John Roberts

BNF Publications 
bnf.org 
________________________________________________________________________________ 

Mr R. Guy Davies 
H.M. Coroner’s Office 
Pydar House 
Pydar Street 
Truro 
Cornwall 
TR1 2AY 

06th July 2023 

Dear Mr Davies, 

We write in response to your Regulation 28 report dated 16th May 2023 which was sent to us as the 
Publisher of the British National Formulary (BNF). We are sorry to hear the sad circumstances of this 
case regarding Mr John Alfred Roberts.  

In light of the findings from your report, we have carried out an assessment of the information 
currently contained in the BNF relating to prednisolone and the corticosteroids drug class, and 
reviewed relevant literature regarding the risk of bowel perforation in patients with diverticular 
disease. The result of that research is that, within the “Cautions” section of all corticosteroid 
monographs in the BNF, we will add “diverticular disease (increased risk of diverticular perforation)”. 
This will be actioned for the August online monthly update. The “Cautions” section of BNF content is 
used to highlight specific clinical situations in which the use of a drug for a given patient is known to 
present a risk of harm that is greater than usual and therefore a healthcare professional should be 
aware so that they can weigh the risks and benefits for their individual patient.  

Side-effects listed within BNF Publications are those for the general population. Where a side-effect 
is reported in a specific population type (e.g. those with diverticular disease), this would be included 
within the Cautions section, as we have set out above.  

We trust that this addresses this important issue.   

Yours sincerely, 

Content Director (BNF Publications) 

_______________________________________________________________________________ 

Royal Pharmaceutical Society  
66-68 East Smithfield, London E1W 1AW

Chief Executive Office  

Royal Cornwall Hospital 

Truro 

Cornwall  

TR1 3LJ 

12 May 2023 

Mr Guy Davies 

Assistant Coroner for Cornwall and the Isles of Scilly 

H.M Coroner’s Office 

Pydar House, Pydar Street 

Truro, Cornwall 

TR1 1XU 

Dear Mr Davies 

Re: Death of John Alfred Roberts - R28 PFD Report & letter (ref: 6930388) 

I write in response to the Regulation 28 Report to Prevent Future Deaths, dated and received 
on the 26th of April 2023, issued as a result of the inquest into the death of Mr John Alfred 
Roberts, which took place over 12 – 14th April 2023. 

I would like to take this opportunity to express my sincerest condolences to the family of Mr 
Roberts for their loss.  

During the course of the inquest, the evidence revealed matters giving rise to concern. These 
are as follows: 

• The concern is the inadvertent reduction of steroid dosage and the arrangements made in 
relation to the administration of medication dosages and the policies regarding dosage errors, 
and the application of those policies.  

 prednisolone was inadvertently reduced to 
• The Court heard that the dosage of 
from 7 to 13 June. The full dose of 
 was given either side of that period, on 5 and 15 
June 2021. No explanation was offered for this reduction other than it being an inadvertent 
mistake.  

• RCHT Consultants accepted that the dosage error was a serious mistake. Furthermore, this 
mistake  was  not  drawn to the  patient  John’s  attention or to the  attention of  the  GP  via the 

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 discharge summary,  which made  no reference to the  dosage error. It  was  unclear  whether 
treating physicians or discharging physicians were aware of the dosage error.  

Please find below an account of the details of the inadvertent prednisolone dosage reduction 
and then a response from the Trust in relation to each concern you have raised: 

Chronology of events regarding prednisolone: 

Mr  Roberts  was  initially  prescribed 
  prednisolone  oral  dosage  alternate  days  on 
admission on the Friday 4th June 2021 and received this dose on 5th June 2021 as prescribed. 
A request came to the pharmacy dispensary on Saturday 5th June 2021 for more prednisolone 
tablets. Mr Roberts was prescribed 
 tablets (note 1) This would 
have meant Mr Roberts swallowing 
 tablets. The dispensary pharmacist on duty switched 
 tablets to reduce the pill burden for Mr Roberts but inadvertently  
the preparation to the 
 on alternate days. This resulted in Mr Roberts receiving a 
did not amend the dose to 

 prednisolone as 

 dose on the 7th,9th,11th and 13th June 2021. 

Note 1 

On admission to hospital, the hospital aims to undertake a medicines reconciliation for each 
patient,  to  ensure  the  medicines  they  have  been  prescribed  on  admission  match  those 
prescribed by their GP. This reconciliation process was undertaken by the ward pharmacist 
on  Monday  7th  June  2021  and  recorded  on  the  Electronic  Prescribing  and  Administration 
system (ePMA) noting system as per the Trust’s policy (see note 2). 

