Komal Halkai, Sharan kumar.Deshmukh, Y. Venkata Rao
ABSTRACT
Background : Medicines are the most common medical interventions to relieve sufferings but as said rightly “drugs are double edged weapons’’ with a potential to cause benefit, as well as harm.
Methods : A prospective hospital-based study over a period of six months (January 2015-june 2015) was carried out by the Department of Pharmacology under PvPIinKamineni Institute Of Medical Sciences. The ADRs of in-patient and outpatient were recorded. The data were subjected to descriptive analysis. The study plan included analysis and assessment of the clinical pattern, spectrum of ADRs reported based on causality, severity, preventability factors.
Results : A total of 100 patients were included in study. Out of which 58%(34.81±6.43) were females and 42% ( 35.47± 7.23)males. The most common drug group causing ADRs was antimicrobials (51%), followed by NSAID’s(20%) and anti-epileptics (10%). The dermatological reactions (43%) were more, followed by gastrointestinal system (31%) and CNS (18%). Majority of ADR’s were reported from OBG department (27%) followed by orthopaedics (24%).95% of ADRs were non-serious, 5% were serious but recovered. As per WHO assessment method 77% ADRs were probable and 23% possible.
Conclusion : The clinical spectrum of ADRs ranged from the more common mild reactions such as skin rashes, itching, nausea, and vomiting to moderately severe reactions prolonging the hospital stay. The predominant causative drugs were antimicrobials, non-steroidal anti-inflammatory drugs. The majority of ADRs were probable/likely in causality assessment, mild in severity and probably preventable. ADRs contribute to increased morbidity and mortality in patients; thereby pose a huge burden on the society.
Keywords: Adverse drug reaction, Causality assessment, Pharmacovigilance, adverse drug reaction centre.