BILL ANALYSIS Ó
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|Hearing Date:April 21, 2014 |Bill No:SB |
| |1258 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: SB 1258Author:DeSaulnier
As Amended:March 25, 2014 Fiscal: Yes
SUBJECT: Controlled substances: prescriptions: reporting.
SUMMARY: Makes a number of changes to the way that controlled
substances are prescribed and tracked in California, including:
mandating that controlled substances be prescribed electronically;
adding Schedule V controlled substances to tracking and monitoring
within the Controlled Substances Utilization Review and Evaluation
System (CURES) program; allowing designated investigators at the
Department of Consumer Affairs (DCA) to access CURES data; and
limiting the amount of controlled substance prescriptions to a
quantity not to exceed a 30-day supply.
Existing law, the Business and Professions Code (BPC):
1) Authorizes a physician and surgeon to prescribe for, or dispense or
administer to, a person under his or her treatment for a medical
condition dangerous drugs or prescription controlled substances for
the treatment of pain or a condition causing pain, including, but
not limited to, intractable pain. Provides that a physician and
surgeon shall not be subject to disciplinary action for
prescribing, dispensing, or administering dangerous drugs or
prescription controlled substances according to certain
requirements. Authorizes the Medical Board of California (MBC) to
take any action against a physician and surgeon who violates laws
related to inappropriate prescribing. Provides that a physician
and surgeon shall exercise reasonable care in determining whether a
particular patient or condition, or the complexity of a patient's
treatment, including, but not limited to, a current or recent
pattern of drug abuse, requires consultation with, or referral to,
a more qualified specialist. (BPC § 2241.5)
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2) Requires the Division of Medical Quality (DMQ) within MBC, to
develop standards before June 1, 2002 to ensure competent review in
cases concerning the management, including, but not limited to, the
under-treatment, under-medication, and overmedication of a
patient's pain. Authorizes DMQ to consult with entities such as
the American Pain Society, the American Academy of Pain Medicine,
the California Society of Anesthesiologists, the California Chapter
of the American College of Emergency Physicians, and any other
medical entity specializing in pain control therapies to develop
the standards utilizing, to the extent they are applicable, current
authoritative clinical practice guidelines. (BPC § 2241.6)
3) Defines "prescription" as an oral, written, or electronic
transmission order that includes certain information. States that
an "Electronic transmission prescription" includes both image and
data prescriptions and means any prescription order for which a
facsimile of the order is received by a pharmacy from a licensed
prescriber and, other than an electronic image transmission
prescription, is electronically transmitted from a licensed
prescriber to a pharmacy. (BPC § 4040)
4) Specifies requirements for pharmacists related to filling oral and
electronic data transmission prescriptions (e-prescriptions) and
allows a prescriber to authorize his or her agent on his or her
behalf to orally or electronically transmit a prescription, except
for Schedule II controlled substance orders. (BPC §§ 4070 and
4071)
5) Authorizes a pharmacist, registered nurse, licensed vocational
nurse, licensed psychiatric technician, or other healing arts
licentiate, if so authorized by administrative regulation, who is
employed by or serves as a consultant for a licensed skilled
nursing, intermediate care, or other health care facility, to
orally or electronically transmit a prescription lawfully ordered
by a person authorized to prescribe drugs or devices. Specifies
that this authority does not extend to Schedule II controlled
substances. (BPC § 4072)
Existing law, the Health and Safety Code (HSC), establishes the
California Uniform Controlled Substances Act which regulates
controlled substances. (HSC §§ 11000-11651)
1) Defines drug as:
a) Substances recognized as drugs in the official United States
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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)
2) 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)
3) Classifies controlled substances in five schedules according to
their danger and potential for abuse. (HSC § 11054-11058)
4) 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)
5) 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)
6) 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)
7) 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))
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8) 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 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))
9) Provides that pharmacies or clinics, in filling a controlled
substance prescription, 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))
10)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)
11)Authorizes DOJ to seek voluntarily contributed private funds from
insurers, health care service plans, qualified manufacturers, as
defined, and other donors for the purpose of supporting CURES and
requires DOJ to make information about the amount and the source of
all private funds it receives for support of CURES available to the
public. (HSC § 11165.5)
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
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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. (HSC § 11190 (c))
This bill:
1) Authorizes a Schedule II controlled substance to be orally or
electronically transmitted by a prescriber's agent on his or her
behalf.
