BILL ANALYSIS Ó
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Loni Hancock, Chair S
2013-2014 Regular Session B
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SB 1258 (DeSaulnier)
As Amended: April 23, 2014
Hearing date: April 29, 2014
Health and Safety Code
Business and Professions Code
JM:sl
CONTROLLED SUBSTANCES:
PRESCRIPTION TRACKING FOR DRUGS IN SCHEDULE V
HISTORY
Source: Author
Prior Legislation: SB 809 (DeSaulnier) - Ch 400, Statutes of
2013)
SB 616 (DeSaulnier) - 2012, Failed Passage in
Assem. Bus. & Prof.
SB 360 (DeSaulnier) - Ch 360, Ch. Stats. 2011
SB 1071 (DeSaulnier) - 2010, Held in Senate Health
AB 2986 (Mullin) - Ch. 286, Stats. 2006
SB 151 (Burton) - Ch. 406, Stats. 2003
AB 2655 (Matthews) - Ch. 345, Stats. 2002
SB 1000 (Johannessen) - 2001, vetoed
AB 2018 (Thomson) - Ch. 1092, Stats 2000
SB 1308 (Business & Professions Committee) - Ch.
655, Stats. 1999
AB 2693 (Migden) - Ch. 789, Stats. 1998
AB 3042 (Takasugi) - Ch. 738, Stats. 1996
SCR 74 (Presley) - Resolution Ch. 116, Stats. 1992
Support: California Statewide Law Enforcement Association;
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California Narcotic Officers Association; California
Police Chiefs Association; National Coalition Against
Prescription Drug Abuse; Troy and Alana Pack Foundation
Opposition:American Civil Liberties Union (Unless Amended);
Association of Northern California Oncologists;
California Hospital Association; California Medical
Association; Medical Oncology Association of Southern
California
KEY ISSUES
SHOULD SCHEDULE V CONTROLLED SUBSTANCES - SUCH AS SPECIFIED COUGH
SUPPRESSANT FORMULATIONS AND ANTI-DIARRHEA MEDICATIONS - BE ADDED TO
CURES - THE CONTROLLED SUBSTANCE UTILIZATION REVIEW AND EVALUATION
SYSTEM?
SHOULD PHYSICIANS AND OTHER AUTHORIZED PRESCRIBERS BE REQUIRED TO
USE ONLY ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES AND
COMPLY WITH FEDERAL DRUG ENFORCEMENT ADMINISTRATION REGULATIONS IN
DOING SO?
SHOULD LIMITS ON THE SUPPLY OR AMOUNT OF CONTROLLED SUBSTANCES IN
PRESCRIPTIONS BE ENACTED?
SHOULD CONSUMER AFFAIRS INVESTIGATORS BE GIVEN SPECIFIC AUTHORITY TO
ACCESS CURES DATA TO INVESTIGATE SUSPECTED MISCONDUCT BY LICENSEES?
PURPOSE
The purpose of this bill is to 1) require controlled substances
to be prescribed electronically in compliance with federal DEA
standards; 2) add Schedule V controlled substances to the CURES
electronic reporting system and Prescription Drug Monitoring
Program (PDMP) for tracking prescriptions for controlled
substances; 3) grant specific authority to Department of
Consumer Affairs investigators to access CURES information if
the investigator has probable cause of misconduct by a licensee;
4) limit any controlled substance prescription to a 30-day
supply, unless that limit would pose a specified hardship; 5)
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limit the number of authorized refills of drugs on specified
schedules; and 6) impose other additional controls and limits on
the prescribing and medical use of controlled substances.
Existing law 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.
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.
The Medical Board of California (MBC) may 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. (Bus. & Prof. Code § 2241.5.)
Existing law 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. (Bus. & Prof. Code §
2241.6.)
Existing law defines "prescription" as an oral, written, or
electronic transmission order that includes certain information.
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"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. (Bus. and Prof. Code § 4040.)
Existing law 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. (Bus. & Prof. Code §§ 4070 and 4071.)
