139: Standards for Creating a Paediatric Drug Monograph

Abstract

BACKGROUND: Adherence to a formulary is essential for rational use of pharmaceuticals. Children represent a unique and challenging population: while efforts toward adult drug monograph formation have been successful, currently many countries lack a standardized formulary for drug therapy in children. Off-label drug use has been associated with an increased risk for adverse drug reactions. Furthermore, paediatric dosing is subject to a high rate of medication errors. Drug monographs (DMs) convey dosing recommendations and evidence supporting therapeutic use in specific populations. The lack of standardized paediatric DMs creates a problem for health care providers, researchers and parents as missing information often results in clinicians choosing the drug, dose and duration of therapy based on personal experience and Institutional recommendations rather than evidence. Current developmental pharmacology indicates that many paediatric subgroups require special dosing considerations, such as premature infants, neonates and obese children. Data on dosing in these populations is very rarely displayed in DMs tailored to the adult population. OBJECTIVES: To develop international standards for developing a paediatric DMs. DESIGN/METHODS: Following an international environmental scan of existing national formularies a committee of experts in paediatric therapeutics was established. It established a survey of essential items to be included in a paediatric DM to be completed via an International Delphi process. The survey covered areas including search criteria, age groups, adverse drug reactions and overdose, drug-drug interactions, dosing, precautions, formulation, drug properties, and lactation/breastfeeding. Participants from 36 countries spanning six continents were invited to participate in the first round of the Delphi in December 2014. RESULTS: Preliminary results include only the first 11 complete responses received. The majority of participants first consult a paediatric formulary (60%) when searching for information to select, prescribe, dispense, administer, monitor and advise on medicines for children. The remaining participant's first source of information was the hospital formulary or a generic search engine (such as google). The most frequently consulted resource for consult was the British National Formulary for Children followed by Paediatric and Neonatal Lexi-drugs, Kinderformularium, NeoFax and the New Zealand formulary for Children. Further DM content specific results will be available at a later date. CONCLUSION: Preliminary results support the importance of developing standards for paediatric DMs as they are most frequently a first point of contact for information regarding paediatric dosing.