Katie Corrigan

HSCA Further Information 
Citygate 
Gallowgate 
Newcastle upon Tyne 
NE1 4PA 

Telephone: 
Fax: 03000 616171 

HM Coroner Mr. Andrew Cox 
Coroner for Cornwall & the Isles of Scilly  
H.M. Coroner’s Office 
The New Lodge 
Newquay Rd 
Penmount 
Truro 
Cornwall TR4 9AA 

BY EMAIL AND POST 

12 April 2021 

Care Quality Commission (CQC) 
Our Reference: 

Dear HM Senior Coroner Cox  

Prevention  of  future  deaths  report  following  the  Inquest  into  the  death  of 
Katie Emma Corrigan. 

Thank you for your Regulation 28 report to prevent future deaths issued following 
the inquest into the sad death of Katie Emma Corrigan.  

Prevention of Future Deaths Report 

Under Section 6 of your report entitled “Action that should be taken” you noted as 
follows in particular: 

  The absence of a requirement for doctors in the private sector to contact a 
registered GP prior to dispensing opiate medication to a patient leaves the 
system open to abuse.  

  One of the on-line pharmacies identified above openly advertises itself as 
offering a ‘discreet’ service which I interpret as a willingness to circumvent 
the existing, inadequate controls. I do not know but am bound to wonder if 
there  is  a  professional  or  financial  relationship  between  the  prescribing 
doctor  and  dispensing  pharmacist  and,  if  so,  whether  this  is  considered 
ethical or meeting current professional standards?  
  The Alert system appears cumbersome and ineffective.  
  All online prescribing services accessible by patients in England should be 
regulated by the CQC, regardless of which professional groups are doing 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 the  prescribing,  regardless  of  where  in  the  world  those  prescribers  are 
registered, and regardless of where in the world the provider’s head office 
is. This would require a change in regulation by the Department of Health & 
Social Care. 

CQC inspection of online provider services 

As you are already aware the Care Quality Commission (CQC) is the independent 
regulator for health and social care in England. CQC’s purpose is to make  sure 
health and social care services provide people with safe, effective, compassionate, 
high-quality care and we encourage care services to improve. CQC’s functions are 
to register health and adult social care service providers in England; to monitor, 
inspect and rate services; and to take action to protect people where appropriate 
using  its  powers  under  Health  and  Social  Care  Act  2008  and  associated 
regulations. 

As part of an online provider inspection CQC routinely checks the management of 
medicines,  prescriptions,  consent  and  sharing  information  with  a  patient’s  other 
health care providers. CQC recognises that a provider’s management of medicines 
and prescriptions in this way can be restricted where patients have not provided 
consent  to  share  information  and/or  where  a  patient  has  used  alternative 
identification. 

CQC  has  published  guidance  for  providers1.  The  guidance  describes  the 
expectations  of  providers  to  ensure  a  patient’s  GP  is  informed  of  prescribed 
medications from their service. We also expect that should the patient decline to 
consent  for  the  sharing  of  such  information  to  take  place,  the  prescriber  should 
consider whether it is still safe to continue and accept the full responsibility for their 
actions and act in line with GMC prescribing guidance. 

All providers must comply with the regulations as set out in The Health and Social 
Care  Act  2008  (Regulated  Activities)  Regulations  2014  (RAR  2014).  The 
regulations  that  would  be  most  relevant  to  any  reviews  around  online  providers 
would be: 

  Regulation 9 (Person-Centred Care); 
  Regulation 11 (Need for Consent); 
  Regulation  12  (Safe  Care  and  Treatment  including  the  safe  use  of 

medicines);  

  Regulation  13  (Safeguarding  service  users  from  abuse  and  improper 

treatment); and 

  Regulation 17 (Good Governance)  

1 How CQC monitors, inspects and regulates ONLINE PRIMARY CARE, April 2019 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 For all health and social care providers, CQC would look at the regulations outlined 
above and determine whether there is evidence of compliance under each of the 
Key Lines of Enquiry (KLOE) relative to the provider type.  

A  registered  provider’s  compliance  with  the  regulations  will  be  assessed  at 
inspection. As part of a CQC comprehensive inspection the online provider will be 
inspected against five key questions, whether a service is safe, effective, caring, 
responsive  and  well  led. Each  of  the  five  key  questions are broken  down  into  a 
further set of questions, the key lines of enquiry (KLOEs). When CQC inspects, 
these  are used  to  help  CQC decide  what  the  inspection needs  to focus  on.  For 
example,  the  inspection  team  will  look  at  the  management  of  medicines  and 
prescriptions,  consent,  identity  checks  and  sharing  information  with  a  patients’ 
other health care providers. As part of the consideration as to whether a service is 
safe, effective, caring, responsive or well led, CQC will consider how governance 
systems, processes and practices keep people safe, how these are monitored and 
improved and whether staff receive effective training in safety systems, processes 
and practices. 

