Evidence map›Paper›PMID 21477143›Full record

ArticleBritish journal of clinical pharmacology2011

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

Diana A van Riet-Nales, Karin E de Jager, Alfred F A M Schobben, Toine C G Egberts, Carin M A Rademaker

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Article in British journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  17. Toxic excipients in medications for neonates in Brazil.European journal of pediatrics · 2014
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Diana A van Riet-NalesNational Institute for Public Health and the Environment, Centre for Quality of Chemical Pharmaceutical Products, Bilthoven, The Netherlands. diana.van.riet@rivm.nl
Karin E de Jager
Alfred F A M Schobben
Toine C G Egberts
Carin M A Rademaker

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo study the number of medicines and active chemical entities that are authorized and commercially available for children in the Netherlands and to evaluate the age-appropriateness of the available paediatric medicines.

methodsThe availability of paediatric medicines and active chemical entities was studied with the help of a Dutch medicines database and the Summary of Product Characteristics. Medicines were categorized with respect to their route of administration, type of oral dosage form and therapeutic category. The age-appropriateness was assessed on three aspects: dose capability, suitability of the dosage form and inclusion of potentially harmful excipients.

resultsThree thousand five hundred and forty-two paediatric medicines containing 703 different active chemical entities were identified. This equalled half of all the medicines and chemical entities available for human use. The percentage of paediatric medicines increased with age and varied for the route of administration from 22% (dermal) to 81% (inhalation) and for the therapeutic category from 11% (uro-genital, sex hormones) to 89% (anti-parasites). The appropriateness of the paediatric medicines with respect to their authorization status, dose capability and dosage form increased with age from 27-88%. Fifty-two percent of all oral paediatric liquid formulations contained a potentially harmful excipient.

conclusionThis study confirms the limited availability of paediatric medicines for a broad range of therapeutic areas and shows that paediatric medicines may not be age-appropriate, even if authorized. While confirming the need for a legislative incentive, the results also provide baseline information for an estimation of the effect of the European Paediatric Regulation in the near future.

Indexed as

Health Knowledge, Attitudes, PracticeAdolescentAge FactorsChildChild, PreschoolDrug ApprovalHumansInfantNetherlandsPharmaceutical PreparationsPractice Patterns, Physicians'Pharmaceutical Preparations

Identifiers

PMID21477143
PMCPMC3175516

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.