BILL ANALYSIS Ó SB 738 Page 1 Date of Hearing: June 23, 2015 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Susan Bonilla, Chair SB 738(Huff) - As Amended May 13, 2015 SENATE VOTE: 36-0 NOTE: This bill is double referred, and if it passes this Committee, it will be referred to the Assembly Judiciary Committee. SUBJECT: Pupil health: epinephrine auto-injectors: liability limitation. SUMMARY: Provides that an authorizing physician and surgeon will not be subject to professional review, liable in a civil action or be the subject of criminal prosecution for issuing a prescription or order, as specified, for an epinephrine auto-injector (EAI), unless the physician or surgeon's issuance constitutes gross negligence or willful or malicious conduct. EXISTING LAW: 1)Authorizes a pharmacy to furnish an EAI to a school district, county office of education (COE), or charter school, as specified, if the following conditions are met: (Business and Professions Code (BPC) Section 4119.2(a)) SB 738 Page 2 a) The EAIs are furnished exclusively for use at a school site, as specified; and, b) A physician and surgeon provides a written order that specifies the quantity of EAIs to be furnished. 2)Requires the records regarding the acquisition and disposition of EAIs to be maintained by the school district, COE, or charter school for a period of three years from the date the records were created and requires the school district, COE, or charter school to be responsible for monitoring the supply of EAIs and ensuring the destruction of expired EAIs. (BPC Section 4119.2(b)) 3)Establishes the responsibilities of the Medical Board of California (MBC) which include: the enforcement of the disciplinary and criminal provisions of the Medical Practice Act (Act); the administration and hearing of disciplinary actions; carrying out disciplinary actions appropriate to findings made by a panel or an administrative law judge (ALJ); suspending, revoking, or otherwise limiting certificates after the conclusion of disciplinary actions; and reviewing the quality of medical practice carried out by physician and surgeon certificate holders under the MBC's jurisdiction. (BPC Section 2004 (a)-(e)) 4)Requires school districts, COEs, and charter schools to provide emergency EAIs to school nurses or trained personnel who have volunteered, as specified, and authorizes school nurses or trained personnel to use EAIs to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. (Education Code (EDC) Section 49414 (a)) 5)Permits each private elementary and secondary school in the state to voluntarily determine whether or not to make EAIs and trained personnel available at its school, as specified. (EDC SB 738 Page 3 Section 49414(c)) 6)Permits each public and private elementary and secondary school in the state to designate one or more volunteers to receive initial and annual refresher training, based on specified standards, regarding the storage and emergency use of an EAI from the school nurse or other qualified person designated by an authorizing physician and surgeon. (EDC Section 49414(d)) 7)Requires the Superintendent to review the minimum standards of training for the administration of EAIs, every five years or sooner, as determined by the Superintendent. (EDC 49414(e)(1)) THIS BILL: 8)States that an authorized physician and surgeon is not subject to professional review, liable in a civil action, or subject to criminal prosecution for the issuance of a prescription or order, as specified, for an EAI unless the physician and surgeon's issuance of the prescription or order constitutes gross negligence or willful or malicious conduct. 9)Updates the name of the Stanford Allergy Center to reflect its current name, the Sean N. Parker Center for Allergy Research. FISCAL EFFECT: None. This bill is keyed non-fiscal by the Legislative Counsel. COMMENTS: SB 738 Page 4 Purpose. This bill is sponsored by the California Society for Allergy, Asthma and Immunology . According to the author, "My office has been informed that this medication was recently used in the San Marcos School District and potentially saved a child's life. This policy is important and is working. We need this last part of the equation to make sure this policy is workable to its full extent and for all schools, not just for schools who have been lucky enough to find a physician willing to go out on a limb. This is a narrowly focused bill in an attempt to make getting prescriptions easier for school nurses and is consistent with current law for similar situations. Without the prescription, this important health policy cannot work." Background. An EAI is used for the emergency treatment of severe allergic reactions, including anaphylaxis, to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise. As a result of SB 1266 (Huff), Chapter 321, Statutes of 2014, it is now required that school districts, COEs, and charter schools provide emergency EAIs to school nurses or trained personnel who have volunteered, and those school nurses or trained personnel may use the EAIs to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. BPC Section 4119.2 permits a pharmacy to furnish EAIs to a school district, COE or charter school, as specified in the EDC, as long as the following conditions are met: 1) the EAI is furnished exclusively