A practice in the Bromley area

5. Mrs A complains about aspects of the care and service she received from the Practice in late 2016. She specifically says that:

• in December 2016, a GP at the Practice prescribed her with an incorrect dosage of Evorel hormone replacement therapy patches • the Practice’s complaint handling has been poor, and its responses do not adequately answer her questions. She says they also provide conflicting information.

6. Mrs A says that due to the GP prescribing her with the incorrect dosage of Evorel patches, this has caused her to have painful engorged breasts for the past eight years which has led to her also experiencing back pain. She also says this has affected her mental health as she has developed depression for which she now takes medication.

7. Furthermore, she says the Practice’s complaint handling has made her feel dismissed and caused her stress. She has lost faith in the Practice due to the conflicting information it has provided within its response and so has moved to a different GP practice.

8. Mrs A is seeking a financial remedy.

9. At the time of the events complained about Mrs A was 48 years of age. She had a preexisting diagnosis of heavy menstrual bleeding (menorrhagia), which was being treated with Cerazette. Cerazette is a progesterone-only contraceptive pill.

10. Mrs A’s presented to her GP with symptoms of anxiety, depression and hot flushes. After trialling different types of antidepressants, her GP referred her for a gynaecology review in mid-autumn 2016.

11. A consultant obstetrician and gynaecologist reviewed Mrs A two weeks later and suspected she was perimenopausal. They prescribed her with 1.25mg Premarin tablets for a two-month period and told her to take this alongside the Cerazette. Premarin is a hormone replacement therapy (HRT) medication designed to alleviate the symptoms of menopause. The consultant made an appointment for a review in 8 weeks’ time.

12. In early Winter 2016, the Practice held a consultation with Mrs A regarding issues with her eyes which she associated as a side effect from the Premarin. The GP advised her to stop taking the tablets and prescribed her with Evorel 100 patches, which she started taking the next day.

13. Evorel Patches are a form of HRT. They contain Estradiol, which is also known as the female hormone oestrogen. The patches work by releasing the oestrogen through the skin (transdermal) over a period of 24 hours.

14. After almost four weeks of using the patches, Mrs A started to experience severe pain, tenderness and engorgement in her breasts.

15. In early 2017, the Practice held a telephone consultation with Mrs A who reported feeling better but was experiencing issues with severe pain and breast swelling. The GP reduced the dosage to Evorel 50 patches, which Mrs A started using straight away.

16. The consultant reviewed Mrs A three days after the telephone consultation with her GP. The consultant advised her to continue with the combination of Cerazette and Evorel 50 patches until the age of 52. Furthermore, they advised Mrs A that they could review her at age 52 and change her HRT for use up to the age of 57.

17. Just over two weeks after the consultant review, the Practice held a further consultation with Mrs A. The GP reduced her prescription further to Evorel 25 patches. They advised her to continue to use the patches alongside the Cerazette.

18. Mrs A continued to use the Evorel 25 patches and Cerazette together for approximately six months. She stopped using Evorel patches completely by mid-2017.

19. Mrs A raised her complaint with the Practice in late summer 2024 and it responded the following day. However, as Mrs A was unhappy with the response, she sent a further letter of complaint to the Practice approximately three weeks later. The Practice issued its final response in early autumn 2024.

Incorrect HRT Dosage

24. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the events complained about had a negative effect which the organisation has not put right. Having done so we cannot link the events complained about with the negative impact Mrs A has claimed.

25. Mrs A complains a GP at the Practice prescribed her with an incorrect dosage of Evorel hormone replacement therapy patches.

26. In its initial complaint response, the Practice explained that Premarin is available in three doses: 300 micrograms, 625 micrograms and 1.25 milligrams. It highlighted that the consultant started her on the highest dosage available.

27. The Practice explained it held a consultation with Mrs A in early winter 2016 and switched her to a like for like dose of HRT in Evorel 100 patches form. It said it held a telephone consultation with her in early 2017 during which, she informed the GP she had breast tenderness and so they amended her prescription to Evorel 50 patches.

28. In its second response, the Practice explained that normally all medications, including HRT are started with a low dose and then increased gradually, if required. It noted the GP decided to start with Evorel 100 patches to continue the HRT trial the consultant had started.

