BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 482 Hearing Date: April 27,
2015
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|Author: |Lara |
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|Version: |April 16, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Mason |
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Subject: Controlled substances: CURES database.
SUMMARY: Requires prescribers to consult the Controlled
Substances Utilization Review and Evaluation System (CURES)
prior to prescribing a Schedule II or III drug to a patient for
the first time and requires a dispenser to consult the CURES
system prior to dispensing a Schedule II or III drug to patient
for the first time. Delays implementation of the above
provisions until the Department of Justice certifies that the
CURES database is ready for statewide use.
Existing law, the Business and Professions Code (BPC):
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).
2) Establishes the Dental Practice Act which provides for the
licensing and regulation of dentists by the Dental Board of
California within DCA.
3) Establishes the Veterinary Medicine Practice Act which
provides for the licensing and regulation of veterinarians
and registered veterinary technicians by the Veterinary
Medical Board within DCA.
4)Establishes the Nursing Practice Act which provides for the
certification and regulation of registered nurses, nurse
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practitioners and advanced practice nurses by the Board of
Registered Nursing within DCA.
5)Provides that a certified nurse-midwife may 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
is in accordance with standardized procedures or protocols as
specified. (BPC § 2746.51)
6)Provides that a nurse practitioner may 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)
7)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.
8)Provides that a physician assistant while under the
supervision of a physician and surgeon may 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)
9)Establishes the Osteopathic Act which provides for the
licensing and regulation of osteopathic physicians and
surgeons by the Osteopathic MBC within the DCA.
10)Establishes the Naturopathic Doctors Act which provides for
the licensing of naturopathic doctors by the Naturopathic
Medicine Committee within the Osteopathic Medical Board of
California within the DCA.
11)Establishes the Optometry Practice Act which provides for the
licensure of optometrists by the California State Board of
Optometry within the DCA.
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12)Establishes the Podiatric Act which provides for the
licensure of doctors of podiatric medicine by the California
Board of Podiatric Medicine within the DCA.
13)Establishes the Pharmacy Law which provides for the licensure
and regulation of pharmacies, pharmacists and wholesalers of
dangerous drugs or devices by the Board of Pharmacy within the
DCA.
14)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)
15)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a
person from furnishing any dangerous drug or device except
upon the prescription of a physician, dentist, podiatrist,
optometrist, veterinarian or naturopathic doctor. (BPC §
4059)
Existing law, the Health and Safety Code (HSC), establishes the
California Uniform Controlled Substances Act which regulates
controlled substances.
(HSC § 11000 et seq.)
1)Defines "dispense" to deliver a controlled substance to an
ultimate user or research subject by or pursuant to the lawful
order of a practitioner, including the prescribing,
furnishing, packaging, labeling, or compounding necessary to
prepare the substance for that delivery and "dispenser" as a
practitioner who dispenses. (HSC §§ 11010 and 11011)
2)Defines "drug" as:
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a) Substances recognized as drugs in the official United
States Pharmacopoeia, official Homeopathic Pharmacopoeia of
the United States, or official National Formulary, or any
supplement to any of them.
b) Substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or
animals.
c) Substances (other than food) intended to affect the
structure or any function of the body of man or animals.
