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ARIZONA HOUSE OF REPRESENTATIVESFifty-seventh Legislature First Regular Session |
Senate: RAGE DPA 5-2-0-0 | 3rd Read 22-7-1-0
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SB 1214: pharmacists; independent testing; treatment
Sponsor: Senator Shope, LD 16
Caucus & COW
Overview
Allows a pharmacist to independently test and treat eligible persons for certain medical conditions. Requires the Arizona State Board of Pharmacy (Board) to develop a statewide written protocol regarding the independent authority and establishes the Independent Testing and Treatment Advisory Committee (Advisory Committee) to assist with developing the state's protocols.
History
The Board licenses and regulates pharmacists in Arizona. Pharmacists applying to the Board for licensure must: 1) be a graduate of a school or college of pharmacy or department of pharmacy of a university recognized by the Board 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 the Board; 3) pass the pharmacist licensure examination and jurisprudence examination approved by the Board; and 4) pay the prescribed application fee. Potential licensees who have not passed a licensure examination in Arizona but have in another jurisdiction may be licensed if certain criteria are met (A.R.S. § 32-1922).
The 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 monitoring 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 pursuant to collaborative practice agreement requirements with a provider; and 10) initiating and administering immunizations or vaccines (A.R.S. § 32-1901).
Facilities in the United States (U.S.) performing laboratory testing on human specimens for health assessment or the diagnosis, prevention or treatment of disease are regulated under 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 approved for waivers under the CLIA criteria. CLIA requires that waived tests must be simple and have a low risk for erroneous results (CDC).
Provisions
Pharmacist Independent Testing and Treatment Statewide Protocols
1. Permits a pharmacist to independently order, perform and interpret tests that are authorized by the FDA and waived under the CLIA. (Sec. 1)
2. Permits a pharmacist to independently initiate treatment to eligible persons 12 years of age or the age authorized by the treatment, 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 or postexposure prophylaxis; or
e) a condition related to an emerging or existing public health threat identified by Arizona Department Health Services for which a statewide standing order, rule or executive order is issued. (Sec. 1)
3. Requires the Board, when developing the statewide written protocol, to address the minimum:
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. (Sec. 1)
4. Directs a pharmacist who orders or conducts testing or treats the prescribed health conditions to use any test that may guide clinical decision-making for which a CLIA waiver has been obtained, federal rules adopted thereunder or any screening procedure that is established by the statewide written protocol. (Sec. 1)
5. Requires a pharmacist to use evidence-based clinical guidelines published by:
a) The Centers for Disease Control and Prevention;
b) The Infectious Diseases Society of America;
c) The American Academy of Pediatrics Committee on Infectious Disease; or
d) another clinically recognized recommendation in providing patient treatment. (Sec. 1)
6. Requires an eligible person to meet criteria for treatment based on the statewide written protocol that specifies:
a) the patient inclusion and exclusion criteria; and
b) an explicit medical referral criteria. (Sec. 1)
7. Instructs a pharmacist to refer a patient to the patient's primary care provider, if one is identified, or recommend follow up to the primary care provider if the patient is either:
a) ineligible for patient treatment and presents with symptoms; or
b) does not respond to the initial treatment provided by the pharmacist. (Sec. 1)
8. Directs a pharmacist who initiates treatment to 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. (Sec. 1)
9. Requires a pharmacist who initiates treatment to make a reasonable effort to identify the patient's primary care provider by at least one of the following methods:
a) checking pharmacy records; or
b) requesting the information from the patient or, for patients under 18 years of age, the patient's parent or guardian. (Sec. 1)
10. Requires a pharmacist who initiates treatment of a patient to:
a) maintain a record of the results of any testing or screening for which a treatment is initiated, a summary of the visit and patient assessment information for a period of seven years;
b) notify the patient's primary care provider, if one is identified, within 48 hours after an occurrence of any adverse reaction that is reported to or witnessed by the pharmacist because of the treatment; and
c) provide informational materials to the patient requesting treatment or, for patients under 18 years of age, to the patient's parent or guardian about the importance of pediatric preventative health care visits as recommended by the American Academy of Pediatrics. (Sec. 1)
11. Permits a pharmacist to delegate the task of performing a test waived by the CLIA to a licensed member of the pharmacy staff who is under the supervision of the pharmacist, except that a pharmacist:
a) may not delegate any tasks that include clinical judgement or treatment; and
b) may delegate only ancillary duties as allowed by Board rules. (Sec. 1)
12. Clarifies 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. (Sec. 1)
13. Prohibits a pharmacist from independently:
a) initiating a treatment using opioids for treatment; and
b) ordering a test, screening or treatment of a minor without the written consent of the minor's parent or guardian. (Sec. 1)
14. Requires a pharmacy to either display a notice or include in a patient's consent paperwork that the:
a) testing and treatment are being performed by a pharmacist without consultation with or oversight by a physician; and
b) patient should consult with a primary care provider if symptoms continue. (Sec. 1)
Independent Testing and Treatment Advisory Committee
15. Directs the Board to appoint an Advisory Committee to assist the Board in developing Arizona's protocols relating to pharmacists' independent authority to order testing and initiate treatments. (Sec. 2)
16. Requires the Advisory Committee to make recommendations to the Board regarding the state's protocols relating to pharmacists' independent authority to order testing and initiate treatments. (Sec. 2)
17. Requires the advisory committee to include at least:
a) two licensed pharmacists;
b) two licensed allopathic physicians who specialize in primary care, at least one of whom has a patient population that is substantially composed of children and adolescents;
c) one person who represents a nonprofit patient advocacy organization; and
d) one licensed nurse practitioner who specializes in primary care and can prescribe medication. (Sec. 2)
18. Specifies that Advisory Committee members are not eligible for compensation or reimbursement of expenses. (Sec. 2)
19. Repeals the Advisory Committee on January 1, 2027. (Sec. 2)
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SB 1214
Initials AG/BG Page 0 Caucus & COW
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