Case study: Posaconazole tablets and liquid (oral suspension)

Background information

A patient in hospital was prescribed the liquid version of posaconazole but was instead given tablets. The liquid and tablet are in different forms and contain a different amount of medicine; they are therefore not to be swapped with each other. This medication error resulted in the patient receiving an overdose of posaconazole, developing kidney problems and a headache. 

When the hospital pharmacist identified this issue, they contacted the pharmaceutical company that makes the medicine. The company sent the report to MHRA, as legally required. Similar Yellow Card reports were sent in by other hospital pharmacists from different areas. The posaconazole tablets and liquid version were swapped with each other, resulting in patients not receiving enough posaconazole and developing infections. 

Investigation

We requested a review by the pharmaceutical company of all available global safety data. This was reviewed alongside all Yellow Card reports and other safety information. After a UK and European review, it was agreed that it was vital to communicate with healthcare professionals to raise awareness of this issue and to prevent patients receiving incorrect amounts of posaconazole. In addition, actions were taken to make the warnings clearer on the labelling of posaconazole products, stating that the oral suspension (liquid) cannot be directly swapped for the tablet or vice versa. The outer packaging for the two products were also changed to prevent confusion between the tablets and the oral suspension. 

Result

To raise awareness among healthcare professionals, we agreed for a letter from the pharmaceutical company to be sent to healthcare professionals about the safety concern. We also published a Drug Safety Update article highlighting the issue and advice to healthcare professionals. 

Important information

Posaconazole is a medication to treat and prevent fungal infections. The medicine is available as a liquid (oral suspension) and as tablets.

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