In this blog Patient Safety Learning considers the safety concerns highlighted by a recent report by the Healthcare Safety Investigation Branch (HSIB) into the administration of high-strength insulin from pen devices in hospitals. This blog argues that without specific and targeted recommendations to improve patient safety in this area, patients will continue to remain at risk from similar incidents.
A new investigation report has been published by HSIB with the aim of helping to improve patient safety in relation to administering high-strength insulin from a pen device to patients with diabetes in a hospital setting.
The investigation focuses on the case of Kathleen, who has type 2 diabetes and was using a high-strength insulin administered from an insulin pen device to manage her condition. The insulin in her pen device was Humulin R U-500 insulin, which is five times the strength of most insulins.
On being admitted to hospital (for a reason unrelated to her diabetes) a nurse administered her insulin as measured by an insulin syringe, rather than the pen device. However, the syringe was intended for use with standard strength insulin and as a result Kathleen was given five times the dose of insulin that she had been prescribed.
She received two overdoses of insulin in this way, on both occasions becoming hypoglycaemic (a condition where a person’s blood glucose level becomes too low, which can be dangerous if not treated quickly) and requiring medical treatment.
Key findings from this investigation included:
The patient safety incident described in this investigation is classed by NHS England and NHS Improvement as a Never Event. These are defined as:
“Serious Incidents that are wholly preventable because guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers”.
A National Patient Safety Alert in 2016 highlighted the risks associated with this specific type of incident and actions required by NHS organisations. This included ensuring staff are made aware of the risks of extracting insulin from pen devices and that they have appropriate training to use these devices.
However, in a report published last year, citing the specific case from this investigation, HSIB stated that in their view the barriers to prevent this type of incident “were neither strong nor systemic”. They suggested that this event did not fit the definition of being “wholly preventable” and should be removed from the Never Event list, with new work needed to develop systemic safety barriers to prevent this reoccurring. In response, NHS England and NHS Improvement noted they reviewed the list of Never Events on an ongoing basis and would welcome any suggestions for implementing stronger safety barriers but made no specific commitments for action regarding this insulin safety incident.
The findings of this investigation indicate that the barriers that are supposed to be in place ensure that this type of incident is “wholly preventable” may not be present amongst all healthcare providers. Patient Safety Learning is concerned that this reference case is unlikely to be a one-off and that there remains a significant risk of avoidable harm from this incident occurring again elsewhere in the NHS.
Patient engagement is key to improving patient safety. In our report, A Blueprint for Action, we identify this as one of the six foundations of safer care. We believe that patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account.
This investigation serves to underline the important role that a patient’s family members can play in highlighting patient safety issues. It was Kathleen’s husband who highlighted concerns with the Nurse Practitioner about her two hypoglycaemic events and querying the dosage she received. This intervention subsequently resulted in the awareness that she had been receiving the incorrect doses because the insulin had been administered by using a syringe rather than a pen device.
This case raises concerns about how a patient’s family member’s expertise is used by healthcare professionals. The report states that Kathleen’s husband had initially told staff on the surgical ward about her medication, including that her insulin was five times stronger than standard insulin. However, we know from the investigation that despite providing this information, this wrong dosage was still given. The report notes that:
“Kathleen’s family had concerns that the nurse administering Kathleen’s insulin in hospital might not be the staff member they had spoken with. Because of this, her Husband felt that “…it puts the responsibility on me” to ensure that Kathleen was given the correct dose.”
Patients must be listened to, and their information, insights and concern must be taken seriously and responded to. In this case, Kathleen was prevented from coming to further harm by the timely action of her husband but unfortunately the opportunity to prevent the two overdoses not prevented.
The report highlights specific concerns about insulin safety training for staff, noting that at the Trust involved the national ‘Safe Use of Insulin’ e-learning programme had not been among the mandatory training requirements for staff (though it has now subsequently been included in this category).
HSIB states that they were told by representatives from the NHS England and NHS Improvement National Diabetes Programme that training, appropriate to the person’s level of responsibility, should be provided to all healthcare staff involved with insulin. However, they also note that:
“The investigation engaged with national leaders to consider how training and support for healthcare professionals could be enhanced to increase the knowledge around insulin use relative to each clinical role. The investigation was told that this would require support from a range of national stakeholders and would need to be co-ordinated by a central NHS body to ensure it was effective.”
As a result of this, HSIB made the following Safety Observation:
“It may be beneficial for insulin training to be competency based and specific to the healthcare practitioner’s role, in line with the ‘Diabetes: getting it right first time’ national specialty report.”
However, there is no specific organisation who is identified as being responsible for the ownership and coordination of this task.
HSIB Recommendations are directed at specific organisations who are asked to respond in 90 days of publication of the report. Their Safety Observations may or may not be directed at a specific organisation and require no formal response. This report makes no recommendations, but four observations.
Patient Safety Learning is concerned that as these patient safety improvement points are only observations, with no specific organisation/s responsible for their delivery and assessment of effectiveness, these are unlikely to reduce the risk of a similar incident occurring in another trust. As noted in our recent report Mind the implementation gap, for HSIB Safety Observations there “appears to be no system to disseminate or act on these, beyond them being published towards the end of numerous patient safety reports”.
We believe that the impact of HSIB investigations on learning and improvement would be significantly strengthened with formal recommendations, which are then implemented in a timely and rigorous manner along with transparent performance monitoring and reporting. Considering the findings of this report, we think there may also be value in a specific assessment by NHS England and NHS Improvement of the rollout and implementation of training for healthcare professionals who dispense, prescribe and/or administer insulin (as recommended in the report Diabetes: getting it right first time.
 HSIB, Administering high-strength insulin from a pen device in hospital, 7 July 2022. https://www.hsib.org.uk/investigations-and-reports/administering-high-strength-insulin-from-a-pen-device-in-hospital/
 NHS England and NHS Improvement, Never Events policy and framework, January 2018. https://www.england.nhs.uk/wp-content/uploads/2020/11/Revised-Never-Events-policy-and-framework-FINAL.pdf
 NHS Improvement, Patient Safety Alert: Risk of severe harm and death due to withdrawing insulin from pen devices, 16 November 2016. https://www.england.nhs.uk/wp-content/uploads/2019/12/Patient_Safety_Alert_-_Withdrawing_insulin_from_pen_devices.pdf
 HSIB, Never Events: analysis of HSIB’s national investigations, January 2021. https://www.hsib.org.uk/investigations-and-reports/never-events-analysis-of-hsibs-national-investigations/
 Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. https://s3-eu-west-1.amazonaws.com/ddme-psl/content/A-Blueprint-for-Action-240619.pdf
 Patient Safety Learning, Mind the implementation gap: The persistence of avoidable harm in the NHS, 7 April 2022. https://www.pslhub.org/learn/patient-safety-learning/patient-safety-learning-documents/patient-safety-learning-mind-the-implementation-gap-the-persistence-of-avoidable-harm-in-the-nhs-7-april-2022-r6564/
 Getting It Right First Time, Diabetes: GIRFT Programme National Specialty Report, November 2020. https://www.gettingitrightfirsttime.co.uk/wp-content/uploads/2020/11/GIRFT-diabetes-report.pdf