Assigned to RAGE AS PASSED BY COMMITTEE ARIZONA STATE SENATE Fifty-Seventh Legislature, First Regular Session AMENDED FACT SHEET FOR S.B. 1214 pharmacists; independent testing; treatment Purpose Allows a pharmacist to independently test for and treat eligible persons for outlined medical conditions. Background Pharmacists in Arizona are licensed and regulated by the Arizona State Board of Pharmacy (ASPB). Prospective pharmacists applying to ASPB for licensure must: 1) be a graduate of a school or college of pharmacy or department of pharmacy of a university recognized by ASPB or the Accreditation Council for Pharmacy Education; 2) have successfully completed a program of practical experience under the direct supervision of a licensed pharmacist approved by ASPB; 3) pass the pharmacist licensure examination and jurisprudence examination approved by ASPB; and 4) pay the prescribed application fee. Prospective licensees who have not passed a licensure examination in Arizona but have in another jurisdiction may be licensed if outlined criteria are met (A.R.S. § 32-1922). Practice of pharmacy means furnishing the following health care services as a medical professional: 1) interpreting, evaluating and dispensing prescription orders in the patient's best interests; 2) compounding drugs pursuant to or in anticipation of a prescription order; 3) labeling drugs and devices in compliance with state and federal requirements; 4) participating in drug selection and drug utilization reviews, drug administration, drug or drug-related research and drug therapy or management; 5) providing patient counseling necessary to provide pharmaceutical care; 6) properly and safely storing drugs and devices in anticipation of dispensing; 7) maintaining required records of drugs and devices; 8) offering or performing acts, services, operations or transactions that are necessary to conduct, operate, manage and control a pharmacy; 9) providing patient care services under a collaborative practice agreement with a provider; and 10) initiating and administering immunizations or vaccines (A.R.S. § 32-1901). All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention or treatment of disease are regulated under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Waived tests include test systems cleared by the U.S. Food and Drug Administration (FDA) for home use and those tests approved for waiver under CLIA criteria. CLIA requires that waived tests must be simple and have a low risk for erroneous results (CDC). There is no anticipated fiscal impact to the state General Fund associated with this legislation. FACT SHEET – Amended S.B. 1214 Page 2 Provisions 1. Allows a pharmacist to independently order, perform and interpret tests authorized by the FDA and waived under CLIA. 2. Allows a pharmacist to independently initiate treatment to eligible persons six years old or the age authorized by the treatment, using whichever age is older, who test positive for: a) influenza; b) group A streptococcus pharyngitis; c) COVID-19 or other coronavirus respiratory illnesses; d) HIV preexposure prophylaxis or postexposure prophylaxis; or e) a condition related to an emerging or existing public health threat identified by DHS for which a statewide standing order, rule or executive order is issued. 3. Requires ASPB to develop a statewide written protocol including, at a minimum, the following: a) documentation; b) records retention; c) referrals; d) patient screening requirements and obtaining relevant medical history; e) exclusion criteria; f) treatment instructions based on the patient's age and medical history; g) follow up maintenance and care plans; and h) any necessary pharmacist training certification. 4. Requires a pharmacist who orders, conducts testing or treats a health condition to use any test that may guide clinical decision-making for which a waiver has been obtained under CLIA or federal law or any screening procedure that is established by the statewide written protocol. 5. Directs pharmacists to use evidence-based clinical guidelines published by the Center for Disease Control and Prevention, the Infectious Diseases Society of America, the American Academy of Pediatrics Committee on Infectious Disease or other clinically recognized recommendation in providing patient treatment. 6. Requires an eligible person to meet criteria for treatment based on current clinical guidelines, if available, or the statewide written protocol that specify: a) patient inclusion and exclusion criteria; and b) explicit medical referral criteria. 