Analysis of notifications involving oral methotrexate – summary report published

24 Mar 2021

The Pharmacy Board of Australia (the Board) has published a summary report of an analysis of notifications involving oral methotrexate.

The report can be found on the Professional practice issues webpage.

Several notifications about oral methotrexate have been recorded since inception of the National Registration and Accreditation Scheme and establishment of the Board in 2010. The Board commissioned the Research Unit of the Australian Health Practitioner Regulation Agency (Ahpra) to undertake an analysis of notifications involving oral methotrexate. The published report provides a summary of findings from this analysis.

The analysis found that:

• since 2010 there have been 28 notifications involving pharmacists and methotrexate
• there were seven deaths and nine patients required presentation to hospital
• errors with dose administration aids and labelling were responsible for the majority of errors, and
• failing to resolve prescribing errors, dispensing methotrexate in error and inadequate counselling all featured as underlying issues.

The summary report concluded that:

• the extent of harm caused by inappropriate dispensing of oral methotrexate is likely greater than that captured by regulatory notifications
• incorrect once-daily packing of methotrexate, rather than weekly packing, was a substantial problem, as was incorrect or absent labelling, and
• while the number of notifications involving oral methotrexate was relatively low, the outcomes were frequently catastrophic.

Pharmacists are reminded that they need to ensure their own processes, and those of the pharmacy where they are practising, support them to exercise their professional responsibilities in the safest way possible. Pharmacists should ensure they are guided by relevant professional practice standards and can also refer to the following Board guidelines for further information to support professional practice:

• Guidelines for dispensing of medicines
  • The dispensing process
  • Dispensing precaution – safety of prescriptions
  • Labelling of dispensed medicines
  • Counselling patients about prescribed medicines
• Guidelines on dose administration aids and staged supply of dispensed medicines
  • Dose administration aids

The Board and other stakeholders publish case studies from time to time, including about errors involving methotrexate. We encourage all pharmacists to read these case studies and be aware of the issues that may lead to a dispensing error.

The Board will continue to engage with key stakeholders about the risk of errors involving methotrexate and share the details of any developments to ensure that these risks remain in the forefront of the minds of all pharmacists and their support staff.

To date, changes have been made to methotrexate packaging and product information, however, the available proprietary packs of methotrexate tablets include more than one month’s supply and therefore, extra care must be taken to ensure that the correct quantity, directions and counselling are provided when supplying this medication to patients.

The Board will also consider any necessary changes to its guidelines for pharmacists when it begins a review this year and will undertake wide-ranging public consultation on any revised proposals.

We will provide further updates on this work in the coming months.