Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0713, written 31 Dec 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 31 Dec 2024 |
|---|---|
| Reference | 2024-0713 |
| Deceased | David Crompton |
| Coroner | Kevin McLoughlin |
| Coroner area | West Yorkshire (Eastern) |
| Category | Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
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.
His Majesty’s Coroner’s Office
The Coroner's Courts
Burgage Square
Wakefield WF1 2TS
Telephone:
Email:
OFFICE OF THE
SENIOR CORONER
for the County of West Yorkshire
(Eastern District)
i | REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
2. General Pharmaceutical Council, Level 14, One Cabot Square, Canary Wharf,
London, E14 4QJ
‘CORONER
1
|
1. Midway Pharmacy, 46 Chapeltown, Pudsey, LS28 8BL |
| am Kevin McLoughlin, Senior Coroner for the Coroner area of West Yorkshire (Eastern).
CORONER’S LEGAL POWERS
| 2 1 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.
: INVESTIGATION and INQUEST ——
|
| On 23% December 2024 | commenced an investigation into the death of David Joseph
Crompton, aged 44. The investigation concluded at the end of the Inquest on 31st December
2024. The conclusion of the Inquest was a Narrative Conclusion based on the following cause
of death:
1(a) Hypoxic ischaemic encephalopathy
1(b) Out of Hospital Cardiac Arrest
1(c) Cervical Spine Injury secondary to fall
| (2) Epilepsy
_ This was resulting from a fall downstairs on 13" December 2024. _ ee
CIRCUMSTANCES OF THE DEATH
‘Mr Crompton had epilepsy and was prescribed, inter alia, the anti-epileptic medication Tegretol.
jin April 2024 he was left without the medication for approximately 10 days as the pharmacy
4 could not supply it. In December 2024 he was again left without the Tegretol. The pharmacy
‘had left a manuscript “IOU” in relation to Tegretol at his home when other medicines were
idelivered. Without his medication his epileptic condition was likely to destabilise and give rise to
fits. His falls both in April and December 2024 occurred when he was left without his essential
imedication. |
CORONER’S CONCERNS
5 /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.
a |
aes nnn neni
‘The MATTERS OF CONCERN are as follows. —
(1) It is important that when anti-epileptic medication is prescribed by a GP that this is obtained
land supplied promptly by the dispensing pharmacy. It is a matter of concern that for relatively
lengthy periods on two occasions Mr Crompton was left without this important medication.
(2) The evidence given by family members at the inquest was that when the pharmacy was
‘unable to supply the prescribed Tegretol medication, it was left to them to contact other
‘pharmacies to see if they could obtain it, rather than for the pharmacy to search for supplies.
i
(3) The inquest was informed that following the April 2024 episode, hospital specialists
jcommented that the absence of Tegretol for around 10 days “will likely have contributed to your
seizure activity”. It is questionable whether lessons were learnt from this potentially dangerous
| interval.
|
(4) Comment was made at the inquest to the effect that the pharmaceutical profession should
‘have clear designated systems to deal with any shortages of supply encountered; for example,
‘reference to hospital departments to ensure patients are not left without important medications.
6 In my opinion action should be taken to prevent future deaths and | believe your organisation
‘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 this report, namely
by 27" February 2025 (to take account of the current holiday period). |, 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.
{
| |
(nother)
(GP), Robin Lane Surgery, Robin Lane, Pudsey, Leeds, LS28 7DE |
i
| 8 I am also under a duty to send the Chief Coroner a copy of your response.
| ‘have sent a copy of my report to the Chief Coroner and to the following Interested Persons:-
| 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.
/ Signed: A Nh nA
| ;
| Kes Wt are
|
}
|
Senior Coroner
|
|
g KEVIN McLOUGHL |
West Yorkshire (E) |
i |
|
|
Date: 31 December 2024 |
2 responses 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.
