Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0009, written 9 Jan 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 9 Jan 2015 |
|---|---|
| Reference | 2015-0009 |
| Deceased | Annette Charlton |
| Coroner | Louise Hunt |
| Coroner area | Birmingham & Solihull |
| 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.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: MHRA Secretary of State for Health NHS England General Pharmaceutical Council Royal Pharmaceutical Society . Crescent Pharma Ltd PARENs 1 | CORONER | am Louise Hunt, Senior Coroner, for the coroner area of Birmingham and Solihull. 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 7" October 2014 | commenced an investigation into the death of Annette Charlton aged 75. The investigation concluded at the end of the inquest on 6" January 2015. The conclusion of the inquest was natural causes. 4 | CIRCUMSTANCES OF THE DEATH The deceased suffered from emphysema and lung Fibrosis requiring continuous oxygen therapy. On 24/09/14 her GP prescribed a course of antibiotics — Phenoxymethylpenicillin 250mg. Her husband attended their local pharmacy. She was inadvertently dispensed Naproxen 250mg. On 27/09/14 she was admitted to Queen Elizabeth Hospital Birmingham very short of breath. They realised the error in the medication and prescribed antibiotics. She died on 28/09/14. The cause of death following post mortem examination was confirmed as end stage pulmonary fibrosis and bronchiectasis. Neither the pathologist, nor a Professor from Queen Elizabeth Hospital Birmingham were able to say that the delay in antibiotics had caused or contributed to the death. Both were able to confirm that the naproxen had not caused the death. The dispensing error occurred as the 2 tablets were in almost identical looking boxes and made by the same manufacturer. The Naproxen had been put on the Phenoxymethylpenicillin shelf by mistake. A further mistake had occurred when the pharmacists failed to spot the wrong medication had been chosen. | attach a colour copy of the medication boxes to show the similarity. | heard evidence at the inquest that this was a national problem namely drug companies packaging medication in almost identical boxes which meant dispensing errors had become “very common issues” Please note the pharmacist in question has already taken remedial action and introduced new process and procedures within his pharmacy to avoid similar events. CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — (1) Manufacturers are able to produce medication in almost identical boxes which is very likely to contribute to dispensing errors and potentially patient deaths. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you AND/OR your organisation has 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 this report, namely by 6" March 2015. I, 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 | have sent a copy of my report to the Chief Coroner and to the following Interested Persons:- | am 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. 9™ January 2015
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.
(Crescent PHARMA LIMITED To: Louise Hunt Senior Coroner 14" January 2015 Dear Mrs Hunt We acknowledge receipt of the Regulation 28 form: Report to Prevent Future deaths. Regarding the issue of packaging similarity, Crescent has scheduled a meeting with the MHRA on the 20" January 2015 to discuss packaging redesign and use of colour to differentiate between different products and strengths, after their request to do so in May 2014. Agreement of design and product range colour chart will lead to the creation of new artwork for all Crescent products, submission for MHRA approval and co-ordination of new artwork introduction after MHRA approval. We are unable to provide a timeline for project completion currently. Crescent are therefore committed to revising product artwork to help minimise pharmacist error, caused by the failure to verify product identity during dispensing. | hope this answers the request to provide a response to the report provided. Yours sincerely RECE Crescent Pharma Limited H e | Units 3 & 4, Quidhampton Business Units, i 5 JAN 2015 | Polhampton Lane, Overton, Hampshire RG25 ED ee | Tel: +44 (0)1256 772730 Fax: +44 (0)1256 772740 www.crescentpharma.com Registered in England, No: 4750933
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