Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0202, written 14 Jun 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 14 Jun 2021 |
|---|---|
| Reference | 2021-0202 |
| Deceased | Ian Hall |
| Coroner | Alison Mutch |
| Coroner area | Greater Manchester South |
| Category | Community health care · Other related deaths · Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
'4!1:k1 Stockport Clinical Commissioning Group 4th Floor Stopford House Piccadilly Stockport SK1 3XE www.stockportccg.nhs.uk Hlnos M3lS3HJN\fV\I M3NOMOJ V\JH lZOZ snv l l • DB Our ref: 6 August 2021 Ms Alison Mutch H M Senior Coroner Coroner's Court 1 Mount Tabor Street Stockport SKl 3AG Dear Ms Mutch Regulation 28 Report - Mr Ian Hall ( deceased) I refer to your letter dated 14 June 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 Mr Hall's death and offer my sincere condolences to his family. Community Pharmacy Services are the responsibility of NHS England and I have therefore liaised with my colleagues at Greater Manchester Health & Social Care Partnership (GMHSCP) to address the issues raised. I note the cause of death as detailed in the report and your concern that future deaths will occur unless action is taken. You have raised two areas of concern which I will address in order and will identify how learnings from this case can be shared across the wider system. The events of concern relate to medication management within Well Pharmacy who have undertaken an investigation focussing on the following points:- (1) How Amytriptyline rather than Atenolol had been dispensed in the community (2) What checks the pharmacy in question had or any pharmacy has to avoid the inadvertent dispensing to a vulnerable adult where the carer's role is to administer whatever medications are collected from the pharmacy in the name of the individual The investigation report by Well Pharmacy found the following: Well Pharmacy standard procedure is for medicines to be dispensed from Central Fulfilment, a hub and spoke dispensing model which uses robots and barcode scanning technology, minimising the risk of errors. Prescriptions for Ian Hall had normally been dispensed in this way (confirmed to be the case for June and October 2020), and the Pharmacy is very confident that there was no selection error through this process. However their records show that in August 2020 his medication was dispensed within the community pharmacy and it is assumed that this is the point at which the error occurred. Within the community pharmacy, Well have Standard Operating Procedures (SOPs) in place for the Dispensers Check and the Accuracy Check. In the event of a dispensing error, a near miss would be reported. In this instance, Well noted they were not alerted to the incident until January 2021, which has unfortunately impacted on their ability to carry out a more thorough investigation. Due to this, a near miss was also not reported. Through the process of investigation, this incident has been highlighted, as well as additional guidance on reducing LASA (looks-alike, sounds-alike) errors, which has been incorporated into their SOPs. The report states that Atenolol and Amitriptyline is not a common LASA error, and has not previously occurred within Well Pharmacy. Following this incident, the location of these medications on the shelves within the community pharmacy has been reviewed in order to minimise the risk of selection error. Key outcomes from the Well Pharmacy investigation: • Shared learning by Well at organisation-wide and individual pharmacy level • Dispensers Check, Accuracy Check and Patient safety SOPs have all been reviewed and shared across all Well Pharmacies week commencing 12/7/21. Staff are required to complete an assessment and declaration by a defined deadline of all new SOPs that are circulated • Location of medicines and visual alerts - the Atenolol and Amitriptyline have been moved onto separate shelves with clear stickers reminding staff to check selection • Area Manager to ensure review of all near misses to ensure LASA trends are spotted Actions taken or being taken to prevent reoccurrence across Greater Manchester. 1. Learning to be presented/shared with the Greater Manchester Quality Board. This meeting is attended by commissioners, including commissioners of specialist services, regulators, Healthwatch and NICE. 2. Shared learning from this and similar cases at Greater Manchester and locality level will be cascaded to professionals through relevant governance and learning forums The Greater Manchester Health and Social Care Partnership (GMHSCP) is committed to improving outcomes for the population of Greater Manchester. In conclusion key learning points and recommendations will be monitored to ensure they are embedded within practice. You refer to the role of a carer in the administering of medications to a vulnerable adult, making the point that as carer staff are not clinically qualified, their responsibility when giving a medication is to simply check that the medication is correctly labelled for the patient they are attending. Having carefully considered this point, I reach the conclusion that the key issue is the pharmacy process as the dispensing of an incorrect medication should not happen if all procedures are correctly followed. My focus has therefore been to address the issue of dispensing and I am satisfied that appropriate steps have been taken to reduce the likelihood of incorrect medications being labelled and dispensed for administering by a carer. I hope this response provides the relevant assurances you require. Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information. Yours sincerely Dr Medical Director
