Evaluation of adverse drug reactions of first line antiretroviral drugs in a tertiary care centre of Telangana, India

Background: The introduction of highly active anti-retroviral therapy (HAART) has led to a significant reduction in AIDS related morbidity and mortality. Most of the adverse drug reactions are preventable. So continuous evaluation will benefit Antiretroviral treatment that helped to achieve ultimate goal of making treatment safer and more effective to patients. The present study was designed to monitor and analyse the incidence, type and nature of adverse events to first line Antiretroviral drugs.Methods: A cross sectional observational study was conducted at Antiretroviral treatment center of Gandhi Hospital, Secunderabd, Telangana. The study was conducted over a period of 6 months involving all HIV patients. After initiation of 1st line regimen- tenofovir 300mg + lamivudine 300mg + efavirenz 600mg (TLE), patients were followed for any adverse event. Descriptive statistics was used for analysis of data.Results: Out of 453 studied, 47 patients developed adverse events. A total of 79 adverse events were reported. The assessment of total adverse drug reaction profile revealed cutaneous 44.30%, hematological 40.50%, renal 11.39%, gastrointestinal 3.79%. WHO-UMC causality assessment scale showed 76.5% and 23.4% Adverse events as probable and possible respectively. Hartwig and Siegel severity scale revealed 93.6%, 2.1% and 4.3% as mild, moderate and severe cases respectively.Conclusions: The TLE regimen found with lower adverse events in this study. The study focuses the importance of active adverse event monitoring to detect early toxicities and to support safe use of anti-retroviral treatment

The pattern of reported adverse drug reactions with reference to specific drug class and organ system

Background: Adverse drug reactions (ADRs) represent a major public health problem. The overall ADR rate is estimated to be 6.5 and 28% of these are preventable.ADR incidence in Indian population ranges between 1.8-25% with 8% resulting in hospitalization. Hence, the present study was undertaken to study the pattern of reported adverse drug reactions with reference to specific drug class and organ system in a tertiary care hospital.Methods: A cross-sectional retrospective study was carried to analyse the ADRs reported over a period of one year (January-December 2019). Individual case safety reports (ICSRs) of all patients of suspected adverse drug reactions seen in various out-patient departments and admitted in the wards of the hospital were included in the study. The ICSRs were analysed for patient demography, causality, severity and with reference to specific drug class and organ system.Results: Among 382 reported ADRs, 27.2% of the ADRs were reported as serious. The most common therapeutic class of drugs causing ADRs where Antimicrobial agents (36.07%). The skin is the most common affected organ system (25.39%).Conclusions: A coordinated system of identifying the ADRs early in the course of treatment and recognizing the preventable ADRs is required by the health care system. The coordination of prescribing physicians and pharmacovigilance personnel can produce better trend of reporting the ADRs