Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered, as specified, and authorizes school nurses and 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. Existing law requires a qualified supervisor of health or administrator at a school district, county office of education, or charter school to obtain the prescription for epinephrine auto-injectors from an authorizing physician and surgeon, as defined, and authorizes the prescription to be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers.

This bill would prohibit an authorizing physician and surgeon from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for the issuance of a prescription or order, pursuant to these provisions, unless the physician and surgeons issuance of the prescription or order constitutes gross negligence or willful or malicious conduct. The bill would also update an entity reference.

Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered, as specified, and authorizes school nurses and 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. Existing law requires a qualified supervisor of health or administrator at a school district, county office of education, or charter school to obtain the prescription for epinephrine auto-injectors from an authorizing physician and surgeon, as defined, and authorizes the prescription to be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers.

This bill would prohibit an authorizing physician and surgeon from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for the issuance of a prescription or order, pursuant to these provisions, unless the physician and surgeons issuance of the prescription or order constitutes gross negligence or willful or malicious conduct. The bill would also update an entity reference.

Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered, as specified, and authorizes school nurses and 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. Existing law requires a qualified supervisor of health or administrator at a school district, county office of education, or charter school to obtain the prescription for epinephrine auto-injectors from an authorizing physician and surgeon, as defined, and authorizes the prescription to be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers.

This bill would prohibit an authorizing physician and surgeon from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for the issuance of a prescription or order, pursuant to these provisions, unless the physician and surgeons issuance of the prescription or order constitutes gross negligence or willful or malicious conduct. The bill would also update an entity reference.

Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered, as specified, and authorizes school nurses and 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. Existing law requires a qualified supervisor of health or administrator at a school district, county office of education, or charter school to obtain the prescription for epinephrine auto-injectors from an authorizing physician and surgeon, as defined, and authorizes the prescription to be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers.

This bill would prohibit an authorizing physician and surgeon from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for any act in the issuing issuance of a prescription or order, pursuant to these provisions, unless the act physician and surgeons issuance constitutes gross negligence or willful or malicious conduct.

Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered, as specified, and authorizes school nurses and 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. Existing law requires a qualified supervisor of health or administrator at a school district, county office of education, or charter school to obtain the prescription for epinephrine auto-injectors from an authorizing physician and surgeon, as defined, and authorizes the prescription to be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers.

This bill would prohibit an authorizing physician and surgeon from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for any act in the issuing of a prescription or order, pursuant to these provisions, unless the act constitutes gross negligence or willful or malicious conduct.

Date of Hearing: June 30, 2015

ASSEMBLY COMMITTEE ON JUDICIARY

Mark Stone, Chair

SBPCA Bill Id:SB 738

Author:(Huff) – As Amended Ver:May 13, 2015

PROPOSED CONSENT

SENATE VOTE: 36-0

SUBJECT: PUPIL HEALTH: EPINEPHRINE AUTO-INJECTORS: LIABILITY LIMITATION

KEY ISSUE: SHOULD A PHYSICIAN WHO ISSUES A PRESCRIPTION FOR AN EPINEPHRINE AUTO-INJECTOR TO A SCHOOL DISTRICT, COUNTY OFFICE OF EDUCATION, OR CHARTER SCHOOL IN ACCORDANCE WITH THE PROVISIONS OF EXISTING LAW BE GIVEN QUALIFIED IMMUNITIY FROM CIVIL AND CRIMINAL LIABILITY FOR NEGLIGENCE, BUT NOT GROSS NEGLIGENCE OR WANTON OR WILLFULL MISCONDUCT, IN CONNECTION WITH THE ISSUANCE OF THE PRESCRIPTION?

SYNOPSIS

This non-controversial public health measure provides qualified immunity to physicians who issue prescriptions for epinephrine auto-injectors to school districts for emergency use on individuals afflicted with anaphylactic reaction. An epinephrine auto-injector (commonly called an “epi-pen” because its size and shape is similar to a writing pen) is a disposable drug delivery system with a spring-activated needle that is designed for emergency administration of epinephrine. It provides rapid, convenient first aid for persons suffering a potentially fatal reaction to anaphylaxis, which can happen when a person, often in this case a child at school, is stung by a bee, ingests food such as shellfish or nuts, or maybe even comes in contact with something as common and generally inoffensive as latex. Epinephrine is the first line of treatment for someone who is experiencing anaphylaxis. It can be easily administered by the use of an epi-pen and has few side-effects or risks of misuse.

