Prescribed medication - duloxetine
21. Ms N complains the Practice prescribed her duloxetine (a type of antidepressant that can also treat nerve pain). She says the Practice should not have prescribed this medication as it is known to cause falls in patients over the age of 65. She says her physiotherapist has told her that the impact from the falls will last over 12-months.
22. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong.
23. The British National Formulary (BNF) gives key information on the selection, prescribing, dispensing, and administration of medicines. Our adviser says BNF guidance puts Ms N in the ‘caution’ category for the prescribing of duloxetine because of her age. He says it is worth noting that age is a ‘caution’ for many prescription drugs.
24. Our adviser says Ms N does not have any of the ‘contra-indicators’ which would mean duloxetine should not be prescribed to her. Therefore, there is nothing to indicate the Practice should not have prescribed this medication to her.
25. Ms N was initially prescribed duloxetine in July 2019. Ms N reported to her GP on 5 September that she felt it was not helping so she stopped taking it. Ms N took the medication for a short period of time and no side effects were reported.
26. Ms N visited the Practice on 12 January 2023 because she was experiencing ongoing issues with back pain and general pain associated with fibromyalgia.
27. NICE guidance for Neuropathic pain in adults: pharmacological management in non-specialist settings [CG173] (November 2013, updated September 2020) point 1.1.8 says to offer a choice of amitriptyline, duloxetine, gabapentin or pregabalin as initial treatment for neuropathic pain (except trigeminal neuralgia).
28. The GP re-issued duloxetine on 12 January 2023 to try to relieve the pain. Ms N continued to take this medication without reporting any issues.
29. In May, Ms N sadly had a fall. The hospital later identified Ms N had suffered a fractured pelvis and sacral bone. She says she stopped taking the medication because she attributed it to the fall.
30. Our adviser says BNF lists falls as a common side effect of duloxetine along with a large number of other potential common side effects. Ms N did not report an issue with falling when she was previously on the medication.
31. A clinic note on 30 November 2022 shows Ms N had suffered a fall four weeks prior to this appointment. This was before duloxetine was prescribed. This does not indicate a reason not to prescribe Ms N with duloxetine. This shows there are a number of reasons and factors to consider for why a person might fall.
32. Our adviser says the prescribing of duloxetine was appropriate and in line with NICE guidance for the symptoms Ms N presented with.
33. We recognise the distress and the huge impact the falls have had on Ms N. We know she has had to undergo physiotherapy to help with her recovery from the injuries she sustained.
34. Having considered all the available evidence, we do not consider the Practice did anything wrong. We consider the Practice acted in line with the relevant clinical guidance when it prescribed Ms N with duloxetine. Therefore, we will be taking no further action.
Incorrect information on medical records
35. Ms N says she discovered the Practice had incorrectly added a diagnosis of lymphosarcoma (a form of cancer that affects the lymphocytes, cells that make up a large part of the body’s immune system) into her medical records on 27 December 2019. She did not discover this until 14 September 2023. At this point, Ms N immediately informed the Practice of its error.
36. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the event(s) complained about had a negative effect which the organisation has not put right. Having done so we have found the Practice has already done enough to put right the impact of these events.
37. GMC guidance, paragraph 21a, says clinical records should include relevant clinical findings. Our adviser says some GP practices put a clinical note on a patient’s record when it receives information from a hospital about a likely diagnosis or finding and then updates the records as necessary once the hospital confirms the diagnosis or finding. Other GP practices would wait until it receives a confirmed diagnosis or finding before inputting into a patient’s record. GMC guidance does not say which is the preferred method.
38. Our adviser says the Practice used the information in the letters it received from the hospital on 7 December 2016 and 23 January 2017 about Ms N’s likely diagnosis of liposarcoma (a rare type of cancer that begins in the fat cells) and inputted this onto her medical records.
39. We are aware of the error that occurred when making the entry. This led to an incorrect entry coding of lymphosarcoma being put on her records instead of liposarcoma.
