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Reporting of adverse drug reactions in India: A review of the current scenario, obstacles and possible solutions

Rubina Mulchandani, Ashish Kumar Kakkar
International Journal of Risk & Safety in Medicine 2019, 30 (1): 33-44
Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug's life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and awareness among health professionals, clinicians' perceptions towards reporting, problems with establishing reporting systems in hospitals and insufficient training to recognize ADRs. Measures to improve the situation include greater involvement of nurses, pharmacists as well as consumers in the reporting of ADRs, making the process simpler and faster through electronic means, introducing educational interventions and training programs for health care providers and spreading awareness about the reporting system amongst caregivers and receivers alike. Providing a momentum to the pharmacovigilance system and ensuring a robust reporting process is a challenge but proper planning, feasible solutions and focussed efforts can help bring about the change ensuring patient safety - the ultimate goal of pharmacovigilance.


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