Aviva Otte, Oscar Barker and Yousef Al-Kharboush

Care Quality Commission

Citygate

Gallowgate

Newcastle upon Tyne

NE1 4PA

Telephone: 

Fax: 

www.cqc.org.uk

Dr Julian Morris,

Coroners Area: London Inner South

Reference: 2024-0628

07 January 2025

Dear Dr Morris,

Thank you for writing to CQC, highlighting matters of concern in relation to the tragic
deaths of Aviva Otte, Oscar Barker and Yousef Al-Kharboush.

We have reviewed the collective concerns, and propose to address points 2 and 3
which are within our remit.

BACKGROUND

CQC is the independent regulator of health and adult social care in England. We
make sure health and social care services provide people with safe, effective,
compassionate, high-quality care and we encourage care services to improve. We
monitor, inspect and regulate services and publish what we find. Where we find poor
care, we will use our powers to take action.

CQC employ a team of pharmacy professionals to assist in regulating the safe and
effective use of medicines. We have an assessment framework to support us in
assessing and monitoring services.

 Our assessment framework

Our assessment framework offers us the opportunity to ask all CQC registered
service providers that handle, prescribe, supply and administer medicines how this is
undertaken safely. This is derived from our Health and Social Care Act 2008
(Regulated Activities) Regulations 2014. Medicines primarily sit within the remit of
Regulation 12, Safe Care and Treatment.

National Aseptics Review and CQC’s role

In 2020, Transforming NHS pharmacy aseptic services in England was published by
the Department of Health and Social Care (DHSC). The national report was based
on a review of the quality, safety and resilience of the hospital-pharmacy, aseptic
service.

The report made two key recommendations for CQC:

“The Care Quality Commission (CQC) should review its oversight of the governance
and assurance arrangements for aseptic services as part of the assessment of the
safe and effective use of medicines in NHS trusts.”

“The CQC should take into consideration the outputs from the EQA (External Quality
Assurance) and accreditation schemes as part of their assessment of whether NHS
services are safe, effective, caring, responsive to people's needs and well-led. This
additional information will support a richer and broader understanding of the quality
of service provided and enable commentary on leadership and governance in these
areas.”

CQC accepted these recommendations and has reviewed its oversight of the
governance arrangements of aseptic services in NHS Trusts. Further details are
provided below.

RESPONDING TO MATTERS OF CONCERN 2 AND 3

Reporting requirements

Key matter of concern (2) is that:

The current reporting structures (for a section 10 entity) involve reporting to NHSE
and the CQC but the threshold or necessity for such reporting appears unclear and,
in essence, up to the Trust.

Reporting requirements for Trusts are now more clearly defined than they were in
2014.

In 2023 NHS England published guidance on Assurance of Aseptic Preparation of
Medicines. The guidance describes the oversight provided by the Care Quality
Commission (CQC) and the inter-relationships between the regulatory bodies, such

 as the CQC, Medicines and Healthcare products Regulatory Agency (MHRA) and
General Pharmaceutical Council (GPhC). This is now much more comprehensive
and organisations involved are better connected than in 2014.

Additionally, Under the CQC’s Registration Regulations, CQC registered providers
are required to report a death in their service. This applies to providers in both the
NHS and independent sector.

CQC access to audit data

In line with the recommendations made by the review on aseptic services, CQC
takes into account NHS England’s commissioned audits on these services as part of
our regulatory assessment of services (iQAAPS, interactive quality assurance of
aseptic preparation services).

NHS England commissions the Specialist Pharmacy Services to undertake these. In
2024, CQC received access to a digital iQAAPS dashboard that enables us to review
audits and risks in NHS services.

Our processes for monitoring services

As part of how we monitor the quality of care offered by registered providers, we
undertake annual engagement conversations with all NHS Trust Chief Pharmacists,
as a minimum. If we need to, we can increase the frequency of these conversations.
This enables us to discuss service specific risks with the Chief Pharmacist. If
required, this would include risks relating to aseptic preparation of medicines and
other sterile products such as Total Parenteral Nutrition (TPN).

Options for escalating concerns

Where we identify concerns about aseptic preparation or incidents that fall within our
remit, CQC have a range of options available in the context of our regulatory
response, which include:

 Closer and more frequent monitoring

 Assessment

 Enforcement

Where we have identified concerns, we would also share these as early as possible
with the relevant NHS England Regional Chief Pharmacist.

