This investigation emphasises that complex and fragmented medicine safety processes are putting patients across the country at risk. The report puts forward recommendations aimed at driving national improvement to reduce potentially fatal medication errors.

Please note that this investigation has previously been known as ‘Wrong route administration of an oral drug into a vein’.

Investigation summary

The investigation was launched after we were made aware of a nine-year old child wrongly administered an oral liquid drug into a vein during a planned renal biopsy. This is classed as a wrong route medication error. Administration of medicine via the wrong route is defined as a ‘never event’ in the NHS. A never event is a serious incident that is entirely preventable. The child stayed in the hospital for monitoring and was discharged with no adverse effects a day later. 

The investigation reviews: 

  • The effectiveness of current processes for the storage of medicines.
  • Equipment design.
  • The prescribing, preparation, checking and administration of medication. 

It also considers the:

  • Contextual, environmental and human factors that influenced the inadvertent administration of an oral solution into a vein.
  • Effectiveness of current processes for implementation of local safety standards for invasive procedures.

Safety recommendations

We made safety recommendations to NHS Improvement (NHSI) and the Royal of College of Physicians (RCP) as a result of this investigation. Both organisations responded to the safety recommendations within 90 days of publication of the investigation report.

Recommendation 2019/028

It is recommended that NHS Improvement, through the National Patient Safety Alert Committee, set standards for all issuers of patient safety alerts which make clear that alert issuers should assess for unintended consequences of the actions in the alert, the effectiveness of barriers created by these actions, and provide appropriate advice for providers on implementation, include ongoing monitoring.

Response from NHS Improvement

Received 15 July 2019:

As chair of the National Patient Safety Alert Committee, whose members include all arms-length bodies and teams who issue national safety guidance in the form of alerts, I [Dr Aidan Fowler, National Director of Patient Safety] welcome the recommendation from HSIB. 

I can confirm that the standards that the National Patient Safety Alert Committee agreed in 2018 include, amongst other criteria, that: “There is a procedure for the development of actions required in the National Patient Safety Alert that includes: an assessment of the actions for potential unintended consequences is carried out [and] an assessment of the likely effectiveness of the actions in reducing future harm is carried out.” 

These standards also include a requirement that “The system [of each alert-issuing body] sets out what types of supporting materials should be provided by the alert issuing team/body for complex National Patient Safety Alerts.” This requirement encompasses materials to support providers with implementation and ongoing monitoring where this is required; we would not expect this support to be required for some National Patient Safety Alerts that are straightforward (for example, some types of drug or device recall) or National Patient Safety Alerts that contain systemic actions that once taken eliminate the need for ongoing monitoring. A key aspect of the work of NaPSAC is the role of CQC in inspecting compliance with National Patient Safety Alerts and where appropriate using its regulatory powers.

The NaPSAC standards became active on 13 May 2019 and the first alert-issuing body is currently preparing its application to become a credentialled issuer of National Patient Safety Alerts. Progress will be publicly reported on NaPSAC webpages.

Recommendation 2019/029

It is recommended that NHS Improvement support the development of necessary knowledge, skills and capacity for the effective operationalisation of hazard identification and risk analysis at a national, regional and local level, as an integral part of the National Patient Safety Strategy.

Response from NHS Improvement

Received 15 July 2019:

I [Dr Aidan Fowler, National Director of Patient Safety] can confirm that, as part of the new NHS Patient Safety Strategy, we are working with Health Education England (HEE) and other partners to develop the first universal patient safety syllabus and training programme for the whole NHS. 

We intend for this to include aspects of hazard identification and risk analysis. The syllabus and associated training will be stratified to ensure that high quality patient safety training is available to staff at an appropriate level, from an introduction to patient safety for staff new to the NHS to specialist training modules for our proposed patient safety specialists and others who are interested. 

We will collaborate with HEE, regulators, other NHS organisations, and education providers through 2019/20 to build on existing curricula and syllabuses, including those developed with the Academy of Medical Royal Colleges and the WHO [World Health Organization].

Recommendation 2019/030

It is recommended that the Royal College of Physicians, in collaboration with the Royal Pharmaceutical Society, British Pharmacological Society, Royal College of General Practitioners, Royal College of Paediatrics and Child Health, NHS Improvement, the professional bodies for the professions regulated by the Health and Care Professions Council, Royal College of Nursing and Royal College of Midwives, provide leadership in recommending the postgraduate learning needs and activities to standardise professional development in medicines safety processes.

