BILL ANALYSIS �
SB 360
Page 1
Date of Hearing: July 5, 2011
Counsel: Sandy Uribe
ASSEMBLY COMMITTEE ON PUBLIC SAFETY
Tom Ammiano, Chair
SB 360 (DeSaulnier) - As Amended: May 10, 2011
As Proposed to be Amended in Committee
SUMMARY : Makes changes to the Controlled Substance Utilization
Review and Evaluation System (CURES) and the Prescription Drug
Monitoring Program (PDMP). Specifically, this bill :
1)Expands the requirements imposed on security-printer
applicants to print prescription forms for controlled
substance prescriptions to include the names and addresses of
any individual owner, partner, corporate officer, manager,
agent, representative, employee or subcontractor with direct
access to, management of, or control over controlled substance
prescription forms; a signed statement regarding any prior
criminal convictions for these parties, and fingerprints for
the same.
2)Clarifies that the fee assessed by the Department of Justice
(DOJ) to process the application of a security printer shall
be sufficient to cover inspections of security printers in
addition to the other costs specified by statutes.
3)Requires that controlled substance forms shall be provided in
person only to established customers.
4)Requires a security printer to obtain the customer's photo
identification and log the information.
5)Limits the mailing of controlled substance only to an address
verified by the Drug Enforcement Agency (DEA) or Medical Board
of California.
6)Requires a security printer to report the theft or loss of
controlled substance prescription forms to DOJ within 24 hours
of its occurrence.
7)Requires DOJ to impose sanctions on security printers who
SB 360
Page 2
violate applicable statutes and regulations, including failure
to comply with guidelines, failure to take reasonably
precautions to prevent dishonest or illegal actions with
regard to the access and control of security prescription
forms, and the theft or fraudulent use of a prescriber's
identity to obtain forms.
8)Specifies that the sanctions for a violation of applicable
statutes and regulations are a fine of up to $1,000 for a
first violation, a fine of up to $2,500 for a second or
subsequent violation; disciplinary proceedings for suspension
or revocation of security printer status for third or
subsequent violations.
9)Modifies the PDMP to include the following features:
a) Allows any practitioner licensed to prescribe controlled
substances of Schedules II-IV or any pharmacist to apply to
participate in the PDMP, as specified; and,
b) Gives the program participant Internet access to view
the electronic history of controlled substances dispensed
to an individual under his or her case based on data
contained in CURES.
10)Provides that a PDMP application may be denied, or a
subscriber suspended from the program for material
falsification of an application, failure to maintain effective
controls for access to the patient activity report, a
suspended or revoked DEA registration, an arrest for a drug
offense, or accessing information for any reason other than
patient care.
11)Requires an authorized subscriber to notify DOJ within 10
days of any changes to the subscriber account.
12)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.
13)Authorizes DOJ to audit the PDMP system and its users.
14)Authorizes DOJ to establish regulations for a system to issue
SB 360
Page 3
citations for unauthorized use of the CURES data by
subscribers with PDMP access, and provides for orders or
abatement, fines of up to $2,500 per violation, and a hearing
process if a subscriber is in violation of the CURES-PDMP
statutes or corresponding regulations.
15)Requires citations issued by DOJ to be in writing, to
particularly describe the violation including a specific
citation to the statute or regulation violated, and to notify
the subscriber of the opportunities to request a hearing
and/or an informal conference, and the deadlines for
requesting them.
16)Provides that the failure of a subscriber to pay a fine
within 30 days, or to comply with an abatement order within
the time subscribed, may result in disciplinary action unless
the citation is being appeal.
17)Provides that any administrative fines collected shall be
deposited in the CURES Program Special Fund.
18)Specifies that the sanctions authorized pursuant to this bill
shall be separate and in addition to any other administrative,
civil or criminal remedies, but that a criminal action may not
be initiated for a specific offense if a citation has been
issued for that matter, and that if a criminal action has been
filed, a citation cannot be issued for the same offense.
Notwithstanding this provision, nothing shall prevent DOJ from
prosecuting a suspension or revocation of a subscriber.
19)Requires an affected PMDP prescriber to immediately report
the theft or loss of controlled substance prescription forms
to DOJ, and specifies the reporting shall be done no later
than three days after the discovery of the theft of loss.
EXISTING LAW :
1)Requires health care providers to obtain prescription forms
for controlled substance prescriptions from security printers
approved by the DOJ. �Health and Safety Code (HSC) Section
11161.5(a).]
2)Requires an entity applying be to security printer to include
specified information in its application and to provide
fingerprints for the purposes. �HSC Section 11161.5(b).]
SB 360
Page 4
3)Requires DOJ to maintain the 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. �HSC Section 11165(a).]
4)Requires a dispensing pharmacy or clinic to provide specified
prescription data for each prescription for a Schedule II,
Schedule III, or Schedule IV controlled substance to DOJ on a
weekly basis. �HSC Section 11165(d).]
