BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 994
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|AUTHOR: |Hill |
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|VERSION: |April 14, 2016 |
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|HEARING DATE: |April 20, 2016 | | |
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|CONSULTANT: |Vince Marchand |
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SUBJECT : Antimicrobial stewardship policies
SUMMARY : Requires primary care clinics and specialty clinics, by
January 1, 2018, and physicians, podiatrists and dentists when
applying for their next renewal license, to adopt and implement
an antibiotic stewardship policy, as defined.
Existing law:
1)Requires general acute care hospitals, by July 1, 2015, to
adopt and implement an antimicrobial stewardship policy (ASP)
in accordance with guidelines established by the federal
government and professional organizations; develop a physician
supervised multidisciplinary antimicrobial stewardship
committee, subcommittee, or workgroup; and report
antimicrobial stewardship program activities to each
appropriate hospital committee undertaking clinical quality
improvement activities.
2)Requires skilled nursing facilities (SNFs), by January 1,
2017, to adopt and implement an ASP that is consistent with
antimicrobial stewardship guidelines developed by the federal
Centers for Disease Control and Prevention (CDC), the federal
Centers for Medicare and Medicaid Services, the Society for
Healthcare Epidemiology of America, or similar recognized
professional organizations. Specifies that failure of a SNF to
comply with this requirement is subject to citation and civil
penalty provisions in existing law.
3)Requires, on or after January 1, 2018, a licensed veterinarian
who renews his or her license to complete a minimum of one
credit hour of continuing education on the judicious use of
medically important antimicrobial drugs, as defined, every
four years as part of his or her continuing education
SB 994 (Hill) Page 2 of ?
requirements.
4)Licenses and regulates primary care clinics and specialty
clinics by the Department of Public Health (DPH). Specialty
clinics include surgical clinics, chronic dialysis clinics,
rehabilitation clinics, and alternative birth centers.
Requires clinics, unless accredited by a recognized
accrediting organization or unless it meets other specified
exceptions, to be periodically inspected for compliance with
licensing laws and regulations no less than once every three
years, and as often as necessary to ensure the quality of care
being provided.
5)Licenses and regulates physicians through the Medical Board of
California, osteopathic physicians through the Osteopathic
Medical Board, podiatrists through the Board of Podiatric
Medicine, and dentists through the Dental Board of California.
This bill:
1)Requires a primary care clinic or a specialty clinic, as
defined, on or before January 1, 2018, to adopt and implement
an ASP, as defined.
2)Requires physicians, osteopathic physicians, podiatrists, and
dentists, who practice in a setting other than a licensed
primary care or specialty clinic, general acute care hospital,
or SNF, to adopt and implement an ASP, as defined, before
applying for a renewal license.
3)Requires physicians, osteopathic physicians, podiatrists, and
dentists, upon filing an application with their respective
licensing board for a renewal license, to certify in writing,
on a form prescribed by their respective board, that he or she
has both adopted an ASP and is in compliance with that policy.
4)Requires the licensing boards for physicians, osteopathic
physicians, podiatrists, and dentists, to audit during each
year a random sample of licensees who have certified
compliance with the ASP policy, but prohibits the boards from
auditing an individual licensee more than once every four
years. Requires licensees selected for an audit to submit to
his or her respective licensing board, on a form prescribed by
that board, a copy of his or her ASP.
5)Requires a licensing board of a physician, osteopathic
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physician, podiatrist, or dentist, if the board determines
that an audited licensee has failed to comply with the ASP
requirement, to require that licensee to comply during the
following renewal period. Specifies that failure to comply
within the following renewal period constitutes unprofessional
conduct, as specified.
6)Defines an ASP as efforts to promote the appropriate
prescribing of antimicrobials for patients, with the goal of
reducing antimicrobial overuse and misuse and minimizing the
development of antimicrobial resistant infections, that is
consistent with one of the following parameters:
a) Antimicrobial stewardship guidelines published
by the CDC, the federal Centers for Medicare and
Medicaid Services, the Society for Healthcare
Epidemiology, the Infectious Disease Society of
America, or similar recognized professional
organizations; or,
b) Evidence-based methods. Requires, to the
extent practicable, evidence-based antimicrobial
stewardship policies to include more than one
intervention or component. Defines "evidence-based
methods" as antimicrobial prescribing intervention
methods that have been proven effective through
outcome evaluations or studies, including, but not
limited to, audit and feedback, academic detailing,
clinical decision support, delayed prescribing
practices, poster-based interventions, accountable
justification, and peer comparison.