Existing law authorizes a pharmacist, registered nurse, licensed
vocational nurse, licensed psychiatric technician, or other
healing arts licentiate, if authorized by administrative
regulation, 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. This authority does not extend to Schedule II
controlled substances. (Bus. & Prof. Code § 4072.)
Existing law defines a drug as:
A substance 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;
A substance intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or
animals; and,
A substances (other than food) intended to affect the
structure or any function of the body of man or animals.
(Health & Saf. Code (HSC) § 11014.)
Existing law defines an opiate as a substance having an
addiction-forming or addiction-sustaining effect similar to
morphine, or that can be converted into a drug having
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addiction-forming or addiction-sustaining effects. (Health &
Saf. Code § 11020.)
Existing law classifies controlled substances in five schedules
according to their danger and potential for abuse. (Health &
Saf. Code §§ 11054-11058.)
Existing law 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. A violation shall result in
imprisonment for up to one year or a fine of up to $20,000, or
both. (Health & Saf. Code § 11153.)
Existing law 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. (Health & Saf. Code §§ 11161.5, 11162.1,
11164.)
Existing law establishes the Controlled Substances Utilization
Review and Evaluation System (CURES) for electronic monitoring
of Schedule II, III and IV controlled substance prescriptions.
CURES provides for electronic transmission of Schedule
II, III and IV controlled substance prescription
information to the Department of Justice (DOJ) at the time
prescriptions are dispensed. (Health & Saf. Code § 11165.)
CURES is intended 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. (Health &
Saf. Code § 11165, subd. (a).)
Existing law establishes privacy protections for patient data
and specifies that CURES data can only be accessed by
appropriate state, local and federal public agencies or
authorized for disciplinary, civil or criminal actions. 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.
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Non-identifying CURES data can be provided to public and private
entities for education, research, peer review and statistical
analysis. (Health & Saf. Code § 11165, subd. (c).)
Existing law provides that a pharmacy or clinic, 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. (Health & Saf. Code § 11165, subd. (d).)
Existing law 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. DOJ may deny an application or suspend a subscriber for
certain violations and falsifying information. A patient's
controlled substance CURES received by a practitioner or
pharmacy is medical information, subject to provisions of the
Confidentiality of Medical Information Act. (Health & Saf. Code
§ 11165.1.)
Existing law authorizes DOJ to seek private, voluntary funds
from insurers, health care service plans, qualified
manufacturers and other donors to support CURES. DOJ shall make
all the sources and amounts of such contributions available to
the public. (Health & Saf. Code § 11165.5.)
Existing law 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. (Health & Saf. Code § 11190, subds. (a) and (b).)
Existing law requires authorized prescribers who 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
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number, state medical license number, National Drug Code number
of the controlled substance dispensed, quantity dispensed,
diagnosis code and original date of dispensing. This
information shall be provided to DOJ on a monthly basis.
(Health & Saf. Code §§ 11190, subd. (c) and 11191.)
This bill authorizes a Schedule II controlled substance to be
orally or electronically transmitted by a prescriber's agent on
his or her behalf.
This bill 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.
This bill 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.
This bill 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 previous prescription.
This bill 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).
This bill requires the prescribing and dispensing of Schedule V
controlled substances to be monitored in CURES.
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This bill 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.
This bill specifies that a prescription for a controlled
substance must contain the address of the person for whom the
controlled substance is prescribed, and 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.
This bill deletes the authority for an oral transmission of a
controlled substance prescription.
This bill makes certain allowances for a Schedule II, III, IV,
or V 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.
For these instances, an agent of the prescriber on his or her
behalf may orally transmit the prescription.
This bill requires a pharmacy or hospital to receive
e-prescriptions.
This bill requires the prescribing and dispensing of Schedule V
controlled substances to be monitored in CURES.
This bill 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
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an application for approval to access CURES information upon a
showing of probable cause.
This bill 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.
This bill prohibits a person from prescribing, filling,
compounding or dispensing a prescription for a controlled
substance in a quantity exceeding a 30-day supply.
