Amended in Assembly March 18, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 2144

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. begin delete 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. end delete begin insert A knowing violation of the Pharmacy Law is a crime. end insert

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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.

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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.

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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.

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This bill would make nonsubstantive changes to begin delete those end delete begin insert that end insert substitution begin delete and warning provisions. end delete begin insert provision. end insert

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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.

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This bill would provide that no reimbursement is required by this act for a specified reason.

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Vote: majority. Appropriation: no. Fiscal committee:  begin delete no end delete begin insert yes end insert . State-mandated local program:  begin delete no end delete begin insert yes end insert .

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. begin insert The health facility shall require each patient to
acknowledge in writing that the patient has received this
information. end insert 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.

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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.

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