40. The Practice responded to Ms N on 12 October 2023 about her concerns over the incorrect entry made on 27 December 2019. The Practice apologises for the incorrect entry. It says this was a genuine error made by the person inputting the information. The member of staff involved in the incorrect coding no longer works at the Practice.
41. The Practice agreed to hold a staff briefing session to learn from Ms N’s experience. The focus of this training was on the need for extra care to be taken when coding GP records after receiving hospital correspondence. The Practice gave evidence to show this session was undertaken on 30 April 2024. It also confirmed new members of staff have access to administration related training, and refresher training is available for existing employees.
42. GMC guidance paragraph 19 says clinical records must be clear, accurate, and legible. It also says you should make records at the same time as the event you are recording or as soon as possible afterwards. There is no specific guidance around how quickly information should be put on a patient’s clinical records.
43. The Practice cannot confidently explain the reason the entry was made on 27 December 2019. One explanation it gave was because Ms N left the Practice in 2017 and later returned, which may have led to a delay in the information being documented on her record.
44. The hospital sent letters to the Practice on 31 March 2017 and 7 May 2017. These letters confirmed a finding of angiomyolipoma (a benign fatty tumour with blood vessels that grow under your skin) with no evidence of malignancy. We can confidently say the Practice received the letters as it has them in Ms N’s records.
45. Our adviser says the Practice should have updated Ms N’s clinical records with the information it later received in the letters dated 31 March 2017 and 7 May 2017 confirming Ms N’s diagnosis.
46. In the Practice’s response dated 12 October, it says she had since left the Practice when she notified it of the mistake. Our adviser says the Practice should update Ms N’s records as soon as it had been notified of the error to ensure her records were accurate. As Ms N was no longer a registered patient at the Practice at the time she raised her concerns, he says it gave her appropriate advice to ask her new GP Practice to amend her records accordingly.
47. Our adviser says there is nothing in the records to indicate the lymphosarcoma entry made on 27 December 2019 had any impact on the treatment she was given by the Practice. All medication and treatment Ms N received from the Practice for her other health conditions were not impacted by having a lymphosarcoma diagnosis on her records.
48. When we see indications of failings, we must then consider if there are indications of an injustice flowing from this and whether the injustice the complainant claims is likely to have happened because of the possible failings.
49. We know the Practice incorrectly inputted information into Ms N’s medical records. We know it did not input information in a timely manner. We therefore recognise the Practice did not act in line with GMC guidance in this instance.
50. We recognise how difficult things have been for Ms N having to watch her husband and sister suffer with cancer. She told us her biggest fear is getting cancer. We therefore understand how upsetting it was for her seeing a cancer diagnosis on her records.
51. We understand Ms N’s reluctance to trust healthcare professionals because of the incorrect information she has had documented in her medical records. We hope our view that the incorrect information had no impact on her care and treatment for her other health conditions provides her with some reassurance.
52. We know Ms N is considering whether she needs counselling. She says this is because of the effect this whole experience has had on her. We understand the difficulties Ms N has faced in her life. We cannot link this claimed impact to the failing that has occurred in this instance.
53. Ms N says having incorrect information on her medical records could have had a negative impact on her obtaining travel insurance. We cannot link this impact to the failing. The inputting of incorrect information did not have a negative impact on Ms N obtaining travel insurance and she did not have to use any insurance to cover for any claim. We are aware Ms N’s new GP Practice has appropriately altered her records with the correct coding entry. This is not something that continues to apply going forward. Therefore, there is no impact in this instance to link to the failing.
54. When we see indications that an injustice flows from failings in care, we must then look at what action the organisation has already taken to put things right and whether this appears to have resolved the case.
55. In this instance, it is not possible for the Practice to put Ms N back in the position that she would have been in had the failings not taken place. We must then look to see what it did to remedy the injustice for her.
56. The NHS standards identify suitable and appropriate ways to put things right for people who raise a complaint. It says the organisation should clearly explain how it will remedy any mistakes made.
