BILL ANALYSIS Ó
SB 482
Page 1
SENATE THIRD READING
SB
482 (Lara)
As Amended August 1, 2016
Majority vote
SENATE VOTE: 28-11
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Business & |16-0 |Salas, Brough, Baker, | |
|Professions | |Bloom, Campos, | |
| | |Chávez, Dahle, Dodd, | |
| | |Eggman, Gatto, Gomez, | |
| | |Holden, Jones, | |
| | |Mullin, Ting, Wood | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Appropriations |20-0 |Gonzalez, Bigelow, | |
| | |Bloom, Bonilla, | |
| | |Bonta, Calderon, | |
| | |Chang, Daly, Eggman, | |
| | |Gallagher, Eduardo | |
| | |Garcia, Holden, | |
| | |Jones, Obernolte, | |
| | |Quirk, Santiago, | |
| | |Wagner, Weber, Wood, | |
SB 482
Page 2
| | |Chau | |
| | | | |
| | | | |
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SUMMARY: This bill requires a health care practitioner, as
specified, authorized to prescribe, order, administer, or
furnish a controlled substance to consult the Controlled
Substance Utilization Review and Evaluation System (CURES)
database before prescribing certain controlled substances, as
specified. Specifically, this bill:
1)Authorizes a health care practitioner to provide a patient
with a copy of the patient's CURES patient activity report and
keep a copy of the report in the patient's medical record if
reasonable care has been taken to ensure that the report is
provided or kept, as specified.
2)Requires a health care practitioner authorized to prescribe,
order, administer, or furnish a controlled substance to
consult the CURES database to review a patient's controlled
substance history before prescribing a Schedule II, Schedule
III, or Schedule IV controlled substance to the patient for
the first time and at least four months thereafter if the
substance remains part of the treatment of the patient.
3)Defines "first time" to mean the initial occurrence in which a
health care practitioner, in his or her role as a health care
practitioner, intends to prescribe, order, administer, or
furnish a Schedule II, Schedule III, or Schedule IV controlled
substance to a patient and has not previously prescribed a
controlled substance to the patient.
4)Requires a health care practitioner to obtain a patient's
controlled substance history from the CURES database no
earlier than 24 hours, or the previous business day, before he
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or she prescribes, orders, administers, or furnishes a
Schedule II, Schedule III, or Schedule IV controlled substance
to the patient.
5)Exempts veterinarians from the duty to consult the CURES
database.
6)Exempts health care practitioners from the duty to consult the
CURES database in any of the following circumstances:
a) If a health care practitioner prescribes, orders, or
furnishes a controlled substance to be administered to a
patient while the patient is admitted to any of the
following facilities or during an emergency transfer
between any of the following facilities for use while on
facility premises:
i) A clinic licensed under the Department of Public
Health (DPH).
ii)An outpatient setting.
iii)A health facility, including acute care hospitals and
skilled nursing facilities.
iv)A county medical facility.
b) If a health care practitioner prescribes, orders,
administers, or furnishes a controlled substance in the
emergency department of a general acute care hospital and
the quantity of the controlled substance does not exceed a
nonrefillable seven-day supply of the controlled substance
to be used in accordance with the directions for use.
c) If a health care practitioner prescribes, orders,
administers, or furnishes a controlled substance to a
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patient currently receiving hospice care.
d) If a health care practitioner prescribes, orders,
administers, or furnishes a controlled substance to a
patient as part of the patient's treatment for a surgical
procedure and the quantity of the controlled substance does
not exceed a nonrefillable five-day supply of the
controlled substance to be used in accordance with the
directions for use, use in any of the following facilities:
i) A clinic licensed under the Department of Public
Health (DPH).
ii)An outpatient setting.
iii)A health facility, including acute care hospitals and
skilled nursing facilities.
iv)A county medical facility.
v) A dental place of practice.
e) Any time all of the following specified circumstances
are satisfied and requires a health care practitioner who
does not consult the CURES database under the circumstances
to document the reason he or she did not consult the
database in the patient's medical record. The required
circumstances are as follows:
i) It is not reasonably possible for a health care
practitioner to access the information in the CURES
database in a timely manner.
ii)Another health care practitioner or designee authorized
to access the CURES database is not reasonably available.
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iii)The quantity of controlled substance prescribed,
ordered, administered, or furnished does not exceed a
nonrefillable five-day supply of the controlled substance
to be used in accordance with the directions for use and
no refill of the controlled substance is allowed.
f) If the CURES database is not operational, as determined
by the Department of Justice (DOJ), or when it cannot be
accessed by a health care practitioner because of a
temporary technological or electrical failure. Requires a
health care practitioner to, without undue delay, seek to
correct any cause of the temporary technological or
electrical failure that is reasonably within his or her
control.
g) If the CURES database cannot be accessed because of
technological limitations that are not reasonably within
the control of a health care practitioner.
h) If the CURES database cannot be accessed because of
exceptional circumstances, as demonstrated by a health care
practitioner.
7)Requires that a health care practitioner who knowingly fails
to consult the CURES database, be referred to the appropriate
state professional licensing board solely for administrative
sanctions, as deemed appropriate by that board.
8)Provides that the requirement to consult the CURES database
does not create a private cause of action against a health
care practitioner.
9)Provides that the requirement does not limit a health care
practitioner's liability for the negligent failure to diagnose
or treat a patient.
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10)Provides that the requirement is not operative until six
months after the DOJ certifies that the CURES database is
ready for statewide use. Requires the DOJ to notify the
Secretary of State and the office of the Legislative Counsel
of the date of the certification.
11)States that all applicable state and federal privacy laws
govern the duties required by this bill.
