BILL NUMBER: SB 482 AMENDED
BILL TEXT
AMENDED IN SENATE APRIL 16, 2015
INTRODUCED BY Senator Lara
FEBRUARY 26, 2015
An act to amend Section 11165 of add
Section 11165.4 to the Health and Safety Code, relating to
controlled substances.
LEGISLATIVE COUNSEL'S DIGEST
SB 482, as amended, Lara. Controlled substances:
reporting. Controlled substances: CURES database.
Existing law classifies certain controlled substances into
designated schedules. Existing law requires the Department of Justice
to maintain the Controlled Substance Utilization Review and
Evaluation System (CURES) for the electronic monitoring of the
prescribing and dispensing of Schedule II, Schedule III, and Schedule
IV controlled substances by all practitioners authorized to
prescribe or dispense these controlled substances. Existing law
requires dispensing pharmacies and clinics to report specified
information for each prescription of a Schedule II, Schedule III, or
Schedule IV controlled substance to the department.
This bill would require all prescribers, as defined, prescribing a
Schedule II or Schedule III controlled substance, and all
dispensers, as defined, dispensing a Schedule II or Schedule III
controlled substance, to consult a patient's electronic history in
the CURES database before prescribing or dispensing the controlled
substance to the patient for the first time. The bill would also
require the prescriber to consult the CURES database at least
annually when the prescribed controlled substance remains part of the
patient's treatment. The bill would prohibit prescribing an
additional Schedule II or Schedule III controlled substance to a
patient with an existing prescription until the prescriber determines
that there is a legitimate need for the controlled substance.
The bill would make the failure to consult a patient's electronic
history in the CURES database a cause for disciplinary action by the
prescriber's or dispenser's licensing board and would require the
respective licensing boards to notify all licensees authorized to
prescribe or dispense controlled substances of these requirements.
The bill would provide that a prescriber or dispenser is not in
violation of these requirements during any time that the CURES
database is suspended or not accessible, or during any time that the
Internet is not operational. The bill would make its provisions
operative upon the Department of Justice's certification that the
CURES database is ready for statewide use.
Existing law classifies certain controlled substances into
designated schedules. Existing law requires the Department of Justice
to maintain the Controlled Substance Utilization Review and
Evaluation System (CURES) for the electronic monitoring of the
prescribing and dispensing of Schedule II, Schedule III, and Schedule
IV controlled substances by all practitioners authorized to
prescribe or dispense these controlled substances. Existing law
requires dispensing pharmacies and clinics to report specified
information for each prescription of a Schedule II, Schedule III, or
Schedule IV controlled substance to the department, no more than 7
days after the controlled substance was dispensed.
This bill would specify that the dispensing pharmacies and clinics
are required to report the specified information to the department
no more than 7 business days after the controlled substance was
dispensed.
Vote: majority. Appropriation: no. Fiscal committee: no
yes . State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 11165.4 is added to the
Health and Safety Code , to read:
11165.4. (a) A prescriber shall access and consult the CURES
database for the electronic history of controlled substances
dispensed to a patient under his or her care before prescribing a
Schedule II or Schedule III controlled substance for the first time
to that patient and at least annually when that prescribed controlled
substance remains part of his or her treatment. If the patient has
an existing prescription for a Schedule II or Schedule III controlled
substance, the prescriber shall not prescribe an additional
controlled substance until the prescriber determines that there is a
legitimate need for that controlled substance.
(b) A dispenser shall access and consult the CURES database for
the electronic history of controlled substances dispensed to a
patient under his or her care before dispensing a Schedule II or
Schedule III controlled substance for the first time to that patient.
If the patient has an existing prescription for a Schedule II or
Schedule III controlled substance, the dispenser shall not dispense
an additional controlled substance until the dispenser checks the
CURES database.
(c) Failure to consult a patient's electronic history as required
by subdivision (a) or (b) is cause for disciplinary action by the
respective licensing board of the prescriber or dispenser. The
licensing boards of all prescribers and dispensers authorized to
write or issue prescriptions for controlled substances shall notify
these licensees of the requirements of this section.
(d) Notwithstanding any other law, a prescriber or dispenser is
not in violation of this section during any period of time in which
the CURES database is suspended or not accessible or any period of
time in which the Internet is not operational.
(e) This section shall not become operative until the Department
of Justice certifies that the CURES database is ready for statewide
use.
(f) For purposes of this section, the following terms shall have
the following meanings:
(1) "Dispenser" means a person who is authorized to dispense a
controlled substance under Section 11011.
