Research on medication errors in pediatric population based on FAERS database_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Panda ^1,2,3,4,5 , NI Yuanming ^1,2,3,4,5 , HUANG Liang ^2,3,4,5 , JIA Zhijun ^1,2,3,4,5 , CHENG Guo ^5,6,7 , ZHANG Wei ^8,9 ,  LI Hailong ^2,3,4,5 , ZHANG Lingli ^2,3,4,5,8,10

1. West China School of Pharmacy, Sichuan University, Chengdu 610041, P. R. China;
2. Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. Children's Medicine Key Laboratory of Sichuan Province, Chengdu 610041, P. R. China;
4. NMPA Key Laboratory for Technical Research on Drug Products in vitro and in vivo Correlation, Chengdu 610041, P. R. China;
5. Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu 610041, P. R. China;
6. Department of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu 610041, P. R. China;
7. Laboratory of Molecular Translational Medicine, Center for Translational Medicine, Sichuan University, Chengdu 610041, P. R. China;
8. West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
9. Medical Big Data Center, Sichuan University, Chengdu 610041, P. R. China;
10. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding?author：

LI Hailong, Email: lhl_stat@scu.edu.cn

Keywords：

Medication error; Child; Pediatric; Adolescent; FAERS; Signal mining

DOI：

10.7507/1672-2531.202508099

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective This study aimed to characterize the adverse reactions related to medication errors (MEs) in pediatric population reported in the US Food and Drug Administration Adverse Event Reporting System (FAERS), and to identify the signals for different drug MEs. Methods Data from pediatric MEs reports in the FAERS from January 1, 2004, to December 1, 2022, were collected. MEs reports were categorized by patient age groups, MEs, and anatomical therapeutic chemical classification system. Disproportionality analyses were performed. Results A total of 16 515 MEs reports were retrieved. Psychostimulants and immunosuppressants were the most frequently reported drugs. Administration errors (72.4%) were most frequent, followed by prescription errors (7.1%) and storage errors (3.9%). In infants (1 year), ibuprofen and paracetamol were the most frequently reported, and MEs signals were found for dose and administration errors. In children (2-11 years), methylphenidate and somatropin recombinant were the most frequently reported, and MEs signals were found for dose omission and prescription errors. In adolescents (12-18 years), somatropin recombinant and adalimumab were the most frequently reported, and MEs signals were found for dose errors. Conclusion This study systematically analyzed pediatric MEs reported in the FAERS database, identifying age-specific high-risk drugs and common error types, and noting that some high-frequency reports may be influenced by reporting mechanisms. Combined with domestic monitoring data and clinical practice experience, the findings highlight the need for age-targeted prescription review, pharmacist involvement, and medication education to reduce pediatric MEs and improve medication safety.

Citation： QIU Panda, NI Yuanming, HUANG Liang, JIA Zhijun, CHENG Guo, ZHANG Wei, LI Hailong, ZHANG Lingli. Research on medication errors in pediatric population based on FAERS database. Chinese Journal of Evidence-Based Medicine, 2026, 26(4): 407-413. doi: 10.7507/1672-2531.202508099 Copy

