2020 -- S 2466 | |
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LC004382 | |
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STATE OF RHODE ISLAND | |
IN GENERAL ASSEMBLY | |
JANUARY SESSION, A.D. 2020 | |
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A N A C T | |
RELATING TO HEALTH AND SAFETY -- VACCINE ADVERSE EVENTS REPORTING | |
ACT | |
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Introduced By: Senator Elaine J. Morgan | |
Date Introduced: February 13, 2020 | |
Referred To: Senate Health & Human Services | |
It is enacted by the General Assembly as follows: | |
1 | SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby |
2 | amended by adding thereto the following chapter: |
3 | CHAPTER 6.6 |
4 | VACCINE ADVERSE EVENTS REPORTING ACT |
5 | 23-6.6-1. Short title. |
6 | This chapter shall be known and may be cited as the "Vaccine Adverse Events Reporting |
7 | Act." |
8 | 23-6.6-2. Legislative declarations. |
9 | The general assembly hereby declares that the United States Department of Health And |
10 | Human Services reports that: |
11 | (1) Fewer than one percent (1%) of vaccine adverse events are reported. |
12 | (2) Low reporting rates preclude or slow the identification of "problem" drugs and |
13 | vaccines that endanger public health. |
14 | (3) New surveillance methods for drug and vaccine adverse effects are needed. |
15 | (4) Barriers to reporting include a lack of clinician awareness, uncertainty about when |
16 | and what to report, as well as the burdens of reporting as reporting is not part of clinicians' usual |
17 | workflow, takes time, and is duplicative. |
18 | 23-6.6-3. Definitions. |
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1 | As used in this chapter: |
2 | (1) "Department" means the department of health; |
3 | (2) "Vaccine adverse event" means any adverse effect related to the administration of a |
4 | vaccine sustained by a patient; and |
5 | (3) "Vaccine provider" means a hospital, medical practice, sole practitioner or medical |
6 | organization that administers vaccinations to its patients by a licensed doctor or nurse. |
7 | 23-6.6-4. Department of health - Collection of data and reporting requirements. |
8 | (a)(1) The department shall provide an internet-based software program (ESP VAERS) to |
9 | facilitate vaccine provider's detection and clinical reporting of vaccine adverse events, in order to |
10 | improve the safety of the Rhode Island vaccination program. |
11 | (2) The software program will provide standardized vaccine adverse events which will |
12 | alert the vaccine provider to assess the need for a potential vaccine adverse event to be directly |
13 | reported to the vaccine adverse event reporting system (VAERS) database. |
14 | (b) The department shall provide the software to be accessible and also provide guidance |
15 | on implementation through written directives to vaccine providers that may be accessed on the |
16 | department of health website. |
17 | (c) The department shall provide guidance and a training video reviewing adverse events |
18 | listed on the reportable events table (RET). The RET reflects what is reportable by law pursuant |
19 | to 42 U.S.C. 300aa-25 to the VAERS database including conditions found in the manufacturer |
20 | package insert. |
21 | (d) The department shall provide a report of the potential vaccine adverse events reported |
22 | to VAERS impacting Rhode Island residents and potential adverse events from vaccines |
23 | administered in Rhode Island annually to the governor and the general assembly. Data points in |
24 | the report shall include: |
25 | (1) Age of vaccinee; |
26 | (2) Sex of vaccinee; |
27 | (3) Date of vaccination; |
28 | (4) Date of onset of potential adverse event; |
29 | (5) Vaccine(s) type; |
30 | (6) Vaccine name and manufacturer; and |
31 | (7) Description of adverse event. |
32 | 23-6.6-5. Vaccine providers - Reporting of data. |
33 | Vaccine providers shall be required to use Internet-based reporting of potential vaccine |
34 | adverse events to the VAERS. Vaccine providers shall meet all of the following conditions: |
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1 | (1) The vaccine provider is required to participate in post-marketing surveillance to |
2 | improve on the safety and quality of the vaccination program; and |
3 | (2) The vaccine provider shall maintain appropriate security protocols to preserve the |
4 | confidentiality of the reports submitted through the system. |
5 | SECTION 2. This act shall take effect upon passage. |
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LC004382 | |
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EXPLANATION | |
BY THE LEGISLATIVE COUNCIL | |
OF | |
A N A C T | |
RELATING TO HEALTH AND SAFETY -- VACCINE ADVERSE EVENTS REPORTING | |
ACT | |
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1 | This act would establish a reporting system to detect and report vaccine adverse events to |
2 | the department of health (DOH) from vaccine providers to improve the safety of the Rhode Island |
3 | vaccination program. |
4 | This act would take effect upon passage. |
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LC004382 | |
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