Kevin McLoughlin Senior Coroner of West Yorkshire By email via: 26 February 2025 Dear Mr McLoughlin Re: Regulation 28 Report to Prevent Future Deaths: Mr David Joseph Crompton Thank you for sending us your Regulation 28 report regarding the death of Mr David Crompton. We are sorry to hear about this sad death and we would like to pass on our sincere condolences to Mr Crompton’s family. By way of background, the GPhC is the independent regulator for pharmacists, pharmacy technicians and pharmacies in Great Britain. Our main job is to protect, promote and maintain the health, safety and wellbeing of members of the public by upholding standards and public trust in pharmacy. This includes maintaining a register of pharmacy professionals and premises, setting regulatory standards and investigating concerns. We note that in the ‘Matters for Concern’ section of the regulation 28 report the Coroner has highlighted four concerns namely. 1.It is important that when anti-epileptic medication is prescribed by a GP that this is obtained and supplied promptly by the dispensing pharmacy. It is a matter of concern that for relatively lengthy periods on two occasions Mr Crompton was left without this important medication. 2.The evidence given by family members at the inquest was that when the pharmacy was unable to supply the prescribed Tegretol medication, it was left to them to contact other pharmacies to see if they could obtain it, rather than for the pharmacy to search for supplies. 3.The inquest was informed that following the April 2024 episode, hospital specialists commented that the absence of Tegretol for around 10 days’ will likely have contributed to your seizure activity’. It is questionable whether lessons were learnt from this potentially dangerous interval. 4.Comment was made at the inquest to the effect that the pharmaceutical profession should have clear designated systems to deal with any shortages of supply encountered; for example, reference to hospital departments to ensure patients are not left without important medications. Leaflets explaining the role of those concerned in this situation were not provided. pharmacyregulation.org | info@pharmacyregulation.org |020 3713 8000 We are aware of supply issues with some Tegretol products. While we do not have a direct role in the manufacturing of medicines or wider issues such as supply and shortages, we understand that medicines shortages can cause problems for patients and carers. We know that pharmacy professionals are also concerned and have to use their professional judgement and make decisions in challenging situations, balancing a range of factors such as individual patient needs and available supplies of medicines. Our standards require pharmacy professionals to deliver patient-centred care, which includes making the care of the patient their first concern and using their judgement to make professional decisions. This may include making decisions about providing medication in an emergency. In November 2024 we published an article about medicines shortage, https://www.pharmacyregulation.org/about-us/news-and-updates/regulate/struggle-around- medicines-shortages The article states that if the pharmacy is unable to supply a particular medicine stated on prescription then they should talk to the patient to discuss their options. The article outlines examples of steps the pharmacy should take. On receipt of the regulation 28 report, the circumstances surrounding the death and the Coroner’s concerns have been considered, together with how the GPhC needs to act to protect the safety of patients, uphold standards and maintain public trust in pharmacy. Inspection The particular pharmacy has been inspected by our Inspection Team, who looked for evidence that the pharmacy was meeting our Standards for Registered Pharmacies. The purpose of these standards is to create and maintain the right environment in pharmacies to protect and improve people’s health and wellbeing. The inspection included looking for evidence about the systems in place to manage medicines which were out of stock at the pharmacy and where there were supply issues at the wholesalers. This was to ensure practices in the pharmacy relating to stock management were appropriate. The Inspection report will be published in due course. Evidence collected during the inspection shows that the pharmacy has robust processes in place to manage out-of-stock medicines, including for Tegretol. The pharmacy uses electronic ordering, with a twice daily check by team members. Patients can receive a text message to inform them when their medicines are available. The pharmacy obtained its medication from recognised wholesalers and all team members across the company accessed a communication platform for queries such as checking stock availability. Action Taken by our Enforcement (Fitness to Practise) Team The GPhC Fitness to Practise team investigates concerns about individual pharmacy professionals where there may be a risk to patient safety and/or where public confidence in pharmacy could be affected. The initial assessment of this case is complete, and an investigation is open. The case has been allocated to a Case Officer who will consider the findings of the GPhC inspection and whether any further evidence is required. Once the investigation is complete, we will assess the evidence in line with our Threshold Criteria to determine whether further action against the individual pharmacist is required. We have opened an investigation into the concerns raised in the regulation 28 report. The Case Officer has been in contact with the Coroner’s Office to request documentation relating to this matter as part of our investigation. Once received the documentation will be assessed by the Case Officer together with other evidence collected as part of the investigation. We hope this information is helpful. If you should require any further information, please do not hesitate to contact me. Yours sincerely Chief Executive and Registrar E
