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“A response to drug which is noxious and unintended and
which occurs at doses normally used in man for prophylaxis,
diagnosis or therapy of diagnosis or therapy of diseases or for
the medication of physiology function.”
ADR REPORTING FORM
(To be filled by MO}
Date of ADR: ‘Time of ADR:
Drug reaction on admission: [_] Yes NO
‘Name of Offending Agent Dosage Route & Rate of Administration
Batch No. Mfg. Date Expiry Date
Was it High Alert Medication? __Yes_| No
“Type of ADR:
OC Mild 1 Moderate CO Life Threatening
Description of Adverse Drug Reaction:
Immediate Action T aken :
Outcome Recovered Date of recovery /_/
‘Not Recovered/Unknown/Fatal | Date of Death: —_/__/
Sequel Yes /No If yes,
Cause of ADR | aeccribe
Name & Signature of person reporting the ADR:
Preventive Action Taken:
RMO/CONSULTANT Signature
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DateTo Be Filled By Quality Assurance Department
Form submission (Date & Time): ADR Number:
Form Received By:
RCA Required: 0 Yes 2 NO
If Yes, detail of RCA with Action Taken
RCA Report Corrective Action Taken.
Name & Signature of Person who did RCA: Name & Signature of Person who has taken
Action:
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