(2) "Prescriber" means a health care practitioner who is
authorized to write or issue prescriptions under Section 11150,
excluding veterinarians.
(g) A violation of this section shall not be subject to the
provisions of Section 11374.
SECTION 1. Section 11165 of the Health and
Safety Code is amended to read:
11165. (a) To assist health care practitioners in their efforts
to ensure appropriate prescribing, ordering, administering,
furnishing, and dispensing of controlled substances, law enforcement
and regulatory agencies in their efforts to control the diversion and
resultant abuse of Schedule II, Schedule III, and Schedule IV
controlled substances, and for statistical analysis, education, and
research, the Department of Justice shall, contingent upon the
availability of adequate funds in the CURES Fund, maintain the
Controlled Substance Utilization Review and Evaluation System (CURES)
for the electronic monitoring of, and Internet access to information
regarding, the prescribing and dispensing of Schedule II, Schedule
III, and Schedule IV controlled substances by all practitioners
authorized to prescribe, order, administer, furnish, or dispense
these controlled substances.
(b) The Department of Justice may seek and use grant funds to pay
the costs incurred by the operation and maintenance of CURES. The
department shall annually report to the Legislature and make
available to the public the amount and source of funds it receives
for support of CURES.
(c) (1) The operation of CURES shall comply with all applicable
federal and state privacy and security laws and regulations.
(2) CURES shall operate under existing law to safeguard the
privacy and confidentiality of patients. Data obtained from CURES
shall only be provided to appropriate state, local, and federal
public agencies for disciplinary, civil, or criminal purposes and to
other agencies or entities, as determined by the Department of
Justice, for the purpose of educating practitioners and others in
lieu of disciplinary, civil, or criminal actions. Data may be
provided to public or private entities, as approved by the Department
of Justice, for educational, peer review, statistical, or research
purposes, provided that patient information, including any
information that may identify the patient, is not compromised.
Further, data disclosed to an individual or agency as described in
this subdivision shall not be disclosed, sold, or transferred to a
third party. The Department of Justice shall establish policies,
procedures, and regulations regarding the use, access, evaluation,
management, implementation, operation, storage, disclosure, and
security of the information within CURES, consistent with this
subdivision.
(d) For each prescription for a Schedule II, Schedule III, or
Schedule IV controlled substance, as defined in the controlled
substances schedules in federal law and regulations, specifically
Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21 of
the Code of Federal Regulations, the dispensing pharmacy, clinic, or
other dispenser shall report the following information to the
Department of Justice as soon as reasonably possible, but not more
than seven business days after the date a controlled substance is
dispensed, in a format specified by the Department of Justice:
(1) Full name, address, and, if available, telephone number of the
ultimate user or research subject, or contact information as
determined by the Secretary of the United States Department of Health
and Human Services, and the gender, and date of birth of the
ultimate user.
(2) The prescriber's category of licensure, license number,
national provider identifier (NPI) number, if applicable, the federal
controlled substance registration number, and the state medical
license number of any prescriber using the federal controlled
substance registration number of a government-exempt facility.
(3) Pharmacy prescription number, license number, NPI number, and
federal controlled substance registration number.
(4) National Drug Code (NDC) number of the controlled substance
dispensed.
(5) Quantity of the controlled substance dispensed.
(6) International Statistical Classification of Diseases, 9th
revision (ICD-9) or 10th revision (ICD-10) Code, if available.
(7) Number of refills ordered.
(8) Whether the drug was dispensed as a refill of a prescription
or as a first-time request.
(9) Date of origin of the prescription.
(10) Date of dispensing of the prescription.
(e) The Department of Justice may invite stakeholders to assist,
advise, and make recommendations on the establishment of rules and
regulations necessary to ensure the proper administration and
enforcement of the CURES database. All prescriber and dispenser
invitees shall be licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, in active practice in California, and a regular
user of CURES.
(f) The Department of Justice shall, prior to upgrading CURES,
consult with prescribers licensed by one of the boards or committees
identified in subdivision (d) of Section 208 of the Business and
Professions Code, one or more of the boards or committees identified
in subdivision (d) of Section 208 of the Business and Professions
Code, and any other stakeholder identified by the department, for the
purpose of identifying desirable capabilities and upgrades to the
CURES Prescription Drug Monitoring Program (PDMP).
(g) The Department of Justice may establish a process to educate
authorized subscribers of the CURES PDMP on how to access and use the
CURES PDMP.