Don’t let a black mark stain your reputation

Case history

A Practice Manager received an email from a 26-year-old patient:

I attended your practice for an iron infusion three weeks ago. During the infusion, I voiced concern on a couple of occasions about swelling and discomfort around the IV site. The nurse checked and said it was OK. I now have a large, unsightly black mark on my forearm. 

I am waiting to see a dermatologist, but my online research suggests the stain will be permanent. I was not warned of the risk of skin staining. I am getting married in three months and I want you to pay for the costs of the dermatology treatment. I also want compensation for my pain and suffering.

The Practice Manager sent the email to MDA National. On review of the patient’s claim, it became apparent that the GP had not warned the patient about the possibility of skin staining – and the nurse was not aware that extravasation could lead to a permanent skin stain. There was also no documentation in the medical records about the infusion, including no notation about the patient’s complaints of swelling and discomfort around the IV site. 

Based on this information, MDA National liaised directly with the patient and promptly resolved her claim by paying for the costs of laser treatment of the skin staining by the dermatologist. 

Iron infusions

The use of iron infusions has increased over the past decade with estimates that intravenous iron was dispensed to one in 50 Australian women of reproductive age in 2017. 

MDA National continues to receive numerous notifications from GPs and practices arising from the administration of intravenous iron. A review of our data reveals that some of the claims associated with iron infusions have settled for amounts in excess of $100,000.

The Medical Board of Australia and the Medical Council of NSW have also raised concerns about an increasing number of complaints associated with skin staining following iron infusions. 

Common themes in these claims and complaints are:

• failure to obtain informed consent
• inadequate practice protocols and staff training
• failure to appropriately monitor the infusion
  
  

Have you obtained informed consent?

This involves a discussion with the patient about the benefits and risks of the intravenous iron, so that the patient can decide whether to proceed with the treatment.

A key issue is to ensure there are appropriate indications for the intravenous iron, i.e. that the potential benefits will outweigh the risks. Treatment alternatives should be discussed, such as oral iron, and the patient given an opportunity to ask questions about the proposed treatment. The risk of skin staining is an important adverse event to discuss and a vital part of the consent process.

Consider the individual patient’s circumstances. The timing of the treatment may be relevant to a patient’s decision. In the case above, the patient may have delayed the treatment until after her wedding. For some patients, a permanent skin stain may have a significant impact on their work, e.g. a professional dancer or model.  

The provision of written information to the patient may be useful, including de-identified photos of skin staining. Ensure the consent process is documented in the patient’s medical records. 

Reducing the risk of skin staining

It is recommended that in order to minimise the risk of injection-site leakage or extravasation, the IV cannula should be flushed with 0.9% saline before and after the administration of the iron.

Ask patients to notify staff if there is any pain, discomfort or swelling during the infusion. 

Staff should be trained in the administration and monitoring of iron infusions. If the patient complains of any symptoms during the infusion, careful clinical assessment should be undertaken and documented in the medical records.  

Practice tips

• Ensure you have obtained informed consent – including warning patients about the risk of permanent skin staining
• Advise patients to immediately report any symptoms during the infusion, such as pain or swelling
• Have practice protocols in place for the administration and supervision of intravenous iron
• Trained staff should monitor patients during the infusion
• Ensure all practice staff have appropriate professional indemnity insurance

More information

BloodSafe – IV Iron Tools

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