Online Provider Regulatory Framework Concerns: 

CQC regulates providers of online primary care services based in England where 
they are delivering a regulated activity by an online means. This includes providers 
prescribing medicines in response to online forms. Providers of controlled drugs 
based in England must comply with legislation, which is enforced by CQC, as well 
as  other  healthcare  regulators  such  as  the  Medicines  and  Healthcare  products 
Regulatory Agency (MHRA) and the General Pharmaceutical Council (GPhC). In 
addition,  all  healthcare  professionals  are  subject  to  their  respective  codes  of 
professional  conduct  and  these  are  enforced  by,  for  example,  the  GPhC  for 
pharmacists or the General Medical Council (GMC) for doctors. 

Through our regulation of independent online primary medical services, CQC has 
identified gaps in the regulatory framework for online providers. We share HM 
Coroner’s concerns that members of the public may be able to source medicines 
with the potential for harm from providers who structure their business in such a 
way as to be outside the scope of registration with the CQC or the GPhC. We are 
also aware that our regulatory partners, including MHRA and the GPhC, share 
our concerns about the lack of regulatory oversight in this area. 

In the last few years, CQC has extensively engaged with members of a UK-wide 
cross-regulatory forum to improve oversight of these providers. Although CQC has 
taken enforcement action against online providers we also identify that our ability 
to regulate in this space in certain circumstances where we see unsafe or criminal 
practice  is  restricted  by  legislative  barriers  and  limitations  in  this  area.  CQC 
recognises the regulatory framework in this area needs to be updated to address 
emerging  risks  and  to  ensure  independent  online  prescribers  adhere  to  safe 
practice. 

3 

 
 
 
 
 
 
 
 
 
 Since January 2021 CQC has been in discussions with, and submitted, proposals 
for legislative changes to the Department of Health and Social Care (DHSC), to 
improve  CQC’s  ability  to  take  action  against  independent  providers  of  online 
primary care services that are putting people’s lives at risk. In particular, we are 
looking to address safety gaps in the following areas:   

  over prescribing of opioids and other medicines online;     
  prescribing  online  without  knowledge  of  a  patient’s  history  or  access  to 

 

 

 

patient records; 
the type and quantities of medicines that can be prescribed by independent 
providers online;   
the lack of measures and checks in place when medicines are dispensed in 
England, following a prescription from outside England; and  
limited jurisdictional ability for UK regulators to take action in response to 
harmful  prescribing  by  providers or  registered  persons  based  outside  the 
UK.  

DHSC are currently working with CQC to look at how regulation can be best 
updated to address the areas outlined above, as well as to address current and 
emerging threats to the health, safety and wellbeing of service users from online 
providers. This includes looking at what issues can be addressed through 
legislative change (primary and secondary). CQC is also looking to work more 
closely with our partners, other regulators (including MHRA and GPhC) and other 
government organisations to explore other opportunities for taking this work 
forward. 

CQC Regulatory Action: 

CQC has inspected each of the registered online providers that you identified from 
the  inquest  into  Ms  Corrigan’s  death  that  Ms  Corrigan  may have used. At  each 
inspection,  management  processes  for  prescribing  medications  were  reviewed 
and if concerns were identified we took regulatory action against the provider or 
the inspection report shared details of the areas needing improvement.  

We have identified that two of the online providers whose details you shared are 
not  currently  registered  to  carry  on  regulated  activities.  You  may  be  aware  that 
under section 10 Health and Social Care Act 2008 it is an offence for persons to 
carry on regulated activities without being registered with the CQC to do so. We 
are  currently  following  our  processes  to  investigate  those  providers  you  shared 
with us, to ensure these do not remain as unregistered providers and we may take 
enforcement  action  as  appropriate  and  necessary  upon  conclusion  of  our 
enquiries. 

4 

 
 
 
 
 
 
 
 
 
 
 
 Where CQC identifies that regulations are not being met, we use our enforcement 
powers to require improvements to be made. We continue to do this and will share 
key learning and practice points from the inquest into the death of Katie Corrigan. 

We  hope  that  this  response  addresses  your  concerns.  Should  you  require  any 
further information then please do not hesitate to get in touch.  

Yours sincerely 

Head of Inspection- PMS South East and South West. 

5

From Nadine Dorries MP 
Minister of State for Patient Safety, 
Suicide Prevention and Mental Health 

39 Victoria Street 
London 
SW1H 0EU 

21 May 2021 

Mr Andrew J Cox 
HM Acting Senior Coroner, 

Cornwall & the Isles of Scilly 

HM Coroner's Office 
The New Lodge 
Newquay Road 
Penmount 
Truro TR4 9AA 

Dear Mr Cox 

Thank you for your letters of 17 February and 8 March 2021 about the death of Katie 
Corrigan.     

