Recurring concern

Inadequate safeguards for medication-safety software overrides

First to latest report 15 Jun 2018 — 25 Nov 2021

Reports that mention this concern
2
Times this concern has been raised
2
Stated actions linked to this concern
6

What this concern includes

Includes failures of medication-safety or prescribing software controls involving inappropriate override authority, missing limits or escalation, inadequate justification, or absent documentation of overrides.

What is not included
  • Excludes failures of non-medication software or systems unless the report explicitly ties them to medication-safety overrides.
  • Excludes general documentation, training, staffing or governance deficiencies that are not specifically dedicated to controlling medication-safety software overrides.
  • Excludes clinical decisions to override guidance or treatment plans where no medication-safety software override is involved.
  • Excludes software failures unrelated to override control, such as failure to recognise a clinical condition, unless the unsafe condition is specifically an inadequately controlled medication-safety override.

Reports and published responses 2 reports

See individual reports that have raised this concern, and the actions taken in response

  1. Berkshire

    AI-generated summary

    Saif Mubeen Hussain · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Saif Mubeen Hussain died at John Radcliffe Hospital on 10 June 2021 after being admitted following an incident in Bracknell, Berkshire, on 3 June 2021; the recorded cause of death was polytrauma. During his transfer between units, he was administered a Heparin infusion at almost eight times the prescribed rate. The report identified concerns about unfamiliarity with anticoagulants, inadequate double-checking, the Guardrails system being switched off, differences between prescription and administration rates not being flagged, and the use of separate hospital computer systems.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to define and document overrides of medication-safety software

    Wider context from the report

    “3. Whether software like Guardrails should be implemented more widely, and consideration given to when and how it is possible to override this, and how that should then be documented. ”

    Source location

    Saif Mubeen Hussain · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Educate staff to use medication libraries and not bypass safety limits except in exceptional circumstances.

    Verbatim wording from the response

    “Each medication library will contain a list of medications with specified concentrations and/or dosing safety limits to reduce the risk of infusion related incidents e.g., overdosing or underdosing. Resource will be allocated to ensure that medication entries on the libraries are accurate, relevant, and appropriate so that staff should not need to override safety limits if following usual practice; the software is designed not to be overridden if inappropriate dosing is entered outside of the safe limits put in place.”

    Source location

    2021-0399-Response-from-Oxford-University-Hospitals_Published
    Page 2 · response
    Published 29 November 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Devise and document an escalation process, standard operating procedure and quick-reference flowsheet for exceptional medication-library overrides.

    Verbatim wording from the response

    “However, in some exceptional circumstances outside the norm, it may be necessary for patient care to deviate from the specified dosing limits and therefore the infusion pumps offer the capability to infuse medication outside of the library where safety limits are not imposed. Staff will be educated that they must not work outside of the medication library unless in exceptional circumstances and an escalation process will be devised to enable a clear audit trail of all communication and decisions made between staff members which will be documented in the patients’ medical notes. This will be detailed in a standard operating procedure and will contain a flowsheet of the escalation process as a quick reference guide for staff members. A working group has been set up on NICU, who already use a medication library, to trial this.”

    Source location

    2021-0399-Response-from-Oxford-University-Hospitals_Published
    Page 2 · response
    Published 29 November 2021

    Open published response

  2. Brighton and Hove

    AI-generated summary

    Darren James CARRINGTON · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Darren James CARRINGTON died after collapsing with a fatal level of Zopiclone in his blood and did not recover. The inquest concluded that the death was misadventure, being an impulsive overdose while under the influence of alcohol. Concerns included the prescribing of potentially dependency-forming medication, excessive Zopiclone prescribing over 57 days, and the ability of receptionists and clinicians to override computer warnings and other safeguards.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of prescribing-system warnings to prevent inappropriate override

    Wider context from the report

    “The method of prescribing medication such as Zopiclone (in this case), Codeine, Morphine, Benzodiazepines etc. to patients which suggests that they either are or are very likely to be becoming dependent upon such medications or are misusing them. Examples of both the above would be too frequent requests for repeat prescriptions and information concerning a history of overdoses. The Inquest discussed whether circumstances, including those outlined above should trigger an automatic/mandatory medication review conducted with the patient; consideration of a different prescribing period and very careful monitoring of the online requests for repeat prescriptions. Alternatively, there could be a ban on the requests for repeat prescriptions with the repeats simply being issued for an appropriate period of time “automatically”. In this case as you will see from ████████ report, over twice the appropriate amount of Zopiclone was issued over a period of 57 days. The patient in question had Zopiclone present at a fatal level in his blood at the time of his collapse from which he never recovered. I remain very worried about these prescribing issues and about the fact that apparently receptionists and clinicians can override the warnings in the surgery’s computer system. I should like this to be carefully investigated and look forward to hearing with a response within the relevant time period. I realise that the situation may be exacerbated by GPs working part time and many part time practitioners being involved in the prescribing procedure as well as many receptionists being involved in it but if this is the trend then it seems to me the safeguards must be extended not made easier to override. The other ‘failsafe device’ is the dispensing pharmacist. When repeats are requested online there is a designated pharmacy. They receive emailed scripts. Their own systems should flag up cases of over or too frequent prescribing as well as other matters. ”

    Source location

    Darren James CARRINGTON · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review high-risk prescribing records and remove online prescription-request access for weekly, controlled, dependency-forming and potentially abusive medicines.

    Verbatim wording from the response

    “• Records of all patients receiving weekly prescriptions have been reviewed and access to on-line requests have been removed.”

    Source location

    2018-0181-Response-from-Commission-Alliance-
    Page 2 · response
    Published 8 July 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Lower computer-alert thresholds for early prescription ordering and increase awareness of relevant alerts.

    Verbatim wording from the response

    “• Computer settings changed with a view to lower thresholds for flagging up early ordering of scripts and increased awareness around the potential significance of these and other alerts.”

    Source location

    2018-0181-Response-from-Commission-Alliance-
    Page 2 · response
    Published 8 July 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Change computer-system thresholds so early-order warnings appear one day before due dates and online ordering closes three days before due dates.

    Verbatim wording from the response

    “4. An investigation into online ordering and script generation by the computer system was conducted in conjunction with the practice IT co-ordinator. As a result, the timings were changed within the system so that warnings about scripts being ordered too early were changed from 7 to 1 day and ordering online from 10 to 3 days.”

    Source location

    2018-0181-Response-from-North-Laine-Medical-Centre
    Page 2 · response
    Published 8 July 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Develop a computer-generated warning identifying patients with overdoses or suicide attempts when high-risk medicines are requested.

    Verbatim wording from the response

    “10. A further meeting is planned with the practice IT coordinator to highlight automatically patients who have taken an overdose when certain high-risk drugs are requested. We hope to have this in place shortly.”

    Source location

    2018-0181-Response-from-North-Laine-Medical-Centre
    Page 2 · response
    Published 8 July 2018

    Open published response

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026