Pharmacovigilance in paediatric population
Corresponding Author(s) : Darawadi Bhuvana
parampharma@gmail.com
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 10 No. 3 (2022): 2022 Volume -10 - Issue 3
Abstract
Pharmacovigilance reflection was first published in the British Medical Journal in 1877 by chloroform issues. New era of the Pharmacovigilance was initiated by the children’s big issues related to teratogenic effects. To ensure the benefits of use of drugs out weights the risks & thus safe guard the health of the paediatric population. Pharmacology in paediatric population has specific needs in Pharmacovigilance. Altered pharmacokinetics and Pharmacodynamic of drugs make paediatric patients susceptible to drugs adverse drug reactions. A systemic review from past few years starting from 1877 considering the deaths noted due to its adverse effects. The WHO global individual case safety report data base reported the ADRs in children upto7.7% by using the spontaneous reporting system. It is necessary to develop a proactive Pharmacovigilance and patient safety programs with a focus in risk analysis and management, in which ADR reporting should be mandatory.
Keywords
Adverse drug reactions, Paediatric, Intensive Pharmacovigilance, Teratogenic effects.
1.
Darawadi Bhuvana, H. Parameshwar, SK Sahil Reza, A.V. Jithan. Pharmacovigilance in paediatric population. Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2022 Sep. 16 [cited 2025 Sep. 21];10(3):332-4. Available from: https://ijamscr.com/ijamscr/article/view/1238
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References
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7. Neubert A. Pharmacovigilance in pediatrics: current challenges. Paediatr Drugs. 2012 Feb;14(1):1-5. doi: 10.2165/11596590-000000000-00000, PMID 21999612.
8. Scheiman M, Gallaway M, Coulter R, Reinstein F, Ciner E, Herzberg C et al. Prevalence of vision and ocular disease conditions in a clinical pediatric population. J Am Optom Assoc. 1996;67(4):193-202. PMID 8888829.
9. 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 J Pharmacol. 2017;49(5):390-5. doi: 10.4103/ijp.IJP_256_17, PMID 29515280.
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References
1. Alvarez L, Rincon-Sánchez AR, Islas-Carbajal MC, Huerta-Olvera SG. BMC Pharmacol Toxicol. 2017; 18: Article number: 79.
2. Bouquet É, Star K, Jonville-Béra AP, Durrieu G. Pharmacovigilance in paediatrics. Therapie. 2018;73(2):171-80. doi: 10.1016/j.therap.2017.11.012, PMID 29598957.
3. De Las Salas R, Soto CMV. Pharmacovigilance in pediatric population. In: London: IntechOpen. doi: 10.5772/intechopen.82253; 2019. Pharmacovigilance [internet] Kothari CS, Shah M, Patel RM, editors [cited Apr 19 2022]. Available from: https://www.intechopen.com/chapters/65578doi.
4. Fabiano V, Mameli C, Zuccotti GV. Adverse drug reactions in newborns, infants and toddlers: pediatric pharmacovigilance between present and future. Expert Opin Drug Saf. 2012 Jan 1;11(1):95-105. doi: 10.1517/14740338.2011.584531, PMID 21548838.
5. Laurie S. Conklin MD,Eric P. Hoffman PhD,john van den anker MD, PhD, FCP 2019.
6. Meibohm B, Läer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005;7(2):E475-87. doi: 10.1208/aapsj070248, PMID 16353925.
7. Neubert A. Pharmacovigilance in pediatrics: current challenges. Paediatr Drugs. 2012 Feb;14(1):1-5. doi: 10.2165/11596590-000000000-00000, PMID 21999612.
8. Scheiman M, Gallaway M, Coulter R, Reinstein F, Ciner E, Herzberg C et al. Prevalence of vision and ocular disease conditions in a clinical pediatric population. J Am Optom Assoc. 1996;67(4):193-202. PMID 8888829.
9. 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 J Pharmacol. 2017;49(5):390-5. doi: 10.4103/ijp.IJP_256_17, PMID 29515280.
10. Bernd Meibohm, Knowledge Gaps in the Pharmacokinetics of Therapeutic Proteins in Pediatric Patients, Frontiers in Pharmacology, 10.3389/fphar.2022.847021, 13, (2022).
2. Bouquet É, Star K, Jonville-Béra AP, Durrieu G. Pharmacovigilance in paediatrics. Therapie. 2018;73(2):171-80. doi: 10.1016/j.therap.2017.11.012, PMID 29598957.
3. De Las Salas R, Soto CMV. Pharmacovigilance in pediatric population. In: London: IntechOpen. doi: 10.5772/intechopen.82253; 2019. Pharmacovigilance [internet] Kothari CS, Shah M, Patel RM, editors [cited Apr 19 2022]. Available from: https://www.intechopen.com/chapters/65578doi.
4. Fabiano V, Mameli C, Zuccotti GV. Adverse drug reactions in newborns, infants and toddlers: pediatric pharmacovigilance between present and future. Expert Opin Drug Saf. 2012 Jan 1;11(1):95-105. doi: 10.1517/14740338.2011.584531, PMID 21548838.
5. Laurie S. Conklin MD,Eric P. Hoffman PhD,john van den anker MD, PhD, FCP 2019.
6. Meibohm B, Läer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005;7(2):E475-87. doi: 10.1208/aapsj070248, PMID 16353925.
7. Neubert A. Pharmacovigilance in pediatrics: current challenges. Paediatr Drugs. 2012 Feb;14(1):1-5. doi: 10.2165/11596590-000000000-00000, PMID 21999612.
8. Scheiman M, Gallaway M, Coulter R, Reinstein F, Ciner E, Herzberg C et al. Prevalence of vision and ocular disease conditions in a clinical pediatric population. J Am Optom Assoc. 1996;67(4):193-202. PMID 8888829.
9. 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 J Pharmacol. 2017;49(5):390-5. doi: 10.4103/ijp.IJP_256_17, PMID 29515280.
10. Bernd Meibohm, Knowledge Gaps in the Pharmacokinetics of Therapeutic Proteins in Pediatric Patients, Frontiers in Pharmacology, 10.3389/fphar.2022.847021, 13, (2022).