BILL ANALYSIS Ó SENATE JUDICIARY COMMITTEE Senator Hannah-Beth Jackson, Chair 2015-2016 Regular Session AB 1386 (Low) Version: June 13, 2016 Hearing Date: June 21, 2016 Fiscal: Yes Urgency: No RD SUBJECT Emergency medical care: epinephrine auto-injectors DESCRIPTION This bill would allow "authorized entities," as defined to include both private and government entities, to obtain epinephrine auto-injectors for the use of any one of their employees, volunteers, or agents, who is a lay rescuer, as specified, to render emergency care to another person. This bill would further ensure, however, that the failure of an authorized entity to possess or administer an epinephrine auto-injector shall not result in civil liability. Additionally, this bill would apply an existing qualified immunity for physicians and surgeons who write prescriptions for epinephrine auto-injectors for use in schools to physicians and surgeons who write prescriptions to prehospital medical care persons, laypersons, or for use of qualifying employees, volunteers, or agents of authorized entities. Lastly, this bill would also authorize pharmacies to furnish prescriptions to authorized entities for these purposes, as specified, and would otherwise revise existing requirements and standards under the Health and Safety Code relating to the administration of epinephrine auto-injectors by Good Samaritans in emergencies. BACKGROUND An epinephrine auto-injector is a disposable medical drug delivery device that delivers a single measured dose of epinephrine, most frequently for the treatment of acute allergic reactions to avoid or treat the onset of anaphylactic shock. AB 1386 (Low) Page 2 of ? Anaphylactic shock can quickly result in death if untreated. Epinephrine auto-injectors can be obtained by prescription only, and California law does not authorize non-physicians to administer an epinephrine auto-injector to another person, except in limited circumstances. Over the years, California law has been amended to permit school districts or county offices of education to provide emergency epinephrine auto-injectors to trained personnel, and to permit trained personnel to utilize the auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction, as it is not uncommon for children to come into contact with specific allergens (such as bee stings) or accidentally ingest foods they are allergic to at school. (See AB 559 (Wiggins, Ch. 458, Stats. 2001); see also SB 1266 (Huff, Ch. 321, Stats. 2014), which was subsequently enacted to require, as opposed to simply authorize, school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to voluntary, trained personnel who, consistent with existing law, may use the auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction.) More recently, in 2013, California law was expanded to also permit certain Good Samaritans (specifically, prehospital emergency medical care persons or lay rescuers), to obtain and administer epinephrine auto-injectors to provide emergency medical aid to persons suffering from anaphylactic shock. (SB 669 (Huff, Ch. 725, Stats. 2013).) In doing so, the legislation granted such individuals, acting in good faith and not for compensation, immunity for any civil damages resulting from any acts or omissions in administering the auto-injector to a person who appears to be experiencing anaphylaxis at the scene of an emergency, as long as the person did not act with gross negligence or willful or wanton misconduct and otherwise complies with certain requirements and standards, including training requirements. Of import to this bill, just this last year, SB 738 (Huff, Ch. 132, Stats. 2015) was brought to address an issue of concern for doctors who are needed to write these prescriptions so that schools may obtain and stock epinephrine auto-injectors as required by these bills. The proponents of SB 738 reported that schools were having difficulty obtaining epinephrine auto-injectors because doctors were declining to write those AB 1386 (Low) Page 3 of ? prescriptions out of fear of both professional disciplinary action and both civil and criminal liability from any resulting acts or omissions in relation to the administration of the prescribed auto-injector in an emergency. While these types of Good Samaritan laws have largely stopped short (intentionally so) of providing immunity to individuals for negligent acts or omissions in the performance of their professional duties, it has also become clear that doctors, in their ordinary practice of medicine, do not and cannot prescribe medication to third persons. Accordingly, SB 738 was enacted to grant any physician or surgeon issuing a prescription or order for these purposes immunity from any potential civil or criminal liability or from professional disciplinary action, unless the physician and surgeon's issuance constitutes gross negligence or willful or malicious conduct. This bill would now add authorization for other "authorized entities" to obtain epinephrine auto-injectors so that any employees, volunteers, or agents of the entity who otherwise meet the existing definition of "lay rescuer" could render emergency care to a person who appears to be suffering from anaphylaxis in accordance with existing law for lay rescuers. This bill would extend the existing qualified immunity for physicians and surgeons to physicians and surgeons who write prescriptions to prehospital medical care persons, laypersons, or for use of qualifying employees, volunteers, or agents of authorized entities, in accordance with specified law. CHANGES TO EXISTING LAW 1.Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to school nurses or trained personnel who have volunteered, as specified, and provides that school nurses or trained personnel may use epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. (Ed. Code Sec. 49414(a).) Existing law provides for the defense and indemnification of any employees who volunteer under this law, from any and all civil liability, in accordance with, but not limited to, the Government Tort Claims Act, as specified. (Ed. Code Sec. 49414(j).) Existing law provides that an authorizing physician and surgeon shall not be subject to professional review, be liable AB 1386 (Low) Page 4 of ? in a civil action, or be subject to criminal prosecution for the issuance of a prescription or order, for the above purposes, unless the physician and surgeon's issuance of the prescription or order constitutes gross negligence or willful or malicious conduct. (Ed. Code Sec. 49414(g)(4).) Existing law provides that any prehospital emergency medical care person or lay rescuer who administers an epinephrine auto-injector, 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 epinephrine auto-injector, if that person has complied with the requirements and standards of Section 1797.197a of Health and Safety Code, below. This protection from civil liability does 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 who renders emergency care treatment by the use of an epinephrine auto-injector. (Civ. Code Sec. 1714.23(b), (c).) This bill would add to the Civil Code that an authorized entity shall not be liable for any civil damages resulting from any act or omission other than an act or omission constituting gross negligence or willful or wanton misconduct connected to the administration of an epinephrine auto-injector by any one of its employees, volunteers, or agents, who is a lay rescuer as defined under existing law. This bill would further provide that the failure of an authorized entity to possess or administer an epinephrine auto-injector shall not result in civil liability. This bill would provide the proposed qualified immunity for authorized entities, and the existing qualified immunity for prehospital emergency medical care person or lay rescuers, shall not affect any other immunity or defense available under law. This bill would add that an authorizing 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 pursuant to this section, unless the issuance of the prescription or order constitutes gross negligence or willful or malicious conduct. AB 1386 (Low) Page 5 of ? 2.Existing law , Section 1797.197a of the Health and Safety Code, requires the Emergency Medical Services authority (EMSA) to establish and approve the authorized training providers and minimum standards for training and the use and administration of epinephrine auto-injectors, as specified. The minimum training and requirements must include, among other things: techniques for recognizing circumstances, signs, and symptoms of anaphylaxis; standards and procedures for proper storage and emergency use of epinephrine auto-injectors; and specified emergency follow up procedures (e.g., calling 9-1-1). (Health & Saf. Code Sec. 1797.197a(c).) Existing law authorizes a prehospital emergency medical care person or lay rescuer to use an epinephrine auto-injector to render emergency care to another person if specified requirements are met. The requirements include, among other things, that: the auto-injector is legally obtained by prescription from an authorized health care provider, as specified; the auto-injector is used on another, with the express or implied consent of that person, for the purpose of treating anaphylaxis; the person using the auto-injector has successfully completed a training course, as specified and has current certification of training issued by the training provider; and the auto-injectors obtained by prehospital emergency medical care personnel from a pharmacy, as authorized by law, are used only when functioning outside the course of the person's occupational duties, or as a volunteer. (Health & Saf. Code Sec. 1797.197a(b).) Existing law permits an authorized health care provider to issue a prescription for an epinephrine auto-injector to a prehospital emergency medical care person or lay rescuer 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 specified. (Health & Saf. Code Sec. 1797.197a(b)(1).) This bill would, instead, authorize a prehospital medical care person or lay