The table below provides a summary highlighting some useful product information relating to oxybutynin 2.5mg tablets for supply as a P medicine. Refer to the full up-to-date product details in the relevant SPC and British National Formulary (BNF). 

Summary of product information

Indication	– Treatment of overactive bladder symptoms (urinary urgency and frequency without dysuria), occasionally leading to incontinence. – Symptoms lasting more than one month. – Symptoms not controlled by bladder training alone for at least six weeks. – Can only be used in women aged between 18 and 65 years old.
Contraindications	– Men. – Women aged over 65 years old and under 18 years old. – Pregnant and breastfeeding women. – Hypersensitivity or allergies to oxybutynin or any of the excipients. People with existing: – Frequent urination caused by diabetes, heart, or kidney disease. – Detrusor overactivity caused by neurogenic conditions. People with history of: – Hypersensitivity to oxybutynin or any of the excipients. – Bladder outflow obstruction causing urinary retention. – Gastrointestinal motility and obstructive disorders. – Muscle diseases. – Glaucoma.
Dose	– One tablet two or three times daily. – Take lowest effective dose depending on response. – Separate doses by six hours.
Administration	– Swallow whole with water. – Combine with bladder training. If symptoms improve after six weeks of treatment: – Review and continue using for another six weeks. – Then stop and continue with bladder training only.
Side/adverse effects	Very common: – Constipation – Nausea – Dizziness – Headache – Somnolence (feeling drowsy or sleepy) – Dry eyes Common: – Diarrhoea – Vomiting – Confusion – Urinary retention – Flushing Uncommon: – Abdominal discomfort – Anorexia – Decreased appetite – Dysphagia (swallowing difficulties) Other risks: Advise to stop and immediately refer if the person experiences: – Glaucoma symptoms – sudden loss of vision, pain, light halos, headaches, dilated pupils, red eye or nausea and vomiting. – Anticholinergic CNS effects – hallucinations, agitation, and confusion. Report any suspected side effects, as appropriate, via the Yellow Card scheme. See our Yellow Card guide for further details.
Interactions	Check all medicines the person is taking (including prescribed, OTC, herbal products, complementary, vitamins, dietary supplements, recreational drugs, alcohol, and tobacco): – Anticholinergics and antimuscarinics. – Medicines with anticholinergic activity – anti-Parkinson’s medicines (e.g. amantadine, procyclidine and levodopa), antihistamines, antipsychotics (e.g, chlorpromazine), butyrophenones (e.g. haloperidol), tricyclic antidepressants (e.g. amitriptyline, clomipramine), atropine, and atrophic antispasmodics. – CYP3A4 inhibitors (e.g. erythromycin, clarithromycin and itraconazole). – Prokinetic therapies (e.g. metoclopramide and domperidone). – Cholinesterase inhibitors (e.g. donepezil, galantamine and rivastigmine). – Rufinamide. – Alcohol. Refer anyone with a clinically relevant interaction to their prescriber, using your professional judgement.
Pregnancy and breastfeeding	– Cannot be used while breastfeeding. – Cannot be used in pregnancy.
Age	Can be used only in women aged: – Over 18 years old and under 65 years old.
When to refer	– If the person has a contraindication. – If the person experiences any side effects. – Recent onset of symptoms (within one month). – If you suspect a person’s symptoms may indicate a condition other than overactive bladder syndrome (e.g. urinary tract infection, diabetes, atrophic vaginitis, malignancy, fibroids, prolapse, obstruction) – refer to prescriber to confirm diagnosis. – Where oxybutynin should be used only under medical supervision. Symptoms to refer to confirm diagnosis include: – Urine – cloudy, painful, poor flow, blood, burning, frequent. – Fever. – Unexplained weight loss. – Recurrent UTIs. – Loin or pelvic pain, discomfort, heaviness, or bloating. – Vaginal – pain, dryness, lumps. – Periods – abnormal bleeding. When oxybutynin should be used under medical supervision only: – Women aged over 65 years old. – Men and children. – People with stress incontinence. – People with autonomic neuropathy or cognitive disorders. – People with hepatic or renal impairment. – People with gastrointestinal motility disorders – hernia and reflux. – People with mental health conditions requiring treatment – anxiety, depression (etc.). – People taking existing anticholinergics, antimuscarinics, CYP3A4 inhibitors, cholinesterase inhibitors, prokinetic therapies. – People with hyperthyroidism. – People with cardiac conditions –congestive heart failure, arrhythmia, coronary heart disease and hypertension. After starting treatment refer people: – If symptoms worsen or don’t improve after six weeks. – If you still need Aquiette after 12 weeks of treatment. – If the person experiences any side effects.

