Asha jyothi* and G. Shireesha
Adverse drug reactions (ADRs) are an established risk to medication use. As defined by the World Health Organization (WHO), an ADR is any response that is noxious and unintended, and that occurs at doses normally used in humans for the prophylaxis, diagnosis, therapy of disease, or for the modification physiological function. ADRs associated morbidity and mortality impose a burden to patient’s health and health care costs. Unfortunately, not all ADRs can be identified in clinical trials, and so post-marketing surveillance is imperative in identifying and evaluating those risks associated with medication use . Spontaneous reporting of unusual or previously unpredicted ADRs by health care professionals (HCPs) can accordingly reduce such risk and promote the safe use of medications. The main advantage of spontaneous reporting is its ability to cover the entire population, which use a wide range of medications, thus identifying rare ADRs as early as possible. Nevertheless, only 6–10% of ADRs area actually reported to drug authorities in Europe, Canada and USA, making underreporting of ADRs a major limitation of spontaneous reporting. In an effort to strengthen the pharmacovigilance in India, government has initiated pharmacovigilance programme of India. Spontaneous reporting of adverse drug reaction is globally practiced it under pharmacovigilance programme. But the major drawback of this system is underreporting. The finding of study suggests a huge scope for improving the awareness about ADRs.
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