Sharing information of concern and learning

Key matter of concern (3) is that:

“There may be times when section 10 entities reach conclusions which would assist
the wider industry and help to assist both other Trusts and commercial organisations
in assessing their own risks and improving the provision of highly specific medication
to a group of vulnerable patients.”

 Sharing learning

Sharing of learning could be improved nationally. The National Medication Safety
Officer Network functions well and could offer an opportunity to formalise and
facilitate improvements in the sharing of information and learning in this area,
including in the independent sector.

Sharing information of concern

Whilst CQC expect providers to report service related deaths in line with our
regulations, we now also have more formal information sharing agreements with
other regulators.

In 2014, there was no Memorandum of Understanding (MOU) in place with other
regulators, such as the Medicines and Healthcare Products Regulatory Agency
(MHRA) and NHS England (formerly Monitor).

These MOUs came into effect in 2015, are still in place, and are updated when
required. These are likely to be reviewed during 2025 and can be found on our
website.

Our actions

Whilst most section 10 units are within NHS settings, there are some that sit with
CQC registered services in the independent sector. These fall within CQC’s remit.
During 2025-26 CQC will review our oversight of providers who are not required to
undertake the NHSE commissioned iQAAPS Audits.

Now CQC has full access to the electronic iQAAPS dashboard, we will undertake a
systematic approach to discussing organisation specific risks with all NHS trusts
during 2025-26.

Kind regards

Deputy Director for Medicines Optimisation and IR(ME)R, Care Quality Commission.

If you have any further questions about the contents of this response, please contact

Parliamentary Under-Secretary of State for   
Patient Safety, Women’s Health and Mental Health 

39 Victoria Street  
London  
SW1H 0EU  

Our ref: 

Dr Julian Morris 
HM Deputy Coroner, Inner London South 
Southwark Coroner’s Court 
1 Tennis Street 
Southwark 
SE1 1YD 

8th January 2025 

Dear Dr Morris  

Thank you for the Regulation 28 report of 15th November 2024 sent to the Secretary of State 
about the deaths of Yousef Al-Kharboush, Oscar Barker and Aviva Otte. I am replying as 
the Minister with responsibility for Patient Safety, Women’s Health and Mental Health.  

Firstly, I would like to say how saddened I was to read of the circumstances of these tragic 
deaths  and  I  offer  my  sincere  condolences  to  their  families  and  loved  ones.  The 
circumstances your report describes are concerning and I am grateful to you for bringing 
these matters to my attention.  

The key matters of concerns were:  

o 

that there is no requirement for a section 10 unit to report any of its findings to 
the Medicines & Healthcare products Regulatory Agency (MHRA), other Trusts 
or the industry in general if an adverse event occurs.  

o  Under section 10, the current reporting structures involve reporting to NHS 
England and the Care Quality Commission (CQC), but the threshold or 
necessity for such reporting appears unclear and is often up to the Trust. 

o  There is no forum (formal or otherwise) for section 10 units to share information 
that help other Trusts and commercial organisations in assessing their own 
risks. 

o  The  same  may  also  be  true  of  commercial  organisations  (or  specials  license 
holders)  but  because  of  MHRA’s  role  regulating  these  organisations,  where 
MHRA  identify  risks,  they  can  issue  recalls  and  disseminate  information  more 
widely 

In preparing this response, my officials have made enquiries with NHS England, CQC and 
MHRA to ensure that we adequately address your concerns. 

 
   
 
 
 
 
 
 
 
 
  
  
 
 
 
  
 Since  these  tragic  deaths  occurred,  there  has  been  considerable  strengthening  of  NHS 
England  guidance  on  aseptic  preparation  of  medicines  and  auditing  (NHS  England  » 
Assurance of aseptic preparation of medicines) replacing previous guidance. Furthermore, 
NHS  England  has 
introduced  strengthened  oversight  and  external  quality  audit 
commissioned  through  the  NHS  Specialist  Pharmacy  Services  (SPS),  including  iQAAPS 
which  is a  web-based  quality  reporting  system  to  support oversight  and external audit of 
unlicensed NHS pharmacy aseptic preparation.  

However, the gap you identified has not been fully addressed by this and there is more work 
to do in this area. NHS England, MHRA and CQC will be sending their individual responses 
to the PFD report to set out how they will address the concerns raised. This includes: 

•  A 2-way information sharing agreement between CQC and NHS England, which 

was not in place in 2014.  

