Pharmacovigilence in pediatrics
Abstract
Pharmacovigilance plays a pivotal role in paediatric care by monitoring and evaluating ADRs to improve patient safety and treatment outcomes. Children's physiological differences from adults necessitate targeted research to understand how they respond to medications, underlining the importance of this study: A systemic review of the previous 10 years (2010–2019) published studies were taken into consideration to describe observational studies on ADRs and to determine the incidence and characteristics of ADRs in paediatrics. Electronic relevant literature was searched in PMC, PubMed, Google Scholar, and Ovides’databases using MESH heading and text words. The titles, text, and abstracts were checked for patients below 18 years of age, nature of ADRs, observational studies (prospective or retrospective), and maximum information was recorded to count their frequency. The studies which discussed specific or particular drug exposures were not selected in this review. Of the 36,689 titles retrieved; 27 studies were selected for full-text review. Ten observational studies were added in the final review. Observational studies on paediatric were carried out in seven distinct nations.
Keywords:
Pharmacovigilance, paediatrics, adverse drug reactions, teratogenic effects, clinical trials
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References
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https://www.researchgate.net/publication/248995990
https://doi.org/10.1002/jcph.1115
2. Bouuquet É, Star K, Jonville-Béra AP, Durrieu G. Pharmacovigilance in pediatrics.
Therapies. 2018 Apr 1;73(2):171-80.
https://doi.org/10.1016/j.therap.2017.11.012
3. Sandes V, Figueras A, Lima EC. Pharmacovigilance Strategies to Address Resistanceto Antibiotics and Inappropriate Use—A Narrative Review. Antibiotics. 2024 May 16;13(5):457.
https://doi.org/10.3390/antibiotics13050457
4. Conroy S, McIntyre J, Choonara I, Stephenson T. Drug trials in children: problems and the way forward. British journal of clinical pharmacology. 2000 Feb;49(2):93. https://doi.org/10.2165/00002018-200326080-00001
5. Patsuree A, Krska J, Jarernsiripornkul N. Experiences relating to adverse drug reactions in the community: a cross-sectional survey among patients and the general public in Thailand. Expert opinion on drug safety. 2016 Mar 3;15(3):287-95.
https://doi.org/10.1517/14740338.2016.1135127
6. levitzen S, Dubrall D, Toni I, Stingl J, Christ P, Köberle U, Schmid M, Neubert A, Sachs B. Adverse drug reactions in children: comparison of reports collected in a pharmacovigilance project versus spontaneously collected ADR reports. Pediatric Drugs. 2023 Mar;25(2):203-15
https: //doi.org/10.1007/s40272-022-00540-z
7. Khan Z, Karataş Y, Kıroğlu O. Evaluation of adverse drug reactions in paediatric patients: a retrospective study in Turkish hospital. Frontiers in pharmacology. 2021 Nov 12;12:786182
https://doi.org/10.3389/fphar.2021.786182
8. Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati
Incidence of adverse drug reactions in paediatric in/out‐patients: a systematic review and meta‐analysis of prospective studies. British journal of clinical pharmacology. 2001 Jul;52(1):77-83.
https://doi.org/10.1046/j.0306-5251.2001.01407.x
9. Liu M, McPeek Hinz ER, Matheny ME, Denny JC, Schildcrout JS, Miller RA, Xu H. Comparative analysis of pharmacovigilance methods in the detection of adverse drug reactions using electronic medical records. Journnformatics Aal of the American Medical Issociation. 2013 May 1;20(3):420-6.
https://doi.org/10.1136/amiajnl-2012-001119
10. Dubrall D, Leitzen S, Toni I, Stingl J, Schulz M,
Schmid M, Neubert A, Sachs B. Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs. BMC Pharmacology and Toxicology. 2021 Dec;22:1-6.
https://doi.org/10.1186/s40360-021-00520-y1
11. Dubrall D, Leitzen S, Toni I, Stingl J, Schulz M, Schmid M, Neubert A, Sachs B. Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs. BMC Pharmacology and Toxicology. 2021 Dec;22:1-6.
https://doi.org/10.1186/s40360-021-00520-y
12. Dubrall D, Leitzen S, Toni I, Stingl J, Schulz M, Schmid M, Neubert A, Sachs B. Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs. BMC Pharmacology and Toxicology. 2021 Dec;22:1-6.
https://doi.org/10.1186/s40360-021-00520-y
13. Neubert A. Pharmacovigilance in pediatrics: current challenges. Pediatric Drugs. 2012 Feb;14:1-5.
https://doi.org/10.2165/11596590-000000000-00000
14. Scheiman M, Gallaway M, Coulter R, Reinstein F, Ciner E, Herzberg C, Parisi M. Prevalence of vision and ocular disease conditions in a clinical pediatric population. Journal of the American Optometric Association. 1996 Apr 1;67(4):193-202.
https://doi.org/10.1111/j.1755-3768.1980.tb04576.x
15. Sharma PK, Misra AK, Gupta N, Khera D, Gupta A, Khera P. Pediatric pharmacovigilance in an institute of national importance: Journey has just begun. Indian Journal of Pharmacology. 2017 Sep 1;49(5):390-5. https://doi.org/10.1186/s43054-020-00038-8
16. Meibohm B. Knowledge gaps in the pharmacokinetics of therapeutic proteins in pediatric patients. Frontiers in Pharmacology. 2022 Feb 10;13:847021.7021. https://doi.org/10.3389/fphar.2022.847021
17. Meibohm B. Knowledge gaps in the pharmacokinetics of therapeutic proteins in pediatric patients. Frontiers in Pharmacology. 2022 Feb 10;13:847021.7021. https://doi.org/10.3389/fphar.2022.847021
18. Aagaard L, Strandell J, Melskens L, Petersen PS, Hansen EH. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase™. Drug safety. 2012 Dec;35:1171-82.
https://doi.org/10.1007/BF03262002
19. Star K, Norén GN, Nordin K, Edwards IR. Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase. Drug safety. 2011 May;34:415-28.
https://doi.org/10.2165/11587540-000000000-00000
20. Zyryanov SK, Butranova OI, Chenkurov MS. Chloramphenicol: new possibilities of the old drug. Obstetrics and Gynecology. 2021 Nov 15(11):81-94. https://doi.org/10.18565/aig.2021.11.81-94
21. Hwisa NT, Gindi S, Rao CB, Katakam P, Rao Chandu B. Evaluation of Antiulcer Activity of Picrasma Quassioides Bennett Aqueous Extract in Rodents. Vedic Res. Int. Phytomedicine. 2013;1:27.
https://www.researchgate.net/publication/248995990
Published
15/08/2025
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[1]
A. P, “Pharmacovigilence in pediatrics”, Int J Indig Herb Drug, vol. 10, no. 3, pp. 23-27, Aug. 2025.
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Review Articles
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