 |
Current Trends National Childhood Vaccine Injury Act: Requirements for
Permanent Vaccination Records and for Reporting of Selected Events After
Vaccination
Since March 21, 1988, health-care providers who administer certain
vaccines and toxoids are required by law to record permanently certain
information and to report certain events.* The vaccines and toxoids to which
these requirements apply follow: diphtheria and tetanus toxoids and
pertussis vaccine (DTP); pertussis vaccine (P); measles, mumps, and rubella
single-antigen vaccines and combination vaccines (MMR, MR); diphtheria and
tetanus toxoids (DT); tetanus and diphtheria toxoids (Td); tetanus toxoid
(T); poliovirus vaccine live, oral (OPV); and poliovirus vaccine inactivated
(IPV) (Table 1). The requirements also will apply to DTP combined with
inactivated poliovirus vaccine (DTP/Polio combined) if it becomes available.
Requirements for Recording
Specifically, all health-care providers who administer one or more of
these vaccines or toxoids are required to ensure that there is recorded in
the vaccine recipient's permanent medical record (or in a permanent office
log or file) the date the vaccine was administered, the manufacturer and lot
number of the vaccine, and the name, address, and title of the person
administering the vaccine. The term health- care provider is defined as any
licensed health-care professional, organization, or institution, whether
private or public (including federal, state, and local departments and
agencies), under whose authority a specified vaccine is administered.
Requirements for Reporting
Health-care providers are required to report to the U.S. Department of
Health and Human Services (DHHS) selected events occurring after
vaccination. Reportable events applicable to the previously mentioned
vaccines and toxoids are shown in Table 1 and include events described in
the vaccine manufacturer's package insert as contraindications to receiving
additional doses of the vaccine. Methods for Reporting
In the United States, vaccines are either publicly or privately
purchased. Publicly purchased vaccines are bought with federal, state,
and/or local government funds. At present, the method and route for
reporting adverse events depend on whether the vaccine administered is
publicly or privately purchased. Events occurring after receipt of publicly
purchased vaccines are reported through local, county, and/or state health
departments to the Centers for Disease Control (CDC) on its Report of
Adverse Events Following Immunization (CDC form 71.19). Events occurring
after receipt of a privately purchased vaccine usually are reported directly
to the Food and Drug Administration (FDA) on its Adverse Reaction Report
(FDA form 1639) by the health-care provider or the manufacturer.
For the time being, these two systems for reporting adverse events are to
be used to implement the requirement of Title XXI of the Public Health
Service Act for reporting adverse events to DHHS (Table 2).
Reportable events occurring after receipt of a publicly purchased vaccine
shall be reported to local, county, and/or state health departments through
channels currently in place at those institutions. The Report of Adverse
Events Following Immunization, available at each state health department,
shall be completed and sent by the state health department to CDC.
Reportable events occurring after receipt of a privately purchased
vaccine shall be reported by the health-care provider directly to the FDA on
the Adverse Reaction Report (FDA form 1639). Health-care providers will need
to ensure that the name of the vaccine manufacturer, the lot number of the
vaccine, and the interval between vaccination and onset of the reaction are
included on this form. FDA form 1639 can be obtained directly from Food and
Drug Administration, HFN-730, Rockville, Maryland 20857. The form also is
printed in FDA Drug Bulletin, the physician's edition of the Physicians'
Desk Reference, USP Drug Information for Health Care Providers, and AMA Drug
Evaluations and can be duplicated.
Health-care providers are requested not to provide the names and other
personal identifiers of patients on FDA form 1639. Such information will be
reported for publicly purchased vaccines to state and local health
departments, which in turn will remove the names and personal identifiers
when submitting CDC form 71.19 to CDC. Reported by: National Vaccine
Program, Office of the Assistant Secretary of Health. Office of Biologics,
Office of Epidemiology and Statistics, Food and Drug Administration. Div of
Immunization, Center for Prevention Services, CDC. *The National Childhood
Vaccine Injury Act of 1986, at Section 2125 of the Public Health Service Act
as codified at 42 U.S.C. (section symbol)300aa-25 (Supp. 1987).
All MMWR HTML documents published before January 1993
electronic conversions from ASCII text into HTML. This conversion may have
resulted in character translation or format errors in the HTML version.
Users should not rely on this HTML document, but are referred to the
original MMWR paper copy for the official text, figures, and tables.
An original paper copy of this issue can be obtained from the Superintendent
of Documents, U.S. Government Printing Office (GPO), Washington, DC
20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.
**Questions or messages regarding errors in formatting should be
addressed to mmwrq@cdc.gov.
Page converted: 08/05/98 |
|