•  NHS England to review, update and strengthen their 2023 guidance (linked 

above) to provide further direction on thresholds for reporting and escalation of 
concerns from section 10 aseptic units into NHS England regionally and 
nationally.  

•  MHRA and NHS England intend to agree and implement a 2-way information 

sharing agreement at organisational level to share learning of serious incidents 
related to aseptic medicines (by end of June 2025). 

Furthermore, DHSC will meet with CQC, NHS England and MHRA to ensure that the 
actions of each organisation to address your concerns are complementary, coordinated 
and completed. I have asked my officials to write to you once these actions are fully 
completed. 

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

Yours sincerely,  

PARLIAMENTARY UNDER-SECRETARY OF STATE FOR 
PATIENT SAFETY, WOMEN’S HEALTH AND MENTAL HEALTH

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

Dr Julian Morris  
Senior Coroner  
London Inner South  
Southwark Coroners Court  
1 Tennis Street 
SE1 1YD 
By email: 

Reference: 

8 January 2025 

Dear Dr Morris, 

Regulation 28 Report: Deaths of babies Yousef Al-Kharboush, Oscar Barker and Aviva 
Otte  

Thank  you  for  your  Regulation  28  Report  of  15  November  2024  in  which  you  asked  the 
Medicines  and  Healthcare  products  Regulatory  Agency  (MHRA)  to  provide  a  response 
following the inquest into the sad deaths of babies Yousef Al-Kharboush, Oscar Barker and 
Aviva Otte. We would like to extend our sincere sympathies to the families and loved ones of 
Yousef, Oscar and Aviva for their loss. 

I am writing in relation to  the concerns raised in your report where you considered  that the 
MHRA should take action to prevent similar events of this kind occurring in the future.  

Role of MHRA in the regulation of the manufacture of unlicensed medicines 
The  MHRA  is  an  executive  agency  of  the  Department  of  Health  and  Social  Care  and  is 
responsible for the regulation of medicinal products, medical devices, and blood components 
for transfusion in the UK. We take all reasonable steps to protect public health and safeguard 
patients, the public and users. 

The  MHRA  is  responsible  for  the  licensing  regime  which  permits  the  supply  of  unlicensed 
medicines  under  Regulation  167  of  The  Human  Medicines  Regulations  2012  (‘the 
Regulations’).  

Regulation  167  provides  an  exemption  from  the  need  for  a  marketing  authorisation  for  a 
medicinal product which is: 

 
 
 
 
 
 
 
 
 
 
 
 a)  supplied in response to an unsolicited order; 
b)  manufactured and assembled in accordance with the specification of a person who 
is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber 
or supplementary prescriber; and 

c)  for use by a patient for whose treatment that person is directly responsible in order 

to fulfil the special needs of that patient. 

Under this regime the unlicensed medicinal products (commonly described as “specials”) may 
only be supplied in order to meet the special needs of an individual patient. Responsibility for 
deciding whether an individual patient has “special needs” which a licensed product cannot 
meet  should  be  a  matter  for  the  doctor,  dentist,  nurse  independent  prescriber,  pharmacist 
independent prescriber or supplementary prescriber responsible for the patient’s care.  

Licensing the manufacture of medicinal products 
In accordance with Regulation 17 of the Regulations, the manufacture of medicinal products 
requires  a  licence  granted  by  the  MHRA.  There  are  a  number  of  different  licence  types, 
depending  on  whether  manufacture  is  of  licensed  medicines,  unlicensed  medicines  or 
investigative medicinal products (clinical trials medicines). Licences are granted to the would-
be licence holder once they have demonstrated that their facility and quality systems are able 
to  operate  in  accordance  with  Good  Manufacturing  Practice  (GMP).  Assurance  of  this  is 
obtained  by  on-site  inspections  by  MHRA  GMP  Inspectors  during  the  licence  application 
phase and is then maintained via the conditions of the licence.  

Once a licence is granted, MHRA inspectors will periodically inspect the facility to ensure GMP 
compliance is maintained. The MHRA operates a risk-based strategy to determine inspection 
periodicity, with the frequency of inspection being dependent on the type of medicines which 
are  manufactured  and  the  manufacturer’s  record  of  compliance.  The  MHRA’s  escalation 
procedures  in  instances  where  critical  deficiencies  are  identified  involve  the  Agency’s 
Inspection  Action  Group  (IAG).  The  IAG  is  a  non-statutory,  multi-disciplinary  group  which 
advises  the  MHRA  on  the  requirement  for  regulatory  or  restrictive  licensing  action,  usually 
following the identification of critical deficiencies at inspection1. 

