::INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES::

CODEN : IAJPBB
issn 2349-7750

News Updates Latest Volumes: COSMOS IMPACT FACTOR (2018)- 4.153, GLOBAL IMPACT FACTOR(2014) - 0.384, (2015) - 0.437, Indo American Journal of Pharmaceutical Sciences,

ResearcherID - CLICK HERE Scientific Journal Impact Factor (SJIF-2020) - CLICK HERE

TITLE:

IDENTIFICATION, ASSESSMENT AND REPORTING OF ADVERSE DRUG REACTIONS (ADRs) IN LARGE TERTIARY CARE HOSPITAL USING SPONTANEOUS REPORTING SYSTEM (SRS): A PROSPECTIVE OBSERVATIONAL STUDY

AUTHORS:

Dr. K S Arun Kumar, P N S Gowravi*, P V N S H Vardhini , G Akhila

ABSTRACT:

Detection, assessment and reporting of Adverse drug reactions (ADRs) is the need of the hour. Under-reporting of ADRs has been a major problem and Health care professionals (HCPs) must be encouraged to identify and report ADRs. Objective: The present study is aimed to Identify, assess and report ADRs in a large tertiary care Government teaching Hospital in South India, Andhra Pradesh. Methods: A Prospective, observational study was carried out in the General Medicine unit. The identified ADRs were analyzed (Causality assessment) and reported through Spontaneous reporting system (SRS) to the ADR Monitoring center located at the study site. Results: A total of 103 ADRs were identified, analyzed and reported in 85 patients. The gender-wise distribution of the study population included both Males (n=42, 49.4%) and females (n=43, 50.6%) with no significant difference in ADR occurrence. Majority of patients who experienced ADRs belong to the age group of 46-55 years (n=25, 29.4%) indicating that ADRs are more prevalent in the middle aged group. Digestive system is the most affected organ system (n=46, 47.4%) and the drug class under which most ADRs were identified was ACE Inhibitors (n=11,10.7%). Conclusion: This study provides a clear understanding on the patterns of occurrence of ADRs in patients admitted in the Department of General Medicine. To determine the precise frequency and incidence of ADRs in the Indian population, more research with larger sample size and duration must be conducted. Keywords: Adverse Drug Reactions, Causality Assessment, Spontaneous Reporting System, ADR Monitoring center.