A coronial enquiry into chemotherapy underdosing in South Australian patients with acute myeloid leukaemia has recommended a complete overhaul of how haematological malignancies are managed in the state’s hospitals.
The SA deputy coroner investigated the deaths of four of 10 AML patients who received incorrect doses of cytarabine as part of consolidation treatment at the Royal Adelaide Hospital (RAH) and Flinders Medical Centre (FMC) between July 2014 and January 2015.
The patients were given cytarabine once daily rather than the recommended twice a day as a result of a typographical error made when new treatment protocols were written and distributed in mid 2014.
Despite an email being sent almost immediately to correct what had by then already been uploaded onto SA Pathology’s intranet, the dosing discrepancy went uncorrected for seven months until questioned by hospital pharmacists.
The coroner said the inquest showed a need for hospitals to use uniform chemotherapy protocols such as EviQ, better incident reporting and more open notification of errors to patients.
His six recommendations, directed at the SA Health Minister, the SA Health chief executive and the haematology heads of the RAH, the FMC and The Queen Elizabeth Hospital were:
- Establish state-wide chemotherapy protocols for haematology illnesses for all hospitals rather than having separate protocols for individual hospitals.
- A “complete overhaul” of clinical governance for haematology departments in SA public hospitals.
- Email should not be used to communicate protocol changes, or used only within very specific circumstances.
- Abandon the adverse event report ‘Safety Learning System’, which failed entirely, and replace it with an immediate report system.
- Chemotherapy should only be prescribed by haematologists with expertise in the specific disease, or in consultation with them.
- Improve the way patients are informed about treatment errors, which should be more open and done by an independent person.
The coroner noted that the underdosing incidents had already been the subject to an independent review by Professor Villis Marshall, who made a series of major recommendation in 2015 on hospital processes, adverse event reporting and open disclosure. The SA cases and a similar underdosing case in NSW have since prompted COSA and the Cancer Council to create updated guidelines for safe prescribing, dispensing and administration of cancer chemotherapy.
In his findings the SA deputy coroner said that on the basis of the evidence and expert witnesses it was not possible to say conclusively whether the underdosing had contributed to the deaths of the four patients, but conversely it was not possible to rule this out.
But he also emphasised that the coroner’s office lacked resources and had limited terms of reference and was therefore unable to examine many of the wider issues or the other patients involved in this matter of “public notoriety”. The incorrect dosing incidents should have been the subject of a Royal Commission of Inquiry, he suggested.
An AHPRA investigation into the practitioners involved in the underdosing resulted in ‘no further action’ on eight matters and a caution on another matters, as previously reported in the limbic in 2017.