COVID-19 neutralising monoclonal antibodies and SPS support

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished

nMABs and SPS support

nMABs

Neutralising monoclonal antibodies (nMAB) will be used in the treatment of COVID-19 infection, with ongoing consideration of their use as prophylaxis against COVID-19 infection. The nMAB products will be used in accordance with the NHSE Commissioning Policy .

SPS support

SPS is supporting Chief Pharmacists in the safe implementation and use of nMABS by providing guidance and resources for the treatments.

Approval considerations

Marketing Authorisations

It is anticipated that these products will routinely hold marketing authorisations (MA) in Great Britain.

Conditional Marketing Authorisation

A conditional marketing authorisation may be granted, which usually simply means that the MA holder needs to gather extra information as the product is in use.

Due to the limitations of the available supply, it maybe that NHSE policy will prioritise an indication or a cohort which differs from those approved via the Summary of Medicinal Product Characteristics.

Batch Specific Variation

Additionally the regulators, on occasion, may permit the certification of batch specific variations which allow licensed packs to be released to the market which are not in full compliance with the marketing authorisation yet are deemed to be safe for patients.

Chief Pharmacist responsibilities

Chief Pharmacist involvement will be required prior to implementation in organisational governance agains the following domains.

Selection of optimal preparation location

The preparation of monoclonal antibodies is often complex and it is recommended that infusions should be prepared in a Pharmacy Aseptic unit wherever possible.

The NPSA Preparation risk assessment score should be taken into account when determining the optimal preparation location for an individual product.

If preparation in clinical areas is necessary, Chief Pharmacists should ensure that measures are in place to do so safely and accurately.

Systems

Setting up systems for receipt, preparation and issue or nMAB products.

Review and management

Ongoing review and deviation management should be in place.