Volume 2, Issue 3 -

Background Hazardous drugs (HD) traces are measured in most hospitals that perform environmental surveillance. Uncertainties exist regarding the cleaning agents and procedures needed to completely remove HD contamination The objective was to evaluate the efficacy of four cleaning solutions and two types of mops in reducing contamination on a floor contaminated with a predetermined amount of cyclophosphamide (CP). Methods This pilot study was divided into three steps: 1) the voluntary contamination of a pre-delimited area on the floor (3600cm 2 ) with a pre-established quantity of cyclophosphamide (20μg); 2) the cleaning of the pre-delimited area using a cleaning scenario. Eight cleaning scenarios were performed: two cleaning mops (disposable and non-disposable) were used to apply four different cleaning products (detergent, quaternary ammonium, sodium hypochlorite, hydrogen peroxide); 3) the quantification of CP detected on the pre-delimited area. Results The average decontamination efficacy of the four cleaning products used was: 99.53%±0.41 % for the detergent, 99.74%±0.15 % for quaternary ammonium, 99.86%±0.11 % for sodium hypochlorite, 99.75%±0.15 %, for hydrogen peroxide. The average decontamination efficacy for disposable mops was 99.58%±0.28 % and 99.86%±0.09 % for non-disposable mops. Conclusion Sodium hypochlorite, hydrogen peroxide, quaternary ammonium and a detergent applied with a disposable or a non-disposable mop were efficient to reduce the CP concentration on the floor contaminated with a predetermined quantity of CP. However, no cleaning scenarios was able to remove 100 % of CP after one cleaning session. Further studies are required to identify an optimal strategy.

Background A method for process monitoring of the Baxter ACD, Exactamix EM2400, by chemically analyzing the concentrations of the ingredients in parenteral nutrition test preparations was evaluated. Methods In the study, three different test preparations were developed consisting of four ingredients varying in volume and concentration, which simulated actual PN products. Each test preparation was produced in triplicate by a trained pharmacy technician using the Exactamix EM2400 from Baxter (Baxter International Inc.). The process was repeated on three consecutive days using the same conditions. The amount of each ingredient in the test preparation was measured in an external contract laboratory using European Pharmacopoeia methods. Based on USP monographies and the Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition from the ASHP the device was tested to be accurate to deliver within 5 % of the amount programmed. Results The study showed that in most cases the ingredient delivery of the automated compounder deviated less than 3 % from the expected concentrations. For certain ingredients out of specification results were detected and analyzed. By resetting the flow factor, it was possible to optimize the performance of the ACD. Conclusion The study emphasizes the need for process monitoring of the Exactamix EM2400 during the initial installation and on a regular basis for each ingredient to ensure the accurate delivery of ingredients. Further methods need to be analyzed to determine the most feasible method to regularly conduct process monitoring tests on an ACD in a hospital pharmacy setting.

Background In France, control of chemotherapy preparations is highly recommended. Analytical control is a method of choice for identifying and quantifying drugs. Pediatric preparations, which often contain small quantities of drugs and are made in low final volumes were until then not analytically controlled. After the development and validation of a new sampling and assaying method for low volume chemotherapy preparations with an UV/Raman automaton (QCPrep +), the quality control results of the preparations intended for the patients were analyzed over a period of eighteen months Methods The results were studied by type of preparation (low and high volume), per molecule, manipulator, and conformity rates dispersion. Results Over the period, 7,548 controls were carried out, representing 87.7% of our production. 75.5% of these controls concerned low-volume preparations (<50mL). The overall conformity rate was 94.4%. The lowest conformity rates were found for vinca alkaloids, methotrexate and some rarely manipulated drugs (cisplatin, decitabine, epirubicin). The study of the results dispersion showed non-conformities increasing with low concentrations, specific to pediatrics. These results show the limits of analytical control for pediatric preparations. The low analytical sensitivity encountered for certain concentrations and drugs requires a complementary quality control tool, like camera or video. However this new analytical method allows us to improve the safety of the injectable chemotherapy circuit. Conclusion Young patients can benefit from the same level of safety and quality as adult patients. Some critical points could be highlighted: the homogenization of the preparations, the analytical sensitivity of some drugs and human factors. This data allow us to focus our work on staff training, improving our calibration ranges and on the development of complementary control tools.

Background Preparation of parenteral nutrition (PN) mixtures is performed in a controlled atmosphere area (CAA) under a laminar flow hood. In 2014 and 2015 quality controls have revealed contaminations of PN bags by Bacillus. The different products used to avoid this contamination were Aniosurf premium ® (prewash), ethanol (disinfection), and Aseptanios Terminal HPH ® (aerosolization). The purpose of this study was to test the efficiency of disinfection on raw materials vials by different products before introduction in the CAA. Methods Five protocols have been tested by varying the disinfection step: hydrogen peroxide (H2O2) or sodium hypochlorite (immersion or spray), ethanol (non sporicidal) only by immersion. Prewash and aerosolization steps remained unchanged. For each series, a quantity of 30 vials have been prewashed, then disinfected according to the tested protocol, and finally aerosolized. In order to quantify the effectiveness of disinfection 10 vials were sampled using contact plates at every step of treatment. Results Microorganisms were found after ethanol disinfection (n=4) and aerosolization (n=2). No germs were found when hydrogen peroxide or sodium hypochlorite were used. The atmospheric rates of H2O2 were 0.2 ppm by immersion and 0.8 ppm by spray, these values are below the recommended value level (1 ppm). Conclusions This study has validated the use and effectiveness of these disinfecting products. Taking into account the efficiency and ease of use for staff, immersion has been preferred to spray and hydrogen peroxide to sodium hypochlorite.

The aim of the European Council’s Resolution CM/res(2016)2 on good reconstitution practices in health care establishments for medicinal products for parenteral use is to guide the health care establishment’s decision as to where reconstitution should take place: in the pharmacy or the clinical area. Injectable preparation in hospital pharmacy is performed in Centralised Intra Venous Additive Services (CIVAS). Nevertheless, challenges such as ensuring the sterility of the preparation, the physicochemical stability of the product, and process validation for instance should be taken into account. This opinion paper examines the challenges, impacts, and responsibilities for pharmacists, nurses, and hospital management related to implementing the resolution, regarding the experience of countries where CIVAS are already implemented. It also discusses the opportunities of implementing CIVAS with regard to patient care safety and potential financial savings.