Underreporting of Adverse Drug Reaction: A Critical Issue in Healthcare


Authors : Satish Kumar B P; Dr. Nandini H B.; Dr. Medhini H Gowda

Volume/Issue : Volume 8 - 2023, Issue 11 - November

Google Scholar : http://tinyurl.com/mtrbyt99

Scribd : http://tinyurl.com/5av7mjx6

DOI : https://doi.org/10.5281/zenodo.10390797

Abstract : Pharmacovigilance (PV), initiated by the World Health Organisation (WHO) in 1968, encompasses the systematic exploration and management of adverse effects associated with medications. The Programme for International Drug Monitoring (PIDM) and WHO Collaborating Centre for International Drug Monitoring (UMC) engage 134 nations, aiming to standardize PV practices amid global pharmaceutical expansion. Adverse drug reactions (ADRs) incur significant morbidity and financial burdens, especially in countries like India with diverse drug usage patterns. Adverse drug events (ADEs), including medication errors and ADRs, challenge global public health, causing harm and escalating healthcare costs. Underreporting persists despite ADR Monitoring Centres (AMCs), necessitating enhanced training, public education, and integrated drug safety education. This article delves into the pervasive issue of underreporting ADEs, exploring its extent and underlying factors. Analyzing the current state is crucial for developing potential solutions to bolster ADE reporting and advance patient safety. ADR identification methods are categorized into combined, active, and passive strategies. Combined methods integrate various approaches comprehensively. Active methods, using computerized reporting and medical note reviews, exhibit reasonable detection rates. Passive methods, specifically spontaneous reporting, reveal lower rates due to workflow interruptions and lack of knowledge. Underreporting factors span fear-based, knowledge- based, system-based, and organizational-based elements. Fear of adverse consequences fosters a culture of silence, hindering comprehensive reporting. Rational solutions involve establishing a global consensus, educational interventions, improving electronic reporting systems, and exploring alternative data sources. Continuous efforts are imperative to enhance knowledge, attitudes, and reporting practices, ultimately improving medication safety and patient care outcomes.

Keywords : Underreporting, Healthcare Professional, Solutions, Adverse Drug Reaction.

Pharmacovigilance (PV), initiated by the World Health Organisation (WHO) in 1968, encompasses the systematic exploration and management of adverse effects associated with medications. The Programme for International Drug Monitoring (PIDM) and WHO Collaborating Centre for International Drug Monitoring (UMC) engage 134 nations, aiming to standardize PV practices amid global pharmaceutical expansion. Adverse drug reactions (ADRs) incur significant morbidity and financial burdens, especially in countries like India with diverse drug usage patterns. Adverse drug events (ADEs), including medication errors and ADRs, challenge global public health, causing harm and escalating healthcare costs. Underreporting persists despite ADR Monitoring Centres (AMCs), necessitating enhanced training, public education, and integrated drug safety education. This article delves into the pervasive issue of underreporting ADEs, exploring its extent and underlying factors. Analyzing the current state is crucial for developing potential solutions to bolster ADE reporting and advance patient safety. ADR identification methods are categorized into combined, active, and passive strategies. Combined methods integrate various approaches comprehensively. Active methods, using computerized reporting and medical note reviews, exhibit reasonable detection rates. Passive methods, specifically spontaneous reporting, reveal lower rates due to workflow interruptions and lack of knowledge. Underreporting factors span fear-based, knowledge- based, system-based, and organizational-based elements. Fear of adverse consequences fosters a culture of silence, hindering comprehensive reporting. Rational solutions involve establishing a global consensus, educational interventions, improving electronic reporting systems, and exploring alternative data sources. Continuous efforts are imperative to enhance knowledge, attitudes, and reporting practices, ultimately improving medication safety and patient care outcomes.

Keywords : Underreporting, Healthcare Professional, Solutions, Adverse Drug Reaction.

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