2) Deletes the requirements under current law for controlled substance
prescriptions to be made on a specified form and instead requires a
prescription for a controlled substance classified in Schedule II,
III, IV, or V of the Controlled Substances Act (Act) to be made by
an e-prescription that complies with regulations promulgated by the
Drug Enforcement Agency (DEA).
3) Requires the prescribing and dispensing of Schedule V controlled
substances to be monitored in CURES.
4) Specifies that a prescription for a controlled substance must
contain the prescriber's address and telephone number; the name 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; refill information, such as the number
of refills ordered and whether the prescription is a first-time
request or a refill; and the name, quantity, strength, and
directions for use of the controlled substance prescribed.
5) Specifies that a prescription for a controlled substance must
contain the address of the person for whom the controlled substance
is prescribed. Specifies that if the prescriber does not specify
the address on the prescription, the pharmacist filling the
prescription, or an employee acting under the direction of the
pharmacist, shall include the address on the prescription or
maintain the information in a readily retrievable form in the
pharmacy.
6) Deletes the authority for an oral transmission of a controlled
substance prescription.
7) Makes certain allowances for a Schedule II, III, IV, or V
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controlled substance prescription to be transmitted on a form or
transmitted orally so that in instances where a technological
failure prevents the e-prescription from being received, or in the
case of an out-of-state-pharmacist filling the order, the
prescription may be written on a specified form so long as it is
also signed and dated by a prescriber in ink. Provides that for
these instances, an agent of the prescriber on his or her behalf
may orally transmit the prescription.
8) Requires a pharmacy or hospital to receive e-prescriptions.
9) Requires the prescribing and dispensing of Schedule V controlled
substances to be monitored in CURES.
10)Authorizes an individual designated by a board, bureau, or program
within the DCA who is investigating the alleged substance abuse of
an applicant or a licensee, to submit an application for approval
to access CURES information. Requires DOJ to release electronic
history of controlled substances dispensed to the applicant or
licensee based on data contained in the CURES to the investigating
individual.
11)Prohibits a person from prescribing, filling, compounding or
dispensing a prescription for a controlled substance in a quantity
exceeding a 30-day supply.
12)Provides that a person may prescribe fill, compound, or dispense a
prescription for a controlled substance in a quantity not exceeding
a 90-day supply if the prescription is issued to treat a panic
disorder, attention deficit disorder, chronic debilitating
neurologic condition characterized as a movement disorder or
exhibiting seizure, convulsive or spasm activity, pain in patients
with conditions or diseases known to be chronic or incurable or
narcolepsy.
13)Provides that a prescription for a Schedule III or IV controlled
substance shall not be refilled more than five times and in an
amount, for all refills of that prescription taken together,
exceeding a 120-day supply.
14)Prohibits a person from issuing, filling, compounding, or
dispensing a prescription for a controlled substance for an
ultimate user for whom a previous prescription for a controlled
substance was issued within the immediately preceding 30 days until
the ultimate user has exhausted all but a seven-day supply of the
controlled substance filled, compounded, or dispensed from the
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previous prescription.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. The Author is the Sponsor of this bill. According to the
Author, automated prescription drug management programs (PDMP) like
CURES are a valuable investigative, preventative, and educational
tool for healthcare providers, law enforcement, and regulatory
boards. The Author believes that increased protections and changes
to current law are needed to prevent prescription drug abuse and to
make the PDMP a better tool to assist in this effort. According to
the Author, by clarifying the law to mandate that controlled
substances be prescribed electronically, adding Schedule V
controlled substances to tracking and monitoring within CURES,
allowing designated investigators at DCA to access CURES data
limiting the amount of controlled substance prescriptions to a
quantity not to exceed a 30-day supply, the system will be
improved.
According to the Author, e-prescribing can assist in the reduction
of prescription pad theft, fraud, and forgery and that ultimately,
an e-prescribing system could assist in advancing accurate
prescribing technology by reducing error, and enabling better
monitoring.
