On October 15, 1991, the U.S. Department of Health and Human
Services (HHS) published in the Federal Register (56 FR 51798) the
vaccine information materials mandated under Section 2126 of the
Public Health Service Act (42 U.S.C. section 300aa-26). The
National Childhood Vaccine Injury Act (Public Law 99-660) required
the Secretary of HHS to develop vaccine information materials for
distribution by health-care providers to each adult or to the legal
representative of each child receiving any of the following
vaccines: diphtheria, tetanus, pertussis, measles, mumps, rubella,
and poliomyelitis vaccines. The vaccine information materials are
written as three pamphlets and cover the following vaccines: one
for diphtheria, tetanus, and pertussis (DTP); the second for
measles, mumps, and rubella (MMR); and the third for poliomyelitis.
The purpose of the vaccine information materials is to ensure
that sufficient writ ten information about the risks for the
diseases and the risks for and benefits of the vaccines is provided
to enable informed choices before vaccination. These materials
include information on the disease each vaccine is designed to
prevent; manifestations of reactions to the vaccine; precautionary
measures that should be taken to reduce the risk for any major
adverse reactions to the vaccine; contraindications to, and basis
for delay of, administration of the vaccine; an identification of
certain groups who may be at substantially higher risk than the
general population for major adverse reactions to the vaccine;
notice of the availability of the National Vaccine Injury
Compensation Program; and federal recommendations concerning a
complete schedule of childhood vaccines.
Drafts of these vaccine information materials were published
in the Federal Register on March 3, 1989 (54 FR 9180). Publication
of these final vaccine information materials by HHS follows public
comment and extensive consultation with health-care providers,
parent organizations, and the Advisory Commission on Childhood
Vaccines.
Effective April 15, 1992, each health-care provider who
administers one of the specified vaccines must provide copies of
the relevant information material to each adult or to the legal
representative of each child receiving any of these vaccines.
Health-care providers who administer privately purchased vaccines
may elect to develop their own information materials, provided
these materials meet the detailed requirements of the law. Whether
using the HHS-developed vaccine information materials or other
materials meeting the requirements of the law, the health-care
provider must provide the relevant material before administration
of the vaccine.
By arrangement with CDC, each state's immunization project
will provide single camera-ready copies of each of the vaccine
information pamphlets to each health-care provider who administers
any of the applicable vaccines.
Additional information is available from the Training
Coordinator, Division of Immunization, National Center for
Prevention Services, CDC; telephone (404) 639-2590 (FTS 236-2590).
Disclaimer
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