I would like to begin by saying how very sorry I was to read the circumstances of Mrs 
Corrigan’s death and my deepest sympathies are with her family and loved ones.   

While the great majority of medicines prescribed online are done so appropriately and 
safely, it is deeply concerning that patients, including Mrs Corrigan, have been able to 
access particular types of medicine, or medicines on a scale that they would not likely be 
prescribed by their GP, with serious, and sadly fatal, consequences.  I would like to assure 
you that we are determined to do all we can to prevent such deaths from occurring again. 

I welcome the action by the Care Quality Commission (CQC) and the General 
Pharmaceutical Council (GPhC) to investigate the online providers identified by your 
investigation of Mrs Corrigan’s death.  Where unsafe or criminal practice is identified it is 
essential that regulatory authorities take appropriate enforcement action within the range 
of enforcement powers available.   

The Department continues to work with healthcare regulators (the CQC), and the 
Medicines and Healthcare products Regulatory Agency (MHRA)), and professional 
regulators (the General Medical Council (GMC) and the GPhC), and others, to explore 
how the regulation of independent online prescribers can be strengthened.  

 Since 2017, a UK-wide regulatory forum, chaired by the CQC and including the relevant 
regulatory bodies, has considered a number of issues around digital health care provision, 
including independent online prescribers.  The group meets regularly and collaborates in 
taking action to safeguard patient safety.   

I am aware that you have received responses from the CQC and the GPhC, providing 
detail on those actions that include the provision of new and strengthened guidance, as 
well as regulatory activity, including enforcement action.   

You may also wish to note that in relation to suppliers of medicines at a distance, following 
the UK’s departure from the European Union, the MHRA is considering, under powers in 
the Medicines and Medical Devices Act 2021, a replacement scheme of registration for 
suppliers of medicines at a distance which has been disapplied in Great Britain.   

This is a complex issue and we recognise that there are remaining concerns about the 
ability of the regulatory framework to protect the public and improve the safety of online 
prescribing. 

As you know, the CQC has identified proposals for legislative change to improve its ability 
to take action against independent online providers where there is unsafe practice and I 
can provide assurance that we will work with the CQC to consider these proposals 
carefully. 

Conflicts of Interest 

Turning to your concern about the potential for abuse in the relationship between a 
prescriber and a pharmacist, independent regulators of healthcare professionals have 
standards and guidance in place to ensure that financial arrangements between 
prescribing doctors and pharmacies are transparent and managed appropriately.  

Guidance from the GMC is available to doctors on conflicts of interest1, as well as 
guidance on good practice2.  The GMC’s guidance states that if a doctor, someone close 
to them, or their employer has a financial or commercial interest in an organisation 
providing healthcare, such as a pharmacy or dispensary, they must not allow that interest 
to affect the way they prescribe for, advise, treat, refer or commission services for patients.  

With effect from April 2021, the GMC also has updated guidance on prescribing3, which 
places emphasis on following the principles of good practice regardless of the medium 
through which a consultation is taking place, face to face or online. 

We would expect all registered pharmacies and pharmacists in England to meet the 
regulatory standards set by the GPhC when dispensing any lawfully valid prescription.  

1 Financial and commercial arrangements and conflicts of interest (gmc-uk.org) 

2 Good medical practice-english (gmc-uk.org) 

3 Good practice in prescribing and managing medicines and devices (gmc-uk.org) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 The GPhC has advised you of its standards for registered pharmacies4 and registered 
pharmacy professionals5, as well as guidance for providing services at a distance, 
including on the internet6.  In addition, I am advised that the GPhC has initiated an 
investigation to consider this matter further and will share any findings and a decision once 
the investigation concludes.  

NHSEI Alert System 

In relation to the effectiveness of NHS England and NHS Improvement’s (NHSEI’s) alert 
system in preventing people from obtaining prescription-only medicines improperly, my 
officials have brought your concerns to the attention of NHSEI. 

As you may already be aware, NHSEI has a clear responsibility in providing systems 
oversight for the management and use of controlled drugs.  NHSEI’s Controlled Drugs 
Accountable Officers (CDAOs)7 undertake this role within each geographical region across 
England.  They provide assurance that all healthcare organisations, including pharmacies, 
adopt a safe practice for appropriate clinical use, prescribing, storage, destruction and 
monitoring of controlled drugs.  

CDAOs facilitate the routes to share concerns, report incidents and take remedial action 
as well as highlighting good practice.  This is shared with wider partners such as clinical 
commissioning groups (CCGs) and the Police through the Controlled Drugs Local 
Intelligence Networks (CDLINs).  Details of all CDAOs in England are held on a national 
register, which is owned and published by the CQC: www.cqc.org.uk/content/controlled-
drugs-accountable-officers. 