Education for pharmacy teams 

Further information and educational materials can be found in the further information section. This includes:

• Aquiette’s SPC
• Aquiette’s pharmacist training guide
• Aquiette’s pharmacist quick reference guide

Ensure the pharmacy team is trained and has read any relevant standard operating procedures (SOPs) and training guides.

It would also be good practice for the pharmacy team to be aware of local services, incontinence clinics and consider keeping a list in the pharmacy to refer to for signposting.

Pharmacists and pharmacy teams may want to carry out roleplay scenarios in advance of their first request for oxybutynin. This can help you gain confidence and familiarise yourselves with the consultation process.

Confidence in consultation skills

Many people will find discussing the personal topic of incontinence difficult or embarrassing. They may be nervous about approaching the pharmacy team. A reminder for the pharmacy team is to always be discreet, non-judgmental and put the person at ease. This will help the person to feel more comfortable and confident in the pharmacy team.

P medicines can be supplied by or under the supervision of a pharmacist. There may be circumstances when a request should be referred to the pharmacist. This should be covered within the standard operating procedure (SOP) and may depend on pharmacy staff competence and training. Counter staff are often the first point of contact so will require suitable training. See the section on education for pharmacy teams for further information.

Below are some practical tips to help support your consultation skills.

Practical tips

• Introduce yourself and invite the person to have a chat with you in the consultation room – consider adjustments that may be needed during the pandemic to keep safe.
• Consider whether the person wants to bring a chaperone.
• Consider whether the person has a preference to speak to a female member of staff – and how to signpost where this isn’t possible.
• Ask open questions to find out what the person needs and how you can help.
• Actively listen to the person – remain non-judgemental, so they feel comfortable discussing their concerns with you. It is important to identify and discuss possible issues during consultation and address any concerns.
• Provide information in a way that is compassionate, empathetic, and respectful of confidentiality.
• Raise awareness by signposting and providing resources, where appropriate.
• Pharmacists and pharmacy teams should be aware of important issues such as vulnerable adults, consent, and confidentiality. If questioning during a consultation leads you to believe that there’s a safeguarding issue refer to your local policy for dealing with safeguarding issues. See our guide on safeguarding for further information.
• Use our decision-making process to decide if a supply is suitable.
• For training on consultation skills see section on further information. 

Other considerations:

Online pharmacies will need to meet General Pharmaceutical Council (GPhC) regulatory standards for providing services at a distance. 

For further information see GPhC guidance on providing pharmacy service at distance, including on the internet and GPhC premises standards. There are some additional points for consideration on the Medicines, Ethics and Practice page.

Decision-making process for supply of oxybutynin 2.5mg tablets 

Use your professional judgement when dealing with requests.

Communicate the process of supply to the person requesting the medicine and that you will need to ask some questions to make sure the medicine is suitable for them.

Explain to the person requesting the medicine that referral to a prescriber may be needed if contraindications are identified or if further investigations are required.

Explore the person’s situation by considering the following:

• Who is requesting a supply? Is it the person who needs the medicine or a representative?
• Are there any safeguarding issues identified?
• Are they already on any other form of antimuscarinics? Consider whether the person should continue with their current antimuscarinic or if they wish to switch to oxybutynin 2.5mg tablets.
• Have they already been prescribed oxybutynin 2.5mg tablets? Oxybutynin 2.5mg tablets can still be purchased from a pharmacy as a P medicine if more practical (e.g. they are unable to get a suitable appointment with their prescriber). 
• Consider if an emergency supply of the person’s prescribed medicine is more appropriate (e.g. if they are being prescribed off-licence).
• Have they already been supplied oxybutynin 2.5mg tablets as a P medicine OTC?
• Have they requested oxybutynin in the past and been refused or have they had to stop treatment for any reason?
  • Find out why and use your professional judgement to decide if it is sufficient reason for referral.
• Are they aware of all the other options available to them including bladder training? They may need referral or see bladder training plans available in the relevant educational risk minimisation materials found under further information.

Repeat supply requests

When a person requests a repeat supply, it will be up to the pharmacist to exercise their professional judgement to decide whether the full consultation is required again.

You’ll need to ensure you are satisfied the medicine is still clinically appropriate and suitable on each occasion. Check if anything has changed since the last supply. This will determine if a repeat supply is suitable or not.