(Health and Safety Code (HSC) § 11014)
1)Defines "opiate" as any substance having an addiction-forming
or addiction-sustaining liability similar to morphine or being
capable of conversion into a drug having addiction-forming or
addiction-sustaining liability. (HSC § 11020)
2)Defines "practitioner" as a physician, dentist, veterinarian,
podiatrist, or pharmacist, registered nurse or physician
assistant acting within the scope of an experimental health
workforce projects authorized by the Office of Statewide
Health Planning and Development (HSC § 128125 et seq.), a
certified nurse-midwife according to BPC provisions outlined
above, a nurse practitioner according to BPC provisions
outlined above, a physician assistant according to BPC
provisions outlined above, or an optometrist licensed under
the Optometry Practice Act. Includes in the definition of
"practitioner" a pharmacy, hospital, or other institution
licensed, registered, or otherwise permitted to distribute,
dispense, conduct research with respect to, or to administer,
a controlled substance in the course of professional practice
or research in this state. Also includes in the definition of
"practitioner" a scientific investigator, or other person
licensed, registered, or otherwise permitted, to distribute,
dispense, conduct research with respect to, or administer, a
controlled substance in the course of professional practice or
research in this state. (BPC § 11026)
3)Classifies controlled substances in five schedules according
to their danger and potential for abuse. (HSC § 11054-11058)
4)Prohibits any person other than a physician, dentist,
podiatrist, veterinarian, naturopathic doctor (according to
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BPC provisions outlined above), pharmacist (according to BPC
provisions above), certified nurse-midwife (according to BPC
provisions outlined above), nurse practitioner (according to
BPC provisions above) ; a pharmacist or registered nurse or
physician assistant acting within the scope of an experimental
health workforce project authorized by the Office of Statewide
Health Planning and Development (HSC § 128125 et seq.); an
optometrist licensed under the Optometry Practice Act., or an
out-of-state prescriber acting in an emergency situation from
writing or issuing a prescription for a controlled substance.
(HSC § 11150)
5)Specifies that a prescription for a controlled substance shall
only be issued for a legitimate medical purpose and
establishes responsibility for proper prescribing on the
prescribing practitioner. States that a violation shall
result in imprisonment for up to one year or a fine of up to
$20,000, or both. (HSC § 11153)
6)Requires special prescription forms for controlled substances
to be obtained from security printers approved by DOJ,
establishes certain criteria for features on the forms and
requires controlled substance prescriptions to be made on the
specified form. (HSC §§ 11161.5, 11162.1, 11164)
7)Establishes the Controlled Substances Utilization Review and
Evaluation System (CURES) for electronic monitoring of
Schedule II, III and IV controlled substance prescriptions.
The CURES provides for the electronic transmission of Schedule
II, III and IV controlled substance prescription information
to the Department of Justice (DOJ) at the time prescriptions
are dispensed. (HSC § 11165)
8)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. (HSC § 11165
(a))
9)Establishes privacy protections for patient data and specifies
that CURES data can only be accessed by appropriate state,
local and federal persons or public agencies for disciplinary,
civil or criminal actions. Specifies that CURES data shall
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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. Authorizes
non-identifying CURES data to be provided to public and
private entities for education, research, peer review and
statistical analysis. (HSC § 11165 (c))
10)Provides that pharmacies or clinics, in filling a
prescription for a federally Scheduled II, III or IV drug,
shall provide weekly information to DOJ including 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. (HSC § 11165 (d))
11)Provides that a licensed health care practitioner eligible to
prescribe Schedule II, III or IV controlled substances, or a
pharmacist, shall apply to participate in the CURES
Prescription Drug Monitoring Program (PDMP) by January 1,
2016. Authorizes DOJ to deny an application or suspend a
subscriber for certain violations and falsifying information.
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, subject to provisions of the Confidentiality of
Medical Information Act. (HSC § 11165.1)
12)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. (HSC § 11190 (a) and (b))
13)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 three years
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. Requires
that this information be provided to DOJ on a monthly basis.
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(HSC § 11190 (c))
This bill:
1)Requires prescribers (authorized to write prescriptions
according to HSC § 11150 outlined above, excluding
veterinarians) to access and consult CURES prior to
prescribing a Schedule II or Schedule III controlled substance
for the first time to a patient and at least annually when
that prescribed controlled substance remains part of the
treatment. Provides that if the patient has an existing
prescription for a Schedule II or Schedule III controlled
substance, the health care practitioner shall not prescribe
any additional controlled substances until the health care
practitioner determines there is a legitimate need.
2)Requires dispensers (as defined by HSC § 11011) to also access
and consult CURES prior to dispensing a Schedule II or
Schedule III controlled substance for the first time to that
patient. Provides that if the patient has an existing
prescription for a Schedule II or Schedule III controlled
substance, the dispenser shall not dispense any additional
controlled substances until the dispenser checks CURES.
3)Provides that failure by a prescriber or dispenser to consult
CURES as specified above is cause for disciplinary action by
the prescriber or dispenser's appropriate licensing board.
