1Junior resident, Government Medical College Miraj, Maharashtra.
2Associate Professor MD Pharmacology, Government Medical College Miraj, Maharashtra.
3Associate Professor MD Pharmacology, Government Medical College Miraj, Maharashtra.
4Senior Resident, MD Pharmacology, Government Medical College Miraj, Maharashtra.
5Senior Resident, MD Pharmacology, Government Medical College Miraj, Maharashtra.
Harmful, unintended reactions to medicines that occur at doses normally used for treatment are called adverse drug reactions (ADRs).1 Drugs may behave differently in children (different pharmacokinetics) compared to adults and may cause different effects (different pharmacodynamics) in children. 2 With Thalidomide tragedy emphasized children are particularly vulnerable to the impact ADRs and may suffer more severe consequences compared to adults.3 Post marketing studies are mostly done for adults and there is paucity of data in children thus reflecting need for study of ADRs in pediatric age group. Hence we carried out this study with aim to study profile of adverse drug reactions (ADRs) in pediatric patients during last five years at an Adverse Drug Monitoring (AMC) with objective to determine the most common adverse drug reactions reported and most common drug reported to cause ADR in pediatric patients at AMC. Methodology: Adverse drug reaction reported in pediatric patient reported to AMC during last 5 years will be analyzed and coded and considered for this study after permission from PvPI and Ethics committee. Data collected for most common ADR, most common drug causing ADR and profile of patients with ADRs. Conclusion Only 4% (59) of the 1430 ADR s reported to AMC were in children. Skin involvement as most common ADR reported and sera and vaccine was most common implicated drug
Adverse drug reactions (ADRs) refer to negative and unintended responses to medications at their usual treatment doses. In the context of children, these reactions tend to be more severe than in adults1. Adverse drug reactions (ADRs) in children can have a relatively more severe effect when compared to adults. 4Adverse drug reactions (ADRs) in children can have severe consequences, including hospital admissions, prolonged hospitalization, permanent disability such as growth impairment e.g excessive use of exogenous corticosteroids can inhibit normal childhood growth., and even death. Drugs may behave differently in children (different pharmacokinetics) compared to adults and may cause different effects (different pharmacodynamics) in children. 2 Children cannot be simply considered as miniaturized versions of adults when it comes to their medical conditions and disease processes, particularly neonates and infants. Therapeutics in children has come a long way but nothing comes for free. “Elixir of Sulphanilamide Tragedy” of 1937, in which more than 100 Americans mostly children died because of the use of diethylene glycol a potent nephrotoxin as a solvent for sulphanilamide.3,5 The increased awareness of adverse drug reactions in children came to the forefront after tragic incidents, highlighting a sorrowful aspect of healthcare that demands our attention and improvement.6Thus, exclusionary language “this drug is not labelled for use in patients under the age of 12”—became the norm. Shirkey coined the term "The Therapeutic Orphan" to highlight that 75% of prescription medications lacked approval for children.7. Since pre-marketing clinical trials primarily focus on adults, it is crucial to gather information on the frequency, severity, and types of drugs involved in adverse reactions specifically in the pediatrics population. This data holds significant importance.8 Recently post marketing studies about use of montelukast in children demonstrated that it is associated with sedation and neuropsychiatric symptoms, such as depression, aggression, nightmares, were significant in children.9 Further the spontaneous ADR reporting in children is not very common.10Hence it reflect the need the post marketing surveillance of ADRs in pediatrics population to detect specific ADRs to children to all the drug introduced to them. Hence with this aim we decide to analyze the profile of ADR observed in Pediatrics patients reported to AMC with objective to determine most common adverse drug reactions reported and most common drug reported to cause adverse drug reactions in pediatric patients .
METHODOLOY:
This was a retrospective report-based study. Adverse drug reaction reported were screened and only ADRs in children ( age 12 year and less) were recorded and coded and considered for this study after permission from PvPI and Ethics committee.
Data regarding most common drug causing ADR and profile of patients with ADRs in predetermined format was collected and frequency was calculated.
RESULTS :
Figure 1 As per figure 1 only 4% (59) of the 1430 ADR s reported to AMC were in children
Figure 2A shows skin was most commonly affected (76.27%) in which generalized rash (22.03%) and urticaria (20.33%)were predominant and antirabies serum and injectable vancomycin being the most frequently implicated drugs.
Figure 2B As per figure 2B ,15.25% of ADRs were reported as constitutional symptoms most commonly seen after post vaccination.