Midway Pharmacy 46 Chapeltown Pudsey LS28 8BL Mr Kevin McLoughlin HM Senior Coroner for West Yorkshire Burgage Square Merchant Gate Wakefield WF1 2TS 26 February 2025 Dear Sir, RE: Regulation 28 Report to Prevent Future Deaths- David Joseph Crompton (deceased) Thank you for your Report to Prevent Future Deaths dated 31st December 2024, concerning the death of David Joseph Crompton on 13th December 2024. In advance of responding to your concerns, I would like to express our deep condolences to Mr Crompton’s family and loved ones. Midway Pharmacy is keen to assure the coroner and family that the concerns raised have been taken seriously and reflected upon. I respond to each of the matters of concern raised in your Report below: (1) It is important that when anti-epileptic medication is prescribed by a GP that this is obtained and supplied promptly by the dispensing pharmacy. It is a matter of concern that for relatively lengthy periods on two occasions Mr Crompton was left without this important medication. We take patient safety very seriously at Midway Pharmacy and endeavour to dispense medication to all our patients in a safe and timely manner. Standard Operating Procedures (SOP) are reviewed robustly to ensure owings are identified promptly. Colleagues are also engaged and actively supported to ensure strict adherence to these processes. As part of managing owings due to supplier shortages, colleagues regularly attempt to source medication from a nearby Midway Pharmacy or by ordering from different wholesalers. Where a medication is prescribed by brand, and there is a clinical risk of switching brands, the patient is advised to try another pharmacy before obtaining an alternative brand from the GP. It is noted that the patient was advised to try another pharmacy due to the clinical risks of switching brands in epilepsy patients and the prescription was returned and made available for the patient to have it dispensed in another pharmacy. Whilst all processes were followed as above, we identified a need for clearer wording on our SOP to ensure comprehensive notes are made on patient records detailing outcomes of patient interactions to ensure completeness of patient’s medical records. The wording on our SOP has also been changed to make this clearer to colleagues. (2) The evidence given by family members at the inquest was that when the pharmacy was unable to supply the prescribed Tegretol medication, it was left to them to contact other pharmacies to see if they could obtain it, rather than for the pharmacy to search for supplies. The process of managing owings is staged to ensure we obtain patients’ medications in a prompt and timely manner. On this occasion, only a single supplier (AAH Pharmaceuticals) had the medication in stock, and other Midway pharmacies could not obtain supplies. There was a clinical risk of changing the brand of medication supplied due to the condition being treated, and Mr Crompton was referred to other pharmacies that may have had the medication in stock. From our findings, national medication shortages played a significant role in our inability to obtain Mr Crompton’s medication. This is not unique to Tegretol but regularly impacts the profession, as detailed in the Community Pharmacy England Report on Medication Shortages, which can be found here: https://cpe.org.uk/wp-content/uploads/2024/05/Pressures-Survey-2024-Medicines-S upply-Report-Final.pdf This report highlights the worsening medicine supply problems affecting pharmacy teams and patients daily. With significant medicine supply challenges, it is imperative that we get a national resolution to ensure the continued supply of high-risk medications that our patients so dearly need. (3) The inquest was informed that following the April 2024 episode, hospital specialists commented that the absence of Tegretol for around 10 days “will likely have contributed to your seizure activity”. It is questionable whether lessons were learnt from this potentially dangerous interval. We have clear processes and procedures in place to ensure incidents are logged for reflection and improvement. Our medication incident reporting system is also tailored to support quick and clear incident logging to ensure the process is not a deterrent to logging in a busy pharmacy environment. Once logged, there are processes in place to ensure incidents are investigated within 7 days, and learnings are shared across the organisation and as part of Monthly Pharmacy Governance sessions. Following thorough checks and investigations, we have been unable to confirm the pharmacy was notified of the incident mentioned in April 2024. However, the case as a whole has provoked a great deal of reflection and emphasises the significant impact of national medicine supply shortages related to Tegretol. (4) Comment was made at the inquest to the effect that the pharmaceutical profession should have clear designated systems to deal with any shortages of supply encountered; for example, reference to hospital departments to ensure patients are not left without important medications. in this situation were not provided. those concerned Leaflets explaining the role of of pharmacy and Mr Crompton’ We would like to reassure the coroner Pharmacy’s commitment to clear and robust processes management owings. From 3rd March 2025, where verbally communicated to a patient and more information also be supplied detail provided, the patient will England’s Medicine Supply Leaflet. A copy of this can be found here: s family of Midway in ensuring the safe an owing has been is required to support the with the Community Pharmacy https://cpe.org.uk/wp-content/uploads/2024/03/Medicines-supply-leaflet-March-2024- Colour.pdf In addition to referring patients to another their GP for a clinical highlight the importance their GP is unable to support further pharmacy, patients are also referred to reworded to review. T o support this, the SOP has also been as the next step, if hospital of referring patients to the local . We consider that an urgent review addressing the current medication circumstances of this case highlight that the reliable especially with high-risk and life-saving medications. of the national The shortages experienced by the profession. medicines supply chain is critical in supply of medication is crucial, these matters to our attention. W e hope that this response to you and to Mr Crompton’ s family that Midway Pharmacy has taken you have raised seriously. If you have any further questions regarding Thank you for bringing demonstrates the concerns our response, please let me know. Yours Sincerely, Superintendent Midway Pharmacy Pharmacist
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