Recurring concern

Inadequate controls for safe propofol use

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First reported 11 Jul 2014•Latest report 29 Jan 2026

Definition

What this concern includes

Includes failures of controls specifically dedicated to safe propofol use, including national guidance, dose limits or principles, protocols, prescribing safeguards, clinician understanding and required monitoring for complications such as propofol infusion syndrome.

Not included

  • Excludes generic medication, sedation or intensive-care deficiencies not specifically tied to propofol safety.
  • Excludes failures concerning other medicines or sedatives unless the report explicitly identifies propofol as the shared safety concern.
  • Excludes isolated administration, monitoring or prescribing errors where no propofol-specific control deficiency is identified.
  • Excludes factual descriptions of propofol toxicity that do not identify an inadequate or unreliable safety control.
Reports
2

Distinct published reports

Individual concerns
9

A report can raise multiple concerns

Date range
2014–2026

First to latest report issue date

Stated actions
4

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Faculty of Intensive Care Medicine1
Frimley Health NHS Foundation Trust1
Medicines and Healthcare products Regulatory Agency1
National Institute for Health and Care Excellence1
NHS England1
Paediatric Critical Care Society1
Royal College of Anaesthetists1
Royal Surrey County Hospital1
The Intensive Care Society1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. West Yorkshire Eastern

    AI-generated summary

    Antonio Galisi-Swallow · 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

    Antonio Galisi-Swallow died in hospital on 7 October 2021 after developing Propofol-Related Infusion Syndrome following continuous propofol sedation after cardiac surgery. The inquest heard that there was no national guidance for short-term propofol sedation in children and young people on PICUs, and an expert witness supported a guideline subsequently developed by Leeds Teaching Hospitals Trust.

    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

    Lack of national guidance for propofol use for short-term sedation in children and young people on PICUs

    Wider context from the report

    “During the inquest, the court was told that there is no national guidance for the use of propofol for short term sedation in children and young people on PICU’s. ”

    Source location

    Antonio Galisi-Swallow · 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

    Produce a joint specialist position statement on propofol use in paediatric critical care for publication on participating organisations’ websites.

    Verbatim wording from the response

    “PCCS has convened a specialist group including paediatric intensivists, anaesthetists and pharmacists, with representation from PCCS, the Association of Paediatric Anaesthetists (APA) and the Neonatal and Paediatric Pharmacists Group (NPPG). This group is producing a joint position statement on the use of propofol in paediatric critical care. We expect to publish this on our respective websites in the Summer of 2026.”

    Source location

    Response from Paediatric Critical Care Society
    Page 1 · response
    Published 8 December 2025

    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

    Introduce a mandatory PCCS Quality Standards requirement for Level 3 units to maintain an agreed local guideline for propofol use.

    Verbatim wording from the response

    “As part of the scheduled update to the PCCS Quality Standards (Version 7), we will introduce a mandatory minimum standard requiring all Level 3 paediatric critical care units to have an agreed local guideline for propofol use. This revision will be published later this year.”

    Source location

    Response from Paediatric Critical Care Society
    Page 1 · response
    Published 8 December 2025

    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

    Add a requirement to the next PCCS standards that every paediatric intensive care unit have a local propofol-use guideline.

    Verbatim wording from the response

    “3. The next iteration of the PCCS standards (Version 7 is currently under development) will include a specific requirement that all PCC units must have a local guideline for the use of propofol in PICU. (Expected completion date: end of 2026)”

    Source location

    Response from NHS England
    Page 2 · response
    Published 8 December 2025

    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

    Support development and implementation of the position statement and standards actions so paediatric intensive care units establish safe propofol-use arrangements.

    Verbatim wording from the response

    “NHS England will support with the development and implementation of the actions to ensure all PICUs have appropriate arrangements in place for the safe use of propofol. Action 2 allows engagement with the relevant professional groups (anaesthetists and pharmacy) and is a formal communication to ensure units take swift action without waiting for the longer-term action of the overall standards re-write (Action 3 listed above).”

    Source location

    Response from NHS England
    Page 2 · response
    Published 8 December 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    Developing national propofol guidance for paediatric intensive care is not within the appropriate organisational role.

