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In clinical practice, fecal microbiota transplantation (FMT) has been established as an unparalleled therapy to date for multiple recurrent Clostridioides difficile infections (CDI). The implementation of the FMT in practice requires a significant investment to meet legal, security and financial requirements. Research on the microbiota is booming and multiple investigations on FMT in indications other than CDI are ongoing.En pratique clinique, la transplantation de microbiote fécal (TMF) s’est établie comme une thérapie sans équivalent à ce jour pour les infections à

Background Use of automated systems for the production of chemotherapy will increase in answer to hospitals’ needs to rationalise production. The aim of the study was to evaluate the performance of a PharmaHelp® automated system for compounding chemotherapy. Methods Viable and non viable particles in air and liquid were measured by particle counter. Surface chemical contamination was simulated with a quinine solution. Microbiological contamination and aseptic processes were studied using media-fill tests. Dose accuracy was evaluated using a gravimetric method, in simulation studies and with real products in daily practice. Productivity was calculated by batch of ten IV-bags. Results No particles or microbiological contamination were detected. Filling was accurate for all the volumes of non-viscous solution studied (97–103 %). Minimum volumes which could be prepared accurately were 2 mL and 5 mL for the non-viscous and viscous solutions, respectively. For 2–5 mL volumes, the robot was less accurate than average, and 0–2 % of bags were rejected (deviation>10 %). Average fill deviations were from 0–3 % for 2–5 mL volumes and Conclusions The automated system was able to produce chemotherapy effectively, delivering appropriate quality with productivity comparable to manual preparations. These results confirmed that such automated systems have the potential to guarantee optimal safety for patients and technicians.

PurposeChemotherapy 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.MethodSimulating 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 30% from the expected concentration were considered as accurate, weakly accurate, inaccurate, and wrong concentrations, respectively.ResultsTwenty-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 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 ConclusionAlthough 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.

Background Our chemotherapy production unit decided to rethink its organisational strategy and to revise its production processes through lean methodology to meet growing activity, in the context budget constraints that limit the increase in staff. Purpose To evaluate the impact of a lean management approach on the efficiency of a chemotherapy unit. Material and methods A five-step lean methodology approach was applied with a team of 12 technicians and five pharmacists supported by a lean expert, from January 2015 to July 2016: DEFINE: objectives, value stream mapping, process flows. MEASURE: steps, process duration, use of stock. ANALYSE: added-value steps, waste, waiting time and causes. IMPLEMENT: imagine and implement solutions. CONTROL: efficiency, performance, satisfaction. Results The team identified 73 items impacting the efficiency of the process during the ‘Measure’ phase. During the ‘Analyse’ step, 18 opportunities divided into four main themes were proposed to improve the organisation: Flow: smoothing the activity and reducing the early morning peak (–12% between 7 and 9 am), producing continuously according to demand of the day (‘Just in time’ eight maximum ongoing preparations), improving occupancy rates of isolators (+25% between 10 and 12 am, and +20% between 1 and 4 pm), revising the steps of double–control and using mistake–proofing resulted in a decrease in crossing time of manufacturing from 9 hour 45 min to 1 hour 45 min. bull; Space: reorganisation with a reduction of unnecessary movements. bull; Management: creation of a position of ‘coordinator of the day’, and daily meetings (‘Obeya’) to reassign tasks. bull; Stock and control: rationalisation of storage and orders. A net gain of 40% full-time equivalent was reached. The satisfaction survey showed a positive acceptance of the project and its conduct. Conclusion The application of a lean methodology allowed the optimisation of the management of our chemotherapy production unit and saved human resources. The main actions were to eliminate waiting time, to smooth daily activity, and to reorganise roles, spatial organisation and storage. The positive impact on the efficiency of our facility and the satisfaction of the team proved that lean methodology is a relevant tool in the hospital pharmacy. No conflict of interest

BACKGROUND: Chemotherapy preparation units have to face an increasing activity with constant staff. Safety is therefore compromised. PURPOSE: The purpose of our experiment was to measure the effect of a work overload on preparations, accuracy and occurrence of errors. MATERIALS AND METHODS: Our 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,30%) criteria. RESULTS: A statistically significant decrease in the preparation time per syringe was observed when workload increased (p30% 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

Background and objectives Centralized chemotherapy preparation units have established systematic strategies to avoid errors. Our work aimed to evaluate the accuracy of manual preparations associated with different control methods. Method A simulation study in an operational setting used phenylephrine and lidocaine as markers. Each operator prepared syringes that were controlled using a different method during each of three sessions (no control, visual double-checking, and gravimetric control). Eight reconstitutions and dilutions were prepared in each session, with variable doses and volumes, using different concentrations of stock solutions. Results were analyzed according to qualitative (choice of stock solution) and quantitative criteria (accurate, 30% deviation). Results Eleven operators carried out 19 sessions. No final preparation (n = 438) contained a wrong drug. The protocol involving no control failed to detect 1 of 3 dose errors made and double-checking failed to detect 3 of 7 dose errors. The gravimetric control method detected all 5 out of 5 dose errors. The accuracy of the doses measured was equivalent across the control methods ( p = 0.63 Kruskal–Wallis). The final preparations ranged from 58% to 60% accurate, 25% to 27% weakly accurate, 14% to 17% inaccurate and 0.9% wrong. A high variability was observed between operators. Discussion Gravimetric control was the only method able to detect all dose errors, but it did not improve dose accuracy. A dose accuracy with

