Iron staining: understanding the risks and prioritising patient safety

An iron infusion is one option for treating iron deficiency. It may be clinically appropriate when oral iron preparations are ineffective or cannot be used, for example, intolerance to oral iron preparations. In addition to treatment, it is also important to investigate the underlying cause of iron deficiency and/or iron deficiency anaemia as part of a comprehensive management plan.

Iron infusions are increasingly being carried out in a GP clinic rather than a hospital environment, which patients may find more convenient. However, doctors administering iron infusions and the patients receiving them should be aware of the potential adverse effects.

Iron staining (also known as ‘iron tattoos’) is a recognised and potentially permanent complication of iron infusion treatment caused by extravasation of the compound during the process of intravenous administration.

Iron staining can occur regardless of best practice and competent clinical performance. Since staining, if it occurs, is likely permanent, patients must be informed and consent to this risk.

According to our data, the majority (63%) of claims relating to iron infusions are for compensation. This is based on over 170 compensation claims and regulatory complaints accepted over the past eight years (FY17-24).

Claims and complaints are mostly against general practitioners, practices and doctors in training (including GP registrars) and have sometimes involved nursing staff. Of the claims and complaints, 69% relate to procedural issues. The most common allegation is poor technique or skill during the administration of the infusion with staining being the most common outcome.

Consider the appropriateness of the treatment

Before administering iron infusions, consider the appropriateness of the treatment for each individual, and document your clinical reasoning in their medical record. An acceptable indication for an infusion may be helpful in responding to any potential complaints that may arise.

Aside from iron staining, there are other possible side effects including headaches, nausea, vomiting, dysgeusia (metallic taste), arthralgia (joint pain), myalgia (muscle pain), dizziness, hypertension, hypotension, influenza-like symptoms, hypophosphataemia, and anaphylaxis. The patient should be made aware of these side effects and risks before agreeing to the infusion.

Additionally, consider that administering iron infusions may not be suitable for certain patients, such as pregnant women in their first trimester, or patients with liver dysfunction, acute or chronic infection, and anaemia not attributed to iron deficiency. Therefore, always check local health service guidelines/protocols and product information before administering these infusions.

Obtained informed patient consent

Take the time to ensure you have given the patient as much information as is needed to obtain their informed consent before proceeding. Ensure the patient understands the complications that can arise as well as the alternative treatment options such as diet and oral supplements and discuss the harms and benefits of intravenous iron supplementation vs oral iron.

You should specifically discuss the risk of permanent skin staining and how this could occur. This may involve showing them pictures of staining. (See QLD Health’s Iron Infusion Consent form, which includes an image of iron staining.) The risk should be documented in the consent form signed by the patient before the infusion.

Also, make sure the patient is aware of the symptoms that the cannula is out of position (pain and swelling) and the importance of notifying the supervising nurse or doctor immediately should they develop any symptoms.

While there is no prescribed format for an intravenous infusion consent form, some practices do develop individualised consent forms. Some general information about the consent process can be found in our factsheet: Consent: the essentials

To reduce the risks related to iron infusions, ensure whoever is performing and monitoring the iron infusion (doctor or nurse):

• is adequately trained in cannula insertion and intravenous iron infusions
• is trained in administration (refer to the product information, which should be referred to within the protocol (consider indications, pathology results and dose calculation)
• follows the practice protocol (consider developing one if there is none)
• is vigilant in their continuing observation and communication with the patient throughout the procedure to recognise any extravasation so action can be taken quickly to stop the infusion.

You should have guidance within the protocol on what to do and not do if the patient experiences pain, extravasation or another adverse effect during the procedure. If you need to adapt the process outlined in the protocol – for example, because of the IV fluid limitations – ensure you document the reasons and that the patient is informed.

Clearly document your discussion with the patient and their decision in your patient records.

National Blood Authority - Iron product choice and dose calculation guide for adults | National Blood Authority

Avant factsheet - Consent: the essentials

Medical council of NSW - Iron infusions – 5 things you can do to avoid a complaint

Queensland Health – Iron polymaltose slow intravenous infusion guideline

NPS MedicineWise – Ferinject (ferric carboxymaltose)

For medico-legal advice, please contact us here, or call 1800 128 268, 24/7 in emergencies.