Dear Ms. Thorne, Re: Mrs Sewa Kaur Chaddha (deceased) Regulation 28 Preventing Future Deaths Response Thank you for your report dated 2nd June 2024, regarding the death of Mrs. Sewa Kaur Chaddha and the concerns raised during her inquest, which concluded on 24th May 2024. On behalf of NHS Frimley Integrated Care Board (ICB), I would like to express our sincere condolences to Mrs. Chaddha’s family. We deeply regret the circumstances of her passing and appreciate you bringing these important issues to our attention.

I am replying as the Chief Pharmacist for NHS Frimley, responsible for medicines optimisation and pharmacy across our system. While we recognise our duty to address the concerns raised, it is important to note that community pharmacies and other healthcare professionals operate as independent contractors under a national framework or contract, limiting our direct influence over their processes.

Your report highlights the concern about the lack of guidance for pharmacists when providing medications in dosette boxes to patients with cognitive impairments who may need additional support to take their medication safely. We are committed to addressing these issues to ensure the safety and well-being of all our residents.

Our goal is to learn from this case and take meaningful steps within our remit to prevent similar incidents in the future and share learning nationally. To thoroughly address the concerns raised, we shared the Prevention of Future Death Report [REDACTED] with a diverse group of pharmacy stakeholders across the South-East region to help the ICB respond effectively to the points you raised.

Bracknell Forest Surrey Heath and Farnham Slough North East Hampshire Royal Borough of Windsor and Maidenhead Below is a summary of the matters of concern outlined by the court and our response.
1. The medications were provided to the couple by the local pharmacy, then known as Lloyds Pharmacy, in separate dosette boxes. Mrs. Chaddha’s medications were provided on a weekly basis. Mr. Chaddha’s were provided monthly

The clinical need of the individual patient is determined by the patients General Practitioner which is used to determine the number of days’ supply of medication. As such this can mean that patients in the same household may be supplied medication at different frequencies.

2. Both patients were elderly and had cognitive impairment.

The report mentioned that both patients had age-related cognitive impairment but did not include details of whether any assessment had taken place to establish the support required by Mr. or Mrs. Chaddha for their physical or cognitive needs by any health or social care organisation. Community pharmacies typically have access to patients' medication records but will rarely receive any information about diagnoses or social care details.

3. The two patients’ dosette boxes were identical to each other except for a small pharmacist’s label with small type with the relevant patient’s name.

Where requested by patients, other healthcare professionals or relatives or where an issue is recognised, pharmacy contractors will under the Equality Act 2010 make reasonable adjustments to support individuals to take their medication safely, for example, by the provision of Medicines Compliance Aids (commonly referred to as dosette boxes), tick charts or large print labels. They are advised to assess the patients’ needs before making any such reasonable adjustments and not simply respond to the request of a patient, carer or other healthcare professional. It should be noted that the adjustment should be reasonable and under the Act does not include all possible solutions.

As a result of this case, the ICB will be updating local resource material to remind healthcare professionals of the importance of carrying out an assessment and will recommend that in doing so they consider other people in the home that may also have additional needs, as well as the individual patient.

4. Mrs. Chaddha used one of Mr. Chaddha’s dosette boxes, rather than her own, for several days. It remains unclear if Mr or Mrs. Chaddha had social care support that could have flagged issues earlier.

Bracknell Forest Surrey Heath and Farnham Slough North East Hampshire Royal Borough of Windsor and Maidenhead
5. Evidence was given at the inquest that there was no guidance or policy in place for pharmacists to follow when issuing medication to patients with cognitive impairments, or if there was, it was not well disseminated among the pharmacist population.

In the UK, there are several sources of guidance, but there is no single national policy for healthcare professionals on managing medications for patients with cognitive impairments. Existing guidelines, such as those from the Royal Pharmaceutical Society, emphasises the need for pharmacists to provide person- centred care tailored to the individual needs of patients.