Existing law authorizes public and private schools in California to voluntarily make emergency epinephrine auto-injectors available to trained personnel who voluntarily agree to provide critically-needed emergency medical aid to persons suffering from anaphylactic reactions. Existing law also requires a school district, county office of education, or charter school to ensure that each school employee who volunteers to be trained and participate in the emergency epinephrine auto-injector program is provided with defense and indemnification by the school district, county office of education, or charter school for any and all civil liability arising from such participation. Meanwhile, current law provides qualified immunity to all volunteers who in good faith, and not for compensation, render emergency medical or nonmedical care at the scene of an emergency. Existing law does not provide for qualified immunity or indemnification of physician or surgeons who prescribes epinephrine auto-injectors to a school nurse, or a school administrator, even though the law requires a prescription to be given to school personnel by a school district physician, the medical director of the local health department, or the local emergency medical services director. This bill provides qualified immunity to physicians and surgeons who issue such standing prescriptions to schools.

The measure is supported by a broad coalition of medical, emergency and other groups who state that it will save lives, especially of children, who are afflicted with anaphylactic reactions that can cause unnecessary harm and even death without speedy medical assistance. It recently passed the Assembly Business and Professions Committee by a vote of 14-0 and has no known opposition.

SUMMARY: Provides qualified immunity to a physician who issues a prescription for an epinephrine auto-injector to a school district, county office of education, or charter school. Specifically, this bill:

1. Provides that a physician who issues a prescription to a school district, county office of education, or charter school for an epinephrine auto-injector shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution, unless the physician’s issuance of the prescription or order constitutes gross negligence or willful or malicious conduct.

2. Updates the name of the Stanford Allergy Center, one of the organizations and providers having expertise in administering epinephrine auto-injectors and administering medication in a school environment with whom the Superintendent is required to consult regarding whether to update training standards for use of the auto-injectors every five years, to reflect its new name: the Sean N. Parker Center for Allergy Research.

EXISTING LAW:

1. Under the Government Tort Claims Act, specifies rules of civil liability that apply to public entities and public employees in California. (Gov. Code Section 810 et seq.)

2. Provides that no person who in good faith, and not for compensation, renders emergency medical or nonmedical care at the scene of an emergency shall 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. (Health and Safety Code Section 1799.102.)

3. In relevant part, requires a school district or county office of education to provide emergency epinephrine auto-injectors to school nurses or trained volunteers, and allows those individuals to utilize epinephrine auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction. (Education Code Section 49414(a). All further statutory references are to the Education Code, unless otherwise indicated.)

4. In relevant part, authorizes each public and private elementary and secondary school in the state to voluntarily determine, as specified, whether or not to make emergency epinephrine auto-injectors and trained personnel available at its school. (Section 49414(c).)

5. Permits each public and private school to designate one or more volunteers to receive initial and annual refresher training, based on specified standards, regarding the storage and emergency use of an epinephrine auto-injector from the school nurse or other qualified person designated by an authorizing physician or surgeon. (Section 49414(d).)

6. Requires a school nurse, or if the school does not have a school nurse or the school nurse is not onsite or available, a school administrator, 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. (Section 49414(g).)

7. Requires the Superintendent to review, every five years, or sooner as deemed necessary by the Superintendent, standards of training for the administration of epinephrine auto-injectors by consulting with organizations and providers with expertise in administering epinephrine auto-injectors and administering medication in a school environment. (Section 49414(e)(1).)

8. Sets minimum requirements for the training described in #7), above, requiring certain topics about anaphylaxis and procedures for rendering emergency treatment to be included in the training, and for the training to be consistent with guidelines of the federal Centers for Disease Control and Prevention. (Section 49414, subdivisions (e)(2) and (e)(3).)

9. Requires a school district, county office of education, or charter school to ensure that each employee who volunteers under this section will be provided defense and indemnification by the school district, county office of education, 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. This information shall be reduced to writing, provided to the volunteer, and retained in the volunteer’s personnel file. (Sections 49414(j), 49414.7(i).)

10. Defines relevant terms, including “anaphylaxis,” “authorizing physician and surgeon,” “epinephrine auto-injector,” “qualified supervisor of health,” “volunteer,” and “trained personnel.” (Section 49414(b).)

11. Identifies the Stanford Allergy Center as one of the organizations and providers having expertise in administering epinephrine auto-injectors and administering medication in a school environment with whom the Superintendent is required to consult regarding whether to update training standards for such auto-injectors every five years. (Section 49414(e)(1).)

FISCAL EFFECT: As currently in print this bill is keyed non-fiscal.

COMMENTS: An epinephrine auto-injector (commonly called an “epi-pen” because its size and shape is similar to a writing pen) 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. Anaphylactic shock can quickly cause 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.

