BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 669 AUTHOR: Huff INTRODUCED: February 22, 2013 HEARING DATE: April 17, 2013 CONSULTANT: Marchand SUBJECT : Emergency medical care: epinephrine auto-injectors. SUMMARY : Permits a prehospital emergency medical care person, first responder, or a lay rescuer to use an epinephrine auto-injector to render emergency care to another person if certain requirements are met, including obtaining specified training and certification. Permits a health care provider to issue a prescription, and permits a pharmacy to dispense, an epinephrine auto-injector to a person who presents current certification as meeting the requirements of this bill. Provides immunity from civil liability to a person who administers an epinephrine auto-injector in conformance with this bill. Existing law: 1.Permits a school district or county office of education to provide emergency epinephrine auto-injectors to trained personnel, and permits trained personnel to utilize these epinephrine auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction. 2.Permits each elementary and secondary school to designate one or more school personnel on a voluntary basis to receive initial and annual refresher training, based on standards developed by the Superintendent of Public Instruction in consultation with organizations with expertise, including the Emergency Medical Services Authority and others. 3.Permits a school nurse, or if the school does not have a nurse then the person who has received the training, to obtain from the school district physician, the medical director of the local health department, or the local emergency medical services director a prescription for epinephrine auto-injectors. 4.Permits a school nurse, or if the school does not have a nurse then the person who has received the training, to immediately administer an epinephrine auto-injector to a person exhibiting Continued--- SB 669 | Page 2 potentially life-threatening symptoms of anaphylaxis at school or a school activity when a physician is not immediately available. 5.Provides civil liability immunity, with certain restrictions, to persons who complete a basic cardiopulmonary resuscitation course and who, in good faith, renders emergency cardiopulmonary resuscitation at the scene of an emergency. 6.Provides civil liability immunity to any person who, in good faith and not for compensation, renders emergency care or treatment by the use of an automated external defibrillator at the scene of an emergency. Specifies that the protections in this bill do not apply in the case of personal injury or wrongful death that results from the gross negligence or willful or wanton misconduct of the person who renders emergency care by the use of an automated external defibrillator. 7.Provides civil liability immunity, as part of a pilot project in seven counties, to a person who administers an opioid antagonist, who is not otherwise licensed to do so, in an emergency without fee if the person has received specified training. Sunsets this provision on January 1, 2016. 8.Establishes the Emergency Medical Services Authority (EMSA) within the California Health and Human Services Agency, and requires EMSA, among other things, to develop planning and implementation guidelines for emergency medical services systems which address specified components, including manpower and training, communications, transportation, system organization and management, data collection and evaluation, and disaster response. 9.Defines pre-hospital emergency medical personnel as any of the following: authorized registered nurse or mobile intensive care nurse, emergency medical technician (EMT)-I EMT-II, EMT-paramedic, lifeguard, firefighter, or peace officer, as defined, or a physician who provides pre-hospital emergency medical care or rescue services. This bill: 1.Permits a pre-hospital emergency medical care person, first responder, or a lay rescuer to use an epinephrine auto-injector to render emergency care to another person if all of the following requirements are met: SB 669 | Page 3 a. The epinephrine auto-injector is legally obtained by prescription from an authorized health care provider; b. The epinephrine auto-injector is used on another person, with the expressed or implied consent of that person, for the treatment of anaphylaxis, as defined; c. The epinephrine auto-injector is stored and maintained as directed by the manufacturer's instructions; and, d. The person using the epinephrine auto-injector has successfully completed a course of training with an authorized training provider, as described in this bill, and has current certification of training issued by the provider. 