Table 1 Data collection fields used in the paper version of the ADE reporting form

Name and dose of the culprit drug(s)

A. Select suspect drug(s)

Enter a list of suspected drugs

B. Suspect drug(s)

Enter the name(s), dose, route of administration, frequency, indication for, date of last dispense, and other relevant information about the suspect drug

Effect(s) of the ADE on the patient

C. What type of ADE do you suspect?

Select the type of ADE that occurred, if it was a drug-drug interaction, describe it in more detail

D. Are there symptoms, diagnoses, or laboratory tests that you suspect are an ADE manifestation?

Describe the symptoms and/or diagnosis caused or exacerbated by the ADE. Include relevant laboratory data and additional comments

Treatment received

E. Treatment recommended or administered

Describe the treatment for the ADE

F. Add new medications

List any newly recommended medications

Outcome

G. Causality and outcome

Describe what happened to the patient’s symptoms after treatment, the outcome of the ADE, and indicate the level of certainty that the event was caused by the suspect drug. List additional comments

H. Report submission

Indicate whether the report should remain in the inpatient record, be submitted to Health Canada or communicated to the drug plan

I. Follow-up items

List additional comments