4)Requires the licensing boards of all prescribers and
dispensers authorized to write or issue prescriptions for
controlled substances to notify all authorized prescribers or
dispensers of the requirement for consulting CURES.
5)Provides that notwithstanding any other provision, a
prescriber or dispenser shall not be in violation of the
requirements in this bill during any time period in which the
CURES system is suspended or not accessible or the Internet is
not operational.
6)Delays implementation of the above provisions until the DOJ
certifies that the CURES database is ready for statewide use.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
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Legislative Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by the Consumer Attorneys of
California and the California Narcotics Officers . According
to the Author, for the last decade the number of deaths due
to drug overdoses of prescription drugs has dramatically
increased. The Author cites data from the Centers for
Disease Control (CDC) estimating that 44 people die every day
from an overdose of prescription drugs. According to the
Author, "This is a serious and deadly problem for our
state?While California was the first state to create a drug
monitoring system, it has lagged behind others in realizing
the full potential its system. Other states like New York
and Tennessee have required prescribers to check their
respective state drug monitoring systems and seen dramatic
decreases in drug overdoses and deaths."
The Author is concerned that in California, prescribers and
dispensers of Schedule II and III drugs must enroll in CURES
by January 2016, but they are not required to consult the
system when prescribing or dispensing. According to the
Author, "in order to eliminate doctor shopping and minimize
the over prescription of narcotics, it is critical
prescribers and dispensers use CURES every time they write or
dispense a new prescription." The Author states that
"Ultimately this bill will ensure prescribers and dispensers
are utilizing CURES to improve public health outcomes and
limit the number of Californians who die as a result of a
drug overdose."
2. Controlled Substances. Through the Controlled Substances Act
of 1970, the federal government regulates the manufacture,
distribution and dispensing of controlled substances. The
act ranks into five schedules those drugs known to have
potential for physical or psychological harm, based on three
considerations: (a) their potential for abuse; (b) their
accepted medical use; and, (c) their accepted safety under
medical supervision.
Schedule I controlled substances have a high potential for
abuse and no generally accepted medical use such as heroin,
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ecstasy, and LSD.
Schedule II controlled 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 controlled 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.
The three classes of prescription drugs that are most
commonly abused are: opioids, which are most often prescribed
to treat pain; central nervous system (CNS) depressants,
which are used to treat anxiety and sleep disorders; and
stimulants, which are prescribed to treat the sleep disorder
narcolepsy and attention-deficit hyperactivity disorder
(ADHD). Each class can induce euphoria, and when
administered by routes other than recommended, such as
snorting or dissolving into liquid to drink or inject, can
intensify that sensation. Opioids, in particular, act on the
same receptors as heroin and, therefore, can be highly
addictive. Common opioids are: hydrocodone (Vicodin),
oxycodone (OxyContin), propoxyphene (Darvon), hydromorphone
(Dilaudid), meperidine (Demerol), and diphenoxylate
(Lomotil).
In August of 2014, the federal Drug Enforcement
Administration (DEA), rescheduled hydrocodone combination
products from Schedule III to Schedule II of the Controlled
Substances Act. DEA requested a scientific and medical
recommendation from the federal Health and Human Services
Agency (HHS) regarding a change of schedule for hydrocodone
combination products in 2009. The Food and Drug
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Administration (FDA), within HHS, considered the eight
statutorily required factors related to the abuse potential
of hydrocodone, including questions about the products'
actual or relative potential for abuse, their liability to
cause psychic or physiological dependence, and dangers they
might pose to public health. According to the FDA,
hydrocodone is the most prescribed opioid in the United
States, including 137 million prescriptions in 2013. The FDA
notes that while it is useful in the treatment of pain, it
has also contributed significantly to the very serious
problem of opioid misuse and abuse in the United States. HHS
ultimately recommended to DEA that hydrocodone combination
products be reclassified into Schedule II, a more restrictive
category of controlled substances that includes other opioid
drugs for pain like morphine and oxycodone. The
reclassification is aimed at limiting the risks of these
potentially addictive but important pain-relieving products
and will result in the following: Now, if a patient needs
additional medication, the prescriber must issue a new
prescription. Phone-in refills for these products are no
longer allowed. In emergencies, small supplies can be
authorized until a new prescription can be provided for the
patient. Patients will still have access to reasonable
quantities of medication, generally up to a 30-day supply.
