BILL ANALYSIS Ó AB 1748 Page 1 Date of Hearing: April 13, 2016 ASSEMBLY COMMITTEE ON EDUCATION Patrick O'Donnell, Chair AB 1748 (Mayes) - As Amended March 18, 2016 [Note: This bill is double-referred to the Judiciary Committee and will be heard by that Committee as it relates to issues under its jurisdiction.] SUBJECT: Pupils: pupil health: opioid antagonist 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. 2)Requires records regarding the acquisition and disposition of AB 1748 Page 2 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. Prohibits school districts, COEs and charter schools from receiving state funds for this purpose. 4)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) "Opioid antagonist" means naloxone or another drug approved by the federal Food and Drug Administration (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. c) "Qualified supervisor of health" may include, but is not limited to, a school nurse. AB 1748 Page 3 d) "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. 5)Authorizes each 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 private 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. 6)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. Prohibits any school choosing to exercise the authority provided by this bill from receiving state funds for this purpose. 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 AB 1748 Page 4 medication in a school environment, including, but not limited to, the State Department of Public Health, 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) Emergency followup procedures, including calling the emergency 911 telephone number and contacting, if possible, the pupil's parent and physician; d) Recommendations on the necessity of instruction and certification in cardiopulmonary resuscitation (CPR); and, e) Written materials covering the information required in the training. 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 AB 1748 Page 5 materials developed for the training. 11)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; and, b) A description of the training that the volunteer will receive. 12)Requires a qualified supervisor of health at a school 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. AB 1748 Page 6 13)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. 14)Provides that a prescription may be filled by local or mail order pharmacies or naloxone or another opioid antagonist manufacturer. 15)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. 16)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. 17)Requires a volunteer to initiate emergency medical services or other appropriate medical followup in accordance with the training materials. AB 1748 Page 7 18)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 Division 3.6 (commencing with Section 810) of Title 1 of the Government Code. Requires this information to be reduced to writing, provided to the volunteer, and retained in the volunteer's personnel file. 19)Specifies that a person trained to provide naloxone or another opioid antagonist who acts with reasonable care in administering naloxone or another opioid antagonist, in good faith, to a person who is experiencing or is suspected of experiencing an opioid overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration. 20)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. EXISTING LAW: 1)Requires school districts, COEs, and charter schools to provide emergency epinephrine auto-injectors to school nurses or trained personnel who have volunteered, and authorizes school nurses or trained personnel to use epinephrine AB 1748 Page 8 auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. (Education Code (EC) Section 49414 et seq.) 2)Authorizes, in the absence of a credentialed school nurse or other licensed nurse onsite at the school, non-medical school personnel to administer medication to a pupil in an emergency, after receiving specified training: a) Glucagon to be administered to students with diabetes suffering from severe hypoglycemia. (EC Section 49414.5) a) Emergency anti-seizure medication to be administered to students with epilepsy suffering from seizures. (EC Section 49414.7) 1)Authorizes peace officers to administer an opioid antagonist to a person at risk of an opioid-related overdose. Requires the Emergency Medical Services Authority to develop and adopt training and standards for all prehospital emergency care personnel regarding the use and administration of naloxone and other opioid antagonists and to include the administration of naloxone in the training and scope of practice, consistent with current law, for emergency medical technician I certification. (Health and Safety Code Section 1797.170) 2)Authorizes a licensed health care provider who is authorized by law to prescribe an opioid antagonist to prescribe and subsequently dispense or distribute an opioid antagonist to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist a AB 1748 Page 9 person at risk of an opioid-related overdose. (Civil Code Section 1714.22) 3)Permits a pharmacist to furnish naloxone pursuant to standardized procedures or protocols developed and approved by the California Board of Pharmacy and the Medical Board of California. (Business and Professions Code Section 4052.01) FISCAL EFFECT: Unknown 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 surgeon. The bill requires the SPI to establish minimum standards for training, in consultation with the State Department of Public Health, the Emergency Medical Services Authority, the California School Nurses Organization, the California Medical Association, the American Academy of Pediatrics, and others. 