BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: SB 994 Hearing Date: April 11,
2016
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|Author: |Hill |
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|Version: |March 28, 2016 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Bill Gage |
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Subject: Antimicrobial stewardship policies
SUMMARY: Specifies that a covered licensee, as defined, that includes
physicians and surgeons, osteopathic physicians and surgeons,
podiatrists and dentists must adopt and implement an
antimicrobial stewardship policy, as defined, before applying
for a renewal license. Requires the covered licensee to certify
in writing upon renewal of their license with the board that
regulates and licenses the practitioner, that he or she has the
adopted the policy as specified, and is in compliance with that
policy. Requires the board to audit a random sample of covered
licensees and for each audited licensee to provide a copy of his
or her antimicrobial stewardship policy. If the covered
licensee fails to provide a copy of their policy then they will
have until their next renewal to comply or be ineligible to
receive their license. Also requires a primary care clinic or
specialty clinic, on or after January 1, 2018, to adopt and
implement an antimicrobial stewardship policy.
Existing law:
1)Specifies that the Department of Public Health (DPH) shall
require that general acute care hospitals, as defined, 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 994 (Hill) Page 2
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(Health and Safety Code (HSC) § 1288.8)
2)Requires each general acute care hospital to adopt and
implement an antimicrobial stewardship policy in accordance
with guidelines established by the federal government and
professional organizations and that this policy shall include
a process to evaluate the judicious use of antibiotics in
accordance with the requirements in Item #1), above. (HSC §
1288.85 (a))
3)Requires the general acute care hospital to develop a
physician supervised multidisciplinary antimicrobial
stewardship committee, subcommittee, or workshop and appoint
to the entity at least one physician or pharmacist who is
knowledgeable about the subject of antimicrobial stewardship,
as specified, and to report antimicrobial stewardship program
activities to each appropriate hospital committee undertaking
clinical quality improvement activities.
(HSC § 1288.85 (b), (c) and (d))
4)Requires on or after January 1, 2017, each skilled nursing
facility, as defined, to adopt and implement an antimicrobial
stewardship policy that is consistent with antimicrobial
guidelines developed by the federal Centers for Disease
Control (CDC) and Prevention, the federal Centers for Medicare
and Medicaid Services, the Society for the Healthcare
Epidemiology of America, or similar recognized professional
organizations. (HSC § 1275.4)
5)Restricts the use of medically important antimicrobial drugs
in livestock for specified purposes beginning January 1, 2018,
requires a veterinarian's prescription or feed directive for
use, and eliminates the over-the-counter availability of these
drugs; requires the California Department of Food and
Agriculture (CDFA) to, in coordination with federal programs
and state agencies, to develop a program to track
antimicrobial drug use in livestock and the emergence of
antimicrobial-resistant bacteria; requires CDFA to develop
antimicrobial stewardship guidelines and best management
practices on the proper use of these drugs; clarifies when
SB 994 (Hill) Page 3
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medically important antimicrobial drugs may be used for
preventative purposes; provides details regarding the CDFA
antimicrobial monitoring program; and provides for penalties
for those who violate the provisions of these new requirements
as specified. (Food and Agriculture Code §§ 14400-14408)
6)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 their continuing education requirements.
(Business and Professions Code (BPC) § 4846.5)
7)Provides for the licensure and regulation of physicians and
surgeons by the Medical Board of California (MBC), for
osteopathic physicians and surgeons by the Osteopathic Medical
Board (OMB), for podiatrists by the California Board of
Podiatric Medicine (BPM) and for dentists by the Dental Board
of California (DBC) under the Department of Consumer Affairs.
8)Provides that a "clinic" means an organized outpatient health
facility that provides direct medical, surgical, dental,
optometric, or podiatric advice, services, or treatment to
patients who remain less than 24 hours, and that may also
provide diagnostic or therapeutic services to patients in the
home as incident to care provided at the clinic facility.
