ASHP Urges More Control Over Sterile Compounding
March 9, 2007
In summary, recent episode involving contaminated heart-surgery solutions from an outsourcing firm implicated in nearly a dozen illnesses and three deaths at a Virginia Hospital has caught the eye of USA Today.The ASHP has called for more active regulation of compounding by the FDA. The cases sparkled lawsuits against the compounder. The ASHP CEO has called the patient injury associated with compounding entirely preventable. It is imperative that the pharmacists and pharmacy technicians be adequately trained and have sufficient facilities and equipment that meet technical and professional standards. The U.S. Pharmacopoeia's 2004 rules governing sterile preparation of pharmaceuticals has issued Chapter 797 which is a valuable set of guidelines that describe a best practise fro establishing safe processes in compounding sterile medications. The hospital has to definetely say that the outsourcer has safe processes in place and good documentation to back it up. In the case of outsourcing firms, the burden of testing will fall on the compounder and not the hospitals that purchase the products. The most important thing is adherence to current standards and best practises, having adequate facilities where sterility can be assured, adequately trained and qualified staff and faithful to sound infection control practises and aseptic techniques. This article was written by Adam Marcus and published in Pharmacy Practise News, Volume 33, Number 10, October 2006.