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Parental reporting of adverse drug events and other drug-related problems in children in Finland

  • Pharmacoepidemiology and Prescription
  • Published:
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Abstract

Purpose

Drug-related problems (DRPs) are common in paediatric pharmacotherapy, but few studies describe them from the parents’ perspective. In the present survey, we have investigated the lifetime prevalence and type of DRPs in children in Finland.

Methods

This was a population-based survey of a random sample of 6,000 children below 12 years of age in 2007. A questionnaire was sent to their parents. The final response rate was 67% with a study population of 4,032. The main outcome measure was the lifetime prevalence and type of DRPs.

Results

The lifetime prevalence of DRPs was 21% (95% CI 20–22). The most common (82%) of the 1,346 reported DRPs were adverse drug events (ADEs). The prevalence of ADEs was 17% (95% CI 16–19), that of other DRPs 5.2% (95% CI 4.5–5.9). The prevalence of serious ADEs was 0.4% and that of unexpected ADEs was 0.8%. The most common system involved in the ADEs was the gastrointestinal tract, comprising 34% of the 1,106 ADEs. The most common of the 240 other DRPs were problems with the administration and dosing of medicine (86%). Overall, 64% of DRPs were related to anti-infectives.

Conclusions

One fifth of the Finnish children below 12 years of age had experienced DRPs. Appropriate counselling, including possible adverse drug reactions and dosing directions, is important for parents and children at both the prescribing and dispensing of medicines for paediatric patients. Reporting of any suspected serious or unexpected ADEs is an essential part of efficient pharmacovigilance in paediatrics.

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Abbreviations

DRP:

Drug-related problem

ADE:

Adverse drug event

ADR:

Adverse drug reaction

EMA:

European Medicines Agency

ATC:

Anatomical therapeutic chemical

MedDRA®:

Medical Dictionary for Regulatory Activities

SOC:

System organ class in MedDRA®

LLT:

Low level terms in MedDRA®

NSAID:

Non-steroidal anti-inflammatory drug

SmPC:

Summary of product characteristics

CI:

Confidence interval

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Acknowledgements

We thank Johanna Kuusamo (JK) for having arranged the parallel classification of other DRPs.

Financial disclosure and conflict of interest

No external funding was used to conduct this population survey. All the work was done at the School of Pharmacy, University of Eastern Finland. The costs were covered by the School. None of the authors has any professional affiliation, financial agreement, or other involvement with any company that might constitute a conflict of interest regarding this manuscript.

All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

Author information

Authors and Affiliations

  1. School of Pharmacy, Social Pharmacy, Faculty of Health Sciences, University of Eastern Finland, P.O. Box 1627, 70211, Kuopio, Finland

    L. Lindell-Osuagwu, K. Sepponen & K. Vainio

  2. Mistvale Chemist, Folkestone, UK

    S. Farooqui

  3. Department of Anaesthesiology and Intensive Care, Kuopio University Hospital, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland

    H. Kokki

  4. Finnish Medicines Agency, Helsinki, Finland

    K. Hämeen-Anttila

Authors
  1. L. Lindell-Osuagwu
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  2. K. Sepponen
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  3. S. Farooqui
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  4. H. Kokki
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  5. K. Hämeen-Anttila
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  6. K. Vainio
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Corresponding author

Correspondence to L. Lindell-Osuagwu.

Additional information

All six authors are responsible for the reported research. LLO, KS, HK, KHA and KV participated in design of the survey. LLO, KS, KHA and KV participated in the acquisition of data. LLO, KS, SF, HK, and KV participated in the analysis and interpretation of data. All authors participated in drafting the article or revising it for content. All authors approve the manuscript as published

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Lindell-Osuagwu, L., Sepponen, K., Farooqui, S. et al. Parental reporting of adverse drug events and other drug-related problems in children in Finland. Eur J Clin Pharmacol 69, 985–994 (2013). https://doi.org/10.1007/s00228-012-1426-z

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  • DOI: https://doi.org/10.1007/s00228-012-1426-z

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