A Study on Assessment Monitoring Documentation and Reporting of Adverse Drug Reactions and Evaluation of Increasing Health Care Costs at a Multi Specialty Tertiary Care Teaching Hospital in South India

Abstract

The prospective observational spontaneous reporting study was carried out at Kovai Medical Center and Hospital, Coimbatore, Tamil Nadu, India. A total of 1227 Adverse Drug Reactions (ADRs) were reported and 950 ADRs were accepted in this study. The incidence of ADRs was more in female than in male patients. ADRs commonly observed in the age group between 41 and 50 years. More than half of our study subjects were not to smoke or drink alcohols. Majority of the study population completed primary education followed by SSLC or Matric. Nearly ninety percent of the study subjects were married. Most of the reported ADRs were observed in inpatients than in outpatients. Majority of the study subjects were do not have any known allergic history. Dermatology department reported more number of ADRs followed by General Medicine Department. Fever was the most commonly observed reason for admission in the population. Diabetes mellitus was found as most common past medical history and also major diagnosis in our study population. Tablet Paracetamol was the most commonly prescribed drug as past medication in the study participants. Most of the suspected or observed ADRs developed in patients during their hospital stay. Skin and appendages were the most commonly affected system in our study. The most common type of ADRs observed in our study was Type-A followed by Type-B ADRs. Maculopapular skin rashes were the most commonly observed ADR, followed by severe gastric irritation and others Antibiotics were the most commonly implicated drug to cause ADRs, in this Amoxicillin and Clavulenic acid combination produced more number of ADRs. More than half of the suspected reactions were moderate in severity followed by mild. Naranjo s scale revealed more than three fourth of the reactions were fall under the category of probable ADR which has a causal relationship with offending drug(s). Most commonly observed barriers for reporting ADRs were lack of knowledge and uncertain about the drug and their reactions. newline