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ADR Form should have at least four sections which should be completed:
1. Patient information:
- patient identifier - age at time of event or date of birth - gender - weight
2. Adverse event or product problem:
- description of event or problem - date of event - date of this report - relevant tests/laboratory data (if available) - other relevant patient information/history - outcomes attributed to adverse event
3. Suspected medication (s):
- name (Generic and brand name) - dose, frequency & route used - therapy date - diagnosis for use - event abated after use stopped or dose reduced - batch number - expiration date - event reappeared after reintroduction of the treatment - concomitant medical products and therapy dates
- name, address and telephone number - speciality and occupation
The completed ADR Report Form should be sent to the national or regional ADR centre or to the manufacturer of the suspected product.