When patients are assessed, they are generally presumed to have capacity unless there is clear evidence of cognitive impairment. All healthcare professionals are expected to assess a patient's capacity, which can include evaluating their ability to retain and recall information. In this case, there was no information indicating whether such an assessment had been conducted by any healthcare or social care professionals.

We recognise that guidance documents alone are often insufficient. Lasting and effective change requires embedding these guidelines within contracts and regulations. We will therefore inform NHS England’s pharmacy team of this case and request that they consider potential changes to the Community Pharmacy Contractual Framework.

6. Evidence was given at the inquest that dosette boxes of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address.

There are several different brands of dosette boxes available and typically a pharmacy will use one particular brand. The decision about whether such an aid is appropriate is made by the pharmacist, and we are unable to direct this choice.

Dosette boxes are not always suitable or the only solution for supporting a patient in taking their medication. Although various types of dosette boxes are available for purchase by the public, there are only a limited number used within community pharmacy due to the requirement that dosettes used must enable fulfilment of the legal labelling requirements. These are not currently available in different colours or label colours.

Bracknell Forest Surrey Heath and Farnham Slough North East Hampshire Royal Borough of Windsor and Maidenhead In response to the coroner's report, we have taken the following steps to address the concerns raised:

Action: NHS Frimley recognises the seriousness of this tragic case and acknowledges that a similar situation could occur in any system. To address this and increase awareness, we organised a cross- system meeting across the South-East region to discuss the issues raised in this report. This took place on 9 July 2024. From these discussions, it was agreed that the circumstances of this case need to be raised on a national level. We therefore will be writing to NHS England, about this case. This response is also being shared within the relevant system and regional groups, including our System Quality group and the Regional Quality Group.

We believe these steps are essential for ensuring the safety and well-being of our residents and we sincerely hope that raising awareness of this case and updating local guidance will help prevent similar tragedies in the future. Thank you for bringing these matters to our attention. We hope this response demonstrates to you and Mrs. Chaddha’s family that NHS Frimley has taken the concerns you raised seriously. If you have any further questions regarding our response, please let me know.

Dear Ms. Thorne, Re: Mrs Sewa Kaur Chaddha (deceased) Regulation 28 Preventing Future Deaths Response Thank you for your report dated 2nd June 2024, regarding the death of Mrs. Sewa Kaur Chaddha and the concerns raised during her inquest, which concluded on 24th May 2024. On behalf of NHS Frimley Integrated Care Board (ICB), I would like to express our sincere condolences to Mrs. Chaddha’s family. We deeply regret the circumstances of her passing and appreciate you bringing these important issues to our attention.

I am replying as the Chief Pharmacist for NHS Frimley, responsible for medicines optimisation and pharmacy across our system. While we recognise our duty to address the concerns raised, it is important to note that community pharmacies and other healthcare professionals operate as independent contractors under a national framework or contract, limiting our direct influence over their processes.

Your report highlights the concern about the lack of guidance for pharmacists when providing medications in dosette boxes to patients with cognitive impairments who may need additional support to take their medication safely. We are committed to addressing these issues to ensure the safety and well-being of all our residents.

Our goal is to learn from this case and take meaningful steps within our remit to prevent similar incidents in the future and share learning nationally. To thoroughly address the concerns raised, we shared the Prevention of Future Death Report [REDACTED] with a diverse group of pharmacy stakeholders across the South-East region to help the ICB respond effectively to the points you raised.

Bracknell Forest Surrey Heath and Farnham Slough North East Hampshire Royal Borough of Windsor and Maidenhead Below is a summary of the matters of concern outlined by the court and our response.
1. The medications were provided to the couple by the local pharmacy, then known as Lloyds Pharmacy, in separate dosette boxes. Mrs. Chaddha’s medications were provided on a weekly basis. Mr. Chaddha’s were provided monthly

The clinical need of the individual patient is determined by the patients General Practitioner which is used to determine the number of days’ supply of medication. As such this can mean that patients in the same household may be supplied medication at different frequencies.

