BILL ANALYSIS
AB 2548
Page 1
Date of Hearing: April 13, 2010
Counsel: Nicole J. Hanson
ASSEMBLY COMMITTEE ON PUBLIC SAFETY
Tom Ammiano, Chair
AB 2548 (Block) - As Introduced: February 19, 2010
SUMMARY : Establishes the Prescription Drug Monitoring Program
(PDMP) under the Department of Justice (DOJ) to monitor
practitioners and pharmacists who have obtained approval to
access, using the Internet, the electronic history of controlled
substances dispensed to individuals. Specifically, this bill :
1)Provides that in order to assist 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 DOJ shall, contingent upon the
availability of adequate funds from the Contingent Fund of the
Medical Board of California, the Pharmacy Board Contingent
Fund, the State Dentistry Fund, the Board of Registered
Nursing Fund, and the Osteopathic Medical Board of California
Contingent Fund, maintain the Controlled Substance Utilization
Review and Evaluation System (CURES) for the electronic
monitoring and Internet accessing 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.
2)Allows a licensed health care practitioner eligible to
prescribe Schedule II, Schedule III, or Schedule IV controlled
substances or a pharmacist to manually or electronically
submit to the DOJ a notarized application developed by DOJ to
obtain approval to 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, and
the DOJ may, upon approval of the application, release to that
practitioner or pharmacist, the electronic history of
controlled substances dispensed to an individual under his or
her care based on data contained in CURES.
3)States an application by a practitioner or pharmacist may be
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denied, or access authorized pursuant to this section for a
practitioner or pharmacist may be suspended, for cause,
including, but not limited to, the following:
a) Materially falsifying an application;
b) Failure to maintain effective controls for access to the
patient activity report;
c) The suspension or revocation of a Drug Enforcement
Agency (DEA) registration;
d) An arrest or conviction for any controlled substance
offense or violation of this section;
e) Accessing information pursuant to this section for any
reason not related to the care of a patient; and,
f) Any practitioner or pharmacist authorized pursuant to
this section to access a patient's history of dispensed
controlled substances shall notify DOJ within 10 days of
any change of pertinent information regarding the
practitioner or pharmacist.
4)Removes provision whereby DOJ may initiate the referral of the
history of controlled substances dispensed to an individual
based on data contained in CURES to licensed health care
practitioners, pharmacists, or both, providing care or
services to the individual to prevent the inappropriate,
improper or illegal use of Schedule II, Schedule III, or
Schedule IV controlled substances.
5)Establishes the PDMP in state government under the DOJ to
monitor any practitioner or pharmacist who has obtained
approval to 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, as well as 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. For the purposes of
this section, a "PDMP subscriber" is defined as a practitioner
or pharmacist who has obtained approval under to access, using
the Internet, the electronic history of controlled substances
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dispensed to an individual under his or her care based on data
contained in CURES.
6)Allows the DOJ to establish, by regulation, a system for the
issuance to a PDMP subscriber of a citation which may contain
an order of abatement or an order to pay an administrative
fine assessed by the department, if the subscriber is in
violation of any provision of this chapter or any regulation
adopted by the department pursuant to this chapter.
7)Provides the citation system shall contain the following
provisions:
a) Citations shall be in writing and shall describe with
particularity the nature of the violation, including
specific reference to the provision of law or regulation of
the department determined to have been violated.
b) Whenever appropriate, the citation shall contain an
order of abatement fixing a reasonable time for abatement
of the violation.
c) In no event shall the administrative fine assessed by
the department exceed $2,500 for each violation. In
assessing a fine, due consideration shall be given to the
appropriateness of the amount of the fine with respect to
such factors as the gravity of the violation, the good
faith of the subscriber, and the history of previous
violations.
d) An order of abatement or a fine assessment issued
pursuant to a citation shall inform the subscriber that if
the subscriber desires a hearing to contest the finding of
a violation, that hearing shall be requested by written
notice to the CURES program of the DOJ within 30 days of
the date of issuance of the citation or assessment.
8)Allows in addition to requesting a hearing, the subscriber
may, within 10 days after service of the citation, request in
writing an opportunity for an informal conference with DOJ
regarding the citation. At the conclusion of the informal
conference, the department may affirm, modify, or dismiss the
citation, including any fine levied or order of abatement
issued. The decision shall be deemed to be a final order with
regard to the citation issued, including the fine levied and
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the order of abatement. However, the subscriber does not
waive its right to request a hearing to contest a citation by
requesting an informal conference. If the citation is
dismissed after the informal conference, the request for a
hearing on the matter of the citation shall be deemed to be
withdrawn. If the citation, including any fine levied or
order of abatement, is modified, the citation originally
issued shall be considered withdrawn and a new citation
issued. If a hearing is requested for a subsequent citation,
it shall be requested within 30 days of service of that
subsequent citation.
9)States that the failure of a subscriber to pay a fine within
30 days of the date of assessment or comply with an order of
abatement within the fixed time, unless the citation is being
appealed, may result in disciplinary action being taken by the
DOJ. If a citation is not contested and a fine is not paid,
the subscriber account shall be terminated.
