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Section 1. Active and Passive Immunization
Informing Patients and Parents
Parents and patients should be informed about the benefits and risks of disease-preventive and therapeutic procedures, including immunization. The patient, parents, and/or legal guardian should be informed about benefits to be derived from vaccines in preventing diseases in immunized people and in the community where they live and about risks of those vaccines. Questions should be encouraged, and adequate time should be allowed so that information is understood.
The National Childhood Vaccine Injury Act (NCVIA) of 1986 included requirements for notifying all patients and parents about vaccine benefits and risks. Whether vaccines are purchased with private or public funds, this legislation mandates that a vaccine information statement (VIS) be provided each time a vaccine covered under the National Vaccine Injury Compensation Program (VICP) is administered (see Table 1.2, p 6). This applies in all settings, including clinics, offices, and hospitals (eg, for the birth dose of hepatitis B vaccine). Providing this information before the day of immunization is desirable. For vaccines not yet included in the VICP, VISs are available but are not mandated unless the vaccine is purchased through a contract with the Centers for Disease Control and Prevention (CDC [ie, the Vaccines for Children Program, state immunization grants, or state purchases through the CDC]). Copies of current VISs are available online from the CDC (www.cdc.gov/vaccines/pubs/VIS/default.htm) and the Immunization Action Coalition Web site (www.immunize.org) in English and many other languages. Copies also can be obtained from the
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