Abstract

OBJECTIVE:To assess the risk factors, incidence and severity of adverse drug reactions in in-patients.METHODS:This prospective study evaluated 472 patients treated at a teaching hospital in Brazil between 2010 and 2013 by five medical specialties: Internal Medicine, General Surgery, Geriatrics, Neurology, and Clinical Immunology and Allergy. The following variables were assessed: patient age, gender, comorbidities, family history of hypersensitivity, personal and family history of atopy, number of prescribed drugs before and during hospitalization, hospital diagnoses, days of hospitalization. The patients were visited every other day, and medical records were reviewed by the investigators to detect adverse drug reactions.RESULTS:There were a total of 94 adverse drug reactions in 75 patients. Most reactions were predictable and of moderate severity. The incidence of adverse drug reactions was 16.2%, and the incidence varied, according to the medical specialty; it was higher in Internal Medicine (30%). Antibiotics were the most commonly involved medication. Chronic renal failure, longer hospital stay, greater number of diagnoses and greater number of medications upon admission were risk factors. For each medication introduced during hospitalization, there was a 10% increase in the rate of adverse drug reaction. In the present study, the probability of observing an adverse drug reaction was 1 in 104 patients per day.CONCLUSIONS:Adverse drug reactions are frequent and potentially serious and should be better monitored in patients with chronic renal failure or prolonged hospitalization and especially in those on ‘polypharmacy’ regimens. The rational use of medications plays an important role in preventing adverse drug reactions.

Highlights

  • Adverse drug reactions (ADRs) in hospitalized patients can be divided into two categories: those that are the cause of hospital admission, and those that occur during hospitalization (1)

  • 15 to 20% of ADRs correspond to hypersensitivity drug reactions (HDRs), which are induced by exposure to a drug in a dose that is usually tolerated by healthy individuals, and the reactions are characterized by objective symptoms that can be reproduced following subsequent re-exposure (2, 3)

  • The overall incidence of ADRs during hospitalization was 16.2%, and the incidence of ADRs according to the medical specialty varied; the incidence was higher in Internal Medicine (Figure 1) (p=0.001)

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Summary

Introduction

Adverse drug reactions (ADRs) in hospitalized patients can be divided into two categories: those that are the cause of hospital admission, and those that occur during hospitalization (1). There are limited data on ADRs, especially regarding the reactions that occur after admission. It is estimated that ADRs occur in 10% of the general population and 10 to 20% of in-patients (1,2). 15 to 20% of ADRs correspond to hypersensitivity drug reactions (HDRs), which are induced by exposure to a drug in a dose that is usually tolerated by healthy individuals, and the reactions are characterized by objective symptoms that can be reproduced following subsequent re-exposure (2, 3).

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