15. 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. Advice to stop HRT medication without any other treatment to manage menopause symptoms
16. As explained above, the Trust advised Miss O to stop her current HRT before her hysteroscopy. Miss O says after one week of stopping her HRT, her menopause symptoms returned; her mood crashed, regular hot flushes returned, which resulted in huge loss of sleep, mental function, co-ordination, concentration issues and extreme tiredness.
17. BMS guidance suggests stopping HRT while awaiting further assessment for unscheduled bleeding on HRT, as bleeding may resolve itself. Moreover, Miss O’s post-menopausal bleeding required urgent investigation to exclude endometrial cancer. Our adviser explains it is common practice to advise patients to stop HRT in this context, as many endometrial cancers are estrogen sensitive, which means they rely on estrogen to grow.
18. Our adviser also says it was reasonable to allow Miss O time to assess the menopausal symptoms she experienced without HRT to determine whether further HRT was necessary. The Trust therefore acted appropriately and in line with guidance in advising Miss O to stop her HRT medication without any other treatment while awaiting her hysteroscopy. We have found no indication anything went wrong in this part of Miss O’s complaint.
After the hysteroscopy on 15 February 2024, the Trust prescribed medication without discussing this with Miss O, and which did not relieve her symptoms
19. On 15 February, after her Hysteroscopy, Miss O’s discharge form notes for her to ‘start back on HRT in the form of a continuous combined preparation such as Evorel patch 50 and utrogestan 100mg nocte’. There is no evidence the Trust discussed the change in medication with Miss O before her discharge. The Trust acknowledged this in its complaint response.
20. GMC guidance says when prescribing medication, doctors should provide relevant information to the patient, check they have understood that information and encourage them to ask questions to clarify any concerns or uncertainty. The guidance recognises it is sometimes difficult, because of time pressures, to give patients as much information as they or the doctor would like. It says, to help with this, they you should consider the role other members of the healthcare team could play, including pharmacists, and refer patients to patient information leaflets and other reliable sources of information.
21. The Trust did not provide information to Miss O about the prescribed medication. It did not check she understood that information and give her an opportunity to ask questions. It did not consider the role other members of its healthcare team could play or refer her to other reliable sources of information. Therefore, the Trust did not act in line with GMC guidance when prescribing this medication.
22. However, our adviser says, after the findings of the hysteroscopy, the prescription of Evorel 50 and utrogestan 100mg was a reasonable prescription of HRT. Changing to a continuous preparation would reduce the risk of bleeding, and the combination of transdermal estrogen (Evorel) and micronized progesterone (Ultragestan) reduces the risk of venous thrombosis and breast cancer.
23. Given this was an appropriate prescription, and Miss O did not know this would not relieve her symptoms until she began it, we do not consider she would have declined to take it upon a discussion with the Trust. We do not consider the Trust’s failure to discuss this prescription with Miss O has a significant impact on her, but we appreciate she may have been somewhat confused and disappointed that this new prescription was not explained to her.
24. We discussed this with the Trust, and it agreed to implement service improvements to prevent this from happening again, and to write to Miss O to acknowledge that it did not discuss this prescription with her. We therefore consider we have been able to reach a resolution on this part of Miss O’s complaint.
On 13 March 2024, the Trust increased her medication which worsened her symptoms
25. On 13 March, Miss O had another Gynaecology appointment. The Trust increased her Evorel 50 to Everol 75, and Utrogestan 100mg to 200mg, and arranged a follow up phone appointment for 19 June.
26. In April Miss O emailed the Trust to say she needed to see a gynaecologist sooner as she was having issues with the prescribed HRT. The Trust saw her on 22 May and documented her sleeping had improved and hot flushes stopped, but she felt exhausted, had some breast tenderness, very low libido and musculoskeletal pain.
27. Our adviser explains, although there is no explicit guidance on this, in general practice HRT is increased incrementally to find the correct dose to manage symptoms while providing the lowest effective dose possible, to avoid over prescribing estrogen. Therefore, an increase from Evorel 50 to Evorel 75 was reasonable as Evorel 50 was insufficient to manage Miss O’s menopausal symptoms and Evorel 75 is the next step up.
28. BMS guidance recommends taking a progestogen dose in proportion to an estrogen dose to reduce unscheduled bleeding and endometrial cancer risk. Evorel 75 would be considered a moderate dose of estrogen which, based on the BMS guidance, should be provided with 100mg of progestogen (Utrogestan). However, our adviser explains if there is erratic bleeding on HRT, often routine management would be to increase the dose of progesterone. While this is not explicit in the guidance, our adviser says this is common consensus in general practice and a good way of managing the symptoms.
