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Patient safety special focus

Reducing harm from high-risk medicines

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This intervention aims to reduce harm from five high-risk medicines

Keywords: High-risk medication, Diabetes, Process review

The goal

The aim is to prevent harm to patients receiving high-risk medicines – anticoagulants, opiates, insulin and anaesthetic sedatives – by preventing, identifying and mitigating risks.


The NPSA has reviewed medication incidents reported via the national reporting and learning system. This confirms that the high-risk medications selected for this intervention have caused death and severe harm in England and Wales.

High-risk medicines are those that are most likely to cause significant harm to patients, even when used as intended. The Institute for Safe Medication Practices reports that incident rates with this group of medicines may not necessarily be higher than with other medicines but, when incidents do occur, the impact on patients can be significant.

The intervention

This intervention has one general component that applies to all high-risk medicines and five components that apply to specific drugs:

  • Overarching actions;
  • Anticoagulants - warfarin;
  • Anticoagulants - heparin;
  • Injectable sedatives - midazolam;
  • Opiates;
  • Insulin.

Trusts can choose one high-risk medicine to start with. Patient Safety First encourages them to tackle warfarin as a priority. While it is associated with the highest medicines-related harm, reducing harm from use of warfarin is also the most complex to resolve. The NPSA (2007) has provided detailed guidance on this.

Overarching principles

There are three suggested actions, based on approaches to developing safer systems, to reduce harm from high-risk medicines: identification; prevention; and mitigation:

  • Identification – monitor INRs>6;
  • Prevention – match strengths of medicines stocked in clinical settings to clinical need;
  • Mitigation – adopt protocols to allow antidotes or reversal agents to be administered without delay.

This section in The ‘How to Guide’ for Reducing Harm from High Risk Medicines provides a worked example for the first of these three actions to demonstrate the method. Teams working on this intervention may refer to this and information in the accompanying campaign document, Introduction to Implementing Campaign Interventions, to work through the remaining two.

Specific high-risk medicines

This section in the How to Guide provides a worked example for each of the high-risk drugs to illustrate the approach being encouraged.

The examples ask trusts to consider what they are trying to achieve, how they will know a change has been an improvement and the changes that can be made that will result in an improvement. The last matter is broken down into organisational, clinical-area and patient-level changes. Outlined below is the worked example for insulin.


What are we trying to achieve?

Find out if you have updated protocols in place. If so, then perform an audit to find out whether staff use them appropriately.

An example of an aim statement could be: Within 18 months we will reduce the use of 25% and 50% glucose used to correct insulin-induced hypoglycaemia by 50%. This will be achieved by reviewing and revising insulin prescribing charts as well as prescribing policy and practice in each clinical setting.

How will we know a change has been an improvement?

Measurement is the only way to know whether a change represents an improvement.

Decide what measures will inform you of progress and how you are going to collect them.

One suggested measure is the number of patients who received 25% or 50% glucose to correct insulin-induced hypoglycaemia. Another suggested measure is the insulin adverse event rate.

What changes can we make that will result in an improvement?

See Table 1 for clinical-area level changes.


CategoriesPossible changes/actionsType of action
Labelling and storage
  • Discard the outer packaging after opening
  • Use one standard concentration for all IV preparations
  • Label all insulin vials and devices with the patient’s name and details and ensure they are taken by the patient or returned to pharmacy at patient discharge
  • Minimise stock held in clinical areas





Monitoring compliance
  • Patient compliance monitored alongside regular clinical monitoring
  • Review processes for patients managing their own insulin



Education and training
  • Education of healthcare professionals in the identification of both overdosage and underdosage
  • Ensure staff training reflects the increasing complexity of insulin types, devices and prescribing. Develop regular bulletins describing update and changes to types of insulin and devices





For information on suggested actions at organisation and patient levels for insulin, and for worked examples on the other high-risk medicines, see the How to Guide’ for Reducing Harm from High Risk Medicines.

Click here for the summary of the guide

Case study: Medway NHS Foundation Trust

Medway NHS Foundation Trust is tackling Patient Safety First’s high-risk medicines intervention. It is one of three interventions the trust is undertaking to reduce harm to patients. The initiative to reduce harm from high-risk medicines focuses specifically on insulin and is trialling an amended prescription form in one ward. 

‘Small changes can really make a big difference,’ says Helen Goodwin, head of governance and risk. ‘We are West Kent’s vascular centre so encounter many patients with diabetes who require vascular surgery. Insulin levels can sometimes be difficult to control after surgery so normal insulin regimens do change with varying dosages and different types of insulin prescribed.’

Ms Goodwin explains: ‘The change from intravenous sliding scale insulin during and immediately post surgery back to a subcutaneous route has resulted in patients suffering from hypoglycaemic and hyperglycaemic episodes.

‘There were also a number of near-misses with nurses misreading prescriptions. We realised there were issues associated with the prescription and administration of insulin for people with diabetes,’ she says.

In Medway’s case, one of the problems was due to the design of the prescription form. Nurses usually take their direction on how much insulin to administer from handwritten prescriptions by doctors, made on a standard prescription sheet that is uniform across the trust.

However, as the trust has realised, there are risks in this process which have the potential to lead to an overdose. This is because the design does not include a printed unit section where doctors note the dosage required. The risk is when the doctor abbreviates the international unit to IU and occasionally even to U, which in turn can be easily mistaken for a 0.

In instances like this it is too easy for the amount of insulin actually intended to be misread, resulting in a dose ten-fold higher than that intended.

Ms Goodwin points out: ‘Errors here are nothing to do with competency or training but simply a case of misreading; a human error we all make.

‘But the answer is so simple. We looked at the forms and eradicated the room for error by filling the unit box with pre-printed stickers with IU on, and there hasn’t been an error or near-miss involving insulin on the reporting system since,’ she says.

Having tested the system on one ward, with the full support of the consultant, the head of pharmacy and the patient safety lead, Medway is now preparing to roll this system out to other wards using the small-step approach to change.

‘We’ll now be trialling this amended form in other wards, starting slowly over a couple of days to make sure that no problems arise, and if we continue without an adverse incident then we’ll look at permanently altering the design of our prescription forms,’ Ms Goodwin adds.

Jacqueline McKenna, director of nursing and strategic planning, comments: ‘We are committed to improving patient safety across the trust and fully support Patient Safety First. This is one of several initiatives running across the trust as part of our overall strategy for patient safety. Involving our frontline staff is essential in making sure that any changes to systems do work in practice.’

Ms Goodwin stresses the importance of staff ownership of changes: ‘Feeling motivated and confident to test ideas that may benefit their patients has really helped staff feel involved in change and, crucially, to feel that they can go it alone, making amendments that improve patient safety without feeling constrained.’ She concludes this is essential in creating a strong patient safety culture.

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