HHS also recommended including rescheduling in "a broad-based
set of actions targeting abuse prevention." HHS identified a
need to work with prescribers and patients to make certain
that patients are prescribed the right number of doses of
hydrocodone for a patient's need to avoid unused hydrocodone
being available for abuse as well as the need for. HHS
advised that the use and abuse of hydrocodone combination
products be monitored carefully to assess the impact of
rescheduling on public health. HHS noted that based on the
results of this monitoring, the agency may need to take
additional actions to "support the appropriate use of
hydrocodone combination products while reducing their tragic
abuse."
3. Prescription Drug Abuse. For the past number of years, abuse
of prescription drugs (taking a prescription medication that
is not prescribed for you, or taking it for reasons or in
dosages other than as prescribed) to get high has become
increasingly prevalent. Federal data for 2014 shows that in
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the past year, abuse of prescription pain killers now ranks
second, just behind marijuana, as the nation's most
widespread illegal drug problem. According to the 2008
National Survey on Drug Use and Health (NSDUH), approximately
52 million Americans aged 12 or older reported non-medical
use of any psychotherapeutic at some point in their
lifetimes, representing 20.8% of the population aged 12 or
older. The National Institute on Drug Abuse's (NIDA)
research report Prescription Drugs: Abuse and Addiction
states that the elderly are among those most vulnerable to
prescription drug abuse or misuse because they are prescribed
more medications than their younger counterparts. Persons 65
years of age and above comprise only 13 percent of the
population, yet account for approximately one-third of all
medications prescribed in the United States. Older patients
are more likely to be prescribed long-term and multiple
prescriptions, which could lead to unintentional misuse. The
report also notes that studies suggest that women are more
likely (in some cases, 55 percent more likely) than men to be
prescribed a drug which can be abused, particularly narcotics
and antianxiety drugs. A 2010 report, Monitoring the Future
Study, showed that as many as 4 percent of high school
students and 3 percent of young adults say they have used
OxyContin in the past year.
Abuse can stem from the fact that prescription drugs are
legal and potentially more easily accessible, as they can be
found at home in a medicine cabinet. Data shows that
individuals who misuse prescription drugs, particularly
teens, believe these substances are safer than illicit drugs
because they are prescribed by a health care professional and
thus are safe to take under any circumstances. NIDA data
states that in actuality, prescription drugs act directly or
indirectly on the same brain systems affected by illicit
drugs, thus, their abuse carries substantial addiction
liability and can lead to a variety of other adverse health
effects.
4. Prescription Drug Deaths. A 2013 CDC analysis found that
drug overdose deaths increased for the 11th consecutive year
in 2010 and prescription drugs, particularly opiod
analgesics, are the top drugs leading the list of those
responsible for fatalities. According to CDC, 38,329 people
died from a drug overdose in 2010, up from 37,004 deaths in
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2009, and 16,849 deaths in 1999. CDC found that nearly 60
percent of the overdose deaths in 2010, involved
pharmaceutical drugs, with opiods associated with
approximately 75 percent of these deaths. Nearly three out
of four prescription drug overdoses are caused by opioid pain
relievers. CDC recommends the use of PDMPs with a focus on
both patients at highest risk in terms of prescription
painkiller dosage, numbers of prescriptions and numbers of
prescribers, as well as prescribers who deviate from accepted
medical practice and those with a high proportion of doctor
shoppers among their patients. CDC also recommends that
PDMPs link to electronic health records systems so that the
information is better integrated into health care providers'
day-to-day practices. CDC believes that state benefits
programs like Medicaid and workers' compensation should
consider monitoring prescription claims information and PDMP
data for signs and inappropriate use of controlled
substances. The organization also acknowledges the value of
PDMPs in taking regulatory action against health care
providers who do operate outside the limits of appropriate
medical practice when it comes to prescription drug
prescribing.
