BILL ANALYSIS Ó
SB 361
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Date of Hearing: July 14, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
SB 361(Hill) - As Amended July 2, 2015
NOTE: The prior version of this bill was heard by the Assembly
Committee on Health on June 23, 2015, and approved on a 19-0
vote.
NOTE: This bill adds an urgency clause.
SENATE VOTE: 35-0
SUBJECT: Antimicrobial stewardship: education and policies.
SUMMARY: Requires a veterinarian who receives his or her
license on or after January 1, 2018, to take a course on
antimicrobial stewardship as part of continuing education (CE),
and requires skilled nursing facilities to adopt and implement
antimicrobial stewardship policies, as specified, on or before
January 1, 2017.
EXISTING LAW:
1)Requires each individual licensed by the Veterinary Medical
Board (VMB) to apply biennially to renew their license or
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registration on or before the last day of the applicant's
birthday month. (Business and Professions Code (BPC) Section
4846.4(a))
2)Requires the VMB to provide license renewals to those
applicants who have completed a minimum of 36 hours of CE in
the preceding two years, as specified. (BPC Section
4846.5(a))
3)Permits licensees to obtain CE credit by attending courses
relevant to veterinary medicine and sponsored or cosponsored
by specified entities. (BPC Section 4846.5(b))
4)Authorizes the VMB to audit the records of all applicants to
verify the completion of the CE requirement, and requires
applicants to maintain records of completion of required CE
coursework for a period of four years, and to make the records
available to the VMB for auditing purposes. (BPC Section
4846.5(e))
5)Permits the VMB, in its discretion, to exempt from the CE
requirement any veterinarian who, for reasons of health,
military service, or undue hardship, cannot meet the CE
requirements. (BPC 4846.5(h))
6)Defines a "skilled nursing facility" as a health facility that
provides skilled nursing care and supportive care to patients
whose primary need is for availability of skilled nursing care
on an extended basis, and includes a "small house skilled
nursing facility, as specified. (Health and Safety Code (HSC)
Section 1250(c))
7)Requires each general acute care hospital to adopt and
implement an antimicrobial stewardship policy in accordance
with guidelines established by the federal government and
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professions and organizations, as specified. (HSC Section
1288.85)
THIS BILL:
8)Requires a veterinarian who receives his or her license, on or
after January 1, 2018, to complete an approved course of the
judicious use of medically important antimicrobial drugs every
four years as part of his or her continuing education
requirements.
9)Defines, for the purpose of number 1) above, "medically
important antimicrobial drug" to mean an antimicrobial drug
listed in appendix A of the federal Food and Drug
Administration's (FDA) Guidance for Industry #152, including
critically important, highly important, and important
antimicrobial drugs as that appendix may be amended.
10)Requires, on or before January 1, 2017, each skilled nursing
facility, as specified, to adopt and implement an
antimicrobial stewardship policy.
11)Requires each skilled nursing facility, within three months
of the establishment of antimicrobial stewardship guidelines
specific to skilled nursing facilities by the federal Centers
for Disease Control and Prevention (CDC), the Society for
Healthcare Epidemiology of America, or similar recognized
professional organizations, to amend its antimicrobial
stewardship policy to be consistent with those newly
established antimicrobial stewardship guidelines.
12)Specifies enforcement actions for skilled nursing facilities
which fail to comply with establishing antimicrobial
stewardship guidelines.
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13)Provides that no reimbursement is required by this bill
pursuant to Section 6 of Article XIIB of the California
Constitution because the only costs that may be incurred by a
local agency or school district will be incurred because this
act creates a new crime or infraction, eliminates a crime or
infraction, or changes the penalty for a crime or infraction.
14)Declares that this bill take effect immediately to protect
Californians from the burden and threats posed by the national
security priority of antimicrobial-resistant infections.
FISCAL EFFECT: According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, the prior version of
this bill would result in negligible state costs. The amended
version of this bill has not been analyzed by a fiscal
committee.
