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Is Your Practice Following Federal Law When Using Vaccine Information Statements?

August 2015

Technically Speaking

Monthly Column by Deborah Wexler, MD

Technically Speaking is a monthly column written by IAC’s Executive Director Deborah Wexler, MD. The column is featured in The Children’s Hospital of Philadelphia Vaccine Education Center’s (VEC’s) monthly e-newsletter for healthcare professionals. Technically Speaking columns cover practical topics in immunization delivery such as needle length, vaccine administration, cold chain, and immunization schedules.

Check out a recent issue of Vaccine Update for Healthcare Providers. The VEC e-newsletter keeps providers up to date on vaccine-related issues and includes reviews of recently published journal articles, media recaps, announcements about new resources, and a regularly updated calendar of events.

TECHNICALLY SPEAKING

Is Your Practice Following Federal Law When Using Vaccine Information Statements?

Published August 2015

Information presented in this article may have changed since the original publication date. For the most current immunization recommendations from the Advisory Committee on Immunization Practices, visit www.immunize.org/acip/acip_vax.asp.

What are Vaccine Information Statements?

Vaccine Information Statements (VISs) are documents produced by the Centers for Disease Control and Prevention (CDC) to properly inform all patients (or their parents/legal representatives) about the risks and benefits of each vaccine.

Use of VISs is legally required!

Federal law (under the National Childhood Vaccine Injury Act) requires the provider to give a copy of the current VIS to the adult patient or to the child’s parent/legal representative before vaccinating an adult or child with a dose of any vaccine containing diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox).

Additional facts about the use of VISs

Fact:

Federal law requires that VISs must be used for patients of ALL ages (adults as well as children) before administering vaccines.

Fact:

VISs must be given to the patient (or parent/legal representative) BEFORE vaccine is administered so they have an opportunity to read them.

Fact:

VISs must be used regardless of whether the vaccine is given in a public or private healthcare setting.

Fact:

At the time of the visit, you must provide a current VIS for each vaccine you administer. This includes providing a VIS before each dose of vaccines given as a series.

Fact:

You must provide VISs whenever you administer combination vaccines. If you administer a combination vaccine that does not have a stand-alone VIS (e.g., DTaP-IPV; DTaP-IPV-HepB; DTaP-Hib-IPV; HepA-HepB), you should provide the patient with individual VISs for the component vaccines.

Fact:

The Multi-Vaccine VIS may be used in place of the individual VISs for DTaP, Hib, hepatitis B, polio, and pneumococcal when two or more of these vaccines are administered during the same visit. It may be used for infants as well as children through 6 years of age. The Multi-Vaccine VIS should not be used for adolescents or adults.

Fact:

To verify that a VIS was given, providers must record in the patient’s medical record (or permanent office log or file) the following information:

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Edition date of the VIS (found on the back at the right bottom corner)

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Date the VIS is provided (e.g., the date of the visit when the vaccine is administered)

In addition, providers must record:

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Office address and name and title of the person who administers the vaccine

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Date the vaccine is administered

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Vaccine manufacturer and lot number

Fact:

VISs are not required by law to be used for certain vaccines not covered under the National Childhood Vaccine Injury Act (i.e., anthrax, Japanese encephalitis, pneumococcal polysaccharide, rabies, shingles, typhoid, and yellow fever), unless they have been purchased under CDC contract. However, CDC recommends that VISs be used whenever these vaccines are given.

Fact:

VISs should be given in a language/format that the recipient can understand, whenever possible. For patients who don’t read or speak English, the law requires that providers ensure all patients (or parent/legal representatives) receive a VIS, regardless of their ability to read English. The Immunization Action Coalition provides VISs in more than 30 languages on its website at www.immunize.org/vis.

Here are some additional important facts about the use of VISs:

Immunization Action Coalition

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“It’s Federal Law: You Must Give Your Patients Current VISs”

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VIS general information and translations in more than 30 languages

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“Current Dates of VISs”

Centers for Disease Control and Prevention

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VIS website

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