Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0016, written 10 Jan 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 10 Jan 2025 |
|---|---|
| Reference | 2025-0016 |
| Deceased | Ava Hodgkinson |
| Coroner | Christopher Long |
| Coroner area | Lancashire and Blackburn with Darwen |
| Category | Child Death (from 2015) · 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.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Care 1 CORONER , Secretary of State for Health and Social I am Mr Christopher Long area coroner, for the coroner area of Lancashire and Blackburn with Darwen 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 21 August 2023 I commenced an investigation into the death of Ava Grace Hodgkinson, age 2. The investigation concluded at the end of the inquest on 8 January 2025. The conclusion of the inquest was that Ava died from natural causes due to overwhelming sepsis caused by Streptococcus A infection.. 4 CIRCUMSTANCES OF THE DEATH Ava Grace HODGKINSON died on 14 December 2022, at Ormskirk District General Hospital, Ormskirk in Lancashire. Following a short illness Ava was examined by a G.P. where no infection was found, but antibiotics were prescribed. The following morning, Ava took the first dose of antibiotics, however her condition later worsened and she was driven to Ormskirk District General Hospital in the early afternoon, where, upon arrival, she was noted to be in cardiac arrest and despite attempts to resuscitate, she did not recover. Miss HODGKINSON died of overwhelming Sepsis, resulting from Group A Streptococcus infection. 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 could 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) In evidence at the inquest it was explained that the Ava had seen her GP who had prescribed amoxicillin with a dose of 250mg/5ml. The pharmacy did not have this strength in stock but did have amoxicillin 125mg/5ml in stock but could not issue this as restrictions currently in place prevent a pharmacist issuing any different strength of medication without an amended prescription, even where the medication can be provided to enable the same dose to be administered (here Ava's parents could have been instructed to provide 10ml enabling the same dose of antibiotics to be provided). This led to a delay in Ava receiving antibiotics. Evidence from the Department of Health and Social Care included that this issue was being actively considered but it was 1 explained the issue was complex and any change was likely to need public consultation and ministerial support. It was also explained that it was not possible to provide any timeframe for any appropriate steps to be taken to consider changing the restrictions preventing pharmacists from issuing medication where they can provide the same dosage of the same medication in a different denomination. 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. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 10 March 2025. 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: Mr & Mrs Hodgkinson (Ava's parents), the Department of Health and Socoial Care and to the Lancashire's Safeguarding Board 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 DATE 10 January 2025 SIGNED BY CORONER 2
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.
Minister of State for Health (Secondary Care) 39 Victoria Street London SW1H 0EU 28 March 2025 Our ref: HM Coroner Christopher Long Coroner’s Court 2 Faraday Court Faraday Drive Preston Lancashire PR2 9NB By email: Dear Mr Long, Thank you for the Regulation 28 report of 10 January 2025 sent to the Secretary of State about the death of Ava Grace Hodgkinson. I am replying as the Minister with responsibility for medicines regulation, pricing and supply. Firstly, I would like to say how saddened I was to read of the circumstances of Ava’s death, and I offer my sincere condolences to her family and loved ones. The report raises concerns over the requirement to supply medication in accordance with the prescription, as set out in the Human Medicines Regulations 2012, which prevent a pharmacist from issuing different strengths of prescribed medication without an amended prescription, even when the same dosage could be achieved. Currently, for most prescriptions, there is clear separation between the function of prescribing and dispensing – this is primarily for patient safety. It provides for a second clinical check on suitability, dose and interactions, and ensures prescribers have clarity about the medication being supplied to the patient. The Human Medicines Regulations 2012 (HMRs 2012) require dispensing to be “in accordance with a prescription”, with some very limited exceptions e.g. Serious Shortage Protocols (SSPs) and more recently introduced original pack dispensing (OPD). This means that in practice, community pharmacists must supply the exact product, quantity, strength and formulation according to what has been originally prescribed. If the exact product isn’t available, there are obvious benefits from pharmacists being able to supply to patients with an alternative straight away – patients are able to start their treatment sooner, patient journeys are reduced and there is a positive impact on the efficient use of GP Practice and pharmacy staff time. However, there are also patient safety risks. For example, if formulations or dosage regimes change, then patients may get confused and not take their medicines as intended and the prescriber will not have a clear view of what their patient is taking. There are also supply chain implications – it could affect suppliers’ ability to predict future demand that is primarily based on historic orders and/or have the unintended effect of creating a shortage of the alternative. The pharmacist may not always be aware of the wider supply situation of any product. For example, if a lower strength was supplied in place of the higher strength due to a shortage, it could mean that stock of the lower dose is rapidly depleted at an increased rate in order to match the required dosage. Serious Shortage Protocols (SSP) are developed with oversight from DHSC's Medicines Supply Team to ensure that any substituted alternative product can adequately support the increased demand. Nevertheless, I am committed to my officials exploring new flexibilities. There has been a recent programme of engagement, since December 2024, as part of which my officials have discussed possibilities with stakeholders such as GP representatives, pharmacy bodies and patient groups. The stakeholder feedback has been sufficiently positive that the Government is minded, subject to the normal machinery of Government clearance processes, to proceed to a formal, public consultation. Any proposed new flexibilities would need amendments to the HMRs 2012 – and a public consultation on such changes is a requirement of the Medicines and Medical Devices Act 2021 and would need to be joint with the Department of Health in Northern Ireland. The consultation will seek wider views than those already canvased on if, and the circumstances in which, it may be appropriate to grant pharmacists the flexibility to supply an alternative dose and formulation to that specified in a prescription written by a prescriber. My expectation at this stage is that consideration will be given to whether or not the flexibilities should be limited to cases of immediate clinical need where it is impractical to obtain a prescription for the alternative medicine without undue delay. I am confident that a solution can be found to granting new flexibilities that will receive patient, professional, NHS and pharmacy businesses’ support. Subject to the normal clearances, my officials aim to publish this by summer 2025. I hope this response is helpful. Thank you for bringing these concerns to my attention. Yours sincerely, Minister of State for Health and Secondary Care
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