Impact statements
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A list of age-inappropriate formulations was identified which could help inform paediatric medicine development by indicating which products need an age-appropriate formulation.
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These assessments provide information to manufacturers about how their product is being administered in hospital practice. Assessment of age-appropriateness is important in product development.
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Assessment of the age-appropriateness of a medicine is an important step when prescribing and dispensing for children, particularly younger children. Clinicians should discuss the most appropriate treatment options available with the child and/or their caregiver to meet the patient’s individual needs.
Introduction
Aim
Ethics approval
Method
Clinical study of medicine administration episodes among paediatric inpatients: the AaF study
Study design and participants
Consent to participate
Eligibility
Data collection
Development of the tool
Categorisation of age-appropriateness
Inter-observer validation
Characterisation of medicine administration episodes
Data analysis
Results
Data collection: medicine administration episodes among paediatric inpatients
No. of participants | AH | LWH | Total |
---|---|---|---|
Consented (to access medical records) | 510 | 100 | 610 |
Eligible | 334 | 93 | 427 |
Male | 190 | 59 | 249 (58.3%) |
Number of MAEs (number of patients) | 1758 (334) | 441 (93) | 2199 (427) |
Mean, median and range of medicines per patient | 5.26; 4; 1–28 | 4.74; 4; 1–15 | |
Age groups | |||
Extremely preterm neonate (< 28 weeks) | 8 | 8 | |
Very preterm neonate (28–< 32 weeks) | 31 | 31 | |
Moderate to late preterm neonate (32–< 37 weeks) | 38 | 38 | |
Term neonate (> 37 weeks+) | 37 | 14 | 51 |
Infant (28 days to ≤ 11 months) | 102 | 2 | 104 |
Toddler (12–≤ 23 months) | 33 | 33 | |
Young child (2–≤ 5 years) | 60 | 60 | |
Older child (6–≤ 11 years) | 49 | 49 | |
Teenager (12–≤ 15 years) | 35 | 35 | |
Adolescent (16–< 18 years old) | 18 | 18 |
Inter-observer agreement
Characterisation of medicine administration episodes
AiFs-AH | Frequency | AiF reason code | AiFs-LWH | Frequency | AiF reason code |
---|---|---|---|---|---|
Melatonin 2 mg capsule | 21 | DF(T)/PF/PP/EA | Phosphate 500 mg (16.1 mmol) effervescent tablet | 7 | DF(S)/PF |
Omeprazole 10 mg MUPs tablet | 19 | DF(S + T)/PF | Teicoplanin 200 mg powder for solution for injection or infusion | 6 | DF(S) |
Aspirin 75 mg dispersible tablet | 16 | DF(S)/Pal/PF/PP | Fluconazole 2 mg per ml solution for Infusion | 4 | DF(S)/EA |
Chloral hydrate 500 mg per 5 ml oral liquid | 11 | LP | Hydrocortisone 100 mg powder for solution for injection or infusion | 4 | DF(S) |
Hyoscine 1.5 mg patch | 11 | DF(S) | Morphine sulphate 1 mg per ml solution for injection or infusion | 4 | DF(S) |
Furosemide 50 mg per 5 ml SF oral solution | 6 | Pal/PF/LP | Sodium chloride 3 g in 10 ml (30%) concentrate for solution for infusion | 4 | DF(S) |
Loperamide 2 mg capsule | 6 | DF(S + T)/PF | Meropenem 500 mg solution for injection or infusion | 3 | DF(S)/LP |
Levothyroxine 25 mcg tablet | 5 | DF(S + T)/PF | Midazolam 5 mg per ml solution for injection, infusion or rectal use | 3 | DF(S) |
Movicol paediatric plain 6.9 g powder for oral solution | 5 | DF(S)/PF | Multivitamin drops | 3 | EA |
Spironolactone 50 mg per 5 ml oral suspension | 5 | Pal/PF/LP | Enoxaparin 20 mg in 0.2 ml pre-filled syringe injection | 2 | DF(S) |
Amiodarone 100 mg tablet | 4 | DF(S + T) | Folic acid 2.5 mg per 5 ml oral solution | 2 | EA |
Dinoprostone 1 mg per ml infusion | 4 | DF(S) | N-acetylcysteine 200 mg per ml concentrate for solution for infusion | 2 | DF(S + T)/PF |
Morphine 20 mg sachet PR granules for oral suspension | 4 | DF(S)/PF | Suxamethonium chloride 100 mg per 2 ml injection | 2 | DF(S)/LP |
Ranitidine 150 mg in 10 ml oral solution | 4 | EA/PF/LP | All other AiFs (OL) with frequency = 1 | 8 | |
Gabapentin 50 mg per ml SF oral solution | 3 | Pal/PF/LP | All other AiFs (UL) with frequency = 1 | 4 | |
Lansoprazole 15 mg orodispersible tablet | 3 | DF(S)/PF | Total number of AiFs identified | 58 | |
Morphine sulphate 10 mg per 5 ml Oral solution | 3 | Pal/LP | |||
N-acetylcysteine 200 mg per ml concentrate for solution for infusion | 3 | DF(S + T)/PF | |||
Paracetamol 120 mg per 5 ml SF oral suspension | 3 | PF/LP | |||
Vigabatrin 500 mg sachet | 3 | DF(S)/PF | |||
Domperidone 1 mg per ml oral suspension | 2 | LP | |||
Glycopyrronium bromide 1 mg per 5 ml oral solution | 2 | LP | |||
Glycopyrronium bromide 1 mg tablet | 2 | DF(S + T)/PF | |||
Levothyroxine 50 mcg tablet | 2 | DF(T)/PF | |||
Lisinopril 2.5 mg Tablet | 2 | DF(T)/Pal | |||
Paracetamol 500 mg caplet | 2 | PP | |||
Phosphate 500 mg (16.1 mmol) effervescent tablet | 2 | DF(S)/PF | |||
Sildenafil 2.5 mg per ml oral suspension | 2 | PF/LP | |||
Sodium chloride 5 mmol per ml oral solution | 2 | EA/LP | |||
Vancomycin 500 mg powder for solution for infusion | 2 | LP | |||
All other AiFs (OL) with frequency = 1 | 35 | ||||
All other AiFs (UL) with frequency = 1 | 7 | ||||
Total number of AiFs identified | 201 |