Prevention of Future Deaths reports · 2014
Regulation 28 report to prevent future deaths, reference 2014-0161, written 9 Apr 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 9 Apr 2014 |
|---|---|
| Reference | 2014-0161 |
| Deceased | Michael Anthony |
| Coroner | Andrew Harris |
| Coroner area | London Inner (South) |
| Category | Community health care and emergency services 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.
Senior Coroner, London Inner South, UK Re: Michael Samuel! lan Anthony case ref 01269-2013 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. | practitioner, PSGP, 2 Princess Street, 2. consultant physician, Older Persons Assessment Unit, Ground Floor, Bermondsey Wing, Guy’s Hospital, Great Maze Pond, London SE1 9RT CORONER | am Andrew Harris, senior coroner for the jurisdiction of London Inner South 2 | CORONER’S LEGAL POWERS | 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 14.05.13 | opened an inquest into the death of Michael Anthony, aged 64, who died on 8" May 2013. The inquest was concluded on 26" March 2014. The conclusion of the inquest was given in a narrative: Mr Anthony was found dead in his flat on 8” May 2013. There were no suspicious circumstances. He died from diabetic ketoacidotic coma. He had a very high Gabapentin level in his blood, which along with a fatty liver from Hepatitis B and/or diabetes, contributed to his death. It was not possible to conclude whether the ketoacidosis was also caused by a reaction to Gabapentin. 4 | CIRCUMSTANCES OF THE DEATH The Gabapentin level was five times-normal therapeutic level. It was not determined why this level was so high. His ketonuria was reported by the toxicologist as either being due to diabetic coma (shortage of insulin) and/or a reaction to the drug Gabapentin. The toxicologist reported that Gabapentin was usually not prescribed in diabetics, as some individuals developed a severe reaction which precipitated diabetic coma. The court read the evidence of the GP, who did not refer to the reasons for prescribing Gabapentin and did not call the consultant physician, but heard it was for pain relief. . 5 | CORONER’S CONCERNS During the course of the inquest the evidence revealed a MATTER OF CONCERN as follows. — (1) It was not known whether Gabapentin was contraindicated to be prescribed in the deceased, who suffered severe Type 1 diabetes, or whether the prescribing doctors were aware of the rare side effect of Gabapentin in precipitating diabetic coma. If they were not there would be a potentially avoidable risk to other patients. ACTION SHOULD BE TAKEN The doctors are asked to review the Prescribing of this drug and its indications and consider whether it is appropriate to update their prescribing knowledge and practice. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by Thursday June 5" 2014. |, the Coroner, may extend the period. Your response must contain details of action taken or Proposed to be taken, setting out the timetable for action, Otherwise you must explain why no action is proposed. COPIES and PUBLICATION I have sent.a co port to the Chief Coroner and to the following Interested Person, sisterf] have also sent it OM senior toxicologist, Imperial College, London. Tam 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 interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. If you would like further information about the Case, please contact my officer, Miss Marianne Mitulescu, on 020 7525 1081, Marianne.mitulescu@southwark.gov.uk. ah cal Dole [SIGNED BY CORON PRY
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.
Guy’s and St Thomas’ INHS|
NHS Foundation Trust
Older Persons Assessment Unit
Ground Floor, Bermondsey Wing
Your Ref: 01269 - 2013 Guy's Hospital .
. Great Maze Pond
London SE1 9RT
Mr John Thompson Department: 020 7188 2519
Clerk to Senior Coroner ; ; Fax: 020 7188 2082
Southwark Coroner's Court Main Switchboard: 020 7188 7188
1 Tennis Street
Southwark, London
SE1 1YD 06 May 2014
Dear Mr John Thompson
Re: MR MICHAEL ANTHONY (DECEASED) Date of Birth: 15-05-1948
NHS No!