rescuer to use an epinephrine auto-injector to render emergency care to another person if, among other AB 1386 (Low) Page 6 of ? things, the epinephrine auto-injector is legally obtained by prescription from an authorized health care provider or from an authorized entity that acquired the epinephrine auto-injector, as specified, below. This bill would permit an authorized health care provider to issue a prescription for an epinephrine auto-injector to a prehospital emergency medical care person or a lay rescuer for the purpose of rendering emergency care to another person upon presentation of a current epinephrine auto-injector certification card issued by the EMSA demonstrating that the person is trained and qualified to administer an epinephrine auto-injector, as specified. This bill would similarly permit an authorized health care provider to issue a prescription for an epinephrine auto-injector to an authorized entity if the authorized entity submits evidence it employs at least one person, or utilizes at least one volunteer or agent, who is trained and has a current epinephrine auto-injector certification card issued by the EMSA demonstrating that the person is qualified to administer an epinephrine auto-injector, as specified. This bill would require a participating authorized entity to: create and maintain on its premises an operations plan that includes, among other things: o the names of the designated employees or agents who have completed the required training program, and who are authorized to administer the auto-injector; and o how and when the auto-injector will be inspected for an expiration date; and submit to the EMSA, as specified, a report of each incident that involves the use of an epinephrine auto-injector, not more than 30 days after each use. The EMSA must, in turn, annually publish a report that summarizes all such reports. This bill would define "authorized entity" to mean any for-profit, nonprofit, or government entity or organization that employs at least one person or utilizes at least one volunteer or agent that has voluntarily completed a training course, as required. 1.Existing law authorizes a pharmacy, notwithstanding any other provision of law, to furnish epinephrine auto-injectors to a AB 1386 (Low) Page 7 of ? school district, county office of education, or charter school pursuant to specified law, if: the auto-injectors are furnished exclusively for use at a school district site or county office of education; and a physician and surgeon provides a written order that specifies the quantity of auto-injectors to be furnished. (Bus. & Prof. Code Sec. 4119.2(a).) Existing law requires a school district, county office of education, or charter school to keep certain records of epinephrine auto-injectors furnished pursuant to the law, above, and makes the entities responsible for monitoring the supply of auto-injectors and ensuring the destruction of expired auto-injectors. (Bus. & Prof. Code Sec. 4119.2(b).) Existing law authorizes a pharmacy, notwithstanding any other law, to dispense epinephrine auto-injectors to a prehospital emergency medical care person or lay rescuer for the purpose of rendering emergency care, in accordance with Section 1797.197a, above, if: A physician and surgeon provides a written order that specifies the quantity of auto-injectors to be dispensed by a prehospital emergency medical care person or lay rescuer, as specified. The prescription may be issued only upon presentation of a current certificate demonstrating that the person is trained and qualified, as specified, to administer an auto-injector to another person in an emergency. The prescription must state certain information and a new prescription is required for any additional auto-injectors. The pharmacy must label each auto-injector dispensed with certain information, including the designations "Section 1797.197a Responder" and "First Aid Purposes Only." (Bus. & Prof. Code Sec. 4119.3(a).) Existing law requires a prehospital emergency medical care person or lay person receiving epinephrine auto-injectors pursuant to the above to make and maintain certain records, as specified, including as to the circumstances and manner of destruction of any auto-injectors. (Bus. & Prof. Code Sec. 4119.3(b).) Existing law specifies that the epinephrine auto-injectors dispensed to prehospital emergency medical care persons or lay rescuers pursuant to the above, may be used only for the AB 1386 (Low) Page 8 of ? purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code. (Bus. & Prof. Code Sec. 4119.3(c).) This bill would authorize a pharmacy, notwithstanding any other law, to furnish epinephrine auto-injectors to an "authorized entity" if: the auto-injectors are furnished exclusively for use by, or in connection with, an authorized entity; and an authorized health care provider provides a prescription that specifies the quantity of auto-injectors to be furnished. The pharmacy must label each auto-injector dispensed with certain information, such as: the name