The Medicines and Healthcare products Regulatory Agency (MHRA) is proposing to make oxybutynin hydrochloride (Aquiette 2.5mg; Maxwellia) — a treatment for overactive bladder — available from pharmacies without a prescription.
However, pharmacists have expressed concerns at the proposal, citing the risks associated with the anticholinergic.
Oxybutynin hydrochloride oral tablets are used to treat women, aged 18–65 years, with milder symptoms of overactive bladder that are not controlled by bladder training alone; symptoms include having to urinate a minimum of eight times per day and more than once during the night, sometimes leading to accidental leaks.
The drug works to control these symptoms by causing relaxation of the detrusor muscle of the bladder, thereby increasing capacity of the bladder to hold urine and reducing the incidence of spontaneous contraction of the bladder.
The MHRA is consulting on reclassifying the medicine, which is currently only available to patients with a prescription, to a Pharmacy (P) medicine.
According to a press release from the MHRA, issued on the 23 April 2022, the Commission on Human Medicines had advised that it was safe for the product to be made available as a P medicine. It also said that if the decision was made to reclassify the treatment, pharmacists would have access to training materials and a checklist to enable them to identify women who can be supplied the medicine safely.
Pharmacy minister Maria Caulfied, who also holds the women’s health portfolio, said in a statement that, when it comes to “sensitive issues”, such as bladder control, speaking to a GP may act as a barrier for some women to seek help.
“Reclassification of Aquiette would enable women to access vital medication without needing a prescription,” she said.
However, pharmacists have expressed concerns about the proposals, describing the switch from a prescription-only-medicine to a P medicine as “inappropriate” owing to the risks associated with the medicine.
Graham Stretch, chief pharmacist at Argyle Health Group and clinical director at Brentworth Primary Care Network, said: “Short term, these include constipation, dry eyes, increased falls, confusion, urinary retention, blurred vision and glaucoma.
“The longer term risks are increasingly clear also, an increased risk of cognitive decline and dementia has now been demonstrated in multiple studies, with data supporting the hypothesis that the cumulative lifetime dose is what matters — the greater the total dose [burden] the higher the risk.”
Stretch said that the literature supported the notion that the medicine “changed the architecture in the brain”.
“Recently, a team, including professor Tony Avery, the new national clinical director of prescribing [at NHS England], published a paper stating they felt the evidence established a causative link between oxybutynin and dementia,” he continued.
“Whilst I’m supportive of making medications more accessible and empowering community colleagues to provide timely care, this particular medicine is inappropriate and many safer alternatives are available.”
Nuttan Tanna, pharmacist consultant in women’s health and osteoporosis at London North West University Healthcare NHS Trust, also expressed concerns relating to the increased risk of falls and cognitive impairment.
“I think my big concern is the woman with multiple comorbidities on many other meds that add to the anticholinergic burden,” she said.
“Also, oxybutynin side effects — blurred vision and dry mouth — [are concerning], so many of our [urogynaecology] patients have had to be changed over to an alternative prescription for their OAB [overactive bladder] symptoms.”
Anna Maxwell, a registered pharmacist and chief executive of Maxwellia, the licence holder for Aquiette 2.5mg tablets, said overactive bladder affects one in five women in the UK.
“Most women don’t present with this condition for up to five years, because they are embarrassed, think it’s a sign of ageing or due to childbirth, relying instead on coping strategies like incontinence pads and reducing fluid intake to manage their symptoms,” she said.
“When they do talk to their GP, then it is usually too late and they may need long-term medication or even surgery.
“Yet with early intervention measures, the progression of mild overactive bladder symptoms can be prevented.”
Maxwell said that by introducing Aquiette as an “early, self-care option” it would “drive awareness” of the condition and let women know that there is treatment available
“If approved, the availability of Aquiette through pharmacies will enable a hidden subset of women (aged 18–65) to treat overactive bladder without the need to interact with a GP. This is all about giving women more choice and more control.”
The consultation closes on 13 May 2022.
- This article was updated on 28 April 2022 to include comments from Anna Maxwell, chief executive of Maxwellia