Reporter Information

Purpose: Captures details of the individual reporting the ADR, ensuring traceability and follow-up.

Includes: Name, contact information, professional status (e.g., healthcare professional or patient).

Patient Information

Purpose: Gathers demographic and clinical data of the patient experiencing the ADR.

Includes: Age, sex, weight, medical history, and relevant clinical information.

Suspected Adverse Drug Reaction

Purpose: Details the adverse event experienced, including its nature and severity.

Includes: Description of the reaction, onset date, outcome, seriousness, and causality assessment.

Suspected Medication Information

Purpose: Identifies the medication believed to be responsible for the ADR.

Includes: Drug name, manufacturer, batch number, expiry date, dosage form, strength, route of administration, start and stop dates.

Concomitant Medication

Purpose: Lists other medications the patient was taking concurrently, which could influence the ADR.

Includes: Names and details of other drugs administered.

Medical History

Purpose: Provides background on the patient's health status to assess potential contributing factors.

Includes: Known allergies, previous ADRs, relevant medical and surgical history.

Outcome of the ADR

Purpose: Assesses the resolution and impact of the ADR on the patient's health.

Includes: Recovery status, any ongoing effects, and long-term implications.

Reporter’s Assessment of Causality

Purpose: Determines the likelihood that the suspected medication caused the ADR.

Includes: Causality assessment using criteria such as the WHO-UMC system.

Glossary of Common Terms

• Adverse Drug Reaction (ADR): An unintended, harmful response to a drug at normal doses used in humans for prophylaxis, diagnosis, or therapy.
• Causality Assessment: The process of determining the likelihood that a drug caused an ADR. Common methods include the WHO-UMC system.
• Serious ADR: An adverse reaction that results in death, is life-threatening, requires hospitalization, causes persistent disability, or leads to congenital abnormalities.
• Concomitant Medication: Other medications the patient is taking alongside the suspected drug, which may interact and contribute to the ADR.
• Outcome: The result of the ADR, including recovery status and any lasting effects.