Quality & Compliance
Safety & Vigilance
18 july 2023
Assessing causality, or the probability of an adverse event related to a drug or medication, is critical to pharmacovigilance and drug safety. It contributes to the thorough evaluation of the risk-benefit profile of medications. Researchers have developed various methods to evaluate the causality of adverse events; however, there is no universally accepted method. Two commonly used methods for causality assessment are the WHO-UMC (World Health Organization-Uppsala Monitoring Centre) method and the Naranjo Adverse Drug Reaction (ADR) probability scale. While both approaches serve the same purpose, their methodology and application differ. Let’s delve into the positives and limitations of each method.
WHO-UMC Causality Assessment: The WHO-UMC method is a widely accepted and frequently used causality assessment tool in drug safety. It offers several positives:
The Naranjo ADR probability scale is a simpler tool that assesses the probability of a drug-related adverse event. It has its own set of positives:
In conclusion, the WHO-UMC causality assessment and the Naranjo ADR probability scale are commonly employed methods for evaluating the causality of adverse drug events. The choice between these methods depends on the specific context, available data, and user preferences. While the WHO-UMC method offers a comprehensive and standardised approach, the Naranjo scale provides a simpler and more quantifiable assessment. Using these methods in conjunction with other assessment tools is often recommended to enhance the accuracy of causality determination.
Casualty is an important parameter in routine pharmacovigilance activities like ICSR, literature monitoring, signal management and PSUR/PADER. We PLG support the causality assessment for medical review during case processing, signal management and PSUR/PADER. The team comprises dedicated medical advisors, professionals and specialists, allowing PLG to deliver a comprehensive range of vigilance needs on diverse product portfolios and various pharmaceuticals.
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