Risk Evaluation for Aseptic Preparation

Risks to patients are greater when injectable medicines are prepared in clinical areas such as wards and theatres than when they are prepared in pharmacy. Ideally all injectable medicines should be prepared in pharmacy where standards are defined (Beaney 2006) [1] and provided to clinical areas in ready-to-use form. Unfortunately, however, aseptic capacity within pharmacy is limited and the pharmaceutical industry has been slow to develop ready-to-use formulations. Consequently nurses continue to prepare the majority of injectable medicines in most cases (Beaney & Goode 2003)Beaney AM, Goode J (2003) [2].

To make best use of the limited capacity within pharmacy aseptic units, risk evaluation is a way of prioritising those products with higher risk for preparation by pharmacy. A risk assessment tool was developed (Beaney et al 2005) [3] to help the targeted transfer of products to pharmacy. This tool became the basis of a patient safety alert in the UK (NPSA 2007) [4] requiring risk assessment of practices and individual injectable products prepared in all clinical areas. The risk assessment allows ranking of product with the aim of reducing risks by providing them in ready-to-use form or by giving guidance such as dose calculation tools.

Nurses preparing products of lower risk that continue to be prepared in clinical areas should be supported by pharmacy involvement in their training and given advice on non-touch techniques (Beaney et al 2005 [3], Beaney & Black 2012 [5]).

The Council of Europe Resolution (2001) [6] on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients includes a section on reconstitution. This states that a risk assessment should be undertaken to identify higher risk products for pharmacy preparation. Lower risk products can be prepared in clinical areas with suitable training. Further guidance is currently being produced on this topic by an EDQM expert working party.