Approximately 6 million children under the age of 18 suffer from life threatening allergies: one in every 13 children, meaning an average of one or two in every classroom. Approximately 25 percent of first time allergic reactions that require epinephrine happen at school. Because neither schools nor the student have knowledge of the severe allergy, they do not have the necessary lifesaving medication on hand. Also, children with known allergies are often sent to school without epinephrine for reasons including cost, non-understanding of the severity of the allergy by parents, or the prohibitive nature of the school process for bringing medication to campus.

Anaphylaxis is a potentially lethal allergic reaction. It can happen when a person is stung by a bee, ingests food such as shellfish or nuts, or maybe even just comes in contact with something as simple as latex. Reactions can be severe, or even fatal, without prompt use of epinephrine. Epinephrine is the first line of treatment for someone who is experiencing anaphylaxis. It can be easily administered and has very minor side effects, including paleness, vomiting, and a rapid pulse. On the other hand, the risk of not using an epi-pen for anaphylaxis can result in death. (Source: HealthTap, https://www.healthtap.com/user_questions/20281.)

Legislative Response. In recent years, California law has been amended to, among other things, 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. Last year’s SB 1266 (Huff, Chap. 321, Stats. 2014) allowed extra epinephrine injectors to be prescribed as a “standing order” to public schools so that epinephrine can be on hand in the event of a severe allergic reaction. SB 1266 also allowed volunteers to be trained for identifying anaphylaxis and administering the necessary medication, epinephrine. Finally, it provided defense and indemnification for those volunteering to administer epinephrine. (The language for the latter provision was modeled upon a provision of the Education Code that provides defense and indemnification to nonmedical school employees who administer medical assistance to pupils with epilepsy suffering from seizures. See Section 49414.7(i).) However, SB 1266 did not provide defense and indemnification, or qualified immunity, to physicians who issue standing orders for epinephrine auto-injector prescriptions to schools.

Qualified Immunity for Good Samaritans. In 2009, the Legislature amended Section 1799.102 to provide that laypersons who provide emergency care or assistance, whether medical or non-medical, shall not be liable for damages caused by their acts or omissions while rendering emergency care, so long as their conduct does not constitute "gross negligence" or "willful or wanton misconduct." (AB 83 (Feuer), Chap. 77, Stats. 2009.) AB 83 was the Legislature’s response to a decision by the California Supreme Court, Van Horn v. Watson (2008) 45 Cal.4th 322. In the Van Horn case, Lisa Torti pulled her friend and co-worker, Alexandra Van Horn, from a crashed vehicle in Los Angeles, fearing the vehicle was about to catch fire or even explode. Tragically, in doing so, Torti may have worsened Van Horn's injuries. Van Horn later sued the driver, who in turn sued Torti for exacerbating Van Horn's injuries. The Court held that the state's "Good Samaritan" statute, when read as part of the overall statutory scheme, only provided immunity to persons with respect to medical care at the scene of an emergency and did not apply to "non-medical" emergency assistance, such as pulling a person from a potentially exploding automobile or a burning building.

AB 83 clarified the general Good Samaritan statute (Section 1799.102), which provides immunity to all rescuers who render emergency care at the scene of an emergency, so that immunity applied as long as the care was rendered “in good faith and not for compensation,” regardless of whether the care is found to be of a medical or non-medical nature. However, AB 83 appropriately clarified that such broad immunity is unavailable to rescuers who engage in grossly negligent or willful or wanton misconduct. The limited or “qualified” immunity adopted by AB 83 is a compromise meant to encourage altruistic behavior, but still protect the public from grossly negligent or deliberately harmful behavior.

Like AB 83, SB 669 (Huff, Chap. 725, Stats. 2013) sought to encourage a trained lay person to render emergency care to a person in anaphylactic shock by granting the layperson qualified immunity from liability for use of an epinephrine auto-injector.

Need for the bill. According to the author:

Once SB 1266 took effect, many physicians began raising questions about issuing the prescription, citing liability concerns. Unlike normal prescriptions made out to a specific individual who physicians have a patient relationship with, a “standing order” for epinephrine will be made out generically so the school can keep it on hand. Physicians have stated having liability coverage in the code (similar to what they have for Automated External Defibrillator (AED) and opioid antagonists) will help ease their concern.

In addition to the calls we have received about this issue from schools, recent data from the California School Nurse Organization shows that many schools who are trying to implement SB 1266 (which took effect January 1, 2015) cannot because they cannot obtain the necessary prescription.

