Royal College of Paediatrics and Child Health
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.
A Task & Finish Group has been established with select members of the cross-organisational Medicines Committee, which is overseen by the RCPCH and has representation from across the child health and medicines community including the Neonatal and Paediatric Pharmacists group, RCPCH, NHS England / NHS Improvement, Royal Pharmaceutical Society, the British National Formulary for Children and the Medicines and Healthcare products Regulatory Agency.
A systematic review has been conducted to ensure evidence-based practice is followed wherever possible, but with a relatively low evidence base in existing research on certain areas around best practice for paediatric ward rounds in relation to medicines, a more robust Delphi process is needed to gather consensus from across all paediatric specialties, parents/carers and the wider multi-disciplinary team. This extensive process will take place over the coming months with the aim of finalising and ratifying the guidance for publication when the Medicines Committee meets later in the year.
Actions planned to deliver safety recommendation:
- Delphi process by Summer 2022
- ratification by RCPCH Medicines Committee by Autumn 2022
- guidance published by RCPCH website by January 2023.
Response received on 28 April 2022.
National Institute for Health and Care Research
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.
The National Institute for Health and Care Research (NIHR) funds health and social care research that improves people’s health and wellbeing. Working with those who use, plan and deliver health services in the UK, we identify and prioritise important topics to fund through specific calls for research.
Following referral from HSIB, the safety recommendation for ‘Weight- based medication errors in children’ will be considered through the NIHR’s established research commissioning processes with the aim of developing practical and deliverable research calls which will provide the evidence needed by decision makers.
After an initial ‘in-house’ assessment of the topic to determine what is already known (the existing evidence base), we will engage with a wide range of individuals with a broad spectrum of knowledge, skills and expertise to develop research question(s) which address outstanding uncertainties. Our engagement will include patients, members of the public, academics, subject experts, clinical staff, service managers and public health professionals.
The research question will then be considered by the NIHR’s relevant programme specific prioritisation committees who review and advise on the development of NIHR commissioned calls and make recommendations about future advertisements.
Actions planned to deliver safety recommendation:
- Identify tractable research question and develop NIHR call specification, by approximately May to June 2022. This activity will include an in-depth review of the current evidence base which may identify existing research studies which already address the evidence gap/question and therefore negate the need for further primary research.
- NIHR call specification considered by relevant NIHR Prioritisation Committee, by July 2022.
- If prioritised, call specification sent for external peer review, by July to September 2022.
- NIHR call specification considered for advertisement by the relevant NIHR Programme Oversight Committee, by October 2022.
- Call advertised (if prioritised by the above) by late 2022, but this date may be subject to change.
Response received on 3 May 2022.
Medicines and Healthcare products Regulatory Agency
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).
The Medicines and Health products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care which is responsible for ensuring that medicines, medical devices and blood components for transfusion meet relevant standards of safety, quality and efficacy. We help to educate and inform the public and healthcare professionals about the risks and benefits of medical devices leading to safer and more effective use.
We welcome this report and thank the HSIB for drawing this patient safety event to the attention of manufacturers and users of electronic prescribing and medicines administration systems (ePMAS).
Depending upon the how the product is intended to be used, ePMAS are likely to be regulated as a medical device and to need to comply with the Medical Device Regulations (2002).
We have already published guidance on software as a medical device and we welcome enquiries from manufacturers about their products and the requirements of the Medical Device Regulations, in order to provide guidance in interpreting the rules. However, it remains the responsibility of the manufacturer to ensure that medical devices placed on the market meet the regulatory requirements and that they are registered with the MHRA.
We will proactively review the ePMAS market to assess the regulatory status of products supplied to the NHS and identify those manufacturers who may need specific guidance from MHRA to ensure that their products, the labelling and the instructions for use are in conformity with the Regulations and in particular where the product is indicated for use in special populations such as children for example. This may result in the need for the manufacturer to work with a Notified Body or UK Approved Body or to take account of this population in risk management procedures and when generating clinical evidence.
We have embarked upon an ambitious programme of regulatory reform to ensure that medical device regulation is fit for purpose for software, which will provide further clarity on some of these matters.
Actions planned to deliver safety recommendation:
- Work with NHSX to identify suppliers of ePMAS to the NHS in England. MHRA will then contact those manufacturers and review the regulatory status of their devices, by 31 May 2022 with other dependency NHSX.
- Consider the most appropriate way to provide additional guidance to those manufacturers who may need to undertake remedial work to ensure that their products comply with the regulations. This could be through a webinar or workshop or on a one to one basis.
- The MHRA have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, which should provide further clarity on some of these matters. Published 26 September 2021.
Response received on 26 May 2022.
Actions delivered:
The MHRA produced a drug safety update in January 2023 in response to this safety recommendation.
The MHRA has been undertaking work with manufacturers of ePMAS devices to improve reporting of potential errors with ePMAS to MHRA, to reduce these risks. ePMAS products and other software, apps and Artificial Intelligence intended to be used for a medical purpose are likely to be medical devices.
NHS Digital |
NHSX
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.
NHS Digital and NHSX accept this recommendation and are actively promoting the requirements for Digital Clinical Safety via the implementation of the Digital Clinical Safety Strategy which was published on 17 September 2021.
Both Clinical Safety teams are working with Health Education England and other patient safety specialists in developing an updated training programme on Digital Clinical Safety to improve awareness of Clinical Risk Management and the mandated Safety standards DCB0129 & DCB0160.
We are also working with the wider NHS, ALBs and suppliers to improve the understanding and compliance with the Safety standards and encouraging the training of Clinical Safety Officers in all health and care organisations.
Actions planned to deliver safety recommendation:
- Ongoing promoting Clinical Risk Management and this relates to the work of the Digital Clinical Safety Strategy Implementation Board.
Response received on 28 April 2022.
Care Quality Commission
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.
This report highlights important risks to patient safety as a result of errors when using electronic prescribing and medicines administration systems.
While the responsibility for the safe use of these systems lies with individual Trusts, we welcome the opportunity to consider what role we can play in ensuring the safe use of these electronic prescribing systems by providers through our regulatory approach. We’re currently developing a new regulatory model in order to adapt to changes in health and care and we’re committed to exploring how this recommendation could be incorporated to support improvements in safety for patients.
However, whilst we can explore how we can give a degree of assurance around the safe use of these systems through our regulation, the root cause of the issues outlined in this report lies at the design and licensing stage. This is outside of our regulation as the independent regulator of health and care services in England.
Actions planned to deliver safety recommendation:
- To consider, in developing the evidence requirements for NHS Trusts, whether evidence about assurance against the Clinical Risk Management standard can be included at either Trust or service level, by Summer 2022.
- Depending on the outcome of the first action, ensure that guidance and best practice related to the implementation of the Clinical Risk Management Standard is included in guidance, by Autumn 2022.
Response received on 28 April 2022.