(HSC § 1200)
9)Provides that a primary care clinics and specialty clinics, as
defined, shall be eligible for licensure with the DPH. (HSC §
1204 (b))
10)Defines a "general acute care hospital" generally as a
facility having a duly constituted governing body with overall
administrative and professional responsibility and an
organized medical staff that provides 24-hour inpatient care,
including the following basic services: medical, nursing,
surgical, anesthesia, laboratory, radiology, pharmacy, and
dietary. (HSC § 1250 (a))
11)Defines a "skilled nursing facility" as a health facility
that provides skilled nursing care and supportive care to
patients whose primary need is for the availability of skilled
nursing care on an extended basis. (HSC § 1250 (c))
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This bill:
1)Defines "antimicrobial stewardship policy" as efforts to
promote the appropriate and optimal selection, dosage, and
duration 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
federal Centers for Disease Control and Prevention, the
federal Centers for Medicare and Medicaid Services, the
Society for Healthcare Epidemiology of America, the
Infectious Diseases Society of American, or similar
recognized, professional organizations.
b) Evidence-based methods. To the extent practicable,
antimicrobial stewardship policies based on proven,
evidence-based methods should include more than one
intervention or component.
2)Provides that a "covered license" means a physician and
surgeon who practices medicine in a setting other that a
clinic licensed pursuant to Section 1204 of the BPC, a general
acute care hospital, as defined in Item # 10) above, or a
skilled nursing facility , as defined in Item # 11) above.
3)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.
4)Requires a covered licensee to adopt and implement an
antimicrobial stewardship policy before applying for a renewal
license.
5)Requires a covered licensee, upon filing an application with
the MBC for a renewal license, to certify in writing, on a
form prescribed by the MBC, that he or she has both adopted an
antimicrobial stewardship policy as specified, and is in
compliance with that policy.
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6)Requires the MBC to audit each year a random sample of covered
licensees who have certified compliance as specified, but that
the MBC shall not audit an individual covered licensee more
than once every four years.
7)Provides that a covered licensee who is selected for an audit
shall submit to the MBC, on a form prescribed by the Board, a
copy of his or her antimicrobial stewardship policy.
8)Provides that if the MBC determines that an audited covered
licensee has failed to comply with the requirements to adopt
and implement an antimicrobial stewardship policy, then the
MBC shall require the covered licensee to comply during the
following renewal period and if the covered licensee fails to
comply within that
period, he or she is ineligible for a subsequent license renewal
until he or she has documented compliance.
9)Specifies that a covered licensee also includes osteopathic
physicians and surgeons licensed and regulated by the OMB,
podiatrists licensed and regulated by the BPM and dentists
licensed and regulated by the DBC, and subjects these
practitioners to the same requirements as those specified in
Items #4) through # 8), above.
10)Requires a primary care clinic or specialty clinic, on or
after January 1, 2018, to adopt and implement an antimicrobial
stewardship policy, as defined, and meets that is consistent
with one of the following parameters as specified in Items #
1) and # 3), above; published antimicrobial stewardship
guidelines published by specified entities or evidence-based
methods, as defined.
FISCAL
EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
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1. Purpose. This measure is sponsored by the Author and is
intended to promote the appropriate antibiotic prescribing
for non-hospitalized patients in ambulatory healthcare
settings. The Author indicates that according to the CDC at
least 2 million Americans are infected with - and at least
23,000 Americans die as a result of - antibiotic resistant
infections every year, resulting in at least $20 billion in
direct health care costs and at least $35 billion in
productivity loss nationwide. In California alone, the DPH
estimates that antibiotic resistant infections are
responsible for at least 3,000 deaths and 260,000 illnesses
every year.
Antibiotic resistance is a growing threat, as stated by the
Author. "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 appropriate and judicious antibiotic
prescribing."
A majority of antibiotics are prescribed in non-hospital health
care settings, as pointed out by the Author, such as medical
offices where physicians, physician assistants and nurse
practitioners work, dentist offices, and podiatric offices.
Based on data from other countries, it can be estimated that
up to 80% of all antibiotic prescriptions are written in the
outpatient setting.
For example, according to the CDC, across the country in 2013,
healthcare providers prescribed 268.6 million courses of
antibiotics in outpatient settings. Primary care physicians
were responsible for 121.7 million prescriptions, physician
assistants and nurse practitioners were responsible for 48.4
million prescriptions and dentists were responsible for 24.5
million prescriptions. The CDC estimates that 50% of these
prescriptions are unnecessary and contributes to the
development of antibiotic resistant infections.