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 The pharmacists use several sources when undertaking the medicines reconciliation process, 
including the summary care record (SCR) and list of medicines from the GP. In this instance 
it would appear the GP list and SCR showed the prednisolone dose to be 10mg on alternate 
days.  

Note 2: 

A later ‘pharmaceutical care plan’ note (see note 3) suggests the ward pharmacist confirmed 
 dose with the ward doctor (this was likely with the renal team who Mr Roberts was 
the 
under the care of, rather than the neurologist). It is common practice for prednisolone doses 
to increase and decrease depending on disease flare; so a dose change would not be unusual. 
The pharmacist noted on the reconciliation record ‘INC AS IP’ (increased as inpatient), as the 
SCR and GP record showed his usual dose to be 

 on alternate days. 

Note 3: 

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 As per note 3, the pharmacist covering the ward on 15th June identified the discrepancy in the 
dosing and recorded it on the ePMA system as an intervention. The medicines reconciliation 
note (note 4) was amended to reflect the 

 alternate days dose. 

Note 4: 

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 Shortly after the medicines reconciliation note was amended on the 15th June 2021, the same 
pharmacist  has  recorded  an  ‘intervention  counselling’  note  (note  5)  onto  ePMA-  stating 
‘counselled  patient  on  all  medicine  changes  and  amended  personal  list’.  We  are  unable to 
confirm if this discussion included a discussion regarding the prednisolone discrepancy. 

Note 5: 

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 The pharmacist also entered two ‘DMR’ (discharge medicines reconciliation) notes (note 6 & 
7).  These  notes  appear  in  the  discharge  letter  that  goes to the  GPs  and  gives  information 
about  changes  to  medication  during  admission.  Note  7  includes  information  relating  to 
reducing  the  prednisolone  dosing  after  discharge,  though  does  not  mention  the  dosing 
discrepancy during the admission. 

Mr Roberts was subsequently discharged home on the 15th June 2021. 

Note 6: 

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 Note 7: 

In relation to each concern you have raised; 

7 

 
 
 
 The concern is the inadvertent reduction of steroid dosage and the arrangements made 
in  relation  to  the  administration  of  medication  dosages  and  the  policies  regarding 
dosage errors, and the application of those policies.  

The  Trust’s  policies  concerning  medicines  reconciliation  on  admission  and  discharge  were 
applied and did pick up the dosage error before any harm came to the patient. The picture 
was confused as Mr Robert’s summary care record and GP list recorded his dose as 
on alternate days. This was a causative factor in the discrepancy not being picked up on the 
admission reconciliation. The error was picked up at the discharge reconciliation and recorded 
on  the  ePMA  system  in  an  ‘intervention  note’  but  with  hindsight  should  also  have  been 
recorded on the Trust’s incident management system-Datix. 

 from 7 to 13 June. The full dose of 

The Court heard that the dosage of 

 prednisolone was inadvertently reduced to 
 was given either side of that period, on 
5 and 15 June 2021. No explanation was offered for this reduction other than it being 
an inadvertent mistake.  

I trust the chronology of events described above gives an explanation to dosage discrepancy, 
how it occurred and how it was rectified.  

RCHT Consultants accepted that the dosage error was a serious mistake. Furthermore, 
this mistake was not drawn to the patient John’s attention or to the attention of the GP 
via  the  discharge  summary,  which  made  no  reference  to  the  dosage  error.  It  was 
unclear  whether  treating  physicians  or  discharging  physicians  were  aware  of  the 
dosage error.  

The  notes  within  the  ePMA  system  (specifically  note  2)  evidence  that  the  treating  and 
discharging physicians were aware of the dosage error. 

Note 4 shows that Mr Roberts was counselled about his medicines and the changes in dosing 
but we cannot confirm this included a discussion around the prednisolone dose.  

As  stated  in  evidence  during  the  inquest  hearing  over  12  -  14  April  2023,  the  dosage 
discrepancy caused no harm to Mr Roberts and there was no action required by the GP in 
 doses administered from the 7th-13th June. It is 
relation to the dose discrepancy of 
not  within  our  procedures  to  communicate  to  the  GP  incidents  that  cause  no  harm  to  the 
patient and require no action by the GP following discharge. 

Information was passed on to the GP relating to any changes in dosing at discharge and any 
subsequent actions that were required, including the need to reduce the prednisolone dose 
(notes 5&6). 

I hope that this letter provides both you and Mr Roberts’ family with assurance that the Trust 
has taken seriously the matter of concerns you raised in your report.  

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 Yours sincerely 

Chief Executive Officer 

Cc  

Care Quality Commission 
VIA email 

Director of Governance  
Bedruthan House, RCHT 

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