Bill Text: CA AB2144 | 2015-2016 | Regular Session | Amended
Bill Title: Pharmacy: prescriptions.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Failed) 2016-11-30 - From committee without further action. [AB2144 Detail]
Download: California-2015-AB2144-Amended.html
BILL NUMBER: AB 2144 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MARCH 18, 2016
INTRODUCED BY Assembly Member Rodriguez
FEBRUARY 17, 2016
An act to amend Sections 4073.5 and 4074 of the Business and
Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
AB 2144, as amended, Rodriguez. Pharmacy: prescriptions.
The Pharmacy Law provides for the licensure and regulation of
pharmacists by the California State Board of Pharmacy. That
law establishes requirements for the substitution of an alternative
biological product when a pharmacist is filling a prescription order
for a prescribed biological product. That law requires a pharmacist
to inform the patient orally or in writing of harmful effects of a
drug dispensed by prescription, if the drug poses substantial risk to
the person consuming the drug when taken in combination with
alcohol, or if the drug may impair a person's ability to drive a
motor vehicle, whichever is applicable, and the board requires by
regulation that warning is to be given. A knowing
violation of the Pharmacy Law is a crime.
The Pharmacy Law requires a health facility to establish and
implement a written policy to ensure that each patient receives
information regarding drugs given to the patient at the time of
discharge or under certain other circumstances, including the use and
storage of each drug, the precautions and relevant warnings, and the
importance of compliance with directions.
This bill would revise that patient information provision to
require that a health facility require each patient to acknowledge in
writing that the patient has received this information. Because a
violation of this requirement would be a crime under certain
circumstances, the bill would impose a state-mandated local program.
The Pharmacy Law establishes requirements for the substitution of
an alternative biological product when a pharmacist is filling a
prescription order for a prescribed biological product.
This bill would make nonsubstantive changes to those
tha t substitution and
warning provisions. provision.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: no
yes . State-mandated local program: no
yes .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4073.5 of the Business and Professions Code is
amended to read:
4073.5. (a) A pharmacist filling a prescription order for a
prescribed biological product may select an alternative biological
product only if all of the following apply:
(1) The alternative biological product is interchangeable.
(2) The prescriber does not personally indicate "Do not
substitute," or words of similar meaning, in the manner provided in
subdivision (e).
(b) Within five days following the dispensing of a biological
product, a dispensing pharmacist or the pharmacists' designee shall
make an entry of the specific biological product provided to the
patient, including the name of the biological product and the
manufacturer. The communication shall be conveyed by making an entry
that can be electronically accessed by the prescriber through one or
more of the following electronic records systems:
(1) An interoperable electronic medical records system.
(2) An electronic prescribing technology.
(3) A pharmacy benefit management system.
(4) A pharmacy record.
(c) Entry into an electronic records system as described in
subdivision (b) is presumed to provide notice to the prescriber.
(d) If the pharmacy does not have access to one or more of the
entry systems in subdivision (b), the pharmacist or the pharmacist's
designee shall communicate the name of the biological product
dispensed to the prescriber using facsimile, telephone, electronic
transmission, or other prevailing means, except that communication
shall not be required in this instance to the prescriber when either
of the following apply:
(1) There is no interchangeable biological product approved by the
federal Food and Drug Administration for the product prescribed.
(2) A refill prescription is not changed from the product
dispensed on the prior filling of the prescription.
(e) A selection shall not be made pursuant to this section if the
prescriber personally indicates, either orally or in his or her own
handwriting, "Do not substitute," or words of similar meaning.
(1) This subdivision shall not prohibit a prescriber from checking
a box on a prescription marked "Do not substitute," provided that
the prescriber personally initials the box or checkmark.
(2) To indicate that a selection shall not be made pursuant to
this section for an electronic data transmission prescription, as
defined in subdivision (c) of Section 4040, a prescriber may indicate
"Do not substitute," or words of similar meaning, in the
prescription as transmitted by electronic data, or may check a box
marked on the prescription "Do not substitute." In either instance,
it shall not be required that the prohibition on substitution be
manually initialed by the prescriber.
