Question 1

What is the Meaning of Reporting Odds Ratio (ROR)?

Accepted Answer

The Reporting Odds Ratio (ROR) quantifies the disproportionality of reported adverse events associated with a specific drug within pharmacovigilance databases. It represents the odds of an adverse event occurring with a particular drug compared to the odds of the same event occurring with all other drugs in the database. This statistical measure helps identify potential safety signals.

Question 2

What is the Context of Reporting Odds Ratio (ROR)?

Accepted Answer

ROR operates within post-market drug surveillance, analyzing large, aggregated spontaneous adverse event reporting systems maintained by regulatory bodies. Its primary role involves screening for unexpected or disproportionately frequent drug-event associations that might suggest a new safety concern. This statistical tool functions as an initial filter for continuous medication safety monitoring.

Question 3

What is the Significance of Reporting Odds Ratio (ROR)?

Accepted Answer

ROR holds substantial practical importance for clinical practice and public health. By highlighting disproportionate reporting of specific drug-adverse event pairs, it assists regulatory agencies and clinicians in detecting potential safety signals early. Such signals can prompt further epidemiological investigation, potentially leading to critical actions like drug label updates, risk management plans, or, rarely, product withdrawal, safeguarding health.

Question 4

What is the Mechanism of Reporting Odds Ratio (ROR)?

Accepted Answer

The ROR is derived from a 2x2 contingency table, comparing the frequency of a specific adverse event with a particular drug against its frequency with all other drugs, and similarly, comparing other events. This calculation provides a ratio of odds, indicating whether the association between a drug and an event is reported more often than expected by chance. It serves as a statistical flag for further clinical review.

Question 5

What is the Application of Reporting Odds Ratio (ROR)?

Accepted Answer

In practice, ROR is a foundational tool for pharmacovigilance specialists who routinely analyze vast datasets of adverse event reports. A calculated ROR exceeding a predetermined threshold, often with a minimum number of cases, indicates a potential safety signal that warrants deeper examination. This prompts review of individual case reports, assessment of biological plausibility, and initiation of rigorous analytical studies to validate the association.

Question 6

What is the Metric of Reporting Odds Ratio (ROR)?

Accepted Answer

ROR is a dimensionless statistical metric, calculated as a ratio from the counts of reported adverse events within a pharmacovigilance database. It is not a direct biological measurement like a serum hormone level. The metric is derived by comparing the reported frequency of an event for a drug against its frequency for other drugs. Its value, with confidence intervals and minimum case counts, guides signal assessment.

Question 7

What is the Risk of Reporting Odds Ratio (ROR)?

Accepted Answer

Over-reliance on ROR without comprehensive clinical and epidemiological follow-up presents inherent risks. ROR is a signal detection tool, not diagnostic; it does not establish causality. Misinterpretation can lead to false alarms or missing genuine safety concerns from under-reporting bias. The metric is susceptible to confounding factors, data quality issues, and varying reporting rates, necessitating careful clinical judgment and confirmatory studies.

Reporting Odds Ratio (ROR)

Meaning

Context

Significance

Mechanism

Application

Metric

Risk

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