BILL ANALYSIS �
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Loni Hancock, Chair S
2011-2012 Regular Session B
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SB 360 (DeSaulnier)
As Amended April 14, 2011
Hearing date: May 3, 2011
Family; Health & Safety Codes
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CONTROLLED SUBSTANCES
HISTORY
Source: Attorney General
Prior Legislation: AB 2986 (Mullin) - Ch. 286, Stats. 2006
SB 1366 (Aanestad) - 2005-06, held in Senate Public
Safety
SB 734 (Torlakson) - Ch. 487, Stats. 2005
SB 151 (Burton) - Ch. 406, Stats. 2004
Support: California Statewide Law Enforcement Association;
Consumer Attorneys of California; California State
Sheriffs' Association; Peace Officers Research
Association of California; California Narcotic Officers
Association; California Police Chiefs Association
Opposition:None known
KEY ISSUES
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SHOULD SCHEDULES I, II, III and IV FOR CONTROLLED SUBSTANCES IN
CURRENT LAW BE EXPANDED TO INCLUDE ADDITIONAL SUBSTANCES, AS
SPECIFIED?
(CONTINUED)
SHOULD SPECIFIED CHANGES BE MADE TO THE LAW REGARDING SECURITY
PRINTERS FOR PRESCRIPTION FORMS FOR CONTROLLED SUBSTANCE
PRESCRIPTIONS, AS SPECIFIED?
SHOULD THE CURES PRESCRIPTION DRUG MONITORING PROGRAM (PDMP) BE
REVISED TO ALLOW PARTICIPATING CONTROLLED SUBSTANCE PRESCRIBERS
AND PHARMACISTS TO ACCESS OVER THE INTERNET THE HISTORY OF
CONTROLLED SUBSTANCE PRESCRIPTIONS OF PERSONS UNDER THEIR CARE,
AS SPECIFIED?
PURPOSE
The purposes of this bill are to 1) add additional substances to
schedules I and IV for controlled substances, as specified; 2)
make certain changes to the law regarding security printers for
prescription forms for controlled substance prescriptions, as
specified; and 3) establish the CURES 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.
Existing law classifies controlled substances in five schedules
according to their danger and potential for abuse. Schedule I
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controlled substances have the greatest restrictions and
penalties, including prohibiting the prescribing of a Schedule I
controlled substance. (Health & Saf. Code �� 11054-11058.)
Existing law provides penalties for sale, possession for sale or
distribution, sale or distribution, and manufacturing of
controlled substances. (Health & Saf. Code �� 11350-11401.)
Existing law , with numerous exceptions, includes the following
penalties:
Heroin, cocaine and other specified drugs (section
references are to the Health and Safety Code):
� � 11350 possession straight felony -
prison term of 16 months, 2 years or 3 years<1>
� � 11351 possession for sale or
distribution - prison for 2, 3 or 4 years
� � 11351.5 possession of cocaine base
(crack) for sale - prison for 3, 4, 5 years
� � 11352 sale or distribution - 3, 6
or 9 years
Marijuana:
� � 11357 possession - misdemeanor
� � 11358 cultivation or processing -
felony
� � 11359 possession for sale - felony
� � 11360 sale or distribution -
felony, 2, 3 or 4 years
Methamphetamine and other specified drugs:
� � 11377 possession - alternate felony-misdemeanor
� � 11378 possession for sale or distribution - felony
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<1> Hereinafter, a description of a crime as a "felony,"
without an additional explanation or description of the
applicable prison sentence, means that the crime is punishable
by imprisonment for 16 months, 2 years or 3 years.
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� � 11379 sale or distribution - felony, 2, 3 or 4 years
Existing law includes numerous enhancement provisions for
controlled substance crimes. These include enhancements based
on the weight and volume of controlled substances and sale
within a certain distance from a school. Examples of
enhancements include the following: enhancement for weight of
controlled substances involved in sale or distribution (Health &
Safety Code � 11370.4, subdivision (b)); enhancement for weight
or volume of controlled substance involved in manufacturing
(Health & Saf. Code � 11379.8); and enhancement where person
dies or suffers great bodily injury in the manufacturing of
methamphetamine.
Existing law provides that any person who manufactures,
compounds, converts, produces, derives, processes, or prepares
either directly or indirectly by chemical extraction or
independently by means of chemical synthesis any controlled
substance is guilty of a felony, punishable by imprisonment in
the state prison for three, five or seven years, and by a fine
of up to $50,000. (Health & Saf. Code � 11379.6.)
Existing law provides that any person who possesses specified
chemicals with the intent to manufacture a controlled substance
is guilty of a felony and shall be punished by imprisonment in
the state prison for two, four or six years. (Health & Saf.
Code � 11383.)
Existing law includes enhancements for controlled substance
crimes that occur in specified places. For example, the
enhancement triad for involving a minor in specified controlled
substance crimes is three, six or nine years. (Health & Saf.
