Access to prescribing information for paediatric medicines in the USA: Post-modernization

Abstract

AIMS: The aims of the present study were to examine the Physicians' Desk Reference (PDR) for changes in the listing of medicines licensed for children in the USA over a 10-year period (1998-2007). METHODS: The USA PDR was used to identify products listed in 1998, 2002 and 2007. Information about generic name (active agent), salt, strength, brand name, suitability of formulation, paediatric licensing information and the lowest age of licensing was extracted. Prescription products were collapsed down to chemical entities/fixed-dose combinations. RESULTS: Of the prescription entities listed in the PDR, 538 (55.9%), 488 (54.3%) and 394 (51.3%) were licensed for children in 1998, 2002 and 2007, respectively. There was a 39% decrease in the number of entities licensed for the newborn and a 34% decrease for children aged 2-6 years between 1998 and 2007. Formulations suitable for children were listed for 611 (63.4%), 550 (61.2%) and 430 (60.6%), respectively. Prescription entities with both a suitable oral formulation and licensing for children numbered 161 (16.7%), 148 (16.5%) and 100 (14.1%) in 1998, 2002 and 2007, respectively. CONCLUSIONS: The listings in the PDR suggest that overall access to prescribing information about drugs in the paediatric population has not shown an increase over the decade. This particularly affected the neonatal age group. © 2009 The Authors.