VCA West Los Angeles, Los Angeles, California, USA.
Green Nile, Inc., Los Angeles, California, USA.
Vet Comp Oncol. 2024 Dec;22(4):536-541. doi: 10.1111/vco.13003. Epub 2024 Aug 20.
The use of compounded formulations of chemotherapy in veterinary medicine is common. The purpose of this study was to evaluate the drug amount of two compounded chemotherapeutics (chlorambucil and cyclophosphamide) from multiple veterinary compounding pharmacies, to determine if there was a difference in drug amounts between those that came from 503A versus 503B pharmacies, and finally to determine heterogeneity in drug amounts within each individual pharmacy. Nine veterinary compounding pharmacies (eight 503A, one 503B) were sampled in total, with two different batches sampled from each pharmacy. Each capsule's actual concentration was compared to the intended (prescribed) concentration. Of the 68 total samples obtained, 20 (29%) tested outside the FDA-acceptable discrepancy of ±10%. Of these, 12 (60%) were chlorambucil and 8 (40%) were cyclophosphamide. 503A cyclophosphamide samples had an average discrepancy of 6.6% from the intended dose while samples from the 503B pharmacy had a discrepancy of 1.8%. 503A chlorambucil samples had an average discrepancy of 10.4% from the intended dose while samples from the 503B pharmacy had a discrepancy of 9.6%. Heterogeneity within the same pharmacy and batch ranged from 0.1% to 51% for the 503A pharmacies and 2.6% to 7.5% for the 503B pharmacy. Heterogeneity between different batches within the same pharmacy ranged from 0.4% to 58.3% for the 503A pharmacies and 5% to 14.8% for the 503B pharmacy. Although the drug amounts of compounded cyclophosphamide and chlorambucil manufactured by the 503B compounding pharmacy was more reliably maintained compared to that compounded by the 503A pharmacies, there was ultimately still potential for variability in drug amounts regardless of the pharmacy designation.
兽用复合化疗制剂的使用较为常见。本研究旨在评估来自多家兽医复合制剂药房的两种复合化疗药物（氯苯丁酸和环磷酰胺）的药物剂量，以确定其来自 503A 或 503B 药房的药物剂量是否存在差异，最后确定每个药房内药物剂量的差异。共采集了 9 家兽医复合制剂药房（8 家 503A，1 家 503B）的样本，每个药房采集了两个不同批次的样本。将每个胶囊的实际浓度与预期（规定）浓度进行比较。在所获得的 68 个总样本中，有 20 个（29%）的样本超出了 FDA 可接受的±10%的差异范围。其中，12 个（60%）为氯苯丁酸，8 个（40%）为环磷酰胺。503A 环磷酰胺样本的实际剂量与预期剂量相差 6.6%，而来自 503B 药房的样本相差 1.8%。503A 氯苯丁酸样本的实际剂量与预期剂量相差 10.4%，而来自 503B 药房的样本相差 9.6%。同一药房和批次内的同批药物的差异在 503A 药房范围内为 0.1%至 51%，在 503B 药房范围内为 2.6%至 7.5%。同一药房内不同批次之间的差异在 503A 药房范围内为 0.4%至 58.3%，在 503B 药房范围内为 5%至 14.8%。虽然来自 503B 复合制剂药房的复合环磷酰胺和氯苯丁酸的药物剂量更可靠地维持，但无论药房的指定如何，药物剂量最终仍存在潜在的变化。
