PFD report

Dominic Martin PHILIP · Prevention of Future Deaths report

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Issued 14 Mar 2025•Northamptonshire

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
3

Raised in this report

Recipients
4

Named on the report

Responses found
4

Of 4 recipients

Stated actions
5

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised3

  1. Unexplained exposure to Lidocaine, including for people allergic to Lidocaine
  2. Lack of pre-injection identification of potential allergy to iodinated contrast agents
    Part of recurring concern: Unsafe administration of intravascular contrast media
  3. Failure to maintain accountable removal and stock counts for Lidocaine
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. Action

    Develop and publish guidance on administering iodinated contrast media and gadolinium through the established working party.

    Stated by Royal College of RadiologistsStated in progressThe respondent said that this action was in progress when they made their response on 15 December 2025.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.8

  1. Position

    No reliable standardised test can currently predict contrast reactions in patients without prior adverse symptoms.

    Stated by University Hospitals of Northamptonshire NHS GroupDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Unexplained exposure to Lidocaine, including for people allergic to Lidocaine

Wider context from the report

“b) Mr Philip did disclose an allergy to Lidocaine. The toxicology report records that Lidocaine was detected in Mr Philip’s blood post-mortem. Despite the hospital conducting a comprehensive review of the care provided, it has not been possible to ascertain why Lidocaine was present in Mr Philip’s system. Aside from the contrast medium, the only medication that Mr Philip received at hospital was IV Tazocin, IV paracetamol, Oramorph and IV saline. The toxicologist has also ruled out any possibility of contamination of the blood sample during testing. The toxicologist adds “I note that Mr Philip described as healthy so I would not expect its use outside a hospital setting”. There was no other source identified at inquest. I am therefore concerned that Mr Philip has come into contact with Lidocaine without any explanation – could there be a contaminated supply of medication? Have there been any similar unexplained occurrences anywhere else in the country? This is of course of particular concern to those who, like Mr Philip, are allergic to Lidocaine. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of pre-injection identification of potential allergy to iodinated contrast agents

Wider context from the report

“a) It was stated in evidence that - an X-Ray is no longer preferred as it is not sensitive enough and a smaller obstruction might be missed; anaphylactic type reactions to iodinated contrast agents are rare accounting for 0.6% of cases with only 0.04% considered aggressive; and almost all contrast reactions that are life threatening occur within 20 minutes of intravenous injection. The current policy appears to be that a patient referred for a CT scan by the Emergency Department is to be accompanied by a doctor trained in advanced life support (ALS). In Mr Philip’s case, he was accompanied by a Core Trainee Year 2 who had ALS training. The policy for planned/outpatient interventions was not fully explored at inquest, but there was a suggestion that there might be some possibility testing for an allergic reaction to the contrast medium in advance of such an appointment? My concern is that if a patient has never before had contrast medium (as was the case with Mr Philip) they cannot possibly know if they have an allergy to it. Making arrangements for ALS after the event seems reactionary and I wondered if any other options might be available which would flag a potential allergy before the contrast is injected. ”

Is this part of a recurring concern?

Yes — Unsafe administration of intravascular contrast media.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to maintain accountable removal and stock counts for Lidocaine

Wider context from the report

“c) It has also been brought to my attention in a different case currently under investigation within my jurisdiction that as Lidocaine is a prescription only medication, it needs to be stored in a locked cupboard. However, Lidocaine is not a Controlled Drug which means that clinicians do not need a double signature to remove the medication from the stock and it is not subject to a count of the stock each time an ampoule is used. The Hospital has stated that “The use of Lidocaine will vary within each area dependant on the patients being seen within each department and treatments given. Stock levels are reviewed by pharmacy to ascertain stock required. Unless a large amount of stock was removed from a single clinical area there would be no alert to indicate that Lidocaine was being removed for reasons other than patient treatment”. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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

Develop and publish guidance on administering iodinated contrast media and gadolinium through the established working party.