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2.	Carnovale C, Mazhar F, Pozzi M, et al. A characterization and disproportionality analysis of medication error related adverse events reported to the FAERS database. Expert Opin Drug Saf, 2018, 17(12): 1161-1169.
3.	Maurette P. To err is human: building a safer health system. Ann Fr Anesth Reanim, 2002, 21(6): 453-454.
4.	Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA, 1997, 277(4): 307-311.
5.	Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA, 2001, 285(16): 2114-2120.
6.	張青霞, 李思妍, 白向榮, 等. 全國臨床安全用藥監測網年度報告(2023年). 藥物不良反應雜志, 2024, 26(7): 390-398.
7.	Rishoej RM, Almarsdóttir AB, Christesen HT, et al. Medication errors in pediatric inpatients: a study based on a national mandatory reporting system. Eur J Pediatr, 2017, 176(12): 1697-1705.
8.	Kunac DL, Tatley MV. Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis. Drug Saf, 2011, 34(1): 59-71.
9.	Rishoej RM, Thybo Christesen H, Juel Kjeldsen L, et al. Disproportionality analysis used to identify patterns in medication error reports involving hospitalized children. Basic Clin Pharmacol Toxicol, 2018, 122(5): 531-533.
10.	Hansen RA, Cornell PY, Ryan PB, et al. Patterns in nursing home medication errors: disproportionality analysis as a novel method to identify quality improvement opportunities. Pharmacoepidemiol Drug Saf, 2010, 19(10): 1087-1094.
11.	邢慧資, 馬瑞娟, 張勝男. 處方前置審核系統在兒科住院患者用藥錯誤攔截中的應用. 中國藥事, 2025, 39(8): 958-966.
12.	陸建華. 兒童家庭安全用藥現狀分析與管理對策. 中醫藥管理雜志, 2019, 27(20): 142-144.
13.	Huang HC, Wang CH, Chen PC, et al. Bibliometric analysis of medication errors and adverse drug events studies. J Patient Saf, 2019, 15(2): 128-134.
14.	Rinke ML, Bundy DG, Shore AD, et al. Pediatric antidepressant medication errors in a national error reporting database. J Dev Behav Pediatr, 2010, 31(2): 129-136.
15.	Rinke ML, Shore AD, Morlock L, et al. Characteristics of pediatric chemotherapy medication errors in a national error reporting database. Cancer, 2007, 110(1): 186-195.
16.	Hu Y, Bai Z, Tang Y, et al. Fournier gangrene associated with sodium-glucose cotransporter-2 inhibitors: a pharmacovigilance study with data from the U. S. FDA Adverse Event Reporting System. J Diabetes Res, 2020, 2020: 3695101.
17.	Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol, 1998, 54(4): 315-321.
18.	Van Puijenbroek E, Diemont W, Van Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf, 2003, 26(5): 293-301.
19.	Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf, 2001, 10(6): 483-486.
20.	Bian S, Li L, Wang Z, et al. Neuropsychiatric side reactions of leukotriene receptor antagonist, antihistamine, and inhaled corticosteroid: a real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). World Allergy Organ J, 2021, 14(10): 100594.
21.	B?hm R, Bulin C, Waetzig V, et al. Pharmacovigilance-based drug repurposing: the search for inverse signals via openvigil identifies putative drugs against viral respiratory infections. Br J Clin Pharmacol, 2021, 87(11): 4421-4431.
22.	World Health Organization Collaborating Centre for Drug Statistics Methodology. ATC classification index with DDDs. 2023.
23.	Van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf, 2002, 11(1): 3-10.
24.	Bate A, Lindquist M, Orre R, et al. Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs. Eur J Clin Pharmacol, 2002, 58(7): 483-490.
25.	Phan M, Cheng C, Dang V, et al. Characterization of pediatric reports in the US Food and Drug Administration Adverse Event Reporting System from 2010-2020: a cross-sectional study. TIRS, 2023, 57(5): 1062-1073.
