The UK medicines regulator is consulting on whether to reclassify Aquiette to make it the first medicine available to purchase from a pharmacy for treating overactive bladder (OAB) without prescription.
The proposal is being brought forward by Maxwellia Ltd to allow pharmacists to provide a maximum of 12 weeks’ treatment of Aquiette 2.5mg tablets (oxybutynin hydrochloride) to women with milder symptoms of OAB that are not controlled by bladder training alone.
Symptoms include having to urinate at least eight times in the day, more than once during the night, sometimes leading to accidental leaks.
Oxybutynin hydrochloride causes relaxation of the detrusor muscle of the bladder, increasing its capacity and reducing the incidence of spontaneous contraction.
If positive responses are received and the decision is made to switch the medicine, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied the medicine safely.
It comes after the Commission on Human Medicines (CHM) advised that the application to make the product available as a Pharmacy (P) medicine could be granted.
The consultation document said pharmacy stakeholders considered there to be an unmet need for an appropriate product available as a P medicine, which would improve awareness that OAB is a treatable condition. Discussions with health policy officials about widening access to the medicine were met with ‘strong support’.
The document also said the MHRA concluded that all risks could be managed through the product information and pharmacist training.
Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: ‘We encourage women and healthcare professionals who have experience of using this vital treatment to engage with the consultation and make your views heard. Every response we receive will help us gain a better picture of whether people think this reclassification would be beneficial.’
Minister for women’s health Maria Caulfield added that when it came to sensitive issues such as bladder control, speaking to a GP may act as a barrier for some women to seek help. She said making it easier for women to access healthcare was ‘essential’ in reducing the gender health gap.
The consultation will close at 11.45pm on 13 May 2022.