Code � 11353.) There are a myriad other special penalty
provisions.
This bill would add additional substances to these schedules, as
specified.
Existing law includes the CURES (Controlled Substance
Utilization Review and Evaluation System) system of electronic
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monitoring of Schedule II, III and IV controlled substance
prescriptions. CURES provides 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 & Saf. Code � 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 & Saf.
Code � 11165, subd. (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 & Saf. Code � 11165, subd. (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 & Saf. Code �
11165.1, subd. (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 & Saf. Code � 11165.1,
subd. (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 & Saf. Code � 11165.1, subd.
(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
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shall also only be provided, as determined by DOJ, to other
agencies or entities for educating practitioners and others, in
lieu of disciplinary, civil or criminal actions. (Health & Saf.
Code � 11165 subd. (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 & Saf. Code � 11165,
subd. (c).)
Existing law provides that prescriptions for controlled
substances must be made on special security forms to prevent
copying or forgery of prescriptions. (Health & Saf. Code �
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 & Saf. Code � 11190, subd. (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 & Saf. Code � 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
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access to, management of, or control over controlled substance
prescription forms.
This bill provides that a security printer shall inform DOJ 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; and
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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:
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; or
accessing information for any reason except patient
care.
This bill provides that an authorized subscriber shall notify
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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.
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 or 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.
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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 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
�PDMP]."
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.
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
For the last several years, severe overcrowding in California's
prisons has been the focus of evolving and expensive litigation.
As these cases have progressed, prison conditions have
continued to be assailed, and the scrutiny of the federal courts
over California's prisons has intensified.
On June 30, 2005, in a class action lawsuit filed four years
earlier, the United States District Court for the Northern
District of California established a Receivership to take
control of the delivery of medical services to all California
state prisoners confined by the California Department of
Corrections and Rehabilitation ("CDCR"). In December of 2006,
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plaintiffs in two federal lawsuits against CDCR sought a
court-ordered limit on the prison population pursuant to the
federal Prison Litigation Reform Act. On January 12, 2010, a
three-judge federal panel issued an order requiring California
to reduce its inmate population to 137.5 percent of design
capacity -- a reduction at that time of roughly 40,000 inmates
-- within two years. The court stayed implementation of its
ruling pending the state's appeal to the U.S. Supreme Court.
On Monday, June 14, 2010, the U.S. Supreme Court agreed to hear
the state's appeal of this order and, on Tuesday, November 30,
2010, the Court heard oral arguments. A decision is expected as
early as this spring.
In response to the unresolved prison capacity crisis, in early
2007 the Senate Committee on Public Safety began holding
legislative proposals which could further exacerbate prison
overcrowding through new or expanded felony prosecutions.
This bill does appear to aggravate the prison overcrowding
crisis described above.
COMMENTS
1. Need for This Bill
According to the author:
Due to the rise in prescription drug abuse, controlled
drugs prescription history information is available
and maintained by the 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
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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.
The existing list of controlled substances in
Schedules II, III, and IV set forth in the California
Health and Safety Code is out of date and no longer in
conformity with the Federal controlled substances
list. As a result, the CURES program is no longer
collecting all controlled substance information as
required by law.
2. Controlled Substance Schedules - Criteria for Listings
The Federal Government classifies drugs into five schedules.
(21 U.S.C. � 812.) California law generally follows federal law
as to the assigned schedule, but does not set out the criteria
for the schedules that are included in federal law. (Health and
Safety Code Section 11054.)
21 U.S.C., Section 812 (b) includes the following explanations:
Schedule I drugs are drugs that have no currently accepted
medical use in treatment in the United States, have a high
potential for abuse, and there is a lack of accepted safety for
use of the drug or other substance under medical supervision.
Schedule I drugs include but are not limited to cannabis,
heroin, GHB, and ecstasy.
Schedule II controlled substances have a currently accepted
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medical use in treatment, a high potential for abuse, which may
lead to severe psychological or physical dependence. Schedule
II drugs include but are not limited to Cocaine, Ritalin,
oxdycodone, morphine, and amphetamines.
Schedule III controlled substances have a currently accepted
medical use in treatment, a potential for abuse that is less
than that for Schedule I and II drugs, and abuse may lead to
moderate or low physical dependence or high psychological
dependence. Schedule III drugs include but are not limited to
anabolic steroids, prescriptions that combine codeine or
hydrocodone with aspirin or another non-narcotic ingredient,
ketamine, and testosterone.
Schedule IV drugs have a currently accepted medical use in
treatment, have a low potential for abuse relative to the
substances in Schedule III, and abuse may lead to limited
physical dependence or psychological dependence. Schedule IV
drugs include but are not limited to Xanax, Librium, Valium,
talwin and Phenobarbital.