The Author cites abuse of promethazine-cough syrup as a public
health concern and notes that prescriptions for these Schedule V
medications are not currently tracked in CURES but that the
addition of these drugs and others with potential for abuse will
help to curb the epidemic. The Author also believes that by
enabling designated, background-checked DCA investigators to
utilize CURES data, licensing boards will be more quickly able to
look into licensees like physicians and pharmacists who may play a
part in prescription drug abuse and overuse. Related to a 30-day
limit on controlled substances, the Author believes that this step
may help to reduce the supply of controlled substances available
for abuse by an individual and may also reduce the amount of
controlled substances available to be given to friends, family, or
others within the community without physician supervision.
2.Electronic Prescribing. Electronic prescribing is lauded as a key
component in the future of health care and one of many strategies
states have promoted in an attempt to improve patient safety and
quality of care while reducing health care costs. Streamlining the
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practice of medicine to be more efficient through tools such as
e-prescribing and electronic health care records has the potential
to, among other benefits, minimize dangerous prescription errors.
In November of 1999, the Institute of Medicine (IOM) released a
report, "To Err is Human: Building a Safer Health System," which
found that approximately 7,000 hospital patients die annually across
the country from preventable medication-related errors. The IOM
report found that 2 out of every 100 hospital patients will die or
be injured as a result of preventable medication errors, and that
each medication error increases the cost of a hospital stay by an
average of $4,700. A white paper issued in 2000 by the Institute
for Safe Medications Practices (ISMP) called for the elimination of
handwritten prescriptions within 3 years. The ISMP paper stated
that the health care industry has been slow to adopt new
technologies, and that prescription writing is perhaps the most
important paper transaction remaining in our increasingly digital
society. Previous hurdles to modernization seem to be phasing out,
as doctors more frequently utilize computers personal digital
assistants (PDAs) and the hardware and software that will allow for
electronic prescribing are more readily available.
A November 2008 issue brief by the California HealthCare Foundation
(CHCF) entitled, "The Outlook for Electronic Prescribing in
California" reported that in 2007, California's retail pharmacies
(excluding Kaiser and the Veterans Administration) filled more than
268 million prescriptions, but, of these transactions, only about
2.4 million were sent electronically between physician practices and
pharmacies. While this amount is a significant improvement from the
311,097 recorded in 2005, it represented only 1.2 percent of the
total prescriptions written in California each year. The CHCF
report stated that the adoption of e-prescribing in California has
been slow for a number of reasons, including the cost involved in
implementing the technology at provider practices, clinics and
pharmacies, legal restrictions that prevent electronic prescribing
of controlled substance prescriptions, and fees associated with
using electronic prescribing networks.
In 2008, the U.S. Congress passed the Medicare Improvements for
Patients and Providers Act (MIPPA) which contained electronic
prescribing incentive payments starting in 2009, and imposed
penalties for those who do not adopt e-prescribing by 2012.
Specifically, pursuant to MIPPA, providers would receive a
reimbursement bonus of 2 percent from Medicare for switching to
e-prescribing by 2009, an amount that is reduced to 1 percent in
2011 and 0.5 percent in 2013. Providers who failed to make use of
the technology would begin to see their payments decreased by 1
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percent in 2012, 1.5 percent in 2013, and 2 percent in 2014 and
beyond.
3.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, 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).
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4. 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 shows 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.
The Senate Committee on Labor held a hearing on March 20, 2013
entitled Opioids and the Workers Compensation System: A Discussion
on Mitigating Abuse and Ensuring Access during which the Committee
reviewed a series of studies conducted by the California Workers'
Compensation Institute (CWCI) which highlighted a rise in opiod
prescriptions by physicians in the state workers' compensation
system. The studies identified trends in widespread, potent use of
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Schedule II drugs by patients with low back pain, significant
growth in the prescribing of all Schedule II drugs in the workers'
compensation system and found that 6.7 percent of all prescriptions
in the system for the first half of 2011 alone were for opiods.
5. Prescription Drug Deaths. A 2013 Centers for Disease Control (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 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.
