Amended in Senate April 16, 2015

Senate Bill No. 482

Introduced by Senator Lara

February 26, 2015

An act to begin delete amend Section 11165 of end delete begin insert add Section 11165.4 to end insert the Health and Safety Code, relating to controlled substances.

LEGISLATIVE COUNSEL’S DIGEST

SB 482, as amended, Lara. begin delete Controlled substances: reporting. end delete begin insert Controlled substances: CURES database. end insert

begin insert

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.

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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.

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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.

end insert begin delete

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.

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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.

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

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

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begin insert SECTION 1. end insert   

end insert

begin insert Section 11165.4 is added to the end insert begin insert Health and Safety
Code end insert begin insert , to read: end insert

begin insert

begin insert 11165.4. end insert   

(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.

end insert

begin delete

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.

end delete