This bill extends the deadline for healthcare providers to
comply with electronic prescribing requirements to January 1,
2016.
This bill includes exceptions to the 30-day supply for
controlled substance prescriptions for persons who face barriers
to obtaining prescriptions for a 30-day supply.
This bill authorizes specified patients to have prescriptions
for more than one controlled substance at a time.
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
For the last several years, severe overcrowding in California's
prisons has been the focus of evolving and expensive litigation
relating to conditions of confinement. On May 23, 2011, the
United States Supreme Court ordered California to reduce its
prison population to 137.5 percent of design capacity within two
years from the date of its ruling, subject to the right of the
state to seek modifications in appropriate circumstances.
Beginning in early 2007, Senate leadership initiated a policy to
hold legislative proposals which could further aggravate the
prison overcrowding crisis through new or expanded felony
prosecutions. Under the resulting policy, known as "ROCA"
(which stands for "Receivership/ Overcrowding Crisis
Aggravation"), the Committee held measures that created a new
felony, expanded the scope or penalty of an existing felony, or
otherwise increased the application of a felony in a manner
which could exacerbate the prison overcrowding crisis. Under
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these principles, ROCA was applied as a content-neutral,
provisional measure necessary to ensure that the Legislature did
not erode progress towards reducing prison overcrowding by
passing legislation, which would increase the prison population.
In January of 2013, just over a year after the enactment of the
historic Public Safety Realignment Act of 2011, the State of
California filed court documents seeking to vacate or modify the
federal court order requiring the state to reduce its prison
population to 137.5 percent of design capacity. The State
submitted that the, ". . . population in the State's 33 prisons
has been reduced by over 24,000 inmates since October 2011 when
public safety realignment went into effect, by more than 36,000
inmates compared to the 2008 population . . . , and by nearly
42,000 inmates since 2006 . . . ." Plaintiffs opposed the
state's motion, arguing that, "California prisons, which
currently average 150% of capacity, and reach as high as 185% of
capacity at one prison, continue to deliver health care that is
constitutionally deficient." In an order dated January 29,
2013, the federal court granted the state a six-month extension
to achieve the 137.5 % inmate population cap by December 31,
2013.
The Three-Judge Court then ordered, on April 11, 2013, the state
of California to "immediately take all steps necessary to comply
with this Court's . . . Order . . . requiring defendants to
reduce overall prison population to 137.5% design capacity by
December 31, 2013." On September 16, 2013, the State asked the
Court to extend that deadline to December 31, 2016. In
response, the Court extended the deadline first to January 27,
2014 and then February 24, 2014, and ordered the parties to
enter into a meet-and-confer process to "explore how defendants
can comply with this Court's June 20, 2013 Order, including
means and dates by which such compliance can be expedited or
accomplished and how this Court can ensure a durable solution to
the prison crowding problem."
The parties were not able to reach an agreement during the
meet-and-confer process. As a result, the Court ordered
briefing on the State's requested extension and, on February 10,
2014, issued an order extending the deadline to reduce the
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in-state adult institution population to 137.5% design capacity
to February 28, 2016. The order requires the state to meet the
following interim and final population reduction benchmarks:
143% of design bed capacity by June 30, 2014;
141.5% of design bed capacity by February 28, 2015; and,
137.5% of design bed capacity by February 28, 2016.
If a benchmark is missed the Compliance Officer (a position
created by the February 10, 2016 order) can order the release of
inmates to bring the State into compliance with that benchmark.
In a status report to the Court dated February 18, 2014, the
state reported that as of February 12, 2014, California's 33
prisons were at 144.3 percent capacity, with 117,686 inmates.
8,768 inmates were housed in out-of-state facilities.
