Dear Mr Shah,

Regulation 28: Report to Prevent Future Deaths – Dominic Martin Philip

Thank you for the Regulation 28 report for Mr Dominic Martin Philip dated 14 March 2025.

I am very sorry to hear that Mr Philip died on 3rd February 2023 at Kettering General Hospital as a result of an anaphylactic reaction to a contrast medium injected for the purposes of an abdominal CT scan to investigate a bowel obstruction. We extend our sincere condolences to his family.

I note that you have raised three matters of concern during the course of your investigation, and I have addressed them in turn as below:

1. Might there be some possibility of testing for an allergic reaction to the contrast medium in advance of an imaging procedure? 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.

The use of diagnostic imaging has been increasing year-on-year with annual figures for the NHS reporting a total of 7.7 million CT scans performed in England in the year to March 2024. As such, the feasibility of pre-procedure screening for contrast medium allergy will need careful evaluation and further discussion with local healthcare providers

and professional bodies with expertise in radiology, in particular the consideration of the potential burden being placed on the healthcare system.

At present, there is no standardised sensitivity test for allergy testing of contrast medium. The approved product information (also known as Summary of Product Characteristics) for contrast medium does not refer to a requirement for allergy testing to be performed in advance of an imaging procedure, as severe reactions to contrast media may not consistently be predictable from sensitivity tests, and there are risks of other adverse reactions associated with contrast medium.

From a regulatory perspective, there are existing and substantial warnings of the potential for allergic reactions/anaphylactoid reactions in the approved product information (SmPC) for contrast medium. Specifically, healthcare professionals are advised to exercise special caution in patients with a positive history of allergy, asthma or untoward reactions to iodinated contrast media. Clinicians are advised to consider the use of contrast media when the benefits outweigh the risks, and the SmPC states that a course of action should be planned in advance to ensure that there are appropriate resources such as necessary medicines, equipment, medical experience and skilled personnel available for the management of anaphylactic reactions should they occur. The SmPC advises that pre- medication (such as antihistamines and steroids) may also be considered in patients at risk of intolerance. However, these are to be decided on a case-by-case basis, as anaphylaxis may occur despite pre-medications. The decision to administer a contrast medium alongside a particular imaging modality, such as CT, should take into account the patient’s presentation and clinical indication based on factors in the individual case. The total potential diagnostic benefits of an imaging examination are determined by a trained practitioner legislated in the UK under The Ionising Radiation (Medical Exposure) Regulations 2017.

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.

2. I am 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.

Your concerns around the unexplained presence of lidocaine in Mr Philip’s system is noted. It seems unclear whether there may have been potential use of over-the-counter products or medical devices prior to Mr Philip’s imaging procedure at Kettering General Hospital that may account for the detection of plasma lidocaine levels post-mortem.

To date, the Defective Medicines Report Centre (DMRC) of the MHRA have not received any reports identified by Marketing Authorisation Holders of licensed medicines that relate to product contamination issues with lidocaine. There was a company-led medicines recall for an over-the-counter product (EXS Delay Spray Plus) in 20241, whereby lidocaine was

1 Company-led medicines recall

found to be present in two affected batches supplied to the UK. However, this incident is unlikely to be related to this case as the affected batches only entered the UK supply chain as of November 2023, which was after the death of Mr Philip.

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.

3. 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 MHRA can confirm that lidocaine is a prescription only medication (POM), however it is not listed in Schedule 2 of the Misuse of Drugs Act 1971 as a Controlled Drug. Regulation 214 of The Human Medicines Regulation 2012 mandates that a person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.

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.

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.

I hope that you find this information helpful.

Dear Mr Shah, RCR Response to Regulation 28: Prevention of Future Deaths report issued on 14 March 2025 in relation to the death of Mr Dominic Martin Philip. I was very sorry to read about the death of Mr Dominic Philip and I would like to express my deepest condolences to Mr Philip’s family. We take the matters raised in your report very seriously and I hope this reply will be helpful in outlining how we are committed to learning from them and supporting our members and Fellows to develop and maintain excellent medical care. The Royal College of Radiologists (RCR) is a charity which works with our members and Fellows to improve medical care across the specialties of Clinical Radiology and Clinical Oncology. We promote excellence in professional practice within our specialties and we produce a range of publications, including standards for the delivery of high-quality radiology services.

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.

It is correct that X-ray imaging has limited diagnostic value in assessing bowel obstruction. A computed tomography scan with ICM is a much more sensitive investigative test for this condition.

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..

It is important to note that any delay in conducting necessary diagnostic tests may be harmful as recognition and treatment of a potentially life-threatening condition would not be made in a timely manner. If testing for allergy was instituted then this would lead to delays in conducting CT for all patients, the vast majority of whom would be exposed to additional risk through delay but would not benefit as they are not allergic to ICM. Furthermore, allergic reactions can sometimes be idiosyncratic, manifesting unpredictably even after uneventful prior exposure.

Anaphylaxis management is commonly included as part of statutory and mandatory training in hospitals, including basic life support, immediate life support, and advanced life support training programmes. In keeping with other medical emergencies there is typically a balance between training staff who will be present to recognise and provide an immediate response with a recognition that frequent practice enables greater expertise and ensuring that suitable assistance is available to respond to such rare events.

We are unable to provide an explanation for the presence of lidocaine in the patient’s blood and trust that the other parties to whom you have sent the notice are better placed to address this concern.

Whilst we do not have specific knowledge of the practices at Kettering General Hospital, we can provide general observations. Local policies are usually in place to ensure clear differentiation between medications. Published literature, such as that from the Anesthesia Patient Safety Foundation, has noted that certain vials of medication, including lidocaine and saline, can have similar appearances, which underscores the importance of robust stock management and pharmacy oversight.

