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Causality Assessment of Adverse Events Following Immunization (AEFI) Lessons learnt and approachesStriving to reach everyone everywhere with safe vaccines Dr. Madhava Ram MD DNB Pharmacovigilance (PVG) WHO HQ, Geneva balakrishnanm@who.intCausality and Causality assessmentCausality* Is the relationship between two events (the cause and the effect), where the second event is a consequence of the firstCausality Assessment Determining if such a relationship exists and if so to what extent*A

How to fill out causality assessment of adverse

How to fill out causality assessment of adverse

1. Gather all relevant information about the adverse event and the suspect medication or intervention.
2. Review the patient's medical history to identify any pre-existing conditions or potential confounding factors.
3. Assess the temporal relationship between the administration of the intervention and the onset of the adverse event.
4. Evaluate other potential causes of the adverse event, such as concurrent medications or underlying health conditions.
5. Utilize a standardized causality assessment tool or algorithm, such as the Naranjo Scale or WHO-UMC system.
6. Score the causality criteria based on the gathered information and the chosen assessment tool.
7. Summarize the results and conclusions from the assessment, including any recommendations for further action.

Who needs causality assessment of adverse?

1. Healthcare professionals involved in patient care or research where adverse drug reactions are monitored.
2. Pharmacovigilance and safety officers responsible for evaluating drug safety.
3. Regulatory agencies that require causality assessment for ongoing safety evaluation of medications.
4. Clinical trial coordinators assessing adverse events for investigational drugs.
5. Patients experiencing adverse effects who want clarity on the relationship to their treatments.

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What is causality assessment of adverse?

Causality assessment of adverse refers to the process of evaluating and determining whether there is a causal relationship between a medical intervention (such as a drug or treatment) and an adverse event experienced by a patient.

Who is required to file causality assessment of adverse?

Healthcare professionals, such as physicians and pharmacists, clinical researchers, and pharmaceutical companies, are typically required to file causality assessments of adverse events, especially when they report incidents to regulatory authorities.

How to fill out causality assessment of adverse?

To fill out a causality assessment of adverse, one should gather relevant clinical information, assess the temporal relationship between the drug and the adverse event, evaluate patient history, and use standardized scales or guidelines to determine the likelihood of causality.

What is the purpose of causality assessment of adverse?

The purpose of causality assessment of adverse is to ensure patient safety, understand the risks associated with treatments, facilitate regulatory compliance, and inform future clinical practice and research.

What information must be reported on causality assessment of adverse?

Information that must be reported includes the patient's demographic details, the description of the adverse event, the timeline of the event concerning the drug administration, relevant medical history, and any potential confounding factors.