The Section 10 exemption  
Section 10 of the Medicines Act 1968, as amended, provides scope for exemptions from the 
requirement  to  hold  a  manufacturer’s  licence  or  marketing  authorisation  in  defined 
circumstances.  A pharmacist (or any person working under their supervision in a registered 
pharmacy), hospital pharmacy, or a pharmacy in a care home service or health centre to whom 
the Section applies may: prepare, assemble or dispense a medicinal product in accordance 
with a prescription given by a practitioner. Facilities that are preparing or assembling medicinal 
products under a Section 10 exemption fall outside the responsibility of MHRA. 

The  preparation  of  medicines  under  Section  10  in  NHS  hospital  pharmacies  remains  an 
essential  enabler  for  patient  care,  including  such  activities  as  parenteral  nutrition,  cancer 
chemotherapy,  clinical  trials  and  innovative  advanced  therapy  medicinal  products.  NHS 
England  (NHSE)  has  oversight  of  the  quality  assurance  of  NHS  hospital  pharmacies  in 
England operating in accordance with Section 10.  The 2020 Department of Health and Social 
Care  report  “Transforming  NHS  pharmacy  aseptic  services  in  England”  made  the  specific 
recommendation to  strengthen  the  accountability  and  responsibility  of  Trusts  operating  s10 

1 https://www.gov.uk/government/groups/inspection-action-groups 

 
 
 
 
 
 
 
 facilities regarding the unlicensed preparation of aseptic medicines and the importance of the 
ability of NHS hospital pharmacies to operate safely under Section 10 was emphasised by the 
NHS.  

Matters of concern 
You  have  expressed  the  following  issues  as  matters of  concern  and  I  address  each  of  the 
matters of concern within the remit of the MHRA below:  

1.  There is no requirement for a section 10 exempt entity to report any of its findings to 
the  MHRA  or indeed to  other Trusts  or the  industry in general if  an  adverse  event 
occurs.  

2.  The current reporting structures (for a section 10 entity) involve reporting to NHSE 
and the CQC but the threshold or necessity for such reporting appears unclear and, 
in essence, up to the Trust. 

3.  There may be times when section 10 entities reach conclusions which would assist 
the wider industry and help to assist both other Trusts and commercial organisations 
in assessing their own risks and improving the provision of highly specific medication 
to a group of vulnerable patients.  

4.  The same may also be true of commercial organisations but they have the power of 
the MHRA controlling and effecting recalls and actions and the wider dissemination 
of information. 

Requirement to report adverse events to MHRA 
It  may  be  helpful  to  first  clarify  the  situation  in  respect  of  the  reporting  of  adverse  events 
(interpreted as manufacturing errors).  Part 5 of the Regulations places an obligation on the 
holder  of  any  manufacturer’s  licence  to  inform  the  licensing  authority  (MHRA)  immediately 
when they become aware of any defect which could result in a recall. This is coordinated using 
the MHRA’s Defective Medicines Report Centre (DMRC) but it is noted that, at the point of 
recall the emphasis is on dissemination of appropriate information to facilitate a recall and not, 
necessarily, the root cause of the defect. Investigations carried out by the licence holder will 
be reported to the MHRA at a later date.  

The Regulations also require that the licence holder implements a system for recording and 
reviewing complaints together with an effective system for recalling, promptly and at any time, 
medicinal products in the distribution network. Medicines extemporaneously prepared under 
Section 10 are done so in accordance with a prescription, so there would not be the possibility 
of a recall. The statutory requirement to inform the MHRA of defective medicines and/or report 
adverse events does not apply to medicines prepared under Section 10. 

Section  64  of  the  1968  Medicines  Act  relates  to  protection  for  the  purchaser  of  medicines 
products  noting  that  ‘No  person  shall,  to  the  prejudice  of  the  purchaser,  sell  any  medicinal 
product which is not of the nature or quality demanded by the purchaser’. This strict liability 
offence  is  mitigated  only  if  extraneous  matter  present  is  an  inevitable  consequence  of  the 
manufacture of the medicine or if the addition or abstraction of a substance was not carried 
out fraudulently and did not injuriously affect the composition of the product2.  

