Administering olanzapine-haloperidol and ziprasidone

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Reference no: EM133867880

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The FDA has provided enough evidence to indicate that Dr. Klein's actions were part of a clinical study. Administering Olanzapine, Haloperidol, Ziprasidone, and Midazolam as she was doing was not a standard medical practice, and in doing so, the subjects were medicated without consent. It was specific to the research protocol to test the effectiveness of the drugs in the Emergency Department for treating severe agitation. The FDA says that the distinction between standard medical practice and clinical studies is outlined in 21 CFR 312.3(b). It states that a clinical trial involves giving a drug to participants instead of only standard medical care. The letter goes on to say that Dr. Klein had constant communication with the sponsor and the ED personnel regarding the specific drug that was going to be given that day. This dictated what medication would be used instead of allowing the physicians to provide routine care. The planned use of each drug over a specific time proves this was a clinical trial, not just a standard treatment.

Reference no: EM133867880

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