Verbatim wording from the response

“There are several different manufacturers of iso-osmolar iodinated contrast medium (ICM) which is typically used when a CT scan is performed. For a number of years the UK radiology community has looked to the European Society of Urogenital Radiology and the Royal Australian and New Zealand College of Radiologists guidelines on the use of such ICM. The RCR has recently established a working party to develop ICM guidance that will provide recommendations on the administration of iodinated ICM and gadolinium. We anticipate this guidance will be published in early 2026.”

Source location

Response from The Royal College of Radiologists
Page 1 · response
Published 15 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

No reliable standardised test can currently predict contrast reactions in patients without prior adverse symptoms.

Verbatim wording from the response

“It should further be noted that there is currently no reliable or standardised test to predict patients that may have a reaction to contrast without any history of adverse symptoms.”

Source location

Response from University Hospitals of Northamptonshire NHS Group
Page 1 · response
Published 15 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

The absence of relevant MHRA alerts makes manufacturer-contaminated medication an unlikely source of the lidocaine.

Verbatim wording from the response

“A review of the MHRA alerts revealed one alert nationally relating to product contamination and this involved a tablet of loperamide. There were no incidences concerning Lidocaine. Therefore, it is unlikely that the patient was given contaminated medication from a manufacturer.”

Source location

Response from University Hospitals of Northamptonshire NHS Group
Page 3 · response
Published 15 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

Routine allergy testing is not viable because services lack capacity and testing could delay diagnostic and cancer-treatment pathways.

Verbatim wording from the response

“This immunology testing is not available at either of the hospitals within the University Hospitals of Northamptonshire (UHN) and patients would need to be referred to tertiary centres such as Leicester, Oxford or Addenbrooke’s to obtain this test. This process would have a potential significant impact on patients in the Northamptonshire area in terms of time, travel and cost.”

Source location

Response from University Hospitals of Northamptonshire NHS Group
Page 2 · response
Published 15 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

Other agencies, particularly the Trust, are responsible for directly addressing the concerns about medicine handling and related safety controls.

Verbatim wording from the response

“Having reviewed these concerns, it is my view that the other agencies with which you have shared the report are best placed to respond directly to the issues you have raised, which are relevant to their respective areas. We did however contact NHS England, and I have shared below the organisation’s comments.”

Source location

Response from Department for Health and Social Care
Page 1 · response
Published 15 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

No product contamination issues involving lidocaine or similar unexplained occurrences have been identified through surveillance.

Verbatim wording from the response

“Based on the MHRA’s pharmacovigilance and post-marketing surveillance activities, we are also not aware of any product contamination issues with prescription only medicines or medical devices in relation to contamination with lidocaine, nor any similar unexplained occurrences elsewhere in the country.”

Source location

Response from Medicines & Healthcare Products Regulatory Agency
Page 3 · response
Published 15 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

Decisions about additional lidocaine governance processes belong to the relevant medicines management committee at the local NHS Trust.

Verbatim wording from the response

“It should be noted that lidocaine is contained in multiple drug formulations which can be administered by different routes, including during medical procedures in the emergency department. Therefore, the consideration of additional governance processes for the management of lidocaine (such as double signatures) should be carefully considered to avoid undue delay to patient access and minimise additional burden on healthcare professionals. As this is not a decision for the MHRA we would advise that additional guidance is sought from the relevant medicines management committee at the local NHS Trust.”

Source location

Response from Medicines & Healthcare Products Regulatory Agency
Page 3 · response
Published 15 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

Additional handling procedures for non-controlled lidocaine are outside the remit unless a specific safety concern exists.

Verbatim wording from the response

“For medicines that are not Controlled Drugs, the requirement for double signatures for stock count and supply processes is generally determined by medicine management procedures within individual hospitals and healthcare providers, who may sometimes consider more stringent controls are warranted due to a medicine’s potential for misuse, cost or other supply-related considerations. Unless there is a safety concern, any additional procedures for the handling of medicines would be outside the remit of the MHRA.”

Source location

Response from Medicines & Healthcare Products Regulatory Agency
Page 3 · response
Published 15 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

Routine pre-exposure allergy testing for iodinated contrast medium is not considered necessary because reactions are rare and testing could delay urgent CT scans.