The MHRA accepts that whilst there is not a requirement to report, nor is there a ‘threshold’, 
this is not a barrier to incidents being reported particularly in the context of Section 64. The 

2 https://www.legislation.gov.uk/ukpga/1968/67 

 
 
 
 
 
 
 
 
 NHSE’s  ‘Assurance  of  Aseptic  Preparation  of  Medicines  Guidance’  of  2023  states,  at 
Appendix 3, that in instances of serious incidents the MHRA will investigate incidents where 
civil or criminal prosecutions may result. Our interpretation of this guidance is that while not a 
requirement, it is incumbent on Trusts to report instances where serious incidents may have 
occurred in their Section 10 NHS Pharmacy facility to the MHRA. The MHRA intends now to 
further  communicate  this  expectation  to  facilities  operating  under  the  s10  exemption  (see 
below).  

Following the outcome of the inquest, the MHRA has discussed this with NHSE officials who 
advised they will review this Guidance to make it clearer that, where investigations of incidents 
in a Section 10 facility identify learnings which may not result in enforcement action, but which 
could impact licensed manufacturers, this should also be communicated without delay to the 
MHRA. It is anticipated that this would be done following escalation from the Trust to either 
NHSE or Care Quality Commission (CQC). It will mean that the MHRA can be contacted for 
reasons  other  than  to  take  enforcement  action,  which  is  the  message  from  the  current 
guidance which needs to be clearer. The initial emphasis is on NHSE but this message will be 
expanded  as  soon  as  is  practical  and  communicated  to  the  devolved  governments  (see 
timescales below). 

Communicating  information  on  adverse  events  to  other  Trusts,  wider  industry  and 
commercial organisations 
The MHRA agrees there are potential scenarios where it could be important to promptly share 
information about a defective medicine prepared under a Section 10 exemption, and how the 
risk should be minimised, with licensed manufacturers. This will be done by the MHRA using 
existing and established mechanisms for communicating to licence holders. In regard to the 
sharing of information from the licensed manufacturing sector, the MHRA has established via 
the DMRC lines of communication to share information regarding defective medicines with the 
NHS compounding community (which includes  Section 10 NHS hospital pharmacies) which 
are in addition to the reporting of defective medicines detailed above.  

This  is  achieved  via  attendance  at  NHS  Pharmacy  QA  Committee  meetings  (DMRC  is  a 
member),  and  which  can  also  be  via  email  correspondence  on  an  ad  hoc  basis  using  the 
established  membership.  This  Committee  is  made  up  of  UK-wide  NHS  regional  quality 
assurance  leads,  one  of  whom  is  appointed  as  chair.  While  this  Committee  facilitates 
communication  in  both  directions,  NHSE  has  indicated  that  there  should  be  an  additional 
approach which would be directly under its governance. It is our expectation that this will be 
covered  in  Memoranda  of  Understanding  with  NHSE  and  equivalent  mechanisms  with 
devolved governments (see below). 

Accordingly, the MHRA will work with NHSE with a view to implementing a memorandum of 
understanding  to  enable  appropriate  categorisation  and mutual  dissemination of  actionable 
safety information and learning from incidents at both an executive and operational level. The 
MHRA is also exploring with NHSE enabling better sharing of information with Trusts whose 
Section  10  NHS  hospital  pharmacy  is  under  compliance  monitoring  by  the  NHS  Specialist 
Pharmacy Services (SPS) and under the oversight of the MHRA’s IAG which, as noted above, 
is  MHRA’s  escalation  route  where  critical  failings  in  GMP  are  identified  and  the  need  for 
regulatory action against a licence may be required. 

 
 
 
 
 
 
 This  plan  also  builds  on  work  which  is  already  being  implemented  to  share  common 
understanding of processes and procedures regarding the auditing of Section 10 NHS hospital 
pharmacies (SPS) and inspecting of licensed facilities (MHRA).  

As detailed above there is a legal requirement for the holder of any manufacturer’s licence, be 
they commercial organisations or NHS Trusts, to notify MHRA and work with us to  instigate 
an appropriate recall. While the matter in question relates to NHS pharmacy units, the MHRA 
notes that the Section 10 exemption is not limited to NHS sites. Registered pharmacies (i.e. 
retail/commercial  pharmacies)  are  under  the  jurisdiction  of  the  General  Pharmaceutical 
Council (GPhC) in Wales Scotland and England and the Pharmaceutical Society of Northern 
Ireland (PSNI) for Northern Ireland.  

