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Documentation of Pediatric Drug Safety in Manufacturers’ Product Monographs

A Cross-Sectional Evaluation of the Canadian Compendium of Pharmaceuticals and Specialities

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Abstract

Objective: To describe the provision of pediatric drug safety information in a national formulary of manufacturers’ drug product monographs.

Methods: We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada.

Results: A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary.

Conclusion: We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.

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Acknowledgments

This research was funded by the Samuel Lunenfeld Summer Research Program. Dr C. Parshuram is a Career Scientist of the Ontario Ministry of Health and Long Term Care. At the time this research was carried out, L.L. Dupuis was a member of the Editorial Advisory Panel, Compendium of Pharmaceuticals and Specialties, Canadian Pharmacists Association.

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Authors and Affiliations

  1. Department of Critical Care Medicine, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada

    Navjeet K. Uppal &  Christopher S. Parshuram

  2. Centre for Safety Research, Hospital for Sick Children, Toronto, Ontario, Canada

    Navjeet K. Uppal, Lee L. Dupuis &  Christopher S. Parshuram

  3. Department of Pharmacy, Hospital for Sick Children, Toronto, Ontario, Canada

    Lee L. Dupuis

  4. Child Health Evaluative Sciences Program, The Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada

    Lee L. Dupuis &  Christopher S. Parshuram

  5. Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada

    Lee L. Dupuis

  6. Department of Paediatrics, Hospital for Sick Children, Toronto, Ontario, Canada

    Christopher S. Parshuram

  7. Department of Paediatrics, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    Christopher S. Parshuram

  8. Interdepartmental Division of Critical Care Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    Christopher S. Parshuram

  9. Department of Health Policy Management and Evaluation, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

    Christopher S. Parshuram

Authors
  1. Navjeet K. Uppal
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  2. Lee L. Dupuis
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  3. Christopher S. Parshuram
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Corresponding author

Correspondence to Christopher S. Parshuram.

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Uppal, N.K., Dupuis, L.L. & Parshuram, C.S. Documentation of Pediatric Drug Safety in Manufacturers’ Product Monographs. Pediatr-Drugs 10, 193–197 (2008). https://doi.org/10.2165/00148581-200810030-00007

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  • DOI: https://doi.org/10.2165/00148581-200810030-00007

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