BILL ANALYSIS �
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|Hearing Date:April 15, 2013 |Bill No:SB |
| |62 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 62 Author:Price
As Amended:April 9, 2013 Fiscal: Yes
SUBJECT: Coroners: reporting requirements: prescription drug use.
SUMMARY: In the event that a coroner determines cause of death to be
a prescription drug overdose, it requires coroners to transmit reports
to various regulatory boards.
Existing law, the Health and Safety Code (HSC), establishes the
California Uniform Controlled Substances Act which regulates
controlled substances. (HSC �� 11000-11651)
1)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)
2)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
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)
3)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
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(a) and (b))
4)Requires prescribers who are authorized to dispense Schedule II, III
or IV controlled substance in their office or place of practice to
record and maintain information for three years for each such
prescription that includes the patient's name, address, gender, and
date of birth, prescriber's license and license number, federal
controlled substance registration number, state medical license
number, NDC number of the controlled substance dispensed, quantity
dispensed, diagnosis code, if available, and original date of
dispensing. Requires that this information be provided to DOJ on a
monthly basis. (HSC � 11190 (c))
Existing law, the Business and Professions Code (BPC):
1)Establishes the Medical Practice Act which provides for the
licensing and regulation of physicians and surgeons by the Medial
Board of California (MBC) within the Department of Consumer Affairs
(DCA).
2)Establishes the Dental Practice Act which provides for the licensing
and regulation of dentists by the Dental Board of California within
the DCA.
3)Establishes the Veterinary Medicine Practice Act which provides for
the licensing and regulation of veterinarians and registered
veterinary technicians by the Veterinary Medical Board within the
DCA.
4)Establishes the Nursing Practice Act which provides for the
certification and regulation of registered nurses, nurse
practitioners and advanced practice nurses by the Board of
Registered Nursing within the DCA.
5)Provides that a certified nurse-midwife may furnish or order drugs
or devices, including controlled substances, if furnished or ordered
incidentally to the provision of family planning services, routine
health care or perinatal care, or care rendered consistent with the
certified nurse-midwife's practice; occurs under physician and
surgeon supervision; and is in accordance with standardized
procedures or protocols as specified. (BPC � 2746.51)
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6)Provides that a nurse practitioner may furnish or order drugs or
devices, including controlled substances, if it is consistent with a
nurse practitioner's educational preparation or for which clinical
competency has been established and maintained; occurs under
physician and surgeon supervision; and is in accordance with
standardized procedures or protocols as specified. (BPC � 2836.1)
7) Establishes the Physician Assistant Practice Act which provides for
the licensing of physician assistants by the Physician Assistant
Committee, under the MBC, within the DCA.
8) Provides that a physician assistant while under the supervision of
a physician and surgeon may administer or provide medication to a
patient, or transmit orally or in writing a drug order under
specified conditions and protocols adopted by the supervising
physician and surgeon. (BPC � 3502.1)
9) Establishes the Osteopathic Act which provides for the licensing
and regulation of osteopathic physicians and surgeons by the
Osteopathic Medical Board of California within the DCA.
10)Establishes the Naturopathic Doctors Act which provides for the
licensing of naturopathic doctors by the Naturopathic Medicine
Committee within the Osteopathic Medical Board of California within
the DCA.
11)Establishes the Optometry Practice Act which provides for the
licensure of optometrists by the California State Board of
Optometry within the DCA.
12)Establishes the Podiatric Act which provides for the licensure of
doctors of podiatric medicine by the California Board of Podiatric
Medicine within the DCA.
13)Establishes the Pharmacy Law which provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of dangerous
drugs or devices by the Board of Pharmacy within the DCA.
14)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian or naturopathic doctor. (BPC � 4059)
15)Requires a coroner to report to the appropriate regulatory board
within the DCA when the coroner determines that a death may be the
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result of a physician and surgeon's, podiatrist's or physician
assistant's gross negligence or incompetence. Provides that this
report shall be confidential and removes a coroner, physician and
surgeon or medical examiner from liability in any civil action as a
result of complying with the reporting requirement. (BPC � 802.5)
Existing law, the Government Code (GC): Requires coroners to inquire
into and determine the circumstances, manner, and cause of all
violent, sudden, or unusual deaths; unattended deaths; deaths where
the deceased has not been attended by either a physician or a
registered nurse, who is a member of a hospice care interdisciplinary
team; and any deaths reported by physicians or other persons having
knowledge of death for inquiry. (GC � 27491)
This bill:
1) Clarifies that a board-certified or California licensed
pathologist, rather than board-eligible pathologist, provides
findings to a coroner indicating that a physician's gross
negligence or incompetence may be the result of a death.
