National Pharmacovigilance Program for

Name: Ethnicity: OPD IPD Street / House No. Village / Town Post / Via District / State

Patient Record Number Age Sex Male Female

2. Description of the suspected Adverse Reactions ( please complete boxes below )

Date and time of intial observation
Description of Reaction

3. List of all ASU drugs including drugs of other systems used by the patient during the reporting period:

Medicine Name	Manufacturer Batch no.	Daily dose	Form Route of Administration	Date Starting	Date Stopped	Reason for use

4. Brief details of the supected ASU medicine :

a. Composition of the formulation / Part of the Drug used
b. Expiry date if any
c. Remaining part of the drug / Procuct label
d. Please select any one from the drop down menu	Ayurveda Siddha Unani Other
e. Adjuvant
f. Dietary Restrictions if any
g. Drug consumed by	Under Medical Supervision Used as self medication
h. Any other relevant information.

5. Treatment provided for suspected adverse reaction

6. Outcome of the supected adverse reaction (please complete the boxes below) Severe Yes No

Recovered Not Recovered Unknown Fatal

If Fatal Date of Death

Reaction abated after drug stopped or dose reduced :
Reaction reappeared after re introduction :
Was the patient admitted to hospital ? If yes, give name and address of hospital

7. Any laboratory investigations done which provides suspicion of drug involvement :

8. Whether the patient is suffering with any chronic disorders		Hepatic Renal Cardiac Deabetes Malnutrition Any Others
9. H/o Previous allergies / Drug reactions :
10. Identification of the reporter:
Profession Doctor Nurse Pharmacist Health worker Patient Attendant Manufacturer Distributor Supplier Any Other	Name:
Street / House No.		Name & address of the RRC - ASU / PPC - ASU
Village / Town
Post / Via
District / State

Who can Report ? Any health care professionals like ASU Doctors / Dentists / Nurse / Pharmacists etc.

What to Report ? - All suspected reactions, Lack of effects, Drug interactions, Dependence and Abuse.

Confidentiality - The patient's identity will be held in strict confidence and protected to the fullest extent. Programme srtaff will not disclose the reporter's identity in response to arequest from the public.

Submission of report doesn't constitute an admission that, medical personnel or manufacturers or the product caused or contributed to the reaction.

For other queries please contact :

The coordinator, National Pharmacovigilance Resourse Centre for ASU Drugs I.P.G.T & R.A.,G.A.U.,Jamnagar, Gujarat - 361 008 E-mail : nprcasu@gmail.com

Technical Support by AVTAR - Arya Vaidya Pharmacy - Coimbatore - India