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. AB 1748 Page 10 Opioid overdose. According to the author, "Drug overdoses are now the leading cause of injury death in the United States, surpassing motor vehicle crash deaths." According to the Centers for Disease Control and Prevention (CDC), from 2000 to 2014, nearly half a million people died from drug overdoses; the majority of drug overdose deaths involve an opioid, including prescription pain relievers and heroin. The most common prescription drugs involved in overdose deaths include methadone, oxycodone (OxyContin ) and hydrocodone (Vicodin ). More recently, fentanyl, a pain reliever that is 50 to 100 times more potent than morphine, has been found in prescription painkiller Norco or what individuals thought was Norco, killing 10 people in the Sacramento area within a two week period. Problem among youth. The 2014 National Survey on Drug Use and Health reported that 50.5% of people who misused prescription painkillers got them from a friend or relative. The survey also reported an estimated .7 percent of adolescents aged 12 to 17 (approximately 168,000) had a pain reliever use disorder in 2014, while 18,000, representing .1 percent of adolescents in the same age group, had a heroin use disorder in 2014. 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. AB 1748 Page 11 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. In a 2014 National Public Radio story, a deputy fire chief from Revere, Massachusetts, said, "It's just incredible, it's like magic?.There's somebody who's on the ground who's literally dead. They have no pulse. Sometimes they're blue, sometimes they're black. And you administer this stuff and sometimes, in a minute or two or three, they're actually up and talking to you." Naloxone is effective for 20 to 90 minutes, during which time emergency services should be sought for the patient. When injected into an overdose victim whose heart is still beating, "it's virtually 100% effective," said Wilson Compton, deputy director at the National Institute on Drug Abuse. 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 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. Even with AB 1748 Page 12 training, the Committee may wish to consider whether individuals with no or little medical background should be given more and more medical-type duties. Training. This bill requires the SPI to develop minimum standards for training volunteers, which is provided by a school nurse or other qualified person designated by an authorizing physician and surgeon. The training must cover techniques for recognizing symptoms of an opioid overdose; standards and procedures for storage, restocking, and emergency use of naloxone; emergency followup procedures; and the importance of instruction and certification in cardiopulmonary resuscitation. The training shall also include written materials on the topics covered by the training. According to the author's office, the training is intended to include hands-on experience in administering naloxone. The California School Employees Association (CSEA) expresses concerns about the over-reliance on the use of school personnel (often classified employees) as volunteers. While "voluntary," CSEA is concerned that classified employees are often pressured into stepping into volunteer roles. The bill contains language requiring a school district, COE, or charter school to ensure that volunteers will be provided defense and indemnification for any and all civil liability in accordance with the Government Code. The bill also specifies that a volunteer who acts with reasonable care in administering naloxone or another opioid antagonist in good faith shall not be subject to professional review, be liable in a civil action or be subject to criminal prosecution for this administration. To strengthen protections for volunteers, staff recommends the following amendments: 1)Clarify that a volunteer may rescind his or her offer to act as a volunteer at any time, including after receipt of training. AB 1748 Page 13 2)Require the notice to all staff to include information about a volunteer's right to rescind his or her agreement to be a volunteer. 3)Allow a volunteer to administer naloxone hydrochloride or another opioid antagonist in the form the volunteer is most comfortable with (syringe, auto-injector or nasal spray). Immunity for school nurses. In addition to providing immunity for volunteers, the bill also 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 issuance of a prescription unless the action constitutes gross negligence or willful or malicious conduct. The California School Nurses Organization (CSNO) has a "Support if Amended" position and seeks an amendment to provide protection to school nurses similar to those provided to physician and surgeons and volunteers. Since this bill is double-referred to the Judiciary Committee, which will consider these legal issues, the author may wish to consider the CSNO's request in that Committee. Writing in support of the bill, the Drug Policy Alliance states, "Naloxone is non-narcotic, does not produce intoxication, and has no potential for addiction or abuse?.Public health experts agree that increasing access to naloxone is a key strategy in preventing drug overdose deaths. The American Medical Association, the White House office of National Drug Control Policy, the US Department of Justice, and the Director of the National Institutes of Drug Abuse, among others, have called for expanded access to naloxone." REGISTERED SUPPORT / OPPOSITION: AB 1748 Page 14 Support California School Nurses Organization (if amended) Drug Policy Alliance Opposition None on file Analysis Prepared by:Sophia Kwong Kim / ED. / (916) 319-2087