Report No. 2008-70
October 2008
Complete Audit Report

Better Implementation of New Law Relating to Influenza Vaccines Needed
The Department of Health and Senior Services (DHSS) provides education and information to the public and health care providers about appropriate administration, storage and handling of vaccines for children, adolescents and adults. The DHSS also ensures the influenza (flu) vaccine is available to as many Missourians as possible. Our audit objective was to evaluate compliance with state law restricting the amount of mercury in vaccines administered to children under 3 and knowingly pregnant women.

Some providers not notified of new state law
DHSS received complaints related to the new mercury-free state law from approximately 100 providers during the 2007-08 flu season, according to a DHSS official. This official said these providers inquired as to when DHSS became aware of the legislation and why the providers were not notified of the legislation. DHSS officials said DHSS communicated the new state law requirements to certain providers. However, DHSS did not notify some providers, professional organizations, or the public through any announcements or system wide notifications before the law became effective. In addition, many providers had already ordered flu vaccines before the notifications were sent. DHSS officials said the state law did not require DHSS to notify the public or providers of the new law; however, one of these officials said the public views DHSS as the resource to communicate new health alerts.

Some children received the flu vaccine containing mercury
Some children under 3 were, and some pregnant women may have been, inappropriately administered the flu vaccine containing mercury because the provider did not become aware of the law until after the flu season began (about six months after the law became effective in April 2007). In addition, a DHSS official stated DHSS received approximately 10 calls from providers who said they had already purchased the flu vaccine containing mercury before they became aware of the law. These 10 providers said they planned to continue to administer the vaccine to children under 3 and/or knowingly pregnant women, even though it violated state law.

Shortage of flu vaccine not defined
State law allows the Director of DHSS, with the approval of the Governor, to exempt the use of a mercury-free vaccine if a potential public health emergency exists, such as a shortage of vaccine. During the September 2007 Advisory Committee on Childhood Immunization (ACCI) meeting, the committee developed a recommendation to assist the Director in determining the circumstances under which an exemption to mercury-free flu vaccines should be enacted. The ACCI documentation stated the purpose of the recommendation is to ensure young children, who are at greatest risk for complications and hospitalizations from influenza, are appropriately immunized if there is a substantial delay or shortage in the supply of mercury-free vaccine. However, DHSS has not approved the committee's recommendation as of June 2008, a nine month delay.

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Missouri State Auditor's Office
moaudit@auditor.mo.gov