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. 







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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  








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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  








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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  








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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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