Pharmacovigilance

PARTICULARS OF PATIENT

Name of Patient*

Age*

Weight*

Contact No*

Email Address

CNIC

Patient Address*

Country*

Gender*

Male

Female

Other

Relevant Medical History

Reason For Reporting

Requires or Prolongs Hospitalization

Life Threatening

Death

Permanently Disabling or Incapacitating

Congential Abnormality

Over Dose

Others

SUSPECTED DRUG

Name of Suspected Drug*

Generic Name*

Date of Occurence*

Starting Date of Medication*

Duration Of Event*

1-2 Days

2 or More Days

Other

Route of Administration*

Discontinuation Of Drug*

No Yes

Dated*

REPORTING

Particulars

Name*

Phone

Clinic / Hospital

Date

GUIDINES TO FILL SERIOUS ADVERSE EVENT REPORT FORM

An adverse event is "Serious", if it

• Is life threatening

• Result in permenant disability

• Result in hospitalization

• Is associated with death

• Prolongations 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 as

• Complication of an underlying disease

• Intercurrent disease

• Coincidental accident

• Drug associated effect

• Concomitant medication