BILL ANALYSIS Ó AB 1748 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 1748 (Mayes) As Amended August 1, 2016 Majority vote -------------------------------------------------------------------- |ASSEMBLY: |74-3 |(May 23, 2016) |SENATE: |37-0 |(August 19, | | | | | | |2016) | | | | | | | | | | | | | | | -------------------------------------------------------------------- Original Committee Reference: ED. SUMMARY: Authorizes school nurses and other trained personnel to use naloxone hydrochloride (naloxone) or another opioid antagonist to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an opioid overdose. Specifically, this bill: 1)Authorizes, in the Business and Professions Code, a pharmacy to furnish naloxone or another opioid antagonist to a school district, county office of education (COE), or charter school if all the naloxone or another opioid antagonist is furnished exclusively for use at a school district schoolsite, COE schoolsite, or charter school, and a physician and surgeon provides a written order that specifies the quantity of naloxone or another opioid antagonist to be furnished. AB 1748 Page 2 2)Requires records regarding the acquisition and disposition of naloxone or another opioid antagonist furnished to be maintained by the school district, COE, or charter school for a period of three years from the date the records were created. Requires the school district, COE, or charter school to be responsible for monitoring the supply of naloxone or another opioid antagonist and ensuring the destruction of expired naloxone or another opioid antagonist. 3)Authorizes school districts, COEs and charter schools to provide emergency naloxone or another opioid antagonist to school nurses or trained personnel for the purpose of providing emergency medical aid to persons suffering, or reasonably believed to be suffering, from an opioid overdose. Establishes the following definitions: a) "Authorizing physician and surgeon" may include, but is not limited to, a physician and surgeon employed by, or contracting with, a local educational agency, a medical director of the local health department, or a local emergency medical services director. b) "Auto-injector" means a disposable delivery device designed for the automatic injection of a premeasured dose of an opioid antagonist into the human body and approved by the federal Food and Drug Administration (FDA) for layperson use. c) "Opioid antagonist" means naloxone or another drug approved by the federal FDA that, when administered, negates or neutralizes in whole or in part the pharmacological effects of an opioid in the body, and has been approved for the treatment of an opioid overdose. d) "Qualified supervisor of health" may include, but is not limited to, a school nurse. AB 1748 Page 3 e) "Volunteer" or "trained personnel" means an employee who has volunteered to administer naloxone or another opioid antagonist to a person if the person is suffering, or reasonably believed to be suffering, from an opioid overdose, has been designated by a school, and has received specified training. 4)Authorizes each public and private elementary and secondary school to voluntarily determine whether or not to make emergency naloxone or another opioid antagonist and trained personnel available at its school. Requires a school to evaluate the emergency medical response time to the school and determine whether initiating emergency medical services is an acceptable alternative to naloxone or another opioid antagonist and trained personnel. Prohibits a private elementary or secondary school choosing to exercise the authority provided by this bill from receiving state funds for this purpose. 5)Authorizes each public and private elementary and secondary school to designate one or more volunteers to receive initial and annual refresher training regarding the storage and emergency use of naloxone or another opioid antagonist from the school nurse or other qualified person designated by an authorizing physician and surgeon. Specifies that a benefit shall not be granted to or withheld from any individual based on his or her offer to volunteer and prohibits retaliation against any individual for rescinding his or her offer to volunteer, including after receiving training. Specifies that a school district, COE, or charter school choosing to exercise the authority provided by this bill shall provide the training for the volunteers at no cost to the volunteer and during the volunteer's regular working hours. 6)Specifies that an employee who volunteers may rescind his or her offer to administer emergency naloxone or another opioid antagonist at any time, including after receipt of training. AB 1748 Page 4 7)Requires the Superintendent of Public Instruction (SPI) to establish minimum standards of training for the administration of naloxone or another opioid antagonist and to review the minimum standards of training every five years, or sooner as deemed necessary by the SPI. Requires the SPI to consult with organizations and providers with expertise in administering naloxone or another opioid antagonist and administering medication in a school environment, including, but not limited to, the California Society of Addiction Medicine, the Emergency Medical Services Authority, the California School Nurses Organization, the California Medical Association, the American Academy of Pediatrics, and others. 