Unlicensed Medicines in Paediatrics

1
Unlicensed Medicines in Paediatrics

• Is there a problem ?

2
AIM

• To discuss the issues relating to the
• use of unlicensed medicines in
• paediatric patients and facilitate
• discussion of the implications
• in practice

3
Objectives

• describe the licensing process
• identify problems of clinical trials in children
• examine the extent of the problem
• discuss seamless care issues
• pose questions for discussion!!!

4
Daily Mirror 28 February 1997

• Kids medicine
• danger shock
• SOME childrens medicines
• have not been approved for
• consumption by youngsters
• according to a report
• published yesterday.
• It warns that most medicines
• either prescribed or sold direct
• are safe but a minority could
• do harm in the wrong doses.
• They are licensed , but
• only for adults.

5
Extent of unlicensed and off-label prescribing in
children

• 90 of babies in neonatal intensive care
• 70 of children in paediatric intensive care
• 67 of children in hospital across Europe
• 11 of children treated at home by their GP

6
Unlicensed and Off-label Medicine Definitions

• Unlicensed
• Extemporaneous dispensing
• Pharmaceutical specials
• Importing medicines licensed in other countries
• Named patient supplies
• Chemicals not licensed at all for human use

• Off label
• Dose
• Age of patient
• Indication
• Route of administration
• Contra-indications

7
The licensing process

• To market a drug in the UK a pharmaceutical
  company must obtain a licence from the licensing
  authority (health ministers guided by the MHRA)
• The aim of a licence is to ensure that all
  medicines in the UK meet acceptable standards of
  safety, quality and efficacy

8
Extent of a product licence

• It allows a company to
• market a drug for
• specified conditions
• in an agreed dose range
• by a particular route
• using a tested formulation
• Based on clinical trial data

9
Paediatric clinical trials

• By an odd and unfortunate twist of fate, infants
  and children are becoming therapeutic orphans
• Shirkey H 1968

10
Lack of Clinical trials

• 1994-9880 of new drugs had no info in paedsWHY
  ?
• ethics
• long term effects
• micro-analytical techniques
• return for investment

11
Directive89/341/EEC

• all doctors can prescribe
• there is no statutory requirement to disclose to
  a patient when a drug is unlicensed
• all unlicensed prescribing / dispensing should be
  done knowingly(?)
• the decision to prescribe unlicensed medicines
• should be in the best interest of the patient
• in accordance with a respectable body of
  professional opinion

12
Practical Implications

• Responsibility for medicine lies with the
  prescriber
• Increased exposure to liability
• PILs
• Routine use implies inappropriate prescribing

13
Practical Issues

• barrier to seamless care
• effective communication systems
• specials manufacturers can not advertise

14
Dispensing Problems

• dose by weight/age
• lack of familiarity
• calculations
• lack of suitable products
• professional check

15
How Extensive is the problem?

• Over to you - some audience participation please

16
Consider the licensing status of the following
medicines for children and neonates

• Buccal midazolam for seizures
• Paraldehyde for seizures (rectal)
• Spironolactone for liver ascites
• Paracetamol for pyrexia
• Phenobarbitone for infantile spasms
• EMLA cream for topical anaesthesia
• Melatonin for sleep disorders in children
• Ibuprofen for pyrexia