10)Allows a citation to be issued without the assessment of an
administrative fine.
11)Limits the assessment of administrative fines to only
particular violations of the law or department regulations.
12)Provides notwithstanding any other provision of law, if a
fine is paid to satisfy an assessment based on the finding of
a violation, payment of the fine shall be represented as
satisfactory resolution of the matter for purposes of public
disclosure.
13)Calls for administrative fines collected pursuant to this
section to be deposited in a fund under DOJ relating to CURES.
These special funds shall be utilized to provide support for
costs associated with informal and formal hearings under,
maintenance of, and updates to CURES.
14)Necessitates that sanctions authorized under this section
shall be separate from, and in addition to, any other
administrative, civil, or criminal remedies; however, a
criminal action shall not be initiated for a specific offense
if a citation has been issued pursuant to this section for
that offense, and a citation may not be issued pursuant to
this section for a specific offense if a criminal action for
that offense has been filed.
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15)Requires PDMP subscribers to manually or electronically
report any theft or loss of prescription information or
prescription forms to the CURES program no later than three
days after the discovery of the theft or loss.
16)Allows notification of theft or loss of prescription
information or prescription forms to be reported
electronically or in writing utilizing a form approved by the
DOJ.
EXISTING LAW :
1)Mandates the reporting of Schedule III and Schedule IV
controlled substance prescriptions to CURES shall be
contingent upon the availability of adequate funds from the
DOJ. The DOJ may seek and use grant funds to pay the costs
incurred from the reporting of controlled substance
prescriptions to CURES. Funds shall not be appropriated from
the Contingent Fund of the Medical Board of California, the
Pharmacy Board Contingent Fund, the State Dentistry Fund, the
Board of Registered Nursing Fund, the Naturopathic Doctor's
Fund, or the Osteopathic Medical Board of California
Contingent Fund to pay the costs of reporting Schedule III and
Schedule IV controlled substance prescriptions to CURES.
[Health and Safety Code Section 11165(b).]
2)Requires CURES to operate under existing provisions of law to
safeguard the privacy and confidentiality of patients. Data
obtained from CURES shall only be provided to appropriate
state, local, and federal persons or public agencies for
disciplinary, civil, or criminal purposes and to other
agencies or entities, as determined by the DOJ, 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
DOJ, 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 any individual or agency as
described in this subdivision shall not be disclosed, sold, or
transferred to any third party. [Health and Safety Code
Section 11165(c).]
3)Provides for each prescription for a Schedule II, Schedule
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III, or Schedule IV controlled substance, the dispensing
pharmacy or clinic shall provide the following information to
the DOJ on a weekly basis and in a format specified by the
DOJ:
a) Full name, address, and the 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;
b) The prescriber's category of licensure and license
number, 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;
c) Pharmacy prescription number, license number, and
federal controlled substance registration number;
d) NDC (National Drug Code) number of the controlled
substance dispensed;
e) Quantity of the controlled substance dispensed;
f) ICD-9 (diagnosis code), if available;
g) Number of refills ordered;
h) Whether the drug was dispensed as a refill of a
prescription or as a first-time request;
i) Date of origin of the prescription; and,
j) Date of dispensing of the prescription. [Health and
Safety Code Section 11165(d).]
4)Provides that in order to prevent the inappropriate, improper,
or illegal use of Schedule II, Schedule III, or Schedule IV
controlled substances, the DOJ may initiate the referral of
the history of controlled substances dispensed to an
individual based on data contained in CURES to licensed health
care practitioners, pharmacists, or both, providing care or
services to the individual. [Health and Safety Code Section
11165.1(b).]
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FISCAL EFFECT : Unknown
COMMENTS :
1)Author's Statement : According to the author, "While CURES
established an electronic monitoring system to prevent the
patient abuse of Controlled Substances II, III, and IV;
further action must be taken to prevent the misuse or unlawful
distribution of these prescriptions on the part of the
individuals who have been approved to access CURES. The PDMP
will provide DOJ with the necessary procedures to prevent the
unlawful distribution or use of patient and prescription
information."
2)Background : According to information provided by the author,
"This bill seeks to establish the PDMP under the DOJ to
monitor PDMP subscribers, or any practitioner or pharmacist
who has obtained approval to access the electronic history of
an individual's data within the CURES. To prevent the abuse
of Controlled Substances II, III, and IV, further action must
be taken to assure that these prescriptions are dispensed in a
safe and lawful manner. Any theft or loss of prescription
information must be reported in a timely manner DOJ to prevent
the distribution of significant material to unlawful parties
or individuals."
3)Controlled Substance Schedules : The Federal Government
classifies drugs into five schedules. (21 U.S.C. 812.)
California law generally follows federal law as to the
assigned schedule. (Heath and Safety Code Section 11054.)
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
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.
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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.
