Appendix C - Vaccine Information Statements - Pink Book

1 Appendix C. Appendix C. Vaccine Information Statements It's Federal Law ..C-1. Instructions for Use of VISs ..C-3. VIS Questions and Answers ..C-4. CDC's Vaccine Information Statement Webpage ..C-9. Centers for Disease Control and Prevention Epidemiology and Prevention of Vaccine -Preventable Diseases,13th Edition Top 10 Facts About VISs You Must Give Your Patients Vaccine Information Statements fact 1. It's federal law! You must give current* VISs to all your patients before vaccinating them. (VISs) It's Federal Law! Federal law requires that VISs must be used for patients of all ages when administering these vaccines: What are Vaccine Information Statements (VISs)? DTaP (includes DT) MMR and MMRV. Td and Tdap meningococcal (MenACWY, MenB). Vaccine Information Statements (VISs) are documents produced Hib pneumococcal conjugate by the Centers for Disease Control and Prevention (CDC), in con- hepatitis A polio sultation with panels of experts and parents, to properly inform vac- hepatitis B rotavirus cinees (or their parents/legal representatives) about the risks and HPV varicella (chickenpox).

2 Benefits of each Vaccine . VISs are not meant to replace interactions i nfluenza (inactivated with healthcare providers, who should address any questions or and live, intranasal). concerns that the vaccinee (or parent/legal representative) may have. For the vaccines not covered under the National Childhood Vaccine Injury Act ( , adenovirus, anthrax, Japanese encephalitis, pneu- Using VISs is legally required! mococcal polysaccharide, rabies, typhoid, yellow fever, and zos- Federal law (under the National Childhood Vaccine Injury Act) ter), providers are not required by federal law to use VISs unless requires a healthcare provider to give a copy of the current VIS to they have been purchased under CDC contract. However, CDC rec- an adult patient or to a child's parent/legal representative before ommends that VISs be used whenever these vaccines are given. vaccinating an adult or child with a dose of the following vaccines: *Federal law allows up to 6 months for a new VIS to be used.

3 Diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influ fact enza, pneumococcal conjugate, meningococcal, rotavirus, human 2 VISs can be given to patients in a variety of ways. papillomavirus (HPV), or varicella (chickenpox). In most medical settings, VISs are provided to patients (or their parents/legal representatives) in paper form. However, VISs also Where to get VISs may be provided using electronic media. Regardless of the format used, the goal is to provide a current VIS just prior to vaccination. All available VISs can be downloaded from the websites of the continued on next page . Immunization Action Coalition at or CDC at Ready to copy versions Most current versions of VISs (table). may also be available from your state or local health department. As of March 21, 2018, the most recent versions of the VISs are as follows: Translations: You can find VISs in more than 30 languages on the Immunization Action Coalition website at 6/11/14 2/12/18.

4 3/21/18 11/5/15. To obtain translations of VIS in languages other than 7/6/17 11/5/15. English, go to 5/17/07 4/24/15. 4/2/15 7/20/16. Hepatitis 7/20/16 10/6/09. Hepatitis 7/20/16 2/23/18. According to CDC, the appropriate VIS must be given: HPV.. 12/2/16 4/11/17. Prior to the vaccination (and prior to each dose of a Influenza.. 8/7/15 Tdap .. 2/24/15. multi-dose series); Japanese enceph.. 1/24/14 Typhoid .. 5/29/12. MenACWY.. 3/31/16 2/12/18. Regardless of the age of the vaccinee;. 8/9/16 Yellow 3/30/11. Regardless of whether the Vaccine is given in a public MMR.. 2/12/18 2/12/18. or private healthcare setting. A handy list of current VIS dates is also available at Technical content reviewed by the Centers for Disease Control and Prevention Saint Paul, Minnesota 651- 647- 9009 Item #P2027 (4/18). It's Federal Law! You Must Give Your Patients Current Vaccine Information Statements (VISs) (continued) page 2 of 2.

5 (For Information on special circumstances involving vaccination The Multi- Vaccine VIS may be used in place of the individual VISs for of a child when a parent/legal representative is not available DTaP, Hib, hepatitis B, polio, and pneumococcal when two or more at the time of vaccination, see CDC's Frequently Asked Questions of these vaccines are administered during the same visit. It may at ) 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. Prior to vaccination, VIS may be: Provided as a paper copy fact VISs should be given in a language/ format that Offered on a permanent, laminated office copy 7 the recipient can understand, whenever possible. Downloaded by the vaccinee (parent/legal representative) to a smartphone or other electronic device (VISs have been specially For patients who don't read or speak English, the law requires that formatted for this purpose) providers ensure all patients (parent/legal representatives) receive Made available to be read before the office visit, , by giving a VIS, regardless of their ability to read English.