COMMENTS:
Purpose. According to the author, "The overuse and misuse of
antibiotics can lead to the development of antibiotic resistant
infections, a major national and worldwide public health
concern. The [CDC] estimates that each year at least 2 million
Americans are infected with - and at least 23,000 Americans die
from - antibiotic resistant infections. Each year, antibiotic
resistant infections result in at least $20 billion in direct
health care costs and at least $35 billion in lost productivity
in the United States. A recent study commissioned by the United
Kingdom determined that by 2050, worldwide, more people will die
from antibiotic resistant infections than from cancer. The
overuse and misuse of antibiotics in human medicine is a
significant factor driving the development of antibiotic
resistance. Nationwide, up to 70% of nursing home residents
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receive an antibiotic every year and 27,000 acquire antibiotic
resistant infections, such as Staphylococcus aureus (MRSA).
Studies suggest that between 25%-75% of antibiotic use in
long-term care settings may be inappropriate, contributing to
the prevalence of antibiotic resistance.
As veterinarians continue to gain more authority in the
administration of these lifesaving drugs, it's important that
veterinarians keep up to date on the most relevant and recent
research as it relates to using antibiotics in the most
effective manner possible. While antibiotic stewardship programs
are used in human medical facilities to promote judicious
prescribing, veterinarians often work in small clinics or out in
the field and the best way to promote the judicious use of
antibiotics by veterinarians is to require continuing education
in the subject. To ensure that veterinarians prescribe
antibiotics in a judicious manner, [this bill] requires
veterinarians to take continuing education units on the
judicious use of antibiotics every four years."
Background. In addition to requiring skilled nursing facilities
to adopt and implement an antimicrobial stewardship policy, this
bill was recently amended to add a new provision which would
require veterinarians who renew their license to take an
approved CE course with instruction about the judicious use of
antibiotics every four years in order to renew their license.
The CE can be completed by taking courses sponsored by various
organizations, such as the American Veterinary Medical
Association, or accredited veterinary medical colleges. The
author notes that 70% of all antibiotics sold across the country
are sold to be used to treat livestock and animals and is a
factor driving the development of antibiotic resistant
infections.
Veterinarians and the Veterinarian Medical Board (VMB). The VMB
is the regulatory entity responsible for the licensure and
regulation of veterinarians, registered veterinary technicians
(RVT), schools and programs along with veterinary premises and
hospitals through the enforcement of the California Veterinary
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Medicine Practice Act. The VMB develops and enforces the
standards for examinations, licensing, and hospital and school
inspections. The VMB licenses over 10,000 Veterinarians and
5,000 RVTs. The veterinary medical profession provides health
care to a variety of animals including livestock, poultry, and
pets including birds, fish, rabbits, hamsters, snakes, dogs,
cats, goats, pigs, horses, and llamas.
In order to be licensed as a veterinarian in California, an
individual must possess a degree in veterinary medicine from an
accredited school, and take and pass a national veterinary
licensing examination and a California-based examination
administered by the VMB. In order to renew a license, an
individual is required to complete 36 hours of CE every
two-years; however, current law does not designate the subject
of the course or courses a licensee must complete. This bill
would require a licensed veterinarian to complete an approved
course on the judicious use of antimicrobial drugs every
four-years in order to renew their license, but does not specify
a minimum or maximum amount of CE hours that can be completed in
this area. As currently drafted, this bill would permit a
licensee to take all 36 CE hours in the judicial use of
antimicrobial drugs or complete just a fraction of those hours.
As the author notes, it is important that veterinarians keep
up-to-date on the most relevant and recent research as it
relates to using antibiotics in the most effective way possible.
By requiring a veterinarian to take CE courses on this topic,
it will help provide veterinarians with relevant information.
Antimicrobial Issues. According to the CDC, antibiotics have
transformed medicine making once lethal infections readily
treatable; however, 20-50 percent of all antibiotics prescribed
in the United States' acute care hospitals are either
unnecessary or inappropriate. The misuse of antibiotics has
contributed to the growing problem of antibiotic resistance, and
the CDC notes that more than 2 million people are sickened every
year with antibiotic-resistant infections with at least 23,000
resulting in death. As noted in the United Stated Department of
Agriculture's (USDA) Action Plan to Address Antimicrobial
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Resistance, the USDA notes that the health of humans and animals
is irrevocable linked and closely connected to the environment.
The California Antimicrobial Stewardship Program and Federal
Guidance. The California Department of Public Health (DPH)
administers an antimicrobial stewardship program. According to
the DPH, California is the first and only state to enact such a
program.