I am advised by NHSEI that on occasion, CDAOs share information about individual 
patients with relevant partners to support the safe management and clinical use of 
controlled drugs, including codeine.  Circumstances where this may occur include where 
there is a credible concern that someone may be accessing controlled drugs 
inappropriately from several clinical services.  I am further advised that information 
provided about individual patients is in line with the Caldicott principles8, and the 
individual’s freedom to choose how they access healthcare is balanced with the need for 
patient safety and public protection. 

Controlled drugs regulations 

Turning to the comments in your report about controlled drugs regulations, as your report 
identifies, decisions on the scheduling of controlled drugs under the relevant legislation are 

4 standards_for_registered_pharmacies_june_2018_0.pdf (pharmacyregulation.org) 

5 standards_for_pharmacy_professionals_may_2017_0.pdf (pharmacyregulation.org) 

6 Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet 
(pharmacyregulation.org) 

1 https://www.england.nhs.uk/contact-us/privacy-notice/how-we-use-your-information/safety-and-quality/controlled-
drugs-accountable-officer-alerts-etc/ 

8 The Eight Caldicott Principles — The UK Caldicott Guardian Council (ukcgc.uk) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 taken by the Home Office.  This is done with the provision of advice from the Advisory 
Council on the Misuse of Drugs.  Any decisions must weigh up the risks of misuse, abuse 
and diversion, against not impeding legitimate use within healthcare.  This Department 
works closely with health system leaders to provide evidence of safety and risk associated 
with medicines to help inform such decisions.   

You highlight in your report that you have been advised that a change in the status of 
codeine linctus from a pharmacy medicine to a prescription-only medicine is needed.   

I can confirm that the MHRA, the independent medicines regulator in the UK, is keeping 
the legal status of codeine, including codeine linctus, under review and will consider all 
sources of evidence and information relating to this issue. 

In the last year, there has been increased police activity and enforcement action by the 
GPhC in relation to codeine linctus and its misuse in the preparation of a street drug.  
There is active engagement between this Department and the Home Office, and with 
relevant stakeholders including the MHRA, the CQC and the GPhC on this issue.   

Categories of medicines where there is a risk of addiction, such as opioids, should only be 
supplied online if appropriate safeguards are in place to make sure they are clinically 
appropriate for patients.  The GPhC has strengthened its guidance9 to UK online 
pharmacies which clearly states that the selling and supplying of medicines online carries 
risks that need to be appropriately managed to protect patient safety.  Not taking 
appropriate steps to follow these guidelines can lead to failure to meet the standards of 
registered pharmacies, which can result in enforcement action.   

Opioids 

In relation to the wider context to this issue and the increasing concern internationally and 
here in the UK, about the overuse and misuse of opioids leading to a growing problem of 
dependence and addiction, I would like to outline the range of action that has been taken 
to protect patients from harm. 

In 2017, the Government asked Public Health England to conduct an evidence review to 
identify the scale, distribution and causes of prescription drug dependence, and what 
might be done to address it.  PHE’s report of the review was published in September 
201910, providing evidence for dependence on, and withdrawal from, prescribed 
medicines, with the aim of making sure that local healthcare systems build awareness and 
support to enhance clinician and patient decision making.   

In support of this, NHSEI is co-ordinating a programme to implement the 
recommendations of the review, working closely with relevant health system partners.  The 
programme covers five classes of medicines including benzodiazepines; Z-drugs; 
gabapentinoids; opioids, for chronic non-cancer pain; and antidepressants.    

9 Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet 
(pharmacyregulation.org) 

10 Prescribed medicines review: summary - GOV.UK (www.gov.uk) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 The MHRA recently reviewed the risk of addiction and dependence with opioid medicines, 
as a result of which, all opioid medications now carry prominent front-of-pack warnings that 
the product contains opioids and may cause addiction.  In addition, warnings on the risk of 
dependence in product information have been strengthened and harmonised.  The MHRA 
has also worked closely with stakeholders and Trades Associations to develop an 
additional, user-tested, safety information leaflet for distribution directly to patients at 
pharmacies and on the MHRA government website. 

In addition, from October 2020, Primary Care Networks of GPs are required to identify and 
prioritise patients, including patients using potentially addictive pain management 
medication, who would benefit from a structured medication review11.  You may also wish 
to note that further to the February 2020 update to the GP contract agreement 2020/21 to 
2023/2412, a Quality Improvement Module in the Quality and Outcomes Framework for 
general practice on preventing prescription drug dependency is in development.  

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

MINISTER OF STATE FOR PATIENT SAFETY, SUICIDE PREVENTION 

NADINE DORRIES 

11 Report template - NHSI website (england.nhs.uk) 

12 Criteria for registration as a pharmacy technician in Great Britain (england.nhs.uk)