2. Both patients were elderly and had cognitive impairment.

The report mentioned that both patients had age-related cognitive impairment but did not include details of whether any assessment had taken place to establish the support required by Mr. or Mrs. Chaddha for their physical or cognitive needs by any health or social care organisation. Community pharmacies typically have access to patients' medication records but will rarely receive any information about diagnoses or social care details.

3. The two patients’ dosette boxes were identical to each other except for a small pharmacist’s label with small type with the relevant patient’s name.

Where requested by patients, other healthcare professionals or relatives or where an issue is recognised, pharmacy contractors will under the Equality Act 2010 make reasonable adjustments to support individuals to take their medication safely, for example, by the provision of Medicines Compliance Aids (commonly referred to as dosette boxes), tick charts or large print labels. They are advised to assess the patients’ needs before making any such reasonable adjustments and not simply respond to the request of a patient, carer or other healthcare professional. It should be noted that the adjustment should be reasonable and under the Act does not include all possible solutions.

As a result of this case, the ICB will be updating local resource material to remind healthcare professionals of the importance of carrying out an assessment and will recommend that in doing so they consider other people in the home that may also have additional needs, as well as the individual patient.

4. Mrs. Chaddha used one of Mr. Chaddha’s dosette boxes, rather than her own, for several days. It remains unclear if Mr or Mrs. Chaddha had social care support that could have flagged issues earlier.

Bracknell Forest Surrey Heath and Farnham Slough North East Hampshire Royal Borough of Windsor and Maidenhead
5. Evidence was given at the inquest that there was no guidance or policy in place for pharmacists to follow when issuing medication to patients with cognitive impairments, or if there was, it was not well disseminated among the pharmacist population.

In the UK, there are several sources of guidance, but there is no single national policy for healthcare professionals on managing medications for patients with cognitive impairments. Existing guidelines, such as those from the Royal Pharmaceutical Society, emphasises the need for pharmacists to provide person- centred care tailored to the individual needs of patients.

When patients are assessed, they are generally presumed to have capacity unless there is clear evidence of cognitive impairment. All healthcare professionals are expected to assess a patient's capacity, which can include evaluating their ability to retain and recall information. In this case, there was no information indicating whether such an assessment had been conducted by any healthcare or social care professionals.

We recognise that guidance documents alone are often insufficient. Lasting and effective change requires embedding these guidelines within contracts and regulations. We will therefore inform NHS England’s pharmacy team of this case and request that they consider potential changes to the Community Pharmacy Contractual Framework.

6. Evidence was given at the inquest that dosette boxes of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address.

There are several different brands of dosette boxes available and typically a pharmacy will use one particular brand. The decision about whether such an aid is appropriate is made by the pharmacist, and we are unable to direct this choice.

Dosette boxes are not always suitable or the only solution for supporting a patient in taking their medication. Although various types of dosette boxes are available for purchase by the public, there are only a limited number used within community pharmacy due to the requirement that dosettes used must enable fulfilment of the legal labelling requirements. These are not currently available in different colours or label colours.

Bracknell Forest Surrey Heath and Farnham Slough North East Hampshire Royal Borough of Windsor and Maidenhead In response to the coroner's report, we have taken the following steps to address the concerns raised:

Action: NHS Frimley recognises the seriousness of this tragic case and acknowledges that a similar situation could occur in any system. To address this and increase awareness, we organised a cross- system meeting across the South-East region to discuss the issues raised in this report. This took place on 9 July 2024. From these discussions, it was agreed that the circumstances of this case need to be raised on a national level. We therefore will be writing to NHS England, about this case. This response is also being shared within the relevant system and regional groups, including our System Quality group and the Regional Quality Group.

We believe these steps are essential for ensuring the safety and well-being of our residents and we sincerely hope that raising awareness of this case and updating local guidance will help prevent similar tragedies in the future. Thank you for bringing these matters to our attention. We hope this response demonstrates to you and Mrs. Chaddha’s family that NHS Frimley has taken the concerns you raised seriously. If you have any further questions regarding our response, please let me know.

