Epinephrine Auto-Injectors for Emergency Administration (216-RICR-20-10-5)
216-RICR-20-10-5 ACTIVE RULE
These regulations are established pursuant to the authority conferred under R.I. Gen. Laws Chapter , for the purpose of establishing the procedures for an authorized entity to acquire and maintain a supply of epinephrine auto-injectors for administration to an individual experiencing anaphylaxis.
A.Wherever used in this Part, the following terms shall be construed as follows:
2.“Administer” means the direct application of an epinephrine auto-injector to the body of an individual.
3.“Authorized entity” means any entity or organization at, or in connection with, where allergens capable of causing anaphylaxis may be present, as specified in § 5.3.1 of this Part.
4.“Authorized health care provider” means a physician, nurse, or other person duly authorized by law, in the state in which they practice, to prescribe drugs.
5.“Department” means the Rhode Island Department of Health.
6."Director" means the Director of the Rhode Island Department of Health.
7.“Epinephrine auto-injector” means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
8.“Provide” means the supplying of one or more epinephrine auto-injectors to an individual.
This Part applies to authorized health care providers, pharmacists and authorized entities, as defined by the Act and this Part.
2.A pre-school, school, college or university as defined in the Department’s rules and regulations pertaining to Immunization and Communicable Disease Testing in Preschool, School, Colleges or Universities (Part 30-05-3 of this Title);
5.A state or local governmental agency or facility;
6.An organized athletic team, league or association; and
7.A place of employment which provides in-house employee health services.
5.4Training for Use of Epinephrine Auto-injectors
1.A healthcare provider (e.g., physician, physician assistant, nurse, EMT, etc.) who is currently licensed by the Department, and who has received anaphylaxis training as part of their professional development, is not required to complete this additional training.
5.4.1Operations Plan Required
A.An authorized entity described in § 5.3.1 of this Part which chooses to acquire and stock a supply of epinephrine auto-injectors must maintain an Operations plan on the premises. The plan shall include at a minimum:
2.How the epinephrine auto-injectors will be acquired.
3.Name and contact information for the prescribing authorized health care provider.
4.Where and how the epinephrine auto-injectors will be stored.
5.Names of the designated employees and/or agents who have completed the training program and are authorized to administer the epinephrine auto-injectors.
6.Description of the process to allow individuals, other than those trained per R.I. Gen. Laws § , to be provided the epinephrine auto-injectors via remote authorization by an authorized health care provider, after consultation with the authorized health care provider by audio, tele-video, or other similar means of electronic communication, pursuant to R.I. Gen. Laws § .
7.How and when the epinephrine auto-injectors will be inspected for an expiration date that has not passed, and how that will be recorded.
8.Description of the process to replace an epinephrine auto-injector that is nearing its expiration date or if one has been administered.
|Title||216||Department of Health|
|Subchapter||10||Screening, Medical Services, and Reporting|
|Part||5||Epinephrine Auto-Injectors for Emergency Administration (216-RICR-20-10-5)|
|Type of Filing||Periodic Refile|
R.I. Gen. Laws § 23-6.4
Purpose and Reason:
This rule is being refiled by the agency pursuant to R.I. Gen. Laws § 42-35-4.1. No changes were made to the text of this rule.