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Unlicensed Medicines in Paediatrics

Unlicensed Medicines in Paediatrics. Is there a problem ?. Scottish Neonatal and Paediatric Pharmacist Group National Paediatric Pre-Registration Pharmacist Study Day January 2011. AIM. To discuss the issues relating to the use of unlicensed medicines in paediatric patients and facilitate

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Unlicensed Medicines in Paediatrics

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  1. Unlicensed Medicines in Paediatrics Is there a problem ? Scottish Neonatal and Paediatric Pharmacist Group National Paediatric Pre-Registration Pharmacist Study Day January 2011

  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. Kids’ medicine ‘danger’ shock SOME children’s 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 wrongdoses. 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 Must use a licensed product when it is suitable

  6. 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 Unlicensed and Off-label Medicine Definitions

  7. Risk Assessment of Options • Licensed products • Route of administration • Confidence in manufacturer • Import licensed medicine from QC approved country • Pharmaceutical Special (Hospital / Commercial) • Extemporaneous • Borderline substance • Labelling language/ PIL language • Finished product testing • Certificate of Analysis • Certificate of Conformity • QC Approved importers/ countries • (e.g. within EU, N America, Australia, Japan, Switzerland, New Zealand)

  8. 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 or EMA) • The aim of a licence is to ensure that all medicines in the UK meet acceptable standards of safety, quality and efficacy

  9. 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

  10. EMA / MHRA Product Licence • Paediatric Investigation Plan (PIP) • Paediatric Regulation to submit a development plan for new medicines • Specific class waivers • Paediatric-Use Marketing Authorisation (PUMA) • Already authorise medicine • 10 years market protection

  11. Paediatric clinical trials “By an odd and unfortunate twist of fate, infants and children are becoming therapeutic orphans” Shirkey H 1968

  12. Lack of Clinical trials • 80% of new drugs had no info in paedsWHY ? • ethics • long term effects • micro-analytical techniques • return for investment

  13. 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

  14. Practical Implications • Responsibility • Liability • Patient Information • Inappropriate prescribing? • Medication Errors • Differing strengths • Differing manufacturer’s

  15. Practical Issues • Barrier to seamless care • Effective communication systems • Unlicensed manufacturer’s / suppliers cannot advertise products

  16. Dispensing Problems • Lack of familiarity • Calculations • Lack of suitable products- risk assessment of options • Only able to order from specific specials suppliers • Medication Errors • Professional check • Cost

  17. How Extensive is the problem? • Over to you - some audience participation please

  18. 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 epilepsy • EMLA cream for topical anaesthesia • Melatonin for sleep disorders in children • Ibuprofen for pyrexia

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