Adverse drug reactions: what information to include in a report
The adverse drug reactions reporting form (blue card) <http://www.tga.gov.au/adr/bluecard.htm> provides a good checklist for the information to include in a report. By providing all data relevant to a specific reaction, a rational and objective assessment of the medicine-reaction association can be made by ADRAC professional staff.
- Patient information (initials/UR No, DOB/age)
- Reporter information (name, address, phone number)
- A description of the reaction
- Any medicines suspected of causing the reaction
- Any other medicines
- Date of onset of reaction
- Dates of starting and stopping the suspected medicine
- Dates of starting and stopping any other medicines
- Details of any treatment of the reaction
- Outcome of the reaction and date of the outcome
- Medical history
- Relevant laboratory data (haematology, biochemistry, imaging, serology, biopsy, etc)
- AUST L number for complementary medicines (this can be identified by the letters "AUST L" followed by some numbers and can be found on the bottle or packaging of the product)
- Batch number for vaccines and for all cases of suspected quality control (manufacturing fault) problems
- In cases where the outcome is fatal, the circumstances, date and cause of death. If a postmortem examination or coroner's enquiry was conducted, a copy of the report would also be useful.
Note: If any of the above information is contained in existing documentation (discharge summary, specialist report, laboratory data, etc), it can be provided as photocopies.