Ade And Near Miss Incident Classification Form (Page 3 of 3) in pdf

Ade And Near Miss Incident Classification Form Page 3

Complete the following table

Yes

Unsure

9.1

Are there any previous reports of this reaction in the

Literature to your knowledge?

9.2

Was the condition present before the administration

of the drug in question?

9.3

Could a non-pharmalogical clinical condition

explain the change noted?

9.4

Was the amount of the drug used too much for this

patient?

9.5

Is there objective evidence of toxicity (eg. from body

fluids, biopsy, blood levels, but NOT rash or vital signs)?

9.6

Did the patient receive an antagonist to the drug?

9.7

Was the antagonist effective?

9.8

Did the patient undergo therapy other than the

antagonist directed at the condition in question?

9.9

Was the therapy effective?

9.10 Does the patient have a known allergy or intolerance to

the drug?

9.11 Was this reaction a rash, hives, itching, or anaphylaxis?

9.12 Was this reaction a commonly reported sensitivity to this

medication (eg. Nausea to opiates)?

10. Was the event ameliorable?

____

1. Yes

2. No

Page 3 of 3

6/6/05

Dataform 5: ADE and Near Miss Incident Classification Form

Version 5.0

Ade And Near Miss Incident Classification Form Page 3