of the person or entity to whom the prescription was issued, and the designations "Section 1797.197a Responder" and "First Aid Purposes Only." This bill would require that the authorized entity maintain certain records of epinephrine auto-injectors furnished to them in accordance with the above, and would provide that the authorized entity shall be responsible for monitoring the supply and the destruction of expired epinephrine auto-injectors. This bill would specify that the epinephrine auto-injector dispensed to authorized entities pursuant to the above, may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code. 1.Existing law provides that an "epinephrine auto-injector" means 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. (Civ. Code Sec. 1714.23(a)(2); Health & Saf. Code Sec. 1797.197a(a)(1)(2), Educ. Code Sec. 49414(b)(3).) This bill would, instead, define "epinephrine auto-injector" to mean a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction. This bill would make other technical and non-substantive changes. AB 1386 (Low) Page 9 of ? COMMENT 1. Stated need for the bill According to the author: Allergies to food, insect stings and other substances that can cause anaphylaxis are increasing. There are approximately 90,000 emergency room visits and an estimated 1,500 deaths a year from anaphylaxis in the United States. This legislation would allow for greater access of epinephrine auto-injectors at locations where individuals could come into contact with allergens known to cause anaphylaxis in those with allergies. While existing law allows individuals who have been trained in recognition of symptoms of allergic reactions and anaphylaxis to administer epinephrine auto-injectors to others in an emergency and provides liability protection for these individuals, current law does not allow the business, group or entity that the individual is employed by or associated with to obtain a prescription for an epinephrine auto-injector or to have liability protection if the epinephrine auto-injector is used on the entities premises. 2. Q ualified immunity for authorized entities As a general rule, California law provides that everyone is responsible, not only for the result of his or her willful acts, but also for an injury occasioned to another by his or her want of ordinary care or skill in the management of his or her property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon himself or herself. (Civ. Code Sec. 1714(a).) Although immunity provisions are rarely preferable because they, by their nature, prevent an injured party from seeking a particular type of recovery, the Legislature has in limited scenarios approved limited immunity from liability (as opposed to blanket immunities) to promote other policy goals that could benefit the public. Along these lines, this Legislature has on multiple occasions, enacted legislation that encourages the use of life saving medications or medical interventions (such as automatic external defibrillators (AEDs), epinephrine auto-injectors (epi-pens), and opioid antagonists) in order to avoid preventable deaths by limiting the liability of "Good Samaritans," as long as certain minimal requirements are met. AB 1386 (Low) Page 10 of ? In most of those scenarios, however, the qualified immunity does not apply in the case of personal injury or wrongful death which results from the gross negligence or willful or wanton misconduct by the person who renders the care. (See Civ. Code Sec. 1714.21.) With respect to epi-pens, specifically, as noted in the Background, California law already encourages the use of this life-saving medication to avoid preventable deaths in both schools and in the general public. Recognizing that public employees (in particular, school nurses) already enjoy liability protections under the Government Tort Claims Act, existing law requires that schools provide defense and indemnification to employees who volunteer for training to administer epi-pens in emergency situations from any and all civil liability, in accordance with, but not limited to, that Act. (See Ed. Code Sec 49414.) Separately, the Civil Code provides certain Good Samaritans-namely, prehospital emergency care persons and lay persons, as defined-acting in good faith and not for compensation, qualified immunity from civil damages for any of their acts or omissions in administering the epi-pen to a person who appears to be suffering from anaphylaxis at the scene of emergency, if the person complies with certain requirements and standards, including training requirements. As mentioned above, this immunity is, however, qualified (i.e., limited), insofar as it does not apply to protect the person from civil damages in any personal injury or wrongful death case involving gross negligence or willful or wanton misconduct in rendering emergency care treatment by use of the auto-injector. This bill would now add similar protection from civil liability for authorized entities that choose to obtain epinephrine for use by their