Dear Mr Moss, Re: Regulation 28 Report to Prevent Future Deaths – Samantha Jane Gould, died 2 September 2018 Thank you for your Regulation 28 Report to Prevent Future Deaths (hereafter “report”) dated 28 May 2021 concerning the death of Ms Samantha Gould on 2 September 2018. Firstly, I would like to express my deep condolences to Ms Gould’s family. I am very sorry it has taken so long to respond and would be grateful if you would convey my apologies to Ms Gould’s parents. Your report concludes Ms Gould’s death was a result of suicide by an overdose of prescribed medication with a wider narrative as follows: “There was a systemic weakness and failing in the lack of a protocol for [Child and Adolescent Mental Health Service – CAMHS] and the GP service to communicate with local pharmacies concerning 16-18 year old patients with mental health conditions who were at risk of deliberate overdose. Sam was therefore able to pick up older prescriptions on 1 September 2018 without challenge. It was those medications … that were fatal in the combined amounts Sam ingested on the night of 1-2 September 2018.” Following the inquest you raised concerns in your report to NHS England and NHS Improvement (NHS E/I) regarding the following points: Point 1: There did not appear to be any national guidance or standards that directed or encouraged appropriate sharing of risk information and care plans with the local pharmacy. As a result, the pharmacy was unsighted on the fact that the treating psychiatric team had a safety plan involving Sam’s parents being responsible for handling and administering all medication. Had the pharmacy been aware of this plan, it is likely that they would either have refused to provide the medication with which Sam overdosed or, at least, contacted Sam’s parents or General Practitioner. National Medical Director NHS England & NHS Improvement and Interim Chief Executive of NHS Improvement Skipton House 80 London Road London SE1 6LH 8th September 2021

Point 2: A local protocol has now been introduced whereby the Cambridgeshire and Peterborough Foundation Trust’s Child and Adolescent Mental Health Service ensures that any pharmacy used regularly by their patients aged 16-17 are (where appropriate) advised of relevant care plans, as well as the responsible GP being so informed. This is now to be part of mandatory training for CAMHS prescribing staff and is to be discussed in the local Joint Prescribing Group to ensure better communication between the local NHS Trusts, G.P.s and local pharmacies. Accordingly, action has already been taken in the local area to prevent similar fatalities.

Point 3: I am concerned that there is a risk of future fatalities if action is not taken at a national level to ensure that pharmacies are appropriately involved in medication safety plans for mental health patients aged 16 – 17, given that such patients may otherwise be able to obtain prescribed medication with which to overdose.

I have set out in the annex some information that is relevant to this tragic incident and if used appropriately will help us ensure the risk of this tragic incident happening again is minimised. To assist in this I have asked Dr , Deputy Chief Pharmaceutical Officer, to establish a working group to build on the work of the Joint Prescribing Group you mention, with the aim of rolling it out, or an improved approach, across the country within the next 6 months, and then subsequently to ensure that facilities like the Summary Care Record and other digital means are used to their full benefit.

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.

Dear Nicholas Moss,

RE: Samantha Jane Gould Deceased

Thank you for your letter dated 28th May 2021 following the recent inquest into the death of Samantha Jane Gould. We would like to express our sincere condolences to Samantha’s family.

As you may know the Royal Pharmaceutical Society (‘RPS’) is the professional body for pharmacists and pharmacy in Great Britain, representing all sectors of pharmacy. Our role is to lead and support the development of the pharmacy profession.

We understand the matters of concern which you have raised and are keen to assist where we can. Our considerations on the concerns you have raised are as follows:

Communication to pharmacy teams about patient safety plans

The Regulation 28 report highlighted the lack of guidance/standards to ensure that the NHS and other providers of care inform community pharmacies of patient safety plans. We would very much welcome guidance/standards in this area.

This is an active area in which the RPS continues to campaign. We believe access and sharing of patient health records for community pharmacies is really important and recognising pharmacists have a legitimate need to access patient health records to improve patient outcomes for patients.

An electronic copy of our policy and position statement is available from our website.

We have also published guidance around keeping patients safe when they transfer between care providers. This is available on our website.

Need for national protocols

We understand from your report that there has been implementation of a local protocol whereby the Cambridgeshire and Peterborough Foundation Trust’s Child and Adolescent Mental Health Service ensures that any pharmacy used regularly by their patients aged 16-17 are (where appropriate) advised of relevant care plans. This sounds like an excellent initiative. We have also heard of other Child and Adolescent Mental Health Services (CAMHS) creating links with local community pharmacies.

We believe that there is a need for more system leadership in this area noting that pharmacies are often the recipients of information. This regulation 28 report has been addressed to pharmacy organisations, and there is parallel need for organisations representing the NHS and CAMMHS services to make changes to prevent deaths.

