Importance of Adverse Events Reporting

Jayawant Fuke

Abstract: Adverse events (AEs) continue to be of concern to all health professionals and are now recognized as an important cause of hospital admissions, with a proportion ranging from 0.9–7.9%1. Several studies conducted in developed countries have confirmed the contribution of Adverse Drug Reaction (ADRs) to mortality and morbidity. A meta-analysis of 39 prospective studies from hospitals in the United States indicated that ADRs ranked as the fourth to sixth leading cause of death. The Uppsala Monitoring Centre (UMC) in Sweden is maintaining the international database of ADR reports and currently about 4.7 million case reports are received from several nations (96 member countries). However, still, it is estimated that only 6-10% of all ADRs are reported 2 3. Even the serious AEs are under reported in all patient-care environments.

Introduction: India is the world’s second most populated country with over one billion potential drug consumers. A study by Ramesh, et al carried out in a tertiary referral centre in South India showed that admissions due to ADRs accounted for 0.7% of total admissions and deaths due to ADRs accounted for 1.8% of total deaths4. Although, India is participating in the UMC program, its contribution to the UMC database is very little, which is expected considering the lack of awareness of reporting concept among Indian Health case professionals (HCP) This problem is essentially due to the absence of a robust ADR monitoring system and also lack of a reporting culture among health care workers. With over 1 billion USD worth of clinical trials conducted in India, it is very important to focus the attention of the medical community on the importance of adverse drug reporting to ensure maximum benefits for Public Health and Safety.
An adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can, therefore, be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.5
Adverse drug reactions are noxious and unintended responses to a medicinal product. A reaction, in contrast to an event, is characterized by the fact that a causal relationship between the drug and the occurrence is suspected. For regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an adverse drug reaction.5



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