BackgroundThe objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices.Methods and FindingsThe 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) and the other using the Phaseal system. Drugs were alternatively compounded in each isolator. Sampling involved wiping three surfaces (gloves, window, worktop), before and after a cleaning process. Exposure to ten antineoplastic drugs (cyclophosphamide, ifosfamide, dacarbazine, 5-FU, methotrexate, gemcitabine, cytarabine, irinotecan, doxorubicine and ganciclovir) was assessed on wipes by LC-MS/MS analysis. Contamination rates were compared using a Chi2 test and drug amounts by a Mann-Whitney test. Significance was defined for p<0.05. Overall contamination was lower in the “Phaseal” isolator than in the “Standard” isolator (12.24% vs. 26.39%; p < 0.0001) although it differed according to drug. Indeed, the contamination rates of gemcitabine were 49.3 and 43.4% (NS) for the Standard and Phaseal isolators, respectively, whereas for ganciclovir, they were 54.2 and 2.8% (p<0.0001). Gemcitabine amounts were 220.6 and 283.6 ng for the Standard and Phaseal isolators (NS), and ganciclovir amounts were 179.9 and 2.4 ng (p<0.0001).ConclusionThis study confirms that using a CSTD may significantly decrease the chemical contamination of barrier isolators compared to standard devices for some drugs, although it does not eliminate contamination totally.

BackgroundThe expiry of patents for infliximab in Europe coincides with the arrival on the market of new biosimilars with potential savings. However, many clinicians are reluctant to consider biosimilars as a treatment option for their patients.PurposeThe aim of this study was to evaluate concerns raised about biosimilars in the medical community in our hospital in order to reference infliximab biosimilars.Material and methodsA questionnaire with different items was put online: knowledge about the regulation of biosimilars in France, the degree of confidence in biosimilars, existence of high level evidence studies on the safety of biosimilars, and the acceptance of prescription and substitution.An item was used to evaluate the prescription frequency of biosimilars: regular prescribers (more than 1 prescription/week), occasional prescribers (between 6 and 12 prescriptions/year) and potential prescribers (<6 prescriptions/year). Comparison between prescriber groups was performed using Fisher’s exact test.Results36 prescribers responded to the survey. 47% (n = 17) were potential prescribers, 30.5% (n = 11) were occasional prescribers and 22% (n = 8) were regular prescribers. 61% (n = 22) had a good knowledge of the regulation of biosimilars. The degree of confidence was high for 70% (n = 25) of prescribers. However, 53% (n = 19) emphasised the lack of high level evidence for safety. 64% (n = 23) of prescribers were willing to prescribe a biosimilar and 50% (n = 18) to authorise substitution in patients already being treated with the originator product. The refusal rate for substitution seemed to be significantly different depending on the prescribing habits (p = 0.031). 75% (n = 6) of regular prescribers refused a substitution, while the refusal rate was 18% (n = 2) among occasional prescribers and 58.8% (n = 10) among potential prescribers. There were no statistically significant differences between prescribers groups about confidence level (p = 0.118).ConclusionMajor concerns voiced about biosimilars in this survey related to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications) and interchangeability with the originator product. However, the acceptance of biosimilars in our hospital seems to be high. This allows pharmacists to initiate a process introducing infliximab biosimilars.References and/or AcknowledgementsThanks to the medical staff.No conflict of interest.

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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.

BackgroundThe use of a post-administration rinsing process for intravenous antineoplastic drugs is very common to help to control occupational exposure to them. In paediatric haemato-oncology, drugs are often compounded in syringes to reduce the volume to be infused. In this case, extension sets with low deadspace volume are used but the required volume to rinse is not clearly specified.PurposeThe 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.Material and methodsA 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 5 different assemblies (device+extension sets) with different deadspace 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).ResultsThe 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.ConclusionThis 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.References and/or acknowledgementsThe author thank each supplier who provided free samples for the experiments.No conflict of interest