Dear Katy Thorne,

Re: Mrs Chaddha (deceased) Regulation 28 Preventing Future Deaths Response Thank you for your report dated 2nd June 2024, regarding the death of Mrs Chaddha and the concerns raised during her inquest, which concluded on 24th May 2024. On behalf of Thames Valley LPC, I would like to express our sympathy for her passing. In response to your report, it must be noted that the LPC represents local pharmacy contractors in the delivery of specific pharmacy services to patients living in our community, the dispensing of medication falls within a national pharmacy contract which is agreed, and negotiated at a national level. With respect to this I have escalated the issues raised with Frimley ICB, who have delegated commissioning for the dispensing of medication, who in turn has raised this matter with NHS England. I have also conversed with our national body – Community Pharmacy England. We do feel it is important however, to ensure that learnings from this incident are shared with local pharmacies, and I have asked that an anonymised case study be used to raise awareness in the local pharmacy community. If there is any more information that you need please do not hesitate to contact us. Regards

Chief Executive Officer

Dear Katy Thorne KC,

Response to the Regulation 28 Report to prevent future deaths - After Inquest CHADDHA S K 10052023

This is the National Pharmacy Association’s (NPA) response to your Regulation 28 report, dated 2nd June 2024, following the tragic death of Mrs Sewa Kaur Chaddha on 10th May 2023.

We are very saddened to hear about the death of Mrs Chaddha and I would like to express our deepest condolences to her family and friends.

Our response is based on the information contained in the Regulation 28 report, as we were not an Interested Person or involved in the Inquest into the death of Mrs Chaddha.

The NPA is a trade association and representative voice of independent community pharmacies across the United Kingdom, and a key provider of services to the pharmacy sector. The vast majority of the approximately 6,000 independent community pharmacies in the UK are NPA Members.

Lloyds Pharmacy, who provided medication to Mrs Chaddha is not/was not an NPA Member.

Matters of concern “Evidence was given at the inquest that there was no guidance or policy in place for Pharmacists to follow when issuing medication to patients with cognitive impairments, or if there was, it was not well disseminated among the pharmacist population.” “Evidence was given at the inquest that dosset boxes of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address.”

The NPA supports its Member pharmacies with advice, guidance and resources to help them to provide person-centred care in accordance with the pharmacy regulator’s, the General Pharmaceutical Council’s, standards. Our support includes guidance on equality, diversity and inclusion, monitored dosage systems (dosette boxes) and reasonable adjustments, including guidance on conducting patient assessments to help pharmacies determine how best to support patients with different needs including visual impairment, confusion and dementia, and signposting to information and support from the General Pharmaceutical Council.

We will review our existing guidance and consider how we can refine it. We will consider how we can continue to further raise awareness of this issue with our Member pharmacies. In our role of Medication Safety Officer (MSO) for independent pharmacies, and a member of the sector-wide Patient Safety Group (which also includes representatives of corporate pharmacies), we will also raise this matter with the Group so that it can be considered by all MSOs across community pharmacy.

Thank you again for highlighting the matter of concern and giving us the opportunity to respond.