2.Permits a pharmacy, notwithstanding any other provision of law, to dispense epinephrine auto-injectors to a pre-hospital emergency care person, first responder, or lay rescuer for the purpose of rendering emergency care if both of the following requirements are met: a. A physician provides a written order that specifies the quantity of epinephrine auto-injectors to be dispensed to a person who has a current training certification, as specified, and the prescription specifies that the auto-injector is for "EMS Purposes Only" and that the named recipient is a "Section 1797.197a Responder;" b. The pharmacy includes the manufacturer's product information sheet for the epinephrine auto-injector and labels each epinephrine auto-injector with the following information: the name of the person to whom the prescription is issued; the designations "Section 1797.197a Responder" and "EMS Purposes Only"; and, the dosage, use and expiration date. 3.Requires a person who is certified, pursuant to the provisions of this bill, as being able to use an epinephrine auto-injector to render emergency care to another person, to make and maintain a record for five years reflecting the dates of receipt, use, and destruction of each auto-injector dispensed, the name of any person to whom epinephrine was administered, and the circumstances and manner of destruction of any auto-injectors. 4.Limits the use of epinephrine auto-injectors dispensed pursuant to this bill to only the purpose, and under the circumstances, described in this bill. SB 669 | Page 4 5.Permits an authorized health care provider to issue a prescription for an epinephrine auto-injector to a person who presents current certification demonstrating that person is trained and qualified, under the provisions of this bill, to administer an epinephrine auto-injector. 6.Requires the authorized training providers, the minimum standards for training, and the use and administration of epinephrine auto-injectors under this bill to be established and approved by EMSA in consultation with the local emergency medical system agency, the county health department, manufacturers, the Department of Health Care Services, the American Academy of Allergy, Asthma and Immunology, the American Academy of Pediatrics, the American Heart Association, the American Red Cross, and the California Medical Association. 7.Requires the minimum training and requirements to include all of the following components: a. Techniques for recognizing circumstances, signs, and symptoms of anaphylaxis; b. Standards and procedures for proper storage and emergency use of epinephrine auto-injectors; c. Emergency follow-up procedures, including 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 epinephrine auto-injectors; e. Written material covering the required information, including the manufacturer product information sheets on commonly available models of epinephrine auto-injectors; f. Completion of a training course in cardiopulmonary resuscitation and the use of an automatic external defibrillator for infants, children, and adults that complies with regulations adopted by the Emergency Medical Services Authority and the standards of the American Heart Association or the American Red Cross, and a current certification for that training; and g. Training certification for no more than two years, after which recertification with an authorized training provider is required. 8.Requires the minimum standards established and approved under this bill to apply to a school district or county office of education, and permits a school district or county office of SB 669 | Page 5 education to adopt more stringent standards for training and the use of epinephrine auto-injectors under specified provisions of the Education Code pertaining to the use of epinephrine in school settings. 9.Provides immunity from civil liability to any person who is certified under this bill who administers an epinephrine auto-injector to another person who appears to be experiencing anaphylaxis at the scene of an emergency situation, in good faith and not for compensation, as long as that person has complied with the requirements and standards of this bill. Specifies that this provision does not grant civil immunity to any person whose conduct in rendering emergency care constitutes gross negligence. 10.Provides immunity from civil liability to any local agency, entity of state or local government, or other public or private organization that sponsors, authorizes, supports, finances or supervises the training of persons to use epinephrine auto-injectors under the provisions of this bill, in order to encourage training. 11.Specifies that nothing in this bill relieves a manufacturer, designer, developer, distributor, or supplier of an epinephrine auto-injector of liability under any other applicable law. 12.Defines various terms for purposes of this bill, including: a. "Anaphylaxis" as a potentially life-threatening hypersensitivity or allergic reaction to a substance, with causes including insect stings or bites, foods, drugs, and other allergens; b. "Epinephrine auto-injector" as a disposable drug delivery system with a spring-activated concealed needle that is designed for emergency administration of epinephrine to provide rapid, convenient first aid for persons suffering from anaphylaxis; c. "First responder" as a police officer, firefighter, rescue worker, or any other person who provides emergency response, first aid care, or other medically related assistance either in the course of the person's occupational duties or as a volunteer; and d. "Lay rescuer as a person not otherwise licensed or certified to use an epinephrine auto-injector on another person who has met the training standards and other SB 669 | Page 6 requirements of this bill. