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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.

In hospitals, a major part of the drugs is administered via the intravenous route. When one wants to evaluate or know the stability of a drug in solution, it is necessary to know several physico-chemical parameters. Several reference works are available to help the hospital pharmacist with this research. However, reading these different sources can make you discover conflicting data. It is therefore necessary at this time to obtain the publications with contradictory results and to read them again. Seven criteria have been identified for judging the quality of a publication on physicochemical stability: full description of equipment, methods and analytical conditions of molecules studied; complete description of the procedures used to validate the analytical method; full indication of time testing and measurement bases or control; documentation on the analytical reproducibility; adequate statistical analysis; appropriate conclusions; appropriate references. In conclusion, everything in a compatibility study is important.

Background: Innovative approaches, including LEAN systems and dashboards, to enhance pharmacy production continue to evolve in a cost and safety conscious health care environment. Furthermore, implementing and evaluating the effectiveness of these novel methods continues to be challenging for pharmacies. Objective: To describe a comprehensive, real-time pharmacy dashboard that incorporated LEAN methodologies and evaluate its utilization in an inpatient Central Intravenous Additives Services (CIVAS) pharmacy. Methods: Long Beach Memorial Hospital (462 adult beds) and Miller Children's and Women's Hospital of Long Beach (combined 324 beds) are tertiary not-for-profit, community-based hospitals that are served by one CIVAS pharmacy. Metrics to evaluate the effectiveness of CIVAS were developed and implemented on a dashboard in real-time from March 2013 to March 2014. Results: The metrics that were designed and implemented to evaluate the effectiveness of CIVAS were quality and value, financial resilience, and the department's people and culture. Using a dashboard that integrated these metrics, the accuracy of manufacturing defect-free products was ≥99.9%, indicating excellent quality and value of CIVAS. The metric for financial resilience demonstrated a cost savings of $78,000 annually within pharmacy by eliminating the outsourcing of products. People and value metrics on the dashboard focused on standard work, with an overall 94.6% compliance to the workflow. Conclusion: A unique dashboard that incorporated metrics to monitor 3 important areas was successfully implemented to improve the effectiveness of CIVAS pharmacy. These metrics helped pharmacy to monitor progress in real-time, allowing attainment of production goals and fostering continuous quality improvement through LEAN work. [ABSTRACT FROM AUTHOR]

Micafungin is a costly treatment and packaging of 50 mg or 100 mg bottles only are available, while doses lower than 5 mg and 20 mg are often necessary in neonates and paediatrics patients, respectively. The stability of micafungin sodium in polypropylene syringes and glass bottles was studied at different concentrations. Solutions of micafungin diluted with NaCl 0.9% were prepared in glass bottles (20 and 10 mg/mL) or syringes (1 and 0.5 mg/mL) and stored at 25 °C, 60% humidity (RH), in the dark (ICH conditions). Solutions were also exposed to heat (70 °C) or alkaline solution (NaOH) in order to force degradation. Samples were analysed at days 1, 5, 8 (for bottles) and also 15 (for syringes) after the preparation and assayed in triplicate. Stability was studied using a stability-indicating high-performance liquid chromatographic method. Syringes stored at 25 °C retained over 90% of their initial concentration over the study period. Temperature and alkaline conditions had significant effect on the stability of micafungin, leading to apparition of degradation products. Moreover, sub visible particles were in the specification of the European Pharmacopeia along 15 days. To conclude, micafungin diluted in NaCl 0.9% and stored in polypropylene syringes was chemically stable for at least 15 days at 25 °C in the dark. [ABSTRACT FROM AUTHOR]

Injectable drugs are high-risk products and their reconstitution in hospital wards is a potential source of errors. Thus, in order to secure the reconstitution process and thereby improve safety, the pharmacy department of Lausanne University Hospital is focusing on developing ready-to-use forms (CIVAS). These preparations are compounded in controlled clean rooms and are analyzed prior to release. In the intensive care unit, amiodarone 12.5 mg/mL in glucose 5% is one of the high-risk preparations, which has led the pharmacy to develop a ready-to-use solution. To this end, a one-year stability study was initiated, and the preliminary results (after six months) are illustrated here. A stability-indicating HPLC method was developed and validated for monitoring the concentration of amiodarone. Batches were stored at 5 °C and 30 °C, which were analyzed immediately after preparation, after one, two, four and six months of storage. The pH and osmolality values were monitored at the respective time intervals. It was observed that after six months, all the results were within specifications. However, the pH values started to decrease after two months when amiodarone was stored at 30 °C. After six months, a degradation peak appeared on the chromatogram of these solutions, which suggested that amiodarone is more stable at 5 °C. The preliminary results obtained in this study indicated that injectable amiodarone solutions are stable for six months under refrigerated storage conditions. The study is ongoing.

