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:

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. Leaflets explaining the role of those concerned in this situation were not provided.

We would like to reassure the coroner and Mr Crompton’ s family of Midway Pharmacy’ s commitment to clear and robust processes in ensuring the safe management of pharmacy owings. From 3rd March 2025, where an owing has been

verbally communicated to a patient and more information is required to support the detail provided, the patient will also be supplied with the Community Pharmacy England’ s Medicine Supply Leaflet. A copy of this can be found here:

Colour .pdf

In addition to referring patients to another pharmacy , patients are also referred to their GP for a clinical review. To support this, the SOP has also been reworded to highlight the importance of referring patients to the local hospital as the next step, if their GP is unable to support further .

We consider that an urgent review of the national medicines supply chain is critical in addressing the current medication shortages experienced by the profession. The circumstances of this case highlight that the reliable supply of medication is crucial, especially with high-risk and life-saving medications.

Thank you for bringing these matters to our attention. W e hope that this response

demonstrates to you and to Mr Crompton’ s family that Midway Pharmacy has taken the concerns you have raised seriously. If you have any further questions regarding our response, please let me know .

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.

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,

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.