A corticosteroid that is essential for the management of adrenal insufficiency, severe acute asthma and acute hypersensitivity reactions in paediatrics
Careful dosing of hydrocortisone in children
Required to avoid serious adverse effects and toxicity
Long-term use poses several challenges for healthcare professionals and patients, particularly in relation to the choice of formulation and ease of administration of appropriate doses
Oral formulations of hydrocortisone available in the UK
Tablets
Soluble tablets
Oral suspensions
Granules in capsules
Pharmacists' role
Advise on the safe use of an appropriate hydrocortisone formulation, including switching and providing counselling to help manage difficult dose administration at home
Ensure patients, parents and carers can recognise the signs and symptoms of adrenal insufficiency
Advise on prescribing alternative formulations during temporary supply shortages
Hydrocortisone is most commonly used in children to treat primary adrenal insufficiency, which is caused by congenital adrenal hyperplasia (CAH) and Addison's disease
CAH affects around 1 in 15,000 children in the UK, while the prevalence of Addison's disease in children is around 1 in 10,000 for the whole population
Ideal paediatric hydrocortisone formulation
Should satisfy high dose reproducibility, practicality, safety, low cost, and have a licensed status
It is unlikely that any one formulation will meet all criteria, so a balance of benefits and risks should be made in relation to the child's individual circumstances
Excess dosing of hydrocortisone causes symptoms of cortisol excess, while under-dosing is associated with symptoms of cortisol insufficiency, which can be life-threatening
Children with adrenal insufficiency require daily doses of 8–10mg/m2 of hydrocortisone, while those with CAH require higher doses of 10–15mg/m2
In 2018, the MHRA issued a drug safety update, advising that prescribers and pharmacists should only consider use of licensed hydrocortisone products for adrenal replacement therapy
Tablets
Concerns have been highlighted around the reproducibility of doses when splitting or dispersing them in water
Halving the 10mg tablet to give 5mg doses appears to provide relatively consistent dosing
Soluble tablets
Produce a true solution rather than a dispersion, potentially offering more accurate dosing over tablets
Oral suspensions
Many current suspensions no longer use the cypionate ester of hydrocortisone, but rather hydrocortisone acetate or micronised hydrocortisone base, providing doses bioequivalent to tablets
Granules in capsules
Provide an accurate and reproducible dosing option, suitable for children who cannot swallow tablets or those requiring doses not in multiples of 2.5mg
The MHRA issued a drug safety update in February 2021, advising that parents or carers should be informed of the need to be extra vigilant for symptoms of adrenal insufficiency when switching children from hydrocortisone tablets to Alkindi granules
Pharmacists can offer to demonstrate how to prepare doses, and provide useful counselling points for patients starting hydrocortisone or switching formulations
Prescribing errors affect around 13% of paediatric prescriptions
Paediatric medication errors - prescribing errors
Some of the most important threats to patient safety in children
Can have lethal consequences
Errors occur more frequently in children than in adults and may be up to three times more likely to cause harm
Prescribing error
A clinically meaningful prescribing decision or prescription that reduces the probability of treatment being timely and effective, or increases risk of harm when compared with generally accepted practice
Steps in the prescribing process
Patient assessment
Medication choice (via shared decision making with the patient)
Prescription writing
Information provision
Monitoring
Paediatric prescribing errors are common, with a UK multicentre study identifying errors in 13.4% of 'medication orders' in hospitalised children
Up to 22% of children in primary care may have received an incorrect prescription
Most errors are intercepted prior to or during administration and do not impact patients
The most severe errors have catastrophic outcomes, with 29 fatal paediatric medication errors reported in UK newspaper articles over an eight-year period
The economic burden of prescribing errors is significant, with an estimated 66 million potentially clinically significant medication errors occurring in England annually, with an associated cost of £98m
Types of paediatric prescribing errors
Incomplete prescriptions
Inappropriate use of abbreviations
Dosing errors (including tenfold errors)
High-risk areas of paediatric prescribing
Care for neonates (particularly in neonatal care unit settings)
The process of medication dosing
Specific drug types (e.g. opiates, benzodiazepines, insulin)
The Swiss cheese model of accident causation
Systems have multiple layers designed to prevent errors, but each layer has holes. When these holes align, errors occur.
Capability-Opportunity-Motivation-Behaviour (COM-B) model
For a behaviour to occur, an individual must have capability, opportunity and motivation
Causes of prescribing errors in children include factors specific to prescribing for children, in addition to causes of error in adult settings
Most errors occur in the context of multiple factors, such as haphazard working environments, poor communication, and individual shortcomings
Paediatric-specific causes of errors
Individualised dosing and calculations
Off-licence prescribing
Different medication formulations
Communication with children and parents
Inexperience with working with children
Individualised dosing
Prescribing a specific dose for each patient based on weight, and the consequent requirement to perform calculations
Individualised dosing is the most frequently cited cause of prescribing errors
Individualised dosing leads to error
Prescribers find calculations challenging, often making errors even in controlled classroom settings
Most prescribers appear susceptible, particularly when distracted, contradicting the belief that this represents incompetence within a minority
Some errors occur because some calculations are particularly complex, while others are 'slips', such as misplaced decimal points
Errors also happen when prescribers fail to adjust doses as children grow; do not recognise that children are overweight or underweight; or act on incorrect weight measurements
While electronic prescribing (EP) has the potential to prevent errors related to individualised dosing and calculations, evidence suggests that they continue to occur even after its implementation
Off-licence prescribing
A common practice in children, owing to a lack of paediatric evidence regarding medication use
Off-licence prescribing is associated with increased risk of error
Off-licence prescribing
Places additional responsibilities on prescribers to choose suitable formulations, especially when using extemporaneous preparations — compounding ingredients to prepare an unlicensed medicine for an individual patient in accordance with a prescription — yet clear information on these formulations may be limited