1. Medicines Across the Ages – From Baby Grows to Growing Babies
Steve Tomlin FRPharmS FFRPS
Chief Pharmacist
ex - Consultant Paediatric Pharmacist
Clinical Reader
NPPG – Professional Secretary

2. Is Paediatrics a clinical speciality?
It is a population base
Couldn’t be more diverse
The population has all clinical specialities
Neonates is completely different
Foetal medicine and obstetrics

3. A Diverse Population - routine health checks and immunisations
about 25% of population under 18
about 1 million with mental health problems
25% children in one-parent families
children are frequent users of health services!!
- routine health checks and immunisations
- 80% of illnesses managed by parents

4. Every Dose Is Different
Is dosing in adults logical?
One size fits all – useful for tablets
Paracetamol, ranitidine
When does a child become an adult?
Mg/kg
When can doses be rounded up or down?
Paracetamol, cefuroxime
Is Licensing Logical?
Aciclovir

5. Therapeutic Orphans
Europe - >50% of medicines used in children have never been tested in children.
Conroy S, Br Med J. 2000, 320:79-82
Australia - 25% of medicines licensed in children do not have appropriate formulations for children.
Tan E, Med J Aust. 2003, 179(4):195-8
1/3 of research papers into children’s medicines did not allow for the work to be reproduced / 51% did not use a paediatric formulation.
Standing J, Paediatrics. 2005, 116(4):
Pandit S, Arch Dis Child. 2010, 95:

6. Policy statement Joint RCPCH/NPPG Standing Committee on Medicines
‘it is not necessary to take additional steps, beyond those taken when prescribing licensed medicines, to obtain the consent of parents, carers and child patients to prescribe or administer unlicensed medicines or licensed medicines for unlicensed applications.’
Treatment Should Be The Best You Can Give!

7. What do children take? Dose (mg) 30 60 120 250 500 Dosage form? Drops
Liquid/melt
Liquid/melt/ tablet
Tablet/ capsule

9. Unlicensed & Off-Label Medication
Proportion of medicines used not licensed:
80% Neonatal Intensive Care Unit (NICU)
40% Paediatric Intensive Care (PICU)
25% general paediatric in-patients
11% children at home
Nunn A, 2003, Arch Dis Child :
ADULTS <2%

10. Intravenous Medicines
Hospital Neonatal Unit
31% of prescriptions < 1/10 vial
4.8% of prescriptions <1/100 vial
Arch Dis Child. 2000; 834:92-6
Benzyl alcohol harmful in infants
contained in e.g. amiodarone and lorazepam injections
Shehab N, Pediatr Crit Care Med (2):
Phenobarbital injection – 90% propylene glycol  hyperosmolality in infants, pH 11

11. Syringe analysis
The current system --Unseen Errors – Are specials the problem or solution?
61.5% deviation
75% in excess
28% > +20% deviation 11 11

14. Oral Formulations Phenobarbital elixir BP – 38% alcohol
Sugar or Sorbitol?
Dispersible Tablets (aspirin and diclofenac)
Captopril – bioequivalence?
Mulla H, Arch Dis Child :

15. Standardisation to a single concentration may be possible in the majority of cases

16. PK in a flash

19. Compliance With Whom! Who is involved Mainly varies with age
How do we know :
if there is compliance
who is affecting it
can we monitor?

20. Compliance Factors Regimen / Palatability / Supply ? SCHOOL
Peer pressure / Embarrassment / Independence
Engagement

22. Current Hot Topics Cannabis Melatonin (MR, liquids, crushing)
Extrapolation (NHSE)
What is evidence base? (coroners, NHSI)