BILL ANALYSIS �
SB 62
Page 1
Date of Hearing: June 25, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Richard S. Gordon, Chair
SB 62 (Price) - As Amended: June 14, 2013
SENATE VOTE : 39-0
SUBJECT : Coroners: reporting requirements: prescription drug
use.
SUMMARY : Requires a coroner to report to the Medical Board of
California (MBC) when he or she receives information indicating
that a death was caused by a Schedule II, III, or IV drug, as
specified. Specifically, this bill :
1)States that a coroner may not report on findings reached by,
or documented and approved by, a board-eligible pathologist,
and may only report on findings by a board-certified or
California-licensed pathologist.
2)Requires a coroner's report indicating gross negligence or
incompetence of a licensee to name any attending physician
assistants.
3)Allows a coroner's report to be filed with MBC as soon as
possible once the coroner's final report of investigation is
complete.
4)Exempts a board-certified or California-licensed pathologist
or authorized agent from liability for civil damages as a
result of his or her providing information to MBC about a
death due to a licensee's gross negligence or incompetence, or
a drug overdose, as specified.
5)States that when a coroner receives information based on
findings that were reached by, or documented and approved by,
a board-certified or California-licensed pathologist
indicating that the cause of death is due to a Schedule II,
III, or IV drug, a report shall be filed with MBC.
6)Requires the initial report to include, when known, the name
of the decedent; date and place of death; attending
physicians, podiatrists, or physician assistants; and all
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other relevant information, including, but not limited to, any
information available to identify the prescription drugs,
prescribing physicians, and dispensing pharmacy.
7)Requires the initial report to be followed, within 90 days or
as soon as possible once the coroner's final report of
investigation is complete, by copies of the coroner's report,
autopsy protocol, and all other relevant information.
8)Makes technical and conforming amendments.
9)States that if the Commission on State Mandates determines
that this act contains costs mandated by the state,
reimbursement to local agencies and school districts for those
costs shall be made pursuant to Part 7 (commencing with
Section 17500) of Division 4 of Title 2 of the Government
Code.
EXISTING LAW :
1)States 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, the violation of which shall result
in imprisonment for up to one year, a fine of up to $20,000,
or both. (Health and Safety Code (HSC) Section 11153)
2)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)(b))
3)Requires prescribers who are authorized to dispense Schedule
II, III or IV controlled substances to record and maintain
prescription information for three years that includes the
patient's name, address, gender, date of birth, prescriber's
license number, federal controlled substance registration
number, state medical license number, National Drug Code
number of the controlled substance dispensed, quantity
dispensed, diagnosis code if available, and original date of
dispensing. Further requires that this information be
provided to the Department of Justice on a monthly basis.
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(HSC 11190 (c))
7) 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
DCA. (Business and Professions Code (BPC) Section 4000, et
seq.)
8) 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)
9) Requires a coroner to report to the appropriate regulatory
board within DCA when the coroner determines that a death may
be the 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)
10)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 the death. (Government Code Section
27491)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill requires coroners to report
prescription drug deaths to MBC in order to aid in MBC's
oversight of physicians and surgeons and help reduce the
overprescribing of dangerous drugs. This bill is
author-sponsored.
2)Author's statement . According to the author, "Coroners
reports are a treasure trove of data that can inform the
appropriate licensing boards about where people are getting
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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.
"This bill connects the dots and creates a very necessary
pathway for prescription drug overdose deaths to be reported
directly to [MBC, which] can take necessary action against
their licensees who may have been directly involved. If [MBC
is] receiving reports from coroners throughout the state, [it]
will be better armed with the necessary tools to make a
correlation to [its] licensees in overprescribing
circumstances and take action."
3)LA Times series on prescription drug overdoses . A Los Angeles
Times investigative series in Fall 2012 entitled "Dying for
Relief" analyzed coroners' reports for over 3,000 deaths
occurring in four counties (Los Angeles, Orange, Ventura and
San Diego) where the cause of death was overdose by
prescription drugs.
The analysis found that in nearly half of these cases, the drug
that caused the overdose had been prescribed directly to the
decedent, as opposed to drugs that were stolen or diverted
from another patient. The report also found that more than 80
of the doctors whose names were listed on prescription bottles
related to the decedent had been the prescribing physician for
three or more dead patients, including one doctor who was
linked to as many as 16 dead patients.
4)MBC sunset report . Current law requires a coroner to report
to the appropriate regulatory board within DCA when the
coroner determines that a death may be the result of gross
negligence or incompetence by a physician and surgeon,
podiatrist or physician assistant. While this reporting is
mandatory under existing law, it is not strictly enforced:
only four reports were received by MBC in FY 2011/2012, and
only one of those reports indicated a drug-related death.
While it is exceptionally likely that more than one death in
California during 2011/2012 was due to grossly negligent or
incompetent prescribing, MBC is not receiving the required
reports because coroners may be hesitant to declare the deaths
to be caused by negligent or incompetent prescribing because
of a lack of information about the case. Coroners are not
privy to a decedent's medical record or history, so a
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determination about whether or not the physician's care could
be highly speculative.
In order to avoid the problem of underreporting because of the
coroners' unwanted responsibility to make difficult causation
determinations, this bill simply requires all deaths related
to prescription drug overdoses to be reported to MBC for
further investigation. This would allow MBC to determine
whether a prescriber was acting inappropriately.
