| Q |
What is the difference between VIS, Important Information Statements, Vaccine Information Pamphlets, and Vaccine Information Materials? |
| A |
Technically, the term Vaccine Information Statement applies to those statements dealing with vaccines covered by the National Childhood Vaccine Injury Act (NCVIA). But for convenience sake, we use the term for all current information statements. Important Information Statements (IIS) is a term that was used prior to the NCVIA (1986), and is still used sometimes to describe non-NCVIA materials. Vaccine Information Pamphlets (VIP) were the first materials developed after NCVIA was passed. They were multi-page booklets rather than single-sheet documents like the current VIS. Vaccine Information Materials (VIM) is a generic term that has been used to describe any of these materials.
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| Q |
Can I still use old materials, such as IISs or VIPs? |
| A |
No. You should use only the most recent materials.
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| Q |
Should the VISs be used for adults getting vaccines as well as for children? |
| A |
Yes. Under the National Childhood Vaccine Injury Act, anyone receiving a covered vaccine should be given the appropriate VIS. The VISs are designed to be used by adults as well as children. The one current exception is the DTP VIS, since pertussis vaccine is not licensed for adults. Adults should use the VIS for adult Td vaccine.
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| Q |
Are VISs "informed consent" forms? |
| A |
No. In fact, even when vaccine information materials had tear-off sheets for parents to sign, they were not technically informed consent forms. The signature was simply to confirm that the "Duty to Warn" clause in the vaccine contract was being fulfilled. There is no Federal requirement for informed consent. VISs are written to fulfill the information requirements of the NCVIA. But because they cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed. Some states may have informed consent laws, covering either procedural requirements (e.g., whether consent may be oral or must be written) or substantive requirements (e.g., types of information required). Check your state medical consent law to determine if there are any specific informed consent requirements relating to immunization.
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| Q |
The law states that vaccine information materials be given to a child's legal representatives. How is "legal representative" defined? |
| A |
A "legal representative" is a parent or other individual who is qualified under state law to consent to the immunization of a minor. There is not an overriding Federal definition.
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| Q |
Must the patient, parent, or legal representative physically take away a copy of each VIS, or can we simply let them read a copy and make sure they understand it? |
| A |
Ideally the person getting the shot, or their representative, should actually take each VIS home. They contain information that may be needed later (e.g., the recommended vaccine schedule, information about what to do in the case of an adverse reaction). Patients may choose not to take the VIS, but the provider should offer them the opportunity to do so.
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| Q |
How should we comply with the law for patients who cannot read the VIS (e.g., those who are illiterate or blind)? |
| A |
The NCVIA requires providers to supplement the VIS with "visual presentations" or oral "explanations" as needed. If patients are unable to read the VIS, it is up to the provider to ensure that they have that information. VISs can be read to these patients, or videotapes can be used as supplements. At least one CD-ROM is being produced on which users can hear the VIS read.
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| Q |
When are new VISs developed? |
| A |
Generally there are two reasons for developing a new VIS: (1) When a vaccine is added to the Vaccine Injury Table, a VIS must be developed for it. (2) When new ACIP recommendations are published on a vaccine, affecting how the vaccine is used or containing new information on its safety, a new VIS is developed to reflect those changes. A third reason would be licensure of a new vaccine that is routinely used, even if it is not covered by the National Childhood Vaccine Injury Act.
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| Q |
When do providers have to start using a new VIS? |
| A |
Once a new VIS has been developed, the date for its required use is announced when the final draft is published in the Federal Register.
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