5. Prescription Drug Monitoring and CURES. With rising levels
of abuse, PDMPs are a critical tool in assisting law
enforcement and regulatory bodies with their efforts to
reduce drug diversion. There are 49 states that currently
have monitoring programs (Missouri is the only state
currently without a PDMP). California has the oldest
prescription drug monitoring program in the nation. Of these
programs throughout the nation, seven are or will be housed
at the state's Department of Justice, 18 are or will be
housed at a state Department of Health or substance abuse
agency and 25 are or will be housed at a state Board of
Pharmacy or state professional licensing agency. There is
currently momentum to share data across these programs from
state to state. The National Boards of Pharmacy (NABP)
currently operates a PDMP, InterConnect that allows
participating states across to be linked, providing a more
effective means of combating drug diversion and drug abuse
nationwide. It was anticipated that approximately 30 states
will be sharing data or in a Memorandum of Understanding to
share data using InterConnect by the end of 2014.
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In California, the Controlled Substance Utilization Review
and Evaluation System (CURES) is an electronic tracking
program that reports all pharmacy (and specified types of
prescriber) dispensing of controlled drugs by drug name,
quantity, prescriber, patient, and pharmacy.
AB 3042 (Takasugi, Chapter 738, Statutes of 1996) established
a three year pilot program, beginning in July 1997, for the
electronic monitoring of prescribing and dispensing of
Schedule II controlled substances. Subsequent legislation
( SB 1308 , Committee on Business and Professions, Chapter 655,
Statutes of 1999) extended the sunset date on the CURES
program to July 1, 2003 and required DOJ to submit annual
status reports on the program to the Legislature. In 2002,
the Legislature passed AB 2655 (Matthews, Chapter 345,
Statutes of 2002) which extended the CURES program to 2008
and provided access to CURES data by licensed health care
providers. Finally, in 2003, SB 151 (Burton, Chapter 406,
Statutes of 2003) made the program permanent. In 2009, then
Attorney General Brown launched an online CURES system at DOJ
to replace the previous system that required mailing or
faxing written requests for information, giving health
professionals (doctors, pharmacists, midwives, and registered
nurses), law enforcement agencies and medical profession
regulatory boards instant computer access to patients'
controlled-substance records. 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.
Data from CURES is managed by DOJ to assist state law
enforcement and regulatory agencies in their efforts to
reduce prescription drug diversion. CURES provides
information that offers the ability to identify if a person
is "doctor shopping" (when a prescription-drug addict visits
multiple doctors to obtain multiple prescriptions for drugs,
or uses multiple pharmacies to obtain prescription drugs).
Information tracked in the system contains the patient name,
prescriber name, pharmacy name, drug name, amount and dosage,
and is available to law enforcement agencies, regulatory
bodies and qualified researchers. The system can also report
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on the top drugs prescribed for a specific time period, drugs
prescribed in a particular county, doctor prescribing data,
pharmacy dispensing data, and is a critical tool for
assessing whether multiple prescriptions for the same patient
may exist. In addition to the Board, CURES data can be
obtained by the MBC, Dental Board of California, Board of
Registered Nursing, Osteopathic Medical Board of California
and Veterinary Medical Board.
Since 2009, more than 8,000 doctors and pharmacists have
signed up to use CURES, which has more than 100 million
prescriptions. The system also has been accessed more than 1
million times for patient activity reports and has been key
in investigations of doctor shoppers and nefarious
physicians. According to the AG's office, CURES assisted in
targeting the top 50 doctor shoppers in the state, who
averaged more than 100 doctor and pharmacy visits to collect
massive quantities of addictive drugs and the crackdown led
to the arrest of dozens of suspects. CURES also provided
information with the prescribing history of a Southern
California physician accused of writing hundreds of
fraudulent prescriptions to feed his patients' drug
addictions, seven of whom died from prescription-drug
overdoses. The system has also been successful in alerting
law enforcement and licensed medical professionals to signs
of illegal drug diversions, including a criminal ring that
stole the identities of eight doctors, illegally wrote
prescriptions, stole the identities of dozens of innocent
citizens who they designated as patients in order to fill the
fraudulent prescriptions, resulting in the group obtaining
more than 11,000 pills of highly addictive drugs like
OxyContin and Vicodin.
