CIVAS : Objectives and strategy
Section of pharmaceutical sciences, University of Geneva, University of Lausanne,
Producing medicines on the hospital site only makes sense if it represents a capital gain, in terms of making available essential drugs which cannot be obtained on the market, preparing forms which are adapted to certain uses (e.g. paediatrics), or increasing the safety of patients and medical personnel. Although much attention has been devoted in recent years to cytotoxic compounds, and measures to protect those handling them, it cannot be denied that use of other injectable drugs carries a high risk for patients. Indeed, the preparation of these drugs in care units increases the risk of dilution error, imprecision and microbiological contamination; the tighter the product’s therapeutic margin, the more risky the delivery method (e.g. intrathecal, intraocular) and the longer the period of treatment, the more critical the potential consequences become.
Having centralised preparation of paediatric parenteral nutrition in the 1970s, and of cytotoxic compounds at the end of the 1990s, in the early 2000s we launched a process to industrialise the production of other high-risk injectable drugs. This project was carried out in close collaboration with several patient care departments, particularly anaesthesiology, resuscitation, paediatric intensive care and ophthalmology.
The priority products for development were selected following a survey of requirements, with an assessment of the risks related to delivery error (potential consequences x frequency of use) and the feasibility of maintaining a stable preparation over a prolonged period of time. On this basis, around ten products were developed in ready-to-use syringes, after stability studies which allowed us to determine conservation periods of between 6 and 12 months at room temperature, in refrigerators or in freezers. The majority of these products are packaged individually, which means unused units can be returned to storage. The labelling has been standardised to comply with the material recommendations of the AFSSAPS, and uses the colour coding system developed by anaesthesiologists. 30,000 syringes were prepared in 2008, and other products are currently under development. We are currently optimising the production process, by acquiring syringe filling equipment and subcontracting some heavily-used preparations.
Industrial manufacture of syringes in the pharmacy department greatly improves the user safety of injectable drugs, thanks to strict adherence to Good Manufacturing Practices. The use of manufacturing protocols, chemical and microbiological quality control of the finished products, controlling the environment in the preparation zones and providing the operators with specific training are the principal factors which explain the very high reliability of drugs manufactured in series within a hospital pharmacy department.
For their part, users of these medicines are very happy to have such a service at their disposal, making their work easier while also improving the quality of patient care.