employees, volunteers, or agents, who otherwise meet the existing definition of "lay rescuer" to render emergency care to a person who appears to be suffering from anaphylaxis in accordance with existing law requirements for lay rescuers. In other words, these individuals would otherwise have to be trained and comply with any other standards of requirements that would apply to other lay rescuers in order to be subject to the existing qualified immunity when administering an epi-pen to render emergency medical care to a person who appears to be suffering from anaphylaxis. Notably, for these purposes, authorized entities include not only nonprofit or for profit private entities or organizations, but also government entities or organizations. Presumably, government entities are AB 1386 (Low) Page 11 of ? already significantly protected from liability under the Government Tort Claims Act. To the extent that this bill creates any new liability protections, however, for nonprofit and for profit entities that obtain epi-pens for such emergency use, or even for government entities, that immunity is also qualified and would not apply where there has been gross negligence or willful or wanton misconduct in connection with the administration of the epi-pen. In support, sponsor Mylan cites that nearly 6 million or 8 percent of children in the U.S. have food allergies-approximately 1 in 13. Food allergens account for 30 percent of fatal cases of anaphylaxis, of which there are approximately 1,500, annually. Mylan writes that "California has made great strides to address this issue, but more can be done to ensure that the state is better prepared in the event that children or adults experience an anaphylactic reaction for the first time or in a public location. Schools were a very important first step in addressing anaphylaxis. This legislation will build upon California's current school access law and expand access to this critical medication. This legislation would expand access to allow colleges and universities, churches, summer camps, sports arenas, restaurants, recreational parks and other places where children and adults could come into contact with potentially life-threatening allergens to stock epinephrine auto-injectors and allow trained personnel to administer them in emergencies." Staff notes, in the years since passing legislation encouraging the stocking and application of epi-pens for emergency use by both schools and trained individuals, the Committee has not received direct reports or anecdotes of any harm that has resulted from the availability and application of the medication by school volunteers, lay rescuers, or prehospital emergency care persons. 3. Suggested amendments to further clarify and narrow the qualified immunity As discussed above, this bill ensures that an authorized entity is not rendered immune from any acts or omissions of its employees, volunteers, or agents that constitute gross negligence or willful or wanton misconduct connected to the administration of the auto-injector. Staff notes, however, that the bill's qualified immunity for authorized entities should also be made contingent upon meeting the statutory requirements AB 1386 (Low) Page 12 of ? imposed on these authorized entities under the Health and Safety Code. Specifically, this bill would revise Section 1797.197a of the Health and Safety Code to require an authorized entity that possesses and makes available epinephrine auto-injectors to create and maintain, on its premises, a specified operations plan that includes, for example: where and how the auto-injector will be stored; the names of the designated employees or agents who have completed the required training program under existing law, and who are authorized to administer the injector; and how and when the auto-injector will be inspected for an expiration date. Furthermore, under that section, the entity would also have to submit a report of each incident that involves the use of an epinephrine auto-injector to the state Emergency Medical Services authority. And, notably, this particular statute (again, as to be amended by the bill) recognizes that the entity must submit evidence that it employs at least one person, or utilizes at least one volunteer or agent, who is trained and has a current epinephrine auto-injector certification card issued by the authority demonstrating that the person is qualified to administer an epinephrine auto-injector, as specified, in order to receive a prescription from a physician. Accordingly, the author has agreed to the following amendment to ensure that the entity has complied with its duties under the Health and Safety Code as a threshold matter, in order to enjoy any immunity for any negligent acts or omissions of its qualifying employees, volunteers, or agents in connection to their administration of the auto-injector: Suggested amendment: On page 5, line 7, add to the end of the sentence: ", if the entity has complied with all applicable requirements of Section 1797.197a of the Health and