29. It acknowledged Evorel 100 patches were not the equivalent of 1.25 milligrams of Premarin as this equated to a 625 patch, which do not exist. The Practice therefore explained the GP decided to go up to the 100 patches rather than go down to the 50 patches. Furthermore, the Practice apologised to Mrs A for not making this rationale clear during the early Winter 2016 consultation.

30. Section 1.5.20 of NICE guidance sets out when HRT should be considered. It says that clinicians should consider HRT to alleviate depressive symptoms (not meeting the criteria for a diagnosis of depression) with onset around the same time as other symptoms associated with menopause.

31. BNF guidance for transdermal application of Estradiol under the brand name of Evorel states therapy should be initiated with an Evorel 50 patch, which can then be adjusted according to response. The guidance states the dose may be reduced to an Evorel 25 patch after the first month, if necessary, for menopause symptoms only.

32. The available evidence shows Mrs A’s GP referred her for a gynaecology review in midautumn 2016 due to ongoing symptoms of anxiousness, depression and hot flushes. It also shows us a consultant obstetrician and gynaecologist reviewed Mrs A a few weeks later and started her on 1.25mg of Premarin HRT tablets for a trial period of two months.

33. Mrs A’s medical records show that in early winter 2016, the Practice held a consultation with her during which it advised her to stop taking the Premarin tablets. This was due to her having a reaction to the tablet form, which we can see she has had to other tablet medications also.

34. The Practice prescribed her with a different HRT in the form of Evorel 100 patches. Furthermore, the records confirm that following a telephone consultation in early 2017, the Practice reduced Mrs A’s prescription to Evorel 50 patches. We can see her prescription was reduced two weeks later to Evorel 25 patches.

35. Our adviser stated that the GP’s decision to change Mrs A onto Evorel patches was sound as they explained the patches are easier to use and usually have less side effects. They advised that Evorel 100 patches are an acceptable dose to prescribe, as per NICE guidance.

36. However, they explained the equivalent dosage to 1.25mg of Premarin is an Evorel 75 patch. Furthermore, our adviser stated the Practice could have prescribed this as Evorel 50 patches alongside Evorel 25 patches. They therefore confirmed the Evorel 100 patches were a higher dose of HRT than the trial the consultant started Mrs A on.

37. We acknowledge and understand the Practice’s reasoning set out in paragraph 29 for starting Mrs A on the higher dose of Evorel patches. It appears the Practice did not follow BNF guidance in early winter 2016. We think the Practice should have started her on Evorel 50 patches and increased this gradually, if necessary.

38. We consider the above to be an indication of failing. We go on to consider the impact of this.

39. Mrs A says that due to the GP prescribing her with the incorrect dosage of Evorel patches, this has caused her to have painful engorged breasts for the past eight years which has led to her also experiencing back pain. She also says this has affected her mental health as she has developed depression for which she now takes medication.

40. Considering the timeline of the events, we have calculated that Mrs A was using the Evorel 100 patches for approximately 27 days in total before the Practice reduced the dose. She then used the Evorel 50 patches for around two weeks before the Practice reduced her prescription again to lowest dose of patch available, Evorel 25 patches.

41. Our adviser explained that breast swelling, and tenderness is a common side effect of HRT at any dose, which usually subsides once HRT is stopped. Furthermore, they explained that HRT can cause growth of the breast tissue that is irreversible. However, the adviser said in Mrs A’s case, this seems unlikely due her being on the increased dose for a very short period of 27 days.

42. We acknowledge that it is possible that the Evorel Patches could have caused Mrs A’s breast engorgement in early winter 2016. However, we are unable to say on the balance of probabilities that it was the increase to Evorel 100 patches that caused it. It is also entirely possible that Mrs A would still have experienced the same problems on the correct or even lowest dose. This is because breast swelling, and tenderness are commonly reported side effects of HRT across all doses.

43. We understand Mrs A has struggled with painful breast engorgement for the past nine years, which in turn has impacted her mental health. We do not wish to diminish the difficulties she has experienced.

44. With all the above in mind, we have decided that we cannot link the indicated failing to the impact Mrs A has claimed. We have therefore decided not to take this element of her complaint further.

Complaint Handling

45. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the events 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.

46. Mrs A complains the Practice’s complaint handling has been poor, and its responses do not adequately answer her questions. She says they also provide conflicting information.

47. Section 8.21 of the NHS Complaint Standards states that organisations will make sure investigations clearly address all the issues raised.

