Clostridium difficile

Updated NICE guidance on antimicrobial prescribing in Clostridium difficile infection was published in July 2021

Available options

These options are not presented in any order of preference.

The preferred choice is dependent on the patient, the care setting, access to extemporaneous preparation services and the characteristics of the products available

Key issues, together with their risks and mitigations where appropriate are discussed for each option.

Licensed capsules

Check patients can swallow capsules

Risk

If patients are unable to swallow capsules, this can lead to omission or delay, or a choking risk.

Mitigation

Support patients to swallow capsules using Medicines for Children advice or our SPS advice on Swallowing difficulties.

Licensed injectable solution with IV needle and Luer syringe

An IV needle and Luer syringe can be used to withdraw the licensed injectable vancomycin solution from the vial for oral administration. Some vancomycin injections are licensed for oral administration, and some are not. Discuss with your local procurement lead.

Wrong route administration

Risk

Wrong route administration, e.g. an oral preparation being given parenterally, is a risk with this option. This is due to liquids intended for oral use being prepared using syringes and needles intended for parenteral use.

Mitigation

To mitigate against this risk, undertake a local risk assessment. Factors to consider include:

• care setting
• other activities undertaken in the preparation area
• staff knowledge and training

Omitted or delayed doses

Risk

This risk may be particularly prevalent due to unfamiliarity with administration of vancomycin by this route.

Mitigation

Staff training mitigates this risk.

Extemporaneously prepared oral liquid

Extemporaneously prepared oral liquid vancomycin is an “off-label” use of a licensed product.

Omitted or delayed doses

Risk

Omitted or delayed doses may occur where the method of preparation has not been planned for and the product is not immediately available.

Mitigation

Local or regional manufacturing facilities may prepare a liquid formulation using the injection.

Work sheets may be available locally, please contact your Regional Quality Assurance lead for further information.

Licensed injectable solution using ENFit devices

Using purple ENFit syringes with an ENFit needle attached (several devices are available) enables withdrawal of licensed injectable vancomycin solution from the vial for oral administration. Some vancomycin injections are licensed for oral administration, and some are not. Discuss with your local procurement lead.

Staff unfamiliarity

Risk

There are specific risks of staff unfamiliarity with these devices.

Mitigation

Education and training will mitigate the risk of unfamiliarity with use of ENFit syringes and needles in the preparation of this product.

Product supply

Risk

These products may be unfamiliar to some departments and there may be a delay obtaining the items.

Mitigation

The risk can be mitigated by reviewing the supply processes to ensure these products are available when required.

Imported oral liquid

Imported oral liquid formulation (of suitable quality) is a possibility as an unlicensed “Special”.

Omitted or delayed doses

Risk

Omitted and delayed doses may occur if there is a delay obtaining and quality assuring the imported “Special” or if products are unavailable.

Mitigation

A number of importers have products in stock and they can be obtained without having to give the MHRA notice of the need to import.

Oral treatment options for Clostridium difficile

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