Adverse Drug Event Reporting Form

Patient Name (abbreviation)

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Card No

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Age, Date of birth

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Sex

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Weight

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Height

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Ethnic group

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Substance of abuse

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Information on suspected drug/vaccine S=suspected drug C=concomitantly used drugs

Drug name(write all information including brand name batch no and manufacturer

S/C

Dose/dosage form, route, frequency

Date drug taking was started

(D/M/Y)

Date drug reaction started

(D/M/Y)

Date drug taking was stopped

(D/M/Y)

Indication

(Reason for drug use)

Adverse drug event description(include all available laboratory test results)

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Reaction necessitated

Discontinuation of drug/s □ YES □ No

Hospitalization prolonged □ YES □ No

Reaction subside after D/C of suspected drug

□ YES □ No □ Information not available

Reaction reappear after restart of suspected drug

□ YES □ No □ Information not available

Treatment of reaction ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Outcome: □ Died due to the adverse event □ Died, drug may be contributory □ Not yet recovered

□ Recovered without sequelae □ Recovered with sequelae □ Unknown

Sequelae

Relevant medical conditions such as allergies, renal disease, liver disease, other chronic diseases, pregnancy etc_____________________________________________________________________________________

Reported by: Name

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Profession:

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Email address:

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Telephone

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Name of health institution

Date

Product quality problem: Color change, separating of components, powdering, crumbling, caking, molding, change of odor, incomplete pack, suspected contamination, poor packaging/poor labeling, etc (Write if anything different than given above)

Drug trade name

Batch No

Registration no

Dosage form and strength

Size /type of package

For office use only

Received on:

Registration no:

Key: D/M/Y ; Date /Month/Year D/C; Discontinue treatment Y;YES N;NO