On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19), which went into effect on the same date.
This legislation expands access to epinephrine, which can be lifesaving when treating anaphylactic allergic reactions. PA 19-19 permits “authorized entities” to acquire and maintain a supply of epinephrine cartridge injectors, subject to certain conditions. With a few exceptions, authorized entities are for-profit or nonprofit entities or organizations that employ at least one “person with training.” The new legislation defines a person with training as a person who either:
- Has completed and received a certification in a first aid course that has been approved by a “prescribing practitioner” pursuant to a medical protocol (as described below); or
- Has received training in the recognition of the signs and symptoms of anaphylaxis, the use of an epinephrine cartridge injector and emergency protocol by a licensed physician, physician assistant, advanced practice registered nurse or emergency medical services personnel.
Prior to PA 19-19, drug wholesalers and manufacturers were permitted to sell epinephrine cartridge injectors to select categories of purchasers, including hospitals, physicians, nursing homes with a full-time pharmacist, pharmacies and certain other institutions with a full-time pharmacist.
PA 19-19 requires authorized entities that desire to acquire or maintain epinephrine cartridge injectors, together with a “prescribing practitioner,” to establish a medical protocol on the administration of epinephrine cartridge injectors by a person with training. Under PA 19-19, a prescribing practitioner is a Connecticut-licensed physician, dentist, podiatrist, optometrist, physician assistant, advanced practice registered nurse, nurse-midwife or veterinarian, authorized to prescribe medication within his or her scope of practice. The medical protocol must address, among other things, proper storage, maintenance and documentation of epinephrine cartridge injectors, and procedures for emergency medical situations involving anaphylactic allergic reactions at the authorized entity’s place of business. The authorized entity must maintain a copy of the medical protocol at the place of business to which it applies, and must review annually the medical protocol with a person with training and a prescribing practitioner.
In the event of an anaphylactic reaction, a person with training may provide, in accordance with the medical protocol, an epinephrine cartridge injector to the individual or to the individual’s parent, guardian or caregiver, or administer the epinephrine cartridge injector, regardless of whether the individual has a prescription or a prior medical diagnosis of an allergic condition. After any such administration of epinephrine, the authorized entity must notify a local emergency medical services organization as well as the prescribing practitioner.
Notably, PA 19-19 holds prescribing practitioners free from civil and criminal liability for establishing the medical protocol or for use of the epinephrine cartridge injector in accordance with PA 19-19. This legislation also holds persons with training and authorized entities free from civil or criminal liability to the individual who experienced anaphylaxis for the provision or administration, in accordance with PA 19-19, of the epinephrine cartridge injector when the person with training has a good faith belief that the individual is experiencing anaphylaxis. However, the immunity does not apply to willful or wanton misconduct or acts or omissions constituting gross negligence.