BILL ANALYSIS Ó SB 669 Page 1 SENATE THIRD READING SB 669 (Huff) As Amended September 3, 2013 Majority vote SENATE VOTE :38-0 BUSINESS & PROFESSIONS 13-0 JUDICIARY 10-0 ----------------------------------------------------------------- |Ayes:|Gordon, Jones, Bocanegra, |Ayes:|Wieckowski, Wagner, | | |Campos, Dickinson, | |Alejo, Chau, Dickinson, | | |Eggman, Hagman, Holden, | |Garcia, Gorell, | | |Maienschein, Mullin, | |Maienschein, Muratsuchi, | | |Skinner, Ting, Wilk | |Stone | | | | | | ----------------------------------------------------------------- APPROPRIATIONS 17-0 ----------------------------------------------------------------- |Ayes:|Gatto, Harkey, Bigelow, | | | | |Bocanegra, Bradford, Ian | | | | |Calderon, Campos, | | | | |Donnelly, Eggman, Gomez, | | | | |Hall, Holden, Linder, | | | | |Pan, Quirk, Wagner, Weber | | | | | | | | ----------------------------------------------------------------- SUMMARY : Permits a prehospital emergency medical care person or lay rescuer to obtain and use an epinephrine auto-injector (EA) in emergency situations with certification of training, as specified. Specifically, this bill : 1)Permits a pharmacy to dispense EAs to a prehospital emergency medical care person or lay rescuer for the purpose of rendering emergency care, as specified, if both of the following requirements are met: a) A physician and surgeon provides a written order, as follows, that specifies the quantity of EAs to be dispensed to prehospital emergency medical care person or a lay rescuer: i) The physician and surgeon has issued the SB 669 Page 2 prescription upon presentation of a current certificate demonstrating that the person is trained and qualified, as specified, to administer an EA to another person in an emergency situation; and, ii) The prescription specifies that the dispensed EA is for "First Aid Purposes Only" and that the named recipient is a "Section 1797.197a Responder;" and a new prescription is required for any additional EAs; and, b) The pharmacy labels each EA dispensed with all of the following: i) The name of the person to whom the prescription was issued; ii) The designations "Section 1797.197a Responder" and "First Aid Purposes Only"; and, iii) The dosage, use, and expiration date. c) Requires each dispensed prescription to include the manufacturer's product information sheet for the EA. 2)Requires each person receiving EAs according to this bill to make and maintain a record for five years reflecting dates of receipt, use, and destruction of each EA dispensed, the name of any person to whom epinephrine was administered using an EA, and the circumstances and manner of destruction of any EAs. 3)States that the EAs dispensed pursuant to this bill may only be used for the following purposes and circumstances: a) The EA is legally obtained by prescription from an authorized health care provider for the purpose of rendering emergency care to another person, upon presentation of current certification demonstrating that person is trained and qualified to administer an epinephrine auto-injector as a prehospital emergency medical care person, or lay rescuer, pursuant to this bill or any other statute or regulation. b) The EA is only used on another person, with the SB 669 Page 3 expressed or implied consent of that person, to treat anaphylaxis; c) The EA is stored and maintained as directed by the manufacturer's instructions for that product; d) The person using the EA has successfully completed a course of training with an authorized training provider, as specified, and has current certification of training issued by the provider; e) The EA obtained by prehospital emergency medical care personnel, as specified, shall be used only when functioning outside the course of the person's occupational duties, or as a volunteer, pursuant to this bill; and, f) The Emergency Medical Services System is activated as soon as practicable when an EA is used. 4)Requires authorized training providers to be approved, and the minimum standards for training and the use and administration of EAs to be established and approved, by Emergency Medical Services Authority (EMS). 5)Permits EMS to designate existing training standards for the use and administration of EAs by prehospital emergency medical care personnel to satisfy the requirements of this section. 6)Requires the following to be included in the minimum training and requirements: a) Techniques for recognizing circumstances, signs, and symptoms of anaphylaxis; b) Standards and procedures for proper storage and emergency use of EAs; c) Emergency follow-up procedures, including activation of the Emergency Medical Services System, by calling the emergency 911 telephone number or otherwise alerting and summoning more advanced medical personnel and services; d) Compliance with all regulations governing the training, indications, use, and precautions concerning EAs; SB 669 Page 4 e) Written material covering the information required under this bill, including the manufacturer product information sheets on commonly available models of EAs; and, f) Completion of a training course in cardiopulmonary resuscitation (CPR) and the use of an automatic external defibrillator for infants, children, and adults that complies with regulations adopted by EMS and the standards of the American Heart Association or the American Red Cross, and a current certification for that training. 