Patient harm
Safety concerns related to the risk of confusion between injectable iron products have potential to affect any patient in a care setting where injectable iron is used.
Confusion between the different injectable iron products can result in the inadvertent prescribing, supply or administration of the incorrect product. This may lead to:
- infusion related adverse effects, including hypersensitivity reactions which may be fatal
- subtherapeutic dosing
- supratherapeutic dosing
Known risks associated with the administration of injectable irons discussed in our article.
Available products
There are several injectable iron products available in England. Similarities in the nomenclature of the generic names and routine use of a generic term ‘iron’ may exacerbate the risk of confusion between these products.
- Ferric carboxymaltose (proprietary [brand] names include Ferinject)
- Ferric derisomaltose (proprietary [brand] names include Monofer and Diafer)
- Iron dextran (proprietary [brand] names include Cosmofer)
- Iron sucrose (proprietary [brand] names include Venofer)
Nomenclature
The MHRA advise that all injectable iron products should have a proprietary (brand) name, which should appear on the packaging, patient information leaflet (PIL) and summary of product characteristics (SmPC). Injectable iron products should also be labelled with the iron product’s generic name (for example, ferric carboxymaltose or ferric derisomaltose).
Expression of strength
Strengths are expressed on the packaging in terms of elemental iron. For example “Each ml contains: Ferric carboxymaltose corresponding to 50mg iron.”
Clinical use
Injectable iron products are used by a range of clinical specialities, including haematology, renal medicine, gastroenterology, care of the elderly, obstetrics, cardiology and surgery.
The BMJ Best Practice resource for iron deficiency anaemia contains information about the use of injectable iron.
Product choice
Different injectable iron products cannot be used interchangeably.
This is because each injectable iron product may differ in:
- strength
- dose
- administration route
- administration method
- administration rate
- manufacturer safety information
- MHRA/CHM advice
The summary of product characteristics (SmPCs) vary between products and can be accessed online via the electronic medicines compendium or MHRA website. Preparation and administration are product specific and the SmPCs and Medusa should be referred to.
Risk
Similarities in the nomenclature of injectable iron products, and the number of products available, may increase the risk of product mis-selection at the point of prescribing, dispensing and administration.
Examples of confusion between the iron products in practice include:
- prescribing the incorrect product from an electronic drop-down list, leading to delays in therapy or administration of the incorrect product
- administering the incorrect dose, due to differences in product strength
- administering the dose using the wrong method or preparation method, due to differences in licensed administration routes, dilution instructions and diluents
- administering the dose at the wrong rate, which may increase the risk infusion-related adverse effects such as hypotension
- supply of the incorrect product to a clinical area, both for ward stock and use by a named-patient
Mitigations
Steps can be taken to minimise the potential for harm where injectable iron is required.
Prescribe using the proprietary name
Ensure all prescribing uses the proprietary (brand) name together with the generic (common) name.
Nomenclature
Use consistent nomenclature in clinical guidelines and protocols, in prescribing systems, and in pharmacy stock control systems.
Electronic systems
Set up electronic prescribing, dispensing and supply systems to ensure use of brand specific products to support users in choosing the correct product.
Stockholding
Review and rationalise stockholding to minimise the potential for selecting the wrong product. Where more than one product is stocked, such as in hospital pharmacies, minimise selection errors by using separate locations and visual alerts.
Promote awareness
Ensure healthcare professionals responsible for prescribing, supply, and administration are aware of the availability of different injectable iron products. As well as the risks associated with selecting the wrong product.