Tuesday, November 12, 2013

Methodological guidelines for stability studies of hospital pharmaceutical preparations

Drug compounding in hospital pharmacies allows the specific needs of hospitalised patients, needs that are not always satisfied by the pharmaceutical industry, to be met. In recent years, the biggest development in this field has been a move towards a rationalisation of that activity, ensuring the clinical efficiency of these medicinal preparations whilst improving their quality. The rationalised development of that activity in hospital pharmacies should be further enhanced in the future by the implementation of risk analysis approaches designed to eliminate drug-related iatrogenia.

In this context, the question of the stability of compounded medications remains a major preoccupation for pharmacists. The present work seeks to answer this concern by adopting an approach that is both didactic and pragmatic. This first opus is the fruit of an extensive collaboration in the form of a joint work group coordinated by Valérie Sautou and bringing together French and Swiss hospital and university hospital practitioners from two learned societies (SFPC and GERPAC), bringing a wealth of experience and skills to bear on the issue of the stability of sterile and non-sterile solutions. Basing their work on international benchmarks, the work group sought to adapt their methodology to focus specifically on the hospital environment, developing a genuinely useful tool for the management of stability studies. To this end, a complementary computer program has been created to offer users concrete assistance with the interpretation of their results. The other great advantage of this work is that it offers a new critical perspective on the existing literature dealing with stability studies.

This work will serve as a valuable tool for drug compounding in hospitals, contributing to the broader objective of optimising quality and making patient care ever safer.

We hope you will use this new tool without moderation! Sylvie Crauste-Manciet (President of GERPAC) - Marie-Claude Saux (President of the SFPC)

Download the Methodological guidelines for stability studies from HERE.