Franche-Comte University Faculty of Medical and Pharmaceutical Sciences, Besançon, France.
Pôle pharmacie, CHU Besançon, Besançon, France.
Eur J Hosp Pharm. 2024 Jun 21;31(4):369-375. doi: 10.1136/ejhpharm-2022-003540.
Dose banding (DB) was used to optimise the individualisation of patient treatments with gemcitabine (Gem) in order to improve workload planning at the pharmacy of the University Hospital Centre of Besançon (UHCB). A new simple and fast high-performance liquid chromatographic (HPLC) method was also developed for the quantification of Gem without dilution of the infusion bags.
Individual doses of Gem preparations were retrospectively analysed over a 1-year period to determine the frequency of prepared doses. Using a maximum gap of 7.5% around the doses chosen, the selected Gem standard doses were 1400 mg, 1600 mg, 1800 mg and 2000 mg. Following the DB scheme, the frequency of prescription of standard and individualised Gem doses was analysed over a period of 10 months. The four selected Gem standard doses were aseptically prepared in polyolefin infusion bags. Each series of 20 bags was stocked under refrigerated storage conditions (4°C) for up to 84 days. The quantification of Gem without dilution of the infusion bags was obtained by the development of a HPLC method coupled to a diode array detector (DAD) or an evaporative light scattering detector (ELSD).
During the 10-month period following implementation of the DB, 75.6% of the 1266 prescribed doses were covered by the four standardised preparations. The number of different Gem doses was reduced from 183 to 55. Concerning the Gem quantification, both heteroscedasticity and non-linearity were observed with DAD. Using an ELSD, the trueness values were between 98.59% and 101.52% with excellent repeatability values between 0.66% and 1.42%.
A new HPLC method has been developed for the quantification of Gem without dilution of the infusion bags prepared in advance as a result of a target DB scheme successfully implemented in our pharmacy department.
为了优化贝桑松大学医疗中心（UHCB）药剂科患者治疗的个体化，使用剂量带（DB）来优化吉西他滨（Gem）的个体化。还开发了一种新的简单、快速的高效液相色谱（HPLC）方法，用于在不稀释输液袋的情况下对 Gem 进行定量。
回顾性分析了 1 年内 Gem 制剂的个体剂量，以确定制备剂量的频率。在所选择的 Gem 标准剂量周围，使用 7.5%的最大差距，选择的 Gem 标准剂量为 1400mg、1600mg、1800mg 和 2000mg。根据 DB 方案，分析了 10 个月期间标准和个体化 Gem 剂量的处方频率。将四个选定的 Gem 标准剂量无菌地制备在聚烯烃输液袋中。每 20 袋系列在冷藏（4°C）条件下储存，最长可达 84 天。通过开发与二极管阵列检测器（DAD）或蒸发光散射检测器（ELSD）耦合的 HPLC 方法，无需稀释输液袋即可获得 Gem 的定量。
在实施 DB 的 10 个月期间，1266 个规定剂量中有 75.6%由四个标准化制剂覆盖。Gem 剂量的数量从 183 减少到 55。关于 Gem 的定量，DAD 观察到异方差和非线性。使用 ELSD，真实值在 98.59%和 101.52%之间，极好的重复性值在 0.66%和 1.42%之间。
由于在我们的药剂科成功实施了目标 DB 方案，因此开发了一种新的 HPLC 方法，用于在不稀释预先制备的输液袋的情况下对 Gem 进行定量。
