ARIZONA STATE SENATE
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MICHAEL MADDEN |
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LEGISLATIVE RESEARCH ANALYST HEALTH & HUMAN SERVICES Telephone: (602) 926-3171 |
RESEARCH STAFF
TO: MEMBERS OF THE SENATE
HEALTH & HUMAN SERVICES COMMITTEE
DATE: February 14, 2022
SUBJECT: Strike everything amendment to S.B. 1016 relating to prescriptions; public health emergency
Purpose
Requires pharmacists to dispense all prescription drug orders that are written by a medical practitioner for off-label use during any public health state of emergency.
Background
The Governor may declare a state of emergency if the Governor finds conditions of disaster or extreme peril to the safety of persons or property within the state caused by air pollution, fire, flood, epidemic, riot, earthquake or other causes that are likely to be beyond the control of any single county or municipality (A.R.S. § 26-301). During a state of emergency, the Governor has complete authority over all agencies of the state government and the right to exercise all police power vested in the state by the Arizona Constitution. Additionally, the Governor may direct all agencies to utilize and employ personnel, equipment and facilities for the performance of activities designed to prevent or alleviate actual or threatened damage due to the emergency. The Governor's state of emergency powers end when the state of emergency proclamation has been terminated by proclamation of the Governor or Concurrent Resolution of the Legislature (A.R.S. § 26-303).
Before a drug manufacturer can market a drug in the United States, the drug must first be tested and approved for use by the U.S. Food and Drug Administration (FDA). Each drug manufacturer must submit clinical data and other information to the FDA that demonstrates the drug is safe and effective for its intended uses. If it is determined that the drug’s benefits outweigh any potential risks, the drug is approved for sale for designated uses (FDA).
An off-label use drug is an FDA-approved drug, biological product or device utilized in a manner other than the use approved by the FDA (A.R.S. § 32-1997).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Requires pharmacists to dispense all prescription drug orders written by a medical practitioner for off-label use during any public health state of emergency.
2. Holds harmless from criminal prosecution, adverse board action or discipline, any pharmacist who in good faith refuses to dispense a prescription that, in the pharmacist’s professional judgement, is:
a) contrary to law;
b) contrary to the health and safety of the patient based on a documented clinical reason other than the prescription being written for off-label use; or
c) impossible or inappropriate because the prescription drug is not yet available to the market, the pharmacist lacks sufficient equipment, inventory or knowledge to dispense the drug safely or the pharmacy does not routinely stock the prescription drug as part of its usual and customary practice.
3. Requires pharmacists to exercise their professional judgement in the best interest of each patient’s health.
4. Defines off-label use.
5. Becomes effective on the general effective date.