Section 1140-03-.18 - PROVISION OF IVERMECTIN(1) A pharmacist may provide ivermectin under this rule to eligible individuals as identified in T.C.A. § 63-10-224 through a valid collaborative pharmacy practice agreement containing a non-patient-specific prescriptive order and standardized procedures developed and executed by one (1) or more authorized prescriber(s). (a) The pharmacist shall maintain the collaborative pharmacy practice agreement in accordance with § 63-10-217 and shall comply with all requirements of Tenn. Comp. R. & Regs. 1140-03-.17 except for patient-specificity.(b) Within 30 days from the effective date of a collaborative pharmacy practice agreement, the prescribing pharmacist shall submit written attestation to the Board for the purpose of notifying the Board of the collaborative agreement.(2) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall provide the patient with and review a screening risk assessment tool that screens for the following elements: (b) Contraindications; and(3) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall provide the patient with a standardized factsheet that includes at minimum the following elements: (a) The statement "Off-label use is not prohibited by state or federal law. The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals. Ivermectin has not gone through the new drug application process with the FDA for COVID-19."(b) FDA factsheet or at least the following elements:1. Approved indications, dosage and administration as listed in the FDA factsheet;2. Contraindications, warnings, and precautions as listed in the FDA factsheet; and3. Adverse reactions as listed in the FDA factsheet.(4) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall counsel the patient on matters contained in Tenn. Comp. R. & Regs. 1140-03-.01(1)(e) 1. through 1140-03-.01(1)(e) 8. at the time ivermectin is prescribed and dispensed.(5) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall advise the patient to consult with the patient's primary care practitioner if their symptoms seem to be worsening.(6) A pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin shall document, at a minimum, the completed self-screening risk assessment and the medication and dosage prescribed to the patient by the pharmacist. While not required by this rule, the pharmacist is authorized to include additional information related to the patient encounter. These records shall be maintained by the pharmacy practice site for a period of ten (10) years. Records regarding the dispensed ivermectin shall be maintained in accordance with Tenn. Comp. R. & Regs. 1140-03-.03.(7) If the pharmacist who is participating in a collaborative pharmacy practice agreement for the provision of ivermectin determines that the patient is eligible to receive ivermectin, then, as soon as it is practicable, the collaborating pharmacist shall dispense ivermectin to the patient or refer the patient to another pharmacy that may dispense ivermectin.Tenn. Comp. R. & Regs. 1140-03-.18
New rule filed December 15, 2023; effective 3/14/2024.Authority: T.C.A. §§ 63-10-217, 63-10-224, and 63-10-308.