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					A National Formulary for
        Children
                   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
        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
                    Structure
• Paediatric Formulary Committee

• Expert advisors

• Editorial staff
         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
        Additional members
• Medicines and Healthcare Products
  Regulatory Agency

• Royal College of General Practitioners
     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
                 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
  Monographs
     • referred to expert advisors and PFC


• Keep up to date with changes and
  developments
           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
                                                                      advice




                                Dissemination


              Bulletins       National                      Guidelines
                              Formulary for              (NICE,SIGN etc)
                              Children



                                Healthcare
                                professional



              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
  users
STARTING NOW !
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
             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
• Considerable overlap in developmental
  issues across the age categories

• Not just doses required but supporting
  information for how to manage drug
  treatment
 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 ?
   Parenteral Administration
• Reconstitution and preparation instructions

• Displacement values

• Compatibility

• Administration concentrations
• Stability data

• Extravasation
         Poisoning/Toxicity
• 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
  information

• Completely separate section
            Formulations
• 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
         Children