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information about Fukushima published in English in Japanese media info publiée en anglais dans la presse japonaise

Iodine pill distribution - Not so obvious

January 1, 2013

 

Iodine pill distribution may be delayed

Distribution of iodine pills to residents near nuclear power plants for use in the event of a nuclear accident, a preventative measure advised by the Nuclear Regulation Authority, could be significantly delayed as additional legal procedures on the drug have now been deemed necessary, according to sources.


It is believed that if the pills were taken before radiation exposure, the iodine could be retained in the thyroid gland to prevent radioactive iodine from accumulating.


The potassium iodide contained in iodine tablets is approved by the Pharmaceutical Affairs Law as a pharmaceutical product effective in curbing excessive secretion of thyroidal hormones and inducing secretion of bronchial mucosa, according to the NRA and other sources.


The drug is widely used in the treatment of thyroid diseases, chronic bronchitis and others.


But the product has yet to be approved as a drug for protection from radiation exposure.


The NRA intends to obtain approval for this category, but local governments around nuclear plants will be unable to specifically include preventive distribution of the drug in their regional disaster management plans to be devised by March. This may affect the restart of idled nuclear reactors as well, according to the sources.


Protective effects of the potassium iodide already have been internationally recognized as seen in their use after the Chernobyl nuclear accident in the former Soviet Union.


In Japan, however, the drug had rarely been used before the outbreak of the crisis at Tokyo Electric Power Co.'s Fukushima No. 1 nuclear power plant, and no pharmaceutical company has filed for approval of the drug for that purpose.


As a result, its legal standing has remained unclear while some local governments have proceeded to stockpile the drug.


The NRA has been considering providing the drug in advance to residents within a five-kilometer radius of a nuclear plant, though the targeted area could be expanded.


But distributing the unauthorized drug could also trigger opposition from local doctors and others.


As long as the drug remains unapproved, victims would not be entitled to receive compensation from the state under a relief system if it were found to have side effects.


The pills are believed to curb cases of thyroid cancer, but could cause such side effects as iodine allergy or hypothyroidism.


NRA officials plan to obtain additional legal approval after holding consultations with Health, Labor and Welfare Ministry officials, the sources said.


But when a drug is approved for additional effectiveness, it often takes more than a year as a pharmaceutical company needs to file at the health ministry after gathering relevant data to prove such effectiveness and obtain approval at a ministry council.


A senior ministry official said, "It is possible [for the NRA] to ask a pharmaceutical company to file [for approval], but it will be difficult to give approval as it is necessary to obtain such data as the dosage taken by workers at the Fukushima plant."


A senior official at the NRA said the nuclear authority wants to hold consultations with the ministry as soon as possible.

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