Abstract
The present study was carried out to determine the incidence of Adverse Drug Reactions (ADRs) in general medicine department and to assess and analyze the causality, severity, and preventability of ADRs. A prospective observational study was conducted in the general medicine department for six months. All patients receiving drug therapy are considered and are selected based on the inclusion criteria. Patient demographic details like age, gender, diagnosis, past medical history, concomitant medications, etc., are recorded from the patient data gathering form. The causality assessment is accomplished using Naranjo and WHO scales. The severity is carried out using the Modified Hartwig and Siegel scale. The preventability evaluation is accomplished using the Modified Schmock and Thornton scale. The study included 385 patients were between the age group of 18 years and, out of which 34 patients developed adverse drug effects including female and male. Patients between the age group of 40-50 years (18.1%) developed a high incidence of ADRs. The causality was assessed using Naranjo’s causality assessment scale, 44.1% reactions were probable; 29.4% reactions were certain, 23.5% reactions were possible and 2.9 % reactions were conditional. When the reactions were assessed most of them were assessed 55.1% were moderate and 61.8% were probably preventable. Appropriate observation of the drug effect is essential to ensure the safety of the patient. This also will have the advantage of reducing the incidence of the ADRs, thus deplete the complications and helps to improve the quality of life of the patients.
Highlights
A drug may be defined as a chemical substance that is used in the treatment, cure, prevention or diagnosis of a disease or used to enhance physical or mental well-being
The incidence of Adverse Drug Reactions (ADRs) was high in patients belonging to the age group 41-50 years while compared to other age groups
The major challenge in spontaneous reporting of ADR is underreporting might be as a result of an increase in workload, of opinion that reporting will not lead to any improvement and lack of knowledge
Summary
A drug may be defined as a chemical substance that is used in the treatment, cure, prevention or diagnosis of a disease or used to enhance physical or mental well-being. An adverse drug reaction may be defined as “any harmful or unpleasant reaction that may be resulting from an intervention which is related to the use of a medicinal product, which predicts a hazard from future administration and warrants prevention or specific treatment or alteration of the dosage regimen or withdrawal”. Underreporting has been the major challenge either in voluntary reporting or spontaneous reporting and it is common even in developed countries with a functional ADR reporting system. This may be due to various reasons like lack of knowledge, increase in the workload etc. The responsibility of ADR reporting is comparatively high and is responsible for considerable morbidity, mortality, prolonged hospitalization and increased cost. [2]
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