A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India

Abstract

Background: Polypharmacy, advancing age and longer duration of hospital stay are the factors responsible for adverse drug reactions (ADRs). This study has attempted to analyze the pattern of antimicrobial prescription in OPD & IPD of the Otolaryngology department and to detect, document, assess and report the suspected ADRs due to antibiotic use and preparation of guidelines to minimize the incidence of ADRs. Methods: A prospective study conducted at the TMMC&RC on patients aged >40 years, who visited the Otolaryngology department over a period of 5 months. Suspected ADRs were assessed for causality and severity using Naranjo’s probability scale and modified Hartwig’s criteria, respectively. Results: Out of 1200, 925 prescriptions were analyzed. Most patients were from 41-60 age (59.45%) followed by 61-80 age (37.29%) and least from >80 yr (3.24%). But the incidence of ADRs were found to be higher in patients of >80 yr age group n=8 (26.66%). The most commonly prescribed antibacterials were β-Lactams (64.61%). Out of 925 prescriptions studied, only 94 were found to have 154 ADRs. The most commonly identified ADRs were Gastrointestinal 47.40%, followed by Neurotoxicity 24.67%, cutaneous reactions 20.12%, Hepatic 4.54% and Kidney 3.24%. 74.67% of the ADRs were probable and 20.77% were possible type and only 4.54% were definite. 74.67% ADRs were found to be type A, and 25.32% type B. Conclusions: Our study showed that prevalence of ADRs was highest in elder age group and diarrhea was the most common ADR found. Therefore elderly patients should be given special attention when prescribing medications to avoid clinically significant harmful consequences. Minimizing unnecessary antibiotic use by even a small percentage could significantly reduce the immediate and direct risks of drug-related adverse events in individual patients. [Int J Basic Clin Pharmacol 2013; 2(5.000): 548-553

A Prospective Study of Adverse Drug Reactions in a Tertiary Care Hospital in South India

“…Following the previous studies by Mahatme and Narasimharao, Gupta et al, and Jung et al, the present study showed the predominance of cutaneous manifestations on presentation of ADRs (75%) [13][14][15] followed by central nervous system manifestations such as dizziness. However, several other studies have observed gastrointestinal symptoms such as vomiting and diarrhea as the most common manifestation of ADR [16][17][18]. The drug dechallenge was done in most of the cases and in some, the dose was reduced while no changes were made in others considering the risk-benefit ratio in particular patients.…”

Pharmacovigilance Programme of India: Recent developments and future perspectives

“…[9] Studies revealed that ADRs are leading to hospitalization and constitute a significant economic burden on patients in India. [101112] A study showed that hospital admissions due to ADRs accounted for 0.7% of total admissions and deaths due to ADRs accounted for 1.8% of total admissions in a territory referral center in South India. [13]…”

Knowledge, attitude and practice of pharmacovigilance towards adverse drug reactions reporting among health care professionals (nurses) in a tertiary care teaching hospital in Eastern India: an observational study

“…3 Studies revealed that ADRs are leading to hospitalization and constitute a significant economic burden on patients in India. [4][5][6] WHO defines "adverse reactions as harmful and unintended responses to a drug and which occur with doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or modifying a physiological function". 7 Studies conducted in several parts of India have estimated the incidence of suspected adverse reactions to be nearly 2% to 3% among hospitalized patients.…”