15. Before we decide if we should do 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 seen any signs that something has gone wrong.
Dermovate prescription
16. Miss U says the Trust continued to prescribe Dermovate, even after she raised concerns about side effects.
17. GMC guidance says doctors must:
‘provide a good standard of practice and care. If [doctors] assess, diagnose or treat patients, [the doctor] must: • adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary • refer a patient to another practitioner when this serves the patient’s needs’.
18. The BAD guidelines for the management of LS say:
‘R7 – offer all female patients with anogenital LS clobetasol propionate (CP) 0·05% ointment on a regimen for 3 months (once a day for a month, alternative days for a month, twice weekly for a month), combined with a soap substitute and a barrier preparation.
R8 - Discuss the amount of topical treatment to be used, the site of application and the safe use of an ultrapotent topical steroid with the patient.
R9 - Offer continued use of CP 0·05% for ongoing active LS disease.
R10 - Consider an individualized treatment regimen of topical steroid to maintain disease control and prevent scarring in female patients with ongoing active LS disease despite good compliance. Treatment should be titrated to maintain symptoms and resolution of skin thickening and ecchymosis, although pallor may not completely resolve.’
19. Dermovate is a brand name for clobetasol propionate. We can see from Miss U’s records that the Trust prescribed Dermovate, combined with a soap substitute and a barrier preparation. This is in line with the BAD guidelines.
20. Miss U’s GP first prescribed Dermovate in 2017 about one month before her new referral to the vulval clinic. She stopped using Dermovate before going to the clinic as she had concerns about its side effects.
21. We have seen in the medical records that throughout Miss U’s attendances the Trust recommended appropriate, targeted use of Dermovate followed by maintenance routine of treatment. It has been documented that less than 30g Dermovate has been used per year, which our adviser says is very little clinically. This is in line with BAD guidelines.
22. Miss U had a diagnosis of ongoing active LS disease. We have considered her concerns about side effects and discussed this with our adviser. We consider the Trust acted in line with guidelines in continuing to prescribe Dermovate. This is because guidelines state that continued use of clobetasol propionate is needed for ongoing active LS.
23. Miss U’s records also show Trust staff acted in response to her concerns about changes to her skin. On 17 October 2017, after she raised concerns, the Trust dermatologist did a small biopsy of her LS (a procedure that involves taking a small sample of body tissue to examine under a microscope). This was in line with GMC guidance to ‘promptly arrange suitable investigations’.
24. The Trust dermatologist also acted in response to concerns Miss U raised during a phone call on 24 May 2022. They explained to Miss U that because of the small area and small amount of steroid used, they did not feel steroids could be responsible for her health condition.
25. During the same call, Miss U asked for antibiotic treatment for her LS. The records show the dermatologist spoke with other specialists about Miss U’s request for antibiotics. They also discussed her concerns with her GP. This is in line with GMC guidance, ‘taking account of…their views and values’.
26. The dermatologist also raised their own concerns with Miss U’s GP, that Miss U was tearful and upset. They offered to refer to clinical psychology if Miss U wanted them to. This is in line with GMC guidance, ‘refer a patient to another practitioner when this serves the patient’s needs.’
27. The Trust also referred Miss U to gynaecology (women’s diseases specialists) for ongoing monitoring. This was to make sure there were no changes to suggest cancer. This is also in line with GMC guidance.
28. In summary, the evidence shows the Trust acted in line with BAD and GMC guidelines. Based on this, we have seen no signs of a failing and have decided to take no further action.
Development of more health conditions
29. Miss U complains that Dermovate has caused her to develop many health complaints and the Trust has denied this.
30. GMC guidance says, ‘You must keep your professional knowledge and skills up to date’. It also says, in section 31: ‘You must listen to patients, take account of their views, and respond honestly to their questions’.
31. In the Trust’s complaint response, it said its clinical director for dermatology recently went to an international conference where ‘one of the world experts in this area gave a lecture.’ This lecture confirmed Dermovate is still the safest treatment for LS.
32. Miss U’s medical records show that when she raised concerns about Dermovate causing cataracts, the dermatologist contacted her optician. The dermatologist confirmed Miss U’s cataracts were not linked with steroid use. Miss U’s records show the dermatologist then explained to her that Dermovate used on her vulva would not cause cataracts.
33. The records also show that when Miss U raised other concerns the dermatologist contacted Miss U’s GP to ask for more information. They then reassured Miss U that Dermovate could not be the cause of these health conditions, especially as she had only used a small amount of Dermovate.
34. These actions show the dermatologist acted in line with GMC guidance as they listened to Miss U’s concerns.
35. We took clinical advice on the chances of Dermovate causing each of the conditions Miss U listed. We decided Dermovate was highly unlikely to be the cause of Miss U’s health conditions.
36. In summary, we have not seen any signs of failings in the Trust’s actions.
37. In reaching our decision, we must consider relevant guidance and if there are signs it was followed. In this instance we have seen the Trust acted in line with guidance.
38. As we have seen nothing to show the Trust got anything wrong, we will not be taking any further action on this complaint. We hope our work will bring some answers to Miss U’s concerns.