A practice in the Rochdale area

3. Mrs P complains about the prescription of anticipatory medications and co-codamol. She complains about how the Practice handled concerns regarding how family members were administering co-codamol. She also complains about how the Practice completed the medical certificate of cause of death.

4. Mrs P feels the Practice prematurely put Mr B on a palliative care pathway and this hastened his death. She says family members regularly gave him co-codamol though it was prescribed to be taken as required. She says B suffered most of the adverse side effects, drastically declined and then died.

5. Mrs P has told us she has been unable to sleep for several months and there are moments each day where she experiences a wave of sadness, guilt and regret because she feels her attempts to help Mr B failed. She says the cause of death should have prompted further investigation.

6. Mrs P would like the Practice to acknowledge its mistakes and apologise.

7. Mr B was in his 80s. He had trouble with his lungs, blood vessels, heart, and blood pressure. This likely made his overall health quite fragile. Mr B was diagnosed with metastatic prostate cancer (where cancer has spread from the prostate gland to other parts of the body) and referred to a hospice for palliative care.

8. A specialist palliative care nurse (SPCN) visited Mr B to carry out a palliative care assessment. Following this assessment, the SPCN asked the Practice to visit him as they were concerned he had unmanaged back pain and was already showing signs of deterioration. A GP carried out a home visit and discussed his illness, prognosis, pain relief and future care.

9. The SPCN contacted the Practice the same day and asked it to prescribe co-codamol (a painkiller that combines paracetamol and codeine) for lower back pain. A GP prescribed co-codamol later that same day. Another GP lowered the dose the following day after a telephone call from Mrs P’s sister.

10. A month later, Mrs P’s daughter (a GP) wrote to the Practice with concerns that relatives were administering too much co-codamol to Mr B. A paramedic from the Practice carried out a home visit around one week later and GPs carried out two home visits in the week that followed.

11. A few days later, a GP noted Mr B appeared to be approaching the end of his life. He very sadly died two days later. Mr B’s cause of death was recorded as: 1a) Frailty of old age and 2) Metastatic prostate cancer. We cannot begin to imagine what a difficult time this must have been for Mrs P and her family.

12. We are aware Mrs P has also raised a concern about the SPCN with the Nursing and Midwifery Council (the NMC). We understand the SPCN has accepted they failed to properly document their rationale for requesting anticipatory medications and gave Mr B’s family incorrect information on how to administer co-codamol.

16. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs something went wrong. We do this by comparing what should have happened with what did happen. We have done this and not found any indications the Practice got anything seriously wrong.

Issue 1: Prescription for anticipatory medication

17. Mrs P complains the Practice prescribed anticipatory medications. She says these should only be issued when death is expected within the next few days or weeks. She says the consultant expected her brother to survive for around two more years.

What happened:

18. The SPCN visited Mr B and carried out a palliative care assessment. They noted he had prostate cancer with widespread bone metastases. They noted he was unable to mobilise upstairs so was living downstairs. They also noted he appeared very low in mood and to not give a true description of his health.

19. The SPCN’s assessment says Mr B reported dull aching lower back pain usually after resting for long periods which subsided on movement. However, the SPCN noted he appeared to be in a lot of pain as he shouted out on mobilising and could not stand straight for even a short while.

20. The SPCN noted Mr B was possibly showing signs of metastatic spinal cord compression (MSCC) but did not want to get this investigated further. MSCC is where cancer spreads to the spine and puts pressure on the spinal cord causing symptoms such as back pain, weakness in the limbs, numbness and problems with bladder or bowel control.

21. The SPCN’s assessment says Mr B told them he usually took two dissolvable paracetamol as needed and they advised him to take paracetamol four times a day. It also says they discussed using morphine, but Mr B did not want to try this and said he was happy with paracetamol.

22. The SPCN contacted the Practice the same day and asked it to add Mr B to the Gold Standards Framework Register. This is a system for identifying patients who might be nearing the end of life to ensure they receive the best possible care. The SPCN also requested a home visit and said Mr B had uncontrolled pain and the potential to deteriorate rapidly.

23. A GP visited Mr B at home three days later. The notes say he told the GP he was happy for end of life care to be put in place but understood it was not needed yet. The GP discussed red flags for lower back pain as well as the signs and symptoms of MSCC and advised him to call 999 if needed. The GP also prescribed anticipatory medications.

What we have seen:

24. Mr B had been diagnosed with prostate cancer that had spread to his bones. Once prostate cancer has spread to the bones, it is considered stage four with treatment focusing on managing symptoms, slowing progression and improving quality of life. We understand the consultant referred him to the hospice.

25. NICE guideline 142 says approaching the end of life includes people in their final weeks, months and sometimes years. It says this includes people with advanced, progressive and incurable conditions like Mr B. The NICE palliative care CKS says palliative care should include anticipatory prescribing (also known as ‘just in case’ medications).

