BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 679 Hearing Date: September
11, 2015
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|Author: |Travis Allen |
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|Version: |September 10, 2015 |
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|Urgency: |Yes |Fiscal: |Yes |
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|Consultant|Mark Mendoza /Sarah Huchel |
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Subject: Controlled substances.
SUMMARY: Extends the date by which specified health care practitioners
and pharmacists must register with the Controlled Substance
Utilization Review and Evaluation System (CURES) Prescription
Drug Monitoring Program (PDMP) by six months, from January 1,
2016 to July 1, 2016. This measure contains an urgency clause.
Existing law:
1) Establishes the Medical Practice Act which provides for the
licensing and regulation of physicians and surgeons by the
Medial Board of California (MBC) within the Department of
Consumer Affairs (DCA). (Business and Professions Code (BPC)
§§ 2000 et seq.)
2) Establishes the Nursing Practice Act which provides for the
certification and regulation of registered nurses, nurse
practitioners and advanced practice nurses by the Board of
Registered Nursing within DCA. (BPC §§ 2700 et seq.)
4)Authorizes a certified nurse-midwife to furnish or order drugs
or devices, including controlled substances, if furnished or
ordered incidentally to the provision of family planning
services, routine health care or perinatal care, or care
rendered consistent with the certified nurse-midwife's
practice; occurs under physician and surgeon supervision; and
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is in accordance with standardized procedures or protocols as
specified. (BPC § 2746.51)
5)Authorizes a nurse practitioner to furnish or order drugs or
devices, including controlled substances if it is consistent
with a nurse practitioner's educational preparation or for
which clinical competency has been established and maintained;
occurs under physician and surgeon supervision; and is in
accordance with standardized procedures or protocols as
specified. (BPC § 2836.1)
6)Establishes the Physician Assistant Practice Act which
provides for the licensing of physician assistants by the
Physician Assistant Committee, under the MBC, within the DCA.
(BPC §§ 3500 et seq.)
7)Authorizes a physician assistant under the supervision of a
physician and surgeon to administer or provide medication to a
patient, or transmit orally or in writing a drug order under
specified conditions and protocols adopted by the supervising
physician and surgeon. (BPC § 3502.1)
8)Defines "dispense" as the furnishing of drugs or devices upon
a prescription from a physician, dentist, optometrist,
podiatrist, veterinarian, or naturopathic doctor or upon an
order to furnish drugs or transmit a prescription from a
certified nurse-midwife, nurse practitioner, physician
assistant, naturopathic doctor, or pharmacist acting within
the scope of his or her practice. Dispense also means and
refers to the furnishing of drugs or devices directly to a
patient by a physician, dentist, optometrist, podiatrist, or
veterinarian, or by a certified nurse-midwife, nurse
practitioner, naturopathic doctor, or physician assistant
acting within the scope of his or her practice. (BPC § 4024)
9)Classifies controlled substances in five schedules according
to their danger and potential for abuse. (Health and Safety
Code (HSC) §§ 11054-11058)
10)Establishes CURES to monitor Schedule II, III and IV
controlled substance prescriptions. CURES provides for the
electronic transmission of information related to the
prescription of Schedule II, III and IV controlled substances
to the Department of Justice (DOJ). (HSC § 11165)
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11)Requires the dispensing pharmacy, clinic, or other dispenser
to report specified information to CURES as soon as reasonably
possible, but not more than seven days after the date a
controlled substance is dispensed, in a format specified by
the DOJ. (HSC § 11165)
12)Requires a health care practitioner eligible to prescribe
Schedule II, III or IV controlled substances, and a
pharmacist, to apply to participate in the CURES Prescription
Drug Monitoring Program (PDMP) by January 1, 2016.
(HSC § 11165.1)
This bill:
1) Requires that a healthcare practitioner authorized to
prescribe, order, administer, furnish, or dispense Schedule
II, Schedule III, or Schedule IV controlled substances submit
an application to the DOJ to obtain approval to access CURES
before July 1, 2016 or upon receipt of a federal DEA
registration, whichever occurs later.
2) Requires a pharmacist to submit an application to the DOJ to
obtain approval to access to CURES before July 1, 2016 or
upon licensure, whichever occurs later.
3) Contains an urgency clause, stating that its immediate effect
is necessary to ensure that health care practitioners and
pharmacists are not out of compliance with the requirement to
apply to access data contained in the CURES PDMP on January
1, 2016.
FISCAL
EFFECT: Unknown. This bill is keyed fiscal by Legislative
Counsel.
COMMENTS:
1. Purpose. According to the Author, this bill is necessary
because the updated version of CURES is not fully operational
at this time and licensees need an additional six months in
order to comply with statutory registration mandates.
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2. Controlled Substances. The federal government regulates the
manufacture, distribution and dispensing of controlled
substances through the Controlled Substances Act of 1970.
The act ranks drugs into five schedules based on their
potential for abuse, accepted medical use, and accepted
safety under medical supervision.
Schedule I substances have a high potential for abuse and no
generally accepted medical use such as heroin, ecstasy, and
LSD.
Schedule II substances have a currently accepted medical use
in treatment, or a currently accepted medical use with severe
restrictions, and have a high potential for abuse and
psychological or physical dependence. Schedule II drugs can
be narcotics or non-narcotic. Examples of Schedule II
controlled substances include morphine, methadone, Ritalin,
Demerol, Dilaudid, Percocet, Percodan, and Oxycontin.
