Dear State/Territorial Epidemiologist:

As you may be aware, the shortage of immune globulin for intramuscular injection (IG) has become more acute because of the recent voluntary withdrawal of this product by Centeon, the major producer (see attached letter). The shortage is not expected to improve for at least six months. However, it is anticipated that the IG being produced by other manufacturers will meet current national needs if hepatitis A vaccine rather than IG is used for pre-exposure prophylaxis of persons > 2 years. To ensure the equitable distribution of IG while supplies are limited, the following allocation scheme, ordering procedures, and prioritizations for the indicated uses of IG have been agreed upon by the manufacturers, the Centers for Disease Control and Prevention (CDC) and the Council of State and Territorial Epidemiologists (CSTE). Dr. Richard Hoffman, State Epidemiologist, Colorado, has represented CSTE on discussions related to the IG shortage.

IG manufactured by Michigan Biologics Institute (Michigan Department of Public Health) continues to be available from FFF Enterprises by calling 1-800-843-7477 from 7AM to 7PM EDT. IG manufactured by the Massachusetts Public Health Biologic Laboratories is available through the American Red Cross Blood Services, New England Region. Information about how to order from the American Red Cross can be obtained by calling 617-461-2000 from 9AM to 5PM EDT and asking for the customer service department. Orders from either manufacturer will be limited to 100 2 ml vials per month and orders can be placed with only one manufacturer each month. Health care providers requiring larger quantities will be referred by both suppliers to an epidemiologist at the Hepatitis Branch at CDC for consultation.

The following prioritization of indications for IG, in decreasing order of priority is suggested:

1. post-exposure prophylaxis of persons who have had household or close personal contact (eg., sexual contact) to a person with hepatitis A and for controlling outbreaks in day care centers; post-exposure measles prophylaxis according to CDC guidelines; persons with true immune deficiencies who are accustomed to using intramuscular IG;
2. pre-exposure prophylaxis of children <2 years of age traveling to areas of intermediate or high hepatitis A endemicity;
3. pre-exposure prophylaxis of older children and adult travelers to areas of intermediate or high hepatitis A endemicity who have true contraindications (see package insert) to receiving hepatitis A vaccine;
4. post-exposure prophylaxis of persons exposed to food handled by a food handler with hepatitis A as defined by established criteria (Carl M, Francis DP, Maynard JE. Food-borne hepatitis A: Recommendations for Control. J Inf Dis 1983;148:1133-5.); and
5. pre-exposure prophylaxis of travelers to areas of intermediate or high hepatitis A endemicity who are departing <2 weeks after hepatitis A vaccination.

Because IG from other sources continues to be available, it should not be necessary to use withdrawn lots of IG. Centeon will make available to physicians, including city, county, and state health officers, the IG PCR test results for the lots in question. The results may be obtained by faxing a written request on letterhead to Centeon at 610-878-4007. Although such situations are not expected to arise, please notify the Hepatitis Branch, CDC (404-639-3048) of any cases of hepatitis A that occurred, in your opinion, because IG was not available.

Epidemiologists at the Hepatitis Branch, CDC (404-639-3048) are available to consult with state epidemiologists concerning indications for IG use in particular situations. Your cooperation is appreciated.

Sincerely,

David W. Fleming, M.D.

Enclosure

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