Llop Talaverón J M, Martorell Puigserver C, Mercadal Orfila G, Badía Tahull M B, Rancaño I, Abascal N, Tabau Molas M, Jódar Masanes R
Servicio de Farmacia, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, España.
Nutr Hosp. 2006 Mar-Apr;21(2):184-8.
Quality and efficiency criteria of allowances associated to technological procedures are developing in a setting that values quality, and from there the Real Decree RD175/2001 has been issued by which the rules of correct elaboration and quality control of formulations and pharmacy preparations. Parenteral nutrition (PN) is a formulation and, as such, its elaboration and control have to agree with the in force regulations. With this aim, at the Bellvitge University Hospital we have developed a project for automation of elaboration of PN mixtures with the MicroMacro Pump 23 Baxa Compounder.
To assess the impact of implementing an automated system of volumetric control in PN elaboration.
The project development may be divided into two differentiated aspects. The first one consisted in the implementation and optimization of the automated system of volumetric control (ASVC). The second aspect comprehends the comparative control performed between the new system and the previous one, and which consisted of a gravimetric system with visual control. For that, real weights were gathered and were compared to predicted weights, and the time of elaboration per bag before and at two times after the implementation of the automated system was registered; the first time just after implementation of the system, and the second time within one year.
For the comparison study between both systems used, 141 preparations in total, corresponding to individualized PN, were analyzed: 47 elaborated by means of the gravimetric system (GS), 47 with the ASVC during the implementation period (PN ASVC period 1), 47 PN elaborated with the ASVC within one year of implementation (PN ASVC period 2). The average variation between real weight and predicted weight at the three periods (pre-ASVC, NP ASVC period 1, NP ASVC period 2) was 2.41%, 1.35% and 1.25% respectively (table I). This decrease was statistically significant (p = 0.014). When analyzing the percentage of preparations out of the 3% variation range, we observed a significant reduction (p = 0.00001) by comparing the three periods (Table II). The average elaboration time with the ASVC increased approximately in 4 minutes by bag (3 min 58 sec) during the first studied period, and 3 min 10 sec during the second period, as compared with the study period with the GS.
The new bag-filling system by means of volumetric control represents an improvement in accuracy control and a decrease in the risk for surpassing the acceptable limits. The implementation of a new technological procedure is a difficult task that implies the change of many aspects of the daily practice and that requires a "cultural" change in the PN Unit with the aim of optimizing the process. However, these issues allow for an adaptation to legal requisites in force regarding the regulations of proper elaboration and quality control of formulations as well as an improvement in the integral quality of care.
与技术程序相关的津贴的质量和效率标准是在重视质量的背景下发展起来的，基于此，已颁布了第RD175/2001号皇家法令，该法令规定了制剂和药房制剂正确配制及质量控制的规则。肠外营养（PN）是一种制剂，因此，其配制和控制必须符合现行法规。为此，在贝尔维特大学医院，我们利用MicroMacro Pump 23 Baxa Compounder开发了一个PN混合液配制自动化项目。
评估在PN配制中实施体积控制自动化系统的影响。
项目开发可分为两个不同方面。第一个方面是体积控制自动化系统（ASVC）的实施和优化。第二个方面包括新系统与先前系统之间的对比控制，先前系统是一个带有视觉控制的重量系统。为此，收集实际重量并与预测重量进行比较，并记录自动化系统实施前、实施后两个时间点每袋的配制时间；第一次是在系统刚实施后，第二次是在一年内。
对于所使用的两个系统之间的比较研究，共分析了141份个体化PN制剂：47份通过重量系统（GS）配制，47份在实施期间通过ASVC配制（PN ASVC第1阶段），47份PN在实施后一年内通过ASVC配制（PN ASVC第2阶段）。三个阶段（ASVC前、NP ASVC第1阶段、NP ASVC第2阶段）实际重量与预测重量的平均差异分别为2.41%、1.35%和1.25%（表I）。这种下降具有统计学意义（p = 0.014）。在分析超出3%变化范围的制剂百分比时，通过比较三个阶段，我们观察到显著降低（p = 0.00001）（表II）。与GS研究阶段相比，在第一个研究阶段，使用ASVC时每袋的平均配制时间增加了约4分钟（3分58秒），在第二个阶段增加了3分10秒。
通过体积控制的新灌装系统在精度控制方面有所改进，并且降低了超过可接受限度的风险。实施新的技术程序是一项艰巨的任务，这意味着日常实践的许多方面都要发生变化，并且需要PN科室进行“文化”变革以优化流程。然而，这些问题有助于适应关于制剂正确配制和质量控制法规的现行法律要求，并提高整体护理质量。
