Access to prescribing information for paediatric medicines in the USA: post‐modernization

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Children have reduced access to medicines because of inadequate prescribing information and paucity of suitable formulations. • The USA has implemented a series of measures designed to improve the licensing of medicines for children, which has resulted in an increase in the number of studies and the number of patients studied in investigational trials of medicines in children. • These measures have increased the number of targeted medicines that have had their labelled use extended to children. WHAT THIS STUDY ADDS • Information in the Physicians' Desk Reference did not indicate that there was an improvement in overall access to, and prescribing information about, drugs in the paediatric population in the USA over the time period 1998–2007. 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.