Trained medical professionals ordinarily are not given the same protection from liability as laypersons for providing emergency medical care. However, there are exceptions. For example, existing law provides a physician who is involved with the placement of an AED in a commercial building with protection from civil liability for any civil damages resulting from the acts or omissions of a person who renders emergency care using the AED as long as the physician complied with existing law and did not act with gross negligence, or engage in willful or wanton misconduct. (See Section 1714.21.) Likewise, AB 635 (Ammiano, Chapter 707, Statutes of 2013), provided similar protections from civil liability and from professional review for licensed health care providers who issue prescriptions or standing orders for naloxone hydrochloride, an opioid antagonist used to treat opioid overdose.

Like naloxone hydrochloride, epinephrine is a highly effective and specialized medication for a specific medical emergency. Like an AED, it is a highly effective life-saving medical treatment in an emergency. The Committee is unaware of any reports of injuries or deaths from the misuse of epinephrine auto-injectors. In fact, the only reports that seem to be available regarding misuse involve cases where epinephrine should have been used, but was not. Therefore, given the minor risks associated with misuse of epinephrine auto-injectors and the significant public health benefits of using this effective and life-saving medication to treat anaphylaxis, qualified immunity for a physician who issues a standing prescription for epinephrine auto-injectors to a school seems to be justified. The physician would still be civilly liable and subject to professional review, however, in any case in which issuance of the prescription or order constituted gross negligence or willful or malicious conduct.

REGISTERED SUPPORT / OPPOSITION:

Support

California Society of Allergy, Asthma and Immunology (sponsor)

Advocacy Council – American College of Allergy, Asthma and Immunology

American Academy of Allergy, Asthma and Immunology

American College of Allergy, Asthma and Immunology

Association of Regional Centers Agencies

California Chapter of the American College of Emergency Physicians

California School Nurses Organization

Civil Justice Association of California

Los Angeles Unified School District

Medical Board of California

Rady Children’s Specialists of San Diego

Sanofi

Santa Clara Office of Education

Sutter Medical Foundation

Three individuals

Opposition

None on file

Analysis Prepared by: Alison Merrilees / JUD. / (916) 319-2334

Date of Hearing: June 23, 2015

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Susan Bonilla, Chair

SBPCA Bill Id:SB 738

Author:(Huff) – As Amended Ver:May 13, 2015

SENATE VOTE: 36-0

NOTE: This bill is double referred, and if it passes this Committee, it will be referred to the Assembly Judiciary Committee.

SUBJECT: Pupil health: epinephrine auto-injectors: liability limitation.

SUMMARY: Provides that an authorizing physician and surgeon will not be subject to professional review, liable in a civil action or be the subject of criminal prosecution for issuing a prescription or order, as specified, for an epinephrine auto-injector (EAI), unless the physician or surgeon's issuance constitutes gross negligence or willful or malicious conduct.

EXISTING LAW:

1. Authorizes a pharmacy to furnish an EAI to a school district, county office of education (COE), or charter school, as specified, if the following conditions are met: (Business and Professions Code (BPC) Section 4119.2(a))

   1. The EAIs are furnished exclusively for use at a school site, as specified; and,

   2. A physician and surgeon provides a written order that specifies the quantity of EAIs to be furnished.

2. Requires the records regarding the acquisition and disposition of EAIs to be maintained by the school district, COE, or charter school for a period of three years from the date the records were created and requires the school district, COE, or charter school to be responsible for monitoring the supply of EAIs and ensuring the destruction of expired EAIs. (BPC Section 4119.2(b))

3. Establishes the responsibilities of the Medical Board of California (MBC) which include: the enforcement of the disciplinary and criminal provisions of the Medical Practice Act (Act); the administration and hearing of disciplinary actions; carrying out disciplinary actions appropriate to findings made by a panel or an administrative law judge (ALJ); suspending, revoking, or otherwise limiting certificates after the conclusion of disciplinary actions; and reviewing the quality of medical practice carried out by physician and surgeon certificate holders under the MBC's jurisdiction. (BPC Section 2004 (a)-(e))

4. Requires school districts, COEs, and charter schools to provide emergency EAIs to school nurses or trained personnel who have volunteered, as specified, and authorizes school nurses or trained personnel to use EAIs to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. (Education Code (EDC) Section 49414 (a))

5. Permits each private elementary and secondary school in the state to voluntarily determine whether or not to make EAIs and trained personnel available at its school, as specified. (EDC Section 49414(c))

6. Permits each public and private elementary and secondary school in the state to designate one or more volunteers to receive initial and annual refresher training, based on specified standards, regarding the storage and emergency use of an EAI from the school nurse or other qualified person designated by an authorizing physician and surgeon. (EDC Section 49414(d))

7. Requires the Superintendent to review the minimum standards of training for the administration of EAIs, every five years or sooner, as determined by the Superintendent. (EDC 49414(e)(1))

THIS BILL:

1. States that an authorized 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, as specified, for an EAI unless the physician and surgeon's issuance of the prescription or order constitutes gross negligence or willful or malicious conduct.

