The MHRA has reminded healthcare professionals of the risks associated with chlorhexidine solutions, particularly in neonates. This is not the old problem of allergy, but an issue that many neonatologists and surgeons know well. Overuse on the skin, pooling and the soaking of materials left in contact with the skin, combined with more fragile skin has left some neonates with severe caustic burns that they have either been the cause or the contribution to the neonate’s death. It is also not only neonates as I have heard similar issues in children and the elderly in particular.
The MHRA’s advice is sensible – take care – do not allow the solution to pool and remove any material that might be soaked with the solution and left in contact with the skin. They recommend that single use containers should be used when possible. They choose not to mention sterility despite it being a condition of licensing for the last 10 years or more. And yes, any adverse events should be reported through the yellow card scheme.
Of course the MHRA have assumed that everyone uses products that are licensed medicines and naturally any product used to disinfect the skin before the insertion of a canula or a minor surgical procedure would come under their jurisdiction.
They know that their thinking is flawed. Two products listed in their review are not licensed medicines. And because of this, they are unable to ask for feedback on more adverse events. And because of this, those products do not come under standard systems of pharmacovigilence. So how many neonates, infants and children have been harmed through unlicensed medicines – well we don’t quite know apart from the two cases that the MHRA identified from the literature.
I applaud those clinicians who published these reports for their honesty. They used products intended for general hygiene (clearly labelled not for therapeutic application) or for wiping medical devices on the skin of frail neonates before inserting a cannula. I wish them well.
Perhaps the MHRA could have mentioned….. Products to be used in this manner – on the skin as a disinfectant prior to an invasive procedure are for us to regulate and monitor their safety and performance. Could we politely ask all clinicians to use licensed medicines in this situation – so we have a chance of doing our job to keep patients safe? They could also ask ward and theatre managers to keep disinfectants well apart from medicines and be clear about which product should be used for which purpose.
Oh and of course – all of the changes in label etc only applies to the products that are licensed.
If, after reading this, just one clinician or nurse holds up a product before they slosh it over a patient and asks “excuse me – is this product licensed for this”, the MHRA will have increased their chances of protecting patient safety. Of course, you healthcare professionals and patients can always read the label.