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Understanding and assessing adverse drug reactions
1University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. HowlandRH@upmc.edu
Journal of Psychosocial Nursing and Mental Health Services
|September 30, 2011
Summary
Determining if a medication caused an adverse event (AE), known as an adverse drug reaction (ADR), is challenging. A validated 10-question method by Naranjo et al. quantifies ADR probability, improving upon subjective clinical judgment.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Drug Safety
Background:
- Establishing causality between medication exposure and adverse events (AEs) is complex.
- AEs may stem from the drug, underlying conditions, or other factors, complicating diagnosis.
- Current methods rely on subjective clinical judgment, varying in reliability.
Purpose of the Study:
- To introduce a systematic and validated method for assessing the probability of adverse drug reactions (ADRs).
- To provide a quantitative approach to ADR assessment, moving beyond subjective clinical judgment.
Main Methods:
- The Naranjo et al. method involves answering 10 specific questions.
- A total score derived from these questions quantifies the probability of an ADR.
Main Results:
- The Naranjo scale offers a standardized approach to ADR probability assessment.
- This method aims to enhance the objectivity and reliability of causality evaluation.
Conclusions:
- The Naranjo et al. method provides a validated tool for quantifying ADR probability.
- This systematic approach improves upon traditional subjective clinical assessments in drug safety.
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