The Ombudsman's final decision:
Summary: The Ombudsmen find there was fault on the part of a Surgery in the care it provided to a patient with dementia. It should have done more before prescribing a sedative on a long-term basis, and it should have performed a more thorough examination when the patient became unwell. These faults have left the patient’s daughter with uncertainty which, in turn, caused distress. The Surgery has agreed to provide an apology and produce an action plan to help put things right.
- In 2018 Mr N was a fee-paying resident of the Maples Care Home (the Care Home), and a patient of Westwood Surgery (the Surgery). He sadly died in December 2018. His daughter, Mrs D, complains:
- The Surgery prescribed and the Care Home administered a sedative to Mr N on a nightly basis. She said this was against the family’s stated instructions, and it happened without anyone telling the family. Mrs D said this was of no benefit to Mr N and caused him to have many falls and led to a deterioration in his health.
- The Surgery and the Care Home failed to arrange for Mr N to be admitted to hospital in October 2018 and, instead, inappropriately prescribed stroke medication. Mrs D has concerns this contributed to a further avoidable deterioration in Mr N’s health.
- Mrs D said she has been left distraught because she trusted the Care Home and the Surgery to look after Mr N.
- Mrs D would like to see procedural changes to prevent recurrences of similar failings.
The Ombudsmen’s role and powers
- The Local Government and Social Care Ombudsman investigates complaints about adult social care providers. We decide whether their actions have caused an injustice, or could have caused injustice, to the person making the complaint. Where something has gone wrong we refer to those actions as ‘fault’. (Local Government Act 1974, sections 34B, and 34C, as amended)
- The Health Service Ombudsman investigates complaints about ‘maladministration’ and ‘service failure’ in the delivery of health services. We use the word ‘fault’ to refer to these. If there has been fault the Health Service Ombudsman considers whether it has caused injustice or hardship. (Health Service Commissioners Act 1993, section 3(1))
- If the actions of a health and social care provider have caused injustice the Ombudsmen may suggest a remedy. Our recommendations might include asking the organisation to apologise or to pay a financial remedy, for example, for inconvenience or worry caused. We might also recommend the organisation takes action to stop the same mistakes happening again.
- If the Ombudsmen are satisfied with the actions or proposed actions of the bodies that are the subject of the complaint, they can complete their investigation and issue a decision statement. (Health Service Commissioners Act 1993, section 18ZA and Local Government Act 1974, section 30(1B) and 34H(i), as amended)
How I considered this complaint
- I read the correspondence Mrs D sent to the Ombudsmen and spoke to her on the telephone. I wrote to the organisations to explain what I intended to investigate and to ask for comments and copies of relevant records. I considered all the comments and records they provided. I also considered relevant legislation and guidance and took advice from a practicing GP with relevant knowledge and experience and no conflicts of interest.
- I shared a confidential copy of my draft decision with Mrs D and the organisations under investigation to explain my provisional findings. I invited their comments and considered those I received in response.
What I found
- Mr N had mixed vascular dementia and Alzheimer’s, along with medical conditions affecting his legs. In 2017 he lived at home with his wife. However, due to his increasing needs this was not sustainable. Mr N went into the Care Home for a two‑week respite stay in November 2017 but, in early December 2017, became a permanent resident.
- At the end of December 2017, when Mr N was permanent resident, the Surgery registered him as a patient, at the request of the Care Home. This is the normal practice for all residents of the Care Home. A GP reviewed Mr N as a new patient the next day.
- Just over a week later, in early January 2018, a GP reviewed him again. They noted concerns from the Care Home that Mr N was awake at night and wandered. The GP prescribed promethazine for the treatment of insomnia, to be given at a dose of 25mg once a night. The GP also referred Mr N to a Community Mental Health Team and planned to review him the next week.
- The Care Home began giving Mr N the prescribed dose of promethazine from that day, on a nightly basis.
- A Community Mental Health Nurse Specialist reviewed Mr N in the middle of February 2018. They made some recommendations for his care but did not plan to see him again.
- In June 2018 the Surgery increased Mr N’s prescription of promethazine to 50mg once a night.
- In early October 2018 staff in the Care Home noted that Mr N appeared weaker than normal and sometimes found it difficult to stand from a chair. In the middle of the month staff saw Mr N fall. They noted he appeared to weaken at the knees and fall straight down.
- Mr N fell again a little over a week later. Staff noted this happened while he was standing from a chair, and that he had appeared unsteady on his feet and stumbled backwards. After attending to Mr N staff spoke to Mrs D. They noted that she agreed that Mr N’s mobility had got worse recently.
