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Radiation in Medicine: A Need for Regulatory Reform
Misadministrations in Byproduct-Related Ionizing Radiation in Medicine
In 1992, NRC data showed 7 diagnostic and 29 therapeutic misadministrations for the 2,228 licensees of the NRC. In that same year, the Agreement States reported 7 diagnostic misadministrations and 10 therapeutic "reportable events" for their 4,944 licensees. Combining the NRC and Agreement State data yields a total, for 1992, of the following numbers of misadministrations or reportable events for 7,172 licensees:
38 in therapeutic radiation oncology (teletherapy and brachytherapy);
1 in therapeutic nuclear medicine; and
14 in diagnostic nuclear medicine.
Even if it is assumed that the numbers are underreported by a factor of 10, owing to confusion as to what is specifically reportable or to intentional non-filing, this level of misadministration is remarkably low.
These figures can be used in conjunction with the total number of administrations in each category to estimate overall error rates. In 1992, about 11 million radiopharmaceutical administrations were given to patients in the United States; approximately 3.5 million of these were provided in NRC-regulated states. Using NRC data on misadministrations for diagnostic procedures (which are higher than those for the Agreement States), these numbers translate to an estimated diagnostic misadministration rate of 0.0002 percent (7 divided by 3.5 million) or about 2 per million administrations (not patients). If data from Agreement States and NRC-regulated states are combined, the estimate of diagnostic misadministrations becomes 0.00012 percent (14 divided by 11,000,000), or about 1.3 per million.2,3
The United States Pharmacopoeia (USP) runs a voluntary program within which users of radiopharmaceuticals report problems encountered in the administration of the drugs. Over a two-year period, from October 1, 1993, to September 30, 1995, only 42 voluntary reports were submitted. These "problems" are not misadministrations, but they do include incidents of incorrect biodistribution and other failures inherent in the patient reaction to the drug. Other USP problem reporting programs estimate that voluntarily submitted reports represent 10 percent of actual problems. Reports dealing with radiopharmaceuticals may represent an even higher percentage of actual problems, as physicians involved in the use of radiopharmaceuticals may be even more conscious of safety and adverse events. In any case, the tiny number of reported problems illustrates the low rate of adverse events associated with radiopharmaceuticals.
(ECRI) data reviewed by the committee showed an occurrence of only 168 total adverse events over a three-year period. These data are rough; there is no indication of the number of at-risk administrations, nor is the completeness of reporting defined. Nonetheless, the denominator must be huge. Additionally, of the total 168 events, only 43 caused actual injury.