Address:
Many thanks for your letter of 40" April last sent to both myself and ae: relation to the
above deceased. We note and acknowledge receipt of the Regulation 28 report to prevent future
deaths on the above addressed to myself a | have asked for full disclosure by email
to the coroner's office of the toxicologists report. In the meantime, we have asked for a review from
the regional drug information service at Guy's. This is attached below and forms part of our
reflection, learning and response. :
We have spoken rear emir Clinical Lead for Diabetes and Endocrinology at Guy's and
St. Thomas’ and Clinical Director for the Clinical Academic Grouping of Diabetes and Endocrinology
in King’s Health Partner, who does not recognise this particular risk and in his own extensive
experience , has not seen it.
land | have conferred. We have used this drug over many years. It is licensed for the
use of the treatment of pain syndrome in diabetics. We have never had any problems such as
described in the case. We both note the comments by the Toxicologist.
We have made the necessary changes by building this review into our day to day practice. If there is
any further comments to be added on receipt of the disclosure requested above, we will reply but at
present we would ask that this letter serves as our conclusion and formal réply to the letter received
from you on behalf of the Chief Coroner.
Yours sincerely
Electronically checked and authorised by
Consultant —. GP
General Practitioner
If for an older person you require Outpatient Rapid Assessment same or next-day or advice from a
Geriatrician - Phone 020 7188 1465
www.guysandstthomas.nhs.uk
Princess Street Group Practice
2 Princess Street, Elephant And Castle
London
SE1 6JP
www.guysandstthomas.nhs.uk
Drug information Search South London DI Service
cea
Thank you for your enquiry in to gabapentin and the potential association with diabetic coma. We have looked
in to the possibility of this side-effect and in particular as a toxic effect.
The understanding is that gabapentin was prescribed for a patient with type 2 diabetes for neuropathic pain.
The most recent information available to us states that he was on a dose of 600mg three times a day. No
information provided as to how long he has been on it for.
The following are the key outcomes of our research in to this enquiry. Details are provided further in the
response.
1. Diabetic ketoacidosis is not a recognised adverse effect of gabapentin at both therapeutic and toxic
doses.[1,2,6]
. 2. We disagree with the statement that gabapentin should not be used in diabetics as itis a licensed
medicine in patients with diabetes to controlled symptoms of painful neuropathy. Licensed doses for
this indication can go up to 3600 mg/day.[1,2]
3. The patient in question was renally impaired. Doses of gabapentin in renal impairment should be
lowered [1, 2]. The named patient was within the referenced licensed doses for his level of impairment
on 14/12/2012, which was the most recent date blood results that were available to us. We are unsure
if after this time his kidney function deteriorated. Gabapentin is eliminated unchanged solely by renal
excretion, [2] therefore an impaired renal function will impair clearance of the drug leading to the
possibility of toxic effects from accumulation.
4. Within both licensed and toxic doses, reports of diabetic ketoacidotic complications or fatalities were
not found, apart from one report that was submitted to the MHRA.[3] Furthermore, toxicology data
does not suggest any information on gabapentin causing diabetic ketoacidosis.[4]
5. A\literature search found one paper which claimed that due to high doses of gabapentin the patient
developed ketoacidosis. It is however, not clear if this is the case reported to the MHRA and details of
the case are not available as the full paper to ascertain how the conclusions were made.