    Verbatim wording from the response

    “The patient safety leads at NICE have discussed the report and understand that your request is that we develop national guidance on propofol for short term sedation in children and young people on paediatric intensive care units (PICUs).”

    Source location

    Response from National Institute for Health and Care Excellence
    Page 1 · response
    Published 8 December 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    NHS England or the Paediatric Critical Care Society should address propofol guidance and consider requiring local PICU protocols.

    Verbatim wording from the response

    “prescribe, review and monitoring details, and limitations on use). As these issues will vary by locality, they are best described in local guidance.”

    Source location

    Response from National Institute for Health and Care Excellence
    Page 2 · response
    Published 8 December 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    Existing mandated local PICU protocols are considered sufficient because they can address patient selection, contraindications, prescribing and monitoring requirements.

    Verbatim wording from the response

    “We have had sight of Professor ████████ response to your Report and concur with him that the above does not mean that propofol cannot be used in clinical practice as many drugs are not licensed for use in children due to a lack of specific paediatric research evidence. However, use of these types of drugs should be supported by strong local protocols. Such protocols should include patient selection, contraindications, cautions, and local prescribing issues (such as who can prescribe, review and monitoring details, and limitations on use).”

    Source location

    Response from NHS England
    Page 1 · response
    Published 8 December 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    Individual PICU services are responsible for developing local propofol guidance under professional and commissioning standards.

    Verbatim wording from the response

    “NHS England commission PICU services in line with Paediatric Critical Care Society (PCCS) standards. Standard L3-505 lists clinical guidance that each PICU should have in use and these include ‘Drug administration and medicines management’ and ‘Procedural sedation and analgesia’. PICU services are responsible for developing their own local guidelines as a requirement of PCCS standards.”

    Source location

    Response from NHS England
    Page 1 · response
    Published 8 December 2025

    Open published response
  2. Surrey

    AI-generated summary

    Maria De Oliveria Alva LOPES · 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

    Maria De Oliveria Alva LOPES died on 9 September 2012 after developing severe sepsis from an obstructing ureteric stone, followed by septic shock, multiorgan failure and rhabdomyolysis associated with propofol-related infusion syndrome. The principal concerns included delayed recognition and escalation of sepsis, delays in intensive care admission and treatment, inadequate supervision and control of propofol use, and insufficient monitoring for propofol-related complications.

    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

    Lack of national understanding and acceptance of safe propofol amounts

    Wider context from the report

    “15. Lack of national understanding and acceptance of the amount of propofol that can be given and the importance of creating and adhering to guidelines or protocols for its use and to implement continual assessment to look for the complications of PRIS (serial CK levels) ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    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 create and adhere to guidelines or protocols for propofol use

    Wider context from the report

    “15. Lack of national understanding and acceptance of the amount of propofol that can be given and the importance of creating and adhering to guidelines or protocols for its use and to implement continual assessment to look for the complications of PRIS (serial CK levels) ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Lack of continual assessment for complications of propofol-related infusion syndrome

    Wider context from the report

    “15. Lack of national understanding and acceptance of the amount of propofol that can be given and the importance of creating and adhering to guidelines or protocols for its use and to implement continual assessment to look for the complications of PRIS (serial CK levels) ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Lack of clarity about propofol infusion duration, volume and dose

    Wider context from the report

    “10. Lack of clarity to the length, volume and dose of propofol infusion to be given in ITU ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Lack of a protocol for propofol use in ITU

    Wider context from the report

    “11. Lack of medical supervision and control of the use of propofol in ITU (no protocol in place) ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Lack of medical supervision and control of propofol use in ITU

    Wider context from the report

    “11. Lack of medical supervision and control of the use of propofol in ITU (no protocol in place) ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Lack of understanding that propofol-related infusion syndrome is a complication of prolonged propofol sedation

    Wider context from the report

    “13. Lack of understanding and acceptance Propofol related infusion syndrome (PRIS) is an accepted albeit rare, complication of the use of prolonged propofol for sedation in Intensive Care Units ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Lack of understanding of atypical adult presentation of propofol-related infusion syndrome

    Wider context from the report

    “14. Lack of understanding that PRIS may have an atypical presentation in adults and should always be a consideration when propofol is used for a protracted period of time ”

    Source location

    Maria De Oliveria Alva LOPES · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
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Data last updated 7 September 2026