for use at the school site, and 2) a physician and surgeon provides a written order that specifies the quantity of EAIs to be furnished. In addition to establishing the processes and procedures for the program, SB 1266 also provided specified liability protections for the employees who volunteer under the program by requiring SB 738 Page 5 the school district, COE or charter school to provide defense and indemnification by for any and all civil liability, as specified. This bill would also provide liability protection to a physician and surgeon by exempting them from professional review for the issuance of a prescription or order for an EAI unless the prescription or order constituted gross negligence or willful or malicious misconduct. In 2013, AB 635 (Ammiano), Chapter 707, Statutes of 2013, provided similar protections from civil liability or from professional review for licensed health care providers who issue prescriptions or standing orders, as specified, for naloxone hydrochloride, which is an opioid antagonist used to treat opioid overdose. Medical Board. The MBC is the regulatory entity responsible for regulating physician and surgeons and a number of other allied health professionals. The jurisdiction of the MBC includes issuing licenses and certificates, the administration and hearing of disciplinary actions, and carrying out disciplinary actions as determined by the appropriate panel or ALJ including suspending, revoking, or otherwise limiting certificates after the conclusion of disciplinary actions. According to the author, since the enactment of SB 1266, many physicians have begun to raise questions about liability concerns with respect to issuing a generic prescription for the purposes of providing EAIs to school sites. This bill will exempt a physician and surgeon from both professional review by the MBC and civil liability for the issuance of a prescription or order for EAIs in school settings as required by the EDC, unless the physician and surgeon's order constitutes gross negligence or willful or malicious conduct. Current Related Legislation. AB 1386 (Low), of 2015, permits a pharmacy to furnish EAIs to an authorized agency, as specified, if the EAIs are furnished exclusively for use at or in connection with an authorized entity, an authorized health care provider provides a prescription, and the records are maintained SB 738 Page 6 by the authorized agency for three years. This bill also contains specified immunity provisions. STATUS: This bill is pending in the Assembly Business and Professions Committee. Prior Related Legislation. SB 1266 (Huff), Chapter 321, Statutes of 2014, requires school districts, COEs, and charter schools to provide emergency EAIs to school nurses or trained personnel who have volunteered, and authorizes school nurses or trained personnel to use EAIs to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. SB 669 (Huff), Chapter 725, Statutes of 2013, permitted a prehospital emergency medical care person, first responder, or lay rescuer to obtain and use an EAI in emergency situations with certification of training, as specified. AB 635 (Ammiano), Chapter 707, Statutes of 2013, revised provisions from the current pilot program authorizing prescription of opioid antagonists for treatment of drug overdose and limiting civil and criminal liability, expanded these provisions statewide, and removed the 2016 sunset date. AB 559 (Wiggins), Chapter 458, Statutes of 2001, allowed school districts or COEs to provide emergency EAIs to trained personnel, and permitted trained personnel to utilize EAIs to provide emergency medical aid to persons suffering from an anaphylactic reaction. ARGUMENTS IN SUPPORT: The American College of Allergy, Asthma and Immunology (ACAAI) and the Advocacy Council (Council) of the Colleges writes in support, "[the] ACAAI and the Council firmly believe in the concept of making undesignated [EAIs] available to appropriately trained school personnel." SB 738 Page 7 The California Chapter of the American College of Emergency Physicians writes in support, "[this bill] will provide physicians the necessary liability protections to fully implement current law. It is similar to what is already in law for other medication and medical devices; applying liability protection to [EAIs] makes sense." The Medical Board of California writes in support, "this bill will help school districts obtain standing order prescriptions so they can benefit from SB 1266 from last year. These standing order prescriptions will allow the schools to obtain the [EAIs] which will provide emergency medical aid to students suffering from anaphylactic reactions." ARGUMENTS IN OPPOSITION: None on file. REGISTERED SUPPORT: California Society for Allergy, Asthma and Immunology (sponsor) American Academy of Allergy, Asthma, and Immunology American College of Allery, Asthma, and Immunology Association of Regional Center Agencies California Chapter of the American College of Emergency Physicians California School Nurses Organization Civil Justice Association of California Los Angeles Unified School District Medical Board of California Sanofi Santa Clara County Office of Education 4 individuals SB 738 Page 8 REGISTERED OPPOSITION: None on file. Analysis Prepared by:Elissa Silva / B. & P. / (916) 319-3301