Schedule III and IV substances have a currently accepted
medical use in treatment, less potential for abuse but are
known to be mixed in specific ways to achieve a narcotic-like
end product. Examples include drugs include Vicodin, Zanex,
Ambien and other anti-anxiety drugs.
Schedule V drugs have a low potential for abuse relative to
substances listed in Schedule IV and consist primarily of
preparations containing limited quantities of certain
narcotics.
3. CURES. With rising levels of abuse, PDMPs have become a
critical tool in assisting law enforcement and regulatory
bodies with their efforts to reduce drug abuse.
The California PDMP maintains the CURES database. CURES
allows authorized users, including licensed healthcare
prescribers eligible to prescribe controlled substances,
pharmacists authorized to dispense controlled substances, law
enforcement, and regulatory boards, to access patient
controlled substance history information maintained in CURES.
CURES is committed to assisting in the reduction of
pharmaceutical drug diversion without affecting legitimate
medical practice or patient care.
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Pharmacists are required to report information relating to
dispensing Schedules II-IV controlled substances at least
weekly, but use of CURES by prescribers and dispensers for
prescription abuse prevention and intervention is voluntary.
CURES' predecessor, the California Triplicate Prescription
Program was created in 1939 and was replaced by CURES in
1998. In 2009, the PDMP system was introduced as a
searchable, client-facing component of CURES. The California
Budget Act of 2011 eliminated all General Fund support of
CURES and PDMP, which included funding for system support,
staff support and related operating expenses. SB 809
(Chapter 400, Statutes of 2013) established a funding
mechanism to update and maintain CURES, required all
prescribing health care practitioners to apply to access
CURES information, and established processes and procedures
for regulating prescribing licensees through CURES and
securing private information.
DOJ is currently in the process of modernizing CURES to more
efficiently serve prescribers, pharmacists and regulatory
entities. DOJ originally anticipated that the new CURES 2.0
system would be operational on July 1, 2015, but among other
functionalities, the streamlined registration process is now
expected to be ready by July 1, 2016.
This bill delays licensee registration requirements to align
statutory mandates with the ready date of the new system,
although there has been no indication from regulatory bodies
that licensees were in danger of prosecution during those six
months.
6. Prior Related Legislation. SB 500 (Lieu) of 2014 would have
required the MBC to update prescriber standards for
controlled substances once every five years and add the
American Cancer Society, specialists in pharmacology and
specialists in addiction medicine to the entities the MBC may
consult with in developing the standards. ( Status: The bill
was amended to deal with a different subject.)
SB 1258 (DeSaulnier) of 2014 would have made several changes
to the ways that controlled substances are prescribed and
tracked in CURES and would have required medical providers to
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use electronic prescribing systems, would have required
additional reporting of controlled substance prescribing, and
would have placed additional restrictions on the prescribing
of controlled substances.
( Status: The bill was held in the Senate Committee on
Appropriations.)
SB 809 (DeSaulnier, Chapter 400, Statutes of 2013)
established a funding mechanism to update and maintain CURES,
required all prescribing health care practitioners to apply
to access CURES information, and established processes and
procedures for regulating prescribing licensees through CURES
and securing private information.
SB 360 (DeSaulnier, Chapter 418, Statutes of 2011) updated
CURES to reflect the new PDMP and authorizes DOJ to initiate
administrative enforcement actions to prevent the misuse of
confidential information collected through CURES.
7. Arguments in Support. The California Medical Association
(CMA) writes, "In 2013, CMA supported SB 809 (DeSaulnier),
which established the requirement [that all dispensers
register for CURES] and increased licensing fees to help fund
the CURES database. CURES compiles information on all
Schedule II, III, and IV prescriptions that are dispensed
within the state. This information can be used by health
care practitioners to help prevent doctor-shopping for these
medications, which have both a medical use and the potential
for abuse. Physicians support the CURES database and want to
have it a s a tool in their clinical practice.
"However, an important component of SB 809 related to the
application process has not yet come to fruition. In
addition to the requirement for covered health care
practitioners to apply for CURES, SB 809 required the
Department of Justice, in conjunction with the Department of
Consumer Affairs and the relevant licensing boards and
commissions, to establish a streamlined application to help
facilitate the application of the thousands of licenses who
are required to meet the mandate.
"This streamlined application process was originally
estimated to be available to licensees in the summer of 2015,
which would have allowed six months for licensees to utilize
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the new process for their application. Though we expect a
new, automated application process very soon, it is not yet
available.
"The new application process will represent great progress
toward establishing, as envisioned in SB 809, a system that
meets the needs of health care providers and patients.
However, we are concerned that the roll out of a new process
in the few months before the application deadline will create
unnecessary confusion among licensees. Extending the
deadline to enroll by six months will allow time for the new
process to be implemented and the changes to be fully
communicated to the licensee community. A smooth enrollment
process will help reinforce efforts to improve the CURES
database and encourage its increased use."
NOTE : Do Pass to the Senate Floor for Consideration.
SUPPORT AND OPPOSITION:
Support:
California Medical Association
Opposition:
None on file.
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