A National Formulary for Children

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A National Formulary for Children
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Aims

• To build on the success of Medicines for
  Children
• To provide an authoritative reference for the
  safe and effective use of medicines in children
• To incorporate evidence based and current best
  practice guidance

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Why do we need one?

• Significant number of medicines used in children
  are not licensed in children
• Off-label
• Unlicensed
• Information on use and dose is in many places
• Quality, evaluation and presentation of
  information varies
• Evidence may be limited

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• There is considerable evidence that drug dosing
  inaccuracies lead to adverse events and even
  fatalities in children
• Baber N Pritchard D
• MCA Post-Licensing Division
• Br. J. Clin. Pharmacol. 2003 56 489-493

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• Substantial safeguards will be in place if
  prescribers routinely refer to the formulary
  Medicines for Children
• Getting the right start
• National Service Framework for Children
• Standard for Hospital Services
• (Department of Health April 2003)

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• Medicines for Children fulfilled this role
• Scale of project means a robust and permanent
  editorial process required
• Increasing information from e.g.US studies
• Increased frequency of publication

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Structure

• Paediatric Formulary Committee
• Expert advisors
• Editorial staff

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Paediatric Formulary Committee

• Chair
• Dr George Rylance
• Representatives nominated by collaborating
  organisations
• Royal College Paediatrics and Child Health
• Neonatal Paediatric Pharmacists Group
• British Medical Association
• Royal Pharmaceutical Society

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Additional members

• Medicines and Healthcare Products Regulatory
  Agency
• Royal College of General Practitioners

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Expert advisors network

• Clinical advisors for each clinical area and
  sub-speciality
• Nominated by the Committee or specialist body
  e.g. Royal Colleges
• Provide expert opinion on subject and advice for
  resolving problems

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Editorial Staff

• Five editorial staff 4 w.t.e.
• Based at BNF
• Supported by BNF staff expertise
• Editorial process
• Structure
• Layout
• Electronic products

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• Each editor assigned specific clinical areas
• Generate content of Guidance and Drug Monographs
• referred to expert advisors and PFC
• Keep up to date with changes and developments

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Scope of project

• All drugs licensed in children and neonates
• Drugs in common use in neonates and children but
  not specifically licensed for this purpose
• Unlicensed drugs for which good evidence exists
  on safety and efficacy

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• Cover treatment up to the age of 18 years
• For all healthcare professionals involved in the
  prescribing, dispensing and administration of
  medicines to children
• Primary, Secondary and Tertiary care

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Sources of Information

• SPCs
• Expert advisers
• Literature
• Systematic reviews
• Consensus guidelines
• Reference books
• Expert centres

• Statutory information
• Comments from readers
• Comments from industry

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Regulatory data
Systematic reviews
Research data
Expert assessment for clinical and local relevance
Textbooks
Expert advice
Dissemination
National Formulary for Children
Bulletins
Guidelines (NICE,SIGN etc)
Healthcare professional
Promotion
Other influences
Peers
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Collaborative approach

• Centre of an information network
• Collaborate closely with health professionals and
  bodies
• Developing links with e.g. NPSA, RCN
• Responsive to opinion and feedback from users

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• STARTING NOW !

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Which of these definitions is correct?

• Age definition for INFANT
• A) Birth to 1 year
• B) 1 month up to 1 year
• C) 1 month up to 2 years
• Answer all of them depending on what you are
  reading!
• C) Licensing Medicines for Children 1996
• BPA / ABPI Joint Report

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• Age definition of Child
• A) 1 to 14 years
• B) 2 up to 12 years
• C) 2 to 10 years
• Answer
• B) ICH Harmonised Tripartite Guideline
• Clinical Investigation of Medicinal Products
• in the Paediatric Population E11

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• Considerable overlap in developmental issues
  across the age categories
• Not just doses required but supporting
  information for how to manage drug treatment

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Pharmacokinetic information

• Always quote or only when clinically relevant for
  adjusting treatment
• Bioavailability
• Vd, tissue distribution, albumin binding
• Liver metabolism, route of elimination, half life
• Position in guidance notes or with drug monograph
• What else would you like to see ?

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Parenteral Administration

• Reconstitution and preparation instructions
• Displacement values
• Compatibility
• Administration concentrations

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• Stability data
• Extravasation

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Poisoning/Toxicity

• Limited information on key poisons ?
• Information for every drug ?
• Removal by haemodialysis or peritoneal dialysis ?
• Information used or refer to poisons centre ?

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Proprietary Medicines

• Include non NHS/OTC products suitable for use in
  children and adolescents?
• Guidance on the drug treatment of minor ailments
  in children?

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• Include POM products when dose includes
  Adolescents but the product is not recommended
  for, or used, for children?
• OCPs 16-18 years
• Mebeverine 12-18 years adult dose

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Neonatal information options

• Within chapters but highlighted by colour for
  both notes and doses in monographs?
• Appendix table of common neonatal drugs and doses
  referring to main text for further information
• Completely separate section

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Formulations

• What extemporaneous formulation information
  should be available?
• None
• Just available
• Formulation stability data

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• We hope you will continue to support and
  contribute to the development of this exciting
  project
• A National Formulary for Children