2, 2022)Īll current SWSOs are available on the NCDHHS site on the following pages: and. Statewide Standing Order for FDA Authorized bivalent (original and Omicron BA.4/BA.5) Moderna COVID-19 Vaccine Administration in Patients 18 Years and Older (Sept.Statewide Standing Order for FDA Authorized bivalent (original and Omicron BA.4/BA.5) Pfizer-BioNTech COVID-19 Vaccine Administration in Patients 12 Years and Older (Sept.The Statewide Standing Order FDA EUA Moderna Bivalent Booster (18+) and Pfizer Bivalent Booster (12+) are now published online and available. State Health Director Betsey Tilson has issued statewide standing orders for the bivalent boosters, along with provider updates: On August 31, 2022, the Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize single booster dose bivalent formulations. STATE HEALTH DIRECTOR TILSON PUBLISHED STATEWIDE STANDING ORDERS FOR PFIZER AND MODERNA BIVALENT COVID-19 BOOSTER VACCINES. Requests are evaluated based on need and approved requests are currently being filled via transfer of pre-positioned product until direct distribution improves.įor questions regarding TPOXX, please contact SEPTEMBER 6, 2022 Providers in need of TPOXX, can place a request using this NC DHHS Monkeypox Medical Countermeasures Request Form. While distribution directly from the Strategic National Stockpile is currently limited, there are more than 900 courses of TPOXX pre-positioned at provider locations across the state. TPOXX is only available through the Strategic National Stockpile. Products are labeled in accordance with State and Federal dispensing laws.There is absolutely no charge to the patient for the drug or act of dispensing, including seeking reimbursement of dispensing fees through 3rd party payors.Physicians, Advanced Practice Registered Nurses and Physicians Assistants with active licensure in good standing with their respective governing bodies can prescribe and dispense TPOXX for treatment of monkeypox in accordance with the EA-IND, from their office, if the following conditions are met: Pharmacies dispensing TPOXX should ensure that signed, informed consent has been obtained by the prescriber prior to dispensing. Detailed information about the EA-IND protocol can be found here. This includes obtaining signed, informed consent from the patient prior to initiating treatment.
Prescribing physicians are responsible for completing the necessary paperwork associated with the EA-IND protocol. Treatment Information for Healthcare Professionals | Monkeypox | Poxvirus | CDC. CDC currently holds a non-research expanded access Investigational New Drug (EA-IND) protocol that allows for the use of TPOXX for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages. TPOXX (tecovirimat), an oral antiviral FDA-approved for the treatment of human smallpox disease, can be considered for treatment of monkeypox. In response to inquiries from practitioners in North Carolina, NCDHHS has issued the following information for pharmacists concerning TPOXX access.Īt this time, there are no FDA-approved treatments for monkeypox infection.
NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES INFORMATION FOR PHARMACISTS REGARDING ACCESS TO TPOXX FOR TREATMENT OF MONKEYPOX. NOTICE OF PUBLIC HEARING AND COMMENT PERIOD - JANU- ON THE FOLLOWING PROPOSED ACTIONS: COVID-19 VACCINATION AND THERAPEUTICS RELATED UPDATES AND RESOURCES.NC BOARD OF PHARMACY STAFF HAVE CONSOLIDATED AND ORGANIZED BY TOPIC ALL COVID-19 UPDATES AS FOLLOWS: Board meetings are live-streamed and past meetings are archived here.
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