Questions you may consider appropriate to ask the person requesting oxybutynin to assess continued suitability:

• Have there been any changes in their health or medical conditions since their last supply?
• Have there been any changes to their medicines (including prescribed, OTC, herbal products, complementary, vitamins, dietary supplements, recreational, alcohol and tobacco) since their last supply?
• Have there been any changes in their overactive bladder symptoms that concern them?
• Have they been experiencing any side effects or signs and symptoms of adverse effects?
  • Serious side/adverse effects may require immediate withdrawal and referral to the prescriber.

Use your professional judgement to decide on suitable action:

• If you feel the supply is suitable then provide counselling.
• If you feel the supply is no longer suitable, if in doubt of suitability or if medical attention, investigations or referral is required, then refer to a prescriber.

Supply to the person’s representative

You will need to use your professional judgement with requests from representatives due to the sensitive nature of the medicine and issue of maintaining confidentiality.

Consider the following:

• Who is requesting on the person’s behalf and why? If you suspect any potential safeguarding issues, you may find our pharmacy guide on safeguarding useful.
• How will you ensure you are satisfied that the treatment is clinically appropriate for the person needing the medicine?
• How can you get in touch with the person to assess suitability and determine whether the request is appropriate and genuine (e.g. by telephone)?
• Be careful not to disclose to the representative what was previously discussed, unless you have consent from the person needing the medicine.

Counselling

Advise the person to read the patient information leaflet (PIL) and packaging, as a reminder of key safety messages.

Discuss the following:

• The medicine – what it is, how it works, how to use (including the importance of adherence).
• Side/adverse effects and risks – make sure the person is aware what signs and symptoms to look out for and when to seek medical attention and advice.
• Avoid alcohol, caffeine, and acidic drinks – these can make your symptoms worse.
• Driving  – the medicine may cause drowsiness.
• Other options and bladder training – the person is aware of all options available to them including bladder training. Provide written information if requested and refer to a prescriber or clinic if the person is interested in bladder training.
• Health promotion – provide general lifestyle and wellbeing advice where appropriate including diet, exercise, smoking cessation, caffeine management, weight management, and fluid intake.            
• Further supplies – the person is aware how to obtain further supplies.
• Interactions – the person is aware to check interactions with their pharmacist before starting any new medicines.
• Referrals – the person is aware when to see a prescriber.
• Advising prescriber – person is aware to inform their prescriber that they are on oxybutynin 2.5mg tablets as soon as possible, so that their medical records can be updated to support future prescribing and checking interactions. Discuss with the person if they are happy for you to inform their prescriber on their behalf.

You may also find our pharmacy guide on counselling people on the use of medicines useful.

Other considerations:

• Record-keeping – see the section on record-keeping.
• Quantity to supply – see the section on quantity to supply.
• Online purchases – highlight the risks of purchasing medicines online.
  • If buying from unregulated sources the medicines may not have been tested for safety or effectiveness.
  • Advise the person to check that the medicine is being supplied from a reputable provider before purchasing – see guidance from GPhC on providing pharmacy services online.
• Disposal – advise the person to return any unused medicines to a pharmacy for disposal.

Quantity to supply

Pharmacists should use their professional judgement on a case-by-case basis to decide if supply of multiple-pack purchases or frequent supplies to the same person is appropriate, in the same way they would for all other P medicines.

The manufacturer of Aquiette doesn’t recommend a quantity to supply. However, the full treatment course is 12 weeks with a six-week review.

Record-keeping

There is no legal requirement to make a record of the supply of a P medicine. 

However, professionally, you may decide to make a record of the following for audit purposes:

• Referrals
• Discussions
• Reasons for the advice that you gave 
• Advice you gave in terms of when and how to seek help if needed (i.e. safety netting)
• Repeat sales
• If the person has asked you to contact their prescriber
• Interaction checks

If you decide to make a record, you need to ensure you have gained consent to do so. See GPhC guidance on confidentiality and consent. You may also find our pharmacy guide on clinical documentation useful.

Further information

Oxybutynin information

• electronic medicines compendium (emc) – SPC and PIL
• BNF
• Stockley’s Drug Interactions

RCPharm

• Yellow Card scheme
• Counselling people on the use of medicines
• Professional judgement
• MEP
• Emergency supply
• Clinical documentation
• Safeguarding

Other

Clinical

• NICE CKS – managing urinary incontinence
• NHS.UK – ten ways to stop leaks
• NHS.UK – non-surgical treatment for urinary incontinence

Consultation skills

• Centre for Pharmacy Postgraduate Education
• Health Education and Improvement Wales
• NHS Education for Scotland