SB 361 Page 1 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 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 professions and organizations, as specified. (HSC Section 1288.85) SB 361 Page 2 THIS BILL: 1) 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. 2) 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. 3) Requires, on or before January 1, 2017, each skilled nursing facility, as specified, to adopt and implement an antimicrobial stewardship policy. 4) 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. 5) Specifies enforcement actions for skilled nursing facilities which fail to comply with establishing antimicrobial stewardship guidelines. 6) 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. 7) 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 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 SB 361 Page 3 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 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 SB 361 Page 4 at least 23,000 resulting in death. As noted in the United Stated Department of Agriculture's (USDA) Action Plan to Address Antimicrobial 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 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. SB 361 Page 5 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 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) REGISTERED OPPOSITION: None on file. Analysis Prepared by: Elissa Silva / B. & P. / (916) 319-3301