5)Understanding drug schedules . Drugs and other substances that
are considered controlled substances under the Controlled
Substances Act are divided into five schedules by the United
States Drug Enforcement Agency. Substances are placed in
their respective schedules based on whether they have a
currently accepted medical use in treatment in the United
States, their relative abuse potential, and likelihood of
causing dependence when abused.
Schedule I drugs have been deemed to have "no currently
accepted medical use in the United States, a lack of accepted
safety for use under medical supervision, and a high potential
for abuse." Examples of Schedule I drugs include heroin, LSD,
marijuana, and Ecstasy.
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| Schedule V drugs, on the opposite end of the spectrum, have a |
| low potential for abuse, and consist primarily of drugs |
| containing limited quantities of certain narcotics. An |
| example of Schedule V substances include cough syrups like |
| Robitussin AC. |
| |
| |
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6)Arguments in support . The Center for Public Interest Law
writes, "SB 62 is a welcome response to the Los Angeles Times
series that reviewed coroners' reports from four counties and
demonstrated the connection between certain doctors and
patient deaths from prescription drug overuse. The reports
found that in nearly half of the cases where prescription drug
overdose was listed as the cause of death, there was a nexus
to a prescribing physician. The series also reported that
more than 80 of the doctors whose names were listed on
prescription bottles found at the home of, or on the body of,
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a person who died had been the prescribing physician for 3 or
more dead patients - and in the case of one doctor, as many as
16 dead patients.
"By requiring a coroner to file a report with the Medical
Board when information indicates that prescription drug abuse
was a cause of death, this measure will play an important role
in helping to identify doctors or pharmacists who have, either
willingly or by negligence, played a role in prescription drug
abuse. CPIL strongly supports a requirement that coroners
report prescription drug overdose deaths to some relevant
state agency; they are clearly not filing those reports now,
such that no state agency knows those deaths are occurring.
Last year, the Medical Board received a total of four (4)
reports from coroners under existing Business and Professions
Code section 802.5."
7)Arguments in opposition . The California Medical Association
writes in opposition, "[SB 62] bill is not the right approach
[to expanding MBC's capacity to enforce against inappropriate
prescribers]. Though it has been narrowed, it will still
require coroners to file many reports to the MBC that are
completely unrelated to the physician patient/relationship.
Seventy percent of people who use drugs for non-medical
purposes do not have a prescription. Other drugs, including
legal drugs like heroin, are involved in about one-half of
deaths involving prescription painkillers. In addition,
alcohol is involved in many deaths attributed to prescription
drug overdose.
"Further, there are significant scientific and procedural
limitations to toxicity testing. Tolerance for a drug can vary
from person to person, and tolerance builds over time.
Patients who use opioids long-term can have levels of the drug
in their body that might be considered toxic in a forensic
examination.
"This over-expansive reporting could have serious unintended
consequences and interrupt the continuity of care between a
patient and the physician. This also puts physicians in a
catch-22 since California recognizes a patient's right to pain
management, allowing for allegations of unprofessional conduct
if he or she does not treat pain."
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8)Suggested Committee amendments . The previous amendments to
this bill deleted the term "board-eligible" pathologist and
added "or California licensed pathologist." A pathologist is
a licensed physician who deals with the causes and nature of
disease and death. In order to become a pathologist, the
physician must have completed a residency program in
pathology, but is not required to be board-certified.
Coroners have expressed that they did not want to be limited to
merely board-eligible or board-certified pathologists,
because they often work with pathologists who have lost their
board-eligibility (a pathologist must be certified within
three to seven years between training and certification,
depending on the specialty). Coroners also occasionally rely
on analyses from out-of-state licensed pathologists.
Representatives of the coroners have suggested adding " or
California licensed pathologist" which, while considered a
term of art within the coroner community to reference a
California-licensed physician who is also a pathologist, has
no meaning in current law because California does not license
pathologists.
In order to clarify the matter and provide that reports may be
based on findings by any pathologist, the Committee
recommends the following technical amendments:
Page 2, line 5, delete "board-certified or California
licensed"
Page 2, line 22, delete "board-certified or California
licensed"
Page 2, line 28, delete "board-certified or California
licensed"
According to the author's office, the coroner reports of drug
deaths required by subdivision (c) of the bill are public
documents, and recent amendments were not intended to make
them confidential by virtue of transmitting them to MBC. The
following amendment would enable MBC to transmit these reports
to other licensing boards, as appropriate.
Page 2, line 18, delete "this section" and add "(a)"
Page 2, delete line 25.
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9)Related legislation . SB 670 (Steinberg), among other
provisions, authorizes MBC to inspect medical records of a
deceased patient and declares it unprofessional conduct for a
licensee who is under investigation by the MBC to fail to
attend an interview, as specified. SB 670 is currently
pending in the Assembly Business, Professions, and Consumer
Protection Committee.
SB 809 (DeSaulnier and Steinberg) is an urgency measure that
makes various changes to the funding and operation of the
Controlled Substances Utilization Review and Evaluation System
(CURES) Prescription Drug Monitoring Program. SB 809 is
currently pending in the Assembly Public Safety Committee.
10)Previous legislation . SB 1196 (Runner) (Chapter 45, Statutes
of 2008) provides that coroners do not have to inquire into,
and determine the circumstances, manner, and cause of, all
deaths where the deceased has been attended by a physician or
a registered nurse who is a member of a hospice care
interdisciplinary team in the 20 days preceding death.
REGISTERED SUPPORT / OPPOSITION :
Support
The Center for Public Interest Law
Medical Board of California
Opposition
California Medical Association
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301