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Background

Our electronic systems are letting down young patients

Medication errors are the leading cause of preventable harm in healthcare, with paediatric patients at particularly high risk (1,2). Recent studies confirm that medication-related adverse events persist, and this remains particularly true for paediatric patients (3–5).  The wide variation in paediatric patient weight—ranging from 0.5 kg to 100 kg - exacerbates the risk of dosing errors, often resulting in ten-fold overdoses (6). Such errors are particularly dangerous due to children’s physiological vulnerability, smaller safety margins for many medications, and distinct metabolic profiles, which heighten their susceptibility to severe adverse drug reactions (6–8).

While Electronic Prescribing and Medicines Administration (EPMA) systems aim to reduce errors, they have introduced new, often paediatric-specific challenges (9,10). This underscores the urgent need for advanced Clinical Decision Support (CDS) tools tailored to address paediatric weight-based and condition-specific dosing requirements, which remain unmet at present. This need was well articulated in a 2024 editorial in BMJ Quality and Safety by David Bates: “leveraging electronic heath records to deliver better clinical decision support… Paediatric medication safety represents a particularly urgent area of need that has been neglected for too long. The highest priority here is weight-based dosing.” (11)

Role of BNF & BNFC

The British National Formulary for Children (BNFC) serves as the authoritative resource for paediatric prescribing guidance in the United Kingdom (UK). BNFC is published under the joint imprint of the British Medical Journal, Pharmaceutical Press, the Royal College of Paediatrics and Child Health, and the Neonatal and Paediatric Pharmacy Group. British National Formulary (BNF) maintains close ties with the ����ֱ�� Office on controlled drug regulations and with the Medicines and Healthcare products Regulatory Agency (including the British Pharmacopoeia Commission), incorporating safety warnings from the Commission on Human Medicines and routine guidelines from UK health departments. Both BNF and BNFC align with UK medicine access and NHS practices and work as  live documents with monthly updates assuring the governance is up-to-date.

However, despite its comprehensive guidance, and availability on the web and as an app, BNFC is not consistently integrated into EPMA systems, leaving paediatric prescribers without immediate access to current, accurate information within EPMA systems. This lack of integration poses a critical gap in paediatric medication safety.

Case Based Report: HSSIB Investigation – five years on

National investigation

The Healthcare Services Safety Investigation Branch (HSSIB) 2021 report on (12), followed a national investigation which underscored the risks involved when dosing paediatric patients. It highlighted that, despite the growing adoption of EPMA systems, medication errors in children continue to cause severe harm due to factors such as inaccurate dosing calculations and unsuitable electronic system configurations.

Paediatric prescribing is inherently personalised, requiring calculations based on each child’s weight, age, gestation, body surface area, and the specific condition being treated. While EPMA systems aim to reduce medication errors, their failure to address these paediatric-specific needs can result in unsafe doses, posing risks of significant harm or even fatality.

Stakeholder responses and gaps

The report drew responses from major stakeholders, each recognising the significant risks identified and proposing measures to address them. However, progress remains uneven, and several critical paediatric-specific needs remain unmet. Below is a summary of key responses:

Regulatory and organisational actions

Stakeholders such as the MHRA and NHS Digital NHSX (now integrated into NHSE) responded with commitments to regulatory oversight and safety promotion:

• MHRA acknowledged the need for clear guidelines to help manufacturers meet Medical Device Regulations, especially for EPMA systems used in paediatrics. While they emphasised plans to review these systems' regulatory compliance, specific recommendations for EPMA functionality or configuration modifications remain the responsibility of EPMA software manufacturers and local healthcare organisations. As a result, this response and its associated actions have had—and are likely to continue to have—limited impact on the daily experience of clinicians using EPMA systems for paediatric prescribing.
• NHS Digital has taken steps to promote digital clinical safety standards, establishing protocols for Clinical Safety Officers to oversee safety cases and monitor adherence. However, despite these regulatory efforts, they do not directly address the need for paediatric-specific functionality in EPMA systems. As a result, the daily challenges clinicians face when prescribing for children remain largely unaddressed.

