Abstract

The Three Mile Island (TMI) nuclear emergency in the U.S. in March 1979 marked the first occasion when use of potassium iodide (KI) was considered for thyroid blocking of the population in the vicinity of a potentially serious release of fission products from a nuclear power reactor. In face of a demand that could not be satisfied by commercial supplies of low-dose KI drug products from the U.S. pharmaceutical industry, the Food and Drug Administration directed the manufacture and stockpiling of sufficient quantities of saturated solution of potassium iodide (SSKI) to provide protection for one million people in the event of a large-scale release of radioiodines. Although the drug was not used, the experience of producing, stockpiling, and making ready for use a large quantity of the drug resulted in significant public policy, regulatory, and logistical issues. A number of these issues have been resolved through scientific debate and consensus, development of official guidance regarding the proper role of KI in nuclear emergencies, and the approval of New Drug Applications for KI products specifically intended for thyroid blocking in nuclear emergencies. Other issues regarding broad-scale implementation of the guidelines remain today. This paper traces the history of the development and implementation of the use of KI from pre-TMI to the present.

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