Gemma Ralph

Mr Daniel Howe 
HM Area Coroner  
Stoke on Trent and North  
Staffordshire Coroner’s Service 
Stoke Town Hall  
Kingsway 
Stoke-on-Trent 
ST4 1HH 

National Medical Director  
NHS England  
Wellington House 
133-155 Waterloo Road  
London 
SE1 8UG 

22 January 2025  

Dear Coroner, 

Re: Regulation 28 Report to Prevent Future Deaths – Gemma Louise Helen 
Ralph who died on 26 January 2024  

Thank  you  for  your  Report  to  Prevent  Future  Deaths  (hereafter  “Report”)  dated  8 
November 2024 concerning the death of Gemma Louise Helen Ralph on 26 January 
2024. In advance of responding to the specific concerns raised in your Report, I would 
like  to  express  my  deep  condolences  to  Gemma’s  family  and  loved  ones.  NHS 
England are keen to assure the family and the Coroner that the concerns raised about 
Gemma’s care have been listened to and reflected upon.   

I am grateful for the further time granted to respond to your Report, and I apologise for 
any  anguish  this  delay  may  have  caused  Gemma’s  family  or  friends.  I  realise  that 
responses to Coroner Reports can form part of the important process of family and 
friends coming to terms with what has happened to their loved ones, and I appreciate 
this will have been an incredibly difficult time for them. 

Your Report raised concerns over a lack of robust monitoring of the supply, storage 
and  use  of  Sevoflurane  at  Cannock  Chase  Hospital,  and  that  The  Royal 
Wolverhampton NHS Trust was unable to confirm or refute that a bottle of Sevoflurane 
found at Gemma’s home had originated from the hospital.  

Professional guidance on the safe and secure handling of medicines, published by the 
Royal  Pharmaceutical  Society  (RPS),  sets  out  the  principles  that  should  inform  the 
approach of all NHS hospitals to ensuring that there are processes in place for the 
safe  storage,  supply  and  use  of  all  medicines.  These  should  include  an  assurance 
mechanism. Such processes are developed under the professional leadership of the 
Trust  Chief  Pharmacist  and  will  be  informed  by  a  local  risk  assessment,  which  will 
include  the  potential  harm  caused  by  the  inadvertent  or  deliberate  diversion  and/or 
misuse  of  the  medicine,  against  the  need  for  timely  and  appropriate  access  for 
administration to patients where clinically indicated. 

The specific challenges that arise in operating departments are acknowledged in the 
RPS  guidance,  as  access  to  some  of  the medicines used  during surgery,  including 
Sevoflurane,  may  be  required  rapidly.  The  Royal  College  of  Anaesthetists  (RCoA) 

                                                                                                                       
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 the  RPS  guidance  and  also  subsequently  published  “Safe  Drug 
endorsed 
Management in Anaesthetic Practice” to supplement this. The RCoA supplementary 
guidance reinforces the need to have processes in place that support patient safety, 
the health and safety of colleagues and public protection. 

The  risk  of  anaesthetics  being  diverted  by  colleagues  was  highlighted  in  the  Care 
Quality  Commission’s  (CQC)  “The  safer  management  of  controlled  drugs:  Annual 
update 2021”. They stated that they had received some reports that an anaesthetic 
(not Sevoflurane) was both being diverted and misused. This information was shared 
by the CQC and NHS England with all NHS trusts. The importance of considering the 
risks  and  possibilities  associated  with  the  potential  misuse  and/or  diversion  of 
anaesthetics, including where it is stored and who has access to it, was emphasised. 

The CQC, as the independent regulator of health and social care in England, includes 
the “…proper and safe management of medicines…” (required under the The Health 
and  Social  Care  Act  2008  (Regulated  Activities)  Regulations  2014  -  SI  2014/2936 
r.12(2)(g))  as  part  of  the  medicines  optimisation  domain  of  their  single  assessment 
framework.  Where  the  CQC  inspects  services  that  include  operating  departments 
and/or  theatres,  the  safe  and  secure  use  of  anaesthetics  would  form  part  of  that 
assurance, with any concerns raised with the trust and NHS England as necessary. 