Dear Katy Thorne KC Regulation 28 Report to Prevent Future Deaths: Sewa Kaur Chaddha Thank you for sending us your Regulation 28 report regarding the death of Sewa Kaur Chaddha. We are sorry to hear about this sad death and we would like to pass on our sincere condolences to Mrs Chaddha’s family. Thank you for sharing the circumstances of what happened and how Mrs Chaddha sadly used one of Mr Chaddha’s dosette boxes, rather than her own, for several days. You have highlighted that the inquest heard evidence that there was no guidance or policy in place for pharmacists to follow when issuing medication to patients with cognitive impairment, or if there was, it was not well disseminated. You also mention evidence at the inquest that dosette boxes of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address. By way of background, the GPhC is the independent regulator for pharmacists, pharmacy technicians and registered pharmacies. Our role is to protect, promote and maintain the health, safety and wellbeing of members of the public by upholding standards and public trust in pharmacy. As part of this, we set regulatory standards for pharmacists, pharmacy technicians and registered pharmacies, which describe how safe and effective care is delivered through ‘person-centred’ professionalism and support the right environments for safe and effective care. We also produce supporting guidance to help pharmacy owners and pharmacy professionals to put the standards into practice. This includes our equality guidance, which is designed to help pharmacy owners improve the experience and healthcare outcomes of patients and members of the public using their pharmacy’s services. The guidance sets out examples taken from our GPhC Knowledge Hub and our pharmacy inspections work about how pharmacy teams are supporting patients with different needs, including cognitive and visual impairment. Linked to our equality, diversity and inclusion strategy, we have also published a series of equality insight articles. These are designed to support pharmacy teams to deliver person-centred and inclusive

care that takes account of the diverse needs and cultural differences in the communities they serve. To share an example, we recently published information to the pharmacy profession about providing services to patients and their carers living with dementia, as an umbrella term for a range of over 200 subtypes of progressive conditions that affect the brain and a person’s ability to remember, think and speak. Through this communication, we highlighted the following points about supporting patients who may need assistance with their medicines:
• The optimal method of supplying medicines is one that meets the person’s health and care needs and provides person-centred care with the ultimate aim of maintaining the person’s independence wherever possible. Pharmacy professionals should make reasonable adjustments to help people with conditions such as dementia take their medicines.
• There are a variety of ways to promote people’s independence including reminder charts, winged bottle caps, large print labels, alarms (such as notifications on mobile phones), tablet splitters and support from carers.
• Multi-compartment compliance aids (MCAs) – such as dosette boxes - are another option, but they may not always simplify how people with cognitive impairment take their medicines. The most appropriate option should be selected in partnership with the patient, their carer if they have one, and other healthcare providers involved in the care of the patient.
• The importance of pharmacy teams connecting with charities and patient groups for further information and support and signposting patients and carers to useful advice. We have also published good practice examples of what pharmacies are doing to support patients with cognitive impairment and progressive conditions such as developing toolkits for staff, collaborating with other local service providers to support patients showing early signs of progressive conditions, and developing services to meet the needs of patients. Finally, thank you for raising this matter with us and we will consider how we can continue to raise awareness of these important issues through our future communications and engagement with the wider pharmacy sector. We will also raise this issue with our colleagues at the professional and representative bodies for pharmacy as they also play an important role in providing advice and support to the pharmacy professions. Please don’t hesitate to contact us if you need anything further.

Dear Ms Thorne

Response of the NHS Specialist Pharmacy Service to the Regulation 28 Report dated 2 June 2024 – Mrs Sewa Kaur Chaddha, who died on 10 May 2023

Please find attached a paper which has been prepared in response to the Regulation 28 Report to Prevent Future Deaths (hereafter “Report”) dated 2 June 2024, concerning the death of Mrs Sewa Kaur Chaddha on 10 May 2023.

We would like to express our condolences to Mrs Chaddha’s family and loved ones. We wish to assure the family and the coroner that the concerns raised have been listened to and reflected upon.

Please do not hesitate to contact us should you require any clarification or further information.

