medical services are interrupted, may be used to create and dispense one-time, 90-day supply emergency refills of Schedule III, Schedule IV, and Schedule V controlled substances. This is particularly important for patients with a prescription for buprenorphine, which is a Schedule III drug that is used in the treatment of opioid use disorders. This exception is in effect for 30 days (until November 3, 2024) unless the DEA issues an extension. Pharmacists with questions about the implementation of this exception should contact the BOP.
The North Carolina STOP Act and Schedule II Controlled Substances
This section was added to the blog post on October 2, 2024 and is comprised of information copied directly from the BOP’s October 1, 2024 website publication regarding Hurricane Helene, which is available here.
From the BOP website:
“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.”
Emergency Related Waivers
Out-of-State Pharmacist and Pharmacy Technician Volunteers
Pursuant to its authority under G.S. 90-85.25(a), the BOP has authorized a waiver of specific provisions of the Pharmacy Practice Act (G.S. 90, Article 4A) and related regulations. The waiver allows pharmacists and nationally-certified pharmacy technicians who are licensed and have a registration in good standing in another state to provide services in parts of North Carolina that are subject to a declared state of emergency for the duration of that emergency declaration.
Pharmacists and nationally-certified pharmacy technicians coming into North Carolina from another state must give notice to the BOP before they begin providing services in North Carolina. More information about the BOP’s waiver and requirements for out-of-state professionals is available here. Pharmacists and pharmacy technicians can find more information about volunteering with the North Carolina Office of Emergency Medical Services on the BOP website.
Operation of a Pharmacy in a Temporary Location
The BOP’s waiver also allows permit holders (pharmacies) that are unable to operate in their permitted location to operate in a temporary location, subject to certain limitations and only for the duration of the declared emergency. Permit holders seeking to operate in a temporary location must first give notice to the BOP and may be required to obtain permission from the Executive Director of the BOP if the permit holder plans to operate more than 10 miles from their regularly permitted location. More information about the BOP waiver and specific requirements for permit holders seeking to operate in a temporary location is available here.
Additional Resources
Updates from NCDHHS and NCDPS
The North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Public Safety (NCDPS) are providing important updates on their websites, including information about waivers and regulatory flexibilities.
Licensed Health Care Professionals
The BOP has set up a webpage dedicated to Helene updates, which can be found here. Other licensed health care professionals should visit the websites for their respective licensing boards for information about any waivers or other updates that those licensing agencies may have issued.
Executive Orders
Executive orders issued by Governor Cooper, including orders related to the current state of emergency and Helene, will be documented and available on the governor’s official website here.
School of Government Resources
The School of Government has set up a webpage with information that may be useful to local governments during the Helene emergency response. This includes links to recent blog posts, a list of faculty areas of expertise, and information about upcoming Zoom office hours where local government officials can drop in and ask our faculty experts questions related to emergency response work. Additional materials, including templates and information about emergency procurement, debris removal, data sharing, and more, can also be found on the School’s emergency management microsite. The School will continue to update and add information and resources to both webpages over the coming days and weeks.
UNC Resources
The Carolina Center for Public Service is serving as the coordinating group for UNC-Chapel Hill’s Helene response work. For more information, please visit their website.
Disclaimers
The information provided in this blog post does not constitute legal or medical advice. The situation following a major natural disaster like Helene is constantly evolving. Legal requirements, licensing board guidance, and other standards may change over the coming weeks and months to address the ongoing emergency response. The author will do her best to make updates to this post as such changes occur.
Notes
[1] For additional information, see the North Carolina Board of Pharmacy’s “Pharmacy Related FAQs” website, and specifically the section titled “Prescriptions” and subsection titled “Refills”: https://www.ncbop.org/faqs/general-pharmacy-faqs.html. See also the section titled “Prescriber Retirement, Death, or Loss of License.”
[2] Personal correspondence between UNC School of Government faculty member Kirsten Leloudis and North Carolina Board of Pharmacy staff, on file with the author. North Carolina and federal law govern the minimum information that must be included on all prescription labels. See 21 U.S.C. 353(b)(2), G.S. 90-85.29, G.S. 106-134.1(b), and 21 N.C.A.C. 46 .1818.
[3] G.S. 90-106.1(c). See also North Carolina Board of Pharmacy, “Frequently Asked Questions about S.L. 2011-349, An Act to Direct Pharmacies to Require Photo Identification Prior to Dispensing Certain Controlled Substances,” https://www.ncbop.org/downloads/PhotoIDControlledSubstancesFAQ.pdf.
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