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					A National Formulary for
• To build on the success of “Medicines for
• To provide an authoritative reference for the
  safe and effective use of medicines in
• To incorporate evidence based and current
  best practice guidance
        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
“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
“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)
• 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
• Paediatric Formulary Committee

• Expert advisors

• Editorial staff
         Paediatric Formulary
• Chair
     • Dr George Rylance

• Representatives nominated by collaborating
     •   Royal College Paediatrics and Child Health
     •   Neonatal & Paediatric Pharmacists Group
     •   British Medical Association
     •   Royal Pharmaceutical Society
        Additional members
• Medicines and Healthcare Products
  Regulatory Agency

• Royal College of General Practitioners
     Expert advisors network
• Clinical advisors for each clinical area and

• Nominated by the Committee or specialist
  body e.g. Royal Colleges

• Provide expert opinion on subject and
  advice for resolving problems
                 Editorial Staff
• Five editorial staff = 4 w.t.e.
• Based at BNF

• Supported by BNF staff expertise
      •   Editorial process
      •   Structure
      •   Layout
      •   Electronic products
• Each editor assigned specific clinical areas

• Generate content of Guidance and Drug
     • referred to expert advisors and PFC

• Keep up to date with changes and
           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
• 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
      Sources of Information
• SPCs                 • Statutory
• Expert advisers        information
• Literature           • Comments from
• Systematic reviews     readers
• Consensus            • Comments from
  guidelines             industry
• Reference books
• Expert centres
 Systematic reviews             Research data                 Regulatory data

                             Expert assessment for
Textbooks                                                             Expert
                          clinical and local relevance


              Bulletins       National                      Guidelines
                              Formulary for              (NICE,SIGN etc)


              Promotion            Peers                  Other influences
     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
Which of these definitions is
      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
             Age definition of “Child”:

    A) 1 to 14 years
    B) 2 up to 12 years
    C) 2 to 10 years

B) : ICH Harmonised Tripartite Guideline
Clinical Investigation of Medicinal Products
in the Paediatric Population E11
• Considerable overlap in developmental
  issues across the age categories

• Not just doses required but supporting
  information for how to manage drug
 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
• What else would you like to see ?
   Parenteral Administration
• Reconstitution and preparation instructions

• Displacement values

• Compatibility

• Administration concentrations
• Stability data

• Extravasation
• Limited information on key poisons ?
• Information for every drug ?

• Removal by haemodialysis or peritoneal
  dialysis ?

• Information used or refer to poisons centre ?
      Proprietary Medicines
• Include non NHS/OTC products suitable for
  use in children and adolescents?

• Guidance on the drug treatment of minor
  ailments in children?
• 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
 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

• Completely separate section
• What extemporaneous formulation
  information should be available?
• None
• Just “available”
• Formulation & stability data
We hope you will continue to support and
  contribute to the development of this
             exciting project

 A National Formulary for