RESUMEN
OBJECTIVE: Medication errors (ME) more frequently affect pediatric patients than adults. Chemotherapeutic drug MEs seems more serious and less detected, among which, the most commonly involved chemotherapeutic agent was methotrexate (MTX). To engage multidisciplinary teams of childhood malignancy in a multisite study using proactive risk assessment methods to identify how MTX errors occur and propose risk reduction strategies. METHODS: We recruited doctors, nurses, pharmacists and parents from three children's hospitals in the northeast and southeast China to participate in failure mode and effects analyses (FMEA). An FMEA is a systematic team-based proactive risk assessment approach in understanding ways a process can fail and develop prevention strategies. Steps included diagram the process, collect failure modes /risks and prioritize failure modes, and propose risk reduction strategies. We focused on MTX-use process in and out of hospitals. RESULTS: A multidisciplinary medication safety team was formed of total 66 members. They developed a four-stage flow diagram with four main phases, based on which, 56 potential risks were recognized and 17 were classified as higher risks by the hazard-scoring matrix. The highest priority failure modes in hospital included wrong solvents, wrong frequency label and lake of monitoring; furthermore, errors involving excessive intake of oral MTX after discharge were worth extra attention. Meanwhile, remediation strategies were developed, consisting of constrained and recommended strategies. CONCLUSION: FMEA is a useful tool to identify the risk of MTX MEs and several years later, with the concerted efforts of all the healthcare staff and technicians, we wish to see a reduction in the potential for errors being made and an improvement of children safety.
RESUMEN
A two_dimensional HPLC method was developed for the determination of methotrexat ( MTX ) in human plasma. The samples were treated with trichloroacetate for sedimentation and high speed centrifugation, and the obtained supernatant was taken for analysis. The analytes in sample were separated on the first dimension column (ASTON C8 100 mm × 4. 6 mm, 5μm), and trapped on the middle column (ASTON SCX 20 mm × 4. 6 mm, 5 μm) using valve_switching technique for purification and storage. Finally, the trapped analytes were transferred to the second_dimension column (SAC C8 100 mm × 4. 6 mm, 5μm) for the second separation. The mobile phase used for the first dimension was 10 mmol/L ammonium acetate_acetonitrile(9∶1, V/V, pH=3. 8) with a flow rate of 1 mL/min and the mobile phase used for middle column was 10 mmol/L phosphoric acid ( pH=3 . 0 ) . The mobile phase used in second_dimension was a mixed solution of 50 mmol/L ammonium acetate and acetonitrile (87∶10, V/V, pH=5. 2). UV detection was carried out at 306 nm and completed in 4 min. The calibration curve showed a linearity range from 0. 0879 to 5. 154 μmol/L (r=0. 99998). The LOQ was 0. 005 μmol/L. The intra_and inter_day precisions were lower than 1. 5% and 1. 8%, respectively. The relative recovery and the absolute recovery were 99. 1% - 101. 2% and 85. 67%-86. 35%, respectively. The assay is simple, accurate, reproducible, and suitable for the therapeutic drug monitoring of MTX in the hospital and the study on the pharmacokinetics of MTX.