先天性心疾患に対するカテーテル治療は今や普遍的治療となっているが，種々のdeviceで国内導入が遅れていたり，使用適応範囲外であったりするなどの問題が存在する．それだけ国内では治療選択肢の制限や，off-label useに迫られる現状に苦しんでおり，第27回JPIC学術集会におけるアンケート調査でもその実情が浮き彫りとなった．他の代替療法との十分な比較検討のもとにoff-label useの決断が下されているのは言うまでもない．しかし有害事象の発生を避けて通れない側面を有しており，ひとたび発生すると公に認められている使用法でないが故に個々の医師の責任追及に終わったり，使用拡大がさらに困難になったりする危険性をはらんでいる．現状打開には，off-label use経験の共有，独立行政法人医薬品医療機器総合機構，厚生労働省医政局経済課医療機器政策室などへの働きかけが必要である．
Cardiac catheterization is a ubiquitous treatment of congenital heart diseases. However, issues such as delayed introduction of various devices and the use of these approved devices off-label, in ways unrelated to their intended applications have been seen in Japan. And there is the scarcity of treatment options, and the numerous cases of off-label use are seen in Japan. Although the decisions to select off-label use are based on sufficient comparison studies on alternative therapies of course, adverse events might happen and this is unavoidable problem. The full burden of responsibility would lie on the physician if the off-label use of the devices would inevitably result in adverse events, because off-label use of devices is not officially sanctioned. Thus the expansion of the application of off-label devices would be even more difficult. Breaking the present deadlock requires the sharing of experiences in off-label device use and proactive lobbying of nationally authorized institutions.
Key words: Catheter Intervention; device lag; off-label use; congenital heart disease; Pharmaceuticals and Medical Devices Agency
© 2016 日本Pediatric Interventional Cardiology学会© 2016 Japanese Society of Pediatric Interventional Cardiology
This page was created on 2016-07-13T11:06:16.431+09:00
This page was last modified on 2016-08-25T16:05:55.590+09:00
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