8)Requires the training to include all of the following: a) Techniques for recognizing symptoms of an opioid overdose; b) Standards and procedures for the storage, restocking, and emergency use of naloxone or another opioid antagonist; c) Basic emergency follow-up procedures, including, but not limited to, a requirement for the school or charter school administrator or, if the administrator is not available, another school staff member to call the emergency 911 telephone number and to contact the pupil's parent or guardian; d) Recommendations on the necessity of instruction and certification in cardiopulmonary resuscitation (CPR); and, e) Written materials covering the information required in the training. AB 1748 Page 5 9)Requires training to be consistent with the most recent guidelines for medication administration issued by the California Department of Education (CDE). 10)Requires a school to retain for reference the written materials developed for the training. 11)Requires the CDE to include on its Internet Web site a clearinghouse for best practices in training nonmedical personnel to administer naloxone or another opioid antagonist to pupils. 12)Requires any school district, COE, or charter school electing to utilize naloxone or another opioid antagonist for emergency aid to distribute a notice at least once per school year to all staff containing the following information: a) A description of the volunteer request stating that the request is for volunteers to be trained to administer naloxone or another opioid antagonist to a person if the person is suffering, or reasonably believed to be suffering, from an opioid overdose; b) A description of the training that the volunteer will receive; c) The right of an employee to rescind his or her offer to volunteer; and, d) A statement that no benefit will be granted to or withheld from any individual based on his or her offer to volunteer and that there will be no retaliation against any individual for rescinding his or her offer to volunteer, including after receiving training. 13)Requires a qualified supervisor of health at a school AB 1748 Page 6 district, COE, or charter school electing to utilize naloxone or another opioid antagonist for emergency aid to do the following: a) Obtain from an authorizing physician and surgeon a prescription for each school for naloxone or another opioid antagonist. b) Be responsible for stocking the naloxone or another opioid antagonist and restocking it if it is used. 14)Specifies that if a school district, COE, or charter school does not have a qualified supervisor of health, an administrator at the school district, COE, or charter school shall carry out the duties. 15)Provides that a prescription may be filled by local or mail order pharmacies or naloxone or another opioid antagonist manufacturer. 16)Specifies that an authorizing physician and surgeon shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for the issuance of a prescription or order pursuant to this bill, unless the physician and surgeon's issuance of the prescription or order constitutes gross negligence or willful or malicious conduct. 17)Specifies that a school nurse or, if the school does not have a school nurse or the school nurse is not onsite or available, a volunteer may administer naloxone or another opioid antagonist to a person exhibiting potentially life-threatening symptoms of an opioid overdose at school or a school activity when a physician is not immediately available. Provides that if the naloxone or another opioid antagonist is used it shall be restocked as soon as reasonably possible, but no later than two weeks after it is used. Naloxone or another opioid antagonist shall be restocked before their expiration date. 18)Specifies that volunteers may administer naloxone or another opioid antagonist only by nasal spray or by auto-injector. AB 1748 Page 7 19)Specifies that volunteers shall be allowed to administer naloxone or another opioid antagonist in the authorized form the volunteer is most comfortable with. 20)Requires a school district, COE, or charter school electing to utilize naloxone or another opioid antagonist for emergency aid to ensure that each employee who volunteers under this section will be provided defense and indemnification by the school district, COE, or charter school for any and all civil liability, in accordance with, but not limited to, that provided in Government Code, Division 3.6 (commencing with Section 810) of Title 1. Requires this information to be reduced to writing, provided to the volunteer, and retained in the volunteer's personnel file. 21)Specifies that a person trained to provide naloxone or another opioid antagonist who administers naloxone or another opioid antagonist, in good faith and not for compensation, to a person who appears to be experiencing an opioid overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for his or her acts or omissions in administering the naloxone or another opioid antagonist. Specifies that the protection shall not apply in as case of gross negligence or willful and wanton misconduct of the person who renders emergency care treatment by the use of naloxone or another opioid antagonist. Specifies that any public employee who volunteers to administer naloxone or another opioid antagonist is not providing emergency medical care "for compensation" notwithstanding the fact that he or she is a paid public employee. 