Presentation on theme: "Safe Supply of Paediatric Unlicensed Medicines"— Presentation transcript:
1 Safe Supply of Paediatric Unlicensed Medicines Steve TomlinConsultant Paediatric PharmacistHonorary Clinical Reader
2 Every Dose Is Different Is dosing in adults logical?One size fits all – useful for tabletsParacetamol, ranitidineWhen does a child become an adult?Mg/kgWhen can doses be rounded up or down?Paracetamol, cefuroximeIs Licensing Logical?Aciclovir
3 What do children take? Dose (mg) 30 60 120 250 500 Dosage form? Drops Liquid/meltLiquid/melt/ tabletTablet/ capsule
4 Therapeutic OrphansEurope - >50% of medicines used in children have never been tested in children.Conroy S, Br Med J. 2000, 320:79-82Australia - 25% of medicines licensed in children do not have appropriate formulations for children.Tan E, Med J Aust. 2003, 179(4):195-81/3 of research papers into children’s medicines did not allow for the work to be reproduced / 51% did not use a paediatric formulation.Standing J, Paediatrics. 2005, 116(4):Pandit S, Arch Dis Child. 2010, 95:
5 Unlicensed & Off-Label Medication Proportion of medicines used not licensed:80% Neonatal Intensive Care Unit (NICU)40% Paediatric Intensive Care (PICU)25% general paediatric in-patients11% children at homeNunn A, 2003, Arch Dis Child :
6 Policy statement Joint RCPCH/NPPG Standing Committee on Medicines ‘it is not necessary to take additional steps, beyond those taken when prescribing licensed medicines, to obtain the consent of parents, carers and child patients to prescribe or administer unlicensed medicines or licensed medicines for unlicensed applications.’Treatment Should Be The Best You Can Give!
7 Paediatric Patient Needs Age-appropriate formulationsType of formulation (liquid / solid)Dose flexibilityExcipients and levelsEase of dosing and compliancePalatabilityFrequency of dosingEase of manipulation (by carer)Perceptions of parent / carer?
8 What medicine are you getting? Licensed In Some ChildrenLicensed Adult MedicineImportSpecialExtemporaneously PreparedProduct aligned to Clinical Need
9 Intravenous Preparations Hospital Neonatal Unit31% of prescriptions < 1/10 vial4.8% of prescriptions <1/100 vialArch Dis Child. 2000; 834:92-6Dose calculations often involve decimal pointsUnits often have to change – how to labelStandard Concentrations
10 IV Formulation Benzyl alcohol harmful in infants contained in e.g. amiodarone and lorazepam injectionsShehab N, Pediatr Crit Care Med (2):Phenobarbital injection – 90% propylene glycol hyperosmolality in infants, pH 11Ibuprofen – lignocaine in premature babiesParacetamol – 10 x overdosesPhenytoin – need to dilute, but it precipitates
11 Oral Formulations Phenobarbital elixir BP – 38% alcohol Sugar or Sorbitol?Dispersible Tablets (aspirin and diclofenac)The history of nifedipineTuleu C, J of Drug Delivery Science & Tech (4):Captopril – bioequivalence?Mulla H, Arch Dis Child :Clobazam – what’s left in the bottleGlass ampoules for oral solutions?(vitamin K, Caffeine)
12 Import/export of captopril oral liquid 10578 miles each wayBMS, UKNo MA for childrenNot bioequivalent to:tabletscompounded liquidsBMS, Victoria, Australia12
13 Changing Medicines Crushing tablets can change profile Increase side effectsDecrease duration
14 Pharmaceutical Issues when Crushing, Opening or Splitting Oral Dosage Forms June 2011 Changing the way in which a dosage form is presented can alter its absorption characteristics, result in medicines instability, produce local irritant effects, cause failure to reach the site of action, may produce occupational health and safety issues, and could result in a preparation with an unacceptable taste... In most circumstances in which no appropriate licensed medicine is available, the prime objective should be to provide patients with a ready-to-use unlicensed medicine.
15 Other Routes INTRANASAL TOPICAL RECTAL Midazolam – why do they cry? Chlorhexidine – it just cleans the skin!!RECTALGlycerine ChipsParacetamol / Morphine
16 The Future Standardisation / Formulary BP? BNF-C? Directed Prescribing Defined Drop down boxesTighter Tariff