Using our advice
This article provides mitigation strategies to minimise harms of hypersensitivity and skin staining due to administration of injectable iron.
Risks with use may be increased due to inadvertent confusion between different injectable iron products. Actions to minimise harms related to the confusion between different iron products are discussed in our article.
Harms related to other adverse effects and inadvertent dosing errors are outside the scope of this article. Individual product literature should be consulted to reduce the risk of harm.
Patient harm
There are known risks associated with the administration of injectable iron.
Known harms associated with the administration of injectable iron include hypersensitivity reactions (which may be fatal) and skin staining which may be long term or permanent. Failure to monitor the patient appropriately during and after administration may increase the related risk of significant or long-term harm.
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. They should only be given in environments with resuscitation facilities available, where patients can be adequately monitored.
The BMJ Best Practice resource for iron deficiency anaemia contains information about the use of injectable iron. It is freely available to healthcare professionals in England with an NHS England OpenAthens account. Register for an NHS England OpenAthens account.
Prescribing information (which can be complex) and administration guidance varies between injectable iron products. Individual summary of product characteristics (SmPCs) should be checked when prescribing and administering injectable iron. These can be accessed online via the electronic medicines compendium or MHRA website.
Medusa the NHS Injectable Medicines Guide can also be referred to for information relating to the administration and monitoring for injectable iron.
Associated advice and healthcare recommendations on the safe use of injectable iron include the MHRA Drug Safety Update ‘Ferric carboxymaltose (Ferinject): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures’. This advises that ferric carboxymaltose (Ferinject) has been associated with cases of hypophosphatemia and osteomalacia.
Hypersensitivity
Serious hypersensitivity reactions, which may be life-threatening or fatal, have been reported in patients treated with injectable iron.
Notably, these hypersensitivity reactions may occur in patients who have previously tolerated injectable iron.
The MHRA Drug Safety Update ‘Intravenous iron and serious hypersensitivity reactions: strengthened recommendations contains information about the risk of hypersensitivity reactions, and provides advice for healthcare professionals.
Assessing risk
The risk of hypersensitivity is increased in individuals with known allergies, immune or inflammatory conditions, or a history of severe asthma, eczema, or other atopic allergy. In these individuals, injectable iron should only be used if the benefits are clearly judged to outweigh the potential risks.
Harms have been reported due to failures in identifying those individuals at risk.
Undertaking a risk assessment prior to infusion may support the identification of individuals at greatest risk and prompt an individualised patient care plan. Some organisations routinely prescribe medications prior to or during an iron infusion to manage hypersensitivity.
Monitoring
The MHRA advise patients should be closely monitored for signs of hypersensitivity during and for at least 30 minutes after every administration of intravenous iron.
Harms have been reported due to inappropriate:
- frequency and duration of monitoring
- reliance on individuals or carers to alert staff to the symptoms of hypersensitivity
- location of the individual during the monitoring period (for example, not being within sight of a healthcare professional)
Responding to hypersensitivity
In the event of a hypersensitivity reaction, treatment should be stopped immediately and appropriate management initiated.
Harms have been reported due to:
- failure to recognise and initiate management for a hypersensitivity reaction
- lack of timely access to medications required to manage hypersensitivity reactions
- failure to treat hypersensitivity symptoms in a timely fashion
- failure to advise patient on symptoms of delayed hypersensitivity
- prescribing and administering out of hours or by untrained staff
Skin staining
Leakage of injectable iron, from the injection site into surrounding tissue, can lead to skin and tissue staining. This may be permanent and brown or dark coloured.
The risk of extravasation and skin staining may be reduced by:
- ensuring vein patency before administration
- using an appropriately sized cannula
- avoiding administration via cannulas sited at joints or points of flexion
- monitoring the patient for signs of extravasation
Informing and consent
The National Infusion and Vascular Access Society (NIVAS) Infiltration and Extravasation – A toolkit to improve practice includes information about skin discolouration associated with intravenous iron. It advises, where possible, informed written consent should be obtained before administration, written patient information should be given, and any complications recorded and reported locally.
Consideration should be given to the supply of patient information leaflets, to support the provision of information to individuals receiving injectable iron.
Mitigations
Steps can be taken to minimise the potential for harm, due to adverse effects, where injectable iron is required.
Standardise practice
Practice relating to the prescribing, supply and administration of injectable iron should be reviewed, and actions taken to ensure that clinical guidelines/protocols include:
- identified clinically appropriate locations, with timely access to resuscitation medicines, for the safe administration and monitoring of individuals receiving parenteral iron
- information about clinically appropriate staffing experience and levels for injectable iron administration
- detailed roles and responsibilities related to monitoring requirements during and post infusion
- monitoring standards during and after injectable iron administration, including the duration, frequency and degree of patient observation
- actions to take in the event of a patient experiencing hypersensitivity or infiltration, including appropriate escalation and treatment
- a robust process to ensure patients are fully informed of potential risks (including hypersensitivity and skin staining) and are provided with written patient information
- a robust process to ensure patients are informed of the relevant symptoms of hypersensitivity and skin staining, and are advised to inform a healthcare professional immediately if they experience these
- a robust process to ensure, where possible, written consent is obtained prior to administration
Awareness and knowledge
Ensure staff involved in the prescribing, supply and administration of injectable iron are aware:
- of the risk of hypersensitivity reactions and skin staining associated with injectable iron use, and the corresponding monitoring requirements
- of their responsibility to inform the patient or carer of the relevant symptoms of hypersensitivity and actions to take should they experience these
- how to report adverse effects using the MHRA Yellow Card System, and the importance of doing this
Acknowledgments
Information on hypersensitivity risks associated with the use of parenteral iron was provided by the Patient Safety Team at NHS England