Risks and medication errors analysis to evaluate the impact of a chemotherapy compounding workflow management system on cancer patients’ safety

Abstract

A failure modes, effects and criticality analysis was supported by an observational medication error rate study to analyze the impact of Phocus Rx®, a new image-based workflow software system, on chemotherapy compounding error rates. Residual risks that should be a target for additional action were identified and prioritized and pharmacy staff satisfaction with the new system was evaluated. In total, 16 potential failure modes were recognized in the pre-implementation phase and 21 after Phocus Rx® implementation. The total reduction of the criticality index was 67 percent, with a reduction of 46 percent in material preparation, 76 percent in drug production and 48 percent in quality control subprocesses. The relative risk reduction of compounding error rate was 63 percent after the implementation of Phocus Rx®, from 0.045 to 0.017 percent. The high-priority recommendations defined were identification of the product with batch and expiration date from scanned bidimensional barcodes on drug vials and process improvements in image-based quality control. Overall satisfaction index was 8.30 (SD 1.06) for technicians and 8.56 (SD 1.42) for pharmacists ( p = 0.655). The introduction of a new workflow management software system was an effective approach to increasing safety in the compounding procedures in the pharmacy department, according to the failure modes, effects and criticality analysis method.

Deviations From Best Practice: Findings From a Certified Patient Safety Organization Remote-Verification Observational Study of Intravenous Compounding of Chemotherapeutic and Ancillary Drugs

“…14 Similarly, in a study assessing chemotherapeutic comparative risk analysis before and after implementation of a remote verification system, the relative risk reduction of compounding error rate was 63% after implementing a workflow system. 16 In this retrospective observational study, use of a remote verification system showed variation between workflow stations and lack of standardization across delivered chemotherapeutics to patients. Image analyses demonstrated that the highest number of orders with a deviation from best practice were those that exceeded the ISMP >10% additive volume guideline.…”

Developments in healthcare information systems in Ireland and internationally

“…Positive results have been seen from digital image-based workflow systems. Such systems enable repetitive processes, such as medication preparation, to be automated (Marzal-Alfaro et al, 2020). One study investigated the impact of an image-based workflow system, which aimed to reduce risk in the medication process of chemotherapy by digitally guiding technicians through the compounding process.…”

“…One study investigated the impact of an image-based workflow system, which aimed to reduce risk in the medication process of chemotherapy by digitally guiding technicians through the compounding process. The authors found the system to be clearly effective in increasing safety (Marzal-Alfaro et al, 2020). In areas such as cancer detection, AI and digital-based image data are also now a common feature.…”

Design and Implementation of a Guideline-Based Workflow Software System for Improving the Chemotherapy Process

“…These errors occur in all cancer treatment plans and may happen in all phases of the chemotherapy process, including prescription, preparation, and administration. They include all types of medication errors, such as wrong patient treatment, administration of wrong regimen, drug, or drug dose, wrong route of administration, errors related to schedules or infusion, and compounding errors (6)(7)(8).…”

“…While the chemotherapy administration phase is complex and requires many different safety checkpoints to prevent errors, according to the literature, the highest rate of medication errors is related to the prescription phase, with almost 33% of all errors categorized as fatal or lifethreatening for cancer patients (9). The chemotherapy preparation phase is usually considered a critical step; however, the risks and errors remain uncertain, because there are no studies specifically designed to detect these errors (8). Other issues of concern that may compromise the safety and quality of the chemotherapy process include long patient waiting time for chemotherapy due to uncertainties in the chemotherapy workflow and appointment schedules; poor communication and coordination between different care providers (e.g., oncologists, nurses, and pharmacists); and inconsistency in the paper-based documentation of prescriptions and administration information, making it difficult to find previous prescriptions and keep track of the chemotherapy cycle (3,4,(10)(11)(12).…”