2. Updates the name of the Stanford Allergy Center to reflect its current name, the Sean N. Parker Center for Allergy Research.

FISCAL EFFECT: None. This bill is keyed non-fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is sponsored by the California Society for Allergy, Asthma and Immunology. According to the author, "My office has been informed that this medication was recently used in the San Marcos School District and potentially saved a child’s life. This policy is important and is working. We need this last part of the equation to make sure this policy is workable to its full extent and for all schools, not just for schools who have been lucky enough to find a physician willing to go out on a limb. This is a narrowly focused bill in an attempt to make getting prescriptions easier for school nurses and is consistent with current law for similar situations. Without the prescription, this important health policy cannot work."

Background. An EAI is used for the emergency treatment of severe allergic reactions, including anaphylaxis, to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

As a result of SB 1266 (Huff), Chapter 321, Statutes of 2014, it is now required that school districts, COEs, and charter schools provide emergency EAIs to school nurses or trained personnel who have volunteered, and those school nurses or trained personnel may use the EAIs to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. BPC Section 4119.2 permits a pharmacy to furnish EAIs to a school district, COE or charter school, as specified in the EDC, as long as the following conditions are met: 1) the EAI is furnished exclusively for use at the school site, and 2) a physician and surgeon provides a written order that specifies the quantity of EAIs to be furnished.

In addition to establishing the processes and procedures for the program, SB 1266 also provided specified liability protections for the employees who volunteer under the program by requiring the school district, COE or charter school to provide defense and indemnification by for any and all civil liability, as specified. This bill would also provide liability protection to a physician and surgeon by exempting them from professional review for the issuance of a prescription or order for an EAI unless the prescription or order constituted gross negligence or willful or malicious misconduct.

In 2013, AB 635 (Ammiano), Chapter 707, Statutes of 2013, provided similar protections from civil liability or from professional review for licensed health care providers who issue prescriptions or standing orders, as specified, for naloxone hydrochloride, which is an opioid antagonist used to treat opioid overdose.

Medical Board. The MBC is the regulatory entity responsible for regulating physician and surgeons and a number of other allied health professionals. The jurisdiction of the MBC includes issuing licenses and certificates, the administration and hearing of disciplinary actions, and carrying out disciplinary actions as determined by the appropriate panel or ALJ including suspending, revoking, or otherwise limiting certificates after the conclusion of disciplinary actions. According to the author, since the enactment of SB 1266, many physicians have begun to raise questions about liability concerns with respect to issuing a generic prescription for the purposes of providing EAIs to school sites. This bill will exempt a physician and surgeon from both professional review by the MBC and civil liability for the issuance of a prescription or order for EAIs in school settings as required by the EDC, unless the physician and surgeon's order constitutes gross negligence or willful or malicious conduct.

Current Related Legislation. AB 1386 (Low), of 2015, permits a pharmacy to furnish EAIs to an authorized agency, as specified, if the EAIs are furnished exclusively for use at or in connection with an authorized entity, an authorized health care provider provides a prescription, and the records are maintained by the authorized agency for three years. This bill also contains specified immunity provisions. STATUS: This bill is pending in the Assembly Business and Professions Committee.

Prior Related Legislation. SB 1266 (Huff), Chapter 321, Statutes of 2014, requires school districts, COEs, and charter schools to provide emergency EAIs to school nurses or trained personnel who have volunteered, and authorizes school nurses or trained personnel to use EAIs to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction.

SB 669 (Huff), Chapter 725, Statutes of 2013, permitted a prehospital emergency medical care person, first responder, or lay rescuer to obtain and use an EAI in emergency situations with certification of training, as specified.

AB 635 (Ammiano), Chapter 707, Statutes of 2013, revised provisions from the current pilot program authorizing prescription of opioid antagonists for treatment of drug overdose and limiting civil and criminal liability, expanded these provisions statewide, and removed the 2016 sunset date.

AB 559 (Wiggins), Chapter 458, Statutes of 2001, allowed school districts or COEs to provide emergency EAIs to trained personnel, and permitted trained personnel to utilize EAIs to provide emergency medical aid to persons suffering from an anaphylactic reaction.

