18. When we look at a complaint, we first refer to the relevant standards, law, policy and guidance to establish what should happen. We then look at all the available evidence to reach a view on what did happen. If we consider this falls short of the expected standards, it is considered a failing. We refer to this as ‘maladministration’. Next, we consider whether we can link an injustice and impact to the failing. Finally, we look at what the organisation has done to recognise a failing and to put things right, and whether this is enough. We call this the ‘remedy.’
On 20 January 2021, the Trust failed to prescribe isotretinoin (Roaccutane) to treat Mr O’s buttock folliculitis
19. First, the relevant guidance we used to tell us what should happen is BAD’s ‘Advice on the safe introduction and continued use of isotretinoin in acne in the UK’. This guidance says isotretinoin is an ‘off-licence’ treatment.
20. The manufacturer of a medication has to provide evidence it works well and is safe to use for a specific condition and for a specific group of patients, in order to obtain a licence for the medication’s use. An ‘off-licence’ medicine is a term used in medicine regulation for a drug being used for a condition it does not have a medical licence for, in this case folliculitis. In the United Kingdom, the only licensed treatment for isotretinoin is severe acne.
21. Second, we looked at BAD’s ‘Guidance for managing patients on isotretinoin during the coronavirus pandemic’, which said dermatologists should only start or continue isotretinoin treatment in patients where the benefits outweighed the risks to the patient. The guidance further explained doctors should consider this carefully in light of the need to reduce face-to-face consultations at the time of the COVID-19 pandemic, and due to the uncertainty of reliable follow-up/monitoring during this period.
22. After seeking clinical advice from our adviser, we understand buttock folliculitis is a skin disorder where the pilosebaceous unit (structure in the skin containing the hair follicle, hair shaft and sebaceous gland - a tiny oil-producing gland in the skin) does not work properly. This condition usually means the pilosebaceous unit becomes inflamed, sore and produces too much oily matter. This causes red, sore spots which are often filled with pus.
23. Mr O has explained to us he originally went to his GP on 5 January 2021 due to the discomfort and pain caused by a rash on his buttocks. The GP referred Mr O to the Trust dermatology department. The GP noted Mr O had previously been prescribed isotretinoin, which improved his condition. The GP included pictures of Mr O’s condition, diagnosing it as buttock folliculitis.
24. Mr O has also explained the Trust informed his GP it could not complete the referral on 20 January 2021, and said at the time it only prescribed isotretinoin for severe cases of skin conditions. The Trust suggested alternative treatments for the GP to consider.
25. Because of this, Mr O sought private treatment on 15 February 2021, and the clinician prescribed isotretinoin. As a result, Mr O believes the Trust should have told the GP to prescribe isotretinoin for his condition through the NHS.
26. In the Trust’s final response, dated 29 September 2021, it explained the Trust’s consultant lead for dermatology services had helped in responding to the complaint.
27. The Trust explained it gave Mr O’s GP an alternative plan of care from the Trust’s dermatologist - a three-month course of lymecycline (an antibiotic medicine used to treat bacterial infections and acne) to be taken orally (by mouth) in combination with a topical therapy (a cream application).
28. The Trust also explained the dermatology department was closed for all routine dermatology work (i.e., closed for all dermatology work apart from the most serious conditions such as skin cancer) during January and February 2021. The Trust said, based on guidance provided from BAD, it would not prescribe isotretinoin for new patients or for patients where the risks outweighed the benefits of the treatment. The Trust explained isotretinoin should be prescribed in face-to-face consultations, rather than remotely. This was because doctors needed to do regular blood tests, assessments for depression and face-to-face skin checks in patients using isotretinoin.
29. We discussed the prescribing of isotretinoin for Mr O with our adviser. They first explained doctors do not directly prescribe isotretinoin for buttock folliculitis. They explained BAD’s ‘Advice on the safe introduction and continued use of isotretinoin in acne in the UK’ says this medication should only be used for severe acne.
30. Our adviser explained dermatology specialists regularly use ‘off-licence’ treatments, but prescribing off-licence requires the clinician to apply careful judgement, working with the patient, to make sure they assess the risk-benefit ratio. They said this should be done during a face-to-face consultation.
31. Based on this, and on clinical standards and guidance, we asked our adviser whether clinicians should have prescribed isotretinoin from the referral information and the photographs. They said they agreed with the person who assessed the referral. They could not have classed the disease severity as severe based on the clinical features in the photographs.
32. Our adviser also explained, as shown in BAD’s ‘Guidance for managing patients on isotretinoin during the coronavirus pandemic’, in January 2021 clinicians were carefully assessing clinical priorities to manage the demands on services and to protect patient safety, balancing the risks and potential benefits. Based on the clinical advice, in Mr O’s case we consider the balance of risks outweighed the potential benefit of arranging a face-to-face consultation and starting isotretinoin.
33. So, we cannot see the Trust acted outside both sets of BAD guidelines. This is because the clinician who assessed the referral from Mr O’s GP correctly recognised Mr O’s condition was not so severe as to justify the use of isotretinoin, which would require face-to-face monitoring for his own safety. In our view, the decision not to prescribe isotretinoin was correct and in line with guidance at the time, as the risks of prescribing isotretinoin outweighed the benefit to Mr O during a time when doctors could not fully monitor him for his own safety.
34. As a result, we cannot see a failing in the Trust not referring Mr O and prescribing isotretinoin on 20 January 2021.