The MHRA already has Memoranda of Understanding with the GPhC and PSNI and will use 
these (including updating, as necessary) to highlight the need to ensure formal exchange of 
information related to the preparation of Section 10 medicines. Similarly, the MHRA will enter 
into  dialogue  with  the  CQC  which  regulates  other  healthcare  settings  in  England  e.g. 
independent hospitals and their equivalents, as these may also prepare medicines under the 
Section 10 exemption and should also be included in  the planned programme of increased 
clarification of roles and responsibilities, information exchange and learnings. 

Timescales for action: 

•  The MHRA will publish an update to the sector detailing issues raised by this case and 

our intentions to address the concerns (by the end of March 2025). 

•  The  MHRA  will  agree  and  implement  a  memorandum  of  Understanding  (MoU)  with 
NHSE  for  routine  updates  (e.g.  sites  identified  as  high  risk,  increased  oversight  or 
under  regulatory  restriction)  and  also  the  dissemination  of  ad  hoc  learnings  from 
incidents (by end of June 2025). 

•  The  MHRA  will  inform  devolved  governments  of  this  requirement  to  improve 
information exchange as soon as practical and agree an approach in line with that for 
the NHSE MoU (by end of September 2025). 

•  The MHRA will remind GPhC and PSNI of their responsibilities regarding commercial 
pharmacies  and  with  CQC  regarding  the  independent  hospitals  (by  end  September 
2025).  

I would be happy to discuss this proposed plan of action with you if that would be helpful. 

Yours sincerely, 

Chief Executive 
Medicines and Healthcare products Regulatory Agency 
E:

Dr Julian Morris 
HM Senior Coroner 
London Inner South  
Southwark Coroners Court  
1 Tennis Street  
London  
SE1 1YD  

Dear Sir, 

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

20 January 2025  

Re: Regulation 28 Report to Prevent Future Deaths –Aviva Otte who died on 2 
January 2014. Yousef Al-Kharboush who died on 1 June 2014, Oscar Barker who 
died on 29 June 2014  

Thank  you  for  your  Report  to  Prevent  Future  Deaths  (hereafter  “Report”)  dated  15 
November 2024 concerning the death of Aviva Otte on 2 January 2014, Yousef Al-
Kharboush on 1 June 2014, and Oscar Barker on 29 June 2014, and sent to the NHS 
England Regional Director for London. I am responding on behalf of the organisation 
in  my  capacity  as  National  Medical  Director  but  would  like  to  assure  you  that  the 
Medical Director for London has also been sighted on this response and has reviewed 
your Report. In advance of responding to the specific concerns raised in your Report, 
I would like to express my deep condolences to Aviva’s, Yousef’s, and Oscar’s parents 
and wider families. NHS England are keen to assure the families and the Coroner that 
the concerns raised in the Report have been listened to and reflected upon.   

I  am  also  grateful  for  the  further  time  granted  to  respond  to  your  Report,  and  I 
apologise for any anguish this delay may have caused to the parents and families of 
Aviva, Yousef and Oscar. I realise that responses to Coroner Reports can form part of 
the  important  process  of  family  coming  to  terms  with  what  has  happened  and 
appreciate this will have been an incredibly difficult time. 

The concerns raised in your Report were that: 

1.  There  is  no  requirement  for  a  section  10  exempt  entity  to  report  any  of  its 
findings to the MHRA or indeed to other Trusts or the industry in general if an 
adverse event occurs. 

2.  The  current  reporting  structures  (for  a  section  10  entity)  involve  reporting  to 
NHS  England  and  the  Care  Quality  Commission  (CQC)  but  the  threshold  or 
necessity for such reporting appears unclear and in essence, up to the Trust. 
3.  There may be times when section 10 entities reach conclusions which would 
assist the wider industry and help to assist both other Trusts and commercial 
organisations in assessing their own risks and improving the provision of highly 
specific medications to a group of vulnerable patients. 

4.  The  same  may  also  be  true  of  commercial  organisations  but  they  have  the 
power of the MHRA controlling and effecting recalls and actions and the wider 
dissemination of information. 

                                                                                                                       
 
 
 
 
 
 
 
  
 
 
 
 My response to your Report has been informed by the Infection Prevention, Patient 
Safety and Pharmacy teams here at NHS England. 

