Risks of preparing injectable medicines
In 2007, in response to limited capacity in Pharmacy Aseptic Units, the National Patient Safety Agency introduced a tool (NPSA Patient Safety Alert 20). The tool was designed to help determine the risks associated with preparation of injectable medicines. The method was based on scoring a number of identified risk factors. The tool was modified in 2026 to take account of new and innovative medicines launched since 2007.
The article Introduction to aseptic manipulation of injectable medicines (SPS page) explains more about the risks associated with manipulation of injectable medicines. For more information about managing the risks of handling monoclonal antibodies see Understanding and managing the risks associated with handling monoclonal antibodies (mAb) (SPS page)
Using the risk assessment tool
Assess individual injectable medicines to mitigate preparation risks and to determine the most appropriate location for preparation of individual doses.
When to use the tool
Organisations should embed preparation risk assessment into their medicines governance processes and document their requirements in local policies and procedures.
Best practice is for a pharmacist and a senior clinical practitioner to carry out the risk assessment when:
- an injectable medicine is first introduced into a provider organisation
- there are changes to recommendations in the Summary of Product Characteristics (SPC) for handling, storage, or preparation
This guide and the associated risk assessment tool is designed to support:
- local assessment and organisational decision-making about the optimal location for preparation of all injectable medicines including licensed, unlicensed and investigational medicine
- mitigation of risks associated with preparation of doses for immediate use in clinical areas, where this is agreed to be the optimal location for preparation
and to
- help authors and users of monographs in the Medusa Injectable Medicines Guide interpret the risk factors
- assess preparation of the finished product as it will be administered to the patient
How to use the tool
Before undertaking the risk assessment, the assessor(s) should refer to the SmPC or clinical trial pharmacy manual and this indicative list of Risk factors: manipulation of injectable medicines (SPS page). Using the relevant template:
- tick all factors that apply
- determine the score associated with each risk factor
- add all scores together
If the preparation scores a total of 8 or more, it is high (red) risk and risk reduction measures are required. Where the calculated risk rating is medium mitigation is recommended.
After appropriate mitigations have been agreed and, assuming they will be successfully implemented, re-score preparation and record the new scores.
Where appropriate mitigations have been identified to allow safe preparation in a clinical area, these must be implemented before the medicines is first introduced into clinical use.
It may not be possible to adequately mitigate the identified risks of preparation in a clinical area, for a cytotoxic for example. In this case the medicine should be prepared only in a pharmacy aseptic unit. If preparation in a pharmacy aseptic unit is impossible, residual risks should be documented and must be formally accepted by the local organisational governance process. The need for an entry in the organisation’s risk register should be considered.
The tool may be adapted locally
If organisations choose to do this the revised tool should be approved through local governance processes.