Chapter 15: Medicines optimization: ensuring quality and safety
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Clinical governance
Risk assessment
It is vital that any mAb that is introduced into clinical practice should undergo an appropriate risk assessment to ensure the area and method of preparation are appropriate for that particular mAb (NHS Pharmaceutical Quality Assurance Committee [234]). Two factors must be considered during this process (NHS PQAC [234]):
- What risk does the mAb pose to staff handling the product due to the agent's nature or mode of action?
- What is the risk of a calculation error being made or of damage or contamination of the product occurring during preparation, leading to risk to the patient?
It is recommended that the National Patient Safety Agency 20 methodology is used to undertake this risk assessment (NHS PQAC [234]). However, this does not provide information specific to staff exposure risks and instead focuses only on the risk of error and product contamination. A modified version of this risk assessment is therefore recommended, which takes into account the level of staff exposure. An example of such an assessment is provided in Figure 15.44.
Figure 15.44 Monoclonal antibodies risk assessment form. Source: adapted from Langford et al. ([167]).
The risk assessment should stratify the mAb into a low, medium or high risk category. High‐risk mAbs should be prepared in pharmacy aseptic units only, medium‐risk mAbs require suitable risk controls to be put in place, and low‐risk mAbs require standard ward‐based aseptic techniques only (NHS PQAC [234]).
Where a medium‐risk mAb is deemed appropriate for preparation in the clinical area, appropriate personal protective equipment (PPE) – including gowns, protective eyewear, masks and respiratory masks – should be provided (NHS PQAC [234]). While the use of closed system reconstitution devices (CSRDs) is not seen as essential for mAb preparation (NHS PQAC [234]), they do provide an additional level of safety in terms of operator protection and can reduce the risk of product contamination in clinical areas (NHS PQAC [234]). They are recommended for use alongside PPE by many organizations (Alexander et al. [6]; King et al. [155]; Meade [193]).