ARGUMENTS IN SUPPORT:

The American College of Allergy, Asthma and Immunology (ACAAI) and the Advocacy Council (Council) of the Colleges writes in support, "[the] ACAAI and the Council firmly believe in the concept of making undesignated [EAIs] available to appropriately trained school personnel."

The California Chapter of the American College of Emergency Physicians writes in support, "[this bill] will provide physicians the necessary liability protections to fully implement current law. It is similar to what is already in law for other medication and medical devices; applying liability protection to [EAIs] makes sense."

The Medical Board of California writes in support, "this bill will help school districts obtain standing order prescriptions so they can benefit from SB 1266 from last year. These standing order prescriptions will allow the schools to obtain the [EAIs] which will provide emergency medical aid to students suffering from anaphylactic reactions."

ARGUMENTS IN OPPOSITION:

None on file.

REGISTERED SUPPORT:

California Society for Allergy, Asthma and Immunology (sponsor)

American Academy of Allergy, Asthma, and Immunology

American College of Allery, Asthma, and Immunology

Association of Regional Center Agencies

California Chapter of the American College of Emergency Physicians

California School Nurses Organization

Civil Justice Association of California

Los Angeles Unified School District

Medical Board of California

Sanofi

Santa Clara County Office of Education

4 individuals

REGISTERED OPPOSITION:

None on file.

Analysis Prepared by: Elissa Silva / B. & P. / (916) 319-3301

 THIRD READING  

Bill No: SB 738

Author: Huff (R)

Amended: 5/13/15

Vote: 21

SENATE JUDICIARY COMMITTEE: 7-0, 5/5/15

AYES: Jackson, Moorlach, Anderson, Hertzberg, Leno, Monning, Wieckowski

SUBJECT: Pupil health: epinephrine auto-injectors: liability limitation

SOURCE: California Society for Allergy, Asthma and Immunology

DIGEST: This bill provides 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 existing law (which requires public schools to obtain a prescription for epinephrine auto-injectors from an authorizing physician and surgeon, as defined, for use in emergencies) unless the physician and surgeon’s issuance of the prescription or order constitutes gross negligence or willful or malicious conduct.

ANALYSIS:

Existing law:

1. 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. Authorizes private elementary and secondary school in the state to voluntarily determine whether or not to make emergency epinephrine auto-injectors and trained personnel available at its school.

2. Provides that each public and private elementary and secondary school in the state may designate one or more volunteers to receive initial and annual refresher training, based on specified standards, regarding the storage and emergency use of an epinephrine auto-injector from the school nurse or other qualified person designated by an authorizing physician and surgeon.

3. Requires, in relevant part, that a qualified supervisor of health at a school district, county office of education, or charter school to obtain from an authorizing physician and surgeon a prescription for each school for epinephrine auto-injectors that, at a minimum, includes, for elementary schools, one regular epinephrine auto-injector and one junior epinephrine auto-injector, and for junior high schools, middle schools, and high schools, if there are no pupils who require a junior epinephrine auto-injector, one regular epinephrine auto-injector. Provides that if a school district, county office of education, or charter school does not have a qualified supervisor of health, an administrator at the school district, county office of education, or charter school shall carry out the above duties.

This bill provides 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 existing law above, unless the physician and surgeon’s issuance of the prescription or order constitutes gross negligence or willful or malicious conduct.

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. 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.

In recent years, California law has been amended to, among other things, 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. (AB 559, Wiggins, Chapter 458, Statutes of 2001.)

Last year, SB 1266 (Huff, Chapter 321, Statutes of 2014) was enacted to require, as opposed to simply authorize, school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to trained personnel who, consistent with existing law, may use the auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction. Under that bill, each public school is required to designate one or more school personnel on a voluntary basis to receive the requisite training for these purposes. In recognition that employees might otherwise hesitate to volunteer out of fear of personal liability, SB 1266 also required that a school district, county office of education, or charter school ensure that each employee who volunteers is provided defense and indemnification by the school district, county office of education, or charter school for any and all civil liability.

This bill now seeks to address an issue of concern to the doctors who are needed to write these prescriptions so that schools may obtain and stock epi-pens for the above purposes. Specifically, this bill provides a physician or surgeon issuing a prescription or order for these purposes with immunity from any potential civil or criminal liability or from professional disciplinary action, unless the physician and surgeon’s issuance of the prescription or order constitutes gross negligence or willful or malicious conduct.

