Amendment ID: S2397-25
Amendment 25
Increasing public access to epinephrine auto-injectors
Mr. Welch moves that the proposed new draft be amended to insert the following section:-“ An Act to reduce the risks associated with allergic reactions
SECTION 1. Chapter 94C of the General Laws is hereby amended by inserting after section 19D the following section:-
Section 19E. (a) As used in this section and unless the context clearly requires otherwise, ''epinephrine auto-injector'' shall mean a medical device for injecting a measured dose or doses of epinephrine by means of auto-injector technology.
(b) A licensed pharmacist may dispense an epinephrine auto-injector to a designated representative of a restaurant in accordance with written, standardized procedures or protocols developed by an actively practicing physician registered with the commissioner to distribute or dispense a controlled substance in the course of professional practice pursuant to section 7; provided, however, that the procedures or protocols developed by such physician are filed at the pharmacist's place of practice and with the board of registration in pharmacy before implementation.
(c) A pharmacist dispensing an epinephrine auto-injector under this section shall annually provide a report to the department that includes the number of times an epinephrine auto-injector is dispensed. Reports made pursuant to this section shall be confidential and shall not be public records as defined in clause Twenty-sixth of section 7 of chapter 4.
(e) The department, the board of registration in medicine and the board of registration in pharmacy shall adopt regulations to implement this section.
SECTION 2. Chapter 111 of the General Laws is hereby amended by adding the following section:-
Section 236. (a) Notwithstanding any general or special law to the contrary, a restaurant may maintain a reasonable supply of epinephrine auto-injectors, that are not patient specific, pursuant to section 19E of chapter 94C, to provide an epinephrine auto-injector for: (i) immediate self-administration by an individual who indicates that they are experiencing anaphylaxis and have a prescription for an epinephrine auto-injector or have been previously diagnosed as being at risk of anaphylaxis due to an allergy; (ii) immediate administration to an individual by an immediate family member or caregiver or (iii) immediate administration to an individual by a licensed health care professional who is trained and authorized to identify anaphylaxis and administer epinephrine.
(b) A restaurant that maintains and makes available epinephrine auto-injectors pursuant to this section shall not be liable for injuries or damages that result from an act or omission related to the administration or self-administration of an epinephrine auto-injector in accordance with this section, unless the act or omission constitutes gross, willful or wanton negligence. The administration of an epinephrine auto-injector pursuant to this section shall not be considered the practice of medicine.
(c) A restaurant that maintains an epinephrine auto-injector pursuant to this section shall provide the health department or board of health in the municipality where it is located with information regarding an epinephrine auto-injector stored on the premises within 3 business days of being dispensed to the designated representative of a restaurant under section 19E of chapter 94C. The information shall include the location and method of secure storage for the epinephrine auto-injector on the premises and the dose, expiration date and protocol for replacement of the epinephrine auto-injector. A restaurant shall also provide a report, in a form and manner determined by the department, of each administration of an epinephrine auto-injector on the premises to the department and to the health department or board of health in the municipality where it is located.
(d) A health department or board of health in the municipality that receives notification from a restaurant of an epinephrine auto-injector placed on the premises of the restaurant pursuant to this section shall include an examination of the epinephrine auto-injector on the premises in its annual restaurant inspections to ensure that the epinephrine auto-injector is placed and stored in accordance with the information filed by the establishment and that it has not expired.
(e) Annually, not later than March 1, the department shall provide a report on its website of any reports of administration of an epinephrine auto-injector received pursuant to subsection (c).
SECTION 3. The department of public health may establish a certification program to recognize a restaurant that has complied with this act.
SECTION 4. The department of public health shall adopt regulations necessary to carry out this act not later than January 1, 2020.
SECTION 5. This act shall take effect on January 1, 2020.