A pharmacy has paid out £500 after an investigation found it failed to complete “necessary clinical checks” before dispensing an “inappropriately prescribed” vaginal pessary for a five-year-old.
The Parliamentary and Health Service Ombudsman (PHSO) said last week that the girl was prescribed the pessary by a physician associate (PA) after being taken to her East Midlands GP practice in March 2023 with itching and vaginal discharge.
The PHSO is an organisation that looks into and makes final decisions on complaints not resolved by the NHS, government department and other public organisations.
That there was “no discussion between the PA and GP” before the GP approved the prescription, and “no questioning of the prescription by the pharmacy that dispensed it”, the PHSO said.
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It added that the treatment was “inappropriately prescribed” by the practice, the pharmacy “did not do the necessary clinical checks before dispensing” the prescription, and its investigation “found failings by all involved”.
Both the pharmacy and GP practice have since “complied” with the PHSO’s recommendations to write to the girl’s mother “to apologise for their failings and acknowledge the impact on her and her daughter”, as well as “make service changes to ensure this does not happen again”.
The pharmacy also paid £500 to the girl’s mother this March, while the GP practice paid her £1,000.
“Traumatising”
The PHSO said a PA carried out the child’s appointment and recommended a clotrimazole vaginal pessary and cream for “suspected thrush”.
It added that the girl’s mother thought her child was being treated by a GP, and was “reassured” by the PA that the treatment and “size of the pessary” were “appropriate”.
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The PHSO said the girl was left “bleeding and in severe pain” after her mother administered the pessary, an experience the mother described as “deeply distressing and psychologically traumatising for them both”.
The mother said the cream “also burnt her daughter’s skin”, it added.
The PHSO noted that the prescription given “was not appropriate” as the child’s symptoms were “consistent with vulvovaginitis” and said a pessary tablet should “should not be given to a five-year-old”.
“No one questioned”
According to the PHSO, the mother said the experience was “a breaking point” that “caused so much stress for the whole family”.
“I trusted what the doctor told me. How are we meant to trust healthcare professionals now?” she said. “The prescription went through three professionals and no one picked it up or questioned why this was being given to a child.”
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The mother added that her daughter is neurodivergent and it has been “even harder for her to move on from the harm this caused”.
“This deeply affected her and added to the struggles she already faces every day; I don’t think she will ever move on from it.”
PHSO recommendations
The PHSO told C+D that it has asked the pharmacy involved to “configure its computer system” so that prescriptions for children under 12 “trigger a mandatory alert to prompt the staff member to consider things such as age-appropriateness of the prescription, licensed route, any red flags and whether prescriber discussion is needed”.
It also recommended that the pharmacy “puts together a written protocol to outline the dedicated contact route to the practice for urgent prescription queries”.
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“This protocol should also outline the expectations for prescriptions downloaded near closing time where the pharmacist cannot verify a high-risk prescription, and where to seek support,” it said. “Consideration should be given for the possibility of the medicine not being dispensed until clarification is obtained.”
And the PHSO told the pharmacy it should add “learning resources relating to paediatrics” in its dispensing standard operating procedure and explore “other ways to conduct additional mandatory training on paediatrics for pharmacists, checking technicians and dispensers to ensure age-appropriateness of formulations and safety prompts”.
“These actions are all in progress,” it noted.
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The PHSO said the GP practice concerned has since “taken action” by introducing an electronic prescribing alert “to flag intravaginal pessary prescriptions for children”, which now require “additional review before authorisation”.
The GP practice has also reviewed the PA’s “scope of practice” and implemented a process for supervisory discussions to be “clearly documented before prescriptions are signed”.
And both the PA and the GP have undertaken “additional training” on appropriate prescribing standards and supervision requirements.
“Poor communication”
PHSO chief executive Rebecca Hilsenrath said this “is a deeply troubling case in which a child suffered physically and psychologically and was left traumatised by her experience”.
She added that it is “all the more concerning” that the situation “could so easily have been avoided by better communication between the professionals involved in caring for this young girl”.
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Hilsenrath said the communication failures between those involved meant the “checks and balances designed to make sure patients are treated appropriately and kept safe were not followed”.
“Poor communication is a recurring theme in our investigations, and the NHS must make sure it operates with candour and clarity both between professionals and in relation to patients and their families,” she added.
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Hilsenrath also welcomed the government’s Leng Review, published last year, which she said provides “clarity and structure around these roles for the benefit of patients, PAs and doctors”.
PAs do not have prescribing rights and must by supervised by a doctor who will sign a prescription following a discussion.
C+D has approached the General Pharmaceutical Council for comment on the pharmacy involved.
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It comes after investigations by security firm TIAA revealed that paper FP10 prescriptions are being misused to fraudulently obtain “high-value” weight loss drugs.
TIAA, which provides counter-fraud services to some NHS organisations, said month that it had identified a “pattern of fraud” involving “the misuse of prescribing systems and paper FP10 prescriptions” to secure weight loss medicines, including Mounjaro.
Editor’s note: GPhC chief enforcement officer Dionne Spence told C+D on June 11 that the regulator’s “previous review of the case found that the pharmacist involved was no longer registered, and this remains the case”.
“We have received assurance that the pharmacy has strengthened its processes and implemented robust safeguards to ensure appropriate clinical checks are carried out and patient safety is protected,” she said.
