Amended in Senate April 9, 2015

Senate Bill No. 587

Introduced by Senator Stone

February 26, 2015

An act to amend Section begin delete 4127.1 end delete begin insert 4052.2 end insert of the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

SB 587, as amended, Stone. Pharmacy: begin delete compounding. end delete begin insert drug regimens: hypertension and hyperlipidemia. end insert

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. begin delete The law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board, and prohibits the board from issuing or renewing that license until the board has, among other things, reviewed a current copy of the pharmacy’s procedures and policies for sterile compounding. end delete begin insert That law authorizes a pharmacist to perform listed procedures or functions as part of the care provided by specified health care entities, including initiating or adjusting the drug regimen of a patient pursuant to a specific written order or authorization made by the individual patient’s treating prescriber, and in accordance with the policies, procedures, or protocols of the health care entity. end insert

begin delete

This bill would make a nonsubstantive change to that licensing provision.

end delete begin insert

This bill would specifically include the treatment of hypertension and hyperlipidemia in the authorized initiation or adjustment of a patient’s drug regimen.

end insert

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 4052.2 of the end insert begin insert Business and Professions
Code end insert begin insert is amended to read: end insert

4052.2.  

(a) Notwithstanding any other begin delete provision of end delete law, a
pharmacist may perform the following procedures or functions as
part of the care provided by a health care facility, a licensed home
health agency, a licensed clinic in which there is a physician
oversight, a provider who contracts with a licensed health care
service plan with regard to the care or services provided to the
enrollees of that health care service plan, or a physician, in
accordance with the policies, procedures, or protocols of that
facility, home health agency, licensed clinic, health care service
plan, or physician, and in accordance with subdivision (c):

(1) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and
respiration.

(2) Ordering drug therapy-related laboratory tests.

(3) Administering drugs and biologicals by injection pursuant
to a prescriber’s order.

(4) Initiating or adjusting the drug regimen of a patient pursuant
to a specific written order or authorization made by the individual
patient’s treating prescriber, and in accordance with the policies,
procedures, or protocols of the health care facility, home health
agency, licensed clinic, health care service plan, or physician.
Adjusting the drug regimen does not include substituting or
selecting a different drug, except as authorized by the protocol.
The pharmacist shall provide written notification to the patient’s
treating prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this paragraph within 24 hours.
begin insert This function may include, but is not limited to, treatment of
hypertension and hyperlipidemia. end insert

(b) A patient’s treating prescriber may prohibit, by written
instruction, any adjustment or change in the patient’s drug regimen
by the pharmacist.

(c) The policies, procedures, or protocols referred to in this
subdivision shall be developed by health care professionals,
including physicians, pharmacists, and registered nurses, begin delete and shall, end delete
begin insert and, end insert at a minimum, begin insert shall end insert do all of the following:

(1) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses. The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.

(2) Require that the medical records of the patient be available
to both the patient’s treating prescriber and the pharmacist.

(3) Require that the procedures to be performed by the
pharmacist relate to a condition for which the patient has first been
seen by a physician.

(4) Except for procedures or functions provided by a health care
facility, a licensed clinic in which there is physician oversight, or
a provider who contracts with a licensed health care plan with
regard to the care or services provided to the enrollees of that health
care service plan, require the procedures to be performed in
accordance with a written, patient-specific protocol approved by
the treating or supervising physician. Any change, adjustment, or
modification of an approved preexisting treatment or drug therapy
shall be provided in writing to the treating or supervising physician
within 24 hours.

(d) Prior to performing any procedure authorized by this section,
a pharmacist shall have done either of the following:

(1) Successfully completed clinical residency training.

(2) Demonstrated clinical experience in direct patient care
delivery.

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SECTION 1.  

Section 4127.1 of the Business and Professions
Code, as added by Section 5 of Chapter 565 of the Statutes of
2013, is amended to read:

4127.1.  

(a) A pharmacy shall not compound sterile drug
products unless the pharmacy has obtained a sterile compounding
pharmacy license from the board pursuant to this section. The
license shall be renewed annually and is not transferable.

(b) A license to compound sterile drug products shall be issued
only to a location that is licensed as a pharmacy and shall be issued
only to the owner of the pharmacy licensed at that location.

(c) A license to compound sterile drug products shall not be
issued or renewed until the location is inspected by the board and
found in compliance with this article and regulations adopted by
the board.

(d) A license to compound sterile drug products shall not be
issued or renewed until the board does all of the following:

(1) Reviews a current copy of the pharmacy’s procedures and
policies for sterile compounding.

(2) Reviews the pharmacy’s completed self-assessment form
required by Section 1735.2 of Title 16 of the California Code of
Regulations.

(3) Is provided with copies of all inspection reports conducted
of the pharmacy’s premises, and any reports from a private
accrediting agency, conducted in the prior 12 months documenting
the pharmacy’s operations.

(4) Receives a list of all sterile medications compounded by the
pharmacy since the last license renewal.

(e) A pharmacy licensed pursuant to this section shall do all of
the following:

(1) Provide to the board a copy of any disciplinary or other
action taken by another state within 10 days of the action.

(2) Notify the board within 10 days of the suspension of any
accreditation held by the pharmacy.

(3) Provide to the board, within 12 hours, any recall notice
issued by the pharmacy for sterile drug products it has
compounded.

(f) Adverse effects reported or potentially attributable to a
pharmacy’s sterile drug product shall be reported to the board
within 12 hours and immediately reported to the MedWatch
program of the federal Food and Drug Administration.

(g) The reconstitution of a sterile powder shall not require a
license pursuant to this section if both of the following
requirements are met:

(1) The sterile powder was obtained from a manufacturer.

(2) The drug is reconstituted for administration to patients by
a health care professional licensed to administer drugs by injection
pursuant to this division.

(h) This section shall become operative on July 1, 2014.

end delete