IV workflow management systems, applied to parenteral chemotherapy (QT) compounding process are one of the main tools to prevent compounding errors (CE). However, due to its recent development, the scientific evidence supporting its potential benefit in healthcare practice is still limited. OBJECTIVES This Doctoral Thesis has been developed in order to improve the knowledge of the added value that these technological systems provide in the parenteral QT compounding process, specifically, the ePASE® System (IMF, SL), that integrates a qualitative control, based on verifying the data-matrix code (DM) of diluents and drugs and a quantitative control based on gravimetry. With this aim, we evaluated its impact in the different dimensions of healthcare quality (effectiveness, safety, efficiency -compared to the compounding process non-assisted by technology- and user satisfaction). The main objective was to quantify the impact of technological control in terms of effectiveness-patient safety compared to standard quality control (based on visual and semi-quantitative methods). MATERIAL AND METHODS The research project was developed in three phases. In Phase I (01/01/2013-03/31/2013), technological control was validated, getting the Sensitivity, Specificity and Predictive Values to intercept CE, and the risks introduced by the technology were analyzed using the Failure Modes and Effects Analysis (FMEA). In Phase II (04/01/2013-11/21/2013) we analyzed the quality of the QT compounding process assisted by ePASE®, in terms of patient and compounder safety. Variability in the dosage of drugs was quantified using the Percentage Gravimetric Error (PGE); the prevalence and typology of the intercepted CEs were analyzed, and risk factors for this CE were identified through logistic regression models. Finally we measured the accumulated time exposure to hazardous drugs per compounder. In Phase III (11/22/2013-30/04/2014) we developed a non-masked randomized quasi-experimental study to demonstrate the superiority of technological control in the interception of CE over the standard control. In addition, the efficiency of technological assisted compounding process vs. non-assisted was evaluated by the incremental cost-effectiveness ratio (ICER) from the National Healthcare Service perspective, taking into account only direct healthcare costs, and for a time horizon of 5 months and 15 years (expected useful life of technology). Finally, the satisfaction of the professionals was investigated through a validated questionnaire. RESULTS In terms of effectiveness-patient safety, technological quality control has doubled the ability to intercept CE compared to standard quality control, with an overall RR of 2.60 (95% CI 1.84-3.65), highlighting the impact on the interception and prevention of errors related to the drug dose. This technological quality control has shown a high diagnostic validity to intercept CE (Sensitivity of 100% and Specificity of 96%), and classifies correctly the preparations as correct or erroneous in 98.1% of cases. Furthermore, it has evidenced the great variability that exists in the dosage of most drugs when using the volumetric method during compounding, which incorporates systematic errors in the process. Thanks to the retrospective analysis of the quality control records of the compounding process allowed by the technological control of the ePASE® System, the prevalence of CE in our institution has been quantified, with 43.6 CE x 1000 preparations (80% quantitative CE, mainly in drug dose) and risk factors for each CE subtype have been identified. This results are relevant to develop preventive strategies in the future. The FMEA carried out has made it possible to identify the risks associated with the use of this new technology, whose incorporation into the parenteral QT compounding process involved 24 new failure modes that were prioritized, based on the associated risk, in order to implement strategies, such as the standardization of processes and the training of professionals, to prevent future quality and safety problems. Regarding the safety of the compounder, the ePASE® System has made it possible to quantify the accumulated time of exposure to dangerous drugs, showing great variability among professionals. In terms of efficiency, the compounding of parenteral QT technologically assisted, has presented a global ICER (compared to non-assisted process) of € 25.92–33.64 / CE for a time horizon of 15 years. The most efficient scenario corresponded to complete gravimetric control (of the drug dose and vehicle volume prepared) and, the least efficient scenario, to the qualitative control of the drug by verifying the DM code. Finally, the global satisfaction of the users has been high and the overall assessment was positive or very positive by all of them. CONCLUSIONS The results obtained in this Doctoral Thesis highlight the added value of IV workflow management systems applied to the compounding process of parenteral QT. In this sense, the integration of the ePASE® System in the compounding process improves the quality of care, since it increases the safety of the patient and the compounder, presents a reasonable ICER and is well accepted by professionals.
2020-07-29