DOJ is currently in the process of modernizing CURES to more
efficiently serve prescribers, pharmacists and entities that
may utilize the data contained within the system and expects
that the new CURES 2.0 system will be operational on July 1,
2015.
6. Related Legislation This Session. AB 611 (Dahle) authorizes
an individual designated to investigate a holder of a
professional license to apply to the DOJ to obtain approval
to access information contained in the CURES PDMP regarding
the controlled substance history of an applicant or a
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licensee, for the purpose of investigating the alleged
substance abuse of a licensee. Clarifies that only a
subscriber who is a health care practitioner or a pharmacist
may have an application denied or be suspended for accessing
subscriber information for any reason other than caring for
his or her patients. Specifies that an application may be
denied, or a subscriber may be suspended, if a subscriber who
has been designated to investigate the holder of a
professional license accesses information for any reason
other than investigating the holder of a professional
license.
( Status: The bill is currently pending in the Assembly
Committee on Business and Professions.)
7. 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
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 616 (DeSaulnier) of 2012 would have increased fees, up to
$10 per licensee that is authorized to prescribe or dispense
controlled substances, to fund CURES. ( Status: The measure
failed passage in the Assembly Committee on Business,
Professions and Consumer Protection.)
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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.
SB 1071 (DeSaulnier) of 2010 would have imposed a tax on
manufacturers or importers of Schedule II, III and IV
controlled substances to pay for ongoing costs of the CURES
program. Fees would have been collected by the BOE, at the
rate of $0.0025 per pill included in Schedule II, III, and
IV. ( Status: The bill was held in the Senate Committee on
Health.)
AB 2516 (Mendoza) of 2008 required a doctor to ensure that
any prescription he or she make be electronically transmitted
to a patient's pharmacy of choice.
( Status: The measure was never heard in a policy committee
of the Legislature.)
AB 1298 (Jones, Chapter 699, Statutes of 2007) sought to
protect the privacy of personally identifiable unencrypted
medical and health insurance information by requiring any
state agency or business that operates in California to
inform any potentially affected state resident of the loss of
that individual's health information. The bill also
prohibited any organization that holds electronic personal
health record data from disclosing that information without
patient consent.
ABX1 (Nunez) of 2007 would have required that by January 1,
2012 all prescribers, prescribers' agents, and pharmacies,
have ability to transmit and receive e-prescriptions, and
would have given licensing boards the authority to enforce
this requirement. ( Status: The measure failed passage in
the Senate Committee on Health.)
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.
SB 734 (Torlakson, Chapter 487, Statutes of 2005) authorized
SB 482 (Lara) Page 17
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tamper resistant online access to the CURES system for
authorized physicians, pharmacists and law enforcement,
pending the acquisition of private funding.
SB 151 (Burton, Chapter 406, Statutes of 2004) made CURES
permanent, among other provisions.
AB 3042 (Takasugi, Chapter 738, Statutes of 1996) establishes
CURES as a three-year pilot program.
8. Arguments in Support. According to law enforcement
organizations like the California Association of Code
Enforcement Officers , California College and University
Police Chiefs Association , California Correctional
Supervisors Organization , California Narcotic Officers'
Association (Sponsor), Los Angeles Los Angeles Police
Protective League and Riverside Sheriffs Organization , the
CURES database is an effective reference point in assuring
that a patient is not engaged in prescription. The
organizations state that this bill will save lives.
The Consumer Attorneys of California (CAOC) cite the growing
problem of prescription drug use and the current lack of
requirement that health care prescribers and dispensers check
the CURES database as rationale for this bill's passage.
According to CAOC, the current voluntary approach has not
been able to attract sufficient participation to make it
truly effective and that it is critical to prevent overdose
deaths and addiction from occurring in the first place by
attacking its problem at the source.
The Consumer Federation of California (CFC) also writes in
support of this bill, stating that only 6 percent of doctors
now use CURES even though it has been operational since 2009.
