Amended in Senate June 24, 2014

Amended in Assembly April 1, 2014

Amended in Assembly March 18, 2014

California Legislature—2013–14 Regular Session

Assembly Bill No. 1535

Introduced by Assembly Member Bloom

(Coauthor: Senator Pavley)

January 21, 2014

An act to add Section 4052.01 to the Business and Professions Code, relating to pharmacists.

LEGISLATIVE COUNSEL’S DIGEST

AB 1535, as amended, Bloom. Pharmacists: naloxone hydrochloride.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. Existing law, generally, authorizes a pharmacist to dispense or furnish drugs only pursuant to a valid prescription. Existing law authorizes a pharmacist to furnish emergency contraceptives and hormonal contraceptives pursuant to standardized procedures or protocols developed and approved by both the board and the Medical Board of California, as specified, or developed by the pharmacist and an authorized prescriber. Existing law also authorizes a pharmacist to furnish nicotine replacement products pursuant to standardized procedures or protocols developed and approved by both the board and the Medical Board of California, as specified. Existing law authorizes a licensed health care provider who is permitted to prescribe an opioid antagonist and is acting with reasonable care to prescribe and dispense or distribute an opioid antagonist for the treatment of an opioid overdose to a person at risk of an opioid-related overdose or a family member, friend, or other person in a position to assist a person at risk of an opioid-related overdose.

This bill would authorize a pharmacist to furnish naloxone hydrochloride in accordance with standardized procedures or protocols developed and approved by both the board and the Medical Board of California, in consultation with specified entities. The bill would require the board and the Medical Board of California, in developing those procedures and protocols, to include procedures requiring the pharmacist to provide a consultation to ensure the education of the person to whom the drug is furnished, as specified, and notification of the patient’s primary care provider of drugs or devices furnished to the patient, as specified. The bill would prohibit a pharmacist furnishing naloxone hydrochloride pursuant to its provisions from permitting the person to whom the drug is furnished to waive the consultation described above. The bill would require a pharmacist to complete a training program on the use of opioid antagonists prior to performing this procedure. The bill would require each board to enforce these provisions with respect to its respective licensees.

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This bill would authorize the California State Board of Pharmacy to adopt emergency regulations to establish the standardized procedures or protocols that would remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted as described above.

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

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

SECTION 1.  

Section 4052.01 is added to the Business and
Professions Code, to read:

4052.01.  

(a) Notwithstanding any other provision of law, a
pharmacist may furnish naloxone hydrochloride in accordance
with standardized procedures or protocols developed and approved
by both the board and the Medical Board of California, in
consultation with the California Society of Addiction Medicine,
the California Pharmacists Association, and other appropriate
entities. In developing those standardized procedures or protocols,
the board and the Medical Board of California shall include the
following:

(1) Procedures to ensure education of the person to whom the
drug is furnished, including, but not limited to, opioid overdose
prevention, recognition, and response, safe administration of
naloxone hydrochloride, potential side effects or adverse events,
and the imperative to seek emergency medical care for the patient.

(2) Procedures to ensure the education of the person to whom
the drug is furnished regarding the availability of drug treatment
programs.

(3) Procedures for the notification of the patient’s primary care
provider with patient consent of any drugs or devices furnished to
the patient, or entry of appropriate information in a patient record
system shared with the primary care provider, as permitted by that
primary care provider, and with patient consent.

(b) A pharmacist furnishing naloxone hydrochloride pursuant
to this section shall not permit the person to whom the drug is
furnished to waive the consultation required by the board and the
Medical Board of California.

(c) Prior to performing a procedure authorized under this section,
a pharmacist shall complete a training program on the use of opioid
antagonists that consists of at least one hour of approved continuing
education on the use of naloxone hydrochloride.

(d) The board and the Medical Board of California are each
authorized to ensure compliance with this section. Each board is
specifically charged with enforcing this section with respect to its
respective licensees. This section does not expand the authority
of a pharmacist to prescribe any prescription medication.

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(e) The board may adopt emergency regulations to establish
the standardized procedures or protocols. The adoption of
regulations pursuant to this subdivision shall be deemed to be an
emergency and necessary for the immediate preservation of the
public peace, health, safety, or general welfare. The emergency
regulations authorized by this subdivision are exempt from review
by the Office of Administrative Law. The emergency regulations
authorized by this subdivision shall be submitted to the Office of
Administrative Law for filing with the Secretary of State and shall
remain in effect until the earlier of 180 days following their
effective date or the effective date of regulations adopted pursuant
to subdivision (a).

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