Gravimetric-based technology-assisted workflow system for injectable anticancer drugs compounding: Design and qualification of an original weighing scale anchored inside an isolator.

Technology-assisted manufacturing such as computer-assisted gravimetric control (CAGC) is a well-established method for injectable anticancer drugs (AD) compounding. The aim of this study was to validate an innovative weighing scale (WS) anchored inside an isolator for in-process gravimetric control (GC) of injectable AD compounding in a French Comprehensive Cancer Centre. The weighing scale studied Cyto-TopControl was designed by hospital pharmacists and the manufacturer LDI.

First-in-man use of a cardiovascular cell-derived secretome in heart failure. Case report.

Background: There is increased evidence that the effects of stem cells can mostly be duplicated by administration of their secretome which might streamline the translation towards the clinics.

Methods: The 12-patient SECRET-HF phase 1 trial has thus been designed to determine the feasibility and safety of repeated intravenous injections of the extracellular vesicle (EV)-enriched secretome of cardiovascular progenitor cells differentiated from pluripotent stem cells in severely symptomatic patients with drug-refractory left ventricular (LV) dysfunction secondary to non-ischemic dilated cardiomyopathy. Here we report the case of the first treated patient (baseline NYHA class III; LV Ejection Fraction:25%) in whom a dose of 20 × 10 particles/kg was intravenously infused three times three weeks apart.

Self-assembly of gold nanoparticles by chitosan for improved epinephrine detection using a portable surface enhanced Raman scattering device.

Surface enhanced Raman scattering (SERS) has become widely used for identification, quantification and providing structural information about molecular structure in low concentrations as it allows signal Raman enhancement using metallic nanoparticles (NPs). Controlling interaction between analyte and NPs is a major point for the optimization of signal exaltation in SERS analysis. The objective of this study is the improvement and the control of SERS analysis by aggregation/self-assembly optimization of AuNPs using quaternized chitosan.

Discriminative and quantitative analysis of norepinephrine and epinephrine by surface-enhanced Raman spectroscopy with gold nanoparticle suspensions.

Surface-enhanced Raman spectroscopy (SERS) is a powerful analytical technique capable of increasing the Raman signal of an analyte using specific nanostructures. The close contact between those nanostructures, usually a suspension of nanoparticles, and the molecule of interest produces an important exaltation of the intensity of the Raman signal. Even if the exaltation leads to an improvement of Raman spectroscopy sensitivity, the complexity of the SERS signal and the numbers of parameters to be controlled allow the use of SERS for detection rather than quantification.

Effectiveness of a 'do not interrupt' vest intervention to reduce medication errors during medication administration: a multicenter cluster randomized controlled trial.

Background: The use of a 'do not interrupt' vest during medication administration rounds is recommended but there have been no controlled randomized studies to evaluate its impact on reducing administration errors. We aimed to evaluate the impact of wearing such a vest on reducing such errors. The secondary objectives were to evaluate the types and potential clinical impact of errors, the association between errors and several risk factors (such as interruptions), and nurses' experiences.

A mathematical approach to deal with nanoparticle polydispersity in surface enhanced Raman spectroscopy to quantify antineoplastic agents.

Antineoplastic agents are, for most of them, highly toxic drugs prepared at hospital following individualized prescription. To protect patients and healthcare workers, it is important to develop analytical tools able to identify and quantify such drugs on a wide concentration range. In this context, surface enhanced Raman spectroscopy (SERS) has been tested as a specific and sensitive technique.

Integration of a Commercial Barcode-Assisted Medication Dispensing System in a Teaching Hospital.

Objectives: A commercial barcode-assisted medication administration (BCMA) system was integrated to secure the medication process and particularly the dispensing stage by technicians and the administration stage with nurses. We aimed to assess the impact of this system on medication dispensing errors and barriers encountered during integration process.

Methods: We conducted a controlled randomized study in a teaching hospital, during dispensing process at the pharmacy department.

Discriminative and Quantitative Analysis of Antineoplastic Taxane Drugs Using a Handheld Raman Spectrometer.

This study was conducted to evaluate the ability of Raman spectroscopy (RS) to control antineoplastic preparations used for chemotherapy in order to ensure its physical and chemical qualities. Three taxane drugs: cabazitaxel (CBX), docetaxel (DCX) and paclitaxel (PCX) at therapeutic concentration ranges were analyzed using a handheld spectrometer at 785 nm. Qualitative and quantitative models were developed and optimized using a calibration set (n=75 per drug) by partial least square discriminant analysis and regression and validated using a test set (n=27 per drug).