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Medicines and Healthcare products Regulatory Agency and NHS Stockport Clinical Commissioning Group 1 CORONER I am Alison Mutch, Senior Coroner, for the Coroner Area of Greater Manchester South 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 17th November 2020 I commenced an investigation into the death of Ian Hall. The investigation concluded on the 3rd June 2021 and the conclusion was one of Narrative: Died from aspiration pneumonia following a choking incident after admission following a fall in combination with Covid-19 pneumonitis. The medical cause of death was 1a Aspiration pneumonia on a background of a choking incident, Covid-19 pneumonitis; II Alzheimer's dementia 1 4 CIRCUMSTANCES OF THE DEATH Ian Hall had Alzheimer's and was vulnerable. He had carers in the community. He was admitted to Stepping Hill Hospital on 27th October following a fall. No injuries resulted from the fall. On 28th October during a post admission medicines reconciliation check at Stepping Hill Hospital it was identified that in the community he had been dispensed by the community pharmacy Amitriptyline rather than Atenolol which was on his prescription. Amitriptyline would have led to increased drowsiness and an increased falls risk. On 28th October he choked on medication. He subsequently developed aspiration pneumonia and was treated but continued to deteriorate. On 2nd November a Covid-19 swab was positive. He was treated for Covid-19 but deteriorated further. On 14th November 2020 he died in Stepping Hill Hospital from a combination of aspiration pneumonia and Covid-19 pneumonitis. 5 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. It was unclear how Amitriptyline rather than Atenolol had been dispensed in the community. 2. It was unclear what checks the pharmacy in question had or any pharmacy has to avoid the inadvertent dispensing to a vulnerable adult where the carers role is to administer whatever medications are collected from the pharmacy in the name of the individual. The inquest was told that the carers in this situation generally will have no clinical training. Therefore, their role is to check the medication is in an individual’s name and give it to the individual in compliance with what is on the label. It is not part of their role to cross check previous medications or query changes to medication. 6 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. 2 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 9th August 2021. 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. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely, useful or of interest. (family of the deceased), who may find it I 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 14th June 2021 Alison Mutch HM Senior Coroner Manchester South 3
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.
Ms Alison Mutch Senior Coroner, Greater Manchester South Medicines & Healthcare products Regulatory Agency 27 July 2021 10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra Dear Ms Mutch, Regulation 28 report into the death of Ian Hall Thank you for your report under Regulation 28 following the inquest into the tragic death of Mr Ian Hall. We note that one of the concerns that you raise is incorrect dispensing of a product in a pharmacy and your report states it is unclear how amitriptyline rather than atenolol had been dispensed in the community. The MHRA is responsible for the assessment of the labelling of all licensed medicines to ensure that the statutory information required to appear is clear, legible and easily assimilated by those who select and administer medicines. It would be helpful to know which particular amitriptyline and atenolol products the pharmacy held at the time Mr Hall was supplied with amitriptyline instead of his prescribed atenolol. Without this, it is difficult to be certain whether and to what degree the medicines packaging may have contributed to the mis- selection in the pharmacy. The primary purpose of medicines labelling is the unambiguous identification of the medicinal product contained within the packaging. We have issued best practice guidance to the pharmaceutical industry which includes amongst other things, a need to ensure that medicines which may be stored together or used concomitantly by patients are well differentiated from each other by the judicious use of colour to reduce the likelihood of medication error. We also issued an article in our 2018 Drug Safety Update (DSU) bulletin to remind healthcare professionals on the need for continued vigilance for these sorts of errors https://www.gov.uk/drug- safety-update/drug-name-confusion-reminder-to-be-vigilant-for-potential-errors. That guidance highlighted a known confusion between atenolol and amiodarone (another antihypertensive) but confusion between atenolol and amitriptyline has not been reported to us previously. The MHRA will review the packaging of these medicines and if we consider on assessment that improvements could be made we will contact any pharmaceutical manufacturers who supply these medicines and seek changes so that the likelihood of future errors of this nature may be reduced. For your information, Ian Hall’s case has been recorded on our adverse drug reaction database with the Yellow Card reference number . Yours sincerely Dr Chief Executive Medicines and Healthcare products Regulatory Agency
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