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Pharmacovigilance reports of drug-related harms in children should include details on age- and drug-specific factors

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Abstract

The safety of medications in paediatric patients is influenced by age- and drug-specific features, but clinical information on specific risk of medicines in this population is limited. In order to provide essential information that will help prevent harm to children, pharmacovigilance reports should include data on the patient characteristics and circumstances involved in the reported adverse drug reaction.

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References

  1. Star K, Edwards IR. Pharmacovigilance for children’s sake. Drug Saf. 2014;37(2):91–8.

    Article  CAS  PubMed  Google Scholar 

  2. Permala J, Hassali MA, Awaisu A, et al. Dosing information in a standard drug reference: are pediatrics still therapeutically neglected? Pediatr Int. 2010;52(2):290–5.

    Article  PubMed  Google Scholar 

  3. Tan E, Cranswick NE, Rayner CR, et al. Dosing information for paediatric patients: are they really “therapeutic orphans”? Med J Aust. 2003;179(4):195–8.

    PubMed  Google Scholar 

  4. Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin Pharmacol Ther. 2012;91(5):796–801.

    Article  CAS  PubMed  Google Scholar 

  5. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002;54(6):665–70.

    Article  PubMed Central  PubMed  Google Scholar 

  6. Bellis JR, Kirkham JJ, Nunn AJ, et al. Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital. Br J Clin Pharmacol. 2014;77(3):545–53.

    Article  CAS  PubMed  Google Scholar 

  7. Bellis JR, Kirkham JJ, Thiesen S, et al. Adverse drug reactions and off-label and unlicensed medicines in children: a nested case–control study of inpatients in a pediatric hospital. BMC Med. 2013;11:238.

    Article  PubMed  Google Scholar 

  8. Pawar S, Kumar A. Issues in the formulation of drugs for oral use in children: role of excipients. Paediatr Drugs. 2002;4(6):371–9.

    Article  PubMed  Google Scholar 

  9. Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology: drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157–67.

    Article  CAS  PubMed  Google Scholar 

  10. Kearns GL, Wilson JT, Neville KA, et al. Drug therapy in pediatric patients. In: van Boxtel CJ, Santoso B, Edwards IR, editors. Drug benefits and risks international textbook of clinical pharmacology. 2nd ed. Amsterdam: IOS Press; 2008. p. 181–201.

    Google Scholar 

  11. Kennedy M. Hormonal regulation of hepatic drug-metabolizing enzyme activity during adolescence. Clin Pharmacol Ther. 2008;84(6):662–73.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  12. Wong IC, Ghaleb MA, Franklin BD, et al. Incidence and nature of dosing errors in paediatric medications: a systematic review. Drug Saf. 2004;27(9):661–70.

    Article  PubMed  Google Scholar 

  13. Conroy S, Sweis D, Planner C, et al. Interventions to reduce dosing errors in children: a systematic review of the literature. Drug Saf. 2007;30(12):1111–25.

    Article  PubMed  Google Scholar 

  14. Carmichael M. Drug safety: double jeopardy. Nature. 2013;498(7455):S14–5.

    Article  CAS  PubMed  Google Scholar 

  15. Diller L. Clinical practice: adult primary care after childhood acute lymphoblastic leukemia. N Engl J Med. 2011;365(15):1417–24.

    Article  CAS  PubMed  Google Scholar 

  16. Choonara I. Educational paper: aspects of clinical pharmacology in children—pharmacovigilance and safety. Eur J Pediatr. 2013;172(2):577–80.

    Article  CAS  PubMed  Google Scholar 

  17. Menniti-Ippolito G, Raschetti R, Da Cas R, et al. Active monitoring of adverse drug reactions in children. Italian Paediatric Pharmacosurveillance Multicenter Group. Lancet. 2000;355(9215):1613–4.

    Article  CAS  PubMed  Google Scholar 

  18. Couper MR, Kaplan SE. Promoting safety of medicines in children. Geneva: World Health Organisation; 2007.

    Google Scholar 

Download references

Disclosure

This article was adapted from Drug Safety 2014;37(2):91–8 [1]. The preparation of these articles was not supported by any external funding.

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Adis Medical Writers. Pharmacovigilance reports of drug-related harms in children should include details on age- and drug-specific factors. Drugs Ther Perspect 30, 298–301 (2014). https://doi.org/10.1007/s40267-014-0127-3

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  • DOI: https://doi.org/10.1007/s40267-014-0127-3

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