BILL ANALYSIS                                                                                                                                                                                                    



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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