Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0186, written 28 May 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 28 May 2021 |
|---|---|
| Reference | 2021-0186 |
| Deceased | Samantha Gould |
| Coroner | Nicholas Moss QC |
| Coroner area | Cambridgeshire and Peterborough |
| Category | Child Death (from 2015) · Suicide (from 2015) · Alcohol, drug and medication related deaths · Community health care · Mental Health related deaths · Other related deaths · Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: (1) Relevant Pharmaceutical Bodies: (a) The Royal Pharmaceutical Society; (b) The General Pharmaceutical Council; (c) The Company Chemists’ Association. (2) NHS England. 1 CORONER I am NICHOLAS MOSS QC, assistant coroner CAMBRIDGESHIRE AND PETERBOROUGH. for the coroner area of 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. https://www.legislation.gov.uk/ukpga/2009/25/schedule/5 https://www.legislation.gov.uk/uksi/2013/1629/part/7/made INVESTIGATION and INQUEST 3 An investigation commenced on 13 September 2018 into the death of SAMANTHA JANE GOULD (Sam) aged 16. The investigation concluded at the end of the inquest on 16 April 2021. The conclusion of the inquest was: • Sam died by suicide by an overdose of prescribed medication. • The main cause of Sam’s death was her borderline personality disorder, which treating clinicians assessed to be related to allegations of prolonged sexual abuse in her earlier childhood. The disorder caused a persistent but unpredictable and fluctuating risk of serious deliberate self-harm and suicide. • There was a wider narrative conclusion, the aspect most relevant to this report being that: “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.” 4 CIRCUMSTANCES OF THE DEATH There was a safety plan agreed with Sam’s consultant psychiatrist whereby, although Sam was over the age of 16, Sam’s parents would be responsible for her medication. On 30 August 2018, Sam’s treating psychiatrist in the community made a change to Sam’s medication giving her a paper prescription. Sam expressed a preference to tell her mother about the change in medication (new prescription of Topiramate) directly and the psychiatrist had to make a judgement call whether or not to breach medical confidence and tell Sam’s mother about this directly. On balance she chose not to. In the event, Sam did not tell her mother about the new prescription. Shortly before 1 pm on Saturday 1 September 2018, Sam instead went to her local pharmacy with the prescription for Topiramate and Lorazepam. She collected those medications as well as 1 older prescriptions for other medications she would previously not have known were being held there. At her home on School Lane, Fulbourn at some time after 01.23 on the morning of 2 September 2018, Sam took a very large quantity of some of the prescribed medications. She went to bed, fell unconscious and died within at most a couple of hours. The local pharmacy (who do not have access to patients’ records on SystmOne) had not been told about the safety plan. As Sam was 16 years old, she was assumed competent to take her own prescriptions and the pharmacists had no immediate reason not to provide them to Sam, being ignorant of the safety plan. 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) 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. (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. However, (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. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe your organisation has 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, 2 namely by 23 JULY 2021. 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. NOTE – There are ongoing reporting restrictions that prevent the publication of details regarding the alleged abuser of Sam and Chris. You must not refer to that person’s identity in any way in your response and you should contact the Coroner’s Officer if you require further guidance in this regard. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: • • Bottisham Village College • The Village Pharmacy, Fulbourn • Cornford House Surgery and • Cambridgeshire Police (Parents) and to the LOCAL SAFEGUARDING BOARD. I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any other person who I believe may find it useful or of interest. 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. 9 28 May 2021 3
4 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.
Company Chemists’ Association 16 Upper Woburn Place London WC1H 0AF www.thecca.org.uk 15 July 2021 Mr Nicholas Moss QC Assistant coroner Cambridgeshire & Peterborough Coroner Service Lawrence Court Princes St Huntingdon PE29 3PA 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. Yours sincerely, Chief Executive Company Chemists’ Association 16 Upper Woburn Place, London, WC1H 0AF | www.thecca.org.uk
Nicholas Moss QC Assistant Coroner, Cambridgeshire and Peterborough 14 July 2021 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 www.pharmacyregulation.org 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. Yours sincerely, Chief Executive & Registrar
HM Assistant Coroner Mr Nicholas Moss QC Cambridgeshire and Peterborough Lawrence Court Princess Street Huntingdon PE29 3PA 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 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. NHS England and NHS Improvement 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 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. , Deputy Chief 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. Yours sincerely, Professor National Medical Director NHS England and NHS Improvement and Interim Chief Executive of NHS Improvement Annex The Summary Care Record (SCR) is available to all community pharmacists to view. The SCR provides detail about a patient’s current medication and any recent changes made by General Practice. The pharmacist must seek consent of the patient before they can view it unless they believe there are overriding concerns and it is in patient’s best interest that they see the record. If the patient’s GP thinks it is helpful that additional information should be available to other clinicians who have access to the SCR they can seek agreement with the patient that additional information is placed in the SCR for those clinicians to view. Not every patient has a SCR and this record does not include any special notes made about the patient, but it does provide the opportunity with appropriate consent in place to provide additional information: “You can also choose to add ‘additional information’ to your Summary Care Record. This will include significant medical history and details about immunisations, your information and / or communication needs and your personal preferences. This will only happen if both you and your GP agree to do this – and you should discuss your wishes with your GP practice.” NHSE/I has identified that it would be helpful to suggest to GPs that additional information could be added to the SCR to flag that a local prescription plan is agreed. HSE/I’s is working with NHS Digital to see how this information can be added . NHS England » Notes about the Standard and Summary Care Records 1. NICE Guideline NG5 (Medicines Optimisation: the safe and effective use of medicines to enable to best outcomes) outlines that “Relevant information about medicines should be shared with patients, and their family members or carers, where appropriate, and between health and social care practitioners when a person moves from one care setting to another, to support high-quality care.” GMC Good guidance in prescribing and managing medicines and devices outlines that prescribers “must share all relevant information with colleagues involved in your patient’s care within and outside the team.” This includes the sharing of relevant information with the patient’s chosen community to ensure safe onward care for the patient and communication of key information in relation to prescribed medication. To facilitate secure communication between community pharmacies and health professionals, every community pharmacy in England is required to have a pharmacy premises specific nhs.net email address. In addition, the Electronic Prescription Service system has the facility for prescribers to add key messages for the community pharmacy to the electronic prescription. The prescriber is also able to annotate any handwritten prescription with key information related to the prescribed medication. Ref: Nice: 1 Recommendations | Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes | Guidance | NICE GMC: Deciding if it is safe to prescribe - GMC (gmc-uk.org)
Nicholas Moss Cambridgeshire & Peterborough Coroner Service Lawrence Court Princes Street Huntingdon PE29 3PA 1 July 2021 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. https://www.rpharms.com/recognition/all-our-campaigns/policy-a-z/patient-health-records We have also published guidance around keeping patients safe when they transfer between care providers. This is available on our website. https://www.rpharms.com/resources/quick-reference-guides/keeping-patients-safe 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 them separately if you haven’t already done so. . You may wish to contact Thank you for bringing this to our attention and I hope our response has been helpful. Yours sincerely Professional Support Manager
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