National and Specialist Acorn Lodge Inpatient Children's Unit, South London and Maudsley NHS Foundation Trust, De Crespigny Park, London SE5 8AF, UK.
BMC Psychiatry. 2013 Oct 4;13:244. doi: 10.1186/1471-244X-13-244.
The appropriateness of use of generic instead of brand-name medication remains unresolved and controversial in several areas of medicine. Some evidence suggestive of variations in bioavailability and clinical effectiveness between different formulations make policy decisions occasionally difficult. The use of generic olanzapine is a widely acceptable practice on the basis of quality, safety and efficacy data and has been adopted in several countries.
The case of a 14 year old boy with bipolar affective disorder, autism and intellectual disability who had brand-name to generic olanzapine switch associated with rapid deterioration of his mental state is described. This clinical change was not related to any physical illness or other medication adjustment and resolved as rapidly when generic olanzapine was switched back to the brand-name formulation.
Caution should be exercised when policy for switching from brand-name to generic psychotropic medications are made, especially when using medications off label, in extremes of age and in those patients with co-morbid complicating factors such as intellectual disability.
在医学的几个领域，使用仿制药而非品牌药的适宜性仍然存在争议，尚未得到解决。一些证据表明，不同制剂之间的生物利用度和临床疗效存在差异，这使得政策决策偶尔变得困难。基于质量、安全性和疗效数据，使用通用奥氮平是一种广泛可接受的做法，并已在多个国家采用。
描述了一例 14 岁男孩，患有双相情感障碍、自闭症和智力残疾，在从品牌药转换为通用奥氮平时，其精神状态迅速恶化。这种临床变化与任何身体疾病或其他药物调整无关，当通用奥氮平重新换回品牌药时，这种变化迅速得到解决。
在制定从品牌药转换为精神药物的通用政策时应谨慎，特别是在超说明书用药、极端年龄以及存在智力残疾等合并并发症的患者中。