5)Allows a licensed health care practitioner who is eligible to
prescribe Schedule II, Schedule III, or Schedule IV controlled
substances, or a pharmacist to make a written request to DOJ
for the history of controlled substances dispensed to an
individual under his or her care. �HSC Section
11165.1(a)(1).]
6)Permits DOJ to give the history of controlled substances
dispensed to an individual based on data contained in CURES to
licensed health care practitioners and pharmacists providing
care or services to the individual in order to prevent the
inappropriate, improper, or illegal use of controlled
substances. �HSC Section 11165.1(b).]
7)Provides that the history of controlled substances dispensed
to an individual based on data contained in CURES that is
received by a practitioner or pharmacist from DOJ pursuant to
this section shall be considered medical information subject
to specified confidentiality provisions. �HSC Section
11165.1(c).]
8)Requires every practitioner, other than a pharmacist, who
prescribes or administers a controlled substance classified in
Schedule II, III or IV to record specified information
relating to the transaction. (HSC Section 11190.)
FISCAL EFFECT : Unknown
COMMENTS :
1)Author's Statement : According to the author, "Due to the rise
in prescription drug abuse, controlled drugs prescription
history information is available and maintained by the
SB 360
Page 5
Department of Justice (DOJ) CURES program. In 2009, the DOJ
launched an automated Prescription Drug Monitoring Program
(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. However, current efforts at maintaining
privacy and control of CURES data are inadequate to protect
confidential patient information and to deter its misuse.
"SB 360 will help to prevent the misuse of confidential
information collected through the CURES and ensure the
integrity of the program and process for practitioners and
pharmacists to appropriately use patient's controlled
substances history information.
"The DOJ manages the California Security Prescription Printer
Program. While the DOJ has established guidelines for the
security of prescription forms, current law lacks sufficient
safeguards against theft and fraudulent use of prescription
pads and the DOJ has seen an increase in criminal enterprises
involved in prescription form theft and fraud. SB 360
provides additional requirements and sanctions for Security
Printers to deter fraudulent use of prescription pads and the
illegal distribution of controlled substances."
2)Background : The CURES was established in 1997 by AB 3042
(Takasugi), Chapter 738, Statutes of 1996, in response to
recommendations of the Controlled Substance Prescription
Advisory Council. (SCR 74, 1992.) The program initially was
intended to electronically monitor the prescribing and
dispensing of Schedule II controlled substances, such as
oxycodone. The CURES provides for real-time electronic
transmission of specified prescription data to DOJ.
Essentially the data is analyzed for indications that
controlled substances are being improperly prescribed, or that
drug abusers are obtaining prescriptions from many doctors
(doctor shopping). Currently, Physicians and pharmacists,
have access to CURES data through patient activity reports.
3)Argument in Support : According to the Attorney General's
Office , the sponsor of this bill: "Under existing law, CURES
provides for electronic monitoring of the prescribing and
SB 360
Page 6
dispensing of Schedule II, III and IV controlled substances.
In 2009, DOJ launched the automated Prescription Drug
Monitoring Program (PDMP). The program allows licenses heath
care practitioners to patient controlled substance
prescription information in real-time, 24 hours a day at the
point of care. 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.
"The PDMP is a valuable investigative, preventative, and
educational tool for law enforcement, regulatory boards, and
health care providers. However, current efforts at
maintaining privacy and control of CURES sate are inadequate
to protect confidential patient information, and to deter
misuse of confidential CURES data. SB 360 authorizes DOJ to
initiate administrative enforcement actions to prevent and
deter misuse of confidential patient information collected
through the CURES program.
"Under existing law, DOJ also manages the California Security
Prescription Printer Program, including approval of "Security
Prescription Printer" applications. Fraudulent prescriptions
are lucrative. One blank prescription pad of 500
prescriptions can generate millions of dollars from the
illegal sale of controlled substances such as Oxycontin,
Xanax, or Vicodin. DOJ has seen an increase in criminal
enterprises, from gangs to organized crime, involved in
prescription drug fraud. Current law lacks adequate
safeguards against the theft and illegal distribution of
prescription pads from Security Prescription Printers. SB 360
provides additional requirements and sanctions for Security
Printers and their employees who have direct contact with, or
access to, controlled substance prescription drug forms to
deter fraudulent prescriptions and illegal distribution of
controlled substances."
4)Prior Legislation :
a) AB 2968 (Mullin), Chapter 286, Statutes of 2006, added
more information to the requirements for a physician to
prescribe a controlled substance, and required electronic
monitoring of Schedule IV drugs.
b) SB 734 (Torlakson), Chapter 487, Statutes of 2005, made
SB 360
Page 7
various technical and clarifying changes to the CURES.
c) SB 151 (Burton), Chapter 406, Statutes of 2004, made the
CURES reporting system permanent
d) AB 3042 (Takasugi), Chapter 738, Statutes of 1996,
established CURES as a three-year pilot program.
REGISTERED SUPPORT / OPPOSITION :
Support
Department of Justice (Sponsor)
California Narcotic Officers' Association
California Peace 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
Opposition
None
Analysis Prepared by : Sandy Uribe / PUB. S. / (916) 319-3744