- Staff noted that Mrs D ‘mentioned in the past that this has been attributed to medication that he had been prescribed at that time. Nurse in charge advised [Mrs D] that [Mr N] would be observed every 30 minutes throughout the night and that Promethazine medication would be omitted due to sedative effect…’
- Mr N’s mobility did not improve over the following days. Staff also noted that he was not responding to simple instructions, appeared more confused and his mood seemed lower. At the end of October 2018 the Care Home emailed the Surgery to highlight the situation and ask for advice. The Surgery planned to do some blood tests.
- A GP reviewed Mr N four days later, in early November 2018. The GP felt Mr N may have suffered a stroke. The GP decided that, in the context of Mr N’s known diagnoses, it would not be appropriate or helpful to admit him to hospital. They planned to manage Mr N’s symptoms and keep him as comfortable as possible. As part of this, the GP prescribed two medications: atorvastatin for cholesterol; and, clopidogrel for circulation.
- Nine days later a Care Home nurse saw Mr N and noted that he was hot, sweaty and not as responsive as usual. They initially called 111 and then, on their advice, arranged for Mr N to go into hospital via ambulance.
- Doctors in the hospital diagnosed Mr N as suffering from a chest infection which they treated with antibiotics. They also found he was dehydrated and treated this with intravenous fluids. In addition, Mr N was noted to have a delirium.
- The hospital discharged Mr N 16 days after he was admitted. It noted that, prior to coming into hospital, the GP had prescribed atorvastatin and clopidogrel for a possible stroke. The hospital noted that it stopped some of Mr N’s regular medication: donepezil (used to treat confusion in dementia); and buprenorphine (pain relief). It did so as it felt they were likely to be contributing to sedation. The hospital noted Mr N’s delirium improved throughout the admission.
- When Mr N left hospital it included a summary of the medication he remained on. This included:
- Promethazine, 50mg a night, for insomnia. Under ‘GP to continue’ it noted ‘GP to Review’ (where other entries simply stated ‘Yes’).
- Atorvastatin, 40mg a day. The instruction to the GP was to continue this.
- Clopidogrel, 75mg a day. The instruction to the GP was to continue this.
- Mr N returned to the Care Home after leaving hospital. Four days later, at the start of December 2018, staff noted his health was getting worse. Mr N returned to hospital but sadly died later that month.
- Mrs D complained to the Care Home at the start of January 2019. The Care Home replied later that month and incorporated statements from a GP. They did not identify any shortcomings in their actions.
Relevant legislation and guidance
- There are standards for safety and quality care homes need to meet (The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014). The Care Quality Commission (the CQC) has written guidance to help care homes meet these standards, known as the Fundamental Standards (Guidance for providers on meeting the regulations, March 2015). Under these regulations care homes need to make sure people are kept safe from avoidable risk and harm, and from unsafe care and treatment (Regulation 12).
- However, it remains the responsibility of appropriately qualified and registered clinical staff to prescribe medication, and to keep its use under review. In 2013 the General Medical Council (the GMC) issued guidance on good medical practice (Good medical practice, 2013). This said:
- ‘In providing clinical care you must:
a. prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs…’ (Paragraph 16 of Good medical practice).
- The GMC also issued separate guidance on prescribing medication (Good practice in prescribing and managing medicines and devices, 2013). This provided more detailed advice on how to comply with the principles of good medical practice. It said:
- ‘You should prescribe medicines only if you have adequate knowledge of the patient’s health and you are satisfied that they serve the patient’s needs’ (Paragraph 14, Good practice in prescribing and managing medicines and devices).
- ‘You must not prescribe medicines for your own convenience or the convenience of other health or social care professionals (for example, those caring for patients with dementia in care homes)’ (Paragraph 16, Good practice in prescribing and managing medicines and devices).
- ‘Together with the patient [or, where appropriate, parents or carers with authority to make decision of behalf of patients. Medicines may be prescribed without consent if it is likely to be of overall benefit to adults who lack capacity, or in accordance with mental health legislation], you should make an assessment of their condition before deciding to prescribe a medicine. You must have or take an adequate history including:
a. any previous adverse reactions to medicines
b. recent use of other medicines…and
c. other medical conditions’ (Paragraph 21, Good practice in prescribing and managing medicines and devices).
- ‘You should reach agreement with the patient on the treatment proposed, explaining:
a. the likely benefits, risks and burdens, including serious and common side effects
b. what to do in the event of a side effect or recurrence of the condition…
e. arrangements for monitoring, follow-up and review…’ (Paragraph 24, Good practice in prescribing and managing medicines and devices).
- ‘You should also provide patients’ carers with information about the medicines you prescribe, either with the patient’s consent or, if the patient lacks capacity to consent, if it is in their best interests’ (Paragraph 26, Good practice in prescribing and managing medicines and devices).
- ‘Whether you prescribe with repeats or on a one-off basis, you must make sure that suitable arrangements are in place for monitoring, follow-up and review, taking account of the patients’ needs and any risks arising from the medicines’ (Paragraph 51, Good practice in prescribing and managing medicines and devices).