A 2012-13 Los Angeles Times series, "Dying For Relief," highlighted
the role of prescription drugs in overdose deaths as determined
through the examination of coroners' reports. Reporters conducted
an analysis of coroners' reports for over 3000 deaths occurring in
four counties (Los Angeles, Orange, Ventura and San Diego) where
toxicology tests found a prescription drug in the deceased's
system, usually a painkiller, anti-anxiety drug or other narcotic;
coroners' investigators reported finding a container of the same
medication bearing the doctor's name, or records of a prescription;
the coroner determined that the drug caused or contributed to the
death. The analysis found that in nearly half of the cases where
prescription drug toxicity was listed as the cause of death, there
was a direct connection to a prescribing physician. The Times
created a database linking overdose deaths to the doctors who
prescribed drugs. They also found that more than 80 of the doctors
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whose names were listed on prescription bottles found at the home
of or on the body of a decedent had been the prescribing physician
for 3 or more dead patients. Their analysis found that one doctor
was linked to as many as 16 dead patients.
6. 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. 49
states 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 50
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 is 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.
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
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patients' controlled-substance records.
Data from CURES is managed by DOJ to assist state law enforcement
and regulatory agencies in their efforts to reduce prescription
drug diversion. The 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 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.
7. Limits on Prescribing Controlled Substances. In response to rising
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concerns about the quantity of certain prescriptions, a number of
entities and states have attempted to address issues related to the
amount of controlled substances that can be prescribed in a given
time frame, with exceptions usually made for certain types of
patients like those suffering from cancer or other terminal
illnesses and diagnosed chronic pain conditions as a means of
preventing abuse and death. Examples of states limiting controlled
substance prescriptions, include: Maine, whose MaineCare (Maine's
Medicaid) allowed a 45 day maximum prescription for non-cancer pain
beginning in April, 2012; Washington state (described in detail
below); Rhode Island, which requires a physical examination prior
to prescribing a controlled substance; Ohio, whose Medical Board
guidelines recently were updated to include an 80mg/day Morphine
Equivalent Dose/day (MED/d) dosing "yellow flag" and; Connecticut,
whose workers compensation policy was updated in 2013 to advise
that the total daily dose of opioids should not be increased above
90mg oral MED/d unless the patient improves in function, pain, or
work capacity.
Updates to prescriber guidelines are also being undertaken to
address the possible role of overprescribing in prescription drug
abuse. In California, MBC is currently working to update its
Guidelines for Prescribing Controlled Substances for Pain and
policy statement entitled "Prescribing Controlled Substances for
Pain." Stemming from studies and discussions about controlled
substances, this policy statement was designed to provide guidance
to improve prescriber standards for pain management, while
simultaneously undermining opportunities for drug diversion and
abuse. The guidelines outlined appropriate steps related to a
patient's examination, treatment plan, informed consent, periodic
review, consultation, records, and compliance with controlled
substances laws. Guidelines are used by physicians as well as MBC
in its regulation of licensees.
In 2007, the Washington State Agency Medical Director's Group
(AMDG), a collaboration of state agencies, joined with clinical
scholars to revise the state's prescriber guidelines. The
Interagency Guidelines on Opioid Dosing for Chronic Non Cancer Pain
advises "that providers not exceed a dosing threshold of 120 mg
MED/d for patients who did not have clinically meaningful
improvement in pain and function without first obtaining a pain
specialist consultation." According to studies and outcomes
following the implementation of the guidelines for workers
compensation patients, this threshold was found to specifically
lower long-acting Schedule II drugs by 27 percent and cut the
amount of workers on doses greater than or equal to 120 mg/day MED
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by 35 percent. The guidelines and this limit is seen as not only
helping combat substance abuse but also helping preserve funds for
the state's workers compensation program. Most notably, studies in
Washington highlighted that the mortality rate decreased by 50
percent after the 120 mg MED/d threshold was implemented. Along
with the implementation of this threshold, Washington also provided
tools for calculated dosages of opioids during treatment and when
tapering should begin. Washington was also the first state to
repeal intractable pain laws that allowed long-term opioid therapy
without a threshold.
8. Related Legislation This Year. SB 500 (Lieu) requires MBC to
update prescriber standards for controlled substances once every
five years and adds the American Cancer Society, specialists in
pharmacology and specialists in addiction medicine to the entities
MBC may consult with in developing the standards. ( Status: The
bill is currently pending in the Assembly.)
