Healthy Skepticism Library item: 10558

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Publication type: Journal Article

Balakrishnan K, Tordoff J, Norris P, Reith D.
Establishing a baseline for the monitoring of medicines availability for children in the UK: 1998-2002.
Br J Clin Pharmacol 2007 Jan; 63:(1):85-91
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2125.2006.02729.x

Abstract:

AIM: To determine changes in the availability, in terms of licensing and formulations, of medicines for children in the UK between 1998 and 2002.

METHODS: Using the Association of British Pharmaceutical Industry (ABPI) Compendium of Data Sheets and Summaries of Product Characteristics (SPC) 1998 and the Medicines Compendium 2002, licensed medicines available in the UK in the calendar years 1998 and 2002 were examined.

RESULTS: In 1998, 61% of chemical entities/fixed-dose combinations were licensed in some form for children compared with 64% in 2002. Of the chemical entities/fixed-dose combinations with oral formulations, 250 (33%) in 1998 had an oral formulation suitable for use by children and in 2002 there were 284 (34%). Of the 129 new chemical entities registered in the UK between 1998 and 2002, only 30 (23%) were licensed for under the age of 12 years and 19 (15%) for the neonatal age group. A total of 480 medicines licensed for children were withdrawn from marketing but only cisapride and primidone had no generic or therapeutic alternatives.

CONCLUSION: Although there was improvement in the availability of medicines for children in the UK over the 5-year period (1998-2002), considerable inequities still existed between children and adults.

Keywords:
MeSH Terms: Child Child, Preschool Drug Approval/statistics & numerical data* Drug Therapy/trends* Great Britain Humans Infant Legislation, Drug Pediatrics/trends* Pharmaceutical Preparations/supply & distribution* Substances: Pharmaceutical Preparations