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Pharmacovigilance for Children’s Sake

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Abstract

Child age-specific information on efficacy and risk of medicines can be limited for healthcare professionals and patients. It is therefore very important to make the best use of a risk planned approach to the pharmacological treatment of children. This means pharmacovigilance in the broadest sense of gaining the best data from the use of medicines in clinical practice. We consider issues that complicate safe medication use in paediatric care, as well as current progress and provide suggestions for building knowledge within paediatric pharmacovigilance to be used to minimise patient harm. The continuous development in children constitutes a challenge to prescribing and administering age-suitable doses for individual children. Children are not only different from adults but differ vastly within their own age group. Physical growth during childhood is apparent to the eye, but less obvious is the ongoing maturation of organ function important for drug disposition and action. Systematic issues such as medication errors, off-label use and the lack of age-suitable formulations are considerable obstacles for safe medication use in paediatrics. The recognition of emerging adverse drug reactions could be more challenging in developing children. Initiatives to improve the situation have been made by the WHO and regulators in the USA and EU. Age-specific changes in physiology, pharmacology and psychology, as well as systematic issues specific for children need to be considered in the work of assessing spontaneous reports in children. Pharmacovigilance needs to broaden its aims considerably beyond merely capturing new associations between drugs and events, and encompass careful collection on patient characteristics and circumstances around the reported adverse drug reaction to provide essential information that will give clues on how to prevent harm to children.

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Acknowledgments

No sources of funding were used to assist in the preparation of this article. Kristina Star and I. Ralph Edwards have no conflicts of interest that are directly relevant to the content of this article. The opinions and conclusions in this study are not necessarily those of the various national pharmacovigilance centres or of the WHO.

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Authors and Affiliations

  1. Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Box 1051, S-751 40, Uppsala, Sweden

    Kristina Star & I. Ralph Edwards

  2. Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden

    Kristina Star

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  1. Kristina Star
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  2. I. Ralph Edwards
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Correspondence to Kristina Star.

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Star, K., Edwards, I.R. Pharmacovigilance for Children’s Sake. Drug Saf 37, 91–98 (2014). https://doi.org/10.1007/s40264-013-0133-8

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