Elaine Inns

4th Floor 
Stopford House 
Piccadilly 
Stockport 
SK1  3XE 

Tel: 0161 426 9900 
www.stockportccg.nhs.uk 

2 November 2021 

Private & Confidential 
Ms Alison Mutch 
H M Senior Coroner 
Coroner’s Court 
1 Mount Tabor Street 
Stockport 
SK1 3AG 

Dear Ms Mutch 

Regulation 28 Report  -  Ms Elaine Michelle Inns (deceased) 

I refer to your letter dated 26 August 2021 in relation to the above and thank you for contacting 
NHS Stockport Clinical Commissioning Group (CCG) in this matter.  I am sorry to learn of the 
circumstances of Ms Inns’s death and offer my sincere condolences to her family. 

I note the cause of death as detailed in the report and your concern that future deaths will 
occur  unless  action  is  taken.    The  areas  of  concern  relate  to  the  prescribing  of  an  opiate 
medication to a  patient who was known to  dose erratically and to use alcohol in significant 
quantity.    I  have  been  assisted  in  my  investigation  by  the  GP  Practice  involved  who  I  was 
pleased to note had undertaken a detailed significant event analysis prior to the CCG receiving 
your Regulation 28 report.   

I will now address the specific points raised within your report:- 

• You express concern that Ms Inns continued to be prescribed a combination
of  medications  including  a  number  of  powerful  pain  killers  although  it  was
well  understood  that  she  was  using  alcohol  in  significant  quantity  whilst
using prescribed medications

 
 From a review of the clinical records in this case it is clear that Ms Inns’ history of alcohol 
excess is included in her history and that attempts to support her in relation to this issue 
had  been  made  previously  including  a  referral  to  the  Drug  &  Alcohol  Service  in  2019.  
However, a review of more recent consultation notes highlighted that Ms Inns’ current level 
of alcohol consumption was not directly explored when undertaking a medication review or 
during consultations relating to her general health and wellbeing.   

Learning & Actions 

The  practice  discussed  the  risk  associated  with  opiate  prescribing  and  the  significant 
polypharmacy in this case which was the result of historical additions to Ms Inns’ medication 
regime, which of which pre-dated current NICE guidance on prescribing for chronic pain.  
The practice acknowledge that it is important to review and challenge these regimes.   

As part of the review of this case the practice re-visited a previous MHRA alert regarding 
the co-prescribing of Oxycodone and Amitriptyline and with this in mind the practice carried 
out a search of all patients with this combination and has now invited them for review with 
the practice pharmacist.   

The investigation identified the need for all clinicians to enquiry specifically about alcohol 
when reviewing patients on opiates and TCAs/ Gabapentinoids as a matter of routine and 
in  order  to  support  this  process  the  medication  review  template  has  been  reviewed  to 
include:- 

•  Discussion about alcohol whilst taking opiates (tick box) 
•  GP informed (tick box) 
•  Confirmation  of  whether  patient  is  takin  any  other  medication  which  may  lead  to 

increased opiate levels / sedation (yes/no) 

All  registered  patients  identified  as  drinking  whilst  prescribed  opiates  are  now  routinely 
flagged for GP review as a matter of urgency. 

•  You express concern that Ms Inns used prescription medications without 

following the prescribing dose instructions 

The  practice  acknowledge  that  despite  dosage  instructions  being  clearly  included  with  any 
prescribed  medications,  Ms  Inns  was  not  following  the  recommended  dose  instructions  and 
there  is  a  need  to  be  explicit  and  clear  when  entering  instructions,  dosage,  quantity  and 
intended frequency of prescription  of controlled medications.  This needs to  be clear to  the 
patient so that they can safely self-administer and also to the prescriber so that they can easily 
identify possible misuse or early requests.   

Learnings and Actions 

 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 All early prescription requests will be rejected and the patient informed; the patient will need 
to consult directly with a GP in relation to the prescription request and circumstances which 
have led to early request.   

Medication  reviews  for  this  group  of  patients  will  be  six  monthly  and  will  be  undertaken  by 
either a GP or a pharmacist.  The review will be brought forward if there are any concerns in 
relation  to  potential  misuse  of  controlled  medications,  or  where  there  is  reference  to  mood 
disturbance, excess alcohol use or other drugs of concern.  

A medication review will include:- 

•  Establish indication and whether other treatment indicated for underlying pain 
•  Clear dosage and directions on prescription 
•  Consider weekly prescriptions if indicated 
•  Task sent to all clinicians to raise awareness if concern 
•  Alert on notes in EMIS clinical system to warn prescribers to check dates if concern 
•  GP to discuss involvement of other teams: psychological medicine in primary care, 

drug and alcohol team, pain clinic as appropriate 
•  Consider drug holiday or supportive dose reduction 
• 

If  continuing  medication  patient  to  sign  opioid  management  plan  and  treatment 
agreement (as per GMMMG) 

In addition, a specific audit is to be undertaken to identify all patients currently prescribed oral 
morphine (acute or repeats).  Notes will e reviewed to ensure identification of the following in 
each case:- 

•  Clear indication in the notes 
•  Dose of oral morphine is clear, and the directions for use include the volume and how 
long  this  should  last  (eg  2.5  to  5  mls  every  4  hours  for  breakthrough  pain,  200  mls 
fortnightly) 

•  Consideration of whether the patient should be on slow release/ slow release dose of 

medication reviewed if high oral morphine use 

•  Check notes for signs of mood disturbance/excess alcohol use/other drugs of concern 
•  Flag any concern / overdue medication review (review y pharmacy team with GP input 

as required) 

Management of Communication 

This  investigation  also  highlighted  that  Ms  Inns  had  consulted  with  Mastercall  Out  of  Hours 
Service on 20/12/2020; she was reported to have been intoxicated and asking for support from 
her GP in relation to alcohol dependency.   Whilst Mastercall did advise the patient to contact 
the practice and did write to the practice.  However as there was no highlighted action within 
the letter, the correspondence was filed without having been referred to the GPs.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Learnings and Actions 

As a result of this  case, the administrative process at the practice  has been changed; in all 
cases where a patient has a safeguarding alert on their records, all out of hours correspondence 
is now referred to the GPs for review / action which means that any such communication would 
be reviewed within 48 hours. 

Conclusion 

Having reviewed this overall investigation and the circumstances which led to the issue of your 
Regulation 28 report, I reach the conclusion that the key issue is the prescribing of opiates and 
I am satisfied that appropriate steps have been taken to ensure the safe prescribing of opiate 
medication  at  the  individual  practice  and  across  the  wider  Stockport  GP  community.    I  will 
ensure that the most up to date opiate prescribing guidance is shared across our practices and 
work with colleagues across our system to ensure adherence to best practice guidance.   

Thank you again for contacting NHS Stockport CCG in this matter; I hope the above provides 
relevant assurance.  However, if you do require any further information then please contact 
me.   

Yours sincerely 

Dr 
Medical Director