7)Makes various legislative findings and declarations, including
that the CDC estimates that at least two million Americans are
infected with, and 23,000 Americans dies as a result of,
antibiotic-resistant infections, and that in one year, 262.5
million courses of antibiotics are written in outpatient
settings, with the CDC estimating that over one-half of the
antibiotics prescribed in outpatient settings are unnecessary.
Also finds and declares that the President's National Action
Plan for Combating Antibiotic-Resistant Bacteria calls for the
establishment of antibiotic stewardship activities in all
healthcare delivery settings, including outpatient settings,
by 2020.
FISCAL
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EFFECT : This bill has not been analyzed by a fiscal committee.
COMMENTS :
1)Author's statement. According to the author, the CDC
estimates that at least 23,000 Americans die as a result of
antibiotic resistant infections every year and the threat is a
growing. A recent study commissioned by the United Kingdom
determined that by 2050, worldwide, more people will die from
antibiotic resistant infections than from cancer. While not
the only cause, the overuse and misuse of antibiotics in
medicine is a significant contributing factor driving the
development of antibiotic resistance and if we are to truly
solve the problem, among other things, we need to focus on
promoting more judicious antibiotic prescribing. A majority of
antibiotics are prescribed in non-hospital health care
settings, such a medical offices where physicians, physician
assistants and nurse practitioners work. Based on data from
other countries, an estimated 80% of antibiotic prescriptions
are written in the outpatient setting. The CDC estimates at
least 50% of the antibiotic prescribing in outpatient settings
is unnecessary or inappropriate. SB 994 will promote better
antibiotic prescribing and ultimately help reduce the burden
of antibiotic resistant infections by requiring antibiotic
stewardship policies in outpatient healthcare settings.
Antibiotic stewardship improves prescribing decisions through
educational interventions.
2)Background. According to the CDC, antibiotic resistance is a
quickly growing, extremely dangerous problem. World health
leaders have described antibiotic-resistant bacteria as
"nightmare bacteria" that "pose a catastrophic threat" to
people in every country in the world. Most infections occur
in the community, like skin infections with
Methicillin-resistant Staphylococcus aureus (MRSA) and
sexually transmitted diseases. However, most deaths related to
antibiotic resistance occur from drug-resistant infections
picked up in healthcare settings, such as hospitals and
nursing homes. According to a February 2013 joint letter from
the Infectious Diseases Society of America (IDSA) and the
Society for Health Epidemiology of America (SHEA) to the
National Quality Forum, ample data exist from both inpatient
and outpatient settings demonstrating that antibiotics are
often prescribed sub-optimally or inappropriately. Antibiotics
are misused in a variety of ways. They are often administered
when they are not needed, continued when they are no longer
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necessary, or prescribed at the wrong dose. Broad-spectrum
agents may be used unnecessarily against bacteria that are
very susceptible or the wrong antibiotic may be given to treat
a particular infection. Over the past 30 years, bacteria that
are extremely resistant to traditional treatments or resistant
to multiple drugs have spread widely among patients in
healthcare settings. In some cases these pathogens have been
pan-resistant, meaning that they are resistant to all
available antibiotics. The unique nature of antibiotics, in
which the use of the drugs in one patient can impact the
effectiveness of the drug in a different patient, make
antibiotic overuse a serious patient safety issue and public
health threat. The World Health Organization has
characterized antibiotic resistance as "a crisis that has been
building up over decades, so that today common and
life-threatening infections are becoming difficult or even
impossible to treat." Resistant infections not only result in
increased morbidity and mortality, but increased economic
burdens. For example, studies have shown that
antibiotic-resistant infections are associated with longer
lengths of stay and increased mortality, both in the hospital
and in intensive care units.
3)Presidential Executive Order and Action Plan. In September of
2014, President Obama issued an executive order, titled
"Combating Antibiotic-Resistant Bacteria." Among other things,
this executive order requires the Health and Human Services
Agency, by the end of calendar year 2016, to review existing
regulations and propose new regulations or other actions, as
appropriate, that require hospitals and other inpatient
healthcare delivery facilities to implement robust antibiotic
stewardship programs that adhere to best practices, such as
those identified by the CDC. The executive order also
established a federal task force that is required to, as
appropriate, define, promulgate, and implement stewardship
programs in other healthcare settings, including office-based
practices, outpatient settings, emergency departments, and
institutional and long-term care facilities, such as nursing
homes, pharmacies, and correctional facilities. In March 2015,
the White House issued the National Action Plan for Combating
Antibiotic-Resistant Bacteria (Action Plan). The Action Plan
lays out a five-year plan to achieve five distinct goals by
2020: 1) slow the emergence of resistant bacteria, 2)
strengthen One-Health surveillance efforts, 3) advance the
development and use of rapid diagnostic tests to identify
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resistant bacteria, 4) accelerate the development of new
antibiotics, other treatments, and vaccines, and 5) improve
international collaboration to achieve these goals.
