BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 360|
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THIRD READING
Bill No: SB 360
Author: DeSaulnier (D)
Amended: 5/10/11
Vote: 21
SENATE PUBLIC SAFETY COMMITTEE : 7-0, 5/3/11
AYES: Hancock, Anderson, Calderon, Harman, Liu, Price,
Steinberg
SENATE APPROPRIATIONS COMMITTEE : 9-0, 5/26/11
AYES: Kehoe, Walters, Alquist, Emmerson, Lieu, Pavley,
Price, Runner, Steinberg
SUBJECT : Controlled substances
SOURCE : Attorney General
DIGEST : This bill makes certain changes to the law
regarding security printers for prescription forms for
controlled substance prescriptions, as specified. This
bill establishes the Controlled Substance Utilization
Review and Evaluation System revise Prescription Drug
Monitoring Program to allow controlled substance
subscribers and pharmacists to have Internet access to the
controlled substance prescription history of persons under
their care, as specified.
ANALYSIS : Existing law includes the Controlled Substance
Utilization Review and Evaluation System (CURES) system of
electronic monitoring of Schedule II, III and IV controlled
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substance prescriptions. CURES provide for the electronic
transmission of Schedule II, III and IV prescription data
to the Department of Justice (DOJ) at the time
prescriptions are dispensed. (Health & Safety Code Section
11165.)
Existing law states that the purpose of CURES is to assist
law enforcement and regulatory agencies in controlling
diversion and abuse of Schedule II, III and IV controlled
substances and for statistical analysis, education and
research. (Health & Safety Code Section 11165, subdivision
(a).)
Existing law provides that pharmacists, in filling a
controlled substance prescription, shall provide to DOJ the
patient's name, date of birth, the name, form, strength and
quantity of the drug, and the pharmacy name, pharmacy
number and the prescribing physician information. (Health
& Safety Code Section 11165, subdivision (d).)
Existing law provides that a licensed health care
practitioner eligible to prescribe Schedule II, III or IV
controlled substances, or a pharmacist, may make a written
request to the DOJ for the history of controlled substances
dispensed to an individual based on the data in CURES.
(Health & Safety Code Section 11165.1, subdivision (a).)
Existing law provides that the DOJ may initiate the
referral of the history controlled substances dispensed to
an individual, based on the CURES data, to licensed health
care practitioners and pharmacists, as specified. (Health
& Safety Code Section 11165.1, subdivision (b).)
Existing law provides that the history of controlled
substances dispensed to a patient based on CURES data that
is received by a practitioner or pharmacist shall be
considered medical information, as specified. (Health &
Safety Code Section 11165.1, subdivision (c).)
Existing law provides that CURES data "shall only be
provided to appropriate state, local and federal persons or
public agencies for disciplinary, civil or criminal
purposes." CURES data shall also only be provided, as
determined by DOJ, to other agencies or entities for
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educating practitioners and others, in lieu of
disciplinary, civil or criminal actions. (Health & Safety
Code Section 11165 subdivision (b).)
Existing law allows non-identifying CURES data to be
provided to public and private entities for education,
research, peer review and statistical analysis. (Health &
Safety Code Section 11165, subdivision (c).)
Existing law provides that prescriptions for controlled
substances must be made on special security forms to
prevent copying or forgery of prescriptions. (Health &
Safety Code Section 11162.1.)
Existing law requires health practitioners who prescribe or
administer a controlled substance classified in Schedule II
to make a record containing the name and address of the
patient, date, and the character, name, strength, and
quantity of the controlled substance prescribed, as well as
the pathology and purpose for which the controlled
substance was administered or prescribed. (Health & Safety
Code Section 11190, subdivision (a)-(b).)
Existing law requires prescribers who are authorized to
dispense Schedule II, III or IV controlled substance in
their office or place of practice to record and maintain
information for each such prescription that includes the
patient's name, address, gender, and date of birth,
prescriber's license and license number, federal controlled
substance registration number, state medical license
number, NDC number of the controlled substance dispensed,
quantity dispensed, diagnosis code, if available, and
original date of dispensing. This information shall be
provided to DOJ on a monthly basis. (Health & Safety Code
Section 11190 subd. (c).)
This bill provides that any security prescription form
printer shall provide DOJ with the following information:
the names and addresses of an owner, partner, corporate
officer, manager, agent, representative, employee or
subcontractor with direct access to, management of, or
control over controlled substance prescription forms.
This bill provides that a security printer shall inform DOJ
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if any owner, partner, corporate officer, manager, agent,
representative, employee or subcontractor with direct
access to, management of, or control over controlled
substance prescription forms has been convicted of, or
pleaded no contest, any crime.
This bill directs DOJ to inform any owner, partner,
corporate officer, manager, agent, representative, employee
or subcontractor with direct access to, management of, or
control over controlled substance prescription forms how to
provide fingerprints and other required information to DOJ
for criminal background checks.
This bill requires that controlled substance forms shall be
provided in person only to established customers. The
printer shall obtain the customer's photo identification
and log the information. Controlled substance forms shall
only be mailed to an address verified by the DEA or Medical
Board of California.
This bill requires security printers to report theft of
loss of controlled substance prescription forms to DOJ by
fax or e-mail within 24 hours.
This bill requires DOJ to impose sanctions on security
printers who violate applicable statutes and regulations,
as specified.
This bill provides that the following security printer
violations are subject to a fine of up to $1,000 for a
first violation, a fine of up to $2,500 for each subsequent
violation; a printer who violates these rules for a third
time is subject to disciplinary proceeding for suspension
or revocation of security printer status:
Failure to comply with guidelines.