According to CFC, "curbing prescription drug abuse and
doctor shopping could save an estimated $300 million annually
for what is now spent by our state and local governments on
prescription drugs for Medi-Cal patients."
Consumer Watchdog writes that prescription drug abuse is at
epidemic levels and databases like CURES can reduce a
patient's risk for overdose and provide an opportunity to
intervene with patients who are abusing medications.
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Labor organizations like the California Conference Board of
the Amalgamated Transit Union , California Conference of
Machinists , California Teamsters Public Affairs Council ,
Engineers and Scientists of California, IFPTE Local 20,
AFL-CIO , International Longshore and Warehouse Union ,
Professional and Technical Engineers, IFPTE Local 21,
AFL-CIO , UNITE-HERE, AFL-CIO and Utility Workers Union of
America support this bill, writing that they are alarmed
about the growing trend of prescription drug abuse which
affects workers directly as often they are prescribed pain
medications for injuries on the job and it's time we took
decisive action to prevent prescription drug addiction.
The International Faith Based Coalition welcomes the changes
contemplated by this bill and notes that this strategy has
been instituted in a number of other states with universal
reduction in prescription drug abuse as well as in overdose
deaths.
9. Concerns. The California Pharmacists Association (CPhA ),
California Retailers Association (CRA) and National
Association of Chain Drug Stores (NACDS) all write to express
concerns about this bill. CPhA pharmacists use their
professional judgment to determine when specific
interventions are necessary and appropriate, in addition to
following guidance provided by the Board of Pharmacy for
specified "red flags" and as such, states that it is not
clear that the mandates in SB 482 are necessary for
pharmacists.
CRA and NACDS are very concerned that the new system will not
have the ability to handle the volume of inquiries nor will
the system effectively integrate with pharmacy technology
systems. The organizations note that pharmacists fill
hundreds of prescriptions a day and cannot work with a state
system that delays, or a system that creates and overly
burdensome requirement that cannot be efficiently and
effectively utilized.
10.Arguments in Opposition. The California Medical Association
(CMA) is opposed to this bill. CMA writes that at its most
basic, this bill legislates the practice of medicine which
the organization opposes. According to CMA, this bill
establishes a nebulous and problematic prohibition against
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prescribing an additional controlled substance until the
prescriber determines that there is a legitimate need and
cites instances in which a patient may be prescribed two
controlled substances, which will create liability for a
physician in any malpractice case in which a patient is
prescribed controlled substances. CMA believes that the
mandate in this bill will fall disproportionately on patients
with a legitimate medical issue and that once a functional
CURES system is in place, the mandates imposed by this bill
will not be necessary, as physicians support the CURES
database and want to have it as a tool in their clinical
practice. The organization also cites existing efforts by
the Medical Board in its updated guidelines for prescribing
controlled substances, Board of Pharmacy precedential
decision that a pharmacist must inquire whenever he or she
believes a prescription may not have been written for a
legitimate medical purpose and reclassification of
hydrocodone products from Schedule III to Schedule II by the
DEA to view the impact of the mandate for checking CURES
outlined in this bill. According to CMA, this bill will
create an unnecessary regulatory burden to prescribing and
increase the threat of litigation, both of which would have a
detrimental impact on patient care while adding limited value
to addressing prescription drug abuse.
CVS Health is opposed to this bill unless the author amends
the bill to remove the obligation of the dispenser to consult
the CURES system prior to dispensing a particular
prescription and encourage CURES 2.0 to require data uploads
every
24 hours. According to CVS Health, CVS Health's pharmacy
operations would be directly and unnecessarily impacted by
this bill based on the requirement that pharmacists consult
and access the database prior to dispensing. CVS Health also
believes that CURES should be updated every 24 hours, not as
soon as reasonably possible as outlined under current law.
CVS Health cites its utilization of patient-level data to
trigger alerts for pharmacists to identify "aberrant behavior
in patients as well as controlled substance prescribers.
These red flags have been identified ?to help us make
appropriate determinations for when dispensing of a
controlled substance should not occur."