4)Electronic Prescription Monitoring: The History of CURES :
The Controlled Substances Prescription Advisory Council,
established in 1992 by Senate Concurrent Resolution 74, was
created to evaluate, among other things, the multiple-copy
prescription programs and electronic data tracking systems
used in other states and the benefits of modernizing the
current system. The Council submitted a report to the
Attorney General (AG) and the Legislature in December 1993.
In the final report submitted to the Legislature and Attorney
General, the Controlled Substances Prescription Advisory
Council recommended that DOJ implement a technologically
sophisticated data monitoring system to collect as much data
as is needed and provide easy access to the data collected for
educational, law enforcement, regulatory, and research
purposes. The Council concluded that the technology was now
available to provide this type of monitoring system at a cost
not dramatically different from current costs.
AB 3042 (Takasugi), Chapter 738, Statutes of 1996, established
the CURES project. AB 3042 was sponsored by the AG who
described the need for that bill: "The information captured
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on the current system is not complete and therefore not useful
in identifying and investigating those suspected of abusing
the prescribing and dispensing process . . . . By integrating
existing systems, virtually 100% of the data could be captured
at the point of sale, and the information made accessible to
law enforcement."
As originally enacted, the CURES project was intended "to assist
law enforcement and regulatory agencies in their efforts to
control the diversion and resultant abuse of Schedule II
controlled substances." (Penal Code Section 11165.) In 1999,
the statutory language regarding the purposes of CURES was
amended to include "and for statistical analysis, education,
and research."
5)Concerns About Confidentiality : 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 condition.
"Patients are concerned that their personal information may be
used inappropriately by those with authorized access or shared
with unauthorized entities." This appears to be a legitimate
concern, given the number of persons and entities with access
to this information.
According to information on CURES provided by the DOJ, the
system currently has 14 million records, with approximately
6,000 pharmacies mandated to report to CURES and approximately
150,000 prescribers within California. If there are 6,000
pharmacies mandated to report to CURES, it must be assumed
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that each pharmacy has a certain number of employees with
access to the system. Pharmacy employees are presumably not
subject to extensive background checks by DOJ and could easily
share information in CURES with unauthorized persons. It is
reasonable to assume that people with diseases such as cancer,
AIDS, multiple sclerosis, etc., would prefer to keep this
information private and not have information about the drugs
they are prescribed distributed to persons with no need to
know and may have criminal intent (theft of drugs; identity
theft, etc.).
According to background information provided by DOJ, DOJ
maintains and oversees the electronic data base, CURES.
Pharmacies use encrypted software to capture and transfer to
the contract vendor, Atlantic Associates Inc. (AAI), which
collects all the prescription information. AAI in turn places
all data into one flat file (FTP). The DOJ is then alerted
when the FTP ready for pick up. AAI encrypts the FTP and
places it on a secure server. DOJ logs on to AAI (via the
Internet) and pulls the data back into DOJ's system where the
data is unpackaged.
DOJ states, "Since DOJ houses the State's criminal justice
computer systems many security systems are in place to keep
out hackers. AAI is utilized by 18 of 22 PDMPS throughout the
nation. AAI is located . . . in Manchester, New Hampshire."
According to DOJ, CURES is not only about prosecuting cases, but
is also useful as an early detection tool for doctors to
identify those at risk for addiction and to initiate early
intervention. Although this case may be made for humans, it
is hard to apply the same reasoning to veterinarians
dispensing, e.g., Phenobarbital to control a dog's seizures.
However, in some cases, CURES data does result in criminal
prosecutions. "In 2004, DOJ had one arrest and conviction,
seven cases opened, five ongoing investigations and two
pending. In 2004, there were 114 requests for CURES
information from law enforcement agencies. To date, in 2006,
there have been 586 requests from law enforcement agencies for
CURES data." The basis for these requests was not specified
and leaves open the question of whether some standards are in
place to assure reasonable cause for the requests.
6)Concerns About Appropriate Medical Treatment : In view of the
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personal information collected by CURES, such as patient's
address, phone number, number of refills of a particular
prescription, date of original prescription, and patients with
chronic or life-threatening illnesses, patients could be
reasonably concerned that their physicians, concerned about
their own financial well-being and medical practices, may be
reluctant to prescribe the appropriate medication or the
appropriate number of refills of that medication.
7)Related Legislation : SB 1071 (DeSaulnier), requires the DOJ,
beginning January 1, 2011, and annually thereafter, to
determine and impose a fee on manufacturers and importers of
controlled substances classified in Schedules II, III, and IV.
SB 1071 also requires the State Board of Equalization to
administer and collect the fee and deposit those fees in a
CURES Fund established by SB 1071. SB 1071 is currently
pending hearing by the Senate Revenue and Taxation Committee.
8)Prior Legislation :
a) 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.
b) 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.
c) SB 734 (Torlakson) Chapter 487, Statutes of 2005, made
technical and clarifying changes to CURES.
d) SB 151 (Burton), Chapter 406, Statutes of 2004, made the
CURES reporting system permanent.
REGISTERED SUPPORT / OPPOSITION :
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Support
None
Opposition
None
Analysis Prepared by : Nicole J. Hanson / PUB. S. / (916)
319-3744