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Since March 2022, the centralized cytotoxic preparation unit at the Lille University Hospital (Lille, France) is equipped with augmented reality eyewear for preparation and quality control. The technology enables a user-friendly guided step by step preparation process. It also assists the user by identifying vials through data matrix scan and recording photos at different stages of preparation in order to replace the in-process double visual inspection which will now be carried out a posteriori during the release control. In this paper, we evaluate user feedback and model the learning curve for this new tool. The team's feedback was evaluated using the System Usability Scale (SUS) and Short User Experience Questionnaire (SUEQ). Both questionnaires showed very good acceptance of the tool by our teams, with scores of 79.7 for the SUS and 2.014 for the UEQ. Finally, a learning curve was drawn up according to Wright, showing a learning curve of 91%. This study shows that the tool has been very well integrated into our preparation unit. [ABSTRACT FROM AUTHOR]

Introduction: Compounding robots are increasingly being implemented in hospital pharmacies. In our hospital, the recent acquisition of a robot (RIVATM, ARxIUM) for intravenous cancer drug compounding obliged us to replace the previously used infusion devices. The objective of the present study was to assess and qualify the new intravenous sets prior to their use in our hospital and prior to the implementation of the compounding robot. Materials and Methods: The ChemoLockTM (ICU Medical) was compared with the devices used previously for compounding (BD PhaSealTM, Becton-Dickinson) and infusion (Connect-ZTM, Codan Medical). The connection/disconnection of infusion devices to/from 50 mL infusion bags was tested with a dynamometer (Multitest-i, Mecmesin). Leakage contamination was visualized by a methylene blue assay and was quantified in simulated pump infusions with 20 mg/mL quinine sulfate (N = 36/group); after the analytical assay had been validated, quinine was detected by UV-spectrophotometry at 280 and 330 nm. Groups were compared using chi-squared or Mann–Whitney U tests. Results: The connection/disconnection test showed that although all the devices complied with the current standard, there was a statistically significant difference in the mean ± standard deviation compression force (51.5 ± 11.6 for the Connect-ZTM vs. 60.3 ± 11.7 for the ChemoLockTM; p = 0.0005). Leaks were detected in 32 (29.1%) of the 110 tests of the ChemoLockTM. The contamination rates were also significantly different: 13.9% for the BD PhaSealTM versus 75.0% for the ChemoLockTM; p < 0.0001). Discussion/conclusion: Our results showed that the new infusion device complied with current standards. However, the presence of contamination emphasizes the need for operators to use the recommended personal protective equipment. Further studies of contamination with cancer drugs are required. [ABSTRACT FROM AUTHOR]

Introduction: Healthcare workers are exposed to hazardous drugs such as antineoplastic drugs, which have potential carcinogenic, mutagenic and teratogenic effects. Protective measures must be taken after appropriate staff training to handle antineoplastic drugs in a safe way. The objective was to assess perception, knowledge, practices and training regarding the risk of exposure of healthcare workers in three French compounding units. Methods: This descriptive study was based on a questionnaire made of 33 questions divided into five sections related to the handling of antineoplastic drugs: perception of the risks, knowledge of the risks, protection practices, specific training and general questions. Results: Among the 39 participants, over half considered their overall risk of exposure to antineoplastic drugs not being very low. Inhalation was known to 69.2% of them as possible route of contamination. The breakroom was identified by 28.9% of them as a place of contamination. The procedure in case of accidental exposure to antineoplastic drugs was known by 69.2%, but only half could explain it. Only 38.5% said they changed their gloves every 30 min as recommended. Barely half said that they had been trained specifically for the handling of antineoplastic drugs during an initial training. Over half wished to be informed, trained and aware of the proper handling of antineoplastic drugs. Conclusion: Although some of these results are encouraging, specifically when compared to the other settings where antineoplastic drugs are handled, there is still room for improvement. Efforts to build an adapted and impactful training program must pursue. Clinical trial registration: Study CONTACT, ref. 19-504. [ABSTRACT FROM AUTHOR]