The ongoing prison overcrowding litigation indicates that prison
capacity and related issues concerning conditions of confinement
remain unresolved. While real gains in reducing the prison
population have been made, even greater reductions may be
required to meet the orders of the federal court. Therefore,
the Committee's consideration of ROCA bills -bills that may
impact the prison population - will be informed by the following
questions:
Whether a measure erodes realignment and impacts the
prison population;
Whether a measure addresses a crime which is directly
dangerous to the physical safety of others for which there
is no other reasonably appropriate sanction;
Whether a bill corrects a constitutional infirmity or
legislative drafting error;
Whether a measure proposes penalties which are
proportionate, and cannot be achieved through any other
reasonably appropriate remedy; and,
Whether a bill addresses a major area of public safety
or criminal activity for which there is no other
reasonable, appropriate remedy.
COMMENTS
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1. Need for This Bill
According to the author:
The automated Prescription Drug Monitoring Program
(PDMP) is a valuable investigative, preventative, and
educational tool for healthcare providers, law
enforcement, and regulatory boards. However,
increased protections are needed to prevent
prescription drug abuse and to make the PDMP a better
tool. By enabling designated, background-checked
investigators at the Department of Consumer Affairs to
utilize CURES data, boards will be more quickly able
to look into physicians and pharmacists who are being
investigated for overprescribing.
Currently, abuse of promethazine-cough syrup and other
Schedule V drugs is a public health concern. These
drugs are scheduled as controlled substances because
it has been determined in federal clinical trials that
they do indeed have potential for abuse. However,
Schedule V controlled substances are not tracked in
CURES. Including tracking of Schedule V drugs, as in
34 states and the District of Columbia, will help to
curb abuse.
Prescription pads, despite extensive security
features, are prone to theft and fraud by organized
criminals. Pads also are prone to error, due to
handwriting and transcription errors. Pads also do
not track and aggregate population level data in the
way that electronic prescription systems have the
potential to do.
Electronic prescribing will reduce prescription pad
theft, fraud, and forgery. Ultimately, an electronic
prescribing could advance accurate prescribing
technology by reducing error and enabling better
monitoring.
Lastly, diversion of controlled substances from the
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patients for whom they were originally prescribed and
into the community for illicit use is the main source
of abused prescription drugs. A 30-day dosage limit,
with flexibility for professional discretion on
medical necessity, may reduce the supply of controlled
substances available for abuse by the patient and the
amount of controlled substances to be given to
friends, family, or others within the community
without physician supervision. States that have
enacted dosage limits, like Rhode Island, have seen
significant reductions in prescription narcotic
overdose deaths.
The bill contains four operative functions:
1. Mandates that controlled substances be prescribed
electronically to reduce error rates, eliminate
prescription pad fraud and theft.
2. Limits the amount of controlled substance
prescription to a quantity not to a 30-day supply,
thus limiting controlled substances available for
diversion in the community.
3. Adds schedule V controlled substances to be
monitored by the CURES program to better monitor
controlled substances prior to epidemic abuse
occurring.
4. Allows designated investigators at the Department
of Consumer Affairs to access the CURES data for
purposes of investigations of licensees to establish
misconduct or clear the person's name.
2. Recent Amendments Address Some Concerns Raised in Prior
Hearings
This bill was the subject of a lengthy hearing in the Senate
Business, Professions and Economic Development Committee on
April 21, 2014. In response to concerns raised by the
California Hospital Association (CHA) and the California Medical
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Association (CMA), the author agreed to the following amendments
prior to the hearing of the bill is this Committee on April 29,
2014. The bill was amended on April 23, 2014 to do the
following:
Lengthen the timeline for mandatory electronic
prescribing and exempt certain providers.
The amendments extend the deadline for e-prescribing of
controlled substances from January 1, 2015 to January 1,
2016 to allow healthcare providers to update systems to
ensure safe e-prescribing. The deadline for practices of
no more than two practitioners, and providers in rural
areas was set at January 1, 2017, as small practices,
especially in rural areas, will have difficulty acquiring
and implementing e-prescribing systems that meet DEA
requirements.
Provide for Certain Exemptions from the 30-Day Supply
Limit for Controlled Substances Prescriptions.
