Veterinary pharmacovigilance. Part 5. Causality and expectedness

Area of Science:

• Veterinary Pharmacology
• Drug Safety Assessment

Background:

• Regulatory bodies require causality assessment for animal adverse drug reactions.
• The European Union utilizes the ABON system, but causality assignment can be challenging.
• Distinguishing expected from unexpected adverse drug reactions is complex, especially across multiple species and breeds.

Purpose of the Study:

• To examine approaches to causality assessment for adverse drug reactions in animals.
• To evaluate the utility of algorithms in facilitating causality assessment.
• To discuss a decision-making framework for adverse drug reactions, referencing human pharmacovigilance.

Main Methods:

• Review of key criteria for causality assessment, including drug administration timing and biological plausibility.
• Examination of algorithms designed to aid the causality assessment process.
• Discussion of a novel approach adapted from human medicinal product pharmacovigilance.

Main Results:

• Causality assessment relies on criteria such as temporal relationship and biological plausibility.
• Algorithms can potentially streamline the complex process of causality assignment.
• A systematic approach, similar to human drug safety, can aid in evaluating adverse events in animals.

Conclusions:

• Causality assessment for animal adverse drug reactions requires careful consideration of multiple factors.
• Algorithmic approaches and human pharmacovigilance models offer valuable tools for improving decision-making.
• Standardized methodologies are crucial for accurate and consistent reporting of adverse drug reactions in veterinary medicine.