Introduction: Ever since the late 1970s, occupational exposure associated with the handling of antineoplastic drugs (ADs) in the healthcare environment has been highlighted and demonstrated. Contamination was detected in both operating rooms (OR) and compounding units (CU), where healthcare workers handle and are exposed to ADs in different ways. In the OR, the risk of exposure is higher and the staff receives less training in handling ADs than in the CU. This study aimed to assess and compare knowledge and practices about the safe handling of ADs by caregivers working in these two locations, namely the CU and OR. Methods: Two questionnaires (one each for the OR and CU) were created by two investigator pharmacists and were completed during a personal interview of 20 min. The questions were related to the following topics: training, knowledge about occupational exposure and questions related to protective practices. A scoring system was implemented to assess the knowledge and practices of each participant. Results: In total, 38 caregivers working in the OR and 39 in the CU were included in our study. Significantly more CU staff had specific initial training (p < 0.001) and ongoing training (p < 0.001) in handling ADs. Concerning the knowledge score, OR caregivers had a significantly lower median score for contamination routes (p < 0.001), contamination surfaces (p < 0.001), existing procedures (p < 0.001) and total knowledge (p < 0.001) than CU caregivers. Concerning protective handling practices of ADs, the two locations had nonsignificantly different median scores (p = 0.892). Conclusion: This study suggests that there is still room for improvement in terms of knowledge and protection practices when handling ADs. An appropriate and tailored training program should be developed and provided to all caregivers who handle or come in contact with ADs. Clinical trial registration Study CONTACT, ref. 19-504. [ABSTRACT FROM AUTHOR]

Many hospitals are now investing in robotic compounding system for the preparation of cytotoxic agents. The objective of the present study was to describe contamination by cytotoxics inside and outside the RIVATM robot (ARxIUM, Winnipeg, Canada).We applied a risk analysis to determine which locations inside and outside the compounding robot should be monitored. Samples were collected by swabbing with a wet swab (using 0.1 mL of sterile water) before the robots was cleaned. Ten cytotoxics compounded with the robot were screened for using LC-MS/MS. We determined the percentage contamination rates inside (CRin) and outside (CRout) the robot and the amounts of each contaminant (in ng/cm²). If a sample was found to be positive, a corrective action was implemented.Our risk analysis highlighted 10 locations inside the robot and 7 outside. Ten sampling campaigns (10 samples per campaign) were performed. The mean CRin (40%) was significantly higher than the mean CRout (2%; p < 10−4). Gemcitabine and cyclophosphamide were the main contaminants. After the implementation of corrective measures (such as daily cleaning with SDS/isopropyl alcohol), the CRin fell from 60% to 10%.The frequency of contamination was lower for robotic compounding than for manual compounding in an isolator. However, robotic compounding tended to generated larger mean amounts of contaminant; this was related to incidents such as splashing when syringes were disposed of after the compounding. The implementation of corrective actions effectively reduced the CRs. Further longer-term studies are required to confirm these results. [ABSTRACT FROM AUTHOR]

Résumé: Les lymphocytes T à récepteur chimérique (CAR-T cells) sont une nouvelle classe de médicaments nécessitant une adaptation des hôpitaux pour pouvoir prendre en charge ces nouveaux traitements et assurer la sécurité des patients traités. Outre les impératifs de parcours de soins médicaux, un autre point primordial est la structuration du circuit intra-hospitalier de ces médicaments. L'objectif de cet article est de décrire le rôle du pharmacien hospitalier dans la mise en œuvre du circuit au sein d'un centre hospitalier universitaire, mais également dans son rôle de pharmacien clinicien. Les différentes étapes du circuit sont détaillées en rappelant le rôle du pharmacien décrit dans la réglementation, et sa place au sein de l'équipe pluri-professionnelle intervenant sur le circuit du médicament, de l'étude de faisabilité jusqu'au suivi du patient au décours de l'hospitalisation. Après trois années d'expérience au sein de notre centre hospitalier, des perspectives d'amélioration sont également présentées pour sécuriser davantage ce circuit pharmaceutique et optimiser la prise en charge des patients. Chimeric receptor T-cells (CAR-T cells) are a new class of drugs that require hospitals to adapt in order to manage these new treatments and ensure the patients' safety. In addition to the imperatives of medical care pathways, another essential point is the structuring of the intra-hospital supply chain for these drugs. The objective of this article is to describe the role of the hospital pharmacist in the implementation of the supply chain within the institution but also in his role as clinical pharmacist. The different steps of the supply chain are detailed by recalling the role of the pharmacist described in the regulation, and his/her place within the multi-professional team involved in this process, from the feasibility study to the follow-up of patients during hospitalization. After 3 years of activity in our university hospital, perspectives for improvement are also presented to further secure this pharmaceutical circuit and optimize patient care. [ABSTRACT FROM AUTHOR]