NHS  England  will  continue  to  explore  and  support  improvements  in  the  controlled, 
authorised and auditable access to medicines. 

With regard to your specific concerns about how Sevoflurane is stored and monitored 
at Cannock Chase Hospital, I note that you have also addressed your Report to the 
hospital  and  refer  you  to  their  response  on  these  issues.  NHS  England  will  also 
consider the hospital’s response and any actions arising from this in due course.   

I  would  also  like  to  provide  further  assurances  on  the  national  NHS  England  work 
taking  place around  the  Reports  to  Prevent Future  Deaths.  All  reports  received  are 
discussed  by  the  Regulation  28  Working  Group,  comprising  Regional  Medical 
Directors,  and  other  clinical  and  quality  colleagues  from  across  the  regions.  This 
ensures  that  key  learnings  and  insights  around  events,  such  as  the  sad  death  of 
Gemma, are shared across the NHS at both a national and regional level and helps 
us to pay close attention to any emerging trends that may require further review and 
action.    

Thank you for bringing these important patient safety issues to my attention and please 
do not hesitate to contact me should you need any further information.  

Yours sincerely,  

 
 
 
 
  
  
  
 
 National Medical Director

Our ref: 

PRIVATE AND CONFIDENTIAL –
TO BE OPENED BY ADDRESSEE ONLY

Mr Daniel Howe
HM Area Coroner
Staffordshire and Stoke-on-Trent Coroner's Service
H M Coroner’s Office
Stoke Town Hall,
Kingsway,
Stoke-on-Trent
ST4 1HH

Email:   

24 December 2024

Dear Coroner Howe

Re: 

In the matter of Regulation 28, Prevention of Future Death Report - Gemma Ralph -
response due by 3 January 2025

Following the inquest on 3 October 2024, you raised the following concerns in relation to this trust:

1.

2.

That bottles of sevoflurane, whether unopened or partially used after theatre, does not
appear to be robustly monitored to the degree that it was possible for a bottle of
sevoflurane to be removed from Cannock Chase Hospital without this being flagged by
the auditing system.

That the trust was unable to confirm or refute that the bottle found at the deceased’s
home address originated from Cannock Chase Hospital.

It is important to note that no witnesses from the trust called to attend court and evidence provided
by the trust was read, there was therefore no opportunity for the trust to present or clarify any
contextual matters that may have arisen during the inquest hearing.

This letter sets out the trust’s response to the Regulation 28 notice received on 8 November 2024.

For context:

Inhaled sevoflurane is used to cause general anaesthesia (loss of consciousness) before and
during surgery. It belongs to the group of medicines known as general anaesthetics.

There are a range of general anaesthetics available in theatre for anaesthetists to choose based
on the specific need of the case.

 Some are delivered via an intravenous (IV) route (directly into a vein), but most are delivered via
an inhaled route (breathed in) and are known as Anaesthetic Gases, those in common used across
the country are nitrous oxide, halothane, isoflurane, desflurane and sevoflurane. They are
administered as primary therapy for preoperative sedation and adjunctive anaesthesia
maintenance to intravenous (IV) anaesthetic agents such as midazolam and propofol in the
perioperative setting.

The Anaesthetic Gases are delivered by an anaesthetic machine through a breathing circuit (pipes)
attached to the patients airway, The types of device to secure the airway can range from open,
semi closed and closed, this means the exact amount given to each patient is difficult to record
with precision because it is varied throughout the surgical procedure to lighten or deepen the
anaesthetic based on a number of patient and surgical factors and circuit leakage can be variable
dependent on the type of airway securing device chosen. They are usually administered by and
under the direct supervision of a trained anaesthesia professional. This is normal practice across
England.

Staff who are permitted legitimate role-based access to all drugs are trusted across England to use
these drugs appropriately, this is conventional and established current practice in all departments
where drugs are used to treat patients.

The bottom line is that, in reality, any drug in the right quantity can end life. The system in place in
England is that only drugs classified under the Controlled Drugs (Supervision of management and
use) Regulations 2013 etc are required to be recorded from production to end use (patient or
disposal). There is no such requirement for other drugs.

This presents complexity and difficulty for the trust in delivering meaningful compliance with the
request in the Regulation 28 report, however the trust can and will make improvements which are
summarised at the end of this letter.   The trust complies with the guidance required as presented
in my report presented to the inquest (attached).

As already mentioned, there is opportunity for the trust to take some form of action in relation to
this Regulation 28 notice but this will not address any risk that sits outside of the trust (the whole of
England) so any action taken by the trust, in context, will provide limited risk reduction across the
country.

Addressing the concerns that you have presented specifically to the trust.

1.

That bottles of sevoflurane, whether unopened or partially used after theatre,
does not appear to be robustly monitored to the degree that it was possible for a
bottle of sevoflurane to be removed from Cannock Chase Hospital without this
being flagged by the auditing system.

The context of this is explained in the narrative above, this risk contextually applies to any drug of
any type that does not fall under the controlled drugs legislation. If the trust were to take some form
of action in relation to sevoflurane specifically it would not close the risk of any person taking a fatal
dose of any other drug that they have legitimate access to as part of their role. To take action to
address this risk in all drugs would be disproportionate to the risk, would create different risks and
most likely be operationally impractical and unaffordable.

2.

That the trust was unable to confirm or refute that the bottle found at the
deceased’s home address originated from Cannock Chase Hospital.

The trust has not been provided with the batch number of the sevoflurane found in Gemma’s
home, even if it had been provided with the batch number it would still not evidence that the
sevoflurane used by Gemma was obtained from the trust. The manufactured batches are large and
supplied to many organisations. Therefore, confirming or refuting where Gemma obtained it from

 would only be possible if there were a trust specific permanent marker on the bottle, again this is
not usual practice.

There have been a number of professionals involved up to now in the consideration of the
practicalities of taking action in relation to this Regulation 28 notice, this includes 
Clinical Director Anaesthesia, Perioperative & Pain Medicine Directorate and 
Director of Pharmacy and Medicines Optimisation, Controlled Drugs Accountable Officer.

,
, Clinical

There is nothing, including making a medicine a controlled drug, that will prevent someone taking a
medicine if they are intent to do so. We do not believe that it would have been possible or practical
to have put anything in place to completely prevent the removal of a bottle of sevoflurane (or any
other medicine), we can only make it more difficult to do this and therefore reduce the risks.

Actions that require national consideration / are outside of the control of the Trust

(cid:127)

(cid:127)

Sevoflurane is one of many drugs that has potential to be abused or misused but is not
classified as a controlled drug. Only controlled drugs have strict laws around storage
and documentation. The government would need to determine whether on balance of
risk and evidence from this Regulation 28 notice, sevoflurane should be made a
controlled drug.
The Royal College of Anaesthetists determines that on a risk basis the medicine
cupboards of theatres which are in use may be left open to enable emergency access,
the only exception to this being controlled drugs. The Royal College may want to review
their position on this and/or determine whether there are any further exceptions.

Actions that are partly within the control of the Trust

(cid:127)

(cid:127)

Scan4Safety is an NHS initiative that involves end to end barcoding of healthcare
products, including medicines. It can track movement of medicines from manufacturer
to patient, therefore increasing accountability and reducing the potential for
fraud/diversion. We are not aware of how mature the systems are, and which Trusts in
England have implemented this. If this was found to offer the potential to reduce risk,
unless mandated nationally it would have limited impact on risk reduction.
Making sevoflurane a controlled drug and/or implementing Scan4Safety are the only
ways we think the Trust may have been able to identify, with a degree of certainty, that
a single bottle of sevoflurane was unaccounted for. The Trust could consider managing
sevoflurane as a controlled drug (we do this for Oramorph for example) but the
practicalities of this are likely to outweigh the current risk of diversion.
o These considerations are:

 Staff capacity to manage sevoflurane as a Controlled Drug
 How volume would be measured because of the characteristics of

administration – possibly have to measure in full bottles and part bottles,
rather than in ml.