- ‘Reviewing medicines will be particularly important where:
a. patients may be at risk, for example, patients who are frail or have multiple illnesses
b. medicines have potentially serious or common side effects…’ (Paragraph 53, Good practice in prescribing and managing medicines and devices).
- ‘When you issue repeat prescriptions…you should make sure that procedures are in place to monitor whether the medicine is still safe and necessary for the patient…’ (Paragraph 59, Good practice in prescribing and managing medicines and devices).
- The GMC also has guidance on treating people who are approaching the end of their life (Treatment and care towards the end of life: good practice in decision making, 2010). This applies to patients with advanced, progressive and incurable conditions, or general frailty and co-existing conditions that mean they are expected to die within 12 months (Paragraph 2, Treatment and care towards the end of life).
- This guidance details that where a patient lacks capacity the doctor should check whether anyone else holds legal authority to make healthcare decisions for them. Further, where there is no legal proxy, doctors should still consult those close to the patient to help make decisions (Paragraph 15, Treatment and care towards the end of life).
- The National Institute for Health and Care Excellence (NICE) produces Clinical Knowledge Summaries. These provide doctors with practical guidance on best practice for a range of conditions. There is a Clinical Knowledge Summary on Dementia which provides guidance on the ongoing care and support of people with the condition. This advises that doctors should seek advice from a specialist if behavioural and psychological symptoms develop which cannot be managed effectively through non-pharmaceutical methods.
- In the UK the Medicines and Healthcare Products Regulatory Agency grants licenses for medicines. Licences confirm the health condition the medicine should be used for and the recommended dosage.
- Promethazine is licensed for the purpose of sedation, at a dose of 25-50mg for adults.
Prescription and administration of promethazine
- Mrs D said the first time she knew Mr N had been given 50mg of promethazine was when she saw an application for Continuing Healthcare funding in January 2019. She said that no one had notified her (or her brother or sister) of this prescription. Mrs D said she had made it clear, earlier in 2018, that Mr N should not be given sleeping tablets as he had taken them in 2017 and suffered many falls.
- The Care Home completed a pre-admission assessment for Mr N when he went in for respite in November 2017. This looked at Mr N’s needs in a range of defined areas. Under ‘Sleeping’ it noted that staff would need to ‘Assess further on admission – feedback from wife and daughter that [Mr N’s] night time routine is increasingly erratic and he may have disturbed night sleep and will need support and supervision to ensure he receives adequate sleep’.
- Under ‘Medication’ the assessment noted ‘Not available to see the medication prescribed. Family will provide. Confirm night sedation as [Mr N’s next of kin] report night pattern is erratic’.
- The daily records from the Care Home (from the date Mr N moved in until the start of January 2018) show that Mr N regularly did not want to go to bed and would wander the corridors into the early hours, and would sometimes try to enter other residents’ rooms.
- A ‘sleeping’ care plan by the Care Home, in place in December 2017, noted that Mr N ‘likes to walk a lot, he walks around the unit throughout the day and night. He walks into other residents room at times’. It also noted [Mr N] ‘doesn’t have a good sleeping pattern, he walks around and refuses to go to bed’. The care plan said staff would need to encourage Mr N to go to bed and remind him to rest in bed. It also noted ‘Nurse to discuss with GP if [Mr N’s] sleeping pattern deteriorates any further. Family to be informed regarding any changes in the condition’.
- When a GP reviewed Mr N at the end of December 2017 they noted, among other things, that Mr N did not sleep, may wander into other resident’s rooms and was at risk of falling. The GP noted they had spoken to the family who advised that Mr N had been more and more unsafe at home. The GP noted they reviewed Mr N’s medication and Care Home staff felt he needed some pain relief. There was no reference to the use of night sedation.
- On the same day as this review staff from the Care Home wrote in its GP Request Book ‘Please consider medication for insomnia’.
- The records show that Care Home allowed around a month to pass before it sought the Surgery’s input about Mr N’s sleeping pattern. During this period it was frequently recorded that Mr N wandered a lot a night and that staff struggled to encourage him to settle. I have not seen any reference in the initial assessment, the care plans or the daily records of an instruction from the family not to give Mr N a sedative at night. Mrs D told me this happened, but I have not found any evidence in the Care Home or Surgery records about it, even in entries where staff noted contact with the family. It was appropriate for the Care Home to allow time for Mr N to settle in, and to see if there was a pattern to his night time behaviour. Further, it was reasonable to seek the view of a medical professional on this issue.
- The next GP review took place about a week later. At this review the GP prescribed promethazine and referred Mr N to a mental health team. In this situation it was reasonable for the GP to use the information the Care Home provided to form an understanding of the issue. However, the family should have been involved in the consideration of how to manage Mr N’s poor sleep pattern. The Surgery should either have made direct contact with the family or asked the Care Home to do so on its behalf. The failure to do so was fault on the part of the Surgery. As a result the family lost an opportunity to be involved in an informed discussion about the relative risks and benefits of using, or not using, medication to help Mr N sleep.
