ADVERSE DRUG REACTION
REPORTING FORM
Sr. No For Report to Drugs Controller Pak Secretariat, Block C, Ministry of Health,
.
REPORT ON SUSPECTED SERIOUS ADVERSE DRUG
REACTION
1. PARTICULARS
OF PATIENT
Name of patient.
Age Weight
(kg) Patient
address
Sex Male Race
Female
Pregnant Yes No Not applicable
Relevant Medical History
2. ADVERSE EVENT
Reason for reporting
Requires or prolongs hospitalization Life
threatening Death
Permanently disabling or incapacitating Congenital
anomaly Overdose
Other (Please Specify)
3. SUSPECTED
DRUG
Name of suspected Drug
Generic Name
Name of manufacturer
Date of occurrence
Duration of Event
Starting date of Medication
Route of administration
Discontinuation of Drug because of
event No Yes Dated
4. REPORTING
DOCTOR’S / PHARMACIST’S / NURSE’S
SIGNATURE
Institution
Date
GUIDELINES TO FILL SERIOUS ADVERSE
EVENT REPORT FORM
An adverse event is “Serious”, if it
• Is life
threatening • Results in permanent disability
• Results in
hospitalization • Is
associated with death
• Prolongation
of hospitalization • Causes a birth defect
• Causes
malignancy • Causes a relevant organ toxicity
• Is an
overdose resulting in clinically
Relevant
signs and / or symptoms
An adverse drug event can be a manifestation of various
etiologies such as
• Complication
of an underlying disease • Intercurrent
disease
• Coincidental
accident • Drug associated effect
• Concomitant
medication