26.	Medical dictionary for regulatory activities (MedDRA?). Standardised MedDRA? queries. 2023.
27.	Gollmann M, Neininger MP, Deters M, et al. Medication errors in inquiries to the Poison Information Center Erfurt - a systematic analysis. Clin Toxicol, 2022, 60(6): 768-774.
28.	Alaje EO, Udoh EE, Akande PA, et al. Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety. Pan Afr Med J, 2020, 36: 350.
29.	Tan E, Braithwaite I, Mckinlay CJD, et al. Comparison of acetaminophen (paracetamol) with ibuprofen for treatment of fever or pain in children younger than 2 years: a systematic review and meta-analysis. Jama Netw Open, 2020, 3(10): e2022398.
30.	Ziesenitz VC, Zutter A, Erb TO, et al. Efficacy and safety of ibuprofen in infants aged between 3 and 6 months. Pediatr Drugs, 2017, 19(4): 277-290.
31.	霍記平, 楊興華, 王興河, 等. 中國家庭中兒童主要照護者的用藥健康素養: 一項全國性調查研究. 醫藥導報, 2021, 40(9): 1287-1295.
32.	Dedonato EA, Spiller HA, Casavant MJ, et al. Non-health care facility anticonvulsant medication errors in the United States. Hum Exp Toxicol, 2018, 37(6): 561-570.
33.	Jense A, Douville A, Weiss A. The safety of rapid infusion levetiracetam: a systematic review. Pharmacotherapy, 2022, 42(6): 495-503.
34.	Laki? A. Depressive symptoms as a side effect of the sustained release form of methylphenidate in a 7-year-old boy with attention-deficit hyperactivity disorder. Vojnosanit Pregl, 2012, 69(2): 201-204.
35.	Guler G, Yildirim V, Kutuk MO, et al. Dystonia in an adolescent on risperidone following the discontinuation of methylphenidate: a case report. Clin Psychopharmacol Neurosci, 2015, 13(1): 115-117.
36.	Zito JM, Safer DJ, Dosreis S, et al. Psychotropic practice patterns for youth: a 10-year perspective. Arch Pediatr Adolesc Med, 2003, 157(1): 17-25.
37.	Steinhausen HC, Bisgaard C. Nationwide time trends in dispensed prescriptions of psychotropic medication for children and adolescents in Denmark. Acta Psychiat Scand, 2014, 129(3): 221-231.
38.	Piovani D, Clavenna A, Bonati M. Prescription prevalence of psychotropic drugs in children and adolescents: an analysis of international data. Eur J Clin Pharmacol, 2019, 75(10): 1333-1346.
39.	Steinhausen HC. Recent international trends in psychotropic medication prescriptions for children and adolescents. Eur Child Adoles Psy, 2015, 24(6): 635-640.
40.	Birnbaum ML, Saito E, Gerhard T, et al. Pharmacoepidemiology of antipsychotic use in youth with ADHD: trends and clinical implications. Curr Psychiatry Rep, 2013, 15(8): 382.
41.	張鑫炎, 胡曉雯, 趙宇璇, 等. 我國兒童精神藥物使用現狀分析. 中國藥學雜志, 2023, 58(10): 933-938.
42.	Wang Z, Wu X, Yu Z, et al. Utilization of drugs for attention-deficit hyperactivity disorder among young patients in China, 2010-2019. Front Psychiatry, 2021, 12: 802489.
43.	Melnik BC. Androgen abuse in the community. Curr Opin Endocrinol Diabetes Obes, 2009, 16(3): 218-223.
44.	Kanayama G, Pope HG Jr. Illicit use of androgens and other hormones: recent advances. Curr Opin Endocrinol Diabetes Obes, 2012, 19(3): 211-219.
45.	Poidvin A, Touzé E, Ecosse E, et al. Growth hormone treatment for childhood short stature and risk of stroke in early adulthood. Neurology, 2014, 83(9): 780-786.
46.	Erfanifar A, Mahjani M, Gohari S, et al. Fatal overdose from injection of human growth hormone; a case report and review of the literature. BMC Endocr Disord, 2022, 22(1): 271.
47.	國家衛生健康委辦公廳. 關于進一步加強兒童臨床用藥管理工作的通知. 2025.