29. It was therefore reasonable to increase Miss O’s Evorel and Utrogestan. We have found no indications anything went wrong in this part of Miss O’s complaint.
On 22 May, the Trust incorrectly wrote her prescription
30. During her appointment on 22 May, the Trust advised Miss O to continue Utrogestan 200mg and Evorel 75 twice-weekly patches, but if the breast tenderness continued, she could alternate her Evorel 75 patches with Evorel 50. The Trust also prescribed Tostran 2% testosterone gel on the same prescription. The Trust did not write Evorel 50 patches on the prescription and noted Utrogestan 100mg instead of 200mg.
31. Miss O’s pharmacy gave her Evorel 75 and Utrogestan 100mg. They advised only these items were covered by her HRT Prescription Prepayment Certificate (HRT PPC), and as the Tostran Gel was not, she needed a separate prescription for this. Her GP Practice advised her to go back to the Trust to get a separate prescription for the Tostran, and her HRT. She later spoke to a GP who wrote two separate prescriptions for her, one for Tostran gel, and one for her HRT, with the correct amount of Utrogestan (200mg).
32. Miss O says the prescription was not clear enough and the Trust should have given her two separate prescriptions. The Trust did write a letter to the GP following this appointment which correctly explained her medication, but this did not arrive for weeks afterwards. Miss O needed another prescription in August which she had difficulty getting. She had an appointment with the Trust in October 2024 and it corrected her prescription then.
33. NHS HRT guidance says listed HRT items should be prescribed on separate prescriptions from other items. Where a patient holds a valid HRT PPC and they present a mixed prescription, it should be returned to the prescriber so separate prescriptions can be issued.
34. Tostran gel is not a listed item covered by a HRT PPC. Therefore, as a menopause specialist prescribing different medications, the consultant should have known a different prescription was needed for this item.
35. Our adviser says the Trust did not need to prescribe Evorel 50, as this was only to be used if there were side effects with the increased dose of Evorel 75. Essentially the consultant was outlining a ‘Plan B’ for after Miss O had trialled Evorel 75, if this was problematic, rather than giving her the option before trailing Evorel 75. Therefore, it did not need to prescribe both doses of Evorel at this point.
36. The prescription should have stated Utrogestan 200mg daily, as this is what Miss O required at that time. We therefore find the consultant did write this prescription incorrectly and should have written Utrogestan 200mg daily, and provided a separate prescription for the Tostran gel.
37. We discussed this with the Trust, and it agreed to implement service improvements to prevent this from happening again, and to write to Miss O to acknowledge what went wrong with her prescription. We therefore consider we have been able to reach a resolution on this part of Miss O’s complaint
Damage to tongue and teeth
38. The records show at the nurse led preoperative assessment on the 6 February 2024, anaesthetic leaflets were explained and given to Miss O. The Trust provided a leaflet with an infographic by Royal College of Anaesthetists (RCoA) on the common events and risks in anaesthesia. This explains the common side effects, including minor lip and tongue injury, and rare side effects including damage to teeth requiring treatment. The leaflet also contained a barcode leading to the RCoA website listing the full details of the risks of anaesthetic, including damage to teeth and the tongue.
39. During the preoperative anaesthetic assessment on the day of the procedure, the anaesthetist discussed with Miss O, and documented, the risks of dental damage.
40. Miss O says, when she arrived back at the ward after her hysteroscopy, her tongue felt numb when drinking tea. Miss O believes the breathing tube was resting on her tongue, either due to being incorrectly placed, or the anaesthetist was leaning against it, and this caused nerve damage to her tongue. She says her tongue was numb for several months after this.
41. On the 24 February, nine days after the surgery, Miss O was eating, and a large piece of her tooth came away. She believes her tooth was damaged either when the anaesthetist was inserting or removing the breathing tube.
42. On 27 February her GP referred her to Oral and Maxillofacial at the Trust to assess whether the damage to her tooth and tongue was caused by the anaesthesia.
43. On 29 February, Miss O says she saw a dentist who advised the tooth was in good health, but she needed treatment as it would rot and become infected. She says they advised her to go back to the hospital.
44. On 1 March she went to the Emergency Department. A Clinical Fellow took a history and observations and diagnosed possible hypoglossal nerve compression and contacted anaesthetists. Two consultants in anaesthetics and pain management saw her and advised it was likely a coincidence that her tooth came apart days after the procedure, as most dental damage due to anaesthetic intervention occurs at the time of airway manipulation and is apparent immediately afterwards.
