BNF for children and formulations Ian Costello British National Formulary

Formulations Evidence for use of medicines in children is often limited Information available in many places Many original actives not licensed for use in children Suitable formulations not available

Options Lack of suitable formulations  crushing/segmenting tablets  dissolving dispersible tablets  powders  use of injections orally  cutting suppositories  extemporaneous preparation  use of chemicals

Crushing tablets / Opening capsules / Powders Whole dose available? Health and safety risk ? –dust –cytotoxic –immunosuppressant –hormones –sensitising agent

Dissolving dispersible tablets Dissolve or disperse ? Volume of water or other vehicle ? Dose reproducibility –homogenous dispersion ? –size of oral syringe ?

Cutting suppositories or tablets Uniform dispersion ? What does score line mean ?

Imported products Supporting information must be in English Evaluate every supply Ensure formulation evaluated –excipients

Extemporaneous preparations Formulation –strength –vehicle/suspending medium –constituents Bioavailability Dose uniformity

Stability Storage Manufacturing environment

Lack of suitable formulations Range of formulations available for the same drug –Clobazam suspension > 10 extemporaneous formulations Dose uniformity unknown –can vary by up to 30% Bioavialability unknown

Risk management issues Lack of familiarity with drug or formulation Quality of product Lack of supporting information –PIL –SPC

Risk Unlicensed medicines usually patient specific – nothing is standardised Strengths of liquids Formulations of liquids Doses

Clinical Governance GPs required to prescribe unfamiliar medicines Unsure how to –prescribe –strength and formulation –monitor

Community pharmacists required to supply unfamiliar medicines –know what they are? –where to get them from? –specification details? –sufficient information to check Rx? –what information to provide? Errors have occurred

Information often not readily available Routine safety check difficult Supplying pharmacist is responsible for quality and specification

Minimising risk and variation Agree specification with supplier Request documentation –certificate of analysis or conformity Evaluate labelling

Provide consistent formulation and manufacturing method Reduce variability in formulation –particle size –uniformity of dose –quality

Clear policy should be available –Prescribing –Purchase –Supply –Administration –Record keeping

Detailing responsibility of –PCT –Trust –Prescriber –Pharmacist

Only use when licensed alternative not available –Alternative licensed drug ? –Can a licensed product be used by another route? –Can a product licensed in another country be imported?

Until appropriate, well characterised formulations are available for children –policies and procedures required –standardised across a locality –primary and secondary care