Procyshyn Ric M, Katzman Martin A, Margolese Howard C, Agid Ofer, Blier Pierre M
Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.
British Columbia Mental Health and Substance Use Research Institute, Vancouver, BC, Canada.
J Psychopharmacol. 2025 Feb;39(2):81-91. doi: 10.1177/02698811241301219. Epub 2025 Jan 31.
Switching between versions of medication products happens commonly despite challenges in achieving bioequivalence and therapeutic equivalence. Central nervous system and psychiatric drugs, especially those that are technically demanding to manufacture and have complex pharmacokinetic properties, such as long-acting injectables (LAIs), pose particular challenges to bioequivalence and safe and efficacious drug switching.
To assess whether drugs deemed "bioequivalent" are truly interchangeable in drug switching.
We assessed the published literature from January 2017 through June 2023 on PubMed using the MeSH terms "drugs, generic" OR "equivalency, generic" combined with terms for different psychiatric drug classes.
While most of the published studies returned in the search found that switching drug products was safe and clinically comparable, data on most drug classes other than those primarily indicated in the treatment of seizure disorder were sparse. Some studies also provided evidence that real-world outcomes such as adherence and hospitalizations may also be affected by switching. In addition, a review of bioequivalence testing guidance showed inconsistency across agencies and a lack of product-specific guidance from Health Canada, which raises questions about potential claims of bioequivalence for more complex products such as LAIs.
Overall, given the difficulty in treating mental health disorders, prescribers should be cautious when switching products and formulations in a patient who has been stabilized on a drug.
尽管在实现生物等效性和治疗等效性方面存在挑战，但药物产品版本之间的转换仍很常见。中枢神经系统和精神类药物，尤其是那些生产技术要求高且具有复杂药代动力学特性的药物，如长效注射剂（LAIs），对生物等效性以及安全有效的药物转换构成了特殊挑战。
评估被认为“生物等效”的药物在药物转换中是否真的可以互换。
我们使用医学主题词（MeSH）“通用药物”或“通用等效性”，并结合不同精神类药物类别的术语，检索了2017年1月至2023年6月发表在PubMed上的文献。
虽然搜索返回的大多数已发表研究发现药物产品转换是安全的且在临床上具有可比性，但除主要用于治疗癫痫症的药物类别外，大多数药物类别的数据都很稀少。一些研究还提供了证据表明，诸如依从性和住院率等实际结果也可能受到转换的影响。此外，对生物等效性测试指南的审查显示各机构之间存在不一致，而且加拿大卫生部缺乏针对特定产品的指南，这引发了对于更复杂产品（如LAIs）生物等效性潜在声明的质疑。
总体而言，鉴于治疗精神疾病存在困难，在已通过药物实现病情稳定的患者中进行产品和剂型转换时，开处方者应谨慎行事。