45. On 20 March she attended Oral and Maxillofacial. They advised the numbness could be due to the anaesthetic tube pressing on her tongue, causing it to dry out and disrupt sensation, or it could be coincidental. They advised that the numbness would likely eventually recover but they could not provide treatment. They advised the tooth was restorable with a filling or a crown, and decay at the bottom of the cavity is likely to have spread to the tooth, putting it at risk of fracture. They advised her to see her dentist for restoration work as they did not provide this.
46. GPAS guidance says all patients undergoing elective procedures should be provided with information on their intended treatment pathway, including information on anaesthesia, prior to admission. It says risks associated with anaesthesia should be discussed and risk infographics such as the RCoA’s ‘Common events and risks in anaesthesia’ should be available.
47. RCoA ‘You and your anaesthetic’ guidance explains there are some common side effects from anaesthesia, or the equipment used, which are usually not serious or long lasting, and risks will vary between individuals and the procedure and anaesthetic technique used. It says an anaesthetist will discuss with a patient the risks they believe are more significant for them and will only discuss the less common risks if they are relevant to the patient.
48. RCoA guidance on the ‘Risks associated with general anaesthesia’ provides information on common, uncommon and rare risks, which includes lip, teeth and tongue injury. It explains, during general anaesthetic, the muscles in the body relax, including those around your throat and chest, which can reduce air intake. Therefore, the anaesthetist may place a breathing tube into the throat to keep the airway open and ensure a continuous flow of oxygen to the lungs.
49. The guidance explains the tubes or masks used can accidentally damage the teeth, lips and tongue. The mouth and lips can sometimes have small cuts or bruising, and teeth can be chipped, made looser or sometimes come out by accident.
50. RCoA guidance explains there is a rare risk of peripheral nerve damage which tends to happen in parts of the body, such as a hand or a leg, but does not mention nerve damage to the tongue. Our adviser suggests this may be because injury to the nerves that supply sensation and movement to the tongue is a rare occurrence.
51. There are only a handful of reported cases in the literature of this happening. The 2023 case report shows there were only six reported cases in 12 years from 2011 to 2023. Therefore, while very rare, this can happen as an uncommon side effect of anesthetic and is not indicative of anesthetic being provided incorrectly.
52. Our adviser says, when damage occurs to teeth, although premolars can occasionally be damaged, this is more like to happen to the front teeth. They also explain damage is more likely to occur with intubation rather from a breathing tube. Intubation is where a metal device is placed into the mouth temporarily to help pass a breathing tube into the airway. It is the metal device which is more likely to cause the damage.
53. The Trust provided information to Miss O about anaesthesia and its risks during the preoperative assessment before admission and provided RCoA’s ‘Common events and risks in anaesthesia’ infographic in line with GPAS guidance. The leaflet it provided also contained a barcode link to RcoA webpages ‘You and your anaesthetic’ and ‘Risks associated with general anaesthesia’. The Trust also discussed risks during the preoperative assessment on the day.
54. The records show the Trust discussed the risks of dental damage and a sore throat. RCoA guidance says an anaesthetist will discuss the risks they believe are more significant for them and will only discuss the less common risks if they are relevant to the patient. The Trust acted in line with guidance by explaining the common risks of anaesthetic. The Trust did not need to mention the risk of nerve damage to the tongue given the high unlikelihood of this occurring.
55. While this is rare, it is possible, and there is no evidence the Trust did anything wrong during the insertion of the breathing tube or the maintenance of anaesthesia. The numbness of Miss O’s tongue therefore appears to be a rare side effect of having a breathing tube placed during a general anaesthetic.
56. While dental damage is a risk of anaesthesia, our adviser explains it is unlikely this was related to Miss O’s anaesthesia. The guidance says an anaesthetist will let a patient know if their teeth have been damaged during an operation and will return teeth to them if they have come out. This shows damage to teeth is known at the time of the procedure, as this happens during intubation. Given Miss O’s tooth broke off 10 days after the insertion of the breathing tube, it is unlikely this was related to her anaesthetic, especially as it occurred whilst she was eating.
57. Moreover, it is usually front teeth which are damaged, and occasionally premolars, number 4 and 5, but Miss O’s tooth was a number 6. The Oral and Maxillofacial review also shows there were caries to the broken tooth. It is therefore likely the loss of Miss O’s tooth was unrelated to her anaesthesia. This is supported by the fact there is no evidence the Trust did anything wrong during the insertion of the breathing tube or the maintenance of anaesthesia. For these reasons, we have found no indication anything went wrong in this part of Miss O’s complaint.
58. As we have found no indications anything went wrong in most parts of Miss O’s complaint, and we have been able to reach a resolution on others, we will take no further action on this complaint. We hope our findings provide reassurance to Miss O on the care she received, and the further action from the Trust provides closure for her complaints about her prescription.