Purpose: Evaluation of containment safety devices designed and introduced to protect preparers and administrators of hazardous drugs, through a multiple-test assessment. Methods: Six devices were compared: (1) Kis1 gravity-fed infusion set (Doran International, France), (2) Tevadaptor Spike Port Adapter (Teva Pharma AG, France), (3) Phaseal Infusion Adapter C100 (Carmel Pharma AB, France), (4) Codan Connect Z (Codan, France), (5) Pchimx with or without a cap (Doran International, France), and (6) Clave extension set 011-H1225 with or without Spiros (Hospira, France). Assessment of exposure to hazardous drugs was performed using quinine as fluorescent marker. Mechanical tests included tightness, tension tests, and estimation of the force required to connect the infusion device to the bag. Ergonomic tests were performed by six pharmaceutical technicians. Microbiological contamination was tested with media-fill, on connected bag. Results: No cytotoxic contamination was detected when using Phaseal, Tevadaptor or the Clave extension set with Spiros, Pchimx with a cap or Connect Z devices. For mechanical tests, all devices complied with the norm. Microbiological growth was observed neither in bags nor in tubings. The ergonomic study revealed differences between the devices for potential cytotoxic contamination risk only, but not for handling. Conclusions. The use of containment safety devices offers improved handling conditions of hazardous compounds. As this study takes various selection criteria into account, its results offer assistance in choosing the most suitable device.

Recently, the control of phosphatidylinositol 3,4,5-trisphosphate (PtdIns(3,4,5)P3)-dependant signaling by phosphatases has emerged, but there is a shortage of information on intranuclear PtdIns(3,4,5)P3 phosphatases. Therefore, we investigated the dephosphorylation of [32P]PtdIns(3,4,5)P3 specifically labeled on the D-3 position of the inositol ring in membrane-free nuclei isolated from pig aorta vascular smooth muscle cells (VSMCs). In vitro PtdIns(3,4,5)P3 phosphatase assays revealed the production of both [32P]PtdIns(3,4)P2 and inorganic phosphate, demonstrating the presence of PtdIns(3,4,5)P3 5- and 3-phosphatase activities inside the VSMC nucleus, respectively. Both activities presented the same potency in cellular lysates, whereas the nuclear PtdIns(3,4,5)P3 5-phosphatase activity appeared to be the most efficient. Immunoblot experiments showed for the first time the expression of the 5-phosphatase SHIP-2 (src homology 2 domain-containing inositol phosphatase) as well as the 3-phosphatase PTEN (phosphatase and tensin homolog deleted on chromosome 10) in VSMC nuclei. In addition, immunoprecipitations from nuclear fractions indicated a [32P]PtdIns(3,4,5)P3 dephosphorylation by both SHIP-2 and PTEN. Moreover, confocal microscopy analyses demonstrated that SHIP-2 but not PTEN colocalized with a speckle-specific component, the SC35 splicing factor. These results suggest that SHIP-2 may be the primary enzyme for metabolizing PtdIns(3,4,5)P3 into PtdIns(3,4)P2 within the nucleus, thus producing another second messenger, whereas PTEN could down-regulate nuclear phosphoinositide 3-kinase signaling. Finally, intranuclear PtdIns(3,4,5)P3 phosphatases might be involved in the control of VSMC proliferation and the pathogenesis of vascular proliferative disorders.

Background Chemotherapy preparation units have to face increasing activity with constant staff. Safety is therefore threatened. Purpose The purpose of our experiment was to measure the effect of work overload on preparation accuracy and error. Material and methods A 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: 30%) criteria. Results A 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 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%; and error: 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. Conclusion Our 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.

Background Human reliability is limited and information technology has the potential to improve the safety of the medication process. In July 2011, a robot (ROWA/ARX) was implemented in our hospital pharmacy to reduce error rates and improve the efficiency of our global drug distribution. Purpose To evaluate the impact of this automation on distribution errors and workload efficiency. Materials and Methods Approximately 52% of the dispensary stock (1126 articles, 50,000 boxes) is managed by the robot. Distribution errors: content accuracy of random orders was verified before and after the implementation of the robot. Errors were classified in three categories: wrong drug, missing drug/quantity or additional quantity. Workload efficiency: time to prepare a sequence of orders manually or with the robot was measured. Results Manual dispensing error rate was 0.93% (n = 5805 ordered lines; wrong drug: 0.36%, missing drug/quantity: 0.31%, additional quantity: 0.26%). By decreasing this error rate to 0.27% (n = 5840; only conveyor errors leading to missing drug/quantity and additional quantity), the automation avoided more than 4500 errors each year. With the distribution of 880 boxes of drugs/hour (reduced to 630 when the automated ‘Pro-log’ filling system was working simultaneously), the robot significantly increased the distribution speed in comparison with the manual picking (303 boxes/hour). Conclusions This reorganisation contributed to safer and more efficient distribution of drugs. No more incorrect picking of medicines occurred thanks to the high reliability of the robot. Remaining errors could still be reduced by improving the conveyor software. With one single person operating the robot, 2 full-time equivalents were saved, leading to an estimated return on investment in 4.5 years. For medicines remaining outside the robot (i.e. controlled drugs, cold chain drugs or those with an unusual size, shape or weight), a scanning system will be introduced and evaluated by the same protocol. No conflict of interest.