Patterns of adverse drug reactions: a study in a tertiary care

Abstract

Background: Adverse drug reaction, usually reported by pharmacovigilance, either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the severity of the drug and also if the ADRs are casual, preventable or severe.Methods: A total of 42 patients satisfied the WHO definition of ‘adverse drug reactions’ were included in the study. The demographic details were taken, and the regular physical examination and clinical examination was done for all the patients. The latest drug they were on and the dosage were analyzed and the type of reaction was assessed. The causality, severity and preventability were also assessed.Results: Majority of the ADRs were found in the medicine department, followed pulmonology, obstetrics-gynecology and paediatrics. B-lactams were the major cause of ADRs with 42.2%, followed by NSAIDs with 23.8%, fluoroquinolones with 19% and 9.5% due to antitubercular drugs. 66.7% of the ADRs were mild, 28.6% were moderate and 4.8% were severe. The most common type of ADR were skin rashes (40.5%), urticara (16.7%), headaches (26.2%), insomnia (21.4%), diarrhoea (21.4%), abdominal pain (14.3%) and vomiting (4.8%). Most of the ADRs were evaluated as probably preventable (69%), definitely preventable (26.2%), non preventable (4.8%).Conclusions: Most of the drug reactions are mild and preventable. More health care professionals as well as patients need to be aware of the drug reactions at much early age so as to prevent the condition before it becomes serious.

A retrospective study of adverse drug reactions in a tertiary care center

“…This was also observed in study done by Raja and Venkatasubbaiah et al 13,14 In this study, skin and appendages constituted the most common system affected, accounting for (59.2%) of total ADRs reported with the predominant symptom being skin rashes seen in 44 (31.7%) of the patients, urticaria in 10 (7.2%). This is in congruence with studies conducted earlier by Kumar et al and Bhabhor et al 2,15 However, Abhishake et al, and Sajin et al, reported different results, documenting gastrointestinal problems to be 39% and 33%, respectively, being most prevalent manifestation among patients with reported ADR. 3,16 General was the next most common system affected in this study, total reported ADRs were (19.4%) with 15 (10.8%) having anaphylaxis, 12 (8.6%) had hypersensitivity reaction and 3 (2.2%) had fever with chills.…”

“…Adverse drug reaction has been described by the WHO as a "noxious, unintended and undesired effect of a drug, which occur at doses used in humans for prophylaxis, diagnosis or cure of a disease." 2 Every time the patient is exposed to a new medication, the risk of Adverse drug reactions (ADRs) is present, as we cannot predict the incidence. Thus, no drug is absolutely safe, even when prescribed in therapeutic doses.…”

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“…This aligns with our study's findings, where antimicrobials, specifically antibiotics, were the most frequently reported culprits 26 . Research studies indicate that non-compliance accounted for 46.6% of drug-related hospitalizations, with ADRs and drug overdose being the primary reasons for drug-related incidents 27 . In our study, 11.32% of DRPs were due to drug use without indication, predominantly associated with multivitamins.…”