22)Authorizes a state agency, the CDE, or a public school to accept gifts, grants, and donations from any source for the support of the public school carrying out the provisions of this bill, including, but not limited to, the acceptance of naloxone or another opioid antagonist from a manufacturer or wholesaler. AB 1748 Page 8 The Senate amendments: 1)Authorize volunteers to administer naloxone hydrochloride or another opioid antagonist by auto-injector, in addition to nasal spray. 2)Establish the definition for "auto-injector." 3)Strike the requirement for the SPI to consult with the State Department of Public Health and instead require the SPI to consult with the California Society of Addition Medicine, among others, in establishing minimum standards for training. 4)Strike the provision specifying that the requirement for the school or charter school administrator or other staff member to call 911 shall not require a pupil to be transported to an emergency room. FISCAL EFFECT: According to the Senate Appropriations Committee, CDE anticipates one-time costs to implement this bill of about $60,000 (General Fund) for a half of a position. This position would develop the minimum training standards, consult with specified entities in developing those standards, and develop a clearinghouse on its website for best practices in training nonmedical personnel to administer an emergency opioid antagonist. There are minor ongoing costs to review the minimum standards at least every five years. COMMENTS: This bill authorizes school districts, COEs and charter schools to obtain naloxone or another opioid antagonist and allow school nurses or other trained volunteer personnel to provide naloxone or another opioid antagonist to persons suffering, or reasonably believed to be suffering from an opioid overdose, if a prescription is received from a physician and AB 1748 Page 9 surgeon. This bill requires the SPI to establish minimum standards for training, in consultation with specified organizations. This bill is modeled after the provisions allowing school nurses or trained personnel to use epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. The major difference is that this bill simply authorizes local educational agencies to obtain and administer opioid antagonist while school districts, COEs and charter schools are required to stock epinephrine auto-injectors. Symptoms of drug overdose. The Opioid Overdose Toolkit from the Substance Abuse and Mental Health Services Administration (SAMHSA), a division of the United States Department of Health and Human Services, states that symptoms of drug overdose may include extreme sleepiness, slow heartbeat and/or low blood pressure, very small pupils in the eyes, fingernails or lips turning blue/purple and breathing problems. Naloxone hydrochloride. Naloxone is approved by the FDA as an antidote to reverse opioid overdose. According to SAMHSA, "The safety profile of naloxone is remarkably high, especially when used in low doses and titrated to effect. When given to individuals who are not opioid-intoxicated or opioid-dependent, naloxone produces no clinical effects, even at high doses. Moreover, although rapid opioid withdrawal in tolerant patients may be unpleasant, it is not life-threatening." Naloxone is administered by a syringe or an auto-injector into a large muscle or given under the skin. It was recently approved by the FDA in a nasal spray form. Naloxone can reverse the effects of an opioid overdose very quickly. As communities and states throughout the country increased the use of naloxone, prices have increased, particularly for the nasal spray. According to the author, the Clinton Health Matters Initiative has partnered with the manufacturer of the nasal spray version AB 1748 Page 10 to offer a discounted public interest price and provide two free doses to every high school in the United States. This bill allows a school to obtain naloxone from a pharmacy or a manufacturer, including accepting donations from a manufacturer. Volunteers. According to the California School Nurses Association, the ratio of school nurse to student in 2014-15 was 1:3,048, with just a total of 2,391 nurses for 6.2 million students in the state. Without a nurse located at each schoolsite, several recent new laws have tapped volunteers to administer medical aid for varying conditions, including epilepsy, diabetes, and anaphylactic reactions. When this bill passed the Assembly, volunteers were allowed to use nasal spray only in the administration of naloxone. Senate amendments added auto-injectors. Analysis Prepared by: Sophia Kwong Kim / ED. / (916) 319-2087 FN: 0004136 FN: