Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Sep 14;15(9):1148.
doi: 10.3390/ph15091148.

Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care

Anne T M Dittrich  1 , Nori J L Smeets  2 , Emma F M de Jong  1 , Juliët L Kämink  1 , Yvet Kroeze  1   3 , Jos M Th Draaisma  1 , Eugène P van Puijenbroek  4   5 , D Maroeska W M Te Loo  2   6
Affiliations

Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care

Anne T M Dittrich et al. Pharmaceuticals (Basel). .

Abstract

For drug safety in pediatric patients, knowledge about adverse drug reactions (ADRs) is essential to balance benefits and risks, especially because of the high incidence of off-label drug use. However, underreporting of ADRs is a serious problem, leading to a deficit in knowledge affecting clinical practice. The aim of this study is to find a method by which we can improve the quantity of ADR reporting while maintaining or improving the quality of the ADR reports. This was done in several steps. First, health care providers were educated to increase awareness of ADRs. Thereafter, a novel active supporting system was introduced, where reporting ADRs was simplified; if clinical physicians suspected an ADR, they only had to send the name or hospital number of the patient, the observed ADR, and the suspected drug to a supportive team. This team collects all information needed about the possible ADR from the patient's medical records and hospital charts. With this information, the supportive team fills in the forms necessary for reporting ADRs to the nationwide pharmacovigilance centre Lareb. With this system, the quantity of ADR reports from both inpatients and outpatients rose dramatically. Subsequently, the quality of the obtained ADR reports was measured using the ClinDoc and vigiGrade systems. This study shows there is no loss of quality of the ADR reports in the active reporting system compared to spontaneous reporting systems. Based on the data of the present study, we suggest that an active reporting system has the potential to increase our knowledge about ADRs in pediatric patients.

Keywords: active reporting ADRs; adverse drug reactions; drug safety; pharmacovigilance; quality of ADR reports.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Literature search results.
Figure 2
Figure 2
Results from vigiGrade: overview of reports in each category for Group A and Group B separately. Total percentage of reports within the two categories; the total absolute number of reports in the category is noted below the percentage.
Figure 3
Figure 3
ClinDoc results: overview of the proportion of reports in each category for Group A and Group B separately. Total percentage of reports within the three categories (well, moderately, or poorly); the total absolute number of reports in the category is noted below the percentage.
Figure 4
Figure 4
Literature search.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Khan L.M. Comparative epidemiology of hospital-acquired adverse drug reactions in adults and children and their impact on cost and hospital stay—A systematic review. Eur. J. Clin. Pharmacol. 2013;69:1985–1996. doi: 10.1007/s00228-013-1563-z. - DOI - PubMed
    1. Sultana J., Cutroneo P., Trifiro G. Clinical and economic burden of adverse drug reactions. J. Pharmacol. Pharmacother. 2013;4((Suppl. 1)):S73–S77. doi: 10.4103/0976-500X.120957. - DOI - PMC - PubMed
    1. Allen H.C., Garbe M.C., Lees J., Aziz N., Chaaban H., Miller J.L., Johnson P., DeLeon S. Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature. J. Okla. State Med. Assoc. 2018;111:776–783. - PMC - PubMed
    1. Cuzzolin L., Atzei A., Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety. Expert Opin. Drug Saf. 2006;5:703–718. doi: 10.1517/14740338.5.5.703. - DOI - PubMed
    1. Choonara I., Conroy S. Unlicensed and off-label drug use in children: Implications for safety. Drug Saf. 2002;25:1–5. doi: 10.2165/00002018-200225010-00001. - DOI - PubMed