We  note  these  tragic  deaths  occurred  over  ten  years  ago  and  can  assure  you  that 
practice  has  changed  since  then.  For  example,  sporicides  (agents  that  kill  harmful 
spores) are now widely used. 

Risk management of TPN manufacturing in the NHS  

We are aware that contaminated Total Parenteral Nutrition (TPN) poses severe risks 
to  patient  safety,  including  hospital  infection  outbreaks.  These  risks  are  particularly 
pronounced among vulnerable populations such as neonates, oncology patients, and 
those  in  critical  care  settings,  where  adverse  outcomes  from  infections  can  be  life-
threatening. 

Whilst TPN is a sterile intravenous solution that provides essential nutrition to patients 
unable  to  eat  or  absorb  nutrients  orally  it  is  susceptible  to  contamination  during  its 
production, storage, or administration. Such contamination can lead to bloodstream 
infections  (BSIs),  sepsis,  and  nosocomial  outbreaks.  Factors  contributing  to  these 
risks  include  inconsistent  practices  in  aseptic  preparation,  improper  handling,  and 
breaches in storage protocols. 

The  risk  of  contamination  of  TPN  can  arise  from  multiple  stages  in  its  lifecycle,  to 
include production, storage and handling and catheter management. 

These issues are compounded in high-risk populations such as neonates, oncology 
patients, and those in intensive care units, where compromised immunity increases 
susceptibility to infections.  

To mitigate against the risk of contamination several mitigations are put in place during 
the production, storage, distribution and administration of TPN. 

To mitigate the risks associated with TPN contamination, a comprehensive approach 
is required: 

•  Education  and  Training:  Healthcare  professionals  should  be  thoroughly 
trained  in  aseptic  preparation  techniques,  proper  storage  protocols,  and  the 
early identification of contamination risks. Consistent education ensures safe 
and standardised TPN handling practices across all settings. 

•  Adherence  to  Guidelines:  Compliance  with  national  and  international 
standards, such as NICE QS61, must be enforced to maintain the highest levels 
of care quality and patient safety. 

•  Operational Oversight: Regular audits and monitoring should be conducted 
to  ensure  adherence  to  established  protocols.  Enhanced  oversight  of  TPN 
preparation  and  administration  is  particularly  critical  for  high-risk  patient 
populations to minimise complications and improve outcomes. 

S.10 Exempt NHS Units – Guidance and effectiveness 

 
 
 
 The  reporting  structure  for  section  10  units  is  now  much  clearer  following  the 
publication of the  NHS England » Assurance of aseptic preparation of medicines.pdf 
in  March  2023,  and  replacing  the  previous  guidance  from  1997.  This  guidance 
…“applies to all NHS pharmacy aseptic facilities in England undertaking preparation 
of sterile medicinal products under Section 10 exemption to the Medicines Act 1968 
(as amended)…”. It is my understanding that a copy of this was previously shared with 
the Coroner. The document outlines the escalation processes for:  

a) periodic quality audit findings,  
b) ongoing monthly quality indicator and action plan monitoring,  
c) serious patient safety incidents 

NHS England commissions the NHS Specialist Pharmacy Service (SPS) to carry out 
quality audits of section 10 units through their regional quality assurance leads (RQAs) 
and to support Trusts in achieving the required quality standards in accordance with 
this guidance.  

Quarterly  unit  status  overview  reports  are  routinely  sent  to  NHSE  Regional  Chief 
Pharmacists  (RCPs),  the  NHSE  Chief  Pharmaceutical  Officer  and  CQC  Medicines 
Optimisation. This achieves a cross sector sharing of s.10 exempt manufacturing and 
ensures the CQC have awareness of any high risk failings or serious incidents. This 
notification/reporting is not a decision made at local level by an NHS body/Trust, but 
forms part of the SPS oversight and escalation in place. Following implementation of 
the new guidance, the first of these quarterly reports was received in Jul 2024. There 
is immediate escalation of high-risk failings or serious patient safety incidents to the 
relevant RCP in the first instance. 

In general, any NHS Trust providing aseptic services under a section 10 exemption 
does  not  need  to  report  to  the  MHRA  as  they’re  not  licensed  units.   However,  all 
incidents from these services will be reported via the current patient safety incident 
reporting route and into the NHS Learn From Patient Safety Events (LFPSE) system.   