7. Requires a pharmacist to refer a patient to the patient's primary care provider, if one is identified, if the patient: a) is not eligible for treatment by a pharmacist under state law and presents with differential symptoms; or b) does not respond to the initial treatment provided by the pharmacist. FACT SHEET – Amended S.B. 1214 Page 3 8. Directs a pharmacist who initiates treatment of a patient to: a) notify the patient's primary care provider, if one is identified, within 72 hours after initiating treatment, including notice of the patient's name, treatment method and the date of treatment by entry into an electronic health record, phone, fax, mail or email; b) make a reasonable effort to identify the patient's primary care provider by checking pharmacy records or requesting the information from the patient or patient's parent or guardian, if applicable; c) maintain a record of any testing or screening results for seven years; d) notify the patient's primary care provider, if one is identified, within 48 hours after an adverse reaction is reported to or witnessed by the pharmacist as a result of treatment; and e) provide informational materials to the patient or patient's parent or guardian, if applicable, about the importance of pediatric preventive health care visits as recommended by the American Academy of Pediatrics. 9. Allows a pharmacist to delegate the task of performing a test waived by CLIA to a licensed member of the pharmacy staff who is under the supervision of the pharmacist, except that the pharmacist: a) may not delegate any tasks that include clinical judgment; and b) may delegate only ancillary duties permitted by ASPB rules. 10. Specifies that a pharmacist's ability to test and treat outlined conditions does not establish a cause of action against a patient's primary care provider for any adverse reaction, complication or negative outcome arising from the treatment initiated by the pharmacist, if the treatment is initiated without a prescription order written by the provider. 11. Prohibits a pharmacist from independently initiating treatment using opioids for a patient. 12. Prohibits a pharmacist from independently ordering a test or screening or treating a minor without consent of the minor's parent or guardian. 13. Requires a pharmacy to either display a notice or include in a patient's consent paperwork that the testing and treatment being performed is being performed by a pharmacist. 14. Establishes an independent testing and treatment advisory committee (Advisory Committee) that is appointed by ASPB to assist ASPB in developing the state's protocols relating to pharmacists' independent authority to order testing and initiate treatments. 15. Allows the Advisory Committee to also make recommendations to ASPB regarding protocols. 16. Requires the Advisory Committee include at least the following: a) two licensed pharmacists; b) one physician licensed through the Arizona Medical Board who specializes in primary care; c) one licensed physician through the Arizona Board of Osteopathic Examiners in Medicine and Surgery who specializes in primary care; and d) one representative from a nonprofit patient advocacy program. 17. Prohibits Advisory Committee members from receiving compensation or reimbursement of expenses. FACT SHEET – Amended S.B. 1214 Page 4 18. Terminates the Advisory Committee on January 1, 2027. 19. Becomes effective on the general effective date. Amendments Adopted by Committee 1. Includes COVID-19 or other coronavirus respiratory illnesses as authorized for testing and treatment, rather than a respiratory illness, condition or disease that does not require additional diagnostic imaging. 2. Removes the requirement for ASPB to consult with the Arizona Medical Board when developing the statewide protocol. 3. Removes the evidence-based research findings from the criteria that a pharmacist must consult when treating an eligible patient. 4. Requires a pharmacy to either display a notice or include in a patient's consent paperwork that the testing and treatment being performed is being performed by a pharmacist. 5. Establishes an independent testing and treatment advisory committee (Advisory Committee) that is appointed by ASPB to assist ASPB in developing the state's protocols relating to pharmacists' independent authority to order testing and initiate treatments. 6. Allows the Advisory Committee to also make recommendations to ASPB regarding protocols. 7. Requires the Advisory Committee include at least the following: a) two licensed pharmacists; b) one physician licensed through the Arizona Medical Board who specializes in primary care; c) one licensed physician through the Arizona Board of Osteopathic Examiners in Medicine and Surgery who specializes in primary care; and d) one representative from a nonprofit patient advocacy program. 8. Prohibits Advisory Committee members from receiving compensation or reimbursement of expenses. 9. Terminates the Advisory Committee on January 1, 2027. Senate Action RAGE 2/5/25 DPA 5-2-0 Prepared by Senate Research February 6, 2025 JT/KP/ci