Rite Aid Corporation opposes this bill, writing that the
SB 482 (Lara) Page 20
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bill's requirements are duplicative of one another, as both
physicians and pharmacists would be required to consult CURES
prior to prescribing or dispensing Schedule II or Schedule
III drugs for the first time to a patient. Rite Aid
questions "the impact this bill will have on preventing
abusive behavior given that under current law, data is only
reported to the CURES system once weekly." According to Rite
Aid, physicians consulting CURES would not even be reviewing
up to date information.
According to The Doctor's Company , this bill would subject
prescribers to discipline for failure to access a system that
currently experiences many interruptions in accessibility.
TDC doubts that the proposed upgrade will be fully functional
as intended and that an outside, independent analysis
attesting to the upgraded system's readiness would help
develop confidence in a system that has been underfunded and
experienced other operational problems in the past.
11.Author's Amendments. In response to concerns raised above
related to a mandate for dispensers to consult CURES prior to
dispensing a Schedule II or Schedule III to a patient for the
first time, the Author is amending this bill to delete
provisions related to dispensers.
On page 3, strike lines 4 through 11.
On page 3, in line 14, after "prescriber", strike "or
dispenser".
On page 3, in line 15, after "prescribers", strike "and
dispensers".
On page 3, in line 18, after "prescriber", strike "or
dispenser".
On page 3, strike lines 27 through 28.
On page 3, in line 29, after "section" strike "the following
terms shall have the following meanings" and strike lines 27
through 31.
On page 3, in line 29, after "section" insert "Prescriber"
means a health care practitioner who is authorized to write
or issue prescriptions under Section 11150, excluding
SB 482 (Lara) Page 21
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veterinarians."
(b) A dispenser shall access and consult the CURES database
for the electronic history of controlled substances
dispensed to a
patient under his or her care before dispensing a Schedule
II or
Schedule III controlled substance for the first time to
that patient.
If the patient has an existing prescription for a Schedule
II or
Schedule III controlled substance, the dispenser shall not
dispense
an additional controlled substance until the dispenser
checks the
CURES database.
(c) Failure to consult a patient's electronic history as
required
by subdivision (a) or (b) is cause for disciplinary action
by the
respective licensing board of the prescriber or dispenser .
The
licensing boards of all prescribers and dispensers
authorized to
write or issue prescriptions for controlled substances
shall notify
these licensees of the requirements of this section.
(d) Notwithstanding any other law, a prescriber or
dispenser
is not in violation of this section during any period of
time in which
the CURES database is suspended or not accessible or any
period
of time in which the Internet is not operational.
(e) This section shall not become operative until the
Department
of Justice certifies that the CURES database is ready for
statewide
use.
(f) For purposes of this section, the following terms shall
SB 482 (Lara) Page 22
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have
the following meanings:
(1) "Dispenser" means a person who is authorized to
dispense
a controlled substance under Section 11011.
(2) "Prescriber" means a health care practitioner who
is
authorized to write or issue prescriptions under Section
11150,
excluding veterinarians. "Prescriber" means a health care
practitioner who is
authorized to write or issue prescriptions under Section
11150,
excluding veterinarians.
SUPPORT AND OPPOSITION:
Support:
California Association of Code Enforcement Officers
California College and University Police Chiefs Association
California Conference Board of the Amalgamated Transit Union
California Conference of Machinists
California Correctional Supervisors Organization
California Narcotic Officers' Association (Co-Sponsor)
California Teamsters Public Affairs Council
Consumer Attorneys of California (Co-Sponsor)
Consumer Federation of California
Consumer Watchdog
Engineers and Scientists of California, IFPTE Local 20, AFL-CIO
International Faith Based Coalition
International Longshore and Warehouse Union
Los Angeles Police Protective League
Professional and Technical Engineers, IFPTE Local 21, AFL-CIO
Riverside Sheriffs Organization
UNITE-HERE, AFL-CIO
Utility Workers Union of America
Concerns:
California Pharmacists Association (CPhA)
California Retailers Association (CRA)
National Association of Chain Drug Stores (NACDS)
SB 482 (Lara) Page 23
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Opposition:
California Medical Association (CMA)
CVS Health
Rite Aid Corporation
The Doctor's Company (TDC)
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