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Table 1 Obligatory and voluntary items on the adverse drug reaction (ADR) report

From: Educational intervention to improve physician reporting of adverse drug reactions (ADRs) in a primary care setting in complementary and alternative medicine

Obligatory Voluntary
Patient details  
Patient initials* Week of pregnancy
Date of birth* Breastfeeding? (yes/no)
Gender* Profession
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  
Date drug stopped  
Suspected of causing ADR (yes/no/unsure)  
Name* Type of diagnose (primary, concomitant, secondary)
ICD-10 code* Diagnosis confirmed on date
Symptom Initial worsening of symptom
Severity according to WHO-ART  
Serious or non-serious according to ICH If serious, why?
Date ADR started  
Date ADR stopped  
Treatment of ADR completed? (yes/no) Reason for not completing treatment of ADR
  1. * Imported electronically from the computerized patient documentation system into QuaDoSta