48. From reviewing Mrs A’s initial letter of complaint, we can see she requested an explanation as to why she was prescribed the highest dosage of Evorel patches rather than the lowest dose. Furthermore, she asked if the Practice agreed that the Evorel 100 patches were the cause of her breast engorgement.

49. As detailed in paragraph 19 above, we can see the Practice initially responded to Mrs A’s complaint the day after she made it. In this initial response, the Practice provided a timeline of her HRT journey from mid-autumn 2016. It also detailed the GP prescribed a likefor-like dose of HRT in Evorel 100 patches form in early winter 2016.

50. When Mrs A complained to the Practice again almost three weeks later, she highlighted she had been informed by the consultant that the Evorel 100 patches are not the equivalent to 1.25mg of Premarin. She therefore asked for the GP’s reasons for stating it was the correct dose. Furthermore, Mrs A highlighted the Practice had not answered her question regarding agreeing the cause of her breast engorgement.

51. The Practice’s initial response does not appear to adhere to NHS Standards as it did not provide her with an explanation for the increase in dosage. We also cannot see that it answered her question regarding the cause of her breast engorgement. We therefore consider this to be an indication of a failing. We will consider the impact of this further in the report.

52. Again, as detailed in paragraph 19 above, we can see the Practice issued a second response to Mrs A. In it, the Practice apologised for not resolving her concerns with its first response. It advised her concerns were discussed with colleagues and other GPs within the Practice to share learning and expertise. Furthermore, it advised it had sought the advice of a consultant gynaecologist as part of its investigation.

53. We can see the Practice then went on to explain the GP’s rationale for increasing the dose of HRT was due to there not being an equivalent Evorel patch to equate to 1.25mg of Premarin. It explained the GP decided to go higher to keep Mrs A’s treatment more in line with the trial the consultant had started her on rather than reducing it. Furthermore, we can see the Practice acknowledged it should have made the rationale for this decision clearer.

54. The Practice then answered Mrs’s A outstanding question regarding the cause of her breast engorgement stating that breast tenderness is a well-recognised side effect of HRT. It stated the consultant gynaecologist it sought advice from agreed that side effects related to breasts usually settle with time, a dose reduction or stopping HRT. It went on to apologise to Mrs A for her ongoing breast issues and apologised for not prescribing a lower dose patch from the start.

55. With the above in mind, we are satisfied the Practice’s final response does provide Mrs A with an explanation for the increase to Evorel 100 patches and does address her question regarding the cause of her breast engorgement.

56. Regarding the impact of the indicated failing, we note Mrs A is seeking a financial remedy.

57. Our Principles state that good practice regarding remedies includes putting things right. Where maladministration or poor service has led to injustice or hardship, public bodies should try to offer a remedy that returns the complainant to the position they would have been in otherwise. If they are unable to do so, the remedy should compensate them appropriately for direct or indirect financial loss, loss of opportunity, inconvenience, distress, or any combination of these

58. Regarding a financial remedy, we do not consider that in this instance, a financial remedy is required. This is because in cases where we expect the person to recover from the injustice quickly once the poor service comes to an end, we would generally consider this to sit at level one of our severity of injustice scale. For cases that sit at level one, we consider that a financial remedy is not appropriate.

59. We recognise that Mrs A has found the Practice’s handling of her complaint stressful and the two differing responses has caused her to lose faith in it. We do not wish to minimise this for her.

60. We consider that the apologies already provided by the Practice in its final response to be a suitable remedy for this element of Mrs A’s complaint. This is because it is our view that it is fair and proportionate in line with the impact of the indications of failings we identified.

61. We thank Mrs A for giving us the opportunity to review her concerns regarding the Practice.

1. We have carefully considered Mrs A complaint about a GP practice in the London Borough of Bromley (the Practice). We are sorry to hear of the painful symptoms Mrs A has detailed and the mental health difficulties she has experienced because of them.

2. In respect of the incorrect hormone replacement therapy (HRT) dosage issue Mrs A has raised, we have seen an indication of a failing. However, we have decided we cannot link the events complained about to the impact claimed. Given the impact Mrs A has experienced, we recognise she will be disappointed by this.

3. Regarding the complaint handling element of Mrs A’s complaint, we have decided the Practice has already done enough to put right the impact this had on Mrs A.

4. We acknowledge that the matters complained about have caused Mrs A to experience stress and to also lose trust in the Practice. Our decision is in no way meant to minimise or diminish the impact for her.