Title: Pharmacovigilance Study of Antiretroviral Drugs in Tertiary Care Hospital - A Prospective Study
Authors: Dr Rajvardhan Rameshrao Solunke, Dr S. C. Dharmadhikari, Dr J.B.Jaju, Dr Sonal Parekar, Dr Aruna Gurung
DOI: https://dx.doi.org/10.18535/jmscr/v6i8.176
Abstract
Background: Anti-retroviral therapy present today has reduced morbidity and prolong life span of patients. Globally physicians are faced everyday with problems of adverse drug reactions (ADRs). World health organization focus on studies reporting adverse reactions for safety of patients. Such studies leads to revision of ART guidelines.
Aim: To carry out Pharmacovigilance study of antiretroviral drugs in our tertiary care hospital.
Objectives: To detect, assess and classify ADRs in patients receiving Highly Active Antiretroviral Therapy (HAART).
Material and Methods: This was a prospective, observational study carried out at Government medical college and tertiary care hospital Latur, Maharashtra. Both old and newly diagnosed patients of either sex and all age group receiving HAART were included in this study. Data was collected in suspected adverse drug reaction reporting form by using patient’s record and analysis was done.
Results: A total 157 patients presented with 223 ADRs during this study. Among them 106 were female and 51 were male. Females in the age group 20-40 years were most commonly affected. Common ADRs observed included anemia, dizziness, giddiness, skin rash. Most of ADRs were Type A, probable, non serious, moderate in severity, probably preventable.
Conclusion: This pharmacovigilance study of antiretroviral drugs concludes that the risk factors for development of ADRs were female gender, age group 20-40 years, people in rural area, labor by occupation taking ZLN and TLE regimens. So there is need of continuous monitoring of ADRs.
Keywords: Phamcovigilance, ADRs, Antiretroviral therapy, Suspected ADRs reporting form.
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