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1.Author's statement. California recently joined other states in finally allowing school nurses to obtain and use epinephrine auto-injectors on students suffocating from anaphylactic shock who were not prescribed an epinephrine auto-injector by their physician. While the use of epinephrine auto-injectors to combat a potentially lethal anaphylactic reaction mostly focuses on protecting kids in school, and even training non-nurses or medical professionals---such as teachers, coaches, group leaders - in how to use it, the same analysis should apply to protecting children when they are not in a school environment. Both adults and children need life-saving intervention when they are not on school grounds. This is why we see states slowly moving to what is being proposed by SB 669. We must allow first responders who receive training to obtain and use these epinephrine auto-injectors - just as they are authorized to do life-saving CPR or administer an automatic external defibrillator, or apply tourniquets. 2.What is anaphylaxis? According to the National Institutes of Health, anaphylaxis is a severe, whole-body allergic reaction to a chemical that has become an allergen. After being exposed to a substance such as bee sting venom, the person's immune system becomes sensitized to it. When the person is exposed to that allergen again, an allergic reaction may occur. Anaphylaxis happens quickly after the exposure, is severe, and involves the whole body. Tissues in different parts of the body release histamine and other substances. This causes the airways to tighten and leads to other symptoms. Some drugs (morphine, x-ray dye, aspirin, and others) may cause an anaphylactic-like reaction (anaphylactoid reaction) when people are first exposed to them. These reactions are not the same as the immune system response that occurs with "true" anaphylaxis. However, the symptoms, risk for complications, and treatment are the same for both types of reactions. Anaphylaxis can occur in response to any allergen. Anaphylaxis is life-threatening and can occur at any time. Risks include a history of any type of allergic reaction. 3.What is an epinephrine auto-injector? An epinephrine SB 669 | Page 7 auto-injector is a medical device used to deliver a measured dose of epinephrine (also known as adrenaline) using autoinjector technology, most frequently for the treatment of acute allergic reactions to avoid or treat the onset of anaphylaxis. The EpiPen (and the version for smaller children, the EpiPen Jr.) are commonly used epinephrine auto-injectors. According to Mylan, which makes the EpiPen and EpiPen Jr., the EpiPen contains 0.3mg of epinephrine and is intended for those who weigh 66 pounds or more, while the EpiPen Jr. contains 0.15mg, and is intended for patients weighing between 33 to 66 pounds. Mylan's product information states that it is not known if EpiPen and EpiPen Jr. are safe and effective in children who weigh less than 33 pounds. The devices are intended to be injected into the middle of the outer thigh, and patients are directed not to inject the device into a vein, buttock, fingers, toes, hands or feet. 4.Study on unintentional injections. An article published in the February 2010 issue of the Journal of Allergy and Clinical Immunology, Voluntarily reported unintentional injections from epinephrine auto-injectors, found that from 1994 to 2007, a total of 15,190 unintentional injections from epinephrine auto-injectors were reported to US Poison Control Centers, with 60% of those reported from 2003 to 2007. Those unintentionally injected had a median age of 14 years, and 85% were injected in a home or other residence. Management of the individual was documented in only 4101 of the cases. In these 4101 cases, 49% of the clinical effects were described as "minor," 20% were described as "minimal clinical effects, not followed," and 15% were described as "moderate." Only 27 cases (0.2%) were reported as "major effect," which was described as "significant signs or symptoms." Most of the unintentional injections (76%) were in a finger or thumb. 5.Double referral. This bill is double referred. Should it pass out of this committee, it will be referred to the Senate Judiciary Committee. 