BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 500|
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THIRD READING
Bill No: SB 500
Author: Lieu (D)
Amended: 1/9/14
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 9-0, 1/13/14
AYES: Lieu, Block, Corbett, Galgiani, Hernandez, Hill, Padilla,
Wyland, Yee
NO VOTE RECORDED: Vacancy
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Medical practice: pain management
SOURCE : Author
DIGEST : This bill requires the Medical Board of California
(MBC) to update prescriber standards for controlled substances
once every five years; and adds the American Cancer Society, a
workers' compensation physician, specialists in pharmacology,
and specialists in addiction medicine to the entities MBC may
consult with in developing the standards.
ANALYSIS :
Existing law:
1. Licenses and regulates physicians and surgeons under the
Medical Practice Act by the MBC within the Department of
Consumer Affairs and states that the protection of the public
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is the highest priority of the MBC in exercising its
functions.
2. Authorizes a physician and surgeon to prescribe, dispense, or
administer prescription drugs, including prescription
controlled substances, to an addict under his/her treatment
for a purpose other than maintenance on, or detoxification
from, prescription drugs or controlled substances.
Authorizes a physician and surgeon to prescribe, dispense, or
administer prescription drugs or prescription controlled
substances to an addict for purposes of maintenance on, or
detoxification from, prescription drugs under certain
circumstances. Provides that a physician and surgeon may not
prescribe, dispense, or administer dangerous drugs or
controlled substances to a person he/she knows or reasonably
believes is using or will use the drugs or substances for a
nonmedical purpose.
3. Authorizes a physician and surgeon to prescribe for, or
dispense or administer to, a person under his/her treatment
for a medical condition dangerous drugs or prescription
controlled substances for the treatment of pain or a
condition causing pain, including, but not limited to,
intractable pain. Provides that a physician and surgeon
shall not be subject to disciplinary action for prescribing,
dispensing, or administering dangerous drugs or prescription
controlled substances according to certain requirements.
Authorizes MBC to take any action against a physician and
surgeon who violates laws related to inappropriate
prescribing. Provides that a physician and surgeon shall
exercise reasonable care in determining whether a particular
patient or condition, or the complexity of a patient's
treatment, including, but not limited to, a current or recent
pattern of drug abuse, requires consultation with, or
referral to, a more qualified specialist.
4. 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 undertreatment, undermedication, and
overmedication of a patient's pain.
5. Authorizes DMQ to consult with entities such as the American
Pain Society, the American Academy of Pain Medicine, the
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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.
This bill:
1. Requires MBC to update standards to ensure competent review
in cases concerning the management, including, but not
limited to, the undertreatment, undermedication, and
overmedication of a patient's pain.
2. Requires MBC to update the standards on or before July 1,
2015, and on or before July 1 every five years.
3. Requires MBC to convene a task force to develop and recommend
the updated standards. Authorizes the task force to consult
with the American Cancer Society, a workers' compensation
physician, specialists in pharmacology and specialists in
addiction medicine, in addition to the entities MBC may
consult with in developing the standards.
Background
Controlled substances . Through the Controlled Substances Act
(CSA), Title II of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, the federal government regulates the
manufacture, distribution and dispensing of controlled
substances. The CSA ranks into five schedules those drugs known
to have potential for physical or psychological harm, based on
their potential for abuse; their accepted medical use; and their
accepted safety under medical supervision. The schedules are as
follows:
-------------------------------------------------------------
|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 |
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| |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 include |
| |morphine, methadone, Ritalin, Demerol, |
| |Dilaudid, Percocet, Percodan, and Oxycontin.) |
|-------------+-----------------------------------------------|
|Schedule |Controlled substances have a currently |
|III/IV |accepted medical use in treatment, less |
| |potential for abuse but are known to be mixed |
| |in specific ways to achieve a narcotic-like |
| |end product. (Examples include 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. |
| | |
-------------------------------------------------------------
Among other requirements, the CSA mandates that all
prescriptions for drugs that fall under Schedules I-V must cite
the physician's federal Drug Enforcement Agency (DEA)
registration number. The DEA provides oversight and enforces
regulations concerning all controlled substances. The DEA
created a practitioner's handbook, originally written in 1990
and most recently updated in 2006, to explicitly outline valid
prescribing, administering, and dispensing requirements. When
physicians register as a prescriber with the DEA, it is presumed
they have read the handbook and guidance on the DEA Web site.