Safety Code." Additionally, because the proposed civil immunity for authorized entities would expressly disallow application of that immunity where there has been gross negligence or willful or wanton misconduct on part of the entity's employee, volunteer or agent in the administration of an epinephrine auto-injector, to avoid confusion the author has also agreed to the following technical amendment to limit the application of the current exception for gross negligence or willful or wanton misconduct to the provision providing immunity for prehospital emergency care persons and lay persons. AB 1386 (Low) Page 13 of ? Technical amendment : On page 5, line 12, amend subdivision (c) of Section 1714.23 of the Civil Code to read: "The protection specified in paragraph (1) of subdivision (b) 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 who renders emergency care treatment by the use of an epinephrine auto-injector." 4. Qualified immunity for physicians As recently amended by the author, in part due to opposition concerns, this bill seeks to provide immunity for doctors who write a prescription for epinephrine auto-injectors to an authorized entity, or to a lay person or prehospital emergency medical care person, for purposes of rendering emergency care to another person who appears to be suffering from anaphylaxis. With respect to the doctors who are relied upon to write the prescription or orders for the medication or medical device, similar liability protection has been provided in both the AED and opioid antagonist context. Most recently, it was also applied in the epi-pen context, but only insofar as the prescription was for a school. As discussed in the Background, just last year, SB 738 (Huff, Ch. 132, Stats. 2015) added a similar provision in law for physicians and surgeons who issue prescriptions or orders for epi-pens to schools, in furtherance of existing California law that requires schools to provide emergency epinephrine auto-injectors to trained personnel who may use the auto-injectors to provide emergency medical aid to persons suffering from anaphylactic reaction. That provision was based, in part, upon those provisions already in place with respect to AEDs and naloxone. For example, existing law provides physicians who are involved with the placement of an AED protection against any civil liability for any civil damages resulting from any acts or omissions of a person who renders emergency care using that AED, if that physician, person, or entity has complied with existing law requirements. That law also provides that any limited liability protection does not apply in the case of personal injury or wrongful death which results from the gross negligence or willful or wanton misconduct of the person who renders emergency care or treatment by the use of an AED. (See Civ. Code AB 1386 (Low) Page 14 of ? Sec. 1714.21.) Separately, in 2013, AB 635 (Ammiano, Ch. 707, Stats. 2013) was enacted to provide that a licensed health care provider who acts with reasonable care shall not be subject to professional review, found liable in a civil action, or be subject to criminal prosecution for issuing a prescription or standing order for 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 person at risk of an opioid-related overdose, as specified. (See Civ. Code Sec. 1714.22.) This bill, modeled upon last year's SB 738, would expand the existing physicians' immunity in the epi-pen context to ensure that an authorizing physician and surgeon will also not be subject to professional review, liable in a civil action, or subject to criminal prosecution for the issuance of a prescription or order to a prehospital emergency medical care person, lay person, or authorized entity, as specified, unless the issuance constitutes gross negligence or willful or malicious conduct. In doing so, the bill would not only be consistent with SB 738, but it would arguably further the original intent of SB 669 (Huff, Ch. 725, Stats. 2013) to ensure that trained personnel and Good Samaritans, acting in good faith and not for compensation, have epi-pens available for the emergency treatment of individuals suffering from anaphylactic shock, in order to avoid preventable deaths. Additionally, the author has agreed to the following amendment to further ensure that the physician and surgeon has prescribed the epi-pen in accordance with the Health and Safety Code, which, under this bill, would authorize providers to issue a prescription to a prehospital emergency medical care person, lay rescuer, or authorized entity, upon the presentation of a specified certification card demonstrating that the person or the entity's employee, agent, or volunteer is trained and qualified to administer an epinephrine auto-injector in accordance with specified law. (Emphasis added.) Suggested amendment On page 5, line 23, strike "pursuant to this section" and insert "and in accordance with Section 1797.197a of the Health and Safety Code" 5. Other clarifying amendments AB 1386 (Low) Page 15 of ? This