Prevention of Future Deaths reports · 2014
Regulation 28 report to prevent future deaths, reference 2014-0266, written 11 Jun 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 11 Jun 2014 |
|---|---|
| Reference | 2014-0266 |
| Deceased | Bridget Cahill |
| Coroner | Robin Balmain |
| Coroner area | Black Country |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
Robin J. Balmain
H.M. SENIOR CORONER
Date:
Smethwick Council House
High Street
Smethwick
West Midlands
B66 3NT
foe Tel: 0845 352 7483
BLACK COUNTRY CORONER’S DISTRICT neon ohed aS,
(SANDWELL ¢ DUDLEY ¢ WALSALL - WOLVERHAMPTON E-mail:
Metropolitan Borough Councils)
11% June 2014 Our Ref: RUB Your Ref:
REGULATION 28 REPORTS TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
National Institute for Health & Clinical Excellence,
Level One
City Tower
Piccadilly Plaza
Manchester
M1 4BD
1. CORONER
I Robin John Balmain am the Senior Coroner for the Black Country Coroners
Jurisdiction
2 CORONER’S LEGAL POWERS
I make this report under {paragraph 7, Schedule 5, of the Coroners and Justice Act
2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013.
3. INVESTIGATION AND INQUEST
On 19% February 2013 commenced an investigation into the death of Bridget May
CAHILL. The investigation concluded at the end of the inquest on 307 May 2014
and the conclusion of the inquest was that death was due to the effects of morphine
properly prescribed ad administered.
4, CIRCUMSTANCES OF THE DEATH
The deceased died in hospital of a morphine overdose.
5 CORONERS CONCERNS
The evidence I heard was that Mrs. Cahill was admitted to Walsall Manor Hospital
on 10% September 2013. She had a one day history of unresponsiveness, had a
background of Parkinson’s disease, dementia and chronic backache. She lived in a
residential home. On admission she had pinpoint pupils suggesting morphine
overdose which was partially reversed with an antidote. Blood tests showed high
calcium levels suggestive of dehydration, or possibly a tumour and there was a
suggestion of possible ongoing infection. She had treatment with IV fluids, IV
antibiotics and Naloxone, but she deteriorated and died. She was on morphine night
and morning and also oral morphine during the day if and when required. The
maximum dose of Oramorph was 20 millilitres per day, 5 millilitres at a time, dosages
to be 4 to 6 hours apart. The evidence I heard was that at no time prior to her death
did she have the maximum permitted dose.
This Office is open Monday to Thursday 8am to 4pm. Friday 8am to 3pm
The MATTERS OF CONCERN are as follows :-
My concern relates to how it is that a person who is prescribed morphine and who
has less than the amount prescribed for them, can nevertheless suffer an overdose. I
write to enquire whether attention needs to be given to the maximum dose that can
be recommended and whether it is, or should be, subject to factors such as body
weight, any co morbidities and any other factors and whether attention should be
directed towards the possible buildup of morphine in the body for those involved in
long-term therapy.
ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you have
the power to take such action.
YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of the
report, namely by THURSDAY 7 AUGUST 2014.
COPIES and PUBLICATIONS
I have sent a copy of my report to the Chief Coroner and to the following interested
Persons :
1am also under a duty to send the Chief Coroner a copy of your response.
The Chief Coroner may publish either or both in a complete or redacted or summary
form. He may send a copy of this report to any person who he believes may find it
useful or of int¢rest_ You may make representations to me, the Coroner, at the time of
R.J. Balmain
Senior Corone
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
IvIHRA tn Me-re. r.d Md3 ‘ MHRA 151 Buckingham Palace Road London SW1W9SZ United Kingdom www.gov.uklmhra Medicines & Healthcare products Regulatory Agency MrZafarSiddique HM Senior Coroner for Black Country Office of H.M. Coroner Smethwick Council House High Street Smethwick West Midlands B66 3NT Your reference: RJB 9th July2015 Dear Mr Saddique Regulation 28 Report Coroners and Justice Act 2009 — Bridget May Cahill. Thank you for following up on our response to the correspondence from your predecessor Dr Balmain concerning the death of Bridget May Cahill (letter dated 22nd July 2014 and the subsequent post-mortem report dated 26th August 2014). He raised the concern that a person who is prescribed morphine and has less than the amount prescribed for them, can nevertheless suffer an overdose. He asked whether: attention needs to be given to the maximum dose that can be recommended and • • whether it is, or should be, subject to factors such as body weight, any co-morbidities and any other factnrs and • whether attenton should be directed towards the possibility of buildup of morphine n the body for t ,ose involved in long-1e rr therapy H aso orsue ea that MHRA was in a posito simila tances. ir rr ak a i to prevent other deaths in We have carefully reviewed the findings of the post mortem report, considered the pharmacokinetics and pharmacodynamics of morphine in the light of current prescribing advice in the Summary of Product Characteristics (SmPC) for morphine and a detailed discussion is attached as Annex 1 The summary of our view is as follows: I Does attention need to be given to the maximum dose that can be recommended? This case does not prompt a review of the maximum permitted dose given the interindividual range of dose needed to achieve analgesia and the tolerance that is expected to develop as a result of chronic morphine administration. 2. Should the maximum dose be subject to factors such as body weight and any co morbidities? In our view no, for the same reasons explained above. The prescribing information already advises on circumstances in which dosage may need to be reduced i.e. in the elderly, patients with moderate-severe renal or hepatic impairment, or where sedation is undesirable, 3. Should attention be directed towards the possible build-up of morphine in the body for those involved in long-term therapy? Although build up could be expected in the elderly as a result of reduced renal function, the evidence in this case does not support an excessive accumulation of the metabolites, as would have been expected (since the metabolites depend primarily on renal function for their elimination, while this is not the case for morphine, which is mainly metabolised). The elderly are known to be particularly sensitive to the effects of many CNS-acting agents and perhaps this is the more important contributing factor in this case. The case highlights the importance of careful titration and review of opioid dosing at regular intervals, as recommended in current treatment guidelines. I sincerely apologise for the oversight which resulted in us not issuing out response Finally, within the required timeframe. Should you have any further queries about our analysis please contact me again. Yours sincerely --.--. Dr Ian Hudson Chief Executive, MHRA T E 02030806100 cn eT e xec vev
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