Impact of drug storage systems: a quasi-experimental study with and without an automated-drug dispensing cabinet.

Objective: To compare the costs and benefits of an automated-drug dispensing cabinet (ADC) versus traditional floor stock storage (TFSS).

Design: A quasi-experimental multicenter study conducted during 2015.

Setting: A teaching hospital (814 beds) equipped with 43 ADCs and a not-for-profit teaching hospital (643 beds) equipped with 38 TFSS systems, in Paris, France.

A centralized automated-dispensing system in a French teaching hospital: return on investment and quality improvement.

Objectives: To evaluate the return on investment (ROI) and quality improvement after implementation of a centralized automated-dispensing system after 8 years of use.

Design: Prospective evaluation of ROI; before and after study to evaluate dispensing errors; user satisfaction questionnaire after 8 years of use.

Setting: The study was conducted at a French teaching hospital in the pharmacy department, which is equipped with decentralized automated medication cabinets in the wards.

Optimization of classification and regression analysis of four monoclonal antibodies from Raman spectra using collaborative machine learning approach.

The use of monoclonal antibodies (mAbs) constitutes one of the most important strategies to treat patients suffering from cancers such as hematological malignancies and solid tumors. These antibodies are prescribed by the physician and prepared by hospital pharmacists. An analytical control enables the quality of the preparations to be ensured.

Rapid discrimination and quantification analysis of five antineoplastic drugs in aqueous solutions using Raman spectroscopy.

The aim of this study was to assess the ability of Raman spectroscopy to discriminate and quantify five antineoplastic drugs in an aqueous matrix at low concentrations before patient administration. Five antineoplastic drugs were studied at therapeutic concentrations in aqueous 0.9% sodium chloride: 5-fluorouracil (5FU), gemcitabine (GEM), cyclophophamide (CYCLO), ifosfamide (IFOS) and doxorubicin (DOXO).

Safety analysis of occupational exposure of healthcare workers to residual contaminations of cytotoxic drugs using FMECA security approach.

Handling cytotoxic drugs is associated with chemical contamination of workplace surfaces. The potential mutagenic, teratogenic and oncogenic properties of those drugs create a risk of occupational exposure for healthcare workers, from reception of starting materials to the preparation and administration of cytotoxic therapies. The Security Failure Mode Effects and Criticality Analysis (FMECA) was used as a proactive method to assess the risks involved in the chemotherapy compounding process.

Rapid discrimination and determination of antibiotics drugs in plastic syringes using near infrared spectroscopy with chemometric analysis: Application to amoxicillin and penicillin.

The aim of this study was to investigate near infrared spectroscopy (NIRS) combined to chemometric analysis to discriminate and quantify three antibiotics by direct measurement in plastic syringes.Solutions of benzylpenicillin (PENI), amoxicillin (AMOX) and amoxicillin/clavulanic acid (AMOX/CLAV) were analyzed at therapeutic concentrations in glass vials and plastic syringes with NIR spectrometer by direct measurement. Chemometric analysis using partial least squares regression and discriminative analysis was conducted to develop qualitative and quantitative calibration models.

Non-invasive quantification of 5 fluorouracil and gemcitabine in aqueous matrix by direct measurement through glass vials using near-infrared spectroscopy.

Fourier transform near infrared spectroscopy (NIRS) was used for quantitative analysis of two cytotoxic drugs used in pharmaceutical infusion, 5-fluorouracil (5FU) and gemcitabine (GEM), at therapeutic concentrations in aqueous matrix. Spectra were collected from 4000 cm(-1) to 13,000 cm(-1) by direct measurement through standard glass vials and calibration models were developed for 5FU and GEM using partial least-squares regression. NIR determination coefficient (R(2)) greater than 0.

Effectiveness of cleaning of workplace cytotoxic surface.

Purpose: To minimize the risk of chronic occupational exposure of antineoplastic drugs, cleaning procedures must be evaluated. This study was conducted to compare the detergent efficiency of cleaning solutions (two hydro-alcoholic solutions, three disinfectants and two detergents) used in different cleaning protocols.

Methods: The central surface of a stainless steel plate (30 × 50 cm) was exposed to a carboplatin solution equivalent to 105,100 ng of platinum.