Dominic Philip

Minister of State for Health (Secondary Care)  

39 Victoria Street  
London  
SW1H 0EU  

HM Assistant Coroner Hassan Shah  
HM Coroner for the County of Northamptonshire,  
The Guildhall,   
St Giles’ Square,   
Northampton   
NN1 1DE  

30 May 2025  

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.    

Yours sincerely,   

MINISTER OF STATE FOR HEALTH

10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Mr Hassan Shah 
Assistant Coroner for Northamptonshire 
West Northamptonshire Council 
The Guildhall, St Giles’ Square 
Northampton NN1 1DE 

24 April 2025 

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.  

Yours sincerely, 

Chief Safety Officer 
Medicines and Healthcare products Regulatory Agency

Assistant Coroner Mr Hassan Shah 
West Northamptonshire Council 
The Guildhall 
St Giles’ Square 
Northampton 
NN1 1DE 

14 April 2025 

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. 

Yours sincerely, 

RCR President

Private and Confidential 
Mr H Shah 
Assistant Coroner 
The Guildhall 
St Giles’ Square 
Northampton 
NN1 1DE 

Medical Directors Office 
Cliftonville 

Northampton 

NN1 5BD 

9 May 2025 

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 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 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.  

Yours sincerely 

Medical Director