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Causality, Severity, and Avoidability of Adverse Drug Reactions in Hospitalized Children: A Prospective Cohort Study
Saurabh Gupta1, Syed A Zaki2, Sanjeevani Masavkar1
1Pediatrics, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, IND.
Insights
Adverse drug reactions (ADRs) affect hospitalized children, with antimicrobials being the most common cause. Increased physician awareness and monitoring are crucial for managing these potentially severe and avoidable events.
Area of Science:
- Pediatric Pharmacology
- Clinical Toxicology
- Hospital Pharmacy
Background:
- Adverse drug reactions (ADRs) are a significant cause of illness and death in patients.
- Data on pediatric ADRs, including implicated drugs and clinical presentations, are limited.
- This study aimed to determine the incidence and features of ADRs in hospitalized children.
Purpose of the Study:
- To determine the incidence of adverse drug reactions in hospitalized pediatric patients.
- To analyze the characteristics of pediatric ADRs, including causality, type, severity, and avoidability.
- To identify the drugs and clinical presentations associated with pediatric ADRs.
Main Methods:
- The study included patients admitted to pediatric wards and intensive care units over a one-year period (January 1, 2013 to December 31, 2013).
- Patients who presented with or developed an ADR during their hospital stay were enrolled.
- Data collected included causality, type, severity, avoidability, implicated drugs, and clinical presentations.
Main Results:
- The incidence of ADRs causing hospital admission was 1.79%, and 1.23% for children exposed to drugs during hospitalization.
- Type B (62.6%) ADRs were more common than Type A (29.1%). Severe ADRs occurred in 13.7% of cases, with two deaths attributed to ADRs.
- Antimicrobials (43.4%) were the most frequent cause, followed by immune system drugs (15.9%) and nervous system drugs (14.3%). Metabolic (29.3%) and neurological (17.6%) ADRs were most common.
Conclusions:
- Adverse drug reactions occur in a significant number of hospitalized children, some being severe and avoidable.
- Physicians should enhance their awareness, monitoring, documentation, and notification of ADRs in pediatric patients.
- Improved vigilance can help mitigate the risks associated with pediatric drug therapy.
Background:
Adverse drug reactions are an important cause of morbidity and mortality in all patients. Information regarding adverse drug reactions in the pediatric age group, especially with regard to the drugs involved and the clinical presentations is scanty. The aim of our study is to determine the incidence of adverse drug reactions and to study their features in terms of causality, type, severity, avoidability, drugs implicated and their clinical presentations.
Methods:
The study was carried out on patients admitted to the pediatric ward and the pediatric intensive care unit over a one-year period (January 1, 2013 to December 31, 2013). Patients either presenting with or developing an adverse drug reaction in the hospital were included in the study.
Results:
The incidence rate for adverse drug reaction causing hospital admission was 1.79% (95% CI 1.48, 2.16) whereas it was 1.23% (95% CI 0.97, 1.53) for children exposed to a drug during their hospital stay. Type B (bizarre or idiosyncratic type) was seen in 114 (62.6%) of the ADRs whereas 53 (29.1%) were of type A (augmented pharmacologic effect). Severe ADRs were seen in 25 (13.7%) of the total ADRs. ADR was responsible for the death of two patients. 15.4% were rated as avoidable. Anti-microbials were the most common group responsible for ADRs (43.4%), followed by drugs acting on the immune system (15.9%) and drugs acting on the nervous system (14.3%). The most common ADRs were metabolic (29.3%) followed by neurological (17.6%).
Conclusions:
Adverse drug reactions can occur in a substantial proportion of hospitalized patients with some of them being severe and potentially avoidable. Awareness among physicians should be encouraged regarding monitoring, documentation and notification of adverse drug reactions.
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