26. Our adviser explained patients do not have to need anticipatory medications at the time they are prescribed. Doctors prescribe them in advance in case patients suddenly deteriorate particularly out of hours. They do this to ensure patients have access to the medications they may need towards the end of their life to ensure they are comfortable.

27. Our adviser said it was in line with NICE guideline 142 and the NICE palliative care CKS to prescribe anticipatory medications. While Mr B was not expected to die very soon, he had been diagnosed with stage four cancer and was under the care of a hospice. Having anticipatory medications should not impact a patient’s management and we have seen no evidence it negatively affected Mr B.

28. Overall, the decision to prescribe anticipatory medications appears to have been in line with relevant guidance.

Issue 2: Prescription for co-codamol

29. Mrs P complains about the Practice’s decision to prescribe co-codamol. She says her brother had been experiencing some pain, but this usually responded to paracetamol. She says he was not used to taking anything other than paracetamol and would not have understood about co-codamol.

What happened:

30. Mr B had a nuclear medicine (NM) bone scan. This is a highly sensitive imaging test used to detect abnormalities in the bones such as metastases. This indicated he had extensive bone metastases in his left shoulder, ribs, spine and pelvis as well as a possible blockage in his left kidney.

31. A clinic letter from the consultant following the scan says investigations suggested he had metastatic prostate cancer. It says his performance status was 2 (mobile but limited)/3 (severely limited). It also says the only real option was hormone therapy to help with weight loss and pain.

32. The SPCN noted Mr B had uncontrolled symptoms when they first assessed him as he shouted out in pain on mobilising. The SPCN visited him again three days later and noted this was due to reports of further lower back pain. They said he declined Oramorph and Oxycodone but agreed to try co-codamol so they asked the Practice to prescribe this.

33. A GP at the Practice prescribed 30mg/500mg co-codamol (high dose), one or two tablets to be taken up to four times a day as required later that same day. Mrs P’s sister telephoned the Practice the next day and said Mr B wanted to try a lower dose so a GP prescribed 15mg/500mg (middle dose).

34. Mr B was admitted to hospital a few days later due to extensive nosebleeds. A Do Not Attempt Resuscitation (DNAR) order was put in place during this admission. It says CPR was unlikely to be successful due to his fragility, prostate cancer, bone cancer, emphysema and congestive cardiac failure.

35. The hospital discharged Mr B soon after. The discharge summary lists 30 to 60mg codeine (moderate to high dose) four times a day for pain relief. Shortly after this, the Practice noted he was on two 30mg/500mg co-codamol tablets in the morning and one 30mg/500mg tablet twice a day.

36. The Practice prescribed 30mg/500mg co-codamol, one or two tablets to be taken up to four times a day as required around a week after his discharge. Codeine and co-codamol are both used to relieve pain, but they differ in composition and strength. Co-codamol usually contains less codeine but adds paracetamol to enhance pain relief.

What we have seen:

37. Mr B had prostate cancer with extensive bone metastases so it is expected he would be in some pain. When prostate cancer spreads to the bones it can cause bone pain, compression of nerves and fractures. The NICE palliative cancer care CKS says doctors should consider a stepwise approach to pain relief using the analgesic ladder.

38. This recommends starting at the appropriate step of the ladder and progressing until the person is comfortable. Step 1 is a non-opioid (e.g. paracetamol) for mild pain. Step 2 is a weak opioid (e.g. codeine) with or without a non-opioid for mild-to-moderate pain. Step 3 is a strong opioid (e.g. morphine) with or without a non-opioid for severe pain.

39. We understand Mr B was only taking paracetamol when he appeared to be in a great deal of pain on movement during the SPCN’s assessment. Paracetamol is step one on the analgesic ladder. From what we have seen, the Practice followed this guidance by moving to step two to relieve his pain.

40. We note the hospital prescribed Mr B 30 to 60mg codeine on discharge (moderate to high dose). Codeine is usually used in situations where paracetamol cannot be taken or when a stronger effect is needed. This prescription supports the SPCN’s notes that say Mr B was experiencing back pain.

41. Overall, the decision to prescribe co-codamol appears to have been in line with relevant guidance.

Issue 3: Handling of concerns about co-codamol

42. Mrs P says the SPCN told family members to give her brother co-codamol regularly. She says he was opioid naïve and became confused, experienced nausea and vomiting, became newly incontinent, started to hallucinate, was barely able to eat or drink, and was increasingly sleepy with reduced levels of alertness.

43. Mrs P says within five weeks of starting co-codamol, her brother was dead. She says neither prostate cancer nor his age could have caused such a rapid decline. She says her daughter wrote a letter to the Practice asking them to do an urgent home visit to assess him and explain to family members that co-codamol is a controlled drug.