2) Clarifies that, in addition to the requirement for coroners to
provide reports to the MBC when a physician's gross negligence may
be the result of a death in 90 days, coroners may provide reports
as soon as possible once the coroner's final report of
investigation is complete.
3) Requires coroners, when he or she receives information based on
findings of a board-certified or California licensed pathologist
indicating that the cause of death is determined to be the result
of prescription drug use, to file a report with the MBC. Provides
that, when known, the report shall include the name of the
decedent, date and place of death, attending physicians,
podiatrists or physician assistants and all other relevant
information including any information available to identify the
prescription drug(s), prescribing physician(s) and dispensing
pharmacy.
4) Clarifies that coroners shall also provide the coroner's report,
autopsy protocol and all other relevant information within 90 days
or as soon as possible once the coroner's final report of
investigation is complete.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by Legislative
Counsel.
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COMMENTS:
1. Purpose. This bill is sponsored by the Author. According to the
Author, coroners' reports are a treasure trove of data that can
inform the appropriate licensing boards about where people are
getting drugs, how much they have when they die of an overdose and
whether they were under the care of a doctor who may have been
prescribing too much. The Author believes that this bill connects
the dots and creates a very necessary pathway for prescription drug
overdose deaths to be reported directly to the boards that can take
necessary action against their licensees who may have been directly
involved due to overprescribing or unsafe, poor prescribing
practices. The Author states that if boards are receiving reports
from coroners throughout the state, they will be better armed with
the necessary tools to make a correlation to their licensees in
overprescribing circumstances and take action.
The Author believes that while some doctors may be negligent in
paying attention to signs that their patients are addicts, in most
instances, boards are probably unaware that there is even any
correlation between an overdose death of a patient and the drugs
prescribed by their doctor. Current law only requires coroners
reports to be transmitted to the MBC in the event that gross
negligence by a physician is determined as the cause of death,
resulting in the board not necessarily having the right information
to begin investigating a licensee or a licensee's prescribing
practices.
In a case where the coroner findings deal with a young person, who
is not a cancer patient on hospice or someone in a health facility
setting, who was found dead in possession of various opioid
combinations, the prescribing doctor and his or her practices may
need to be looked into. Particularly in instances where the same
doctor is listed as the prescribing physician on the medication
bottles of numerous dead patients, the licensing board should have
that information readily available.
2. Background. Current law only requires coroners to report to the
MBC when the coroner determines that the death may be the result of
physician gross negligence or incompetence. In FY 2011/12, the MBC
only received four of these reports, and according to them, only
one indicated a drug related death. The MBC reported to this
Committee that while numerous deaths have occurred in California,
which may be directly related to prescription drug overdoses, it is
difficult for them to obtain a complaint which, in turn, would
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trigger an investigation.
Coroners' reports vary from county to county and there are
currently no specified standards for the format of reports
throughout the state. Coroners do not have a uniform category for
prescription drug deaths that allow the death to be automatically
determined as caused by a prescription drug. Similarly, some
counties may have additional resources or access to the very
limited amount of forensic pathologists throughout the state and
may not investigate the same types of deaths the same way. For
example, in one county, a drug addict's cause of death may be
listed as natural while the death of that same person may be ruled
accidental in another county if they died from a drug overdose.
Many coroner investigations include the collection of all drugs
found at the scene of the death for a number of reasons as follows:
Public health reasons, to ensure that somebody does not
pick up controlled substances belonging to the deceased and
then use and/or sell them.
Clues to determine cause of death. Drugs found at the
scene often give the coroner information as to the cause of
death, such as diseases or conditions being treated with the
drug that the coroner should look for. They are also able to
look at the pill count on the label and compare that with the
date of the prescription and compare that with how many are
left in the pill bottle to determine possible overdose.
Determination of what medication a decedent was taking.
The pill bottle is the source of information about
prescriptions and prescribers and looking at these can also
lead a coroner to ask the decedent's loved ones a standard
battery of questions regarding, for example, whether the
decedent had suicidal indications or mental illness in trying
to determine cause of death.
