Suspected adverse drug reaction (ADR). Action: collect the minimum data (patient, suspected drug, reaction and chronology), assess severity and report on the Infarmed RAM Portal — even without certainty of causality.
Severe cutaneous reaction (blisters, peeling, fever — suspicion of SJS/TEN), angioedema, anaphylaxis, blood dyscrasia or hepatic/renal injury → immediate contact with the prescribing physician.
Identifiable patient (age, sex), suspected drug with dose and duration, description of the reaction, chronology (onset and evolution) and other drugs in use.
Assess severity (death, life-threatening, hospitalisation, disability, congenital anomaly) and causality in a simplified way: plausible chronology, improvement on withdrawal, recurrence on re-exposure.
Report on the Infarmed RAM Portal — even without certainty of causality. Serious reactions must be reported urgently. Keep the registration number of the report.
Serious reactions: stop the suspected drug (with medical advice), inform the prescriber, record in the chart and contraindicate in the future. Follow up the outcome of the reaction.
Always report when there is suspicion — certainty of causality is not required. Minimum data: identifiable patient, suspected drug, reaction and reporter with contact. Serious reactions must be reported urgently.