BRIEFING AUGUST 2015 NEW LEGISLATION SB PHYSICIAN IMMUNITY FOR EMERGENCY EPINEPHRINE AUTO-INJECTOR PRESCRIPTIONS THE ISSUE

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1 BRIEFING AUGUST 2015 NEW LEGISLATION SB PHYSICIAN IMMUNITY FOR EMERGENCY EPINEPHRINE AUTO-INJECTOR PRESCRIPTIONS THE ISSUE Senate Bill 1266, effective January 1, 2015, required all school districts, county offices of education and charter schools to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered to administer epinephrine injections. SB 1266 further authorized 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. As school districts were attempting to comply with the requirements of SB 1266, they were met with resistance from physicians who are accustomed to only writing a prescription to an individual they have a patient relationship with. Physicians expressed concern with the potential liability of providing a generic prescription or standing order to a school district. THE SOLUTION The California Legislature responded with SB 738, approved by Governor Brown on July 16, 2015, amending Education Code Section to read 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 of the prescription or order constitutes gross negligence or willful or malicious conduct. SB 738 goes into effect on January 1, In the Legislative analysis, it was cited that 6 million children under the age of 18 suffer from life threatening allergies, which is 1 in every 13 children or an average of 2 in every classroom. Approximately 25% of first time allergic reactions that require epinephrine occur at school. Epinephrine is the first line of treatment for someone who is experiencing anaphylaxis. Children are often sent to school without epinephrine for reasons including cost, non-understanding of the severity of the allergy by the parents or the school s process for bringing medication to campus. SB 1266 provided defense and indemnification for those volunteering to administer epinephrine but did not provide defense, indemnification or qualified immunity to physicians who issue the standing orders. ASSISTANCE WITH COMPLIANCE To assist school districts, Keenan Claim Analysts will be bringing SB 738 to the attention of frontline providers who partner with schools to treat industrial injuries. With full knowledge of SB 738, frontline providers may be a resource for obtaining epinephrine prescriptions or standing orders. However, some providers may still be reluctant to issue prescriptions prior to the SB 738 effective date of January 1, Keenan & Associates 1

2 Through our PRIME program, Keenan has developed the attached resource EpiPen4Schools Program and FAQ, which includes information on how to obtain free EpiPen devices for your school district. This resource is also available on P&C Bridge. For more information regarding SB 738, or for assistance providing information to your frontline provider, please contact your Claims Analyst or Christine Gerbasi at or , Ext Keenan & Associates is not a law firm and no opinion, suggestion, or recommendation of the firm or its employees shall constitute legal advice. Clients are advised to consult with their own attorney for a determination of their legal rights, responsibilities and liabilities, including the interpretation of any statute or regulation, or its application to the clients business activities Keenan & Associates 2

3 EpiPen4Schools Program and FAQ

4 TABLE OF CONTENTS FREQUENTLY ASKED QUESTIONS... 1 ORDER CERTIFICATION FORM... 5 ADMINISTRATION DOCUMENTATION... 6 SUPPLY REPLENISHMENT... 7 i

5 FREQUENTLY ASKED QUESTIONS FREQUENTLY ASKED QUESTIONS REGARDING SENATE BILL 1266 Does SB 1266 require all school districts to provide emergency epinephrine autoinjectors? According to (a) School districts, county offices of education, and charter schools shall provide emergency epinephrine auto-injectors to school nurses or trained personnel who have volunteered pursuant to subdivision (d), and 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. When was this bill enacted and when do schools need to be in compliance? The law took effect on January 1, Where can I read the SB 1226 in its entirety? Is there funding for the emergency epinephrine auto-injectors? Mylan (who markets the EpiPen ) will provide four (4) free EpiPens (either regular or junior) for each school site through the EpiPen4Schools Program ( A school district just needs to provide Mylan with a written prescription for the total number of EpiPen requested. What Physician resources support your school district obtaining a prescription for the Epinephrine Auto Injectors? 1) Your Frontline Medical Provider for Work Related Injuries 2) Local public health officers 3) Local physician allergy specialists in your area 4) Your own physician What does the law state regarding trained volunteer? Volunteer means an employee who has volunteered to administer an emergency epinephrine auto-injector, has received training in the use of an epinephrine auto-injector, and has been designated by the school as a trained volunteer who will administer epinephrine auto-injector to a pupil if the pupil is suffering or reasonably believed to be suffering from anaphylaxis. How will volunteers be identified? A school district, county office of education, or charter school shall distribute a notice at least once per school year to all staff that contains the following information: A description of the volunteer request stating that the request is for volunteers to be trained to administer an 1

6 EpiPen4Schools Program and FAQ epinephrine auto-injector as well as a description of the training the volunteer will have to undergo. What constitutes training? There are current guidelines regarding epinephrine auto-injectors in place on the California Department of Education website: Every five years, or sooner as deemed necessary by the (State) Superintendent, the Superintendent shall review minimum standards of training for the administration of epinephrine auto-injectors. Training established pursuant to this subdivision shall include all of the following: Techniques for recognizing the symptoms of anaphylaxis. Standards and procedures, for the storage, restocking and emergency use of emergency epinephrine auto-injectors. Emergency follow up procedures, including calling Emergency Medical Services (EMS). Recommendation on the necessity of cardiopulmonary resuscitation (CPR) certification. Instruction on how to determine whether to use an adult epinephrine auto-injector or a junior epinephrine auto injector, which shall include consideration of grade level or age as a guideline of equivalency for appropriate pupil weight determination. Written material covering the information. How many staff must be trained? Each school may designate one or more school personnel on a voluntary basis to be trained. How frequently must the staff be trained? Volunteer personnel shall receive initial and annual refresher training. Who provides the training? Training is provided either by the school nurse or other qualified person designated by the physician or surgeon employed or contracted with the Local Educational Authority, the medical director of the local health department or the local emergency medical services director. Is there protection for volunteers who act in an emergency and administer the emergency epinephrine auto-injector? Yes, a school district, county office of education or charter school shall ensure that each employee who volunteers will be provided defense and indemnification by the school district, county office of education or charter school for any and all civil liability. 2

