Epinephrine Auto-Injector Use – Other State Statutes and Legislation SB1197 Workgroup Joe Hilbert Director of Governmental and Regulatory Affairs May 27, 2015

Summary of Initial Findings Rhode Island and Florida enacted legislation in 2014 that contained provisions similar but not identical to Virginia’s SB1197 o Implementation still in progress Eight additional states (WV, IN, GA, IA, AR, OK, UT, KY) enacted legislation in 2015 o Specific provisions vary in each state Legislation defeated in 3 states, including Virginia, in 2015 Legislation still pending in 16 other states Two states (OR and ND) use a different statutory framework to address this issue.

Rhode Island Statute “Authorized Entity” – entity at which allergens capable of causing anaphylaxis may be present Health care providers may prescribe epinephrine auto-injectors to authorized entities. Authorized entities may maintain supply by designating trained employee responsible for oversight Employee of authorized entity that has completed appropriate training may provide or directly administer “Expanded availability” –May make auto-injectors available for use by non-trained laypersons Training requirements: o Through nationally recognized organization, or an entity or individual approved by the department o (1) how to recognize anaphylaxis, (2) storage and administration, and (3) emergency follow-up. Training entity issues a certificate to those who successfully complete the training Required incident report, department must issue annual report Good Samaritan and civil immunity protections

Rhode Island Implementation Still in initial phases Promulgated regulations o Defines authorized entity as food businesses, schools, family day care homes, governmental facilities, athletic teams, and a place of employment which provides in- house employee health services Department has not yet received any applications from an entity wishing to become authorized

Florida Statute “Authorized entity” - at which allergens capable of causing anaphylaxis may be present, including, but not limited to, restaurants, recreation camps, youth sports leagues, theme parks and resorts, and sports arenas Individual who completes training program may, on the premises of or in connection with an authorized entity, use auto injector on person believed to be experiencing a severe allergic reaction when physician not immediately available Department of health to adopt rules, approve training programs, and issue and renew training certificates Individual seeking a certificate must be 18 years or older, have reasonable responsibility for or contact with at least one other person due to volunteer or occupational status, and has completed the training program Expanded Availability provision

Florida Implementation Still in beginning stages, regulations not yet promulgated Reviewing potential issues that may arise with laypersons having this authority No entities other than two school districts have yet applied or expressed explicit interest in becoming authorized entities.

Other States’ Legislation (2015) EXISTING PASSED PENDING DEFEATED

Legislation Enacted in 2015 West Virginia: Training requirements do not cover storage/disposal procedures or follow- up steps No reporting requirements No expanded availability

Enacted 2015 Indiana: “entity”: any business, association, or governmental entity, including any branch location of the entity. administration to an agent, employee, or visitor of the entity permitted by a nurse employed by the entity, in addition to trained employees or agents (laypersons) Training requirements do not cover storage/disposal procedures or follow-up steps No reporting requirements No expanded availability

Enacted 2015 Kentucky: Training programs for certification to be from entities specifically listed or approved by department Training requirements do not cover storage/disposal procedures or follow-up steps No reporting requirements No expanded availability

Enacted 2015 Georgia: No expanded availability

Enacted 2015 Iowa: “Facility” (rather than “authorized entity”): food establishment (as defined elsewhere), a carnival (as defined elsewhere), a recreational camp, a youth sports facility, or a sports area No expanded availability provision Training requirements to be outlined in regulations No reporting requirements

Enacted 2015 Arkansas: Can receive training from a physician Training requirements do not cover storage/disposal procedures or follow- up steps No expanded availability provision

Enacted 2015 Oklahoma: “Emergency public access station” (same purpose as expanded availability provision) No reporting requirements

Enacted 2015 Utah: Designated individual at qualified entities must complete annual refresher training course No reporting requirements No expanded availability

Pending 2015 (As of 5/18/2015) California (regulations) Colorado Illinois Maine Minnesota Missouri Nevada New Hampshire New Jersey New York Ohio Oregon Pennsylvania South Carolina Vermont Washington

Oregon Statute and Regulations Authorizes a trained layperson to possess an epinephrine auto- injector for the purpose of administration to persons who have severe allergic responses when a licensed health care professional is not immediately available. Person must have, or reasonably expect to have, responsibility for or contact with at least one other person as a result of the eligible person’s occupational or volunteer status. Training must be conducted by a licensed health care practitioner or an EMT Statement of completion (must be signed by physician or nurse practitioner) includes authorization for prescription to obtain emergency supply of epinephrine auto injectors for one adult and one child; can be refilled 4 times in 3-year period

Defeated 2015 Arizona Hawaii Virginia

QUESTIONS? Joe Hilbert Director of Governmental and Regulatory Affairs Virginia Department of Health