4)California's program. In February 2010, the DPH Healthcare
Associated Infection (HAI) Program developed a statewide
antimicrobial stewardship program (ASP) initiative in order to
strengthen and promote optimization of antimicrobial
utilization in California health care facilities. According to
DPH, the purpose of an antimicrobial stewardship program in a
healthcare facility is to measure and promote the appropriate
use of antimicrobials by selecting the appropriate agent,
dose, duration and route of administration in order to improve
patient outcomes, while minimizing toxicity and the emergence
of antimicrobial resistance. Although guidelines exist for
developing ASPs, there is limited information on practical
implementation of these guidelines, particularly in
resource-limited settings. According to DPH, its partners in
this statewide initiative include the Division of Healthcare
Quality and Promotion at CDC, Infectious Disease Association
of California, and SHEA. According to the DPH website,
current program activities include:
a) The HAI Program has launched a statewide
Antimicrobial Stewardship Program Collaborative, with the
goal of ensuring that all California hospitals have a
functional and robust ASP to promote patient safety and
to decrease antimicrobial resistance. The Collaborative
will extend for one year from January through December
2015;
b) Spotlight on ASP Project, which helps define
antimicrobial stewardship programs and activities, and
spotlights volunteer hospitals that want to highlight and
share with others their ASP progress;
c) Utilization of a statewide assessment of ASPs
present in California healthcare facilities (May 2010 -
March 2011) to develop evidence-based recommendations on
how to implement or strengthen ASPs given available
resources and facility attributes;
d) Developing recommendations with the Antimicrobial
Stewardship Subcommittee of the California HAI Advisory
Committee;
e) Defining activities that comprise ASPs in California
hospitals; and,
f) The California Antibiogram Project, which collects
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information on specific antimicrobial-organism
combinations across California general acute care
hospitals.
5)Double referral. This bill was heard in the Senate Business,
Professions and Economic Development Committee on April 11,
2016, and passed with a 7-0 vote.
6)Prior legislation. SB 361 (Hill, Chapter 764, Statutes of
2015), required SNFs to adopt and implement an antimicrobial
stewardship policy by January 1, 2017.
SB 27 (Hill, Chapter 758, Statutes of 2015), restricted the
use of antimicrobial drugs in livestock, required a
veterinarian's prescription or feed directive for use,
eliminated the over-the-counter availability of these drugs,
required the CDFA to develop antimicrobial stewardship
guidelines and best management practices for veterinarians, as
well as livestock owners and their employees on the proper use
of antimicrobial drugs, and to develop a program to track
antimicrobial drug use in livestock.
SB 1311 (Hill, Chapter 843, Statutes of 2014), required
general acute care hospitals, by July 1, 2015, to adopt and
implement an antimicrobial stewardship policy, as specified;
develop a physician supervised multidisciplinary antimicrobial
stewardship committee, subcommittee, or workgroup; appoint at
least one physician or pharmacist who has attended training
specifically on antimicrobial stewardship to the committee,
subcommittee, or workgroup, as specified; and, report
antimicrobial stewardship program activities to appropriate
hospital committees, as specified.
SB 158 (Florez, Chapter 294, Statutes of 2008), established an
infection surveillance, prevention, and control program within
DPH to provide oversight of hospital prevention and reporting
of general acute care hospital-associated infections, expanded
the responsibilities of DPH's HAI Advisory Committee, and
requires all hospitals to institute a patient safety plan for
the purpose of improving the health and safety of patients and
reducing preventable patient safety events.
SB 1058 (Alquist, Chapter 296, Statutes of 2008), established
the Medical Facility Infection Control and Prevention Act,
which requires hospitals to implement specified procedures for
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screening, prevention, and reporting specified health care
associated infections also known as HAIs. Requires hospitals
to report positive MRSA and other HAI test results to DPH and
requires DPH to make specified information public on its
website.
SB 739 (Speier, Chapter 526, Statutes of 2006), created a
state HAI advisory committee to make recommendations regarding
reporting cases of HAI in hospitals. Requires each general
acute care hospital, after January 1, 2008, to implement and
annually report to DPH its implementation of infection
surveillance and infection prevention process measures that
have been recommended by CDC Healthcare Infection Control
Practices Advisory Committee, as suitable for a mandatory
public reporting program. Required, initially, these process
measures to include the CDC guidelines for central line
insertion practices, surgical antimicrobial prophylaxis, and
influenza vaccination of patients and healthcare personnel.
Requires DPH, in consultation with the HAI advisory committee,
to make this information public no later than six months after
receiving the data. Required that general acute care hospitals
develop a process for evaluating the judicious use of
antibiotics, the results of which shall be monitored jointly
by appropriate representatives and committees involved in
quality improvement activities.
