During the 2023 Legislative Session, the General Assembly passed, and the Governor signed into law, a statute making gabapentin a drug whose dispensing must be reported to the Controlled Substance Reporting System (CSRS). Gabapentin becomes reportable on March 1, 2024. The Drug Control Unit, which administers the CSRS, has created an FAQ guidance document for dispensers. Pharmacists with additional questions should contact the Drug Control Unit. 

Note that based on an NC Retail Merchants Association amendment, pharmacies are not required to report gabapentin to the CSRS when gabapentin is a component of a compounded prescription that is dispensed in dosages of 100 milligrams or less; see new G.S. 90-113.73(c)(1). 

Also in North Carolina, on January 10, Medicaid released the following concerning pharmacy eligibility to serve as Medicaid providers. All questions should be directed to Medicaid. 

Beginning in May 2021, NC Medicaid started taking additional steps, as outlined in the NCTracks Changes to Provider Verification Process bulletin, to ensure providers meet their contractual obligation to maintain their credentials on their NCTracks provider enrollment record. Multiple bulletin articles were published to notify providers of the change, and providers receive four targeted reminders prior to their suspension notification. Regardless of these efforts to inform and assist providers with this responsibility, we continue to see a fairly large number suspended, and subsequently terminated, from the NC Medicaid program due to their expired credential.

For this reason, and as part of an additional outreach effort, we are notifying NC associations when the number of provider taxonomy suspensions exceeds a defined threshold of unique providers on the report received at the end of each month.

On December 31, 2023, approximately 115 Pharmacist providers were suspended due to an expired credential. These providers have sixty days from the date of suspension to ensure that their license is renewed, and their NCTracks provider enrollment record is updated to avoid termination. Providers may update their NCTracks provider record through the Manage Change Request process. NCTracks User Guides and Fact Sheets offer basic instructions for making the necessary update and any additional questions may be referred to the NCTracks Call Center at 800-668-6696. 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

The Board of Pharmacy has completed its rulemaking on the authorization for, and regulation of, the use of direct-to-patient (DTP) dispensing systems. Board Rule .1821 provides that authorization and the standards that apply to the use of DTP systems. Board Rule .1616 authorizes limited service permits to be issued for operation of a DTP system when the system is not located on-site at the home pharmacy. 

The board staff has completed programming to implement a limited-service permit application for an off-site DTP system and to allow an existing pharmacy to notify the Board that it will deploy an on-site DTP system.  

Detailed guidance on the rules and standards governing DTP systems, as well as step-by-step instructions to add an on-site DTP system to an existing pharmacy’s services or to apply for an off-site DTP system limited-service permit are found here. 

The general limited-service permit guidance document has also been updated to include information on DTP system permits. 

Also in North Carolina, effective November 1, Medicaid waived the copay for antiretrovirals used to decrease viral load in members living with HIV (Human Immunodeficiency Virus). 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

IMMUNIZING PHARMACISTS’ AUTHORITY TO ADMINISTER COVID-19 AND FLU VACCINES TO PEDIATRIC PATIENTS. With flu and COVID vaccine season upon us, several pharmacists have reached out to Board staff about immunizing pharmacist authority to administer flu and COVID vaccine to pediatric patients. With all the recent changes to North Carolina law and PREP (Public Readiness and Emergency Preparedness) Act declarations, it can be confusing. Here is the skinny on flu and COVID vaccine authority: 

1. PREP Act declarations authorizing pharmacists to administer flu and COVID vaccine to patients aged 3 years and older are still in effect and will be until December 31, 2024. 

1. State law now allows immunizing pharmacists to administer flu and COVID vaccine to patients aged 7 years and older pursuant to protocol and parental permission. State law allows immunizing pharmacists to administer any ACIP-recommended vaccine to patients 6 and older pursuant to prescription and parental permission. 

1. So, for flu and COVID – immunizing pharmacists can administer to patients 3 years and older and can do that under their own authority under the PREP Act. Immunizing pharmacists can also use Dr. Tilson’s statewide standing order to do this for COVID vaccine (which typically makes billing and recordkeeping easier). These paths are available until December 31, 2024. 