The Author further points out that worldwide antibiotic
consumption is rising. Between 2000 and 2010, global
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consumption of antibiotics increased by 30%, according to the
Center for Disease Dynamics, Economics, & Policy. The United
States has the highest per capita consumption of antibiotics
and consumes the third highest amount of antibiotics overall,
preceded only by China and India. Inappropriate antibiotic
use means using antibiotics when no benefit is possible (e.g.
to treat a viral infection), or using the wrong antibiotic,
or prescribing the wrong dosage.
The Author believes that many different solutions are needed,
but one of the most important actions that can be taken to
slow the development of antibiotic resistance is to ensure
that antibiotics are used judiciously and only when needed.
To promote judicious use the CDC recommends the establishment
of antibiotic stewardship programs, which represent a
"commitment to always use antibiotics only when they are
necessary to treat and in some cases prevent, disease; to
choose the right antibiotics; and to administer them in the
right way in every case. Effective stewardship ensures that
every patient gets the maximum benefit from the antibiotics,
avoids unnecessary harm from allergic reaction and side
effects, and helps preserve the life-saving potential of
these drugs for the future." Antibiotic stewardship programs
in outpatient settings can help decrease inappropriate
prescribing and decrease the development of antibiotic
resistance.
2. Background. Antimicrobial drugs were first developed in 1928
and became widely used in human medicine in the 1940s. These
new drugs quickly proved to have significant health benefits
in both human and animal medicine and to this day are
extremely valuable tools used to treat and prevent illness
and infection. However, incidences of antimicrobial
resistance have been recorded over time and, if not
addressed, pose a serious threat to public health.
Antimicrobial resistance may develop for several reasons. One of
the most widely accepted contributors to antimicrobial
resistance is the misuse of antimicrobial drugs. When
bacteria are exposed to an antimicrobial drug, it provides
the opportunity for "survival of the fittest" where only the
strongest, most immune bacteria survive. These surviving,
antimicrobial-resistant bacteria then multiply to form new
colonies of resistant bacteria that may spread and infect
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other individuals. For this reason, it is important to use
antimicrobial drugs judiciously in both human and animal
medicine as one method to mitigate resistance.
According to a February 2013 joint letter from the Infectious
Diseases Society of America and the Society for Healthcare
Epidemiology of American (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 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 health
care 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.
The Centers for Disease Control and Prevention (CDC) issued a
report titled, Antibiotic Resistance Threats in the United
States, 2013. The CDC estimates that in the United States
more than 2 million people are sickened every year with
antibiotic-resistant infections with at least 23,000
Americans who die as a result of antibiotic infections every
year. In its report, the CDC lists four core actions that
fight the spread of antibiotic resistance: 1) preventing
infections from occurring and preventing resistant bacteria
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from spreading, 2) tracking resistant bacteria, 3) improving
the use of antibiotics, and 4) promoting the development of
new antibiotics and new diagnostic tests for resistant
bacteria. The CDC notes that the use of antibiotics is the
single most important factor leading to antibiotic resistance
around the world. Up to 50% of all antibiotics prescribed
for people are either not needed or not optimally effective
as prescribed.
On September 18, 2014, President Obama issued Executive Order
13676: Combating Antibiotic-Resistant Bacteria, which states
that this is an issue of national security and that "the
Federal Government will work domestically and internationally
to detect, prevent, and control illness and death related to
antibiotic-resistant infections by implementing measures that
reduce the emergence and spread of antibiotic-resistant
bacteria and help ensure the continued availability of
effective therapeutics for the treatment of bacterial
infections." Later that same month, the White House issued
the National Strategy for Combating Antibiotic-Resistant
Bacteria, and 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 with five distinct
goals: 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
resistant bacteria, 4) accelerate the development of new
antibiotics, other treatments, and vaccines, and 5) improve
international collaboration to achieve these goals.
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 health care 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 existed for developing ASPs, there was
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limited information on practical implementation of these
guidelines, particularly in resource-limited settings.
According to DPH, its partners in this statewide initiative
included the Division of Healthcare Quality and Promotion at
CDC, Infectious Disease Association of California, and SHEA.
SB 1311 (Hill, Chapter 843, Statutes of 2014) more
specifically required acute care hospitals to adopt and
implement antimicrobial stewardship policy (ASP) in
accordance with guidelines established by the federal
government and professional organizations. Prior to SB 1311,
only 50 percent of hospitals had actually established an ASP
and only 22 percent said they were influenced by the current
requirement to develop a stewardship program.
