1Parul Institute of Pharmacy, Parul University, Vadodara, Gujarat – 391760, India
2Parul College of Pharmacy and Research, Parul University, Ahmedabad, Gujarat – 380058, India
An adverse drug reaction (ADRs) is a response to a drug which is noxious, unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function. They are one of the growing reasons of morbidity and mortality internationally, and could stay an enormous public health trouble, and represent a massive economic burden in terms of care prices, which contributes to a major proportion of hospital admissions. As per the findings from the Centre for Health Policy Research, the proportion of approved drugs in the U.S. associated with adverse reactions that go undetected during clinical trials is about 50%. Studies conducted in several parts of India have estimated the incidence of suspected ADRs to be nearly 2% to 3% among hospitalized patients. A recent systematic review estimated the median incidence of ADRs that led to hospitalization and those that developed during hospitalization as 2.85% and 6.34% respectively. According to several reports, ADR associated hospital admission is around 5% and almost 15-20% of patients admitted to hospital experience ADRs. Sometimes, ADR-related costs, such as hospitalization, surgery and lost productivity, exceed the cost of the medications. The study was conducted in a tertiary care hospital were 125 suspected ADRs were reported to the Pharmacovigilance department of the hospital and then forwarded to the regional ADR reporting center, and CDSCO.
Adverse drug reaction, Pharmacovigilance, Regional ADR reporting center, CDSCO