Failure to take reasonable precautions to prevent
dishonest or illegal actions concerning control of
controlled substance forms.
Theft or fraudulent use of a prescriber's identity
to obtain forms.
This bill establishes the Prescription Drug Monitoring
Program (PDMP), with the following features:
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Any practitioner licensed to prescribe Schedules II
through IV controlled substances or pharmacist may
apply to participate in the PMDP, as specified.
Under the PMDP the participating practitioner or
pharmacist (subscriber) may access, using the
Internet, the electronic history of controlled
substances dispensed to an individual under his or her
care based on data contained in CURES.
A practitioner or pharmacist PDMP subscriber may
access through the PDMP the number, amount, and type
of controlled substances being dispensed to an
individual under his or her care, in order to control
the diversion and resultant abuse of, and to ensure
the safe and lawful dispensing of, Schedule II,
Schedule III, and Schedule IV controlled substances.
DOJ may release to the subscribing practitioner or
pharmacist the electronic history of controlled
substances dispensed to a person under the care of the
practitioner or pharmacist based on data in the CURES
Prescription Drum Monitoring Program (PDMP).
This bill provides that an application may be denied, or a
subscriber suspended, for any of the following:
Materially falsifying an application.
Failing to maintain effective controls for access
to the patient activity report.
Suspended or revoked DEA registration.
Arrest of a subscriber for a controlled substance
offense.
Accessing information for any reason except patient
care.
This bill provides that an authorized subscriber shall
notify DOJ within 10 days of any changes to the subscriber
account.
This bill allows, until July 12, 2012, a health care
practitioner or pharmacist to make a written request for
controlled substance history information about a person
under the care of the practitioner or pharmacist, in order
to provide sufficient time for subscribers to apply for
access to PDMP.
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This bill provides that DOJ may audit the PDMP system and
its users.
This bill provides that DOJ may establish, by regulation, a
system for issuing a citation to a PDMP subscriber.
This bill provides that the citation may contain an order
or abatement or to pay a fine if the subscriber is in
violation of the CURES-PDMP statutes or corresponding
regulations:
Citations shall be written and particularly
describe the violation, including a specific citation
of the statute or regulation violated.
When appropriate, the citation shall include a
reasonable time for abatement of the violation.
An administrative fine shall not exceed $2,500 for
each violation and shall be based on the gravity of
the violation, the good faith of the subscriber and
any previous violations.
The citation shall inform the subscriber that
he/she may, within 30 days of receiving a citation,
request a hearing.
A subscriber may, within 10 days of receiving a
citation, request in writing an informal conference
with DOJ. DOJ may, pursuant to the conference,
affirm, modify or dismiss the citation.
If the citation is affirmed, the subscriber may
request a formal hearing.
If the citation is modified, the original citation
shall be deemed withdrawn and a new citation issued.
The subscriber may request a formal hearing on the
subsequent citation.
Failure to pay a fine within 30 days, or to comply
with an order of abatement within the time prescribed
to do so, may result in disciplinary action by DOJ,
unless the citation is being appealed.
If the citation is not contested and the fine is
not paid, the subscriber's account will be terminated.
A citation may be issued without a fine.
Fines may be limited to particular violations.
If a fine is paid, payment shall represent
satisfactory resolution of the matter for public
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disclosure.
Administrative fines shall be deposited in the
CURES Program Special Fund and "shall provide support
for costs association with hearings, maintenance, and
updates to the ÝPDMP]."
These sanctions shall be in separate form and in
addition to any other administrative, civil or
criminal remedies.
A criminal action may not be initiated for a
specific offense if a citation has been issued for
that matter. A citation may not be issued for a
specific offense, if a criminal action has been filed
for that violation. However, nothing in the citation
provisions shall prevent DOJ from prosecuting a
suspension or revocation of a subscriber.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
Major Provisions 2011-12 2012-13
2013-14 Funds
Regulation development Unknown;
significant costs in the General
and establishment of hundreds
of thousands; future offset Special*
system for regulation of in whole or in part by fine/fee
revenue
PDMP access
Expanded security Unknown,
enforcement costs fully Special*
printer requirementsoffset by fee/fine revenue
and fines
PDMP maintenance Potential minor
cost pressure to Special**
contracts existing contracts
*CURES Program Special Fund
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**Contingent Fund of Medical Board, Pharmacy Board
Contingent Fund, State Dentistry Fund, Board of Registered
Nursing Fund, Osteopathic Medical Board Contingent Fund
SUPPORT : (Verified 5/26/11)
Attorney General (source)
California Narcotic Officers Association
California Police Chiefs Association
California State Sheriffs' Association
California Statewide Law Enforcement Association
Consumer Attorneys of California
Peace Officers Research Association of California
ARGUMENTS IN SUPPORT : According to the author's office,
due to the rise in prescription drug abuse, controlled
drugs prescription history information is available and
maintained by the DOJ CURES program. In 2009, the DOJ
launched an automated PDMP. The program allows licensed
health care practitioners eligible to prescribe controlled
substances access to patient controlled substance
prescription information. Prescribers and pharmacists can
now make informed decisions about patient care and detect
patients who may be abusing controlled substances by
obtaining multiple prescriptions from various
practitioners. Current efforts at maintaining privacy and
control of CURES data are inadequate to protect
confidential patient information and to deter its misuse.
The DOJ also manages the California Security Prescription
Printer Program. While DOJ has established guidelines for
the security of prescription forms, current law lacks
sufficient safeguards against theft and fraudulent use of
prescription pads. The DOJ has seen an increase in
criminal enterprises involved in prescription theft and
fraud.
RJG:do 5/27/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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