HSIB: Weight-based medication errors in children (3 February 2022)

Summary

The purpose of this investigation by the Healthcare Safety Investigation Branch (HSIB) is to help improve patient safety in relation to the prescribing of medicines for children based on their weight.

This HSIB investigation reviewed the case of a four-year-old child who was diagnosed with a blood clot in her leg following a surgical procedure in hospital. She was prescribed an anticoagulant medicine using an electronic prescribing and medicines administration (ePMA) system. Errors in the prescription, dispensing and administration processes meant that the child received ten times the intended dose on five separate occasions over three days.

A scan of the child’s brain showed evidence of a bleed and she was admitted to the paediatric intensive care unit. Following three months in hospital, the child was discharged home with an ongoing care plan.

Content

Findings

Findings of this investigation included:

• There is limited standardisation of handovers, ward rounds (visits to each patient in a ward to review and discuss their care) and huddles (short, focused staff briefings), in terms of which members of the multidisciplinary team are involved, and how they are conducted for maximum effectiveness.
• Processes for the checking of medicines varied without evidence of what constituted the most effective process.
• The environments within which staff prepared and checked medicines influenced their performance.
• There are no standards for what safety-critical functionality should be available in ePMA systems configured for use in paediatrics (for example, the use of weightbased dose bands, where individually calculated doses are rounded to a set of predefined doses).
• Local configuration of ePMA systems potentially introduces variability and risks if not undertaken with clear understanding of the potential hazards and their mitigations.

Recommendations

The report makes the following safety recommendations:

• HSIB recommends that the Royal College of Paediatrics and Child Health identifies the best practice principles for effective paediatric ward rounds in relation to medicines, and disseminates them to its members.
• HSIB recommends that NHS Digital and NHSX promote the organisational requirements for digital clinical safety, including organisations’ responsibilities in terms of safety cases and clinical safety officers, to encompass system functionality and processes.
• HSIB recommends that the Care Quality Commission (CQC) reviews whether a provider’s assurance of its compliance with the Clinical Risk Management standard specific to electronic prescribing and medicines administration systems in healthcare, can form part of the CQC’s developing regulatory model.
• HSIB recommends that the National Institute for Health Research assesses the priority, feasibility and impact of future research on processes for second checking medication, and considers the most appropriate way of building up the evidence base on this topic.
• HSIB recommends that the Medicines and Healthcare products Regulatory Agency works with the manufacturers of electronic prescribing and medicines administration systems to provide guidance on their obligations under the Medical Devices Regulations 2002 (as amended).