6.Prior legislation. AB 559 (Wiggins), Chapter 458, Statutes of 2001, established provisions of law that permit a school district or county office of education to provide emergency epinephrine auto-injectors to trained personnel, and permit trained personnel to utilize these epinephrine auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction at a school or during a school activity. SB 669 | Page 8 7.Support. This bill is sponsored by the Conference of California Bar Associations (CCBA), representing more than 25 metropolitan, regional and specialty bar associations. CCBA states that like almost all states, California has responded to the dangers of anaphylaxis in our schools by enacting legislation to permit school districts or county offices of education to provide emergency epinephrine auto-injectors to trained personnel, and to permit those personnel to utilize these auto-injectors to provide emergency medical aid to students suffering from an anaphylactic reaction. CCBA states that this bill would enable California to join a growing group of states that provide training in the proper use of epinephrine auto-injectors and which makes these auto-injectors available by prescription to individuals who have successfully completed the training. The purpose of this bill is to increase the chances that if a person suffers a life-threatening allergic reaction, there will be someone close by with an epinephrine auto-injector. Additionally, if the person already has their own epinephrine auto-injector but is unable to use it, this bill will increase the odds there will be someone close by who can assist in the proper administration. This bill is supported by the California Hospital Association (CHA), which states that death from anaphylaxis remains a real and widespread problem. Currently, anaphylaxis leads to 500-1,000 deaths per 2.4 million in the United States. While mortality rates have decreased, the incidence of anaphylaxis appears to be increasing from 20 per 100,000 per year in the 1980s to 50 per 100,000 in the 1990s. CHA states that there is no effective treatment to prevent anaphylactic cardiac arrest in the community unless the victim has an epinephrine auto-injector and is able to self-administer the injection before losing consciousness. 8.Oppose unless amended. The California School Employees Association, AFL-CIO (CSEA) is opposed to this bill unless it is amended to ensure that the provisions of this bill do not in any way impact current epinephrine auto-injector laws governing school districts and county offices of education and their employees. CSEA is requesting that the provision in this bill applying the minimum standards created by this bill to school districts and county offices of education be deleted from the bill (p. 7, lines 16-20). Additionally, CSEA is requesting that a new provision be added which states the SB 669 | Page 9 following "(d) This section shall not apply to school districts and county offices of education and their personnel in epinephrine auto-injector programs established pursuant to Section 49914 of the Education Code." The Consumer Attorneys of California (CAC) have also written a letter of concern, stating that this bill provides broad immunities to persons who use an epinephrine auto-injector to render emergency care to another person. CAC states that while it recognizes the benefit to have appropriately trained personnel deliver life-saving injections, it would like to work with the author and sponsor to narrow the bill if or as it proceeds to the Senate Judiciary Committee. 9.Prehospital emergency personnel may already have this ability. This bill permits not only lay rescuers, but also prehospital emergency medical care personnel and first responders to administer an epinephrine auto-injector, but only if the person is trained and certified under the provisions of this bill. This bill requires EMSA to establish and approve the training standards. However, some prehospital emergency personnel already have it within their scope of practice to administer epinephrine, and this bill could be interpreted to require these personnel to get additional training and certification before they are permitted to continue utilizing this part of their training. According to EMSA, epinephrine auto-injectors are a local optional scope of practice item for EMT-Is (meaning it would have to be approved by the local emergency medical services agency), while EMT-II/Advanced EMTs and EMT-Paramedics have the administration of epinephrine for allergic reaction in their basic scopes of practice. When it is part of their scope of practice, EMSA states that the EMTs employer would stock the epinephrine auto-injectors. The author may wish to consider amending this bill to ensure that any professional who is already licensed to administer epinephrine auto-injectors under their current scope of practice may continue to do so without obtaining the additional training and certification required by this bill. 10.Technical amendments. On page 6, lines 23 through 25, this bill requires EMSA to consult with "the local emergency medical system agency, the county health department," and the Department of Health Care Services. Given that there are multiple county health departments and multiple local SB 669 | Page 10 emergency medical services agencies, this bill should either delete these references, or specify that EMSA consult with a "representative from a local emergency medical services agency" and "a representative from a county health department." Additionally, the bill should refer to the Department of Public Health, rather than the Department of Health Care Services, which primarily governs the state's Medi-Cal program. SUPPORT AND OPPOSITION : Support: Conference of California Bar Associations (sponsor) California Hospital Association Oppose: None received -- END --