 |
ARIZONA STATE SENATE
Fifty-Sixth Legislature, Second Regular Session
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 (Board). Prospective 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. 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 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 the 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.
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 therapy to eligible persons who are at least three years old that test positive for:
a) influenza;
b) group A streptococcus pharyngitis;
c) SARS-CoV-2 or any other respiratory illness, condition or disease; or
d) a condition related to an emerging or existing public health threat identified by the Department of Health Services for which a statewide standing order, rule or executive order is issued.
3. 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 federal law or any screening procedure that is established by the statewide written protocol.
4. Directs pharmacists to use evidence-based clinical guidelines published by the Centers for Disease Control or other clinically recognized recommendations in providing patient treatment.
5. Requires an eligible person to meet criteria for treatment based on current clinical guidelines, if available, or evidence-based research findings that specify:
a) patient inclusion and exclusion criteria; and
b) explicit medical referral criteria.
6. 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.
7. Directs a pharmacist who initiates treatment of a patient to:
a) notify the patient's identified 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 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;
d) notify the patient's identified 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.
8. Allows a pharmacist to delegate the administrative and technical tasks of performing a test to a trained 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) must delegate only ancillary duties permitted by Board rules.
9. Prohibits a health insurer from denying reimbursement for any test, screening or treatment performed by a pharmacist, that is within the scope of the pharmacist's license, and would be covered if otherwise performed by a medical or osteopathic physician, nurse practitioner or physician assistant.
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 ordering a test or screening or treating a minor without consent of the minor's parent or guardian.
12. Requires the Board's statewide written protocol for medical testing and treatment by a pharmacist to be made in consultation with the Arizona Medical Board.
13. Defines health insurer as a disability insurer, group disability insurer, blanket disability insurer, health care services organization, hospital service corporation, medical service corporation or hospital, medical, dental and optometric service corporation and includes the health insurer's designee.
14. Becomes effective on the general effective date.
Prepared by Senate Research
January 26, 2024
MM/slp