Dear Madam Regulation 28: Berkshire Coroner’s Ofϐice concerning Mrs Sewa Kaur Chaddha (deceased) Thank you for your report dated 2nd June 2024 on Mrs Chadda’s death and the concerns identified during the inquest. On behalf of Community Pharmacy England may I offer our sincere condolences to her family for her passing and the circumstances in which this occurred. We represent community pharmacy businesses of all sizes in England and negotiate the NHS Community Pharmacy Contractual Framework (CPCF) with NHS England and the Department of Health and Social Care through which NHS community pharmacies in England provide pharmaceutical services, including the Essential Dispensing Service – dispensing of medicines to patients. We liaise with other national pharmacy bodies as appropriate. Community pharmacies dispensing medicines should make reasonable adjustments as required by the Equality Act, to seek to ensure that all patients can take their dispensed medicines appropriately; and one reasonable adjustment is Multi-compartment compliance aids (MCAs) or ‘dosette boxes’. The most recent and comprehensive guidance on MCAs is published by the Royal Pharmaceutical Society (RPS). The RPS guidance indicates, amongst other matters, that MCAs are not a universal solution, there are other reasonable adjustments to consider; there is a professional decision to make on the suitability of an MCA and there are risks and benefits with MCAs. While benefits include helping a patient remember which medicines to take

Community Pharmacy England is the operating name of the Pharmaceutical Services Negotiating Committee. cpe.org.uk and when to take them, for a better quality of life; risks include reducing a person’s knowledge, skill and understanding of medicines, and disempowering people if they can’t identify specific medicines in the compartment they want to take. On the specific concerns raised: Weekly and monthly MCA provision. The medicines prescribed on an (FP10) NHS prescription are dispensed in one go. For various reasons, including reducing medicines waste and additional funding to support the cost of the MCAs, pharmacies generally seek 7-day prescriptions for MDS provision (funding is per prescription so 4 x 7-day prescriptions = 4 x £1.27, receive 4 times more funding than 1 x 28 day prescription = 1 x £1.27). However, the prescriber determines the ‘period of treatment’ (e.g. 7 or 28 days). Both patients had cognitive impairment. This is relevant as indicated above, including the decision to dispense medicines in an MCA and the benefits and risks of using an MCA. Remaining concerns including the evidence given at the inquest that MDSs of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address. I am not aware of any explicit guidance or encouragement for pharmacists and pharmacies to do this, or explicit guidance for pharmacies to take additional steps (to the dispensing label) to avoid the potential for the tragic confusion that occurred in this case in this household. Our action. We will bring this concern – the need for different MCAs in one household to be very clearly identified in such a way that those with cognitive impairment remain safe and take their medicines - to the RPS and the Community Pharmacy Patient Safety Group (CPPSG), and ask each to consider additional guidance and/or information to be made available to pharmacies and pharmacists. We will also make community pharmacy owners we represent aware of this concern or specific risk, initially ourselves and subsequently if the RPS or CPPSG issues any advice or reports. We will seek to take these actions in the autumn of this year.

Dear Mr xxx, We have recently been informed that you have tried to contact us regarding an incident at the former Lloyds pharmacy branch on 10 Upton Lea Parade, Slough, SL25JU. We have taken over the business in July 2023 from lloydspharmacy. Unfortunately, when purchasing we were not informed about the incident and the subsequent processes going on. We have only found out from the staff and would like to express our regents. We believe Lloyds pharmacy was operating under lloydspharmacy sops when the incident took place. We as Slough pharmacy upon taking over now use our own sops. Upon finding out we have amended our processes further to ensure that this does not happen again. We operate strict standard operating procedures which involve each tray being removed from packaging and double checked again with the patient. We have further added to our sops, and now provide a different brand of trays with totally different packaging to any households that involve more than one person with trays. We regularly review our process to ensure we are proving and safe service. Many thanks

Dear , Thank you for your email of 03 June and the attached Regulation 28 report. We have reviewed the matters of concern and do not believe we are the right organisation to take these matters forward. We are the medicines regulator, and our approvals cover the placing of medicines onto the market, in their original packaging and are designed to ensure the safety, quality and eƯicacy of medicines on the UK market. However, the matters of concern relate to actions taken by a pharmacist during the dispensing process, and we believe therefore they are better addressed to the regulatory body for pharmacies and pharmacists, the General Pharmaceutical Council. A link to their website and an email address for their enquiry team can be found below:

info@pharmacyregulation.org We hope this information is helpful to you, please come back to us if you need anything further. Kind regards MHRA Customer Experience Centre