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Royal Devon University Healthcare NHS Foundation Trust

P-001972 · Statement · Decision date: 4 April 2023 · View Royal Devon University Healthcare Foundation Trust scorecard
Drugs / medication Poor prescription security
Complaint (AI summary)
Ms D complained about the 2014 prescription of Isotretinoin for acne rosacea, alleging it caused severe side effects affecting her arms and legs, preventing her from working.
Outcome (AI summary)
The ombudsman closed the complaint as it was outside the time limit, and Ms D's reasons for delayed submission were insufficient to waive it.

Full decision details

The Complaint

3. Ms D complains about the prescription of Isotretinoin the Trust gave for her acne rosacea (a long-term skin condition affecting the face) in July 2014.

4. Ms D said she was fit and healthy before taking the medication, but her health got much worse. She says the medication affected her arms and legs and she worried it would eventually paralyse her. Because of this she says she was not strong enough to work.

5. Ms D wants a full investigation into the side effects of Isotretinoin and financial compensation for her loss of earnings and medical costs.

Background

6. Ms D’s dermatologist prescribed 40mgs of Isotretinoin to take daily.

In September 2014, the dermatologist reviewed Ms D and advised her to continue with the prescription.

7. Ms D says shortly after getting the first prescription she described her pain to the dermatology department, who explained her symptoms are not uncommon side effects of the medication.

Findings

9. The law (section 9 of the Health Service Commissioners Act 1993) says a person needs to make their complaint to us within a year of becoming aware of the problem. We cannot investigate complaints brought to us after one year, unless we consider there is a good reason to.

10. Ms D was aware of the problem in July 2014 because we can see she challenged the decision to put her on the medication. Ms D told us the dermatologist advised her not to do anything physical because, with the medication, her muscles would hurt. She says she immediately told the dermatologist she should not be on this medication because her job is physical and she needs to be on her feet all day.

11. Based on this, Ms D had until July 2015 to bring her complaint to us. She complained to us on 16 February 2022, eight years and seven months later. This means her complaint is seven years and seven months outside of our time limit.

12. We have discussed this with Ms D to understand why she did not complain sooner.

13. Ms D says she was in a lot of pain after taking Isotretinoin and this made her forgetful and unable to put sentences together. She explains she was in so much pain and was told to give the side effects time to wear off, until she was given steroids. She felt this was the best thing to do at the time.

14. Ms D says the growing threat of COVID-19 also stopped her from bringing the complaint to us sooner.

15. She also explained she is not taking this medication anymore and she put herself on a strict diet to help clear it out of her body, which is the only thing that is working. She explains this is why she is able to speak clearly now.

16. We accept how distressing and difficult things were during COVID-19. Ms D could have raised her complaint before the pandemic started (between 2014 and 2020). We appreciate COVID-19 may have had an impact between March 2020 and when she first complained to the Trust in January 2021, but the main period of delay is in the six years before the pandemic started.

17. We do not underestimate how much pain Ms D was in and how this affected her. We understand she was following her doctor’s advice in waiting for the side effects to wear off. But this does not account for it taking Ms D over seven years to come to us. Ms D told us she realised something was wrong when she was in constant pain and the medication made her forgetful. We think she should have complained when she made this link.

18. We can see Ms D was able to get support from Citizen Advice in January 2021 when she first complained to the Trust. This service or any other advocacy service could have helped her to bring her complaint to us earlier. We do not think it is unreasonable to expect people to get this kind of help when coming to us. This type of support can help people to put sentences and a complaint together. We can also make reasonable adjustments to support people who use our service and come to us within the expected time.

19. We recognise there were factors that might have made it more difficult for Ms D to complain. But we do not think these were significant enough to explain the long delay.

20. We realise this is not the outcome Ms D was hoping for. We recognise the pain and distress Ms D experienced and would like to thank her for taking the time to tell us about her complaint.

Our Decision

1. The Parliamentary and Health Service Ombudsman has carefully considered Ms D’s complaint about Royal Devon University Healthcare NHS Foundation Trust (the Trust). We are sorry to hear about the side effects Ms D says she experienced after taking Isotretinoin (a treatment for acne).

2. The complaint falls outside of our time limit. We have considered Ms D’s reasons for not bringing her complaint to us sooner and these are not enough for us to put our time limit aside.

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