(f) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (e). A pharmacist
who selects an alternative biological product to be dispensed
pursuant to this section shall assume the same responsibility for
substituting the biological product as would be incurred in filling a
prescription for a biological product prescribed by name. There
shall be no liability on the prescriber for an act or omission by a
pharmacist in selecting, preparing, or dispensing a biological
product pursuant to this section. The pharmacist shall not select a
biological product that meets the requirements of subdivision (a)
unless the cost to the patient of the biological product selected is
the same or less than the cost of the prescribed biological product.
"Cost," as used in this subdivision, includes any professional fee
that may be charged by the pharmacist.
(g) This section shall apply to all prescriptions, including those
presented by or on behalf of persons receiving assistance from the
federal government or pursuant to the Medi-Cal Act set forth in
Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of
the Welfare and Institutions Code.
(h) When a selection is made pursuant to this section, the
substitution of a biological product shall be communicated to the
patient.
(i) The board shall maintain on its public Internet Web site a
link to the current list, if available, of biological products
determined by the federal Food and Drug Administration to be
interchangeable.
(j) For purposes of this section, the following terms shall have
the following meanings:
(1) "Biological product" has the same meaning that applies to that
term under Section 351 of the federal Public Health Service Act (42
U.S.C. Sec. 262(i)).
(2) "Interchangeable" means a biological product that the federal
Food and Drug Administration has determined meets the standards set
forth in Section 262(k)(4) of Title 42 of the United States Code, or
has been deemed therapeutically equivalent by the federal Food and
Drug Administration as set forth in the latest addition or supplement
of the Approved Drug Products with Therapeutic Equivalence
Evaluations.
(3) "Prescription," with respect to a biological product, means a
prescription for a product that is subject to Section 503(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(k) This section shall not prohibit the administration of
immunizations, as permitted in Sections 4052 and 4052.8.
(l) This section shall not prohibit a disability insurer or health
care service plan from requiring prior authorization or imposing
other appropriate utilization controls in approving coverage for any
biological product.
SEC. 2. Section 4074 of the Business and Professions Code is
amended to read:
4074. (a) A pharmacist shall inform a patient orally or in
writing of the harmful effects of a drug dispensed by prescription if
both of the following apply:
(1) The drug poses substantial risk to the person consuming the
drug when taken in combination with alcohol or the drug may impair a
person's ability to drive a motor vehicle, whichever is applicable.
(2) The drug is determined by the board pursuant to subdivision
(c) to be a drug or drug type for which this warning shall be given.
(b) In addition to the requirement described in subdivision (a),
on and after July 1, 2014, if a pharmacist exercising his or her
professional judgment determines that a drug may impair a person's
ability to operate a vehicle or vessel, the pharmacist shall include
a written label on the drug container indicating that the drug may
impair a person's ability to operate a vehicle or vessel. The label
required by this subdivision may be printed on an auxiliary label
that is affixed to the prescription container.
(c) The board, by regulation, may require additional information
or labeling.
(d) This section shall not apply to a drug furnished to a patient
in conjunction with treatment or emergency services provided in a
health facility or, except as provided in subdivision (e), to a drug
furnished to a patient pursuant to subdivision (a) of Section 4056.
(e) A health facility shall establish and implement a written
policy to ensure that each patient shall receive information
regarding each drug given at the time of discharge and each drug
given pursuant to subdivision (a) of Section 4056. This information
shall include the use and storage of each drug, the precautions and
relevant warnings, and the importance of compliance with directions.
The health facility shall require each patient to acknowledge in
writing that the patient has received this information. This
information shall be given by a pharmacist or registered nurse,
unless already provided by a patient's prescriber, and the written
policy shall be developed in collaboration with a physician, a
pharmacist, and a registered nurse. The written policy shall be
approved by the medical staff. Nothing in this subdivision or any
other law shall be construed to require that only a pharmacist
provide this consultation.
SEC. 3. No reimbursement is required by this act
pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.