7)States that certification of training shall be valid for no more than two years, after which recertification with an authorized training provider is required. 8)Authorizes the EMS director to deny, suspend, or revoke any approval issued by this bill or may place any approved training provider on probation upon a finding by the director of an imminent threat to public health and safety, as evidenced by any of the following: a) Fraud; b) Incompetence; c) The commission of any fraudulent, dishonest, or corrupt act that is substantially related to the qualifications, functions, or duties of training program directors or instructors; d) Conviction of any crime that is substantially related to the qualifications, functions, or duties of training program directors or instructors. The record of conviction or a certified copy of the record shall be conclusive evidence of the conviction; or, e) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of this section or the regulations promulgated by the authority pertaining to the review and approval of training programs in anaphylaxis and the use and administration of EA. SB 669 Page 5 9)Requires EMS to assess a fee pursuant to regulation sufficient to cover the reasonable costs incurred by EMS for the ongoing review and approval of training and certification. 10)Requires the fee to be deposited in the Specialized First Aid Training Program Approval Fund (Fund), which is created in the State Treasury, and all monies deposited in the fund shall be made available, upon appropriation, to the authority for purposes of authorizing training providers. 11)Permits EMS to transfer unused portions of the Fund to the Surplus Money Investment Fund (SFund). Funds transferred to the SFund shall be placed in a separate trust account, and shall be available for transfer to the Fund, together with the interest earned, when requested by EMS. 12)Requires EMS to maintain a reserve balance in the Fund of 5% of annual revenues. Any increase in the fees deposited in the Fund shall be effective upon determination by EMS that additional moneys are required. 13)Exempts certain provisions of this bill for a school district or county office of education, or its personnel, which provides and utilizes EAs to provide emergency medical aid, as specified. 14)States that this bill shall not be construed to limit or restrict the ability of prehospital emergency medical care personnel, under any other statute or regulation, to administer epinephrine, including the use of EAs, or to require additional training or certification beyond what is already required under the other statute or regulation. 15)States that any person authorized by this bill who administers an EA, in good faith and not for compensation, to another person who appears to be experiencing anaphylaxis at the scene of an emergency situation is not liable for any civil damages resulting from his or her acts or omissions in administering the EA, if that person has complied with the requirements and standards of this bill. 16)States that the liability exemption shall not apply in a case of personal injury or wrongful death that results from the gross negligence or willful or wanton misconduct of the person SB 669 Page 6 who renders emergency care treatment by the use of an EA. 17)States that nothing in this bill relieves a manufacturer, designer, developer, distributor, or supplier of an EA of liability under any other applicable law. 18)Defines the terms "Anaphylaxis," "EA," "Lay rescuer," and "Prehospital emergency medical care person." 19)Makes clarifying and technical amendments. 20)States that no reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution. FISCAL EFFECT : According to the Assembly Appropriations Committee: 1)One-time costs to EMSA of $500,000 General Fund (GF) over two years to convene a task force, revise and create regulations related to training standards, create an approval process for training providers, and modify IT systems. 2)Ongoing costs to EMSA of $200,000 (special fund) annually to review and update standards, and to approve training providers. 3)Ongoing fee revenue of $200,000 to the Specialized First Aid Training Approval special fund to support ongoing program activities. COMMENTS : 1)Purpose of this bill . This bill authorizes prehospital emergency medical care personnel and lay rescuers to obtain and use an EA in emergency situations after receiving certification of training. This bill is aimed at expanding the use of EA's by authorizing additional qualified personnel to use them and granting immunity from civil liability when SB 669 Page 7 used properly. This bill is sponsored by Conference of California Bar Associations. 