Adverse drug reaction-causality assessment scales

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

N Chandra Sekhar

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Adverse drug reaction according to WHO is defined as ?Any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function?. Adverse drug reaction (ADR) monitoring involves following steps 1. Identifying adverse drug reaction (ADR). 2. Assessing causality between drug and suspected reaction by using various algorithms. 3. Documentation of ADR in patient?s medical records. 4. Reporting serious ADRs to pharmacovigilance centers /ADR regulating authorities. For the assessment of causality between drug and suspected ADR, various causality assessment scales been used. Most commonly used causality assessment scales are Naranjo ADR probability scale and WHO?UMC causality categories. These causality assessment scales will be displayed and discussed during this poster presentation.