7 EpiPen4Schools Program and FAQ Are the emergency epinephrine auto-injectors required to be available for off-site school activities? The law does not address field trips or other off site school activities. The law states, The emergency epinephrine auto-injectors are furnished exclusively for use at a school district site, county office of education or charter school. Who is responsible for obtaining the prescription? A school nurse or, if not available, a school administrator or employee who has volunteered shall obtain a prescription from a physician employed by or contracting with the Local Educational Authority, the medical director of the local health department or the local emergency medical services director. Resource suggestions include contracting with your Workers Comp clinic or physician, your sports physician, or local physician such as an ED or other practitioner who is willing to contract with the school district to review Standing Orders and write a prescription. If the prescription is non-patient specific, whose name should be on it? The current law does not specify how the emergency epinephrine auto-injectors are labeled. This would be the prescribing physician and/or pharmacy s decision. Some may wish to have the school s name on the prescription and on the label attached to the container in which the epinephrine auto-injectors are packaged. Please note, the devices provided by the EpiPen4Schools Program have no specific labeling/name information. How many emergency epinephrine auto injectors must a school obtain? An elementary school should obtain at minimum, one regular epinephrine auto-injector and one junior epinephrine auto-injector. For junior and high schools, one regular epinephrine auto injector, unless they have students who meet the criteria for a junior epinephrine auto injector. If the emergency epinephrine auto injector is used, when does it need to be restocked by? If an emergency epinephrine auto-injector is used, it shall be restocked as soon as reasonably possible, but no later than 2 weeks after the use. Which epinephrine auto-injector should a school get? The statute does not specify a particular brand of epinephrine auto-injector. However, the prescribing physician may indicate which epinephrine auto-injector to dispense. There are a number of epinephrine auto-injectors that have been approved by the Food and Drug Administration (FDA) and are available with a prescription for the management of life threatening allergies. The devices operate in different ways, so it is critically important that schools ensure that the designated school personnel are trained to use the specific epinephrine auto-injector that is prescribed and dispensed. 3

8 EpiPen4Schools Program and FAQ Are there any current resources for Standing Orders, Board Policies, additional information, etc? Training standards for the administration of epinephrine auto-injectors in accordance with Education Code Section can be found at the following website: 4

9 ORDER CERTIFICATION FORM Free EpiPen Auto-Injector EpiPen4Schools Program 5

10 ADMINISTRATION DOCUMENTATION Epinephrine Auto-Injector (EAI) Confidential (Send to School Nurse/Administrator) Date: School Building: Name of person receiving EAI: Grade Age: Time incident began: Time EAI was given: Time second EAI given: EMS called (time): EMS arrived (time): EMS given information (time of EAI administration(s), a copy of the emergency card and/or the student specific Anaphylaxis Action Plan) Parent/guardian notified: Check all that apply: Student had individual Anaphylaxis Action Plan on file for the current school year EAI(s) used were supplied by the family as ordered Student was known to have severe allergy but no EAIs were provided and stock EAI used Family notified that EAIs need to be replaced Student had no previously known severe allergy and stock EAI was used for suspected anaphylaxis Person other than k-12 student was given stock EAI for suspected anaphylaxis Stock EAIs were ordered for replacement Check possible trigger for anaphylaxis: Food (Specific food if known or other relevant information, such as location of ingestion) - Stinging insect (Type if known, location on campus, other)- Latex (source if known)- Other (Circumstances surrounding reaction that might be relevant to cause of anaphylaxis)- Symptoms leading to administration of EAI: Other known health issues, such as asthma, eczema, allergies: Symptoms if a second EAI was used: Information being kept for incident review and yearly report to the State of California Person Filing Report: Date: Signature of above person: 6

11 SUPPLY REPLENISHMENT Epinephrine Auto-Injector (EAI) Mylan Specialty will replenish your school s supply of EpiPen or EpiPen Jr Auto-Injectors prior to your annual eligibility date and at no additional cost, provided that your school used the EpiPen4Schools free product to treat a life-threatening allergic reaction (anaphylaxis) in your school. First, please complete all of the fields below. School Name/District Name: School Address: City/State/Zip: School Phone: School Contact Name: School Contact What was the date of the anaphylactic event? MM/DD/YYYY Where did the anaphylactic event occur? Class room Cafeteria Playground Gym Other What was the suspected cause of the anaphylactic event? Food Bee sting Latex Medication Other Did the person who experienced anaphylaxis have a known life-threatening allergy? Yes No 7

12 EpiPen4Schools Program and FAQ Was the person who experienced anaphylaxis a: Student Staff member Visitor Other Was an EpiPen or EpiPen Jr Auto-Injector administered to treat the anaphylactic event? EpiPen Auto-Injector EpiPen Jr Auto-Injector Was more than one EpiPen or EpiPen Jr Auto-Injector administered to treat the anaphylactic event? Yes No Who administered the EpiPen or EpiPen Jr Auto-Injector to the person experiencing anaphylaxis? School Nurse Student Staff member Was 911 called? Yes No Did the person who experienced anaphylaxis receive emergency medical care? Yes No 8