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Intranasal Epinephrine/Guidelines/Higher Learning, the official text

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SPONSOR: Rep. Neal & Sen. Sokola
                                                                               Rep. K. Johnson

                                      HOUSE OF REPRESENTATIVES
                                        153rd GENERAL ASSEMBLY

                                                   HOUSE BILL NO. 466

    AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO THE APPLICATION OF NASAL
    EPINEPHRINE.

    BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

1   Section 1. Amend Subchapter II, Chapter 30E, Title 16 of the Delaware Code by making deletions as shown by

2 strike through and insertions as shown by underline as follows:

3   Subchapter II. Access to Epinephrine Autoinjectors and Intranasal Epinephrine Sprays in Institutions of Higher

4 Education

5   § 3011E. Definitions.

6   For purposes of this subchapter:

7            (1) “Administer” means the direct application of an epinephrine autoinjector or intranasal epinephrine spray to

8   the body of an individual.

9            (2) “Dispensing” means providing 1 or more epinephrine autoinjectors or intranasal epinephrine sprays

10  according to an order of a licensed health-care provider.

11           (3) “Epinephrine autoinjector” means a single-use device used for the automatic injection of a premeasured

12  dose of epinephrine into the human body.

13           (4) “Institution of higher education” means a public or private educational institution, physically located in

14  this State, that provides a program of education beyond the high school level and awards an associate’s, bachelor’s, or

15  advanced degree.

16           (5) “Licensed health-care provider” means a physician or an individual licensed and authorized to write

17  prescriptions for individuals under Title 24.

18           (6) “Records’' means the recordings of interviews and all oral or written reports, statements, minutes,

19  memoranda, charts, statistics, data, and other documentation generated by the State Emergency Medical Services

20  Medical Director any administration or review of epinephrine autoinjectors.

21           (7) “Self-administration” means the process whereby an individual gives themselves a single dose of

22  epinephrine from a previously dispensed, properly labeled autoinjector or intranasal epinephrine spray.

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23             (8) “Intranasal epinephrine spray” means a single-dose nasal spray that delivers epinephrine through the

24  nostrils.

25           § 3012E. Emergency access to epinephrine autoinjectors and Intranasal epinephrine sprays.

26           The Department shall do all of the following:

27             (1) Promote the safe use of epinephrine autoinjectors and intranasal epinephrine sprays at institutions of

28  higher education to reduce deaths from anaphylaxis.

29             (2) Promulgate regulations to implement this subchapter.

30           § 3013E. Epinephrine autoinjectors; autoinjectors and intranasal epinephrine sprays; prescribing, dispensing,

31 storage.

32           (a) A licensed health-care provider may prescribe epinephrine autoinjectors and intranasal epinephrine sprays in

33 the name of an institution of higher education for use under this subchapter.

34           (b) A licensed health-care provider or pharmacist may dispense epinephrine autoinjectors and intranasal

35 epinephrine sprays under a prescription issued in the name of an institution of higher education.

36           (c) An institution of higher education may acquire and stock a supply of epinephrine autoinjectors and intranasal

37 epinephrine sprays under a prescription issued under this subchapter as follows:

38             (1) The epinephrine autoinjectors and intranasal epinephrine sprays must be stored in a location readily

39  accessible in an emergency.

40             (2) The epinephrine autoinjectors and intranasal epinephrine sprays must be stored in accordance with the

41  epinephrine autoinjector’s instructions for use and any additional requirements established by the Department.

42             (3) An institution of higher education shall designate employees or agents who have completed the training

43  required under § 3015E of this title to be responsible for the storage, maintenance, and general oversight of epinephrine

44  autoinjectors and intranasal epinephrine sprays acquired by the institution of higher education.

45           § 3014E. Epinephrine autoinjectors; autoinjectors and intranasal epinephrine sprays administration.

46           (a) An employee or agent of an institution of higher education, who has completed the training required under §

47 3015E of this title may, on the premises of or in connection with the institution of higher education, use epinephrine

48 autoinjectors or intranasal epinephrine sprays prescribed under § 3013E of this title as follows:

49             (1) Provide an epinephrine autoinjector or intranasal epinephrine spray to an individual who the employee,

50  agent, or the individual believes in good faith is experiencing anaphylaxis for immediate self-administration, regardless

51  of whether the individual has a prescription for an epinephrine autoinjector or intranasal epinephrine spray or has

52  previously been diagnosed with an allergy.

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53            (2) Administer an epinephrine autoinjector or intranasal epinephrine spray to any individual who the

54  employee or agent believes in good faith is experiencing anaphylaxis, regardless of whether the individual has a

55  prescription for an epinephrine autoinjector or intranasal epinephrine spray or has previously been diagnosed with an

56  allergy.

57  (b) An individual who uses an epinephrine autoinjector or intranasal epinephrine spray under subsection (a) of this

58 section must do all of the following:

59            (1) Notify the appropriate emergency medical service units as soon as possible.

60            (2) Report the use to the appropriate licensed physician or medical authority, if known.

61  § 3015E. Epinephrine autoinjectors; autoinjectors and intranasal epinephrine sprays training.