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. I am grateful to you for bringing these matters of concern to our attention and for giving us the opportunity to respond. Once again, I express my deepest condolences to Mr Philip’s family and loved ones.

Dear Mr Shah

Mr Dominic Martin Philip: Regulation 28 Report

I write to formally acknowledge receipt of the above Regulation 28 Report issued to this Trust and to provide a response detailing the actions we have taken.

You raised a concern that, whilst the trust asks all patients who undergo a CT contrast study whether they have any allergies or are allergic to the contrast, patients that have not been exposed to contrast will not know if they have an allergy. You requested that the trust explores whether allergy testing prior to a planned contrast study would be beneficial.

Anaphylaxis is a severe, potentially life-threatening allergic reaction that can occur rapidly after exposure to an allergen. Any medication, substance or environmental factor has the potential to trigger an anaphylactic reaction in susceptible individuals. In considering the benefit to patients who are attending the hospital for a planned CT contrast diagnostic test, it should be noted that life threatening reactions following CT contrast, account for less than 0.2% of patients attending. Mortality following contrast is less than one death per 100,000 patients. Kim MH, et al Anaphylaxis to iodinated contrast media: clinical characteristics related with development of anaphylactic shock. (2014) 16;9(6)

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.

In patients who have shown a reaction previously to contrast and who require further testing to accurately determine allergy status there are a combination of 3 tests including a skin prick test, an intradermal test and a provocation test (where a small

Medical Directors Office Private and Confidential Cliftonville Mr H Shah Assistant Coroner Northampton The Guildhall NN1 5BD St Giles’ Square

Northampton

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9 May 2025

amount of contrast is introduced to determine whether there is a true allergy to the contrast).

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.

Last year UHN performed 59,598 CT scans with contrast. The number of individual patients may be slightly less due to some patients receiving multiple scans, but the immunology services would not be able to absorb this number of extra patients within its service, and significant national investment would be required. It should also be noted that, often patients are referred for CT contrast studies within a cancer pathway to determine diagnosis. There is a risk in introducing a routine allergy test there will be delays in these diagnostic pathways and ultimately treatment of cancer. Therefore, on the balance of risk to both the NHS in the use of resources and the potential impact on patients it is not considered that routine testing would be viable.

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.

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.

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.

There was a concern raised that Lidocaine was found to be present on the toxicology report Mr Dominic Phillips and despite investigation it was not possible to determine where the lidocaine came from. You asked us to review the possibility of there being contaminated medication containing lidocaine

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK’s primary regulatory body for medicines, medical devices and blood products. The MHRA regulates all aspects of medicines, from their development and manufacture to their use and safety monitoring.

The MHRA uses a yellow card scheme to collect information about suspected side effects and adverse incidences including those related to contaminated medication. For any contamination of medication, the MHRA would initiate a recall, send a defect notification, and safety communications to inform the public and healthcare professionals about potential safety issues.

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.

It is unclear from the toxicology report the amount of lidocaine that was present to enable an understanding of potential sources of administration.

The trust can therefore not determine the source of the lidocaine, despite its extensive investigations and noting that there has been no alert in respect of contaminated medications.

Dear Mr Shah,

Thank you for the Regulation 28 report of 14th March 2025 sent to the Secretary of State / the Department of Health and Social Care about the death of Mr Dominic Martin Philip. I am replying as the Minister with responsibility for medicine regulation and prescribing.

Firstly, I would like to say how saddened I was to read of the circumstances of Mr Philip’s death and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention. Thank you for the additional time provided to the department to provide a response to the concern/s raised in the report.

The report raises the following concerns:

• Testing for an allergic reaction to contrast medium is not carried out in advance of usage.
• Mr Philip had come into contact with lidocaine (which Mr Philip had disclosed an allergy to) without explanation.
• Safety controls around obtaining lidocaine within a clinical setting. Lidocaine is not a controlled drug and so it does not need a double signature to be removed from a hospital storage facility and it is not subject to stock checks to identify anomalies.

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. In regard to your concern about safe and secure handling of medicines in healthcare settings, NHS England has provided the following information. In general the trust senior leadership team has overall accountability for the safe and secure handling of medicines in the organisation. It needs to ensure that relevant legislative and regulatory requirements are

met. The Royal Pharmaceutical Society has published comprehensive professional guidance that covers all aspects of the safe and secure handling of medicines in healthcare settings. Safe and secure handling of medicines is also referenced by the Care Quality Commission as part of its regulatory function. The trust Chief Pharmacist (or equivalent) will usually have delegated responsibility for medicines governance within the organisation. However, operationally, safe and secure handling of medicines in wards and Departments is the responsibility of the senior ward or department manager (usually the lead nurse). Their responsibilities include agreeing and managing stock levels of medicines that will be kept in the ward or department (in discussion with the trust’s pharmacy team) and ensuring that access to them is restricted as per local governance arrangements. As you have written to the University Hospitals of Northamptonshire NHS Group, I expect that the Trust will address this specific concern.

As you may be aware, lidocaine is a prescription only medicine (POM) and as such should be stored in a locked cupboard in a room that can also be locked. There may be a small number of exceptions for medicines that may be needed in an emergency situation. However, these should be risk assessed and documented in local medicines policies and procedures. Given that lidocaine is not a controlled drug, there is no legal requirement for a register to be kept nor for a record of access to be made. The advent of automated medicines storage cabinets which are increasingly being implemented (some with biometric only access) in trusts will make it easier to monitor medicines use and provide a more robust audit trail. However, they are not universally available in all trusts.

I hope this response is helpful. Thank you for bringing these concerns to my attention.