Section 20-633f - [Effective Until 10/1/2024] Ordering and administration of COVID-19-related, HIV-related and influenza-related tests, and prescribing of HIV-related prophylaxes, by licensed pharmacists. Recordkeeping. Confidentiality. Disclosure. Regulations(a) For the purposes of this section: (1) "COVID-19" means the respiratory disease designated by the World Health Organization on February 11, 2020, as coronavirus 2019, and any related mutation thereof recognized by said organization;(2) "COVID-19-related test" means any laboratory test, or series of laboratory tests, for any virus, antibody, antigen or etiologic agent thought to cause, or indicate the presence of, COVID-19;(3) "HIV-related prophylaxis" means any drug approved by the federal Food and Drug Administration or any successor agency as a pre-exposure or post-exposure prophylaxis for the human immunodeficiency virus;(4) "HIV-related test" has the same meaning as provided in section 19a-7o; and(5) "Influenza-related test" means any laboratory test, or series of laboratory tests, for any virus, antibody, antigen or etiologic agent thought to cause, or indicate the presence of, influenza disease.(b)(1) Any pharmacist licensed under this chapter may order, and administer to a patient, a COVID-19-related test or influenza-related test if: (A) Such pharmacist (i) is employed by a pharmacy that has submitted to the Department of Public Health a complete clinical laboratory improvement amendment application for certification for the COVID-19-related test or influenza-related test and the Department of Public Health has approved such application, and (ii) has completed any training required by the Department of Consumer Protection; and(B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.(2) Any pharmacist licensed under this chapter may order, and administer to a patient, a COVID-19-related test or influenza-related test if: (A) Such pharmacist is employed by a hospital; and(B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.(c)(1) On or after the adoption of regulations pursuant to subsection (g) of this section, any pharmacist licensed under this chapter may order, and administer to a patient, an HIV-related test if: (A) Such pharmacist (i) is employed by a pharmacy that has submitted to the Department of Public Health a complete clinical laboratory improvement amendment application for certification for the HIV-related test and the Department of Public Health has approved such application, and (ii) has completed the training required under regulations adopted pursuant to subsection (g) of this section; and(B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.(2) On or after the adoption of regulations pursuant to subsection (g) of this section, any pharmacist licensed under this chapter may order, and administer to a patient, an HIV-related test if: (A) Such pharmacist is employed by a hospital; and(B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age and such pharmacist has obtained (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.(d) If a pharmacist orders and administers a COVID-19-related test or influenza-related test under subsection (b) of this section, or an HIV-related test under subsection (c) of this section, the pharmacist shall: (1) Provide the results of such test to (A) the patient, in writing, (B) the patient's primary care provider, if the patient identifies any such primary care provider, and (C) the Commissioner of Consumer Protection or said commissioner's designee, upon request by said commissioner or such designee;(2) report the results of such test to the director of health of the town, city or borough in which such case resides and to the Department of Public Health in the manner set forth in section 19a-215 and applicable regulations; and(3) maintain a record of the results of such test for three years.(e)(1) If a pharmacist orders and administers an HIV-related test under subsection (c) of this section and the result of such test is negative, the pharmacist may prescribe and dispense to the patient any HIV-related prophylaxis according to the manufacturer's package insert, provided: (A) Such pharmacist has completed the training required under the regulations adopted pursuant to subsection (g) of this section;(B) such patient satisfies the criteria established in such package insert; and(C) such HIV-related prophylaxis is prescribed and dispensed in accordance with all applicable requirements established in (i) this section, (ii) this chapter, or (iii) any regulations adopted pursuant to subsection (g) of this section or this chapter.(2) If a pharmacist prescribes any HIV-related prophylaxis under subdivision (1) of this subsection, the pharmacist shall provide to the Commissioner of Consumer Protection or the commissioner's designee, upon request by said commissioner or such designee: (A) A copy of the results of the HIV-related test described in subdivision (1) of this subsection;(B) prescription information maintained pursuant to this chapter; and(C) any other documentation the commissioner may require in regulations adopted pursuant to subsection (g) of this section.(f) Notwithstanding the provisions of section 1-210, all information a pharmacist submits to the Department of Consumer Protection pursuant to this section, or any regulation adopted pursuant to subsection (g) of this section, shall be confidential. The department shall use such information to perform the department's duties concerning pharmacy, to ensure compliance with and enforce provisions of the general statutes and regulations of Connecticut state agencies concerning pharmacy and for no other purpose. If the department brings an enforcement action and uses any such information as part of such action, the department may disclose such information to the parties to such action only if such disclosure is required by applicable law. No such party shall further disclose such information except to a tribunal, the Commission of Pharmacy, an administrative agency or a court with jurisdiction over such action. Such tribunal, commission, agency or court shall ensure that such information is subject to a qualified protective order, as defined in 45 CFR 164.512(e), as amended from time to time.(g) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, the Commission of Pharmacy, a state-wide professional society representing the interests of physicians practicing medicine in this state and a state-wide organization representing the interests of health care professionals and scientists specializing in the control and prevention of infectious diseases, shall adopt regulations, in accordance with chapter 54, to implement the provisions of this section. Such regulations shall, at a minimum: (1) Ensure compliance with all applicable guidance issued by the federal Centers for Disease Control and Prevention; (2) ensure that each HIV-related prophylaxis prescribed and dispensed under subsection (e) of this section is prescribed and dispensed in accordance with the approval the federal Food and Drug Administration has granted for such HIV-related prophylaxis;(3) establish permissible routes of administration;(4) establish prescription duration limits not to exceed (A) sixty days for any pre-exposure HIV-related prophylaxis, or (B) thirty days for any post-exposure HIV-related prophylaxis;(5) specify (A) how frequently a pharmacist shall provide treatment to a patient under this section, (B) when a pharmacist providing treatment to a patient under this section shall refer such patient to such patient's primary care provider or any other health care provider identified by such patient, and (C) the circumstances in which a pharmacist shall recommend that a patient undergo screenings for sexually transmitted infections other than the human immunodeficiency virus;(6) establish requirements concerning private areas for consultations between pharmacists and patients;(7) establish training requirements concerning (A) methods to obtain a patient's complete sexual history, (B) delivering a positive HIV-related test result to a patient, (C) referring a patient who has tested positive for the human immunodeficiency virus to the services that are available to such patient, and (D) using HIV-related prophylaxes for patients who have tested negative for the human immunodeficiency virus;(8) identify qualifying training programs, which are accredited by the National Centers for Disease Control and Prevention, the Accreditation Council for Pharmacy Education or another appropriate national accrediting body; and (9) establish a system of control and reporting.Conn. Gen. Stat. § 20-633f
Added by P.A. 23-0019, S. 2 of the Connecticut Acts of the 2023 Regular Session, eff. 7/1/2023.This section is set out more than once due to postponed, multiple, or conflicting amendments.