Verbatim wording from the response

“Regarding drug allergies, it is an inherent characteristic of all medications that a patient may not be aware of an allergy until they are exposed to the drug. Given the very low incidence of allergic reactions, routine pre-exposure testing for all patients is not standard medical practice for most medications and ICM has a lower incidence of provoking an anaphylactoid reaction than many other medications which are similarly not assessed.”

Source location

Response from The Royal College of Radiologists
Page 1 · response
Published 15 December 2025

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.4

  1. 1

    Provide appropriate emergency equipment to support patients experiencing life-threatening reactions.

    Stated by University Hospitals of Northamptonshire NHS GroupStated completedThe respondent said that this action was complete when they made their response on 15 December 2025.
  2. 2

    Use newer contrast agents with an improved safety profile for diagnostic testing.

    Stated by University Hospitals of Northamptonshire NHS GroupStated completedThe respondent said that this action was complete when they made their response on 15 December 2025.
  3. 3

    Train staff to manage emergency situations arising within diagnostic departments.

    Stated by University Hospitals of Northamptonshire NHS GroupStated completedThe respondent said that this action was complete when they made their response on 15 December 2025.
  4. 4

    Continue monitoring and reviewing adverse-event reports for contrast media through pharmacovigilance activities.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 15 December 2025.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.2

  1. 1

    Existing emergency training, equipment and newer, safer contrast agents are considered sufficient to mitigate rare contrast anaphylaxis risks.

    Stated by University Hospitals of Northamptonshire NHS GroupExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
  2. 2

    Individual medication-dose tracking cannot generally be implemented because most NHS hospitals lack the required IT capability and resources for training and workload changes.

    Stated by Royal College of RadiologistsUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

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

Provide appropriate emergency equipment to support patients experiencing life-threatening reactions.

Verbatim wording from the response

“The trust is assured that staff are trained in the management of emergency situations within the departments and that appropriate equipment is available to support patients in these rare and life-threatening situations.”

Source location

Response from University Hospitals of Northamptonshire NHS Group
Page 2 · response
Published 15 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

Use newer contrast agents with an improved safety profile for diagnostic testing.

Verbatim wording from the response

“There have been developments in the safety of contrast used in diagnostic testing with newer contrasts that are used by the trust thereby having an improved safety profile.”

Source location

Response from University Hospitals of Northamptonshire NHS Group
Page 2 · response
Published 15 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

Train staff to manage emergency situations arising within diagnostic departments.

Verbatim wording from the response

“The trust is assured that staff are trained in the management of emergency situations within the departments and that appropriate equipment is available to support patients in these rare and life-threatening situations.”

Source location

Response from University Hospitals of Northamptonshire NHS Group
Page 2 · response
Published 15 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

Continue monitoring and reviewing adverse-event reports for contrast media through pharmacovigilance activities.

Verbatim wording from the response

“The MHRA will continue to monitor and review adverse event reporting for contrast media as part of our pharmacovigilance activities and consider appropriate actions where applicable.”

Source location

Response from Medicines & Healthcare Products Regulatory Agency
Page 2 · response
Published 15 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 emergency training, equipment and newer, safer contrast agents are considered sufficient to mitigate rare contrast anaphylaxis risks.

Verbatim wording from the response

“The Royal College of Radiologists refer to the Royal Australian and New Zealand College of Radiologists in its recommendations for managing the risk of contrast anaphylaxis and cite the diagnosis of anaphylaxis and appropriate emergency preparedness as being essential in managing and mitigating the risks associated with anaphylaxis.”

Source location

Response from University Hospitals of Northamptonshire NHS Group
Page 2 · response
Published 15 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 medication-dose tracking cannot generally be implemented because most NHS hospitals lack the required IT capability and resources for training and workload changes.

Verbatim wording from the response

“It would be technically possible to track an individual dose of medication to an individual patient. While such tracking would be technically feasible, implementing this process would necessitate significant IT system upgrades, which are currently beyond the capabilities of most NHS hospitals and would have staff training and workload implications.”

Source location

Response from The Royal College of Radiologists
Page 2 · response
Published 15 December 2025

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
4/4

Data last updated 7 September 2026