1. After December 31, 2024, immunizing pharmacists can administer flu and COVID vaccine pursuant to protocol, but only to patients aged 7 years or older, or pursuant to prescription for patients aged 6 years or older. 

For a comprehensive overview of immunizing pharmacist authority, see the FAQ guidance. 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

Governor Roy Cooper (D) declared a State of Emergency ahead of the impact of Hurricane Idalia. Pharmacists are reminded that a state of emergency declaration triggers obligations for health benefit plans to cover emergency refills of prescriptions. More information from the NC Department of Insurance is here. Pharmacists and pharmacies are reminded that 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. With Hurricane Idalia’s approach, now is the time to review that policy and start implementing plans to ensure continuity of patient care. 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

State Health Director Dr. Betsey Tilson will hold a Provider Webinar on Wednesday, September 6 from 12:30 p.m. to 1:00 p.m. EST concerning the upcoming fall vaccines. See information below.  

Join ZoomGov Meeting:
https://protect-us.mimecast.com/s/gWEfCo28zRFr1qK1I1Zx5d?domain=zoomgov.com 

Also in North Carolina, Gov. Roy Cooper (D) declared a State of Emergency ahead of the impact of Hurricane Idalia. Pharmacists are reminded that a state of emergency declaration triggers obligations for health benefit plans to cover emergency refills of prescriptions. More information from the NC Department of Insurance is here. Pharmacists and pharmacies are reminded that 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. With Hurricane Idalia’s approach, now is the time to review that policy and start implementing plans to ensure continuity of patient care. The policy is found here. 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

The Board of Pharmacy issued updated guidance on immunization authority for pharmacists, pharmacy technicians and pharmacy interns. This updated guidance relates to legislation initiated in the 2023 Legislative Session (SB 206 and HB 190). 

Also in North Carolina, please see the August Medicaid Newsletter which contains essential information on expiration of current standing orders (contraceptives, naloxone, tobacco cessation, PEP (Post Exposure Prophylaxis)) as well as information on donation programs, 72-hour emergency supplies and PDL (Preferred Drug List) updates. 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

Proposed Rules from the Board of Pharmacy concerning direct-to-patient delivery systems (21 NCAC 46.1821) are slated for a public hearing on June 13 and written comments are due to the Board by June 16.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

Please see the May 2023 North Carolina Medicaid Pharmacy Newsletter.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

The Board of Pharmacy announced it is pursuing administrative rulemaking concerning “direct-to-patient delivery systems” for pharmacies allowing for technologies where drugs are dispensed directly to patients. The Board will host a public hearing on this issue on June 13, and written comments are due by June 16.  Below is more information on this proposed rule which the North Carolina Retail Merchants Association is in the process of analyzing.   

PUBLIC HEARING AND COMMENT PERIOD — JUNE 13, 2023 — ON THE FOLLOWING PROPOSED ACTIONS: 

ADOPTION OF 21 NCAC 46 .1821 DIRECT-TO-PATIENT DELIVERY SYSTEMS 

AMENDMENT TO 21 NCAC 46 .1616 LIMITED SERVICE PERMITS 

Reason for Proposed Action: 

The Board of Pharmacy proposes to adopt a rule permitting pharmacies to employ certain direct to patient systems, which are technologies that dispense drugs directly to patients. The proposed rule contains provisions to allow pharmacies to comply with the laws governing dispensing drugs, devices, or medical equipment while using these systems. The proposed rule further contains provisions that would ensure that the systems can be used safely and securely, that required records are maintained, that the home pharmacy can adequately supervise and service these systems, and that patients may use these systems while also receiving information, safeguards and counseling that they need to use their drugs, devices, and medical equipment safely. There is an accompanying proposed change to the Board of Pharmacy’s limited-service permit rules to provide for permitting of systems that a pharmacy may place in a location other than the home pharmacy’s facility. 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.