The Trust mishandled Mr O’s complaint by not responding within the correct timeframes
35. The relevant guidance to tell us what should happen is the NHS Complaints Guidance, which states trusts should confirm receipt of complaints within three working days, and they should aim to address these in 40 days. However, in our work, we note this is not a firm commitment regarding complaint handling times - it is more a statement of intent. As a complaint progresses, depending on its individual complexity, handling times may vary.
36. Although trusts may set out their intentions for complaint handling time scales, these may change depending on the nature of the complaint, and whether an organisation needs to seek and bring into the complaint response comments or other evidence to form its response.
37. We also refer to the Local Authority Social Services and NHS Complaints (England) Regulations of 2009, which inform the NHS Complaints Guidance and say if an organisation has not provided a complete response to a complaint within six months, it should formally write to the complainant, outlining what is happening and how it intends to address the complaint after it has breached the six-month time scale.
38. In the work we do, when we see a complaint has gone beyond the six-month window, we consider this an excessive complaint handling timeframe. The regulations would then demand that the organisation communicates what is happening to the complainant, and what it is proposing to do.
39. Mr O has explained to us he felt his complaint was delayed. We asked him to explain how exactly he felt the Trust had mishandled his complaint. He told us the main issue was the timeframes for getting responses to his complaint at each stage of the process.
40. The NHS Complaints Guidance does not specify what should or should not happen regarding the amount of time for each stage of complaint handling. This is solely dependent on the type of complaint and differs on a case-by-case basis. Mr O says the Trust did not respond within its specified timeframes, and this represented poor complaints management.
41. We can see Mr O first raised his complaint with the Trust in an email on 16 August 2021. This was because he received a copy of the referral rejection from his GP (his GP had previously told him they could not prescribe isotretinoin).
42. The Trust responded on 2 September 2021, noting it had forwarded Mr O’s email of complaint to the CEO’s office, as Mr O had requested. The Trust also apologised it had not received Mr O’s original email dated 16 August 2021, but could see Mr O was chasing a response from this date.
43. In this case, although we can see the Trust did not respond within three working days, as we have outlined above, the NHS Complaints Guidance does not specify set timeframes regarding complaint handling, and although it says trusts should confirm receipt of a complaint within three days, on this occasion this did not happen.
44. We can see around 17 days lapsed from the first complaint on 16 August to Mr O receiving an update on its progress. The Trust apologised for this. We consider this aspect a low-level injustice on our Severity of Injustice Scale, a measure which helps us to reach a view consistently and transparently on the failings we identify and the injustices they cause.
45. Based on our scale, we consider this to be a ‘low level one’ injustice on a six-point scale, where the person affected has experienced a lower level of injustice arising from a one-off event, where the effects on a complainant are of a short duration (just over two weeks in this instance), and where there are no other impacts or harmful effects.
46. Based on this low level of injustice measure, we would normally expect an apology to be an appropriate remedy. As we have seen the Trust apologised, we consider this is suitable and do not view this aspect to be unresolved. So, we will take no further action on this delay aspect of the complaint.
47. On 3 September 2021, the Trust followed up on Mr O’s enquiries in an email, saying they would respond to Mr O within 25 working days. The Trust later clarified for Mr O, when he chased a response on 21 September 2021, that 25 working days from 3 September 2021 would be a response by 8 October 2021.
48. The Trust provided a full response to Mr O’s complaint on 29 September 2021, outlining its reasons why it was not appropriate for the Trust to prescribe isotretinoin. This was within the 25 working day target it had outlined to Mr O on 3 September 2021.
49. Mr O responded to this letter by email on 7 October 2021. This led the Trust to reopen the complaint. The Trust provided a final response and a signposting to us by email on 3 November 2021.
50. We take 16 August 2021 to be the date Mr O first complained to the Trust, with 3 November 2021 being the end of the local resolution process. This represents a period of 2 months and 18 days of complaint handling, in which the Trust concluded their enquiries. We note Mr O chose to return to the Trust during this period with further queries, which the Trust also answered.
51. We know from the NHS Complaints Guidance an organisation should respond to complaints at the earliest opportunity and consistently meet expected time scales for confirming receipt of a complaint. They should also give clear timeframes for how long it will take to look at the issues, taking into account the complexity of the matter.
52. In this case, we do not consider the Trust sending a first full response to Mr O in just over one month as an irregular or excessive timeframe (16 August 2021 to 29 September 2021). This is because we can see the Trust, after confirming receipt of his complaint on 2 September 2021, explained to Mr O it had been passed to the CEO’s office. We can also see the response dated 29 September 2021 was thorough and considered to be the initial conclusion to the local resolution process.
53. We can also see the Trust responded within the 25 working day target it had outlined on 3 September 2021, providing a first full response on 29 September 2021. The Trust had outlined the deadline for a response as 8 October 2021. We would expect to see this as part of the NHS Complaint Standards - a set timeframe being given and observed.
54. When we consider Mr O’s further approaches to the Trust and the gaps in response time, we cannot see these were excessive, and we can see the Trust acted quickly and thoroughly in responding to Mr O’s queries.
55. We can see the Trust acted within the NHS Complaints Guidance framework of responding at the earliest opportunity. In its response to Mr O, the Trust gave a clear deadline for a full response within 25 working days, updating him at various junctures, and which the Trust observed.
56. Although we recognise Mr O’s frustrations in communicating with the Trust regarding its complaint handling, apart from the initial delay in recognising his complaint, we have not seen a failing with the delay handling times and actions. We consider the Trust’s apology for the initial delay as fair and appropriate. As we do not see any sign of failing regarding the remaining part of the complaint handling, we will take no further action in this matter.