57. The Practice apologised for the incorrect entry made in Ms N’s medical records in its complaint response dated 12 October 2023. The Practice has taken steps to put this right in the staff briefing it held on 30 April 2024 and with the training available for new and existing staff.
58. Ms N wanted the Practice to apologise for its failings and to undertake staff training to stop this happening again to anyone else in the future.
59. Having considered all the available evidence, we consider the Practice’s apology and the steps it has taken to prevent this happening again in the future has given Ms N two outcomes she had hoped to achieve. We also consider the Practice has taken appropriate steps to remedy the distress caused to her. Therefore, we do not need to take any further action.
Frailty assessment and score 60. On 28 July 2023, a frailty score became visible on Ms N’s medical records.
61. On 3 August, Ms N complained to the Practice. She says she does not consider herself to be frail. She asked the Practice to explain why the frailty score is present on her records.
62. The Practice says in its response dated 4 September that a frailty index score is calculated by an electronic tool which runs silently in the background of GP clinical systems. This is something that is a requirement by NHS England and is something that is scored automatically and is not inputted by anyone in the Practice.
63. The electronic frailty index (eFI) uses existing information within the electronic primary health care record to identify populations of people aged 65 and over who may be living with varying degrees of frailty.
64. The eFI is made up of 36 deficits comprising around 2,000 ‘read codes’ (a coded thesaurus of clinical terms). The score is strongly predictive of adverse outcomes and has been validated in around 900,000 patient records.
65. Our adviser could not say whether having the lymphosarcoma diagnosis on Ms N’s medical records had an impact on the frailty score populated. As the eFI uses codes from a patient’s record, it is likely the lymphosarcoma coding did influence her frailty score.
66. We know Ms N was also unhappy about the word ‘carer’ being put on her record and felt this information was covertly inputted onto her record. Ms N says she had told the Practice she has a ‘cleaner’ not a ‘carer.’ Our adviser again could not confidently say whether the word ‘carer’ on Ms N’s record had an impact on her frailty score. He assumes, as the eFI uses read codes, it is unlikely to pick up free text within the clinical records.
67. The Practice did not incorrectly input falls recorded on Ms N’s record. It is likely the coding and information inputted around the falls she experienced would have affected her frailty score.
68. As frailty scores are fluid based on information inputted into a patient’s record, the score can change if a patient’s recorded health condition(s) improve or deteriorate.
69. Patients with a severe frailty score are highlighted to practices. A practice would look individually at each of these patients to see whether further or enhanced care should be given to improve their health and quality of life. Further or enhanced care is not always needed as the patient may not be as frail as the score indicates. The score just highlights appropriate patients for the Practice to consider.
70. We recognise the incorrect information inputted into Ms N’s records could have influenced her frailty score. We understand the impact this had on her when reading her score, especially given she did not consider herself to be frail.
71. Our adviser says the frailty score does not reflect Ms N’s actual level of frailty at that time. He says this score did not have a negative impact on her in terms of the care and treatment she received by the Practice. The score aimed to inform the Practice of the need to prioritise and look at whether further and enhanced care could be given to Ms N to improve her health and quality of life.
72. The Practice is not responsible for the score the electronic system populates. Therefore, we cannot hold it accountable for the score on Ms N’s record.
73. The Practice is responsible for the information it inputs into medical records for the electronic system to work effectively. The Practice has apologised for the incorrect information inputted into Ms N’s records. It has also undertaken further staff training to prevent this happening again in the future. We consider the Practice has taken appropriate steps to remedy the distress caused. Therefore, we will not be taking any further action.
74. We hope Ms N’s experience with her new GP Practice, and the information we have provided within this complaint response, goes some way to restore her faith in the NHS.
75. We consider the Practice has learnt from the complaint Ms N has made. It has given a suitable remedy for the distress caused by the inputting of incorrect information on Ms N’s medical records.
76. We hope we have clearly explained our decision and Ms N now has some answers to find the closure she needs.
77. We would like to thank Ms N for taking the time to bring this complaint to us. We wish her all the best for the future.