12)States that the provisions of this bill, once they become
law, are severable. States that if any provision or its
application is held invalid, that invalidity shall not affect
other provisions or applications that can be given effect
without the invalid provision or application.
13)Provides that, if a health care practitioner authorized to
prescribe, order, administer, or furnish a controlled
substance is not required to consult the CURES database the
first time he or she prescribes, orders, administers, or
furnishes a controlled substance to a patient pursuant to one
of those exemptions, the health care practitioner shall
consult the CURES database before subsequently prescribing a
Schedule II, Schedule III, or Schedule IV controlled substance
to the patient and at least once every four months thereafter
if the substance remains part of the treatment of the patient.
FISCAL EFFECT: According to the Assembly Appropriations
Committee:
1)Boards within the Department of Consumer Affairs that license
health professionals will incur likely minor and absorbable
costs to notify licensees and enforce the bill's requirements,
as well as make any necessary information technology changes
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(various fee-supported special funds). The 2016-17 budget
provides $500,000 from the CURES Fund for additional user
outreach and staffing support.
2)No anticipated costs to the Department of Justice, who
administers CURES. An upgrade to the CURES system was
completed last year to address shortcomings in usability and
reliability. The DOJ indicates the upgraded system is
designed to accommodate high usage by prescribers and will be
able to accommodate the projected demand if this bill is
enacted.
COMMENTS:
Purpose. This bill is co-sponsored by the Consumer Attorneys of
California and the California Narcotics Officers' Association.
According to the author, "According to the Centers for Disease
Control and Prevention, drug overdoses are the top cause of
accidental death in the United States. Nearly 23,000 people
died from an overdose of pharmaceuticals in 2013 nationally -
more than 70% of them from opiate prescription painkillers. The
CURES database is an invaluable investigative, preventative, and
educational tool for law enforcement and the healthcare
community. The current voluntary approach has not been able to
attract sufficient participation to make it truly effective. SB
482 requires all prescribers to consult the CURES system before
issuing Schedule II, III, and IV drugs. This will enable
prescribers to make informed decisions about their patient's
care and limit the number of people who doctor shop and over use
prescription drugs."
Background. According to the United States Drug Enforcement
Agency, drugs, substances, and certain chemicals used to make
drugs are classified into five distinct categories or schedules
depending upon the drug's acceptable medical use and the drug's
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abuse or dependency potential. Schedule I drugs have the
highest potential for abuse while Schedule V is the lowest.
Prescription Drug Overdose Deaths. According to the Centers for
Disease Control and Prevention (CDC), drug overdoses are the top
cause of accidental deaths in the United States. Overdose
deaths involving prescription opioids have quadrupled since
1999, as well as sales of these prescription drugs.
Additionally, approximately 20% of prescribers prescribe 80% of
all prescription painkillers.
In the years spanning 1999 to 2014, over 165,000 people died in
the United States from overdoses related to prescription
opioids. During this time period, overdose rates were highest
among people age 25 to 54 years. Overdose rates were higher
among non-Hispanic whites and American Indian or Alaskan
Natives, compared to non-Hispanic blacks and Hispanics. In
addition, men were more likely to die from overdose, but the
mortality gap between men and women is closing.
CURES. In 1996, California enacted the first prescription
monitoring drug program in the United States. According to the
California Department of Justice, CURES is a database of
Schedule II, III, and IV controlled substance prescriptions
dispensed in California serving the public health, regulatory
oversight agencies, and law enforcement. Access to CURES is
limited to licensed prescribers and licensed pharmacists
strictly for patients in their direct care; and regulatory board
staff and law enforcement personnel for official oversight or
investigatory purposes.
CURES receives about one million prescription records per week.
The database contains approximately 400 million entries of
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controlled substance prescriptions dispensed in California. The
system retains seven years of prescription data that is
de-identified.
As of February 5, 2016, there were 74, 258 registrants of the
CURES system. All California licensed prescribers authorized to
prescribe scheduled drugs are required to register for access to
CURES version 2.0 by July 1, 2016, or upon issuance of a Drug
Enforcement Administration Controlled Substance Registration
Certificate, whichever occurs later. Licensed pharmacists must
register for access to CURES 2.0 by July 1, 2016, or upon
issuance of a Board of Pharmacy Pharmacist License, whichever
occurs later (Health and Safety Code Section 11165.1). Use of
CURES by prescribers and dispensers for prescription abuse
prevention or intervention is voluntary.
Other States. Forty-nine states currently have prescription
drug monitoring programs. Approximately 24 states have mandates
for prescribers to check a state based prescription drug
monitoring system (National Alliance for Model State Drug Laws,
Reporting Requirements and Exemptions to Reporting, 2014).
Significantly improved public health outcomes have been seen in
states that have required prescribers to check their drug
monitoring systems. According to information obtained from the
CDC, in 2012, Tennessee required prescribers to check the
state's prescription drug monitoring program (PDMP) before
prescribing painkillers. Within one year, there was a 36%
decline in patients who were seeing multiple prescribers to
obtain the same drugs. In Virginia, the number of doctor
shoppers fell by 73% after use of the database became mandatory.
In Oklahoma, which requires mandatory checks for methadone,
overdose rates dropped approximately 21% in a single year.
There are current efforts to link PDMP systems nationwide. The
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National Association of Boards of Pharmacies (NABP) InterConnect
system permits authorized PDMP users in participating states to
access interstate data by logging directly into the state PDMP
in which they are a registered user. Currently, 33 states,
excluding California, have PDMPs that are linked to the NABP
InterConnect system.
Analysis Prepared by:
Le Ondra Clark Harvey Ph.D. / B. & P. / (916)
319-3301 FN:
0003857