Selection criteria of injectables prepared in the hospital

The last 15 years have witnessed the development of strategies to improve patient safety, based on an increased awareness following the publication of the report “To err is human” by the Institute of medicine in December 1999. The importance of human factors was particularly highlighted and actions aimed at improving the reliability of the perilous stages of selection, calculation of dilution are heavily promoted. Injectable drugs are approximately 3 times more likely to cause harm or death than other drugs, because of the complexity of the process of use and the major clinical impact for patients when an error occurs.

To deal with these new challenges, many actions have been launched. For medication safety, the mains are the following :

• risk management tools have been implemented (i.e. reporting and investigation of incidents, prospective risk analysis);

• organizational measures have been proposed by different institutions for high risk drugs;

• standardization of dilutions and labeling have been promoted, especially in high risk areas (anesthesiology, intensive care, emergency);

• ready-to-use (CIVAS) injectables have been made available, to reduce or even suppress the possibility of error.

In the HUG, an approach to provide CIVAS was initiated in 2002, just after the centralization of the preparation of cytostatics. Tools to help in the selection of priority products have been developed, to put in place a strategy corresponding to the needs of users, taking into account the stability data and production constraints in the pharmacy. About 15 products have been developed, which corresponds to an annual production of about 30.000 ready-to-use syringes.

Although only few studies have formally demonstrated the impact of CIVAS on chemical and microbiological safety, it is clear that these products significantly contribute to the improvement of patient safety. For that approach to succeed, some factors must however be meet :

• an adequate production and quality control infrastructure must be available;

• a good knowledge of the GMPs should be in place;

• a structured approach must be used to select product candidates;

• a good collaboration should be established with clinicians.

In future years, a few issues exist to stimulate the development of these new production activities. It will be in particular important to pursue the efforts of standardization for the different types of injectables (nutrition, cytostatics and others), to develop production synergies between hospitals including industrial subcontracting, to adapt continuously to the evolution of the GMPs and to not forget the implementation of other organizational measures advocated to control the whole circuit of high risk drugs.

The presentation can be downloaded at the address: http://pharmacie.hug-ge.ch/ens/conferences.html