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

     

     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:

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     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 6.6

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VACCINE ADVERSE EVENTS REPORTING ACT

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     23-6.6-1. Short title.

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     This chapter shall be known and may be cited as the "Vaccine Adverse Events Reporting

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Act."

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     23-6.6-2. Legislative declarations.

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     The general assembly hereby declares that the United States Department of Health And

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Human Services reports that:

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     (1) Fewer than one percent (1%) of vaccine adverse events are reported.

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     (2) Low reporting rates preclude or slow the identification of "problem" drugs and

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vaccines that endanger public health.

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     (3) New surveillance methods for drug and vaccine adverse effects are needed.

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     (4) Barriers to reporting include a lack of clinician awareness, uncertainty about when

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and what to report, as well as the burdens of reporting as reporting is not part of clinicians' usual

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workflow, takes time, and is duplicative.

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     23-6.6-3. Definitions.

 

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     As used in this chapter:

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     (1) "Department" means the department of health;

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     (2) "Vaccine adverse event" means any adverse effect related to the administration of a

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vaccine sustained by a patient; and

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     (3) "Vaccine provider" means a hospital, medical practice, sole practitioner or medical

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organization that administers vaccinations to its patients by a licensed doctor or nurse.

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     23-6.6-4. Department of health - Collection of data and reporting requirements.

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(a)(1) The department shall provide an internet-based software program (ESP VAERS) to

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facilitate vaccine provider's detection and clinical reporting of vaccine adverse events, in order to

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improve the safety of the Rhode Island vaccination program.

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     (2) The software program will provide standardized vaccine adverse events which will

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alert the vaccine provider to assess the need for a potential vaccine adverse event to be directly

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reported to the vaccine adverse event reporting system (VAERS) database.

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     (b) The department shall provide the software to be accessible and also provide guidance

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on implementation through written directives to vaccine providers that may be accessed on the

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department of health website.

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     (c) The department shall provide guidance and a training video reviewing adverse events

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listed on the reportable events table (RET). The RET reflects what is reportable by law pursuant

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to 42 U.S.C. 300aa-25 to the VAERS database including conditions found in the manufacturer

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package insert.

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     (d) The department shall provide a report of the potential vaccine adverse events reported

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to VAERS impacting Rhode Island residents and potential adverse events from vaccines

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administered in Rhode Island annually to the governor and the general assembly. Data points in

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the report shall include:

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     (1) Age of vaccinee;

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     (2) Sex of vaccinee;

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     (3) Date of vaccination;

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     (4) Date of onset of potential adverse event;

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     (5) Vaccine(s) type;

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     (6) Vaccine name and manufacturer; and

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     (7) Description of adverse event.

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     23-6.6-5. Vaccine providers - Reporting of data.

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     Vaccine providers shall be required to use Internet-based reporting of potential vaccine

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adverse events to the VAERS. Vaccine providers shall meet all of the following conditions:

 

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     (1) The vaccine provider is required to participate in post-marketing surveillance to

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improve on the safety and quality of the vaccination program; and

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     (2) The vaccine provider shall maintain appropriate security protocols to preserve the

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confidentiality of the reports submitted through the system.

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     SECTION 2. This act shall take effect upon passage.

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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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     This act would establish a reporting system to detect and report vaccine adverse events to

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the department of health (DOH) from vaccine providers to improve the safety of the Rhode Island

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vaccination program.

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     This act would take effect upon passage.

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