Abstract

A PROSPECTIVE OBSERVATIONAL STUDY ON MONITORING, EVALUATING AND REPORTING OF ADRs IN A TERTIARY CARE HOSPITAL

Dr. Mohammed Abuzar Ghufran*, Dr. T. S. Sunil Kumar, Dr. Bandari Kiran, Dr. D. Shravan Kumar

ABSTRACT

The objective of the study was to assess the incidence and pattern of ADRs based on age, gender, assess causality, severity, preventability, types of ADRs and the offending drugs, monitoring and reporting suspected adverse drug reactions. A total of 947 Patients were studied and out of which 57 Patients developed ADRs which has the incidence rate of 6% to develop ADRs. Suspected ADRs were reported and evaluated out of which 32(56.14%) were male and 25(43.85%) were female. Geriatric patients experienced maximum ADRs 27(47.36%). Drug class most commonly associated with ADRs was Antibiotics 16(28.07%). WHO probability scale of assessment of ADRs revealed 29(50.87%) as possible, 23(40.35%) as probable and certain 5(8.77%). Naranjo’s assessment revealed 30(52.63%) as possible, probable 22(38.59%) and Definite 5(8.77%) in view of causality. While 31(54.38%) were found to be moderate, 23(40.35%) as mild and 3(5.26%) as severe ADRs in case of severity assessment. Based on type of reactions 37 (64.91%) ADRs were Type H, 18(31.57%) as Type A and 2(3.50%) Type D reactions. Preventability criteria of ADRs showed 42(73.68%) were definitely preventable and 15(26.31%) as probably preventable. Clinical categorization and the drugs causing ADRs are found to be similar to those observed in previous studies except some minor variations. Clinical Pharmacists (CP) have an important responsibility in monitoring the ongoing safety of medicines by providing pharmaceutical care and management as a part of their professional practices. This study suggests the hospital-based monitoring of ADRs by clinical pharmacists is an essential role in prevention of ADRs.

Keywords: Adverse Drug Reactions (ADRs), Causality, Probability, severity, Monitoring, Clinical Pharmacists (CP).