 Space in CD cupboards to store

Actions that the Trust could consider to improve audit and / or restrict access to sevoflurane to
authorised registered staff only are listed below.
These measures would improve on what we already have but would not necessarily identify if
someone was diverting small volumes of sevoflurane and therefore deliver limited effect on risk
reduction.
(cid:127)

Introduce daily stock counts of full bottles, part bottles and empty bottles to ensure all
are accounted for. NB. Raises the question that if we did this for sevoflurane why
wouldn’t we do it for all other non-controlled drugs that could be abused. Unless this is
made a national requirement it would deliver limited effect on risk reduction across
England.
Ensure sevoflurane is in a locked cupboard unless under direct physical supervision of
the anaesthetist. No sevoflurane to be stored in anaesthetic room cupboards that are
left open during a theatre list. Unless this is made a national requirement it would
deliver limited effect on risk reduction across England.

(cid:127)

 (cid:127)

(cid:127)

Implement auditable locks (swipe card / biometric) on drug storage cupboards (bulk and
anaesthetic room) and ensure locked at all times (even when theatre is in use). This
should mean that staff can access in an emergency without having to find keys but
would provide greater security. These types of locks also allow audit of who has been
accessing the cupboards. Unless this is made a national requirement it would deliver
limited effect on risk reduction across England.
Implement automated medicines cabinets for bulk storage and auditable locks or Abloy
keys for drug storage cupboards in anaesthetic rooms. Unless this is made a national
requirement it would deliver limited effect on risk reduction across England.

We have discussed the Regulation 28 notice with the Regional Chief Pharmacist, and he is in
agreement with the above.  We will however look at risk reduction strategies e.g. improved use of
automation, ensuring our storage, recording and audit processes are robust.

The plan and timescales for what is within the trusts control and is reasonably practicable is set out
below.

Lead

Timescale
Complete

Comments


Q1 2025/26







The amount of sevoflurane stored in each theatre has been
reduced to 2 bottles; the in-use bottle and 1 spare
bottle.  Both bottles are under the direct supervision of the
anaesthetist and are locked away at the end of the theatre
session.
Bulk supply of sevoflurane is in the theatres bulk drug storage
areas in locked cupboards which are only accessible to
authorised and registered healthcare
professionals.  Compliance is monitored as part of the
pharmacy-led annual medicines storage audit.
Collaborative work has commenced within the Black Country
Provider Collaborative Pharmacy Network to write a
systemwide business case to purchase and install automated
medicines storage cabinets at RWT, DGFT and WHT, with
agreement within the network that theatres will be a priority
area.  There is significant variation within the Black Country
ICS as SWB have fully implemented automated medicines
storage cabinets across the new MMUH, and therefore if
approved, the business case will bring all Black Country
Trusts to a similar standard of inventory control.
There is a significant risk that a business case will not be
approved due to lack of capital monies within the Trust and
Black Country ICS, therefore as an interim measure RWT
have commenced discussions with the provider of existing
automated storage cabinets used for storage of dressings
and medical devices in theatres, as to whether it is possible to
repurpose these for medicine storage. Early conversations
indicate they may not be suitable for medicines storage, thus
requiring new cabinets to be purchased.

Action
Sevoflurane bottles to
be in a locked drug
cupboard unless
under the direct
supervision of the
anaesthetist.

To submit a business
case to the Trust
Board and Black
Country ICB for
capital monies to
purchase and install
automated medicines
storage cabinets for
bulk storage of drugs
and auditable locks
for drug cupboards.

Yours sincerely

Group Director of Assurance