We understand that said patient had chronic kidney disease. From the data available, we were able to work
out the level of impairment. The last set of renal data we have (14/12/2012) suggests that the patient's
creatinine clearance was approximately 56.7ml/min, which means that he had moderate (stage 3) renal
impairment. Doses of gabapentin according to the summary of product characteristics should see gabapentin
up to a total daily dose of 1800mg in renal impairment.[2] This patient was within this limit. It cannot be
determined whether this was an appropriate dose at the time of the patient's death as an up to date renal
profile was not available: Gabapentin toxicity in patients with impaired renal function can manifest as coma.[{5]
Within licensed doses we found the most common adverse effects are sedation, ataxia, dizziness, fatigue,
nystagmus, changes in blood pressure.[6] Toxic effects found signs such as those above and slurred speech,
movement disorders, and gastrointestinal upset. In more severe cases, patients may present with mild
hypotension and profound central nervous system depression requiring intubation. Usually withdrawal of the
drug leads to reversal of these effects. [1,2,6]
One non-fatal report was found by the MHRA yellow card adverse reporting system for the development of
diabetic ketoacidosis.{3} Please note that the likelihood of experiencing an adverse drug reaction when taking
a medicine cannot be estimated from the information provided in these reports. This is due to limited
information about how many people have taken the medicine without experiencing a reaction.[3]
An extensive {literature search was done using Medline and Embase databases.[7,8] One paper found a
patient on haemodialysis was found to have potential gabapentin toxicity which caused admission to hospital
after a series of seizures. A review of her medicines found high doses of gabapentin, which was then
discontinued. She showed improvement after stopping drug. The admission was complicated with diabetic
ketoacidosis. The paper concluded this to be caused by gabapentin. It is however, unclear whether this is
linked to the report found with the MHRA. Full text of paper not currently available. [9]
www.guysandstthomas.nhs.uk
Toxicology data shows that toxicity is "probably" low with gabapentin. Adult patients have ingested up to 30g
with only mild symptoms seen. Furthermore, ingestion of up to 90g caused transient drowsiness, dizziness and
ataxia. Ni! information found about diabetic ketoacidosis. [4]
It is a possibility that high levels of gabapentin contributed to the fatality of named patient. However, it cannot
be exclusive that this was the main cause. The licensing information states that in the treatment of peripheral
neuropathic pain such as painful diabetic neuropathy, efficacy and safety have not been examined in clinical
studies for treatment periods /onger than 5 months. This may have been a contributing factor, in particular
because the patient was renally impaired.
This case has been reported via the MHRA yellow card reporting system.
| hope this information has been useful for you. Please feel free to contact us if any further information is
required.
Kind Regards,
Loran STEP Pharmacist
information | Pharmacy department .
Guy's and St Thomas' NHS Foundation Trust | Great Maze Pond | London | SE1 9RT
Telephone: 02071888750 | Fax. 0207 188 3857
References:
1) BNF.org. British National formulary. http:/(www.medicinescomplete.com/me/bnf/current/ Last accessed
09/05/2014
2) Summary of product characteristics for Gabapentin. Electronic medicines compendium.
www.medicines.org.uk/eme/. Last accessed: 25/04/2014
3) Yellow card data (CHM Drug Analysis Prints)-Gabapentin. MHRA
www. mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/T heYellowCardScheme/Yel
lowCarddata/Druganalysisprints/index.htm. Accessed: 29/04/2014
4) Gabapentin monograph. Toxbase. www.toxbase.org. Last accessed 25/04/2014
5) Pierce D.A. Holt S.R. Reeves-Daniel. 2008. A Probable case of hearing loss in patient with acute renal
failure. Clinical Therapeutics. Vol./is. 30/9 Pages:1681-1684
6) Micromedex. www.micromedexsolutions.com/home/dispatch. Last accessed 25/04/2014
7) Medline. www.evidence.nhs.uk/nhs-evidence-content/journals-and-databases. Last accessed: 09/05/14
8) Embase. www.evidence.nhs.uk/nhs-evidence-content/journals-and-databases Last accessed: 09/05/14
9) Patel S., Malhotra R. 2013. Gabapentin related neurotoxicity in hemodialysis patient. Journal of General
Internal Medicine. vol./is. 28/(S330). Pages: 0884-8734
10)Stockleys Drug Interactions. http://www.medicinescomplete.com. Last accessed: 06/05/2014
www.guysandstthomas.nhs.uk
See every Prevention of Future Deaths report matching Community health care and emergency services related deaths, and how often a new one appears.
What would an alert for this have sent me? Search the full text
Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.
These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.