Generic placeholder image

Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Research Article

Pattern of Adverse Drug Reactions among Pregnant Women and Pediatric Patients in a Tertiary Care Hospital

Author(s): Neha Rani*

Volume 18, Issue 2, 2023

Published on: 27 July, 2022

Page: [190 - 195] Pages: 6

DOI: 10.2174/1574886317666220404105653

Price: $65

Abstract

Background: Adverse drug reactions (ADRs) among pregnant women and pediatric patients are a significant public health concern. ADRs monitoring and documentation are considered essential practices to decrease the chances of ADRs and ensure the safe use of drugs.

Objective: Therefore, the study was designed to evaluate the pattern of adverse drug reactions among pregnant women and pediatric patients in a tertiary care hospital.

Methods: The study was conducted at Kalpana Chawla Government Medical College and Hospital, Karnal, Haryana, for a period of 2 years. During this period, ADRs reported by the healthcare professionals of gynecology and pediatric department to the ADRs monitoring centre of our institute were included in the study.

Results: Out of 54 total ADRs, 40 ADRs occurred among pregnant women, and 14 ADRs were reported in pediatric patients. The majority of the ADRs were observed in the age group of 21-30 years (pregnant women) and 3-5 years (pediatric patients). Antibiotics were most commonly implicated in ADRs among pregnant women (60%) and pediatric patients (79%). In our study, the dermatological system was mostly affected among pregnant women and pediatric patients. Urticaria, contact dermatitis, and erythematous rash were the most commonly reported ADRs among pregnant women and pediatric patients.

Conclusion: Over-prescribing and irrational use of antibiotics make these vulnerable populations more susceptible to ADRs and antibiotic resistance. Therefore, there is a need to create awareness among health care professionals regarding the spontaneous reporting of ADRs for ensuring drug safety and reducing morbidity and mortality among pregnant women and pediatric patients.

Keywords: Adverse drug reactions, pregnant women, pediatric patients, antibiotics, tertiary care hospital, healthcare professionals, pharmacovigilance.