SB 1487 (Speier, 2004), would have required specified
hospitals to have written infection control plans and report
to Office of Statewide Health Planning and Development (OSHPD)
data, including the rate of HAIs and risk-adjusted infection
rate data according to the risk-adjustment methodology
determined by CDC. SB 1487 was vetoed by then Governor
Schwarzenegger, whose veto message suggested that it was
unnecessary because of other national efforts, which could
call into question the quality and validity of the data
without proper auditing, and because it would impose
significant costs to hospitals and OSHPD.
7)Support. The Alliance for the Prudent Use of Antibiotics
(APUA) states in support, a majority of antibiotics are
prescribed in non-hospital health care settings, such as
medical offices where physicians, physician assistants and
nurse practitioners work, dentist offices, and podiatric
offices. APUA states that many different solutions are needed,
but one of the most important actions that can be taken to
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slow the development of antibiotic resistance is to ensure
that antibiotics are used judiciously and only when needed.
The California Hospital Association also supports this bill,
stating that ASPs are already required in hospitals and
nursing homes, and this bill will require ambulatory health
care settings that serve non-hospitalized patients to
establish an ASP.
8)Opposition. The California Medical Association (CMA) states
in opposition that the most recent data from the CDC suggests
that California is ahead of the curve as it relates to the
issue of excessive antibiotic prescribing, and that California
is one of the states at the low end of per capita antibiotic
prescribing. CMA states that although well-intentioned, this
bill would be onerous and confusing to comply with, and that
the criteria for successfully meeting the bill's requirements
are unclear and ripe for misinterpretation. CMA also points
out that requiring licensing boards to ensure, though an
annual audit of a random sample, that licensees have both
adopted and are in compliance with an ASP has the potential to
create significant workload for the licensing board. The
American Academy of Pediatrics (AAP) states in opposition that
while the language seeks to exempt people who only practice in
licensed facilities, it is unlikely to significantly reduce
the bill's reach since may physicians practice in several
settings, with both hospital privileges and a private
practice. AAP argues that a physician may then be subject to
multiple different ASPs, resulting in confusion. This bill is
also opposed by the California Dental Association (CDA), which
states that this bill is premature, confusing, and raises
enforcement feasibility questions. CDA states that just five
months ago, the CDC presented to the American Dental
Association on antibiotic stewardship, and detailed the lack
of data or evidence on the prescribing behaviors of dentists.
According to CDA, the CDC discussed the challenges of
implementing any interventions without the data from which to
develop them, and stated that the next steps would be to
measure and characterize antibiotic prescribing by dentists.
9)Inclusion of dentists and podiatrists. The concern over the
inappropriate prescribing of antibiotics in outpatient
settings has historically focused on the use of antibiotics in
primary care settings to treat what are often viral
infections, rather than bacterial infections. The data on
dental and podiatric prescribing behavior is less robust. With
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regard to dental prescribing, the author cites a review of
studies published in July of 2010 in the journal Therapeutics
and Clinical Risk Management (TCRM report), which reviewed
studies on dental prescribing published worldwide. According
to the TCRM report, dentists prescribe between 7% and 11% of
all common antibiotics, mainly for the treatment of infections
that originate in the tooth or surrounding tissue. The TCRM
report concluded that the prescribing practices of dentists
are inadequate and this is manifested by over-prescribing, and
recommended improving antibiotic prescribing practices in
dental offices. However, this was a review of literature
worldwide, and there does not appear to be much data specific
to the United States. The American Dental Association, in a
statement that it made supporting the responsible use of
antibiotics, pointed to a study published in March of 2015 in
the journal Clinical Infectious Diseases which looked at oral
antibiotic prescribing data among all outpatients, and it
found that after family practitioners, pediatricians and
internists, dentists were the next most-frequent prescriber of
oral antibiotics in an outpatient setting at 10% of all
prescriptions.
10)Policy Comment. Currently, the CDC and other organizations
have only published antibiotic stewardship guidelines for
hospitals and other institutional settings. According to the
author, the CDC is expected to publish antibiotic stewardship
guidelines for outpatient settings later this year. While this
bill allows compliance through "evidence-based methods," such
as poster-based interventions or accountable justification
(writing justifications for prescribing antibiotics in the
patient's medical record), given the lack of published
guidelines specific to outpatient settings, the author may
wish to consider a delayed implementation to allow for these
guidelines to be published.
SUPPORT AND OPPOSITION :
Support: Alliance for the Prudent Use of Antibiotics
California Hospital Association
County Health Executives Association of California
Oppose: American Academy of Pediatrics
California Dental Association
California Medical Association
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