It would not be within the scope of our role to mandate local changes are adopted across the NHS and by other care providers, however we recognise the need for community pharmacies to be involved in the development of medication safety plans. If changes can be made by the relevant NHS organisations to ensure pharmacy teams are involved in this process, we will raise awareness of this amongst the pharmacy profession.

Further considerations

You may be aware of the Healthcare Safety Investigation Branch (HSIB). They are a government organisation that conducts independent investigations of patient safety concerns in NHS-funded care across England and are able to make safety recommendations to improve healthcare systems and processes in order to reduce risk and improve safety.

If you would like to make a referral, their contact details are: HSIB, A1, Cody Technology Park, Farnborough, GU14 0LX . You may wish to contact them separately if you haven’t already done so.

Thank you for bringing this to our attention and I hope our response has been helpful.

Dear Mr Moss Re: REGULATION 28: REPORT TO PREVENT FUTURE DEATHS Thank you for sending us your report, raising with us the circumstances surrounding the death of Samantha Jane Gould. We are very sorry to hear about this and would like to pass on our sincere condolences to Samantha’s family. The General Pharmaceutical Council (GPhC) has a statutory purpose to protect patients by setting and upholding the standards for registered pharmacies and the standards for pharmacy professionals to ensure that registered pharmacies are safe to provide services, and that pharmacy professionals are fit to practise. We also produce guidance to support pharmacy owners and pharmacy professionals to meet our standards. The GPhC standards are outcome-focused. This means that we identify the outcomes, rather than the specific actions, that pharmacy professionals need to achieve to meet our standards. Our standards describe how safe and effective care is delivered through person-centred professionalism and require pharmacy professionals to work in partnership with others, where everyone is contributing towards providing the person with the care they need. This includes the person and will also include other healthcare professionals and teams. For example, carers, relatives and professionals in other settings – such as social workers and public health officials. Pharmacy professionals must also take action to safeguard people, particularly children and those that are vulnerable. All pharmacy professionals are personally accountable for meeting the standards. We expect pharmacy professionals to meet our standards, comply with their legal duties, as well as considering any relevant guidance when making decisions. We have also published guidance for pharmacist prescribers, where we set out the key areas we expect pharmacist prescribers to consider when applying the standards to their prescribing practice. The guidance states that prescribing information should be shared with the person’s prescriber, or others 25 Canada Square, London E14 5LQ

involved in their care, so the person receives safe and effective care. All prescribers should use their professional judgement when deciding what information to share. We will proactively look for opportunities to share the learnings from this extremely sad case with our key stakeholders and encourage them to explore how pharmacies can work more effectively with other healthcare teams to improve patient outcomes. Also, I note that your report has been sent to NHS England. Whilst we produce guidance and advice of our standards, NHS England may be better placed to provide you information on medication safety plans at a national level. We hope this information is helpful. If you should require any further information, please do not hesitate to contact me.

Dear Mr Moss, Inquest into the death of Samantha Gould – regulation 28 notice Thank you for providing us with a copy of your report dated 28 May 2021, regarding the tragic death of Samantha Gould. First and foremost, I would like to express my sincere condolences to the family of Samantha. By way of information, the Company Chemists’ Association Limited (CCA) is a trade association representing the interests of large multiple community pharmacies. Our members are Asda, Boots, LloydsPharmacy, Morrisons, Rowlands, Superdrug, Tesco and Well. The CCA represents the interests of its members and provides a forum to bring together their knowledge, skills, resources, and experience for the benefit of patients and the NHS. The CCA does not operate any community pharmacies, nor do we set standards or provide guidance for our members or other pharmacy operators. As such we are, unfortunately, not in a position to undertake direct action in this regard. Having said this, the CCA provides the secretariat for the Community Pharmacy Patient Safety Group (CPPSG). This non-statutory Group brings together representatives from the 19 largest community pharmacy organisations to work together to promote patient safety. The CPPSG is driven by the principles of sharing and learning. The Group will discuss this tragic incident at its next meeting in July. They will consider Samantha’s case to identify learnings and share best practice so that the risk of similar events can be prevented. A summary of this discussion will be shared with the community pharmacy network nationally via members of the group’s internal communications channels and via the trade press. This regulation 28 notice raises an important question about sharing of information and the inclusion of community pharmacy in care planning processes. Whilst neither the CCA nor the Patient Safety Group has legislative authority to change processes, we do share your concerns. We will work with the other organisations identified in your report (the GPhC, RPS and NHS England) to further consider how practice can be improved. If there is anything else that you would like us to do in this regard, then please do not hesitate to contact me.