44. Mrs P says no GP visit happened and a paramedic visited her brother instead. She says the paramedic told him they were there to discuss his life end of life care. She says a GP attended via video call, but the reception was poor, so they did not fully take part as the Practice claims.

What happened:

45. The Practice received a letter from Mrs P’s daughter around one month after it first prescribed co-codamol. A paramedic from the Practice carried out a home visit around one week later. The notes say Mr B was sat on the sofa eating Weetabix and the family said he was doing much better. They noted he spoke in full sentences and told them he felt fine.

46. The paramedic’s notes say Mrs P was present and concerned he was having too much co-codamol so they explained Mr B could have co-codamol as needed. They noted his heart rate (slightly raised at 105 bpm), respiratory rate (normal) and temperature (normal). They also noted he was sat on the sofa eating ice cream when they left.

47. A GP then carried out a home visit three days later. They noted Mr B was alert and talking. They noted his temperature, heart rate and oxygen saturation were all normal. They also noted Mrs P’s concerns about family members giving Mr B co-codamol regularly. The notes say Mr B said he did not need pain relief.

48. Mrs P had contacted the Practice and said Mr B seemed delirious which she thought was linked to co-codamol. The GP noted he could have one or two tablets four times a day or as required. Another GP visited three days after this and gave Mrs P’s other brother the same advice about co-codamol.

What we have seen:

49. ‘As required’ prescribing should not routinely become regular administration without clinical review. We would expect the Practice’s response to focus on reassessing Mr B’s analgesic need and ensuring safe prescribing rather than treating his relatives’ actions as automatically inappropriate.

50. We can see the Practice carried out three home visits following the letter from Mrs P’s daughter. The notes of these visits all say the clinicians gave clear instructions to Mr B and his family on how to take co-codamol. The notes do not indicate any signs of someone being overdosed or suffering from significant side effects as Mr B was alert and speaking in full sentences.

51. Based on what we have seen, the Practice responded to concerns in line with GMC Good medical practice. This says doctors must adequately assess a patient’s conditions and consider the needs and welfare of people who may be vulnerable and offer them help if they think their rights are being abused or denied.

52. Overall, the Practice’s response to Mrs P and her daughter’s concerns appears to have been in line with relevant guidance.

Issue 4: Cause of death

53. Mrs P says the Practice changed Mr B’s medical certificate of cause of death from metastatic prostate cancer to frailty of old age after her daughter raised concerns about his care and treatment. She says frailty does not cause someone to decline rapidly over a five-week period.

What happened:

54. A GP at the Practice initially said Mr B’s cause of death was (1a) Metastatic prostate cancer and 2) Frailty or old age, Atrial Fibrillation. They then changed this to 1a) Frailty of old age and 2) Metastatic prostate cancer following discussion with the coroner who in turn spoke with the consultant.

55. Mrs P has provided us with a letter she received from the consultant following Mr B’s death. This says Mr B’s test results indicated his cancer was stable and it would be unexpected for his death to have been primarily due to prostate cancer. However, they noted he had very significant comorbidities particularly those involving his heart.

What we have seen:

56. The DHSC guidance says doctors should record the immediate direct cause of death under ‘1a’ and then go back through the sequence of events/conditions that led to the death until they reach the condition that started the fatal sequence. It says doctors should record any other diseases/injuries/conditions/events that contributed to the death under ‘2’.

57. The GP initially said cause of death was (1a) Metastatic prostate cancer and 2) Frailty or old age, Atrial Fibrillation. Our adviser said this was not unreasonable or disingenuous as Mr B was diagnosed with metastatic prostate cancer and died within three months. We also note this followed discussion with the coroner’s office.

58. However, the coroner’s office then spoke with the consultant, and they said a more plausible cause of death was 1a) Frailty of old age and 2) Metastatic prostate cancer. From what we have seen, the GP initially proposed a reasonable cause of death based on Mr B’s recent diagnosis of stage four metastatic prostate cancer.

59. Overall, the medical certificate of cause of death appears to have been completed in line with relevant guidance.

Overall

60. We have not seen any indications anything went seriously wrong with the Practice’s care and treatment. We hope our consideration addresses Mrs P’s concerns and provides some sense of closure. We would like to thank her for bringing her complaint to us and wish her the very best for the future.

1. Mrs P complains about the care and treatment the Practice provided to her brother, Mr B, following a diagnosis of prostate cancer. We have carefully considered her concerns and seen no indications anything went seriously wrong. We will therefore be closing her complaint at this stage.

2. We would like to take this opportunity to share our sincere condolences with Mrs P. We know how difficult it can be to raise a complaint about the care a loved one received and then keep pursuing this while trying to grieve their loss. We hope this statement provides her with reassurance around what happened.