Purpose The aims of this study were to propose a simple methodology to assess the rinsing volume of syringe extension sets and to compare several marketed devices. Methods A UV-spectrophotometry assay using quinine hydrochloride as drug substitute was developed. Quinine concentration ranged from 20 to 200 µg/ml. The assay was validated with the accuracy profile method and tested on five different assemblies (device+extension sets) with different dead-space volumes (1.28–2.80 ml) and at two different quinine concentrations (0.3 and 8.0 mg/ml). Rinsing was performed stepwise with water for injection until reaching an undetectable quinine concentration. After fitting the data with a Weibull model, assemblies were compared with an ANOVA performed on ranks (GraphPad, La Jolla, USA). Results The within-day and between-day precision ranges were 0.39–0.81 and 0.48–0.84%, respectively. The lower limit of quantification was 4.26 µg/ml. The volume required to completely rinse the infusion line was different according to the initial drug concentration and to the device assessed: from 6 to 10 ml for a low quinine concentration and from 7 to 17 ml for a high quinine concentration. Conclusion This study shows that a simple, cheap and easy-to-use methodology may be used to assess the rinsing volume of syringe extension sets. The rinsing volume is different according to the tested device. [ABSTRACT FROM AUTHOR]

Introduction: Many hospitals are now investing in robotic compounding system for the preparation of cytotoxic agents. The objective of the present study was to describe contamination by cytotoxics inside and outside the RIVA TM robot (ARxIUM, Winnipeg, Canada)., Material & Methods: We applied a risk analysis to determine which locations inside and outside the compounding robot should be monitored. Samples were collected by swabbing with a wet swab (using 0.1 mL of sterile water) before the robots was cleaned. Ten cytotoxics compounded with the robot were screened for using LC-MS/MS. We determined the percentage contamination rates inside (CR in ) and outside (CR out ) the robot and the amounts of each contaminant (in ng/cm²). If a sample was found to be positive, a corrective action was implemented., Results: Our risk analysis highlighted 10 locations inside the robot and 7 outside. Ten sampling campaigns (10 samples per campaign) were performed. The mean CR in (40%) was significantly higher than the mean CR out (2%; p < 10 -4 ). Gemcitabine and cyclophosphamide were the main contaminants. After the implementation of corrective measures (such as daily cleaning with SDS/isopropyl alcohol), the CR in fell from 60% to 10%., Discussion/conclusion: The frequency of contamination was lower for robotic compounding than for manual compounding in an isolator. However, robotic compounding tended to generated larger mean amounts of contaminant; this was related to incidents such as splashing when syringes were disposed of after the compounding. The implementation of corrective actions effectively reduced the CRs. Further longer-term studies are required to confirm these results., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Following the 2005 decree on securing the medicine supply chain, the production of "chemotherapies", anticancer drugs (cytotoxic, cytostatic, immunotherapy), was centralised within hospital pharmacies. To cope with increasingly growing activities, pharmacies are moving towards robotisation. This work offers feedback from four French sites pioneers in robotic production., Material and Method: A review of the literature was carried out on the PubMed and Google Scholar scientific databases and GERPAC publications relating to the robotic production of chemotherapy preparations. This review allowed to select 25 articles., Results: The robotisation of the production of "chemotherapies" requires infrastructural prerequisites, a reengineering of the manufacturing process and the patient journey. This impacts all the parties involved in this complex process. The "cobotisation" concept or collaborative robotics must be anticipated by the teams. Robotisation is an institutional decision, which must be owned by the pharmaceutical team and endorsed by the medical team and management., Discussion/conclusion: For reasons of optimisation, safeguarding and management of human resources, a large number of centres get equipped with robotic systems. Robotic preparation should extend to other non-hazardous preparation, as it is already the case in other countries. This strategic view should be carried out today to anticipate problems, ensure safety and improve the healthcare quality., (Copyright © 2023. Published by Elsevier Masson SAS.)