[1]
Coleman JJ, Pontefract SK. Adverse drug reactions. Clin Med (Lond) 2016; 16(5): 481-5.
[http://dx.doi.org/10.7861/clinmedicine.16-5-481] [PMID: 27697815]
[2]
Edwards IR, Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet 2000; 356(9237): 1255-9.
[http://dx.doi.org/10.1016/S0140-6736(00)02799-9] [PMID: 11072960]
[3]
Formica D, Sultana J, Cutroneo PM, et al. The economic burden of preventable adverse drug reactions: A systematic review of observational studies. Expert Opin Drug Saf 2018; 17(7): 681-95.
[http://dx.doi.org/10.1080/14740338.2018.1491547] [PMID: 29952667]
[4]
Wooten JM. Adverse drug reactions: Part I. South Med J 2010; 103(10): 1025-8.
[http://dx.doi.org/10.1097/SMJ.0b013e3181f0c866] [PMID: 20818299]
[5]
Alomar MJ. Factors affecting the development of adverse drug reactions (Review article). Saudi Pharm J 2014; 22(2): 83-94.
[http://dx.doi.org/10.1016/j.jsps.2013.02.003] [PMID: 24648818]
[6]
Rieder M. Adverse drug reactions across the age continuum: Epidemiology, diagnostic challenges, prevention, and treatments. J Clin Pharmacol 2018; 58 (Suppl. 10): S36-47.
[http://dx.doi.org/10.1002/jcph.1115] [PMID: 30248196]
[7]
Welch MJ, Lally R, Miller JE, et al. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clin Trials 2015; 12(5): 503-10.
[http://dx.doi.org/10.1177/1740774515597701] [PMID: 26374681]
[8]
Matsui D, Koren G. Creating a new ethical climate for drug research in children and pregnant women. Paediatr Drugs 2015; 17(1): 1-3.
[http://dx.doi.org/10.1007/s40272-014-0112-2] [PMID: 25614124]
[9]
Karpa KD, Felix TM, Lewis PR. Adverse effects of common drugs: Children and adolescents. FP Essent 2015; 436: 17-22.
[PMID: 26375994]
[10]
Feghali M, Venkataramanan R, Caritis S. Pharmacokinetics of drugs in pregnancy. Semin Perinatol 2015; 39(7): 512-9.
[http://dx.doi.org/10.1053/j.semperi.2015.08.003] [PMID: 26452316]
[11]
Knoppert D. Safety and efficacy of drugs in pregnancy. J Popul Ther Clin Pharmacol 2011; 18(3): e506-12.
[PMID: 22113261]
[12]
Härmark L, van Grootheest AC. Pharmacovigilance: Methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008; 64(8): 743-52.
[http://dx.doi.org/10.1007/s00228-008-0475-9] [PMID: 18523760]
[13]
Brown SD Jr, Landry FJ. Recognizing, reporting, and reducing adverse drug reactions. South Med J 2001; 94(4): 370-3.
[http://dx.doi.org/10.1097/00007611-200194040-00002] [PMID: 11332899]
[14]
Pushkin R, Frassetto L, Tsourounis C, Segal ES, Kim S. Improving the reporting of adverse drug reactions in the hospital setting. Postgrad Med 2010; 122(6): 154-64.
[http://dx.doi.org/10.3810/pgm.2010.11.2233] [PMID: 21084792]
[15]
Tan Y, Hu Y, Liu X, Yin Z, Chen XW, Liu M. Improving drug safety: From adverse drug reaction knowledge discovery to clinical implementation. Methods 2016; 110: 14-25.
[http://dx.doi.org/10.1016/j.ymeth.2016.07.023] [PMID: 27485605]
[16]
Khan Z, Muhammad K, Karatas Y, Bilen C, Khan FU, Khan FU. Pharmacovigilance and incidence of adverse drug reactions in hospitalized pediatric patients: A mini systematic review. Egypt Pediatric Association Gaz 2020; 68(1): 24.
[http://dx.doi.org/10.1186/s43054-020-00038-8]
[17]
Clavenna A, Bonati M. Adverse drug reactions in childhood: A review of prospective studies and safety alerts. Arch Dis Child 2009; 94(9): 724-8.
[http://dx.doi.org/10.1136/adc.2008.154377] [PMID: 19531524]
[18]
da Silva KDL, Fernandes FEM, de Lima Pessoa T, Lima SIVC, Oliveira AG, Martins RR. Prevalence and profile of adverse drug reactions in high-risk pregnancy: A cohort study. BMC Pregnancy Childbirth 2019; 19(1): 199.
[http://dx.doi.org/10.1186/s12884-019-2321-8] [PMID: 31185941]
[19]
da Costa TX, de Almeida Pimenta Cunha MD, do Vale Bezerra PK, Azeredo FJ, Martins RR, Oliveira AG. Incidence of adverse drug reactions in high-risk pregnancy: A prospective cohort study in obstetric intensive care. Eur J Clin Pharmacol 2020; 76(2): 291-8.
[http://dx.doi.org/10.1007/s00228-019-02789-9] [PMID: 31768575]
[20]
The use of the WHO–UMC system for standardised case causality assessment. Available from: https://www.WHO-UMC.org/media/2768/standardised-case-causality-assessment.pdf
[21]
Kaur R, Singh R. Evaluation of adverse drug reactions of drugs used in gynaecology department for different complications at a tertiary care teaching hospital. Int J Health Sci Res 2018; 8(9): 110-4.
[22]
Jayanthi CR, Darshini MB. A study to analyze the pattern, causality, severity, predictability, and preventability of adverse drug reactions among patients attending the department of obstetrics and gynecology at a tertiary care hospital. Natl J Physiol Pharm Pharmacol 2019; 9(2): 172-7.
[http://dx.doi.org/10.5455/njppp.2019.9.1236921122018]
[23]
Dash M, Jena M, Mishra S, Panda M, Patro N. Monitoring of adverse drug reactions in pediatric department of a tertiary care teaching hospital: A hospital based observational study. Int J of Pharm Res & All Sci 2015; 4(4): 69-76.
[24]
Bourgeois FT, Mandl KD, Valim C, Shannon MW. Pediatric adverse drug events in the outpatient setting: An 11-year national analysis. Pediatrics 2009; 124(4): e744-50.
[http://dx.doi.org/10.1542/peds.2008-3505] [PMID: 19786435]
[25]
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.
[http://dx.doi.org/10.4103/ijp.IJP_256_17] [PMID: 29515280]
[26]
Mangla R, Verma S, Gupta MC, et al. Adverse drug reaction monitoring of commonly prescribed medicines in gynaecology patients in a tertiary care hospital in North India. Int J Health Sci Res 2017; 7(11): 111-7.
[27]
Dhar K, Chauhan S, Sharma J, Gaur P, Chopra VS, Bajaj U. To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynecology unit in a tertiary care hospital. Indian J Pharm Biol Res 2014; 2(3): 112-9.
[http://dx.doi.org/10.30750/ijpbr.2.3.17]
[28]
Priyadharsini R, Surendiran A, Adithan C, Sreenivasan S, Sahoo FK. A study of adverse drug reactions in pediatric patients. J Pharmacol Pharmacother 2011; 2(4): 277-80.
[http://dx.doi.org/10.4103/0976-500X.85957] [PMID: 22025857]
[29]
Ramos SF, Araújo-Neto FC, Aires-Moreno GT, de Araújo DCSA, Lima EDC, de Lyra DP Jr. Causality and avoidability of adverse drug reactions of antibiotics in hospitalized children: A cohort study. Int J Clin Pharm 2021; 43(5): 1293-301.
[http://dx.doi.org/10.1007/s11096-021-01249-8] [PMID: 33656658]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy