Manchester University NHS Foundation Trust

5. Mr C complains that on 7 January 2022 the Trust prescribed steroids for an eye condition but did not tell him about all the possible side effects. He explains this meant he was not able to make an informed choice about whether to take the steroids.

6. Mr C says the steroid medication caused him to experience a mental health episode that lasted several weeks. He says it was very scary and frightening, he became violent and did not know what he was doing. This caused him distress later when he realised what he had done. Mr C would like the Trust to accept its failings and apologise. He would also like service improvements and a financial payment.

7. Mr C lost vision in his left eye on 15 December 2021 due to a condition called nonarteritic anterior ischaemic optic neuropathy (NAION). This is when there is a loss of blood flow to the optic nerve. This condition causes sudden loss of vision and an injury to the optic nerve, which disrupts the ability to send information to the brain.

8. Mr C went to the Trust’s emergency department (ED) on 7 January 2022 with a severe infection in his right eye. The Trust said he now had NAION in both eyes. He was seen by the ophthalmologist (doctor who treats eye conditions) who prescribed steroids to treat the inflammation.

9. On 16 January, Mr C started experiencing disrupted sleep and bad headaches as side effects of the steroids. On this day he went to the ED because of a ‘massive headache’. The side effects got worse and he became aggressive, experienced psychosis (a condition when you cannot tell what is real or not, which can involve seeing or hearing things that other people cannot see or hear) and was found wandering in the street at different times of the day and night for no reason. He started hallucinating, seeing people and animals and seeing dust on people.

10. Mr C went to the Trust and another hospital many times because of his symptoms. He was admitted to hospital a couple of times and had tests to investigate what was wrong.

11. Mr C was an inpatient at the Trust from 21 to 29 January and was diagnosed with steroid-induced psychosis with hallucinations, insomnia (when you cannot sleep) and behaviour changes. He was removed from the Trust by a security guard on 29 January because of his behaviour.

12. Mr C went to the Trust on 3 February and it noted he had ‘steroid mania’. On 6 February, the Trust noted that the community mental health team were seeing him and advised him to stop taking the steroids. Three days later, Mr C was taken by ambulance and admitted to another Trust where staff noted he had ‘steroid psychosis’.

Prescribing steroids

17. GMC guidance says when giving clinical care, doctors must give effective treatment based on the best available evidence. There is no proven treatment for NAION, but there is a small amount of evidence that steroids can sometimes help by reducing the swelling on the optic nerve. The Trust explained that based on this evidence its consultants sometimes prescribe steroids, like they did for Mr C.

18. Our ophthalmology adviser agreed it is common practice for patients with NAION to be given steroids, as there are no other treatments.

19. There was only a small possibility that the steroids would help Mr C’s eye condition. Because there is no other treatment available, the Trust’s decision was in line with GMC guidance.

20. There is also evidence that steroids can cause psychosis, even though this is rare. Mr C had some mental health issues before. GMC guidance says doctors must check a patient’s previous and existing conditions before giving treatment. Our ophthalmology adviser said there was nothing in Mr C’s medical history that would mean the Trust should not have prescribed steroids.

21. Our decision is the Trust did not do anything wrong when it prescribed Mr C steroids for his NAION condition. In line with the GMC guidelines, the Trust gave treatment based on the best available evidence. We understand from what Mr C told us that his experience was very distressing and because he lost sight in his right eye, he worries that something went wrong. We hope our explanation has given him some reassurance about this.

Communication of side effects

22. Mr C says the Trust did not fully explain the possible side effects of the steroids. He says if he had known it could have caused psychosis, he would not have agreed to take them. He says he was unaware of what was happening to him.

23. GMC guidelines on communication say:

‘The amount of information you give to each patient will vary according to the nature of their condition, the potential risks and side-effects, and the patient’s needs and wishes. You should check that the patient has understood the information and encourage them to ask questions to clarify any concerns or uncertainty. You should consider the benefits of written information, information in other languages and aids for disabled patients to help them understand and consider and retain information in a way suited to their needs.’

24. Mr C’s medical notes from 7 January 2022 say the doctor had a ‘lengthy discussion’ with him. The notes do not include any specific discussion about side effects.

