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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).

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