Original Research Article
Year: 2016 | Month: September | Volume: 3 | Issue: 9 | Pages: 30-34
An Evaluation of Adverse Drug Reactions Profile at a Tertiary Care Teaching Hospital
Akanksha Mathur, Nimit Goswami, Prashant Shah, Niyati Trivedi
Department Of Pharmacology, Medical College Baroda, Vadodara (Gujarat)-390001.
Corresponding Author: Prashant Shah
ABSTRACT
Objective: Adverse drug reactions (ADRs) are inevitable consequences of drug therapy as no pharmacotherapeutic agent is completely free from noxious and unintended effects. However, ADR reporting in India is inadequate. Developing awareness in patients and healthcare professionals (HCPs) will help in reducing the ADRs, its suffering and socioeconomic impact. Hence, the present study was carried out in various clinical departments of a tertiary care teaching hospital with the main objective to assess the ADR patterns in outpatient and inpatient of the hospital and also to assess the causality, severity, and preventability of these ADRs.
Materials and Methods: A prospective study was conducted over 2 years. Spontaneous type of reporting method was used. The WHO definition of ADR was adopted. All the patients reported to have ADR were included in the study. The study plan included analysis and assessment of spectrum of ADRs reported based on causality, severity and preventability factors.
Results: A total of 225 ADRs were reported and evaluated. 55.11% were males and 44.88% females. The most common drug group causing ADRs was antitubercular (26.66%) followed by antibacterial (23.11%) and antiepileptic agents (17.33%). Skin (45.77%) was the most common organ system involved followed by central nervous system (19.11%) and gastrointestinal system (10.22%).As per WHO causality assessment, 50.66% of ADRs were possible and 48.88% were probable.
Conclusion: The clinical spectrum of ADRs ranged from the more common mild reactions to life threatening reactions and disability. The predominant causative drug was antitubercular agents. The majority of ADRs were possible in causality assessment, mild in severity and not preventable.
Keywords: Adverse drug reactions, Pharmacovigilance, Causality.