BILL ANALYSIS Ó
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|Hearing Date:January 13, 2014 |Bill No:SB |
| |500 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: SB 500Author:Lieu
As Amended:January 9, 2014 Fiscal: Yes
SUBJECT: Medical practice: pain management.
SUMMARY: Requires the Medical Board of California to update
prescriber standards for controlled substances once every five years.
Adds the American Cancer Society, specialists in pharmacology and
specialists in addiction medicine to the entities MBC may consult with
in developing the standards.
Existing law:
1) Licenses and regulates physicians and surgeons under the Medical
Practice Act (Act) by the Medical Board of California (MBC) within
the Department of Consumer Affairs (DCA) and states that the
protection of the public is the highest priority of the MBC in
exercising its functions. (Business and Professions Code (BPC) §
2000 et. seq.)
2) Authorizes a physician and surgeon to prescribe, dispense, or
administer prescription drugs, including prescription controlled
substances, to an addict under his or 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 or she knows or reasonably
believes is using or will use the drugs or substances for a
nonmedical purpose. (BPC § 2241)
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3) Authorizes a physician and surgeon to prescribe for, or dispense or
administer to, a person under his or her treatment for a medical
condition dangerous drugs or prescription controlled substances for
the treatment of pain or a condition causing pain, including, but
not limited to, intractable pain. Provides that a physician and
surgeon shall not be subject to disciplinary action for
prescribing, dispensing, or administering dangerous drugs or
prescription controlled substances according to certain
requirements. Authorizes MBC to take any action against a
physician and surgeon who violates laws related to inappropriate
prescribing. Provides that a physician and surgeon shall exercise
reasonable care in determining whether a particular patient or
condition, or the complexity of a patient's treatment, including,
but not limited to, a current or recent pattern of drug abuse,
requires consultation with, or referral to, a more qualified
specialist. (BPC § 2241.5)
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. (BPC § 2241.6)
5) 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. (Id)
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,
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in addition to the entities MBC may consult with in developing the
standards.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. The Author is the Sponsor of this bill. According to the
Author, 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 Medical Board 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."
Guidelines from different national professional organization, as
well as recommendations from government agencies may change, taking
into account new information, practices or different medication.
For example, the FDA issued recommendations to DEA federal
Department of Health and Human Services to limit a patient to 90
days of pain medicine treatment, down from 180 days. Under these
recommendations, after 90 days, patients must revisit a physician
who will decide whether or not the patient needs further treatment
in the form of pain medication. The Medical Board last revised its
guidelines for prescribing controlled substances in 2007. This
bill will reflect the changing nature of guidelines, standards and
guidance for a critical issue in our health care system.
2. Background: Controlled Substances. Through the Controlled
Substances Act, 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 Act ranks into five schedules those drugs known to have
potential for physical or psychological harm, based on three
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considerations: (a) their potential for abuse; (b) their accepted
medical use; and, (c) 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 currently accepted medical use with severe
restrictions, and have a high potential for abuse and psychological
or physical dependence. Schedule II drugs can be narcotics or
non-narcotic. Examples of Schedule II controlled substances
include morphine, methadone, Ritalin, Demerol, Dilaudid, Percocet,
Percodan, and Oxycontin.
Schedule III and IV controlled substances have a currently accepted
medical use in treatment, less potential for abuse but are known to
be mixed in specific ways to achieve a narcotic-like end product.
Examples include drugs include Vicodin, Zanex, Ambien and other
anti-anxiety drugs.
Schedule V drugs have a low potential for abuse, a currently
accepted medical use and are available over the counter.
Among other requirements, the Act 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 website.
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.
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Common opioids are: hydrocodone (Vicodin), oxycodone (OxyContin),
propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine
(Demerol), and diphenoxylate (Lomotil).
3. 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.
Subsequent to MBC's 1994 action, legislation that took effect in
2002 ( AB 487 , Aroner, Chapter 518, Statutes of 2001) created a task
force to revisit the 1994 guidelines to develop standards assuring
competent review in cases concerning the under-treatment and
under-medication of a patient's pain and also required continuing
education courses for physicians in the subjects of pain management
and the treatment of terminally ill and dying patients. The intent
of the bill was to broaden and update the knowledge base of all
physicians related to the appropriate care and treatment of
patients suffering from pain, and terminally ill and dying
patients. As a result, the task force amended the guidelines from
referencing only intractable pain to all kinds of pain.
The passage of AB 2198 in 2006 (Houston, Chapter 350, Statutes of
2006) updated California law governing the use of drugs to treat
pain by clarifying that health care professionals with a medical
basis, including the treatment of pain, for prescribing,
furnishing, dispensing, or administering dangerous drugs or
prescription controlled substances, may do so without being subject
to disciplinary action or prosecution. AB 2198 stemmed from MBC's
efforts to better reflect the current state of treating pain, as
well as the current manner of investigating and disciplining
physicians who treat patients with pain, who often require large
quantities of medication. The bill recognized that existing
standards of care require physicians in some instances to prescribe
pain medications to addicts, outside of treatment for
detoxification and maintenance, creating circumstances under which
a practitioner could prescribe, dispense, or administer
prescription drugs, including controlled substances, to an addict.
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MBC currently encourages all licensees to consult the policy
statement and Guidelines for Prescribing Controlled Substances for
Pain. According to the MBC website, "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 or she would for any other 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 website, 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."
SUPPORT AND OPPOSITION:
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Support:
None received as of January 8, 2013.
Opposition:
None received as of January 8, 2013.
Consultant:Sarah Mason and Mark Mendoza