Comment

As stated by the author:

Last year, the Legislature unanimously passed and the Governor signed SB 1266 [Huff, Chapter 321, Statutes of 2014] requiring extra epinephrine auto injectors be prescribed as a “standing order” ensuring the lifesaving medication can be on hand in public schools when there is a school nurse or volunteer who is trained to administer. Epinephrine is the first line of treatment for someone who is experiencing anaphylaxis (a potentially lethal allergic reaction). It is easily administered and has very little side-effect.

Once SB 1266 took effect, many physicians began raising questions about issuing the prescription, citing liability concerns. Unlike normal prescriptions made out to a specific individual who physicians have a patient relationship with, a “standing order” for epinephrine will be made out generically so the school can keep it on hand. Physicians have stated having liability coverage in the code (similar to what they have for Automated External Defibrillator (AED) and opioid antagonists) will help ease their concern.

The author reports that recent data from the California School Nurse Organization shows that many schools who are trying to implement SB 1266 are having difficulty doing so because they cannot obtain the necessary prescription.

FISCAL EFFECT: Appropriation: No Fiscal Com.: No Local: No

SUPPORT: (Verified 5/13/15)

California Society for Allergy, Asthma and Immunology (source)

Advocacy Council of the American College of Allergy, Asthma and Immunology

American Academy of Allergy Asthma & Immunology

American College of Allergy, Asthma and Immunology

Association of Regional Center Agencies

California Chapter of the American College of Emergency Physicians

Civil Justice Association of California

Los Angeles Unified School District

Two individuals

OPPOSITION: (Verified 5/13/15)

None received

Prepared by: Ronak Daylami / JUD. / (916) 651-4113

5/13/15 17:26:24

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SENATE JUDICIARY COMMITTEE

Senator Hannah-Beth Jackson, Chair

2015 - 2016 Regular Session

Bill No: SB 738 (Author:Huff)

Amended: Version: April 15, 2015

Hearing Date: May 5, 2015

Fiscal: No

Urgency: No

Consultant: RD

SUBJECT

Pupil health: epinephrine auto-injectors: liability limitation

DESCRIPTION

Existing law requires public schools to have a trained volunteer to administer epinephrine auto-injectors in emergencies and requires that each employee who volunteers is provided defense and indemnification by the school district, county office of education, or charter school for any and all civil liability, as specified. Existing law requires a qualified supervisor of health or administrator at a school district, county office of education, or charter school to obtain the prescription for epinephrine auto-injectors from an authorizing physician and surgeon, as defined.

This bill would provide 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 section, unless the physician and surgeon’s issuance constitutes gross negligence or willful or malicious conduct.

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. 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.

In recent years, California law has been amended to, among other things, 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. (AB 559 (Wiggins, Ch. 458, Stats. 2001).)

Last year, SB 1266 (Huff, Ch. 321, Stats. 2014) was enacted to require, as opposed to simply authorize, school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to trained personnel who, consistent with existing law, may use the auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction. Under that bill, each public school is required to designate one or more school personnel on a voluntary basis to receive the requisite training for these purposes. In recognition that employees might otherwise hesitate to volunteer out of fear of personal liability, SB 1266 also required that a school district, county office of education, or charter school ensure that each employee who volunteers is provided defense and indemnification by the school district, county office of education, or charter school for any and all civil liability.

This bill now seeks to address an issue of concern to the doctors who are needed to write these prescriptions so that schools may obtain and stock epi-pens for the above purposes. Specifically, the bill would provide 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.

CHANGES TO EXISTING LAW

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. (Educ. Code Sec. 49414(a).) Existing law authorizes private elementary and secondary school in the state to voluntarily determine whether or not to make emergency epinephrine auto-injectors and trained personnel available at its school. (Ed. Code Sec. 49414(c).)

Existing law provides that each public and private elementary and secondary school in the state may designate one or more volunteers to receive initial and annual refresher training, based on specified standards, regarding the storage and emergency use of an epinephrine auto-injector from the school nurse or other qualified person designated by an authorizing physician and surgeon. (Ed. Code Sec. 49414(d).)

Existing law, in relevant part, requires a qualified supervisor of health at a school district, county office of education, or charter school to obtain from an authorizing physician and surgeon a prescription for each school for epinephrine auto-injectors that, at a minimum, includes, for elementary schools, one regular epinephrine auto-injector and one junior epinephrine auto-injector, and for junior high schools, middle schools, and high schools, if there are no pupils who require a junior epinephrine auto-injector, one regular epinephrine auto-injector. (Ed. Code Sec. 49414(g)(1).) Existing law provides that if a school district, county office of education, or charter school does not have a qualified supervisor of health, an administrator at the school district, county office of education, or charter school shall carry out the above duties. (Ed. Code Sec. 49414(g)(2).)

