BACKGROUND: Reported rates of unlicensed and off-label use of medicines in children raise concerns regarding overall access of children to medicines OBJECTIVE: To assess changes in availability of proprietary formulations suitable for infants and young children; licensing of medicines; and subsidization of medicines for children in New Zealand. METHODS: Review of the New Ethicals Catalogue, New Ethicals Compendium, product data sheets and the New Zealand Pharmaceutical Schedule covering the years 1998-2002 inclusive. RESULTS: There was a decrease in the total number of medicines licensed in New Zealand from 2014 to 1840; but there was an increase in the number and percentage of suitable formulations that were licensed for paediatric use from 616[31%] to 642[35%]. The number of suitable paediatric formulations that were subsidized decreased from 281[13.9%] to 260[14.1%]. The number of orally available chemical entities with suitable formulations, licensed and subsidized for paediatric use declined from 101[5.0%] to 94[5.1%], but all of these chemical entities that were withdrawn had therapeutic alternatives that were licensed and subsidized. Only 36% of new medicines that had licensing for children were licensed for the 0-23 month age group. CONCLUSION: There have been modest improvements in licensing of medicines for children in New Zealand from 1998 to 2002.
BACKGROUND: Reported rates of unlicensed and off-label use of medicines in children raise concerns regarding overall access of children to medicines OBJECTIVE: To assess changes in availability of proprietary formulations suitable for infants and young children; licensing of medicines; and subsidization of medicines for children in New Zealand. METHODS: Review of the New Ethicals Catalogue, New Ethicals Compendium, product data sheets and the New Zealand Pharmaceutical Schedule covering the years 1998-2002 inclusive. RESULTS: There was a decrease in the total number of medicines licensed in New Zealand from 2014 to 1840; but there was an increase in the number and percentage of suitable formulations that were licensed for paediatric use from 616[31%] to 642[35%]. The number of suitable paediatric formulations that were subsidized decreased from 281[13.9%] to 260[14.1%]. The number of orally available chemical entities with suitable formulations, licensed and subsidized for paediatric use declined from 101[5.0%] to 94[5.1%], but all of these chemical entities that were withdrawn had therapeutic alternatives that were licensed and subsidized. Only 36% of new medicines that had licensing for children were licensed for the 0-23 month age group. CONCLUSION: There have been modest improvements in licensing of medicines for children in New Zealand from 1998 to 2002.
Authors: S Conroy; I Choonara; P Impicciatore; A Mohn; H Arnell; A Rane; C Knoeppel; H Seyberth; C Pandolfini; M P Raffaelli; F Rocchi; M Bonati; G Jong; M de Hoog; J van den Anker Journal: BMJ Date: 2000-01-08
Authors: M Chalumeau; J M Tréluyer; B Salanave; R Assathiany; G Chéron; N Crocheton; C Rougeron; M Mares; G Bréart; G Pons Journal: Arch Dis Child Date: 2000-12 Impact factor: 3.791
Authors: Diana A van Riet-Nales; Karin E de Jager; Alfred F A M Schobben; Toine C G Egberts; Carin M A Rademaker Journal: Br J Clin Pharmacol Date: 2011-09 Impact factor: 4.335