A practice in the Blaby area

9. Mrs N complains about the care and treatment her five-year-old daughter, H, received from a GP Practice in the Leicestershire area (the Practice) on 31 March 2023. She says a Physician Associate (PA) inappropriately prescribed a vaginal pessary tablet and cream to treat her daughter’s symptoms of potential thrush. She says the Practice did not give an appropriate level of GP oversight before the prescription was made.

10. Mrs N also complains that a Pharmacy in the Leicestershire area (the Pharmacy) did not do the necessary clinical checks before dispensing the medication to a child.

11. Mrs N says inserting the pessary tablet into her daughter’s vagina made her bleed and scream in pain. She says, since this has been inserted, her daughter continues to secrete a green vaginal discharge twice a week. She also says the prescribed cream burnt her daughter’s skin.

12. Mrs N says her and her daughter both suffer from psychological trauma because of this experience. This includes Mrs N being questioned about possible sexual abuse of her daughter. She is extremely upset, frustrated, and disappointed about the number of missed opportunities professionals had to stop it from happening. She says this has further affected her ability to trust people.

13. Mrs N says the Practice and the Pharmacy’s failings have impacted her and her daughter to the point where it now forms part of their everyday life.

14. By bringing this complaint to us, Mrs N would like the Practice to ensure there are appropriate processes for the supervision of prescriptions. She would also like the Pharmacy to ensure relevant clinical checks are undertaken before dispensing medication.

15. Alongside this, Mrs N would like the Practice and the Pharmacy to: • apologise for its failings and acknowledge the impact it has had on her and her daughter’s life • pay a financial remedy for the trauma and distress this has caused.

16. On 31 March 2023, Mrs N took her five-year-old daughter, H, to the Practice. A PA saw H and recommended a prescription of a vaginal pessary tablet and cream to treat what they considered to be potential thrush.

17. The prescription was authorised by a GP at the Practice and was sent to the Pharmacy for collection.

18. Mrs N went to the Pharmacy to collect the authorised prescription and the Pharmacy dispensed the medication.

19. Mrs N inserted the pessary tablet into her daughter’s vagina. She also applied the cream twice a day for a week.

20. Mrs N again attended the Practice with H on 5 April. H was still suffering with internal and external vaginal itching and was still experiencing pain when urinating (dysuria).

21. On 28 May, Mrs N took H to an out of hours GP appointment. This was because her vagina was red and sore and she had green vaginal discharge in her knickers. At this appointment, the out of hours GP questioned Mrs N about possible sexual abuse of her daughter.

The Practice

25. On 31 March 2023, Mrs N took her five-year-old daughter, H, to the Practice because her skin had been itchy around her vagina and she had creamy white vaginal discharge in her knickers. A PA examined H and recorded that her vagina was a ‘bit inflamed around entrance to vagina’. The PA also recorded that there were no other symptoms, such as fever or abdominal pain.

26. The PA recommended a prescription for Clotrimazole (an anti-fungal) as a vaginal pessary tablet and cream to treat what they considered to be potential thrush.

27. Mrs N says she was not aware that it was a PA that examined her daughter and not a fully qualified GP. Mrs N says she questioned the use of a vaginal pessary tablet and says she was reassured this was the only treatment for her daughter’s symptoms. Mrs N says she also asked whether it would be a smaller size given it was to be used on a child. She says she was told there are no child sizes.

28. BNFC ‘Clotrimazole’ guidance says to avoid intravaginal preparations, particularly those that require use of an applicator, in young girls who are not sexually active.

29. Our GP adviser says a vaginal pessary tablet should not have been prescribed for a five-year-old child. This prescription was not in line with the BNFC and we find this to be a failing.

30. The GMC ‘Good practice in proposing, prescribing, providing, and managing medicines and devices’ guidance explains that GPs must prescribe drugs or treatment, including repeat prescriptions, only when they have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs.

31. The NHS ‘Health Careers – Physician Associate’ webpage explains that a PA is a graduate who has undertaken postgraduate medical training. Their work includes performing physical examinations and diagnosing illnesses. However, as they are not qualified GPs, and do not have prescribing rights, they must work under the supervision of a doctor.