This bill would provide 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 section, unless the physician and surgeon’s issuance constitutes gross negligence or willful or malicious conduct.

COMMENT

1. Stated need for the bill

According to the author:

Last year, the Legislature unanimously passed and the Governor signed SB 1266 [Huff, Ch. 321, Stats. 2014] requiring extra epinephrine auto injectors be prescribed as a “standing order” ensuring the lifesaving medication can be on hand in public schools when there is a school nurse or volunteer who is trained to administer. Epinephrine is the first line of treatment for someone who is experiencing anaphylaxis (a potentially lethal allergic reaction). It is easily administered and has very little side-effect.

Once SB 1266 took effect, many physicians began raising questions about issuing the prescription, citing liability concerns. Unlike normal prescriptions made out to a specific individual who physicians have a patient relationship with, a “standing order” for epinephrine will be made out generically so the school can keep it on hand. Physicians have stated having liability coverage in the code (similar to what they have for Automated External Defibrillator (AED) and opioid antagonists) will help ease their concern.

The author reports that recent data from the California School Nurse Organization shows that many schools who are trying to implement SB 1266 are having difficulty doing so because they cannot obtain the necessary prescription.

Two individual doctors write in support of this bill describing the reasons behind the hesitation of physicians to issue prescriptions or orders for these purposes. One doctor writes that “[a]s a consulting physician for about 30 school districts across California, it has been distressing to me how few of my physician colleagues have written Epinephrine prescriptions. . . . [P]hysicians’ own medical liability insurance only covers them for patients in their own practices, not for schools in their neighborhoods. Understandably, physicians are currently reluctant to assist schools with an anaphylaxis-protection program for which they feasibly have little oversight. SB 738 should provide physicians across California with the peace of mind they now require in order to write prescriptions for this life-saving medication. Compliance with SB 1266 is based on this factor.”

2. Bill provides qualified immunity for physicians issuing epi-pen prescriptions or orders

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. 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 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, but not in the epi-pen context. This bill would add 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 is similar to those 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 Sec. 1714.21.)

More recently, 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.)

As noted above, this bill, in the epi-pen context, would provide 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 section, unless the physician and surgeon’s issuance constitutes gross negligence or willful or malicious conduct. In doing so, the bill would arguably further the original intent of SB 1266 (Huff, Ch. 321, Stats. 2014) and prior bills that have sought to ensure that schools have epi-pens available for the emergency treatment of children who are suffering from anaphylactic shock, in order to avoid preventable deaths.

3. Technical amendment

The following technical amendment would address a drafting error:

Technical amendment:

On page 5, line 12, after “unless the physician and surgeon’s issuance” insert “of the prescription or order”

The following author’s amendment would also update the name of the Stanford Allergy Center to reflect the center’s current name.

Author’s amendment:

On page 3, line 32, strike “Stanford Allergy Center” and insert, “Sean N. Parker Center for Allergy Research”

Support: American Academy of Allergy Asthma & Immunology; Association of Regional Center Agencies; California Chapter of the American College of Emergency Physicians; Civil Justice Association of California; two individuals

Opposition: None Known

HISTORY

Source: California Society for Allergy, Asthma and Immunology (CSAAI)

Related Pending Legislation:

SB 744 (Huff, 2015) is a spot bill that makes nonsubstantive changes to the provisions requiring schools to provide emergency epi-pens to school nurses or trained personnel who have volunteered and authorizing those individuals to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. That bill is currently in the Senate Rules Committee.

AB 1386 (Low, 2015) would add various limited liability provisions relating to the provision or administration of an epi-pen, as specified. One such provision provides that an authorized health care provider that prescribes an epi-pen to specified persons or authorized entities is not liable for any civil damages resulting from any act or omission related to the provision of an epi-pen. This bill is currently awaiting hearing in the Assembly Business and Professions Committee.

Prior Legislation:

SB 1266 (Huff, Ch. 321, Stats. 2014) See Background.

SB 669 (Huff, Ch. 725, Stats. 2013), among other things, authorized a trained pre-hospital emergency medical care person, first responder, or lay rescuer to obtain and use epinephrine auto-injectors to render emergency care to another person, pursuant to specified requirements, and granted them limited liability, as specified.

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 a credentialed school nurse or other licensed nurse onsite at the school or charter school, emergency medical assistance to pupils with epilepsy suffering from seizures, in accordance with specified guidelines. SB 161 also provided each employee who volunteers under the bill 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), was enacted 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.

AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was ultimately vetoed by the Governor.

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