Cannot be judged because information is insufficient or contradictory.More data for proper assessment needed, or.Disease or other drugs provide plausible explanations.Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable (but not impossible).Information on drug withdrawal may be lacking or unclear.Could also be explained by disease or other drugs.Response to withdrawal clinically reasonable.Unlikely to be attributed to disease or other drugs.Event or laboratory test abnormality, with reasonable time relationship to drug intake.an objective and specific medical disorder or a recognised pharmacological phenomenon)
The following causality terms are defined based on their respective assessment criteria. Risk factors: Age (both paediatric and geriatric patients), hepatic and renal impairment patients etc.Social life: Alcohol use, smoking (both history & concurrent use), obesity, diet, profession etc.,.Other medicinal product use: Concomitant medication details and past drug history.Medical conditions: Underlying concurrent medical conditions of patient (e.g., diabetes, heart diseases, autoimmune disease etc.,) or past medical history and prior or ongoing surgical procedures.Below are the possible contributors attributed to an AE. Alternative causality: Other contributory factors for the cause of adverse event.Negative Rechallenge: Adverse event has not recurred even after drug restart.Positive Rechallenge: Re-occurrence of adverse event after restarting of drug.It also can be classified into below two categories: The re‑introduction/restarting of drug therapy after the event resolution. Rechallenge: This is applicable in the positive dechallenge scenario.It is persisting irrespective of drug suspension/withdrawal and reduced dose. Negative Dechallenge: There is no change in the outcome of AE.Positive Dechallenge: The complete or partial resolution of adverse event followed by suspension/withdrawal of drug/reduced dose of drug.Based on outcome of AE, it is further classified into two categories: Dechallenge: The assessment of the outcome of adverse event followed by suspension/withdrawal of drug/reduced dose of drug in response to the adverse event.Abnormal Laboratory tests: There are some adverse event incidences which cannot be ruled out from the causal relation with drug based on unusual or abnormal values in the laboratory investigation.Temporal relationship: It is the time relationship between the drug administration (Date of therapy start date, therapy duration) and occurrence of adverse event (Event onset date/date of initial symptoms observed).It is basically a combined assessment considering the clinical-pharmacological aspects of the case history and the quality of the documentation of the observation.īelow key concepts will aid in ease understanding of various criteria for assessing causality. It is meant as a practical tool for the assessment of causal relationship in ICSRs. The World Health Organisation (WHO) and Upsala Monitoring center (UMC) at Sweden has developed a system for causality assessment in consultation with the National Centers participating in the International Drug Monitoring Programme.
However, there were no internationally agreed upon standards or criteria for assessing causality in individual case safety reports (ICSRs).īelow two methods are widely accepted and used for assessing causality globally. There are several methods published to perform causality assessment. The assessment of causality is a common procedure in pharmacovigilance, which is done at different levels which included physicians, investigators, professionals working in drug safety department of a pharmaceutical company and national health authorities which can assist in taking regulatory decisions.Ĭausality is the key factor for identification of new signals, measuring the strength of evidence, and in evaluating benefit risk profile of pharmaceutical medicinal products. When a causal relationship is identified, then adverse drug event (ADE) would be called as adverse drug reaction (ADR). Causality is an assessment procedure used for the determination of relationship between a drug treatment and the occurrence of an adverse drug event.