1. National Coordinating Council for Medication Error Reporting and Prevention. About medication errors. 2023.
2. Carnovale C, Mazhar F, Pozzi M, et al. A characterization and disproportionality analysis of medication error related adverse events reported to the FAERS database. Expert Opin Drug Saf, 2018, 17(12): 1161-1169.
3. Maurette P. To err is human: building a safer health system. Ann Fr Anesth Reanim, 2002, 21(6): 453-454.
4. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA, 1997, 277(4): 307-311.
5. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA, 2001, 285(16): 2114-2120.
6. 張青霞, 李思妍, 白向榮, 等. 全國臨床安全用藥監測網年度報告(2023年). 藥物不良反應雜志, 2024, 26(7): 390-398.
7. Rishoej RM, Almarsdóttir AB, Christesen HT, et al. Medication errors in pediatric inpatients: a study based on a national mandatory reporting system. Eur J Pediatr, 2017, 176(12): 1697-1705.
8. Kunac DL, Tatley MV. Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis. Drug Saf, 2011, 34(1): 59-71.
9. Rishoej RM, Thybo Christesen H, Juel Kjeldsen L, et al. Disproportionality analysis used to identify patterns in medication error reports involving hospitalized children. Basic Clin Pharmacol Toxicol, 2018, 122(5): 531-533.
10. Hansen RA, Cornell PY, Ryan PB, et al. Patterns in nursing home medication errors: disproportionality analysis as a novel method to identify quality improvement opportunities. Pharmacoepidemiol Drug Saf, 2010, 19(10): 1087-1094.
11. 邢慧資, 馬瑞娟, 張勝男. 處方前置審核系統在兒科住院患者用藥錯誤攔截中的應用. 中國藥事, 2025, 39(8): 958-966.
12. 陸建華. 兒童家庭安全用藥現狀分析與管理對策. 中醫藥管理雜志, 2019, 27(20): 142-144.
13. Huang HC, Wang CH, Chen PC, et al. Bibliometric analysis of medication errors and adverse drug events studies. J Patient Saf, 2019, 15(2): 128-134.
14. Rinke ML, Bundy DG, Shore AD, et al. Pediatric antidepressant medication errors in a national error reporting database. J Dev Behav Pediatr, 2010, 31(2): 129-136.
15. Rinke ML, Shore AD, Morlock L, et al. Characteristics of pediatric chemotherapy medication errors in a national error reporting database. Cancer, 2007, 110(1): 186-195.
16. Hu Y, Bai Z, Tang Y, et al. Fournier gangrene associated with sodium-glucose cotransporter-2 inhibitors: a pharmacovigilance study with data from the U. S. FDA Adverse Event Reporting System. J Diabetes Res, 2020, 2020: 3695101.
17. Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol, 1998, 54(4): 315-321.
18. Van Puijenbroek E, Diemont W, Van Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf, 2003, 26(5): 293-301.
19. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf, 2001, 10(6): 483-486.
20. Bian S, Li L, Wang Z, et al. Neuropsychiatric side reactions of leukotriene receptor antagonist, antihistamine, and inhaled corticosteroid: a real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). World Allergy Organ J, 2021, 14(10): 100594.
21. B?hm R, Bulin C, Waetzig V, et al. Pharmacovigilance-based drug repurposing: the search for inverse signals via openvigil identifies putative drugs against viral respiratory infections. Br J Clin Pharmacol, 2021, 87(11): 4421-4431.
22. World Health Organization Collaborating Centre for Drug Statistics Methodology. ATC classification index with DDDs. 2023.
23. Van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf, 2002, 11(1): 3-10.
24. Bate A, Lindquist M, Orre R, et al. Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs. Eur J Clin Pharmacol, 2002, 58(7): 483-490.
25. Phan M, Cheng C, Dang V, et al. Characterization of pediatric reports in the US Food and Drug Administration Adverse Event Reporting System from 2010-2020: a cross-sectional study. TIRS, 2023, 57(5): 1062-1073.
