Abstract
Background: Pharmacovigilance (PV) deals with the detection, collection, assessment,
understanding, and prevention of adverse effects associated with drugs. The objective of PV is to
ensure the safety of the medicines and patients by monitoring and reporting all adverse drug reactions
(ADRs) associated with prescribed medicine usage. Findings have indicated that about 0.2-
24% of hospitalization cases are due to ADRs, of which 3.7% of patients have lethal ADRs. The
reasons include the number of prescribed drugs, an increased number of new medicines in the market,
an inadequate PV system for ADR monitoring, and a need for more awareness and knowledge
about ADR reporting. Severe ADRs lead to enhanced hospital stays, increased treatment costs, risk
of death, and many medical and economic consequences. Therefore, ADR reporting at its first instance
is essential to avoid further harmful effects of the prescribed drugs. In India, the rate of
ADR reporting is less than 1%, whereas worldwide, it is 5% due to a need for more awareness
about PV and ADR monitoring among healthcare providers and patients. The main objective of
this review is to highlight the current scenario and possible futuristic ways of ADR reporting
methods in rural areas of India. We have searched the literature using PubMed, Google scholar, Indian
citation index to retrieve the resources related to ADR monitoring and reporting in India's urban
and rural areas. Spontaneous reporting is the most commonly used PV method to report ADRs
in India's urban and rural areas. Evidence revealed that no effective ADR reporting mechanisms
developed in rural areas causing underreporting of ADR, thus increasing the threat to the rural
population. Hence, PV and ADR reporting awareness among healthcare professionals and patients,
telecommunication, telemedicine, use of social media and electronic medical records, and artificial
intelligence are the potential approaches for prevention, monitoring, and reporting of ADRs in rural
areas.
Keywords:
Adverse drug reactions (ADRs), drug safety, pharmacovigilance, pharmacovigilance methods, rural areas, patients.
Graphical Abstract
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