32. Our GP adviser said in line with this PA’s can electronically add information into a patient’s GP record and recommend medication they deem to be appropriate based on the patient’s presenting symptoms. However, it is the responsibility of the supervising GP to electronically sign the prescription following discussion with the PA.

33. Our GP adviser said this discussion ensures that in line with the GMC guidance, the GP has enough knowledge and understanding of the patient, their presenting symptoms, and whether the prescription meets their needs before it is authorised.

34. We have seen evidence from the Practice that the prescription was authorised by a GP before it was sent to the Pharmacy for collection. We have not seen evidence of any discussion taking place between the PA and the GP before this was completed.

35. Due to the lack of discussion, we find the GP failed to appropriately supervise the PA and get the necessary information about the patient in line with the GMC guidance before authorising the prescription. We find this to be a failing.

36. Patient info ‘paediatric vulvovaginitis’ explains that yeast infections, such as thrush, are rare in younger girls and not usually the cause of vulvovaginitis in this age group.

37. It says paediatric vulvovaginitis is a common cause of soreness or irritation of the genital area of young girls before puberty. The external genital area can often look red and sometimes slightly swollen. There can also be a yellow or green discharge. It is usually caused by a combination of a natural lack of oestrogen and not wiping properly after going to the toilet. It can usually be alleviated by some simple hygiene and bathing changes.

38. Our GP adviser says the prescribing of a vaginal pessary tablet and cream for potential thrush was also not appropriate as it appears from the records that H’s presenting symptoms were consistent with vulvovaginitis and not thrush.

39. Therefore, had the right level of supervision and discussions taken place, we consider the prescription would not have been authorised. This is because the BNFC says not to prescribe a vaginal pessary tablet to a child and her symptoms were not consistent with thrush. We go on to discuss the impact below.

The Pharmacy

40. Mrs N says the Pharmacy should not have dispensed the vaginal pessary tablet and cream for her five-year-old daughter. She says she is extremely upset, frustrated, and disappointed that this was a further opportunity by a medical professional to prevent this occurring. She says this has further affected her ability to trust people.

41. GPhC ‘Standards for Pharmacy Professionals’ requires pharmacy professionals to take action to safeguard people, particularly children and vulnerable adults.

42. The Pharmacy also has its own Standard Operating Procedures (SOPs) which it follows to ensure safety. SOP three ‘Pharmaceutical Assessment of Prescriptions’ explains the importance of checking the appropriateness of a drug for the patient, with particular care for young children. It also says to check the form, strength, and route, using references such as the BNFC.

43. Our pharmacist adviser says the Pharmacy should not have dispensed the medication. This is because intravaginal preparations should be avoided in young girls who are not sexually active, unless there is no alternative, as outlined in BNFC guidance. Had the appropriate checks taken place, this would not have been dispensed.

44. The Pharmacy’s own SOP five ‘Interventions and Problem Solving’ explains the process to be followed if there is a query on a prescription or an intervention is necessary. This again includes consulting references such as BNFC. Further, it explains the pharmacist should contact the prescriber when there are interventions or queries relating to a prescription. The outcome should then be accurately documented with appropriate detail.

45. There is no evidence to show the Pharmacy queried the prescription with the Practice before it was dispensed.

46. Therefore, we have found the Pharmacy failed to act in line with BNFC, its own SOPs, and the GPhC standards when it dispensed this prescription. This is a failing. This meant an inappropriate prescription was dispensed. We go on to discuss the impact below.

Impact

47. On 31 March 2023, Mrs N inserted the pessary tablet into H’s vagina. Mrs N says this made H bleed and scream in pain and the experience was psychologically traumatising for both herself and her daughter. She says this was further compounded when she realised she had administered inappropriate medication to her child.

48. Mrs N also applied the cream twice daily for a week. She says this burnt H’s skin.

49. Mrs N took H to a further appointment at the Practice on 5 April. This was because H was still suffering with internal and external vaginal itching and experiencing pain when urinating (dysuria). She had also started to itch her anus. The plan was to watch and wait. The PA told Mrs N that if she noticed worms in H’s stools then she was to seek treatment from the pharmacy for threadworm.