- Promethazine is licensed for use as a sedative, but the British National Formulary guide this should be for short term use. It was appropriate for the Surgery to refer Mr N to a mental health team for its advice on Mr N’s health. However, the referral should have been clearer that the Surgery had prescribed promethazine to help Mr N sleep. Further, it should have specifically asked for the mental health team’s advice on the use of this medication in the short- and long-term. This is evidence of further fault by the Surgery.
- Once the Surgery had prescribed promethazine it was reasonable for the Care Home to administer it. It is normal practice for care staff to follow the advice and directions of medical professionals.
- It is hard to determine the impact of this faults that occurred when prescribing the medication. In the middle of February 2018 a Mental Health Nurse Specialist reviewed Mr N, in response to the Surgery’s referral. The Nurse Specialist noted the prescription of promethazine, among other observations. In their plan they did not recommend any changes to this prescription. It is possible that, even with an explicit request to comment on this medication, they still would not have recommended any changes to the prescription.
- Nevertheless, the faults – in not speaking to the family or seeking complete advice from the mental health team – has caused uncertainty about whether the prescription would have gone ahead if the faults had not happened.
- Later, when the Surgery increased the dose of promethazine, there is no record to explain why. This is further fault. According to the GMC’s guidance on good medical practice there should be a clear record of the clinical rationale. Further, given the recommendation to use this medication as a short-term sedative, it would have been appropriate for the Surgery have sought further advice from the mental health team about this issue. Therefore, there was further fault when the Surgery increased the dose.
- In terms of the overall impact, it seems probable that, had the family been involved in the initial discussions they would have objected to the prescription of this medication. Mrs D has concerns that its prolonged use directly led to an avoidable deterioration in Mr N’s health. It is possible that its use contributed to confusion and dizziness, as these are known side effects. However, there is also a possibility the medication did have some positive effects for Mr N. In addition, I cannot discount that Mr N had a significant, progressive underlying illness which, in and of itself, was likely to cause a deterioration in his health during this time period. There is evidence to show that Mr N suffered falls before he was on this medication. It is notable that the Mental Health Nurse Specialist did not alter the prescription in February. Also, in November, while the hospital stopped two medications for their sedative effect, it did not stop the prescription of promethazine.
- Overall, there is evidence of fault on the part of the Surgery in terms of the process it followed when prescribing then increasing the dose of promethazine. Even on the balance of probabilities, it is not possible to say what impact this medication had on Mr N. However, this uncertainty has been a source of distress to Mrs D and this, on its own, is an injustice.
Diagnosis of a possible stroke
- The GP made a note of their review of Mr N at the start of November 2018. This included an explanation for their conclusion that Mr N had probably suffered a stroke. However, according to the NICE Clinical Knowledge Summary on Dementia, doctors should first take steps to discount other possible causes of changes in a patient’s cognition and presentation. Doctors should take a history, conduct a physical examination and look for physical causes, such as infection. The records of this encounter do not provide evidence of a proportionate assessment. Therefore, the diagnosis of a suspected stroke was made without properly excluding other possible causes of deterioration, such as an infection. This was fault.
- The medications the Surgery prescribed for the suspected stroke are unlikely to have caused Mr N any harm. The hospital did not stop them after Mr N was admitted. Further, using Mr N’s observations as they were recorded by the Care Home at the end of October, it is not clear that his presentation would have warranted a hospital admission at that time. However, a more thorough examination may have resulted in the prescription of antibiotics which may have been of some benefit to him.
- As with the previous issue, it is not possible to say the fault here had a direct, avoidable impact on Mr N’s health. However, as before, it has left uncertainty and caused Mrs D distress which is an injustice.
- Within one month of the date of the final decision the Surgery will write to Mrs D and acknowledge the faults that have been identified in this investigation (detailed in paragraphs 43, 44, 48 and 51). The Surgery will acknowledge that this has caused uncertainty about whether, had matters been handled without fault, Mr N’s health may not have deteriorated as it did. The Surgery will also apologise for the distress this has caused Mrs D.
- Within three months of the date of the final decision the Surgery will arrange to review this case, relevant national guidance and any relevant internal policies it has. The Surgery will take steps to ensure national guidance, about caring for people with dementia and who lack capacity, is properly understood and embedded in its practices. The Surgery will provide the Ombudsmen with evidence it has completed this work.
- I have completed this investigation on the basis there was fault on the part of the Surgery which led to an injustice. The Surgery has agreed to recommendations to help address this injustice and to ensure improvements are made to prevent recurrences.
Investigator’s decision on behalf of the Ombudsmen
Investigator's decision on behalf of the Ombudsman