2)Author's statement . According to the author's office, California law permits school nurses and trained personnel to obtain and use [EAs] to provide emergency medical aid to students experiencing anaphylactic shock, where authorized by local school board or county offices of education, and permits school nurses and designated personnel to assist a student in the self-administration of an epinephrine auto-injector provided a current authorization and release is on file. These laws are consistent with laws adopted across the nation reflecting the understanding that the timely administration of epinephrine is essential to avoiding serious injury or death in cases of anaphylaxis, and that epinephrine auto-injectors - which contain carefully metered doses of this life-saving medication - are safe to administer by properly trained individuals. [EAs] are safe, consumer-friendly, in widespread distribution, intended to be carried and self-administered by adults and even children to protect against life-threatening anaphylactic shock. The problem is that the risk of anaphylaxis is not limited to children, nor is it limited to school or home. Suffocation and death from an anaphylactic reaction to substances can occur anywhere, anytime, to anyone, without warning or adequate time to obtain definitive medical care. Under current law, it is illegal for first responders to possess or carry [EAs] to save lives for anyone else suffering anaphylaxis, be it in the wilderness, or even in the community where medical care cannot be timely obtained. Not everyone who has been prescribed an [EA] will have it at the time of need. Not everyone who has one will be able to self-administer it in time. Further, not SB 669 Page 8 everyone who suffers a potentially lethal anaphylactic reaction will have known of their allergic predisposition in advance, much less have had an [EA] prescribed. Yet, people are unnecessarily exposed to the real risk of death. People die from anaphylaxis because what they need---epinephrine---is not always readily available by someone who can legally administer it. SB 669 addresses this real but unnecessary problem. It allows those group leaders or first responders who successfully complete a certified training course, to obtain and use [EA] to provide life-saving first aid in the event of anaphylaxis, just as many are already trained and authorized to do in rendering immediate CPR, administering a shock from an automatic external defibrillator, applying tourniquets for unremitting life-threatening hemorrhage, and effectuating emergency evacuations even in face of spinal injuries. And, like other Good Samaritan laws, it provides immunity to properly certified individuals from civil liability, except in cases of gross negligence. 3)Epinephrine and auto-injectors . According to the National Institutes of Health, an epinephrine injection is used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Epinephrine works by relaxing the muscles in the airways and tightening the blood vessels. An auto-injector is usually a type of easy-to-use spring-loaded syringe, intended for self-administration by the patient or by untrained personnel. 4)Providers currently authorized to administer EAs . In addition to certain licensed healthcare professionals, existing law permits a school nurse or other qualified person designated by the school district physician, the medical director of the local health department, or the local emergency medical SB 669 Page 9 services director to administer an EA. This bill would permit prehospital emergency medical care persons, and lay rescuers to obtain and administer EAs with proper training and certification as well. 5)EA authorization in other states . According to information provided by the author's office, seven states (Arkansas, Florida, Maryland, Missouri, North Carolina, North Dakota, and South Carolina) have certificate programs for lay rescuers, typically providing for the training and certification of persons who reasonably expect to have responsibility for others as a result of occupational or volunteer status, such as camp counselors, forest rangers, and tour guides. Certified persons are authorized to obtain EAs and are granted "Good Samaritan" liability protection. Six other states also provide some form of immunity for EA use. Three states provide Good Samaritan immunity for persons who have received authorized training (Connecticut, New York, and Oregon), and more three states deem that the administration of epinephrine by a volunteer rescuer in an emergency is entitled to Good Samaritan protection (Arizona, Rhode Island, and Virginia). Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916) 319-3301 FN: 0002268