6 To obtain VISs in the patient or parent a copy to take home during a prior visit, or more than 30 languages, visit the Immunization Action Coalition telling them how to download or view a copy from the Internet. website at Providers can supplement VISs These patients must still be offered a copy in one of the formats with visual presentations or oral explanations as needed. described previously to read during the immunization visit, as a reminder. fact Federal law does not require signed consent in 8 order for a person to be vaccinated. Regardless of the way the patient is given the VIS to read, providers must still offer a copy (which can be an electronic copy) of each Signed consent is not required by federal law for vaccination appropriate VIS to take home following the vaccination. However, (although some states may require it). the vaccinee may decline. fact To verify that a VIS was given, providers must fact VISs are required in both public and private 9 record in the patient's medical record (or perma- 3 sector healthcare settings.)

7 Nent office log or file) the following Information : Federal law requires the use of VISs in both public and private sec- The edition date of the VIS The date the VIS is provided tor settings, regardless of the source of payment for the Vaccine . (found on the back at the ( , the date of the visit when right bottom corner) the Vaccine is administered). fact You must provide a current VIS before a Vaccine 4 In addition, providers must record: is administered to the patient. The office address and name The date the Vaccine is A VIS provides Information about the disease and the Vaccine and and title of the person who administered must be given to the patient before a Vaccine is administered. administers the Vaccine The Vaccine manufacturer It is also acceptable to hand out the VIS well before administering and lot number vaccines ( , at a prenatal visit or at birth for vaccines an infant will receive during infancy), as long as you still provide a current fact VISs should not be altered before giving them to VIS right before administering vaccines.

8 10 patients, but you can add some Information . fact You must provide a current VIS for each dose Providers should not change a VIS or write their own VISs. However, 5 of Vaccine you administer. it is permissible to add a practice's name, address, and contact Information to an existing VIS. The most current VIS must be provided before each dose of Vaccine is given, including vaccines given as a series of doses. For example, if 5 doses of a single Vaccine are required ( , DTaP), the patient Additional resources on VISs and their use are available from (parent/legal representative) must have the opportunity to read the following organizations: the Information on the VIS before each dose is given. Immunization Action Coalition VIS general Information and translations in more than 30 languages: fact You must provide VISs whenever you administer 6 combination vaccines. Current Dates of Vaccine Information Statements : If you administer a combination Vaccine that does not have a stand alone VIS ( , Kinrix, Quadracel, Pediarix, Pentacel, Twinrix).

9 Centers for Disease Control and Prevention you should provide the patient with individual VISs for the compo- VIS website: nent vaccines, or use the Multi Vaccine VIS (see below). VIS Facts: VIS FAQs: Immunization Action Coalition Saint Paul, Minnesota 651- 647- 9009 Item #P2027 (4/18). Instructions for the Use of Vaccine Information Statements Required Use 1. Provide a Vaccine Information Statement 2. Record Information for each VIS provided. (VIS) when a vaccination is given. Health care providers shall make a notation in each As required under the National Childhood Vaccine patient's permanent medical record at the time Vaccine Injury Act (42 300aa-26), all health care Information materials are provided, indicating: providers in the United States who administer, to (1) . any child or adult, any of the following vaccines . diphtheria, tetanus, pertussis, measles, mumps, rubella, (2) the date the VIS was provided.

10 Polio, hepatitis A, hepatitis B, Haemophilus influenzae This recordkeeping requirement supplements the type b (Hib), influenza, pneumococcal conjugate, requirement of 42 300aa-25 that all health care meningococcal, rotavirus, human papillomavirus providers administering these vaccines must record (HPV), or varicella (chickenpox) shall, prior to in the patient's permanent medical record (or in a administration of each dose of the Vaccine , provide a permanent office log): copy to keep of the relevant current edition Vaccine (3) the name, address and title of the individual who Information materials that have been produced by the administers the Vaccine , Centers for Disease Control and Prevention (CDC): (4) the date of administration, and (5) the Vaccine manufacturer and lot number of the Vaccine used. Vaccine , or 1.. If there is not a single VIS for a combination Vaccine , use 2.