9. Prior Related Legislation. 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.)
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
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heard in policy committee.)
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 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.
10.Arguments in Support. Supporters believe that this bill will
improve prescription drug laws and bring about greater patient
safety and protection. According to the National Coaliton Against
Prescription Drug Abuse (NCAPDA), mandating that controlled
substances be prescribed electronically would end the diversion of
medications through counterfeit and illegally obtained prescription
pads. NCAPDA also believes that limiting controlled substances to
a 30-day supply would "help control the overprescribing of
narcotics that can be diverted downstream and also help reduce the
levels of controlled substance overdose in California."
The Troy and Alana Pack Foundation writes in support of this bill,
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stating that the issue of prescription drug abuse in California
hardly needs statistics or justification, as the epidemic is well
under way and the state instead needs new laws that will balance
legitimate need for pain medication with protecting people from the
consequences of highly addictive compounds.
According to the California Statewide Law Enforcement Association
(CSLEA), allowing additional non-peace officer investigators
working on behalf of DCA licensing board to access CURES when
investigating allegations related to substance abuse by applicants
or licensees will assist in providing information relevant to
investigations.
11.Arguments in Opposition. The California Hospital Association (CHA)
has taken an "Oppose Unless Amended" position on this bill, stating
that the bill would cause harm to patients who legitimately need
controlled substances medications. Specifically, CHA believes that
while electronic prescribing for controlled substances is a
laudable goal, it is not practical. CHA cites the impediments
faced by small rural hospitals and small physician group practices
which are still in the beginning stages of developing electronic
charting and e-prescribing and notes that the technology is not
universally available yet and if this bill passes, patient needs
will go unmet. CHA also believes that there should be exceptions
to the limits on controlled substance prescriptions to address
issues such as loss, theft or long-term overseas travel that may
warrant additional supply.
The California Medical Association (CMA), also has an "Oppose
Unless Amended" position on this bill which it believes would tip
the balance away from the appropriate clinical application of
controlled substances. CMA believes that there should be
additional privacy protections for information contained within
CURES. CMA also opposes the requirement for e-prescribing of
controlled substances, as the requirements for prescribing
controlled substances are already onerous and "a mandate to
e-prescribe would result in many providers forgoing controlled
substances prescribing altogether" which CMA believes would
interfere with patient care. CMA also believes that establishing a
limit on refilling controlled substances does not anticipate all of
the situations a clinician faces and will create hardship for
patients. CMA also states that this limitation would lend to a
limit for each patient to have only one controlled substance
prescription at a time which would lead to poor outcomes.
12.Author's Amendments. In response to concerns raised by the CHA and
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CMA, the Author plans to take the following as Author's amendments:
a) Lengthen the timeline for mandatory electronic prescribing and
exempt certain providers.
The Author plans to extend the implementation timeframe for
e-prescribing from 2015 to 2016 to allow healthcare providers to
update systems to ensure safe e-prescribing. The Author also
plans to exempt certain providers and healthcare settings like
those in rural areas or small practice groups from the 2016
implementation date, to accommodate their unique needs and
potential hurdles in acquiring and using e-prescribing systems,
and will establish a date past 2016 for those practitioners to be
in compliance.
b) Provide for certain exemptions from the limits proposed for
controlled substances prescriptions.
The Author plans to provide certain patients, such as those who
have barriers in accessing providers or whose unique
circumstances may warrant a larger supply, an allowance for a
larger quantity of controlled substances than the 30-day limit
proposed in this bill.
c) Technical corrections.
The Author plans to take technical and clarifying amendments on
Page 15 of the bill to ensure that patients are not potentially
prohibited from having more than one controlled substance
prescription at one time.
NOTE : Double-referral to Senate Committee on Public Safety (second).
Any amendments should be taken in the next policy committee.
SUPPORT AND OPPOSITION:
Support:
California Statewide Law Enforcement Association
National Coalition Against Prescription Drug Abuse
Troy and Alana Pack Foundation
Opposition:
California Hospital Association
California Medical Association
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Consultant:Sarah Mason