3. Prior Related Legislation . SB 27 (Hill, Chapter 758,
Statutes of 2015) restricts the use of antimicrobial drugs in
livestock, requires a veterinarian's prescription or feed
directive for use, eliminate the over-the-counter
availability of these drugs, requires 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 361 (Hill, Chapter 764, Statutes of 2015) requires, on or
after January 1, 2017, each skilled nursing facility, as
defined, to adopt and implement an antimicrobial stewardship
policy consistent with guidelines development by federal or
professional organizations, as specified. Requires a
veterinarian upon renewal of their license to have completed
a continuing education course in the judicious use of
medically important antimicrobial drugs, as specified.
SB 1311 (Hill, Chapter 843, Statutes of 2014) requires each
general acute care hospital, as defined, to adopt and
implement an antimicrobial stewardship policy in accordance
with guidelines established by the federal government and
professional organizations and that this policy shall include
a process to evaluate the judicious use of antibiotics, as
specified.
SB 158 (Florez, Chapter 294, Statutes of 2008) established an
infection surveillance, prevention, and control program
SB 994 (Hill) Page 11
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within DPH to provide oversight of hospital prevention and
reporting of general acute care hospital-associated
infections, expanded the responsibilities of DPH's Healthcare
Associated Infection (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
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
Internet Web site.
4. Arguments in Support. The California Hospital Association
(CHA) is in support of this bill and indicates that "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 appropriate and judicious antibiotic prescribing. The
CHA goes on to state that 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. CDC estimates at least
50 percent of the antibiotic prescribing in outpatient settings
is unnecessary or inappropriate. The CHA believes this
measure is important because it will require ambulatory
health care settings that serve non-hospitalized patients to
establish an antibiotic stewardship policy that is similar to
the requirements for hospitals and nursing homes.
The Society of Infectious Diseases Pharmacists (SIDP) is also in
support of this measure. SIDP indicates that growing
bacterial resistance is contributing to increased morbidity
and mortality of patients across California and the county as
a whole. Overuse and inappropriate use of antibiotics is
common, and contributing to this increasing resistance,
therefore expanding the reach of microbial stewardship to
reduce unnecessary and inappropriate use in primary clinics
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is important. SIDP believes that directing primary care
clinics to initiate antimicrobial stewardship efforts can
help to educate the public and prescribers regarding the
appropriate antibiotic use and thus have meaningful impacts
on society.
5. Policy Issue . Should the "Covered Licensee" be ineligible
for a subsequent license renewal until he or she has
documented compliance with adopting the antimicrobial policy?
The Author may want to consider rather than subjecting the
practitioner to possible loss of their license for
non-compliance with adopting the antimicrobial policy, that
instead provide that it would be unprofessional conduct on
the part of the licensee if they did not adopt the policy.
This would allow some latitude with the individual licensing
board as to what appropriate action to take to assure
compliance with the requirement to have an antimicrobial
stewardship policy in place. The board could determine that
they could do anything from cite and fine the licensee for
non-compliance to more formal disciplinary action if
determined necessary.
6. Suggested Technical Amendment. On page 10, line 29, after
"specialty clinic" insert the following: ,licensed pursuant
to Section 1204,
7. Author's Amendment. The Author would like to clarify the
definition of antimicrobial stewardship policy by making the
following change:
On Page 6, line 19, strike the following, and optimal selection,
dosage, and duration of and insert prescribing of
The definition would then read as follows: "Antimicrobial
stewardship policy" as efforts to promote the appropriate
prescribing of 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 federal Centers for Disease Control and
Prevention, the federal Centers for Medicare and
Medicaid Services, the Society for Healthcare
SB 994 (Hill) Page 13
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Epidemiology of America, the Infectious Diseases
Society of American, or similar recognized,
professional organizations.
b) Evidence-based methods. To the extent
practicable, antimicrobial stewardship policies based
on proven, evidence-based methods should include more
than one intervention or component.
NOTE : Double-referral to Health Committee.
SUPPORT AND OPPOSITION:
Support:
California Hospital Association
Society of Infectious Diseases Pharmacists
Opposition: None on file as of April 5, 2016.
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