Facts About VISs
A VIS or Vaccine Information Statement is a document, produced by CDC, that informs vaccine recipients - or their parents or legal representatives - about the benefits and risks of a vaccine they are receiving.
All vaccine providers, public or private, are required by the National Vaccine Childhood Injury Act (NCVIA - 42 U.S.C. § 300aa-26 [2 pages]) to give the appropriate VIS to the patient (or parent or legal representative) prior to every dose of specific vaccines.
The appropriate VIS must be given prior to the vaccination, and must be given prior to each dose of a multi-dose series. It must be given regardless of the age of the recipient. See "Ways to give a VIS".
In the past, healthcare providers and public health entities interpreted federal law as a requirement that a paper copy of each VIS had to be handed to the recipient prior to vaccination, and that the recipient must take this copy away with him or her following the vaccination.
The evolution of electronic media has resulted in broadening of this interpretation. For example, now:
- A practice may produce permanent, laminated, office copies of each VIS, which may be read by recipients prior to vaccination.
- VISs may be reviewed on a computer monitor (or any video display).
- VISs may be downloaded by the recipient to a smartphone or other electronic device to read at his or her convenience. (VISs have been specially formatted for this purpose.)
- VISs may be made available to be read before the immunization visit (e.g., by giving the patient or parent a copy to take home during a prior visit, or telling them how to download or view a copy from the Internet). These patients must still be offered a copy in one of the formats described previously to read during the immunization visit, as a reminder.
- Providers must still offer a copy (which can be an electronic copy) of each appropriate VIS to take away following the vaccination. However, the recipient may decline.
CDC maintains a current English language VIS for each vaccine. You and your patients can
- View and display the web page
- Download and print the PDF file
- Import the RTF (text) file into an electronic system
- View on a smartphone, tablet or other web-accessible mobile device
VISs have been translated into about 40 languages. These can be found on the website of CDC’s partner, the Immunization Action Coalition. Not every VIS has been translated into every language.
In addition to distributing VISs, as described above, providers are required to record specific information in the patient’s medical record (which can include an electronic medical record), or in a permanent office log:
- The edition date of the VIS (found on the back at the right bottom corner).
- The date the VIS is provided (i.e., the date of the visit when the vaccine is administered).
- The office address and name and title of the person who administers the vaccine.
- The date the vaccine is administered.
- The vaccine manufacturer and lot number.
Providers may add the name, address, and contact information of their practice to an existing VIS, but may not make any substantive changes.
In addition to providing a VIS to patients to read, you can
- read it to them,
- provide a videotaped version,
- give additional printed material,
or help recipients understand the disease and vaccine in any other way.
Always offer the patient an opportunity to ask questions about the vaccine you are giving them.
Beginning in 2013, each new or updated VIS will be accompanied with a "Provider Information" document, which will summarize relevant ACIP recommendations; include more detailed information about indications, schedules, and precautions; and contain other information giving providers a quick reference to help address common patients' questions.
VISs for these vaccines are required under the NCVIA, as of March 2013:
- Diphtheria, tetanus and pertussis containing vaccines (DTaP, DT, Td, and Tdap)
- Haemophilus influenzae type b (Hib)
- Hepatitis A
- Hepatitis B
- Human Papillomavirus (HPV)
- Influenza (both Inactivated and Live, Intranasal vaccines)
- Pneumococcal Conjugate (PCV13)
VISs also exist for vaccines that are not covered by the NCVIA. CDC encourages healthcare providers to use these whenever they give one of these vaccines, but they must be used when the vaccine is purchased under CDC contract. The legal basis for this is not the NCVIA, but a "Duty to Warn" clause in CDC's vaccine contracts.
These vaccines are:
- Adenovirus (Military Use Only)
- Japanese Encephalitis (Ixiaro)
- Pneumococcal Polysaccharide
- Yellow Fever
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