Response from the Royal College of Physicians

Received 8 July 2019:

The Royal College of Physicians has coordinated a joint working group with other professional bodies to jointly develop and deliver work related to Medication Safety.

Members of the working group include Royal College of Physicians, Royal Pharmaceutical Society, British Pharmacological Society, Royal College of Nursing, Royal College of General Practitioners, Royal College of Paediatrics and Child Health, Health Education England, NHS Improvement and NHS England. 

Through this group and in part informed by your report we recognise that interprofessional learning activities are required to address many of the patient safety issues that may be encompassed in practice and that are illustrated by the report and findings.

Over the next 12 months we aim to:

  • Review the literature and evidence on medication safety and inter-professional workplace-based learning.
  • Explore current best practice in this area, building on the work of Health Education England in Wessex and including the EPIFFANY programme.
  • Develop a new model of inter-professional training to improve patient safety.
  • Test pilots of the workplace-based training and activities in practice.
  • Recommend how to spread this practice across the NHS.

Recommendation 2019/031

It is recommended that NHS Improvement undertake a formal evaluation of banding, time and resource given to the Medication Safety Officer role across England and publish its findings and mandate minimum resources and standards.

Response from NHS Improvement

Received 15 July 2019:

NHS Improvement and the Medicines and Healthcare products Regulatory Agency jointly support the Medication Safety Officer (MSO), and the Medical Device Safety Officer (MDSO), networks. Both organisations regularly review these networks to continually improve their effectiveness; including surveying members in relation to banding, time commitment and support.

The timing of the HSIB recommendation is to be welcomed. Internal work has been ongoing to review the networks in relation to the recently published national Patient Safety Strategy, which outlines the establishment of Patient Safety Specialists (PSS) for all organisations. We therefore plan to use the lessons learnt from the establishment of the MSO and MDSO networks to influence how the PSS network is established to ensure a robust triumvirate of patient safety experts working cohesively to improve patient safety across each organisation.

The strategy outlines the need to “agree the key attributes that specialists should have on an enduring basis, what they should be responsible for and how they can be supported to perform their role. We will explore the potential for further professionalising the role, through accreditation or similar mechanisms”. This process will be extended to include a review of the MSO and MDSO roles to ensure that the expectation of all these roles is clear and unambiguous in relation to the expected level of resource and standards. As with the patient safety specialist roles we expect that the key will lie less in mandating the level of resource and more in achieving a good match between role description, skills development and expectations.

Safety observations

This investigation makes the following safety observations:

  1. It is recommended that staff with a responsibility for medicines safety, for example Medicines Management and Chief Pharmacists, Clinical Governance Leads, Heads of Medicines Optimisation and Medication Safety Officers are familiar with the contents of the existing National Institute for Health and Care Excellence clinical guidance on medicines optimisation and can demonstrate how they have implemented the quality standard on medicines optimisation [QS120] and quality statement 3, ‘Learning from medicines-related patient safety incidents’.
  2. It would be beneficial to define a national standard for independent two-person checking when preparing high-risk medication for administration to minimise medication errors associated with high-risk medications.
  3. Availability of oral/enteral syringes in all clinical areas (in accordance with the requirements contained in the National Patient Safety Agency’s Patient Safety Alert 19) is inconsistent. A national audit tool may be helpful to organisations.
  4. Colouring of high-risk and/or oral liquid medications (such as midazolam) may have a justifiable role in improving safety as it will offer a signal to differentiate oral from parenteral preparations.
  5. It would be beneficial if potential interventions designed to reduce wrong route administration medication errors were subjected to human factors testing, review, evaluation and modification prior to being introduced at scale; this includes standards, processes, and the design of medication and administration devices.
  6. SCRIPT is an eLearning programme to improve safety and competency among healthcare professionals around prescribing, therapeutics and medicines management. It would be beneficial to roll out SCRIPT as a mandatory requirement for all prescribers.
  7. There is an opportunity with the new General Medical Council Medical Licensing Assessment to mandate additional therapeutic practical skills for example, the practical aspects of medicines administration, as part of the Clinical Practical Skills Assessment.

Safety observations are made when there is insufficient or incomplete information on which to make a definitive recommendation for action, although findings are deemed to warrant attention.