Schedule V drugs have a low potential for abuse, have a
currently accepted medical use in treatment, and abuse of the
drug may lead to limited physical dependence or psychological
dependence. Schedule V drugs include but are not limited to
narcotic drugs containing active medicinal qualities other than
those possessed by narcotic drugs alone, such as cough
suppressants containing small amounts of codeine.
3. The CURES Program: Electronic Monitoring of Controlled
Substance Prescriptions, Private Contractor
The CURES program was established in 1997 by AB 3042 (Takasugi)
in response to recommendations of the Controlled Substance
Prescription Advisory Council. (SCR 74, 1992.) A CURE
initially was intended to electronically monitor the prescribing
and dispensing of Schedule II controlled substances such as
oxycodone. 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
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improperly prescribed, or that drug abusers are obtaining
prescriptions from many doctors (doctor shopping). Physicians
and pharmacists, in addition to DOJ, have access to CURES data
through PAR - patient activity reports. A private contractor -
Atlantic Associates - collects CURES data for DOJ. The previous
vendor was Infinite Solutions.
4. Confidentiality Concerns
According to a report issued by the General Accounting Office
(GAO) in May 2002:
Both physicians who legitimately prescribe prescription
drugs and patients who legitimately use them are
concerned that the information collected, centrally
maintained, and monitored by state PDMP's may be used
inappropriately or compromised. �P]DMP's, particularly
those with electronic databases, raise additional
confidentiality concerns, however, because their
databases contain complete dispensing records that can
more quickly identify individual patients, physicians
and pharmacies and provide an individual report on
their prescription drug history. Physicians are
concerned that their prescribing decisions and patterns
may be questioned, and that they could be investigated
without sufficient cause. Some physicians contend that
patients may suffer because physicians will be
reluctant to prescribe appropriate controlled
substances to manage a patient's pain or treat their
conditions?Patients are concerned that their personal
information may be used inappropriately by those with
authorized access or shared with unauthorized entities.
(U.S. Gen. Accounting Office, Prescription Drugs,
State Monitoring Programs Provide Useful Tool to Reduce
Diversion, (May, 2002) p. 18;
http://www.gao.gov/new.items/d02634.pdf.)
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This appears to be a legitimate concern, given the number of
persons and entities with access to this information. This bill
provides penalties for unauthorized use of CURES data by those
with PDMP access. The question is raised as to whether privacy
may be better protected by preventive measures than penalties
imposed after misuse of CURES information.
WHAT MEASURES COULD BE IMPLEMENTED TO PREVENT MISUSE OF CURES
DATA?
WOULD PREVENTION OF MISUSE BE MORE EFFECTIVE THAN IMPOSING
SANCTIONS AFTER MISUSE OF THE DATA OR IMPROPER ACCESS?
5. Prior Legislation Amending the CURES System
AB 2986 (Mullin), Chapter 286, Statutes of 2006,
required designated prescription forms for controlled
substances and prescriptions for controlled substances to
contain additional information identifying the final
consumer and any refill information. AB 2986 also added
Schedule IV drugs to the controlled substances subject to
electronic reporting and monitoring system under CURES.
SB 1366 (Aanestad), of the 2005-06 Legislative Session,
would have removed the requirement that authorized persons
write prescriptions for controlled substances on a
specialized secured prescription form and would have
allowed courts to issue an order prohibiting prescriber
from prescribing controlled substances when the prescriber
is charged with a specified felony offense. SB 1366 was
held in the Senate Committee on Public Safety.
SB 734 (Torlakson), Chapter 487, Statutes of 2005, made
technical and clarifying changes to CURES.
SB 151 (Burton), Chapter 406, Statutes of 2004, made the
CURES reporting system permanent.
6. Expansion of Existing Felonies; Potential ROCA Remedy
As explained in detail above, under existing law the unlawful
possession of certain controlled substances (as well as other
conduct relating to controlled substances) can be a felony.
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Because this bill would include additional substances in the
schedules of controlled substances, it would violate ROCA. The
Committee and the author may wish to consider the following
amendments, which would remedy the bill's ROCA implications:
1) Strike additions to the California controlled substance
schedules and related provisions.
These amendments would strike SECTION 1 through SECTION 5 of the
bill. (p. 3, line 1, through p. 22, line 24.) These amendments
also would strike SECTION 13 through SECTION 24 of the bill.
(p. 34, line 37 through p. 40, line 32.)
2) Direct prescribers and pharmacists to report to CURES
prescriptions for controlled substances listed in Schedules II,
III and IV of the federal controlled substance schedules.
The bill could be amended to provide that prescribers and
pharmacists shall report prescriptions for controlled substances
to CURES that are listed in Schedules II, III and IV of the
federal controlled substance schedules set out in 21 U.S.C. �
812 and as updated in 21 Code of Federal Regulations, Sections
1308.12, 1308.13 and 1308.14.
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