Consumer reporting of adverse drug reactions: A current perspective

Dr. Sukanta Sen


Adverse drug reactions (ADRs) have been identified as one of the leading causes of hospitalization leading to morbidity and mortality worldwide. Reporting of ADRs to national databases is thus necessary. To strengthen this system, consumers apart from health-care professionals have also been empowered to report any ADRs directly to the regulatory agencies. Direct and spontaneous patient or consumer reporting offers various benefits beyond pharmacovigilance (PV). Consumer reporting of ADRs has existed in several countries for decades, but in India, the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the European Union. The World Health Organization is promoting the role of the consumer in spontaneous ADR reporting as an adjunct to existing PV strategies. Indian Pharmacopoeia Commission has launched the ambitious medicines adverse effect reporting form for consumers along with a patient centric helpline number for the general public to enable reporting of ADRs directly. Consumer reporting is an integral part of the spontaneous reporting systems with yearly numbers of reports constantly increasing

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