Risks of handling monoclonal antibodies (mAb) in the healthcare setting

Historically, mAb have mostly been prepared in pharmacy aseptic units, however increasing use of mAb and increasing capacity constraints for NHS pharmacy aseptic units mean that Trusts are reviewing this practice. Risk based decisions must be made about which mAb require pharmacy aseptic preparation, and which can safely be prepared in clinical areas. 

The risk of mAb in the healthcare setting can be viewed in two ways, clinical risk to the patient and occupational exposure risk to staff handling the molecule.  

Clinical risks

Published guidance should be followed to determine the clinical risk to the patient in line with NPSA Patient Safety Alert 20 Promoting safer use of injectable medicines.

Occupational exposure risks

Unlike cytotoxic medicines and radiopharmaceuticals, there is a scarcity of information about the occupational health and safety risks associated with handling mAb. Due to this lack of information, in early clinical trials and when first introduced into routine clinical practice, most doses were made in NHS pharmacy aseptic facilities as a precaution. 

This series of articles focuses on understanding these risks to inform decisions about where they can safely be handled.   

Conjugated mAb

These articles refer exclusively to handling of unconjugated mAb  

Monoclonal antibodies conjugated with cytotoxic agents or radioactive isotopes are specifically excluded from the following advice. These medicines should be handled according to relevant guidance and regulations using established controls, in pharmacy aseptic or radiopharmacy facilities.  

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