bill permits pharmacies to furnish epinephrine auto-injectors to authorized entities for the purpose of rendering emergency care in accordance with specified Health and Safety Code standards, as long as: (1) a physician and surgeon provides a prescription that specifies the quantity of epinephrine auto-injectors to be furnished; and (2) the epinephrine auto-injectors are furnished exclusively for use by, or in connection with, an authorized entity. Staff notes, however, that in a parallel statute authorizing a pharmacy to dispense an epinephrine auto-injector to lay rescuers and prehospital emergency medical persons, existing law additionally specifies that the physician and surgeon may issue the underlying prescription only upon presentation of a current certificate demonstrating that the person is trained and qualified under Section 1797.197a of the Health and Safety Code to administer an epinephrine auto-injector to another person in an emergency situation. (See Bus. & Prof. Code Sec. 4119.3.) By way of another example, under existing law, the epi-pen must not only specify that the dispensed epinephrine auto-injector is for "First Aid Purposes Only" and that the named recipient is a "Section 1797.197a Responder"(which this bill would similarly require), but also, a new prescription must be written for any additional epinephrine auto-injectors required (which this bill does not expressly require). The following amendments will add further consistency between the existing provisions governing pharmacies that dispense epi-pens to a prehospital medical care person or lay person and the bill's correlating provision for authorized entities. Suggested amendments: On page 3, lines 10-11, after "the quantity of epinephrine auto-injectors to be furnished" insert "to an authorized entity described in subdivision (a) of Section 1797.197a of the Health and Safety Code. A new prescription shall be written for any additional epinephrine auto-injectors required." On page 3, lines 3-6, amend proposed Section 4119.4 of the Business and Professions Code to read: "Notwithstanding any other law, a pharmacy may furnish epinephrine auto-injectors to an authorized entity, as defined by Section 1979.197a of the Health and Safety Code,for the purpose of rendering emergency care in accordance with Section 1797.197a of the AB 1386 (Low) Page 16 of ? Health and Safety Code , if both of the following are met:" 6. Removal of opposition Staff notes that the organizations previously registered in opposition to this bill have since removed their opposition based on the June 13, 2016, version of the bill, which added a qualified immunity for physicians. Those groups, the Allergy & Asthma Network, California Society of Allergy, Asthma and Immunology, and Food Allergy Research & Education, are now in support of the bill. Support : Allergy & Asthma Network; Allergy Station @ SacENT; American Latex Allergy Association; American Red Cross; California Society of Allergy, Asthma and Immunology; California Chapter of the American College of Emergency Physicians; California Retailers Association; Food Allergy Research & Education; SF Bay Area Food Allergy Network; two individuals Opposition : None Known HISTORY Source : Mylan Related Pending Legislation : AB 1748 (Mayes, 2016) would, among other things, authorize school nurses or, if the school does not have a school nurse, a person who has received training regarding opioid antagonists, as specified, to immediately administer the medication under certain circumstances. The bill would provide for various immunities, as specified. AB 1719 (Rodriguez, 2016) would provide for various immunities relating to the instruction of students in compression-only CPR or use of an AED. Prior Legislation : SB 738 (Huff, Ch. 132, Stats. 2015) See Background. SB 1266 (Huff, Ch. 321, Stats. 2014) See Background. SB 669 (Huff, Ch. 725, Stats. 2013) See Background. AB 1386 (Low) Page 17 of ? SB 635 (Ammiano, Ch. 707, Stats. 2013) See Comment 2. SB 161 (Huff, Ch. 560, Stats. 2011) authorized a school district, county office of education, or charter school to participate in a program to provide nonmedical school employees with voluntary emergency medical training to provide, in the absence of an onsite credentialed school nurse or other licensed nurse, emergency medical assistance to pupils with epilepsy suffering from seizures, in accordance with specified guidelines. SB 161 provided volunteers with defense and indemnification by the school district, county office of education, or charter school, for any and all civil liability, as specified. AB 559 (Wiggins, Ch. 458, Stats. 2001) See Background. AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was ultimately vetoed. Prior Vote : Senate Health Committee (Ayes 7, Noes 0) Assembly Floor (Ayes 78, Noes 0) Assembly Appropriations Committee (Ayes 17, Noes 0) Assembly Judiciary Committee (Ayes 9, Noes 0) Assembly Business and Professions Committee (Ayes 14, Noes 0) Assembly Rules Committee (Ayes 10, Noes 0) **************