Purpose Chemotherapy preparation units face peaks in activity leading to high workloads and increased stress. The present study evaluated the impact of work overloads on the safety and accuracy of manual preparations. Method Simulating overwork, operators were asked to produce increasing numbers of syringes (8, 16, and 24), with markers (phenylephrine or lidocaine), within 1 h, in an isolator, under aseptic conditions. Results were analyzed using qualitative and quantitative criteria. Concentration deviations of < 5%, 5%–10%, 10%–30%, and >30% from the expected concentration were considered as accurate, weakly accurate, inaccurate, and wrong concentrations, respectively. Results Twenty-one pharmacy technicians and pharmacists carried out 63 preparation sessions (n = 1007 syringes). A statistically significant decrease in the manufacturing time for one syringe was observed when workload increased (p < 0.0001). Thirty-nine preparation errors were recorded: 30 wrong concentrations (deviation > 30%), 6 mislabeling, 2 wrong diluents, and 1 wrong drug. There was no statistically significant difference in the mean concentration accuracy of final preparations across the three workloads. The overall error rate increased with the number of preparations made in 1 h: 1.8% for 8 preparations, 2.7% for 16 preparations, and 5.4% for 24 preparations (p < 0.05). Conclusion Although pharmacy technicians and pharmacists were able to increase production speeds with no effect on mean concentration accuracy under stressful conditions, there were greater probability errors being made. These results should encourage actions to spread workloads out over the day to avoid peaks in activity.

BackgroundChemotherapy preparation units have to face an increasing activity with constant staff. Safety is therefore compromised.PurposeThe purpose of our experiment was to measure the effect of a work overload on preparations, accuracy and occurrence of errors.Materials and MethodsOur work was performed in a real working environment using simulated preparations and two tracer drugs (phenylephrine or lidocaine). Twenty-one operators participated in three preparation sessions and had to produce an increasing number of syringes (8, 16 and 24) within a same time period (1 hour). Syringes were assayed by a validated capillary electrophoresis method. Results were analysed according to qualitative (choice of wrong stock solution, diluents and labelling) and quantitative (dose deviation from the target concentration: accurate,<5%; weakly accurate, 5% to 10%; inaccurate, 10% to 30%; wrong,>30%) criteria.ResultsA statistically significant decrease in the preparation time per syringe was observed when workload increased (p<0.0001). The average time per preparation was 279 s (95% CI: 246 to 312), 193 s (95% CI: 173 to 214) and 158 s (95%: CI: 138 to 178) for the sessions with 8, 16 and 24 syringes, respectively. The mean accuracy of the doses in the syringes was not statistically different between the three workloads (mean=98.1% (95% CI: 89.6 to 108.6) of the target concentration). The distribution of the doses was: accurate 45% to 51%, inaccurate 23% to 26%, weakly accurate 22% to 29%, and 2% to 4% wrong. Thirty-nine errors of preparations were observed: 30 wrong doses (>30% deviation), six mislabelling, two wrong diluents and one wrong drug. The overall error rate increased with the number of preparations performed in 1 hour: 1.8% for eight preparations, 2.7% for 16% and 5.4% for 24 (p<0.05). The study also showed a strong heterogeneity in the dose accuracy between operators (p<0.0001) and between the preparations for the same operator (p<0.0001).ConclusionOur study demonstrated that operators can increase their production speed without impacting the mean dose accuracy. However, the acceleration of manual production rate is associated with a greater probability of error’s occurrence. These results must strongly encourage cytotoxic production unit managers to take actions to smooth the workload over the day.AcknowledgementsNo conflict of interest

Background Our parenteral nutrition production (PN) decreased after we introduced standard solutions. To keep just a small number of daily PN items cost-effective, we decided to validate a once a week setting up of an automated compounder device (ACD). Purpose To test the operation and performance of an ACD (Baxa MM12) for a once a day and a once a week use. Materials and Methods Accuracy (mean in % of the expected value) and precision (Coefficient of Variation) of the ACD was evaluated by weighing different volumes of water 10 times (0.5 to 40 mL; daily operational qualification) and different volumes of nutrients (0.5 to 100 mL; daily performance qualification) over 3 consecutive days. The concentration of nutrients (glucose, Na and K) in PN, particulate contamination and media-fill tests were checked each day while the machine’s settings were only adjusted once a week (3 consecutive weeks). Some bottles were changed during the week and other remained in place, according to a predefined protocol. The ACD was installed in a laminar airflow hood GMP Class A with a cleanroom Class B background and a temperature around 20°C. Results Daily operational and performance results: 0.5 mL 40 mL 100 mL Accuracy Precision Accuracy Precision Accuracy Precision Water 100.9% 3.2% 98.9% 0.3% Nutrient 99.3–102.7* 2.7–3.9%* 100–100.4%* 0.7–1.5%* *Depending on nutrient The concentrations of nutrients in PN products made weekly always met the specifications (internal limits ±15% for Na, ±10% for glucose and −15% to +10% for K). No particles or microbiological contamination were detected. Conclusions Validation proved the acceptable accuracy, precision and aseptic conditions in the course of the week. A sepsis can only be guaranteed by a strict application of GMP in a high quality compounding environment. In those conditions, PN products can be produced safely for one week with the same settings. Setting it just once a week saves technician time (300 hours/year) and money (15,000 Euro/year). No conflict of interest.

BackgroundChemotherapy preparation units have to face increasing activity with constant staff. Safety is therefore threatened.PurposeThe purpose of our experiment was to measure the effect of work overload on preparation accuracy and error.Material and methodsA simulation study using tracers (lidocaine and phenylephrine) was conducted in an operational context. 12 operators had to produce 1, 2 or 3 sets of 8 preparations in a fixed time of 1 h. For each series of 8 preparations, 4 syringes at different dosages and volumes, starting from 2 concentrations of stock solutions, were compounded for each tracer. Results were analysed according to qualitative (visual observation, choice of stock solution, diluents and label) and quantitative (validated CE methods; accurate: <5% deviation from the target concentration; weakly accurate: 5–10%; inaccurate: 10–30%; error: >30%) criteria.ResultsA gradual reduction in preparation time, inversely correlated with workload, was obtained (4 min 11 s, 3 min 07 s and 2 min 35 s for sessions with 8, 16 and 24 syringes, respectivelyp <0.0001).No difference in the accuracy of the doses was observed between the 3 levels of workload (p = 0.23, Cox model regression). The distribution of quantitative analysis for the production of 8, 16 and 24 syringes was as follows:accurate: 57%, 51% and 49%;weakly accurate: 26%, 25% and 32%;inaccurate: 16%, 23% and 17%; anderror: 1%, 1% and 2%.The observed error rate (qualitative and quantitative analysis) for the preparation of 8, 16 and 24 syringes was 1.1%, 2.1% and 4.5%, respectively. The difference in errors rates between the 3 levels was not statistically significant (mixed effects logistic regression, p = 0.15), possibly due to a lack of power.ConclusionOur pilot study showed that operators are able to increase their working speed without impacting on dose accuracy. However, a large proportion of inaccurate preparations were observed and inclusion of robust control methods in the process is recommended. Acceleration of the manual production rate appears to be possibly associated with a greater probability of making a mistake, but this trend has to be confirmed in a larger sample size study.No conflict of interest.