26. Medical dictionary for regulatory activities (MedDRA?). Standardised MedDRA? queries. 2023.
27. Gollmann M, Neininger MP, Deters M, et al. Medication errors in inquiries to the Poison Information Center Erfurt - a systematic analysis. Clin Toxicol, 2022, 60(6): 768-774.
28. Alaje EO, Udoh EE, Akande PA, et al. Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety. Pan Afr Med J, 2020, 36: 350.
29. Tan E, Braithwaite I, Mckinlay CJD, et al. Comparison of acetaminophen (paracetamol) with ibuprofen for treatment of fever or pain in children younger than 2 years: a systematic review and meta-analysis. Jama Netw Open, 2020, 3(10): e2022398.
30. Ziesenitz VC, Zutter A, Erb TO, et al. Efficacy and safety of ibuprofen in infants aged between 3 and 6 months. Pediatr Drugs, 2017, 19(4): 277-290.
31. 霍記平, 楊興華, 王興河, 等. 中國家庭中兒童主要照護者的用藥健康素養: 一項全國性調查研究. 醫藥導報, 2021, 40(9): 1287-1295.
32. Dedonato EA, Spiller HA, Casavant MJ, et al. Non-health care facility anticonvulsant medication errors in the United States. Hum Exp Toxicol, 2018, 37(6): 561-570.
33. Jense A, Douville A, Weiss A. The safety of rapid infusion levetiracetam: a systematic review. Pharmacotherapy, 2022, 42(6): 495-503.
34. Laki? A. Depressive symptoms as a side effect of the sustained release form of methylphenidate in a 7-year-old boy with attention-deficit hyperactivity disorder. Vojnosanit Pregl, 2012, 69(2): 201-204.
35. Guler G, Yildirim V, Kutuk MO, et al. Dystonia in an adolescent on risperidone following the discontinuation of methylphenidate: a case report. Clin Psychopharmacol Neurosci, 2015, 13(1): 115-117.
36. Zito JM, Safer DJ, Dosreis S, et al. Psychotropic practice patterns for youth: a 10-year perspective. Arch Pediatr Adolesc Med, 2003, 157(1): 17-25.
37. Steinhausen HC, Bisgaard C. Nationwide time trends in dispensed prescriptions of psychotropic medication for children and adolescents in Denmark. Acta Psychiat Scand, 2014, 129(3): 221-231.
38. Piovani D, Clavenna A, Bonati M. Prescription prevalence of psychotropic drugs in children and adolescents: an analysis of international data. Eur J Clin Pharmacol, 2019, 75(10): 1333-1346.
39. Steinhausen HC. Recent international trends in psychotropic medication prescriptions for children and adolescents. Eur Child Adoles Psy, 2015, 24(6): 635-640.
40. Birnbaum ML, Saito E, Gerhard T, et al. Pharmacoepidemiology of antipsychotic use in youth with ADHD: trends and clinical implications. Curr Psychiatry Rep, 2013, 15(8): 382.
41. 張鑫炎, 胡曉雯, 趙宇璇, 等. 我國兒童精神藥物使用現狀分析. 中國藥學雜志, 2023, 58(10): 933-938.
42. Wang Z, Wu X, Yu Z, et al. Utilization of drugs for attention-deficit hyperactivity disorder among young patients in China, 2010-2019. Front Psychiatry, 2021, 12: 802489.
43. Melnik BC. Androgen abuse in the community. Curr Opin Endocrinol Diabetes Obes, 2009, 16(3): 218-223.
44. Kanayama G, Pope HG Jr. Illicit use of androgens and other hormones: recent advances. Curr Opin Endocrinol Diabetes Obes, 2012, 19(3): 211-219.
45. Poidvin A, Touzé E, Ecosse E, et al. Growth hormone treatment for childhood short stature and risk of stroke in early adulthood. Neurology, 2014, 83(9): 780-786.
46. Erfanifar A, Mahjani M, Gohari S, et al. Fatal overdose from injection of human growth hormone; a case report and review of the literature. BMC Endocr Disord, 2022, 22(1): 271.
47. 國家衛生健康委辦公廳. 關于進一步加強兒童臨床用藥管理工作的通知. 2025.

Chinese Journal of Evidence-Based Medicine

Research on medication errors in pediatric population based on FAERS database

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