The amendments provide that physicians can prescribe
controlled substances in excess of the 30-day supply limit
in cases of a documented and noted medical necessity.
Clarify Grounds for Access to CURES and PDMP information
by Department of Consumer Affairs Investigators.
The amendments specifically provide that an investigator
designated by a Department of Consumer Affairs to
investigate alleged controlled substance abuse by a
professional licensee shall be supported by probable cause.
The amendments strike a reference to license applicants in
this regard.
Make Technical Corrections
The technical and clarifying amendments ensure that
patients are not prohibited from having more than one
controlled substance prescription at one time.
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3. National All Schedules Prescription Electronic Reporting
(NASPER) Act of 2005 - Federal Grants to States for
Electronic Reporting of Controlled Substance
Prescriptions
NASPER was signed into law on August 12, 2005. The purpose
of the Act is to "foster the establishment of
state-administered controlled substance monitoring systems
in order to ensure that health care providers have access
to the accurate, timely prescription history information
that they may use as a tool for the early identification of
patients at risk for addiction in order to initiate
appropriate medical interventions and avert the ?
consequences of untreated addiction." The additional
purpose of the Act is to establish "best practices ? [for]
new state programs and the improvement of existing
programs."<1>
The Act included a grant program under which a state
submits an application to demonstrate how the state has
adopted an electronic controlled substance reporting system
that complies with federal guidelines. These guidelines
appear to require electronic reporting and evaluation of
prescriptions for controlled substances in Schedules II,
III and IV and frequent reporting of data.
4. California CURES Data Processed by Private Contractor -
Atlantic Associates, a New Hampshire Corporation
By statute, DOJ is tasked with operating CURES. DOJ has
contracted with private entities to handle and process CURES
data. DOJ previously contracted with Infinite Solutions. DOJ
now uses Atlantic Associates, a firm headquartered in Manchester
New Hampshire specializing in prescription drug data
management.<2> The company Website states: "AAI serves as a
liaison between the State agencies, the pharmacies and their
software vendors to ensure the State agencies in charge of the
PMP's has the time to concentrate on core operations, leaving
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<1> http://www.nasper.org/Documents/SRep109-117.pdf
<2> http://www.aainh.com/CACures.html
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all the Pharmacy support, clerical duties and file processing to
us."
5. Electronic Prescribing
Electronic Prescribing Generally
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
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
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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 percent in 2012, 1.5 percent in 2013, and 2 percent in 2014
and beyond.
DEA Regulation of Electronic Prescriptions for Controlled
Substances
The use of electronic prescriptions for controlled substances is
part of a push for conversion of all medical records to
electronic forms. It appears that implementation of the
Affordable Care Act will accelerate the transition to electronic
medical records, including prescribing and dispensing of
controlled substances.
The federal DEA has been developing regulations and standards
for electronic prescribing of controlled substances. A glance
at the DEA Website concerning electronic controlled substance
prescriptions demonstrates that the subject and the DEA
directives are very detailed and complex. Physicians and
medical organizations have testified that meeting the DEA
requirements for electronic prescribing of controlled substances
for many practitioners will be burdensome, if not impossible.
It is clear from the DEA publications and commentaries that the
agency has serious concerns about the security of electronic
prescriptions, especially because entities with different
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electronic systems must communicate rapidly and often have to
handle the information involved in these transactions.
As noted above, the DEA Website on electronic prescribing is
extensive and complex. The DEA Website summarizes the agency's
main requirements for electronic prescribers:
Based on DEA's concerns, certain requirements must
exist for any system to be used for the electronic
prescribing of controlled substances:
Only DEA registrants may be granted the authority
to sign controlled substance electronic prescriptions.
The approach must, to the greatest extent possible,
protect against the theft of registrants' identities.
The method used to authenticate a practitioner to
the electronic prescribing system must ensure to the
greatest extent possible that the practitioner cannot
repudiate the prescription. Authentication methods
that can be compromised without the practitioner being
aware of the compromise are not acceptable.
