12. 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 anything has gone wrong.
Prescribing lercanidipine
13. Miss U had a longstanding history of high blood pressure that was managed by medication prescribed by the Practice. Miss U was monitoring her own blood pressure results at home and reporting them to the Practice.
14. On 24 February 2022, the Practice noted that Miss U’s blood pressure readings were ‘raised’. On 28 February, a pharmacist at the Practice decided to change Miss U’s prescription to lercanidipine to manage her blood pressure, with a plan to review her in four weeks. Miss U was told about the change to her prescription on 3 March.
15. GMC guidance says doctors must have good knowledge of a patient’s health and be satisfied that drugs or treatments serve their needs. As Miss U had submitted her blood pressure readings, they were reviewed by a GP.
16. Our adviser told us that Miss U’s blood pressure levels were outside of the normal levels according to NICE guidance. So the decision to escalate her treatment by prescribing lercanidipine was appropriate and in line with guidance.
17. Miss U believes the Practice did not take into consideration the intolerances she had to similar medication before. Miss U’s medical notes from 28 February 2022 mention her intolerance of amlodipine and felodipine (similar blood pressure medications).
18. GMC guidance says doctors must ‘provide effective treatments based on the best available evidence and take all possible steps to alleviate pain and distress whether or not a cure may be possible’.
19. The evidence of previous intolerances are noted in the Practice’s complaint response and the reactions are documented as swollen ankles. In Miss U’s medical notes, the pharmacist documented that they were aware of her previous reactions but had made a clinical decision that lercanidipine offered the ‘best side effect profile’ to manage her raised blood pressure instead of other medications that Miss U had reacted to before.
20. Based on this, we can see no evidence of a failing in the Practice prescribing lercanidipine. The records show the Practice did consider Miss U’s intolerances and decided the risk of these did not outweigh the potential benefits of controlling her blood pressure.
Failure to diagnose allergic reaction
21. Miss U says the Practice failed to diagnose her symptoms as an allergic reaction and to refer her to the dermatologist. When prescribing lercanidipine, the Practice planned to review her in four weeks.
22. On 27 April 2022, four weeks after starting taking lercanidipine, the Practice followed up with Miss U as it had planned to. Miss U also requested a repeat prescription of lercanidipine. The Practice noted that the medication was suiting her well and Miss U stated she was feeling ‘lots better’.
23. In early May, Miss U developed a rash across her face. On 6 May, the Practice diagnosed this as an eczema flare up, something Miss U had suffered from in the past. Miss U’s symptoms continued and she visited the Practice again on 10 May. The Practice diagnosed an eczema flare up again. Miss U then visited a walk-in centre on 19 and 20 May and was diagnosed with an allergic reaction to lercanidipine. The walk-in centre advised her to stop taking it.
24. When Miss U’s symptoms began, she had been on lercanidipine for around two months and had reported that it was suiting her well. The BNF guidance states that common side effects of lercanidipine are ‘flushing and skin reactions’. But there had been a significant amount of time between starting the medication and the symptoms starting.
25. Miss U only visited her GP at the Practice twice about her skin problems since starting lercanidipine. The two later appointments were at a walk-in centre. Given Miss U’s history of eczema and the length of time between starting the medication and her skin symptoms starting, our adviser said the GP used reasonable clinical judgement in line with the GMC guidance when diagnosing eczema.
26. We can see no evidence of a failing when the Practice diagnosed Miss U’s skin problems as eczema rather than an allergic reaction.
Failure to communicate potential side effects
27. GMC safe prescribing guidance states that prescribers should include patients in decisions about their healthcare and explain the ‘likely benefits, risks and impact, including serious and common side effects’ of treatments.
28. On 28 February 2022, it is documented in Miss U’s medical notes that the prescriber needed to ‘counsel and safety net’. In the 3 March notes, there is no sign that Miss U was told about the potential side effects or what to do if she experienced them.
29. It is a sign of a failing if the Practice did not talk to Miss U about the serious and common side effects of lercanidipine. This is not in line with the GMC safe prescribing guidance or the pharmacist’s instruction to ‘counsel and safety net’ Miss U.
30. When we see a sign of a failing, we look at whether this had a negative effect on the person that the organisation has not put right. Having done this, we are satisfied the Practice has already done enough to put things right and no further action is needed.
31. We appreciate Miss U had to take time off from work due to her symptoms and this has affected her financially and physically.
32. On balance, we cannot say whether Miss U would have refused the medication if she was aware of the side effects. Given the need to control her blood pressure, it seems likely she would have still tried the medication even if the Practice had told her about the potential side effects. As Miss U had experienced side effects with other similar medication, she will have been aware of this being a possibility with lercanidipine.
33. There is also information in the medication packaging to tell patients about the potential side effects. This refers to the possibility of skin changes and allergic reaction. So, although the Practice did not explain about potential side effects, it is likely she would have known about them from the patient information leaflet. We also see that Miss U got advice when she started to experience side effects, which is what a GP would have advised.
34. In summary, we think that even if the Practice had explained about the side effects of lercanidipine, it is likely Miss U would still have tried it and unfortunately had a negative reaction. Given the length of time between Miss U starting the medication and her symptoms starting, it is likely the Practice would still have diagnosed eczema rather than advising to stop taking the medication. We cannot see any signs that the Practice’s actions can be linked to the pain and financial loss Miss U experienced.
35. We understand Miss U’s frustration that the Practice did not warn her about side effects when it prescribed lercanidipine.
36. The Practice has apologised to Miss U and offered a clear explanation of the events. We think this is reasonable and enough to put things right in line with our Principles.