Epinephrine Auto-Injector Use –Other State Statutes and Legislation

SB1197 WorkgroupJoe Hilbert

Director of Governmental and Regulatory AffairsMay 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)

EXISTINGPASSEDPENDINGDEFEATED

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)ColoradoIllinoisMaineMinnesotaMissouriNevadaNew HampshireNew JerseyNew YorkOhioOregonPennsylvaniaSouth CarolinaVermontWashington

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

ArizonaHawaiiVirginia

QUESTIONS?

Joe HilbertDirector of Governmental and Regulatory Affairs

Virginia Department of HealthJoe.Hilbert@vdh.virginia.gov