Buja Alessandra, De Luca Giuseppe, Ottolitri Ketti, Marchi Elena, De Siena Francesco Paolo, Leone Giovanni, Maculan Pietro, Bolzonella Umberto, Caberlotto Riccardo, Cappella Giovanni, Grotto Giulia, Lattavo Gaia, Sforzi Benedetta, Venturato Giovanni, Saieva Anna Maria, Baldo Vincenzo
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, 35131, Padua, Italy.
Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
J Pharm Policy Pract. 2023 Jan 19;16(1):9. doi: 10.1186/s40545-023-00512-9.
Administering cancer drugs is a high-risk process, and mistakes can have fatal consequences. Failure Mode, Effect and Criticality Analysis (FMECA) is a widely recognized method for identifying and preventing potential risks, applied in various settings, including healthcare. The aim of this study was to recognize potential failures in cancer treatment prescription and administration, with a view to enabling the adoption of measures to prevent them.
This study consists of a FMECA. A team of resident doctors in public health at the University of Padua examined the cancer chemotherapy process with the support of a multidisciplinary team from the Veneto Institute of Oncology (an acknowledged comprehensive cancer center), and two other provincial hospitals. A diagram was drafted to illustrate 9 different phases of chemotherapy, from the adoption of a treatment plan to its administration, and to identify all possible failure modes. Criticality was ascertained by rating severity, frequency and likelihood of a failure being detected, using adapted versions of already published scales. Safety strategies were identified and summarized.
Twenty-two failure modes came to light, distributed over the various phases of the cancer treatment process, and seven of them were classified as high risk. All phases of the cancer chemotherapy process were defined as potentially critical and at least one action was identified for a single high-risk failure mode. To reduce the likelihood of the cause, or to improve the chances of a failure mode being detected, a total of 10 recommendations have been identified.
FMECA can be useful for identifying potential failures in a process considered to be at high risk. Safety strategies were devised for each high-risk failure mode identified.
施用癌症药物是一个高风险过程，失误可能会带来致命后果。失效模式与效应分析（FMECA）是一种广泛认可的识别和预防潜在风险的方法，应用于包括医疗保健在内的各种环境。本研究的目的是识别癌症治疗处方和给药过程中的潜在失误，以便采取预防措施。
本研究采用FMECA。帕多瓦大学的一组公共卫生住院医生在威尼托肿瘤研究所（一家公认的综合性癌症中心）以及另外两家省级医院的多学科团队的支持下，对癌症化疗过程进行了检查。绘制了一张图表来说明化疗从采用治疗方案到给药的9个不同阶段，并识别所有可能的失效模式。通过使用已发表量表的改编版本对失效的严重程度、发生频率和被检测到的可能性进行评级，确定关键性。识别并总结了安全策略。
发现了22种失效模式，分布在癌症治疗过程的各个阶段，其中7种被归类为高风险。癌症化疗过程的所有阶段都被定义为潜在关键阶段，并且针对单个高风险失效模式确定了至少一项措施。为了降低原因发生的可能性，或提高检测到失效模式的机会，共确定了10条建议。
FMECA有助于识别被认为高风险过程中的潜在失误。针对识别出的每种高风险失效模式制定了安全策略。