62  (a) An employee or agent of an institution of higher education must complete an anaphylaxis training program

63 before providing or administering an epinephrine autoinjector or intranasal epinephrine spray made available by an

64 institution of higher education. The training must be conducted by a nationally-recognized organization experienced in

65 training laypersons in emergency health treatment or an entity or individual approved by the Department. Training may be

66 conducted online or in person and, at a minimum, must cover all of the following:

67            (1) Techniques on how to recognize symptoms of severe allergic reactions, including anaphylaxis.

68            (2) Standards and procedures for the storage and administration of an epinephrine autoinjector. autoinjector

69  and intranasal epinephrine spray.

70            (3) Risks of administering an epinephrine autoinjector or intranasal epinephrine spray that has expired or that

71  was not stored at the proper temperature.

72            (4) Potential contraindications, risks, side effects, or medication reactions after appropriate use.

73            (5) The differences in usage, storage, and administration of an EpiPen Jr. autoinjectors autoinjectors and

74  intranasal epinephrine sprays.

75            (6) What to do if an individual is at a borderline weight.

76            (7) Emergency follow-up procedures.

77  (b) The entity that conducts the training shall issue a certificate, on a form developed or approved by the

78 Department, to each person who successfully completes the anaphylaxis training program.

79  (c) An individual who successfully completes an anaphylaxis training under this section may use epinephrine

80 autoinjectors and intranasal epinephrine sprays prescribed under § 3013E of this title for 2 years from the date of

81 completion on the certificate issued under subsection (b) of this section.

82  § 3016E. Epinephrine autoinjectors; autoinjector and intranasal epinephrine spray immunity.

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83   (a) A licensed health-care provider who prescribes or dispenses an epinephrine autoinjector or intranasal

84 epinephrine spray to an institution of higher education under this subchapter must do so in good faith and with reasonable

85 care. Unless it is established that the licensed health-care provider caused injuries or death as a result of unreasonable care,

86 wilfully, wantonly, or by gross negligence, a licensed health-care provider is not subject to any of the following as a result

87 of prescribing or dispensing an epinephrine autoinjector or intranasal epinephrine spray under this subchapter:

88   (1)  Disciplinary or other adverse action under the professional licensing laws of this State.

89   (2)  Criminal liability.

90   (3)  Liability for damages for injuries or death.

91   (b) A pharmacist who dispenses an epinephrine autoinjector or intranasal epinephrine spray to an institution of

92 higher education under this subchapter must do so in good faith and with reasonable care. Unless it is established that the

93 pharmacist caused injuries or death as a result of unreasonable care, wilfully, wantonly, or by gross negligence, a

94 pharmacist is not subject to any of the following as a result of dispensing an epinephrine autoinjector or intranasal

95 epinephrine spray under this subchapter:

96   (1)  Disciplinary or other adverse action under the professional licensing laws of this State.

97   (2)  Criminal liability.

98   (3)  Liability for damages for injuries or death.

99   (c) An institution of higher education that possesses and makes available epinephrine autoinjector or intranasal

100 epinephrine spray under this subchapter must do so in good faith and with reasonable care. Unless it is established that the

101 institution of higher education caused injuries or death as a result of unreasonable care, wilfully, wantonly, or by gross

102 negligence, an institution of higher education is not subject to any of the following as a result of possessing or making

103 available an epinephrine autoinjector or intranasal epinephrine spray under this subchapter:

104  (1)  Disciplinary or other adverse action under the professional licensing laws of this State.

105  (2)  Criminal liability.

106  (3)  Liability for damages for injuries or death.

107  (d) An individual who administers or provides an epinephrine autoinjector or intranasal epinephrine spray under

108 this subchapter is exempt from liability under § 6801 of this title.

109  § 3017E. Epinephrine autoinjectors; autoinjectors and intranasal epinephrine sprays reports.

110  (a) An institution of higher education that possesses and makes available epinephrine autoinjectors or intranasal

111 epinephrine spray shall must submit to the Department, on a form developed by the Department, a report of each incident

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112 that involves the administration of the institution of higher education’s epinephrine autoinjector or intranasal epinephrine

113 spray.

114         (b) Records of the State Emergency Medical Services Medical Director, and emergency medical services quality

115 care review committee relating to epinephrine autoinjector or intranasal epinephrine spray reviews and audits are

116 confidential and privileged, protected, and are not subject to discovery, subpoena, or admission into evidence in any judicial

117 or administrative proceeding. Raw data used in any epinephrine autoinjector or intranasal epinephrine spray review or audit

118 is not a public record under Chapter 100 of Title 29 and is confidential under § 1768(b) of Title 24.

119         (c) The Department shall file an annual report with the General Assembly by January 1 that provides all of the

120 following information for the prior academic year:

121              (1) A summary and analysis of all reports submitted under subsection (a) of this section.

122              (2) The number of institutions of higher education that received epinephrine autoinjectors under this

123  subchapter.

124              (3) The number of individuals trained to administer epinephrine autoinjectors under this subchapter.

125 [Repealed].

                                                                         SYNOPSIS

               This Act adds authority and guidelines for access to and use of intranasal epinephrine nasal sprays at institutions of
     higher education to the existing framework for access to and use of epinephrine injectors. This Act also removes the
     requirement of the Department of Public Health from filing an annual report regarding the use of epinephrine autoinjectors
     for the prior academic year with the General Assembly under this section.

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