The drugs found at the scene of a death are typically documented on
a "medication inventory sheet" or a "drug work-up sheet" or a
"property log," as these may be referenced differently from county
to county. The document usually includes the name of the drug
found at the scene of the death, the dosage, the number of pills
prescribed, the number of pills remaining in the bottle, the
dispensing pharmacy (sometimes with phone number and address), and
the prescriber (sometimes with name and address).
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A current Los Angeles Times series, "Dying For Relief," has
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, the first of its kind,
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. The approach that these reporters have
taken is unique in that they are specifically talking about abuse
and subsequent death to patients taking drugs prescribed by their
doctors.
1. 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
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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, a currently
accepted medical use and are available over the counter.
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).
2. 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 that 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 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
an abusable prescription drug, particularly narcotics and
antianxiety drugs. A 2010 report, Monitoring the Future Study,
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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.
3. Prescription Drug Deaths. A recent 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 Prescription Drug
Monitoring Programs (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
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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.
4. 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.
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. Data from CURES is managed by DOJ to assist state
law enforcement and regulatory agencies in their efforts to reduce
prescription drug diversion. CURES provides information that
offers the ability to identify if a person is "doctor shopping;"
when a prescription-drug addict visits multiple doctors to obtain
multiple prescriptions for drugs, or uses multiple pharmacies to
obtain prescription drugs. Information tracked in the system
contains the patient name, prescriber name, pharmacy name, drug
name, amount and dosage, and is available to law enforcement
agencies, regulatory bodies and qualified researchers. The system
can also report 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.
CURES data can be obtained by the MBC, Board of Pharmacy, 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
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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.
5. Arguments in Support. The Center for Public Interest Law (CPIL)
writes in support of this bill, noting that it will play an
important role in helping to identify doctors who have, either
willingly or by negligence, played a role in prescription drug
abuse. CPIL also provides recommendations for strengthening the
bill, including requiring reports to be transmitted to the CURES.
The MBC has written a "Support if Amended" position on this measure
and indicates that it would like to see the mandated reporting by
coroners limited to deaths in which the cause of death is related
to toxicity from a Schedule II, III or IV drug and Schedule II,
III or IV drugs played a contributing factor.
6. Arguments in Opposition. The California Medical Association (CMA)
writes that they are opposed to this bill unless it is amended,
stating that since many of these overdose deaths are unrelated to a
physician/patient relationship, the related reports will create
extra work for both already overburdened coroners and the MBC. CMA
believes this bill is overly broad and would encompass more cases
than "rationally intended to meet its goal". CMA is requesting the
following amendments:
a) Narrow the mandated reporting by coroners to deaths to those
in which the cause of death is related to toxicity from a
Schedule II, III or IV drug and Schedule II, III or IV drugs
played a contributing factor.
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b) Remove the Board of Pharmacy as an entity that receives
reports since it has no authority to regulate prescribers.
c) Require MBC to provide notification to licensees when it
receives a report filed by a coroner, consistent with the process
for other third-party reports.
1. Author's Amendments. In response to concerns raised by the CMA and
the MBC, the Author plans to take the following as Author's
amendments:
a) Narrow the mandated reporting by coroners to deaths to those
in which the cause of death is related to toxicity from a
Schedule II, III or IV drug and Schedule II, III or IV drugs
played a contributing factor .
The Author intends for this bill to be a pragmatic approach to
providing regulatory boards with important data about their
licensees.
b) Remove the Board of Pharmacy as an entity that receives
reports .
The Author believes that a thorough investigation by the MBC
based on a report from one of California's 58 county coroners
will include sharing information with appropriate regulatory
boards and other entities as necessary. The Author is also
concerned about increasing the workload of coroners in providing
reports to the MBC and seeks to streamline the process for this
reporting.
10.Notification to Prescriber. The last amendment requested by CMA,
requiring MBC to notify licensees when it receives a report from a
coroner with information that includes a prescriber's name, is not
appropriate. MBC receives complaints from various sources and
through myriad methods all the time, many of which do not result in
a lengthy licensee investigation. There is also no precedent for
MBC being required to notify licensees that they may be subject to
an investigation by MBC. For example, MBC receives third-party
reports from entities like county clerks and local law enforcement
or district attorneys that serve as evidence in a MBC investigation.
As such, the licensee does not have right to notification of
receipt of reports by MBC used pursuant to an investigation until
such time as an accusation may be filed.
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SUPPORT AND OPPOSITION:
Support: Center for Public Interest Law (CPIL)
Support If Amended: Medical Board of California (MBC)
Opposition: California Medical Association (CMA)
Consultant:Sarah Mason