50. Mrs N had to take H to an out of hours GP on 28 May 2023 because her vagina continued to be red and sore. She had also noticed green vaginal discharge in her knickers, and she was having to change them every hour.

51. The records from this appointment indicate H was scared to be examined. The doctor recorded that H had asked them not to put their finger in during the examination. This prompted the GP to discuss possible sexual abuse of H with Mrs N. Mrs N reported having used the vaginal pessary tablet and this was likely the reason for H being ‘scared’.

52. The records also state H had ’redness on the vagina’ and there was ‘genital ulceration/blistering’ at this appointment.

53. The records also show the GP made a telephone call to the Safeguarding team because they were concerned. A consultant contacted the out of hours GP and explained the likely ulceration and the green vaginal discharge was from the inappropriate prescribing of the vaginal pessary tablet and cream.

54. The consultant explained that this should not have been prescribed to a prepubertal child and that it is also known to burn the skin and cause an ‘overgrowth in bacteria’.

55. Mrs N explained that it was extremely distressing and embarrassing for the GP to question her about possible sexual abuse of her daughter during this appointment. She says this experience caused her further psychological trauma.

56. Taking everything into account, we find that if the failings in this case had not occurred, Mrs N would not have been given the vaginal pessary tablet or cream and therefore she would not have administered them. This would have prevented the traumatic experience for both H and Mrs N of inserting the vaginal pessary tablet, and the psychological harm to H thereafter. It also would have prevented the psychological harm to Mrs N knowing she administered inappropriate medication to her child.

57. We also find that it would have prevented the pain and bleeding caused to H from the insertion of the vaginal pessary tablet, and the burning and irritation caused from the cream which was still present at the appointment on 28 May. Finally, it would also have prevented Mrs N from being questioned about possible sexual assault and the further psychological harm this caused.

58. Mrs N feels that the insertion of the pessary tablet also caused the green discharge that she reported during the appointment on 28 May.

59. Our adviser says green discharge can happen as a result of by an infection caused by the insertion of a vaginal pessary tablet, but it is also a common symptom of vulvovaginitis. As H is still experiencing green vaginal discharge, our adviser said it is unlikely that she would still have an infection and it is more likely due to undiagnosed and/or untreated vulvovaginitis.

60. As such, we cannot say that the inappropriate prescription caused the green discharge that H has been experiencing.

61. We recognise that the impact of these failings has greatly affected H and Mrs N and still continues to affect Mrs N’s ability to trust professionals. We hope the recommendations we have made gives Mrs N the closure and reassurance she needs that this will not happen again to someone else.

1. We are very sorry to hear of Mrs N’s concerns about the inappropriate prescription given to her five-year-old daughter, H. We recognise the pain H endured from the medication and the traumatic experience they both had as a result. We understand the additional distress and upset it has caused Mrs N knowing she administered inappropriate medication to her child.

2. Further, we understand the upset and distress it caused Mrs N when she was questioned about the possible sexual abuse of her daughter. We acknowledge what a difficult time this has been for them both and how their trust in professionals has been affected.

3. We have found the Practice inappropriately prescribed H with a vaginal pessary tablet and cream for potential thrush.

4. We have found the Pharmacy did not undertake the necessary clinical checks before dispensing the medication.

5. We conclude if these failings had not occurred, the vaginal pessary tablet and cream would not have been prescribed or dispensed, and this would have prevented Mrs N from using the pessary tablet and cream on her five-year-old daughter.

6. We have found that inserting the pessary tablet was traumatic for both Mrs N and H and caused H to bleed and suffer in pain. The cream caused her burning and irritation. These could have been avoided. We recognise this has affected Mrs N’s ability to trust professionals.

7. For these reasons, we uphold this complaint.

8. We have recommended that the Practice and the Pharmacy send a letter to Mrs N to apologise for its failings and acknowledge the impact it has had on her and her daughter, H. We also recommend the Practice and the Pharmacy make service changes to ensure this does not happen again going forward. Further, we recommend the Practice pays £1000 and the Pharmacy pays £500 to Mrs N to put things right.