Assigned to RAGE AS PASSED BY COW 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 (ASBP). Prospective pharmacists applying to ASBP for licensure must: 1) be a graduate of a school or college of pharmacy or department of pharmacy of a university recognized by ASBP 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 ASBP; 3) pass the pharmacist licensure examination and jurisprudence examination approved by ASBP; 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 12 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 ASBP 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 or certification requirements. 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 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, or recommend follow up with a primary provider, if the patient: a) is not eligible for treatment by a pharmacist under state law and presents with 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, including a summary of the visit and patient assessment information 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 or treatment; and b) may delegate only ancillary duties permitted by ASBP 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. 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 without consultation with or oversight by a physician and that the patient should consult with a primary care provider if symptoms continuation. 14. Establishes an independent testing and treatment advisory committee (advisory committee) that is appointed by ASBP to assist ASBP 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 ASBP regarding protocols. 16. Requires the advisory committee to include at least the following: a) two licensed pharmacists; b) two physicians licensed through the Arizona Medical Board (AMB) who specializes in primary care, at least one of whom has a patient population that is substantially composed of children and adolescents; c) one representative from a nonprofit patient advocacy program; and FACT SHEET – Amended S.B. 1214 Page 4 d) one nurse practitioner who is licensed through the Arizona State Board of Nursing and specializes in primary care and is able to prescribe medication. 17. Prohibits advisory committee members from receiving compensation or reimbursement of expenses. 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 ASBP to consult with the AMB 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 that is appointed by ASBP to assist ASBP 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 ASBP regarding protocols. 7. Requires the advisory committee to include at least the following: a) two licensed pharmacists; b) one physician licensed through the AMB who specializes in primary care; c) one licensed physician through the Arizona Board of Osteopathic Examiners in Medicine and Surgery (ABOE) 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. Amendments Adopted by the Committee of the Whole 1. Increases the treatment age from at least 6 years old to at least 12 years old for persons eligible for treatment provided by a pharmacist. FACT SHEET – Amended S.B. 1214 Page 5 2. Specifies that any necessary pharmacist training or certification requirements must be included in the statewide written protocol. 3. Removes current clinical guidelines from the criteria for treatment of an eligible person. 4. Clarifies that a pharmacist providing treatment to a patient must recommend follow-up with a primary care provider if the patient either: a) is not eligible for patient treatment and presents with symptoms; or b) does not respond to the initial treatment provided. 5. Requires a pharmacist who initiates treatment to maintain a summary of a visit and patient assessment information for a period of seven years. 6. Prohibits a pharmacist from delegating treatment to a licensed member of the pharmacy staff who is under supervision of the pharmacist. 7. Specifies that any treatment initiated by a pharmacist does not establish a cause of action against a patient's primary care provider for any adverse reaction, complication or negative outcome for the pharmacist provided treatment regardless of if the treatment is initiated without a prescription order written by the patient's primary care provider. 8. Adds, to the displayed notice or patient's consent paperwork, that testing and treatment is being performed by a pharmacist without consultation with or oversight by a physician and that the patient should consult with a primary care provider if symptoms continue. 9. Increases, from one to two, the number of physicians licensed by the AMB on the advisory committee who specialize in primary care. 10. Requires at least one the physicians on the advisory committee to have a patient population that is substantially composed of children and adolescents. 11. Eliminates, from the advisory committee, the one physician licensed by the ABOE. 12. Adds, to the advisory committee, one licensed nurse practitioner through the Arizona State Board of Nursing who specializes in primary care and is able to prescribe medication. Senate Action RAGE 2/5/25 DPA 5-2-0 Prepared by Senate Research February 25, 2025 JT/KP/ci