A new device for IV admixtures has been developed in Israel, the Vialink minibag. It consists of a partly filled minibag, attached by rubber tubing to a sterile receptacle into which various types of vials containing drugs can be firmly inserted. Time and motion studies were conducted to determine the time and cost associated with the preparation, dispensing and administration of reconstituted parenteral antibiotics via CIVAS (within minibags or Vialink bags) and preparation by nurses in wards in minibags. CIVAS with minibags was least expensive, followed by Vialink minibags. Self preparation on the ward by nurses was found to be the most expensive system. Only 55 % of all IV admixtures can be prepared by the Vialink system. As only one hospital in Israel has CIVAS, the study provides a solid justification for implementing pharmacy intravenous admixture services in all Israeli hospitals. The advantages and disadvantages of each method are discussed. CIVAS (minibags and Vialink) permits the individualised preparation of sterile admixtures for each patient and provides advantages in terms of efficiency, economy and prevention of errors. [ABSTRACT FROM AUTHOR]

Management of chemotherapies is a strategic issue for european healthcare. Dose-banding enables to reduce waiting time of patients in day care units and drug wastage. The aim of this study was to assess the stability of 5-Fluorouracile (5-FU) at standardised rounded doses of 4 and 5 g in MyFuser® portable infusion pump for in-advance preparation. Ten MyFuser® (4 and 5 gr 5-FU added to NaCl 0.9%) were prepared under aseptic conditions and stored at room temperature (23 ± 2 °C) for 28 days then at 30 °C for three days. Physical stability tests were periodically performed: visual and microscopic inspection, pH measurements and optical densities. The concentration of solutions was measured by High Performance Liquid Chromatography/UV detector. Results confirm the stability of 5-FU at selected SRD of 4 g and 5 g with NaCl 0.9% in MyFuser® for at least 28 days at room temperature and three days at 30 °C, allowing in-advance preparation.

Purpose: To present the results of a survey involving 97 centralised intravenous admixture service (CIVAS) centres in China to review the recent advances of Chinese CIVAS., Methods: 103 CIVAS centres in first- or second-class Chinese hospital settings were surveyed by email questionnaire., Results: Ninety-seven centres responded(response rate 94%). With regard to scale and output issues, large CIVAS centres with a daily output of more than 10 000 bags accounted for 10% while the per workbench and per square metre output varied dramatically among different centres. For personnel structure, 80% of CIVAS centres chose the combination model of pharmacy and nursing. For the CIVAS operation model, more than 80% of centres adopted the drug centralised compounding model., Conclusion: CIVAS centres are playing an important role in Chinese hospital pharmacy and have developed into an emerging pharmaceutical industry. The development of Chinese CIVAS centres is very variable. With regard to the personnel structure, the pharmacy-nursing combination model is recommended, while the operation model should be selected according to specific hospitals. Universal guidelines for CIVAS operation and personnel training are urgently needed., Competing Interests: Competing interests: None to be declared.

Objective: Microwave freeze-thaw treatment (MFTT) of injectable drugs can support the development of centralized intravenous admixtures services (CIVAS). The aim of the review is to collect information and results about this method., Methods: A systematic review of the scientific literature about injectable drug stability studies was performed. The data are presented in a table and describe name of the drug, producer, final concentration, temperature and time of freezing storage, type of microwave oven, thawing power, method of dosage and results after treatment or final long-term storage at 5±3 °C., Results: From 1980 to 2014, 59 drugs were studied by MFTT and the results were presented in 49 publications. Forty papers were presented by 8 teams (2 to 18 by team). The temperatures of freezing storage vary from -70 °C to -10 °C, the time storage from 4 hours to 12 months, the thaw from low to full power. Dosages are mainly made by high performance liquid chromatography. Most of the 59 drugs are stable during and after treatment. Only 3 teams have tested the long-term stability after MFTT, the first for ganciclovir after 7 days, the second for ceftizoxime after 30 days and the third for 19 drugs after 11 to 70 days., Conclusions: This review can help CIVAS to take in charge the productions of ready-to-use injectable drugs., (Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)