There  is  also  an  informal  system  in  place  to  specifically  monitor  errors  from  NHS 
aseptic  units  –  NAERS  –  National  Aseptic  Error  Reporting  System.  This  has  been 
established  by  the  Pharmacy  Aseptic  Service  Group,  a  national  specialist  interest 
network, but this is not formally mandated and neither the group nor the system are 
formally connected to NHS process and governance. 

Recently, there have been conversations between the NHSE hospital pharmacy team, 
SPS quality assurance lead and MHRA inspectorate about sharing trends from audit 
and inspection findings, and indeed both SPS and the MHRA shared findings at the 
last  Quality  Assurance  and  Technical  Services  in  October  2024:  Pharmaceutical 
Aseptic  Services  Group:  Quality  Assurance  and  Technical  Services  Symposium 
(QATS).  

However,  the  MHRA has no  regulatory  role  in  section  10  units  so  a  requirement  to 
report to them would not follow the governance and accountability arrangements in 
the NHS, nor would such a reporting line be consistent with MHRA’s scope of activity, 
given it does not have a mandate over s.10 exempt units. 

 
 
 
 The  SPS  quality  assurance  service  issues  a  regular  newsletter  and  holds  virtual 
workshops  and  seminars  for  NHS  staff  to  highlight  risks  and  support  in  aseptic 
services. This does not extend to commercial manufacturers producing TPN, who can 
continue to seek guidance and input from the MHRA. The SPS is intended to connect 
NHS  s.10  exempt  pharmacies  and  share  sector  knowledge  as  part  of  continuous 
improvement and learning across that group.  

With respect to effecting recalls and actions, the situation is different for section 10 
units compared to units under MHRA control because for a section 10 unit any recalls 
or  actions  and  patients  affected  would  be  managed  entirely  within  their  own 
organisation. Generally, products will have already been administered by the time a 
problem  is  identified,  so  recall  prior  to  use  is  not  relevant  and  the  current  MHRA 
Defective  Medicine  Report  Centre  (DMRC)  would  not  have  a  role.  Situation 
management will follow usual incident management and oversight arrangements for 
NHS trusts in the same way as any other serious internal incident would be managed, 
identifying causes for the incident and implementing recommendations and learning 
to mitigate the risk of recurrence where possible. 

In relation to the 4th aspect of the PFD report captured above, the MHRA will have a 
role in licensed unit manufacturers investigating incidents and the MHRA may choose 
to  amend  their  guidance  as  a  result  (as  we  understand  they  did  following  the 
investigation into the June 2014 outbreak).  

Updated position – joint approach 

In early December 2024, my colleagues from the Hospital Pharmacy Team met with 
the  DHSC,  MHRA,  CQC  and  SPS  to  understand  current  arrangements  (included 
above) and consider actions. There was general consensus that useful actions could 
include: 

1.  NHSE  reviewing  and  updating  the  2023  Assurance  of  aseptic  preparation  of 
medicines guidance to provide further direction on thresholds for reporting and 
escalation of concerns from section 10 aseptic units. 

2.  Development  and  implementation  of  a  2-way  information  sharing  agreement 
between the MHRA and NHSE at organisational level to share learning from 
serious incidents related to aseptic medicines preparation/manufacture. Criteria 
would need to be established to prevent over-reporting but information relevant 
to stakeholders could be cascaded through existing MHRA and NHSE safety 
alert mechanisms. 

NHS England is happy to undertake to update the Coroner on future actions arising 
from this.  

It  was  noted  at  this  meeting  that  for  some  time  the  MHRA  and  CQC  have  had  a 
Memorandum of Understanding (MOU) in place between them for sharing information 
on  matters  of  concern  and  that  the  independent  sector  also  operates  section  10 
aseptic units that only the CQC have authority over as the regulator, i.e. no MHRA, 
SPS or NHS involvement or oversight. The communication MOU referenced as action 
2 above, will therefore address the NHS s.10 exempt pharmacy production incident 
point  in  the  PFD,  but  it  will  not  capture  any  independent  sector  s.10  exempt  units. 

 These remain subject to reporting to CQC in the same way as the NHS reports safety 
incidents,  both  of  which  then depend on  the  CQC  sharing  that  information  with  the 
MHRA under the MOU.  

I would also like to provide further assurances on 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 deaths of Aviva, Yousef and 
Oscar, 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