Report calls for regulation of technology systems to reduce weight-based medication errors

Regulation of electronic prescribing systems software could help to reduce the chance of harmful weight-based prescribing errors, says Healthcare Safety Investigation Branch’s (HSIB) latest report.

HSIB identified the finding during a national investigation focused on weight-based prescribing errors in children. The case they examined to highlight the impact of the safety risks involved Felicity, a four-year-old girl who was given 10 times the intended dose of dalteparin (a blood thinner) five times over the course of one weekend. A subsequent CT scan showed she had a bleed on the brain, which could have been contributed to by the medication. Studies show that prescribing errors are the most frequent type of medication error in children’s inpatient settings. Prescribing medications for children is complex because prescriptions must be tailored to the individual child based on a number of parameters such as weight, age, gestation and body surface area.

The investigation examined the patient safety risks that relate to prescribing medications to children and split their findings into three areas. Six of the 16 findings were focused on the implementation of ‘off the shelf’ electronic prescribing systems in specific contexts, particularly in paediatric prescribing. A significant finding was that some electronic prescribing and medicines administration systems may not currently be registered as medical devices in line with the Medical Device Regulations 2002, despite meeting the criteria.

As a result of this finding, HSIB has recommended that the Medicines and Healthcare products Regulatory Agency (MHRA) works with the manufacturers of electronic prescribing and medicines administration (ePMA) systems to provide guidance on their obligations under the Regulations, if their systems meet the criteria for a medical device. HSIB has also made a safety observation suggesting that manufacturers of ePMA systems conduct assessments of their products against the relevant regulations, to identify whether they meet the definition of a medical device and if so, to ensure associated regulatory requirements are met.

A further five findings in the report examined the theme of co-ordination of multi-disciplinary teams and decision making – for example identifying that email discussions may be being used for discussion of critical decisions in relation to patient care, with limited dissemination to the wider team. Another five findings focused on understanding the factors which contribute to reduction in the effectiveness of checking of medication as a barrier, for example environmental layouts and limited resource resulted in workarounds. Alongside the recommendation made to MHRA, four others were made focusing on identifying best-practice principles for paediatric ward rounds; assessing whether future research on processes for second checking medication would be feasible and add value; clarifying to organisations their responsibilities for digital clinical safety; and reviewing whether a provider’s assurance of its compliance with the Clinical Risk Management standard can form part of the Care Quality Commission’s regulatory model.

Helen Jones, National Investigator at HSIB says: 

“ We focused on prescribing medication to children as it is highly individualised. Our investigation emphasises that safety barriers need to take into account this complexity because any unsafe dose of medication could potentially lead to serious injury or death. A study we reviewed during the investigation showed that in paediatrics,13% of prescriptions written for children contain errors and children like Felicity, will be even more vulnerable due to the need for ongoing or regular medical treatment.

“Although we made a number of findings and recommendations, we felt it important to highlight those associated with the regulation and governance of ePMA systems. This is because it is the change that could happen right at the start of the process; working with the manufacturers to ensure that systems are designed to safety principles before they are even out of the door. Along with other recommendations around safety barriers, this will be crucial in reducing errors and ensuring a safe level of medication is administered to all patients.”

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