Department of Psychiatry, McGill University, Montreal, Quebec, Canada.
Int Clin Psychopharmacol. 2010 May;25(3):180-2. doi: 10.1097/YIC.0b013e328337910b.
Generic formulations of medications are marketed as therapeutically equivalent and less expensive than branded ones. Multiple studies and case reports have described relapses and worsening clinical outcome in patients after a switch from a brand name to a generic medication. Recent studies have shown that generics do not always lead to the expected costs savings, reducing the impetus to proceed with compulsory generic switching. We report on three patients who experienced clinical deterioration after commencing the generic formulation of their previous brand name psychotropic medication. We discuss key clinical differences between original and generic formulations of the same medication. The use of bioequivalence as an indicator of therapeutic and clinical equivalence, the lack of appropriate studies comparing generic and brand name medications and differences in excipients are some of the factors that could explain variation in clinical response between generic and brand name medications. Generic switching should be decided on a case-by-case basis with disclosure of potential consequences to the patient.
药物的通用配方以治疗等效且价格低于品牌药物进行销售。多项研究和病例报告描述了患者从品牌药物转换为通用药物后出现的病情复发和临床结果恶化。最近的研究表明,通用药物并不总是能带来预期的成本节约,这降低了强制转换为通用药物的动力。我们报告了 3 名患者,他们在开始使用之前的品牌精神药物的通用配方后经历了临床恶化。我们讨论了同一药物的原始配方和通用配方之间的关键临床差异。生物等效性作为治疗等效性和临床等效性的指标、缺乏比较通用药物和品牌药物的适当研究以及赋形剂的差异是解释通用药物和品牌药物之间临床反应差异的一些因素。通用药物转换应根据具体情况决定,并向患者披露潜在后果。