Nationally, a presidential Executive Order - Combatting
Antibiotic-Resistant Bacteria, issued in September 2014,
requires federal agencies to review existing regulations and
propose new regulations or other actions to require hospitals to
implement robust stewardship programs that adhere to best
practices; agencies will also be required to define, promulgate
and implement stewardship programs in other settings such as
long-term care facilities and outpatient settings. This bill
requires skilled nursing facilities to implement an
antimicrobial stewardship policy on or before January 1, 2017
which is already required for each general acute care hospital
in California.
The CDC reports that "antibiotics must be used judiciously in
humans and animals because both uses contribute to the
emergence, persistence, and spread of resistant bacteria.
Resistant bacteria in food-producing animals are of particular
concern. Food animals serve as a reservoir of resistant
pathogens and resistance mechanisms that can directly or
indirectly result in antibiotic resistant infections in humans.
For example, resistant bacteria may be transmitted to humans
through the foods we eat."
As a result, the FDA, in conjunction with the CDC and the USDA,
established the National Antimicrobial Resistance Monitoring
System which monitors trends in antimicrobial resistance from
human, retail meat, and food animal samples. The goals and
objectives of the system are to monitor trends among foodborne
bacteria, conduct research to better understand the emergence
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and spread of bacterial, and to assist the FDA in the
decision-making process for the approval of antimicrobial drugs
for animals.
To ensure veterinarians stay current on these issues, this bill
requires licensees to complete a course on the judicious use of
antimicrobial drugs as part of their CE requirements.
Current Related Legislation. The portion of this bill that
requires veterinarians to take CE courses every four years, in
the judicious use of antimicrobial drugs, in order to renew his
or her license, is complimentary to SB 27 (Hill) of the current
legislative session. This bill aims to change the way in which
medically important antimicrobial drugs are utilized in
livestock. SB 27 proposes to restrict the use of medically
important antimicrobial drugs in livestock, require a
veterinarian's prescription or feed directive for use, eliminate
the over-the-counter availability of these drugs, require the
California Department of Food and Agriculture (CDFA) to develop
a program to track antimicrobial drug use in livestock and the
emergence of antimicrobial-resistant bacteria, and require CDFA
to adopt judicious use and antimicrobial stewardship guidelines.
As SB 27 proposes to reshape the landscape with respect to
veterinarian's issuance of antibiotics, this bill aims to
provide a useful tool to educate veterinarians on the issues
surrounding antimicrobial drugs. NOTE: This bill is currently
pending in the Assembly Appropriations Committee.
Prior Related Legislation. SB 1311 (Hill), Chapter 843,
Statutes of 2014, requires all general acute-care hospitals to
adopt and implement an antimicrobial stewardship policy that
includes a process to evaluate the judicious use of antibiotics.
POLICY ISSUES AND AMENDMENT:
As drafted, it is unclear if this bill would apply to current
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licensees or only to those individuals who become licensed after
January 1, 2018. The author notes that this bill should apply
to all licensees who are subject to CE requirements for
licensure renewal. Also, this bill does not specify the number
of CE units a licensee may obtain in the judicious use of
antimicrobial drugs in order to provide discretion to those
licensees who may wish to take multiple CE courses on this
topic; however, as drafted, this bill does not clearly provide
for that flexibility.
In order to make it explicitly clear that this bill applies to
all licensees, including both existing and new, and that a
veterinarian must obtain a minimum of 1 CE unit on the judicious
use of antimicrobial drugs, the author may wish to accept the
following amendment:
Replace the current proposed BPC Section 4846.5 (k)(1) with the
following:
On or after January 1, 2018, a licensed veterinarian who renews
his or her license shall complete a minimum of one unit of
continuing education on the judicious use of medically important
antimicrobial drugs every four years as part of his or her
continuing education requirements.
REGISTERED SUPPORT:
California Veterinary Medical Association
CALPIRG (3/26/15 version)
Blue Shield of California (3/26/15 version)
California Long-Term Care Ombudsman Association (3/26/15
version)
California Optometric Association (3/26/15 version)
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REGISTERED OPPOSITION:
None on file.
Analysis Prepared by:Elissa Silva / B. & P. / (916) 319-3301