TY  - JOUR
T1  - Pharmacovigilance Should Separate Signal Strength from Clinical Actionability
A1  - Krzysztof Wiśniewski
A1  - Małgorzata Nowak
A1  - Tomasz Adamczyk
JF  - International Journal of Pharmaceutical Research and Allied Sciences
JO  - Int J Pharm Res Allied Sci
SN  - 2277-3657
Y1  - 2025
VL  - 14
IS  - 1
DO  - 10.51847/oRSou6YA6w
SP  - 122
EP  - 131
N2  - Pharmacovigilance often treats a statistically prominent drug–event association as if it were inherently closer to clinical or regulatory action. That inference is unsafe. Disproportionality, machine-learning prioritisation, longitudinal healthcare data, case-level assessment, and other signal methods answer questions about whether an association is unusual, reproducible, temporally coherent, or evidentially credible. They do not by themselves determine whether an intervention is warranted. Actionability additionally depends on the seriousness, magnitude, reversibility and preventability of harm; background risk; exposed-population vulnerability; therapeutic alternatives; time sensitivity; and the feasibility and consequences of intervention. This Current Opinion argues for an explicit separation between signal strength and clinical actionability. Statistical strength should describe the credibility and maturity of the safety association, whereas actionability should describe the consequence-sensitive case for doing something under current uncertainty. The distinction explains two recurrent pharmacovigilance problems: strong signals that remain insufficiently decision-ready and modest signals for which proportionate early action may nevertheless be justified. The proposed separation is a conceptual framework, not a validated scoring system, causal algorithm, or regulatory rule.
UR  - https://ijpras.com/article/pharmacovigilance-should-separate-signal-strength-from-clinical-actionability-qolf0gj6izuubsa
ER  -