| 1 | Adverse Drug Reaction (ADR) |
Relevant? Yes, No |
Present? Yes, No |
| A | Proper description of the ADR | Yes a | |
| B | Specification reaction ‘localization’ and ‘characterization’ To ‘strengthen the diagnosis (subdomain c or d or e applicable): |
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| C | Treatment; or | ||
| D | Visual material (photo, video); or | ||
| E | Lab values, test | ||
| 2 | Chronology | Relevant? Yes, no |
Present? Yes, no |
| A | Latency | Yes a | |
| B | Description of the course of the ADR | ||
| C | Action taken on drug | Yes a | |
| D | Outcome of the ADR | Yes a | |
| 3 | Suspected drug | Relevant? Yes, no |
Present? Yes, no |
| A | Brand name in case of drug substitution? | ||
| B | Different forms or route of administration for suspected drug? | ||
| C | Dose-relationship with ADR? | ||
| D | Batch number of relevance? | ||
| 4 | Patient characteristics | Relevant? Yes, no |
Present? Yes, no |
| A | Risk factors/medical history/comorbidity/indication | ||
| B | Concomitant medication | Yes a | |
| C | Age/gender/length/weight | ||
| D | Patient’s lifestyle or other risk factors | ||
| a: always relevant, Calculation of score: domain score: Number of present subdomains/number of relevant subdomains * 100%, Final score: Average relevant domain scores, Cut off values: Poorly (≤45%), moderately (from 46–74%) and well (≥75%). | |||