Unaddressed recommendations and missed opportunities

Despite recognising the need for specialised adaptations in EPMA systems to improve paediatric safety, many critical recommendations remain unmet, leaving significant safety risks unaddressed. The report also lacked detailed guidance on implementing proactive, paediatric-specific decision support, an area where stakeholder responses have made limited progress:

• RCPCH and NPPG. The Medicines Committee’s response highlighted major concerns over the lack of paediatric-optimised CDS tools and the urgent need for EPMA systems to incorporate paediatric-specific dosing calculations based on weight, age, and body surface area. It also stressed the importance of filtering out adult-specific content, a gap that poses ongoing safety risks in paediatric care. To address these issues, the Medicines Committee established a Task & Finish Group to develop evidence-based guidance, conducting a systematic review and engaging a Delphi process to gather insights from paediatric specialists, parents/carers, and the multidisciplinary team. This resulted in a clinical practice guideline for effective paediatric ward rounds (13). However, this work did not include a defined set of functional expectations for safe EPMA use in children.
• National Institute for Health Research (NIHR). The response from the NIHR indicated support for targeted research into paediatric medication safety. This approach aims to create actionable research calls to address evidence gaps critical to paediatric medication safety. To date, the NIHR has commissioned research on topics such as double-checking protocols, but their response has yet to result in a clear set of functional expectations for EPMA systems in paediatrics. Instead, NIHR’s approach focuses on preliminary assessment and broad consultation to identify research questions, leaving the need for immediate, defined guidance on EPMA functionality for safe paediatric prescribing unmet.
• Care Quality Commission (CQC). The CQC response acknowledged the patient safety risks posed by errors in EPMA systems. While the CQC recognises its regulatory role, it emphasised that the responsibility for safe EPMA system use ultimately lies with individual Trusts. In response to the HSSIB report, the CQC expressed willingness to explore how its evolving regulatory model might address EPMA safety, specifically considering whether assurances against Clinical Risk Management standards could be included at the Trust or service level.

Review of case

The Medicines Committee acknowledges the HSSIB report’s detailed identification of risks within EPMA systems for paediatric dosing, particularly how these systems can sometimes contribute to incorrect doses being prescribed rather than preventing them. Despite the report’s publication and subsequent organisational responses, for frontline prescribers and the patients they treat, nothing has materially changed.  Practical, paediatric-specific standards for EPMA functionality remain undefined, leaving clinicians without the defences necessary for accurate, safe dosing.

From a human factors perspective, the Medicines Committee is concerned that as EPMA systems are more widely implemented, dosing errors are likely to increase without tailored safeguards for paediatrics. The complexity of paediatric dosing requires systems capable of accurately adjusting for weight, age, body surface area, and specific conditions—needs unmet by current EPMA configurations.

The Medicines Committee views this case as part of a systemic issue within EPMA adoption and advocates for establishing a structured approach to integrate safety standards in paediatric EPMA systems, ensuring clinicians can rely on these tools for safe and precise dosing.

Recommendations

1. All EPMA systems should be based on the recommendations outlined below in Table 1
2. As BNF for Children (BNFC) serves as the definitive national resource for safe and effective paediatric prescribing providing a foundation for standardised dose based on age, weight, body surface area (BSA), BNFC based dosing should be used across the UK as the basis for EPMA systems to calculate paediatric dosages and set safety dose limits; all of which should ideally account for child anthropometry and the medical condition being treated.
3. Local guidelines may be needed to supplement BNFC, but these additions should be limited to genuinely necessary cases and should be clearly marked to distinguish them from national standards, preserving governance clarity and consistency. 
4. Consideration should be given to setting up a process for sharing variation in practice with the RCPCH for others to learn from and a commitment from providers to share this variation with the RCPCH to ensure other providers can learn and improve. 
5. Consideration should be given by key stakeholders including the RCPCH to developing paediatric specific standards with associated measures and improvement support tools.
    

Table 1: Recommendations linked to specific safety issues

References

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