Risks associated with the outsourcing of the aseptic compounding of parenteral nutrition (June 2015)

Summary

It is acknowledged that aseptic compounding is one of, if not the, highest risk activities undertaken in pharmacy. Within the field of aseptic compounding, parenteral nutrition (PN) solutions are amongst the most complex and high risk products that are handled, due to their complexity, the number of ingredients, complex stability issues and the potential for the support of microbiological growth.

The high risk nature of PN solutions has unfortunately been highlighted by a number of tragic incidents associated with compounding errors and microbiological contamination in recent years that have at times resulted in patient harm and even death. These incidents have occurred in the UK and abroad, and within the UK have been seen in both NHS facilities and commercial specials manufacturers. It is clear that wherever the compounding takes place, there is a risk of these errors and contamination incidents occurring and so robust systems need to be in place to ensure the risks are adequately controlled. This is equally relevant whether the PN is made in house or when the decision is made by a Trust to outsource PN to an external third party provider whether NHS or commercial.

The purpose of this document is to give guidance to those outsourcing PN compounding on the risks in the outsourcing and supply process and to enable them identify where local risk control strategies will need to be developed and implemented to manage these risks. However, many of the risks highlighted will also apply to in house compounding and so those NHS units making PN for their own patients may also find this document a useful source of reference. Exploring the drivers for outsourcing and whether this is in fact the best option for supply of PN solutions is outside of the scope of this document; however these should be considered before an outsourcing decision is made.