The three classes of prescription drugs that are most commonly
abused are (1) opioids, which are most often prescribed to treat
pain; (2) central nervous system (CNS) depressants, which are
used to treat anxiety and sleep disorders; and (3) 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),
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hydromorphone (Dilaudid), meperidine (Demerol), and
diphenoxylate (Lomotil).
Guidelines for prescribing controlled substances . In 1994, MBC
unanimously adopted a policy statement entitled "Prescribing
Controlled Substances for Pain." Stemming from studies and
discussions about controlled substances, this policy statement
was designed to provide guidance to improve prescriber standards
for pain management, while simultaneously undermining
opportunities for drug diversion and abuse. The guidelines
outlined appropriate steps related to a patient's examination,
treatment plan, informed consent, periodic review, consultation,
records, and compliance with controlled substances laws.
Guidelines are used by physicians as well as MBC in its
regulation of licensees.
MBC currently encourages all licensees to consult the policy
statement and Guidelines for Prescribing Controlled Substances
for Pain. According to the MBC Web site, "The board strongly
urges physicians and surgeons to view effective pain management
as a high priority in all patients, including children, the
elderly, and patients who are terminally ill. Pain should be
assessed and treated promptly, effectively and for as long as
pain persists. The medical management of pain should be based
on up-to-date knowledge about pain, pain assessment and pain
treatment. Pain treatment may involve the use of several
medications and non-pharmacological treatment modalities, often
in combination. For some types of pain, the use of medications
is emphasized and should be pursued vigorously; for other types,
the use of medications is better de-emphasized in favor of other
therapeutic modalities. Physicians and surgeons should have
sufficient knowledge or utilize consultations to make such
judgments for their patients. Medications, in particular opioid
analgesics, are considered the cornerstone of treatment for pain
associated with trauma, surgery, medical procedures, or cancer."
MBC also highlights that while it is lawful under both federal
and California law to prescribe controlled substances for the
treatment of pain, including intractable pain, there are
limitations on the prescribing of controlled substances to or
for patients for the treatment of chemical dependency. MBC
expects that a licensee follow the same standard of care when
prescribing and/or administering a narcotic controlled substance
to a "known addict" patient as he/she would for any other
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patient. The physician and surgeon must (1) perform an
appropriate prior medical examination; (2) identify a medical
indication; (3) keep accurate and complete medical records,
including treatments, medications, periodic reviews of treatment
plans, etc.; and (4) provide ongoing and follow-up medical care
as appropriate and necessary.
According to the MBC Web site, MBC "emphasizes the above issues,
both to ensure physicians and surgeons know that a patient in
pain who is also chemically dependent should not be deprived of
appropriate pain relief, and to recognize the special issues and
difficulties associated with patients who suffer both from drug
addiction and pain. The MBC expects that the acute pain from
trauma or surgery will be addressed regardless of the patient's
current or prior history of substance abuse."
Comments
According to the author's office, this bill simply ensures that
important standards guiding physicians in their prescribing of
controlled substances are updated regularly, and in consultation
with key stakeholders who can best inform the MBC and highlight
current practice. The author states that "particularly when we
are talking about prescription medications that are incredibly
potent and may result in significant impacts to a patient, it is
important that the right people are informing the Board
regularly to ensure that guidelines are crafted appropriately."
According to the author, "it is important for the Medical
Board's prescriber guidelines to strike the right balance so
that patients in pain are treated appropriately, timely and in a
consistent and safe manner by their doctor. Similarly, it is
critical for the Board to have appropriate, current guidelines
that take into account the realities
faced by patients, physicians and regulators in the Board's
efforts managing the important issue of prescribing controlled
substances."
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
MW:d 1/22/14 Senate Floor Analyses
SUPPORT/OPPOSITION: NONE RECEIVED
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