Cancellieri Giulia, Provenzani Alessio, Polidori Carlo, Polidori Piera
School of Specialization in Hospital Pharmacy, Università degli Studi di Palermo, Palermo, Sicilia, Italy
Clinical Pharmacy Service, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), Palermo, Sicilia, Italy.
Eur J Hosp Pharm. 2025 Feb 21;32(2):121-125. doi: 10.1136/ejhpharm-2024-004154.
Hospital pharmacists collaborate in clinical trials by managing the reception, conservation, distribution, return and destruction of the investigational medical products (IMP). However, errors can happen during the simultaneous management of multiple trials because each clinical trial stipulates its own method for managing the drug under study. In order to promote optimal management by hospital pharmacists, we developed a method for calculating a risk of error index for each experimental protocol, and wrote standard procedures for managing trials assigned low, moderate and high risk levels, to provide hospital pharmacists with a systematic tool for reducing human error in the management of IMPs for multiple clinical trials.
Calculation of this risk of error index (ρ) entails four factors: the pharmacological risk of error (φ) inherent in the pharmacological characteristics and route of administration of the IMP (carcinogenic, mutagenic, cytotoxic nature of the drug, parental or non-parenteral administration), the technological risk of error (α) involved should drug compounding be required, the risk of error related to the number of patients enrolled (n) and the risk of error intrinsic to the protocol (π) when it involves placebos, randomisation or other factors. We developed the formula [Formula: see text] to define trials as low (ρ<50), moderate (51<ρ<150) and high risk (ρ>151) for hospital pharmacist error.
Calculations of this formula for 60 active trials indicated that seven (11.7%) of the protocols were low risk of hospital pharmacist error, 43 (71.7%) were moderate risk and 10 (16.6%) were high risk. For each of these categories (low, moderate and high risk) we have outlined standard procedures in order to minimise the occurrence of any errors.
Following validation of our formula and standard procedures by the ISMETT Research Institute, we are promoting the use of the tool in other clinical centres as we believe it can help hospital pharmacists minimise the risk of error in managing experimental drugs for clinical trials.
医院药剂师通过管理试验用医疗产品（IMP）的接收、保存、分发、回收及销毁来参与临床试验。然而，在同时管理多个试验时可能会出现差错，因为每个临床试验都规定了其自身管理研究药物的方法。为促进医院药剂师的优化管理，我们开发了一种为每个试验方案计算差错风险指数的方法，并编写了针对低、中、高风险水平试验的管理标准程序，为医院药剂师提供一种系统工具，以减少在多个临床试验中管理IMP时的人为差错。
该差错风险指数（ρ）的计算涉及四个因素：IMP的药理学特性和给药途径所固有的药理学差错风险（φ）（药物的致癌、致突变、细胞毒性性质，静脉或非静脉给药）、若需要药物配制所涉及的技术差错风险（α）、与入组患者数量（n）相关的差错风险以及试验方案涉及安慰剂、随机分组或其他因素时所固有的差错风险（π）。我们开发了公式[公式：见原文]来将试验定义为医院药剂师差错低风险（ρ<50）、中风险（51<ρ<150）和高风险（ρ>151）。
对60项正在进行的试验计算该公式表明，7项（11.7%）试验方案为医院药剂师差错低风险，43项（71.7%）为中风险，10项（16.6%）为高风险。针对这些类别（低、中、高风险）中的每一类，我们都概述了标准程序，以尽量减少任何差错的发生。
在ISMETT研究所对我们的公式和标准程序进行验证后，我们正在推动该工具在其他临床中心的使用，因为我们认为它可以帮助医院药剂师在管理临床试验用试验药物时将差错风险降至最低。
