Resolution CM/Res(2016)2 and Centralised Intra Venous Additive Services (CIVAS): Challenges and Opportunities

Abstract

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.

Keywords

• resolution cm/res(2016)2
• civas
• risk assessment
• hospital pharmacy services
• injectable preparation