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The Morbidity and Mortality Weekly Report is prepared by the Centers for Disease Control, Atlanta, Georgia, and available on a paid subscription basis from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402, (202) 783-3238.

The data in this report are provisional, based on weekly reports to CDC by state health departments. The reporting week concludes at close of business on Friday; compiled data on a national basis are officially released to the public on the succeeding Friday. The editor welcomes accounts of interesting cases, outbreaks, environmental hazards, or other public health problems of current interest to health officials. Such reports and any other matters pertaining to editorial or other textual considerations should be addressed to: Editor, Morbidity and Mortality Weekly Report, Centers for Disease Control, Atlanta, Georgia 30333. Director, Centers for Disease Control

Editor James O. Mason, M.D., Dr.P.H.

Michael B. Gregg, M.D. Director, Epidemiology Program Office

Managing Editor Carl W. Tyler, Jr., M.D.

Gwendolyn A. Ingraham

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AMWR

1
CENTERS FOR DISEASE CONTROL

April 8, 1988 / Vol. 37 / No. 13
197 National Childhood Vaccine Injury Act:

Requirements for Permantent

Vaccination Records and for Reporting - PUBLIC HEALTH

of Selected Events After Vaccination SA

200 High Prevalence of Iron Deficiency

Anemia Amolng Alaskan Native

Children A107

207 Influenza – United States

210 CDC Symposium on Statistics in 137 No.13 IDITY AND MORTALITY WEEKLY REPORT Surveillance Apr. 1988

MATUNCO
C.2

The University
Current Trends

of Michigan
PUBLIC HEALTH LID??

Public Health
National Childhood Vaccine Injury Act:""
Requirements for Permanent Vaccination Records and for

Reporting of Selected Events After Vaccination

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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.

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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 healthcare 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.

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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.

*The National Childhood Vaccine Injury Act of 1986, at Section 2125 of the Public Health Service Act as codified at 42 U.S.C. $ 300aa-25 (Supp. 1987).

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES / PUBLIC HEALTH SERVICE

U.S. DEPOSITORY APR 28 1988

Vaccine Continued
TABLE 1. Reportable events following vaccination
Vaccine/Toxoid

Event

Interval from Vaccination DTP, P,

A. Anaphylaxis or anaphylactic shock 24 hours DTP/Polio B. Encephalopathy (or encephalitis)*

7 days Combined C. Shock-collapse or hypotonic

7 days
hyporesponsive collapse*
D. Residual seizure disorder*

(See Aids to Interpretation*) E. Any acute complication or sequela

No limit
(including death) of above events
F. Events in vaccinees described in

(See package insert)
manufacturer's package insert
as contraindications to additional

doses of vaccine (such as convulsions) Measles,

A. Anaphylaxis or anaphylactic shock 24 hours Mumps, and B. Encephalopathy (or encephalitis)* 15 days for measles, mumps, Rubella; DT,

and rubella vaccines; 7 days Td, Tetanus

for DT, TD, and T toxoids Toxoid C. Residual seizure disorder*

(See Aids to Interpretation*) D. Any acute complication or sequela No limit

(including death) of above events
E. Events in vaccinees described in

(See package insert)
manufacturer's package insert as
contraindications to additional

doses of vaccinet Oral Polio A. Paralytic poliomyelitis Vaccine

-in a non-immunodeficient recipient 30 days
- in an immunodeficient recipient

6 months
- in a vaccine-associated community case No limit
B. Any acute complication or sequela No limit

(including death) of above events
C. Events in vaccinees described in

(See package insert)
manufacturer's package insert as
contraindications to additional

doses of vaccine
Inactivated A. Anaphylaxis or anaphylactic shock 24 hours
Polio
B. Any acute complication or sequela

No limit
Vaccine

(including death) of above event
C. Events in vaccinees described in

(See package insert)
manufacturer's package insert as
contraindications to additional

doses of vaccine *Aids to Interpretation: Shock-collapse or hypotonic-hyporesponsive collapse may be evidenced by signs or symptoms such as decrease in or loss of muscle tone, paralysis (partial or complete), hemiplegia, hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of or loss of consciousness, prolonged sleeping with difficulty arousing, or cardiovascular or respiratory arrest. Residual seizure disorder may be considered to have occurred if no other seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102°F occurred before the first seizure or convulsion after the administration of the vaccine involved, AND, if in the case of measles-, mumps-, or rubella-containing vaccines, the first seizure or convulsion occurred within 15 days after vaccination OR in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after vaccination, AND, if two or more seizures or convulsions unaccompanied by fever or accompanied by a fever of less than 102 'F occurred within 1 year after vaccination. The terms seizure and convulsion include grand mal, petit mal, absence, myoclonic, tonic-clonic, and focal motor seizures and signs. Encephalopathy means any significant acquired abnormality of, injury to, or impairment of function of the brain. Among the frequent manifestations of encephalopathy are focal and diffuse neurologic signs, increased intracranial pressure, or changes lasting at least 6 hours in level of consciousness, with or without convulsions. The neurologic signs and symptoms of encephalopathy may be temporary with complete recovery, or they may result in various degrees of permanent impairment. Signs and symptoms such as high-pitched and unusual screaming, persistent unconsolable crying, and bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram. *The health-care provider must refer to the CONTRAINDICATION section of the manufacturer's package insert for each vaccine.

Vaccine Continued
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.

TABLE 2. Reporting of events occurring after vaccination
Vaccine Purchased

Vaccine Purchased
with Public Money

with Private Money Who Reports: Health-care provider who

Health-care provider who administered the vaccine

administered the vaccine

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Vaccine - Continued

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.

Topics in Minority Health

High Prevalence of Iron Deficiency Anemia

Among Alaskan Native Children

Iron deficiency anemia has long been recognized as a common nutritional problem among Alaskan Native children (1-3). Even though the prevalence of childhood iron deficiency anemia in the United States as a whole has declined in the past decade (4), data from several sources show that the prevalence of anemia remains high among Alaskan Native children. These sources include 1) the database of the Alaska Area Native Health Service for children aged 5-72 months, 2) a survey of Yupik Eskimo schoolchildren (aged 6-17 years) in 15 villages in the Yukon-Kuskokwim Delta (YKD) region in 1986-1987, and 3) a 1987 survey of 318 schoolchildren in seven villages in the Bristol Bay region.

The computerized medical-record database for the Alaska Area Native Health Service includes hemoglobin and hematocrit values for 1983-1985 for children aged 5-72 months who were eligible for care. Testing is recommended as part of routine well-baby care at ages 6, 10, and 18 months and before the child enters school. In the years 1983-1985, more than 4,000 test results were recorded annually, and the prevalence of anemia (hemoglobin<11 g/dL, hematocrit<34%) ranged from 22% to 28% in children under 5 years of age.

The two regional surveys focused on determining hemoglobin values in schoolaged children (Table 1). A total of 876 children were tested in the 15 YKD villages, and 318 in the seven Bristol Bay villages. Overall, the combined prevalence of anemia for the Bristol Bay area was 23% and for the YKD area, 10%. Serum ferritin levels were

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