The prescription records must be reliable enough to
be used in legal actions (enforcing laws relating to
controlled substances) without diminishing the ability
to establish the relevant facts and without requiring
the calling of excessive numbers of witnesses to
verify records.
The security systems used by any electronic
prescription application must, to the greatest extent
possible, prevent the possibility of insider creation
or alteration of controlled substance
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prescriptions.<3>
6. Fourth Amendment Issues
It appears from the history of bills on the California CURES
system, similar programs in other states and federal controlled
substance monitoring that it has been largely assumed that
allowing law enforcement access to controlled substance
prescription information or data does not violate the 4th
Amendment prohibition on unreasonable searches and seizures.
However, it does appear that challenges are being made to law
enforcement access to these systems.
The American Civil Liberties Union (ACLU) joined with the State
of Oregon to challenge a DEA claim that the agency could obtain
Oregon prescription records with a non-judicial administrative
subpoena, not a warrant. The Oregon prescription drug
monitoring law includes a requirement that law enforcement
agencies obtain a warrant to access information in the database
for an investigation:
In 2009, the Oregon legislature created the Oregon
Prescription Drug Monitoring Program, a database that
tracks prescriptions for use as a public health tool
by physicians and pharmacists. The state included
privacy protections, including a warrant requirement
for police access. However, the DEA claimed that a
federal law allowed them to access the database using
only an "administrative subpoena," which does not
involve a judge or require the government to show
probable cause
"We opposed creating a massive database that would
contain the prescription records of Oregon patients
and physicians who had done nothing wrong," said David
Fidanque, executive director of the ACLU of Oregon.
"Nevertheless, we helped convince Oregon lawmakers to
add important safeguards to the program, and we're
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<3>
http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.htm
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pleased that the court has recognized the importance
of protecting medical privacy.
The State of Oregon filed a lawsuit against the DEA,
and the ACLU joined the case. Today's ruling granted
the ACLU's motion for summary judgment and denied the
federal government's motion, with the result that the
DEA must get a warrant to access the prescription
records in Oregon. (Italics added.)<4>
7. Controlled Substances - Definitions and Background
Through the Controlled Substances Act of 1970, the federal
government regulates the manufacture, distribution and
dispensing of controlled substances. The act ranks drugs into
five schedules with decreasing 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. Federal law
includes relatively detailed explanations of the factors and
standards for placement of drugs in the various schedules.
California law does not explain how the schedules are organized.
Schedule I controlled substances, such as heroin,
ecstasy, and LSD, have a high potential for abuse and no
generally accepted medical use.
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
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<4>
https://www.aclu.org/technology-and-liberty/court-rules-warrant-r
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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 usually prescribed to treat the sleep disorder narcolepsy
and attention-deficit hyperactivity disorder (ADHD). Most of
the drugs in each class of drugs can induce euphoria or
intoxication. When drugs producing euphoria or intoxication
are administered by routes other than recommended, such as
snorting or dissolving into a liquid to drink or inject, the
effect of the drug is typically intensified. Synthetic
opioids act on the same receptors as heroin and morphine and
therefore can be highly addictive. Common opioids are:
hydrocodone (Vicodin), oxycodone (OxyContin), propoxyphene
(Darvon), hydromorphone (Dilaudid), meperidine (Demerol), and
diphenoxylate (Lomotil).
8. 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 in 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
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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 opioid prescriptions by physicians in the
state workers' compensation system. The studies identified
trends in widespread, potent use of 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 opioids.
9. Prescription Drug Deaths
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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 opioid 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
opioids 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
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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 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.
10. 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 currently is 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 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, 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
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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.
Data from CURES is managed by DOJ to assist state law
enforcement and regulatory agencies in their efforts to reduce
prescription drug diversion. DOJ hires a private contractor to
actually manage the information in CURES. 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
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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.
11. Limits on Prescribing Controlled Substances
In response to rising 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
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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 outline 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.
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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 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.
12. 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. The bill is currently
pending in the Assembly.
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