Table 1 Obligatory and voluntary items on the adverse drug reaction (ADR) report
Obligatory | Voluntary |
|---|---|
Patient details | Â |
Patient initials* | Week of pregnancy |
Date of birth* | Breastfeeding? (yes/no) |
Gender* | Profession |
Height* | Â |
Weight* | Â |
Drug | Â |
Name of drug* | If used previously, was the drug tolerated at the time? |
Prescribed for* | Was the drug continued or read ministered after onset of ADR? |
Date drug started | Â |
Date drug stopped | Â |
Suspected of causing ADR (yes/no/unsure) | Â |
Dosage | Â |
Diagnosis | Â |
Name* | Type of diagnose (primary, concomitant, secondary) |
ICD-10 code* | Diagnosis confirmed on date |
ADR | Â |
Symptom | Initial worsening of symptom |
Severity according to WHO-ART | Â |
Serious or non-serious according to ICH | If serious, why? |
Date ADR started | Â |
Date ADR stopped | Â |
Treatment of ADR completed? (yes/no) | Reason for not completing treatment of ADR |
Causality | Â |