Other States with Similar Epinephrine Legislation: Interview Observations Presentation to SB1167 Workgroup Joe Hilbert Director of Governmental and Regulatory Affairs Virginia Department of Health July 30, 2015

States Interviewed The following states with recently passed epinephrine auto-injector use expansion bills were reached for discussion by VDH: GEORGIA WEST VIRGINIA RHODE ISLAND NEVADA UTAH KENTUCKY OKLAHOMA FLORIDA MARYLAND

Next Steps for Implementation GA, KY, MD, NV, and UT plan to promulgate regulations, or have already begun this process Many are tasked with developing the training programs or guidelines, but some believe the nationally recognized training programs are sufficient OK and WV note that no regulations are needed as the legislation outlines the process sufficiently to function without interference NV has plans to spread awareness of the statutory amongst the department and EMS, coordinate training funding through a grant, incorporate epinephrine auto-injector layperson use reporting measures in the existing system, and eventually use this data to develop useful reports

Regulatory Plans The regulatory plans range from adding a small section pertaining to authorized entities to the existing language regarding epi-pens in schools, to writing comprehensive regulations While most states have not yet reached the point of what specific language will be included, many agreed that most of the groundwork is laid by existing language for schools and by the legislation’s language Most big regulatory decisions will center around what an “authorized entity” will include, and what the training requirements will be

How “Authorized Entity” Will Be Operationalized For most of these states, this term is left fairly open in the legislation, and they are not yet at the point of deciding on specific language or parameters to define the term. However, possible paths noted include: o GA may determine which groups are interested in becoming authorized, and build a list from there o OK will recognize the practitioner’s judgment of which entities qualify to be authorized based on the legislation language o WV and UT wish to leave it broad  WV notes that language suggesting the types of facilities that could be included was removed during the bill’s deliberation to keep the definition broad NV notes that restaurant facilities have shown the most interest UT notes that boy/girl scouts, camps, and schools have shown the most interest and many are already trained – closed systems or removed places that would be far from help in an emergency

Training Several have not yet determined their plans for the training component of the legislation MD noted it will model this language after the training required for epi-pens in schools NV’s EMS Division to help design and implement a training program. Individuals wishing to get trained may also do so through a physician or pharmacist OK believes this oversight would be the practitioner’s responsibility UT’s health department does not provide training, but must approve the program, as they felt this aspect was the most important part of the equation. Red Cross and other mainstream programs are already approved WV feels the minimum requirements set forth in the legislation are sufficient and will not interfere on this aspect unless problems arise

Reporting Requirements Many of these states’ provisions did not contain reporting requirements. Those that did have not yet decided how they will regulate that aspect

Prescribing, Dispensing and Picking Up Prescriptions in the Name of an Entity When asked this question, most states had not considered this aspect of the process, were not yet at that point in the regulatory or guideline writing process, or did not feel it was the Department’s or the Board’s scope of duties with this legislation NV believed that the individual noted in the legislation that must be trained and responsible for general oversight of the prescription would be the one obtaining a prescription and dispensing. Any authorized practitioner could prescribe it in the name of the entity and any pharmacy could dispense it OK also noted that they believe it would transpire similar to individuals’ prescriptions, and mentioned that for schools, it is usually the medical director that is responsible for these duties

Aspects in Need of Extra Attention, or Potential Issues Most states did not foresee any potential issues, noting that the legislation was very straightforward and the practice of administering epinephrine is not difficult KY’s most significant hurdle will be working with nonprofits to incentivize them to offer training and certification courses for free NV noted that initially with epi-pens in schools, physicians were reluctant to prescribe due to perceived insufficient legal coverage, but stronger liability protections were later added to alleviate their concerns UT noted that with earlier authorizations (schools, EMT, etc.) they were worried about the potential for adverse incidents with laypersons, but in 5 or so years there have been no incidents and it has run smoothly

Florida Follow-Up The Department’s immediate responsibilities were to identify a national organization and an application for approval as a training program The department identified the American Red Cross (ARC), Anaphylaxis and Epinephrine Auto-Injector course as a nationally recognized organization experienced in training laypersons in emergency health treatment ARC will be the primary training source. It will be an online course that covers the minimum topics laid out in the legislation The department does offer training and developed a tool for soliciting applications from entities or individuals interested in receiving training It is in the process of promulgating a minor rule update to the Florida Administrative Code To date, only several individuals have applied for certification

Rhode Island Follow-Up RI has not received any filings for establishments to maintain epinephrine auto-injectors, so there is no update at this time. As for training, the use of auto-injectors can be included in first aid classes, such as those taught by the Red Cross, American Heart Association, National Safety Council, etc.