Figure 2C From above figure 2c git (6.78%)and cns (1.7%) related ADRs were reported
DISCUSSION:
Adverse drug reactions (ADRs) in children are a significant concern for public health. Even though attempts are being made to decrease the occurrence of medication-related problems, the mortality and morbidity, particularly in the pediatric population due to drug-induced reactions, remain excessively high.11,12 Research has been conducted globally to explore ADRs among pediatric patients.8 The findings reveal that ADR is an important cause of mortality.13This underscores the ongoing challenge and emphasizes the importance of addressing and reducing the impact of ADRs in the pediatric demographic. In developed countries they find that about 5.8% of ADRs in children are reported spontaneously14. Our study shows a similar number, around 4%, when we compare the two. This means our findings are in line with what is observed in well-developed areas, highlighting that the issue of ADRs in kids is consistent across different regions. Our study found that 67.79% of ADRs were in males, while females comprised 32.21%, similar to Ratikanta Tripathy, Swarnalata Da etal study15: suggesting similar trend. This reflects two possibilities either male inherently develop more ADR or gender bias affects reporting of ADRs. A meta-analysis revealed that around 12.3% of cases involved severe adverse drug reactions (ADRs. 16 Our study similarly found a rate of 15%, indicating a close resemblance in the occurrence of severe ADRs between the two studies. The most ADRs observed in present study was related to skin (76.27% % of ADRs) out of which urticaria(28.89%) and generalized rash (26.66%). Although studies by Priyadharsini R, Surendiran A et al 17 and and Dash M, Jena M, 18 and Tripathy R, Das S, Das P 15reveal a ubiquitous presence of cutaneous involvement in adverse drug reactions, they did not cite any ADR to vaccines and sera; Where as we observed 57.62 % reaction associated to vaccine and sera of which 33.89 % were due to Antirabies serum and were related to skin. One of the reasons skin could be the most common observed ADR could be the readily noticeable nature of skin symptoms unlike behavioral changes or abnormal laboratory findings . In our study, we found that constitutional symptoms, like fever with other symptoms was second most commonly (ADRs), like study done by Priyadharsini R, Surendiran A et al. In contrast Dash M, Jena M et al17 and Tripathy R, Das S, Das P18 cite gastrointestinal issues as the most frequently reported symptoms Fever is a well-known side effect after vaccination 19and all cases of fever to vaccination are not reported as ADRs to the ADR monitoring center due to a policy of counselling the mothers at time of vaccination and in our study, only those ADRs linked with other symptoms were reported. Most cases were associated with the use of the pentavalent vaccine. It's worth noting that our study observed one case of convulsion following a Pentavalent vaccination, highlighting a potential serious side effect. Although the present study cannot reflect prevalence in general population the findings are still significant for following reasons 1) vaccines are administered to healthy children20.2)Other ADR monitoring studies15 which included vaccines have not reported any ADRs to vaccines 3)Other ADR monitoring17,18 studies have not included vaccine in their study Tripathy et al 18 previously identified third-generation Cephalosporins as common cause of adverse drug reactions (ADRs) in children. However, our study found that Vancomycin is often associated with such reactions. While Vancomycin is approved for use in children, specific adverse effects related to children's use are not well-documented21.Available literature exhibits a notable scarcity of detailed information concerning specific adverse effects associated with children's use, indicating a lack of well-documented data on potential risks in this context. This could be due to difficulty in conducting clinical trials in children 22as a result most of the data regarding safety in children becomes available after post marketing surveillance .16 This highlights the importance of further understanding and closely monitoring the safety of drugs used in pediatric patients to ensure its rational use in this age group. Therefore, its crucial to ensure that pediatricians and caregivers are well-informed about Adverse Drug Reactions (ADRs) in children and report them. Implementing an active monitoring system for ADRs is essential.
Limitations:
It is a retrospective report-based study, therefore, we cannot ascertain the history and clinical profile of the patients.
ACKNOWLEDGEMENT:
We extend our sincere thanks to PVPI coordinator and PVPI India for their valuable support and collaboration. This concise acknowledgment expresses gratitude to PVPI India for their contribution to the project.
REFERENCES
I. B. Deshmukh, S. R. Burute, S. M. Pore, A. S., F. M., Retrospective Study Of Adverse Reaction In Paediatric Patients, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 4, 550-555. https://doi.org/10.5281/zenodo.10945158
10.5281/zenodo.10945158
