Literature DB >> 19220278

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

Larissa Young1, Francis Lawes, June Tordoff, Pauline Norris, David Reith.   

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.

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Year:  2008        PMID: 19220278      PMCID: PMC2675045          DOI: 10.1111/j.1365-2125.2008.03356.x

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN: 0306-5251            Impact factor:   4.335


  9 in total

1.  Changes in availability of paediatric medicines in Australia between 1998 and 2002.

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2.  Establishing a baseline for the monitoring of medicines availability for children in the UK: 1998-2002.

Authors:  Komathi Balakrishnan; June Tordoff; Pauline Norris; David Reith
Journal:  Br J Clin Pharmacol       Date:  2006-07-26       Impact factor: 4.335

3.  Peer-reviewed publication of clinical trials completed for pediatric exclusivity.

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4.  Pediatric licensing status and the availability of suitable formulations for new medical entities approved in the United States between 1998 and 2002.

Authors:  Komathi Balakrishnan; Joanne Grieve; June Tordoff; Pauline Norris; David Reith
Journal:  J Clin Pharmacol       Date:  2006-09       Impact factor: 3.126

5.  Economic return of clinical trials performed under the pediatric exclusivity program.

Authors:  Jennifer S Li; Eric L Eisenstein; Henry G Grabowski; Elizabeth D Reid; Barry Mangum; Kevin A Schulman; John V Goldsmith; M Dianne Murphy; Robert M Califf; Daniel K Benjamin
Journal:  JAMA       Date:  2007-02-07       Impact factor: 56.272

6.  Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial.

Authors:  Robert S Bresalier; Robert S Sandler; Hui Quan; James A Bolognese; Bettina Oxenius; Kevin Horgan; Christopher Lines; Robert Riddell; Dion Morton; Angel Lanas; Marvin A Konstam; John A Baron
Journal:  N Engl J Med       Date:  2005-02-15       Impact factor: 91.245

7.  Pediatric drug formulations: challenges and potential solutions.

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8.  Effect of the pediatric exclusivity provision on children's access to medicines.

Authors:  Joanne Grieve; June Tordoff; David Reith; Pauline Norris
Journal:  Br J Clin Pharmacol       Date:  2005-06       Impact factor: 4.335

9.  Trends in accessibility to medicines for children in New Zealand: 1998-2002.

Authors:  Jocelyn Chui; June Tordoff; Julia Kennedy; David Reith
Journal:  Br J Clin Pharmacol       Date:  2004-03       Impact factor: 4.335

  9 in total
  5 in total

1.  Access to children's medicines in the United Kingdom, Australia and New Zealand in 1998, 2002 and 2007.

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Review 2.  Two decades of off-label prescribing in children: a literature review.

Authors:  Shamala Balan; Mohamed Azmi Ahmad Hassali; Vivienne S L Mak
Journal:  World J Pediatr       Date:  2018-09-14       Impact factor: 2.764

3.  The availability and age-appropriateness of medicines authorized for children in The Netherlands.

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

4.  Developing drugs for children and the adjustment of medication-is it a new challenge or an adaptation of past ideas?

Authors:  Pascale Gauthier; Jean-Michel Cardot
Journal:  J Pers Med       Date:  2011-12-06

5.  Availability of pediatric-evaluated formulations in Serbia.

Authors:  Bojana Božić; Sanja Stupar; Duško Stupar; Uroš Babić; Milica Bajčetić
Journal:  Indian J Pharmacol       Date:  2017 Mar-Apr       Impact factor: 1.200

  5 in total

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