Department of Psychiatry, 7799The Alfred Hospital, Melbourne, Australia.
Australas Psychiatry. 2023 Apr;31(2):186-189. doi: 10.1177/10398562231156475. Epub 2023 Feb 20.
To review the sequence of events that led to the Therapeutic Goods Administration (TGA) approval of esketamine in Australia, and to explore the potential ethical and clinical consequences of it.
Trust in the TGA is of paramount importance to Australian psychiatrists. The approval of esketamine raises serious questions about the processes, independence and authority of the TGA, and therefore the confidence Australian psychiatrists can have in the 'quality, safety and efficacy' of the drugs they offer their patients.
回顾导致治疗商品管理局（TGA）在澳大利亚批准氯胺酮的事件顺序，并探讨其潜在的伦理和临床后果。
TGA 对澳大利亚精神病医生的信任至关重要。氯胺酮的批准对 TGA 的程序、独立性和权威性提出了严重质疑，因此，澳大利亚精神病医生对他们提供给患者的药物的“质量、安全性和疗效”的信心也受到了影响。