25. The Trust’s complaint response says when the consultant discusses prescribing medication with patients, they normally describe the side effects. For steroids this includes bone and stomach health, blood pressure, sugar levels, diabetes and effects on patient mood. The Trust said Mr C’s medical records do not mention a previous history of mental health issues and psychosis is a rare side effect of steroid use.

26. Our psychology adviser explained the disorder Mr C experienced comes under the WHO classification of ‘Mental and behavioural disorders due to psychoactive substance use’. They said steroids can have a range of psychiatric side effects which are well reported on. But they agreed it is rare for patients to develop steroid-induced psychosis.

27. The Journal of Affective Disorder article on steroid-induced psychiatric syndromes says psychiatric symptoms can happen after taking steroids. It is very rare to have a severe psychotic reaction to steroids and only five percent experience psychotic disturbance, generally early on in the course of steroids.

28. The ophthalmologist’s letter from 21 January after Mr C had been readmitted reported Mr C’s symptoms as ‘presumed steroid induced psychosis with visual hallucinations, insomnia and behavioural changes’. Our ophthalmology adviser said this description of symptoms is in keeping with steroid-induced psychosis.

29. The records we have seen do not include enough information for us to say what was explained to Mr C about side effects. Based on what we have seen and what Mr C and the Trust have told us, the Trust did not mention the possibility of any psychological side effects. This is not in line with the GMC guidelines for good communication. We think the Trust missed the opportunity to fully advise Mr C before he decided to take the steroids. If it had done this, Mr C would have understood the symptoms he started to feel afterwards.

30. We cannot say that had Mr C known about the side effects, he would not have taken the steroids. But the communication did not meet the required standards, so we have looked at how this affected Mr C.

31. Mr C experienced rare side effects that led him to have a psychotic episode and the effects lasted a month. He did not know what was happening and people were concerned for his safety and wellbeing. Mr C experienced distress, anxiety and upset.

32. In response to this complaint, the Trust said Mr C’s hospital visits during January were to monitor his eye condition. Based on the evidence we have seen, this does not seem to be the case. The ophthalmology letter from 21 January confirms that Mr C had steroid-induced psychosis.

33. The Trust has not accepted that something went wrong with its communication and it has not taken steps to put things right in line with our ‘Principles for Remedy’. We partly uphold this complaint and make recommendations.

1. Mr C is concerned the Trust did not give him full information about the steroids it prescribed to him for his eye condition on 7 January 2022. He thinks the Trust should have discussed with him information about possible side effects, especially since he ended up losing sight in both eyes.

2. We found the Trust did nothing wrong when prescribing steroids but it did not tell him about the possible side effects. This is not in line with relevant guidelines and is a failing.

3. The Trust apologised for Mr C’s ‘unsatisfactory experience’ but it did not accept what it got wrong or the impact this had. We recommend it writes to Mr C to acknowledge the failing and apologise for how it affected him. It should make a payment to Mr C of £700. We also recommend the Trust writes an action plan to show how it will learn and improve.

4. We partly uphold this complaint. We hope Mr C is reassured that his complaint has been taken seriously.

34. In considering our recommendations, we have referred to our ‘Principles for Remedy’. These say that where something has gone wrong that has had an impact, the organisation responsible should take steps to put things right.

35. We recommend that within four weeks of the date of this report, the Trust should write to Mr C to acknowledge that something went wrong with its communication about potential side effects. It should apologise for the significant distress, anxiety and upset this failing caused him.

36. We also recommend that within three months of the date of this report, the Trust should complete an action plan to address the failing in communication. The action plan should include what it will do, who is responsible for the action, the timescale for completing it and how it will be monitored to make sure of improvement. It should send a copy of the completed action plan to us, the Care Quality Commission and NHS Improvement.

37. Our Principles say that organisations should put things right and if possible, return the person affected to the position they would have been in if the mistakes had not happened. If that is not possible, they should compensate them appropriately.

38. To decide on a level of financial payment, we look at similar cases where the person has experienced a similar impact, along with our severity of injustice scale. After doing this, we recommend that within three months of the date of this report the Trust should pay Mr C £700. This is to recognise the distress and worry he experienced when he experienced steroid-induced psychosis.