Table 2

Case study

Mathew, an 8 year old with cerebral palsy, attends his appointment with Dr P, his neurologist. Sarah, Matthew's mum, reports that she is concerned that he is struggling to clear his excessive saliva and upper airway secretions, and feels this is contributing to his choking fits and chest infections. Dr P decides that a trial of glycopyrronium bromide would be beneficial, and he calls Jenny, the paediatric pharmacist, for advice on how to prescribe this.
Having confirmed that Matthew does not have any contraindications or drug interactions to prevent the use of glycopyrronium, Jenny notes that it is not licensed for the management of upper airway secretions but that the BNF for Children provides dosing recommendations for this indication. Jenny confirms that the oral route would be appropriate, and Sarah tells Jenny that Matthew receives his feeds and medicines via a PEG tube due to his swallowing problems.
As Matthew weighs 23 kg and the BNF_C recommends a dose of 40–100 μg/kg (max 2 mg) 3–4 times daily,8 Jenny calculates the dose range for Matthew would be 920–2000 μg. They agree to start at the lower end of the range to minimise side effects and allow the dose to be adjusted according to Matthew’s response.
Jenny considers the options to supply glycopyrronium; The only licensed formulation available in the UK is ampoules for injection; however, the BNF-C notes that 1 and 2 mg tablets are available by import, and also the injection may be given orally or the tablets crushed and suspended in water.8
Options:
Form dose costAdvantagesDisadvantages
Ampoules:
920 μg from 200 μg/mL (supply 2×600 μg (3 mL ampoules)) = 4.6 mL
▸ UK licensed formulation
▸ In stock in hospital dispensary
▸ Liquid
▸ Measurable dose
▸ Flexibility to adjust dose
▸ Off-label use
▸ Not routinely stocked outside of hospitals (may be difficult to obtain from community pharmacy),
▸ Glass ampoule—risk of injury on opening, risk of glass fragment administration unless filtered (requires filter straws to be supplied)
▸ Complexity of technique may preclude school staff administering
▸ Difficult to do when not at home
Imported tablets:dose rounded up to 1 mg=1 mg tablet dispersed in 10 mL water.▸ EU licensed formulation
▸ Simple preparation
▸ Measurable and accurate dose
▸ Simple to transport and prepare away from home
▸ Can be kept in stock on dispensary shelf (1 year + expiry)
▸ Unlicensed use
▸ Not liquid—requires manipulation
▸ May be difficult to obtain from community pharmacy
▸ Less flexibility to adjust dose—only 1 and 2 mg strengths available
▸ Labelling not in English
▸ Long lead time if not in stock at importer
Extemporaneously prepared liquid: (using injection solution)▸ Liquid
▸ Measurable dose
▸ Flexibility to adjust dose
▸ Possible to make same day within pharmacy
▸ Unlicensed
▸ Quality assurance low
▸ Stability data lacking—only 7-day expiry, requires fridge storage (poor convenience)
▸ May be difficult to obtain from community pharmacy
‘Special’ liquid from licensed manufacturer ▸ Liquid
▸ Measurable dose
▸ Flexibility to adjust dose
▸ Better quality assurance than extemporaneously prepared product
▸ Unlicensed
▸ Unknown availability (time to source manufacturer)
▸ Only 28-day expiry, requires fridge storage
▸ Delay in obtaining from manufacturer
▸ May be difficult to obtain from community pharmacy
▸ Possible variability in formulation between different manufacturers
Jenny discusses the options with Dr P and Sarah. They agree that while a ‘special’ may be the ideal option, the imported tablets are an option if Dr P agrees to start at 1 mg dose. They have the benefit of a reasonably simple manipulation, and are kept in stock for Matthew to try today. They agreed they could consider prescribing a liquid in the future if Matthew required a fine dose adjustment.
Dr P prescribes glycopyrronium bromide tablets 1 mg three times a day for 1 month.
Jenny advises Sarah to disperse the 1 mg tablet in 10 mL water and to administer the entire quantity of liquid and any solid particles. Sarah should monitor Matthews bowel and bladder opening, as he may be come constipated or develop urinary retention. Jenny gives Sarah a letter for her general practitioner (GP) and community pharmacy explaining what product to prescribe and how to obtain it.
The following month Jenny sees Sarah and checks how they have been getting on. Sarah reports that Matthew seems to have tolerated the medicine quite well and it has made some improvement so they have agreed with Dr P to increase the dose to 1 mg four times a day for the next month. The GP has agreed to prescribe and the community pharmacy are ordering this in for them in accordance with the information provided by Jenny.