PHARMACOVIGILANCE

DEAR MEMBER ,
PLEASE READ THE BELOW MATTER CAREFULLY AND SEND UR FEEDBACK.

The IMA Pharmaco Vigilance Cell at IMA Hqs., New Delhi is fully operational now. We have designed an Adverse Drug Reaction (ADR) / Adverse Event (AE) reporting form for further reporting to the concerned departments. Some dedicated hon'ble members have already started reporting Adverse Reactions to our cell in the prescribed format.

We attach a softcopy of the IMA ADR Form herewith for your kind perusal. We request you to kindly give utmost importance to this issue and collect as much data on Adverse Drug reactions and Adverse events as possible and report the same to us.

You may like to send the attached Adverse Drug Reporting form complete in all respects for every ADR / AE observed in daily practice by you or your colleagues to us either by post or by email to:-

Dr.S.C.L.Gupta
Director,
IMA Pharmaco Vigilance Education Cell
IMA House, I.P.Marg,
New Delhi-110002.

Email : imapharmaco.vigilance@gmail.com

INDIAN MEDICAL ASSOCIATION PHARMACO VIGILANCE CELL
IMA HOUSE, I.P.MARG, NEW DELHI-110002
Tel. +91-11-23370009, 23378053, 23370352; Fax : +91-11-23379470; 23370352
Email : imapharmaco.vigilance@gmail.com

ADVERSE DRUG EVENT REPORTING FORM.

For VOLUNTARY reporting of Adverse Drugs Events by IMA Members

A. Patient information

1. Patient identifier (initials) _______________________ __________________________ _____________________
First Last Age or Date of Birth

2. Sex F  M  Weight __________ kgs

B. Suspected Adverse Event

3. Outcome attributed to adverse event (Check all that apply):
Death _________________ (dd/mm/yy)
Life-threatening Hospitalization – initial or prolonged Disability
Congenital anomaly Required intervention to prevent permanent impairment/damage
Other______________________________

4. Dates of event starting _________________ (dd/mm/yy)
Dates of event stopping _______________ (dd/mm/yy)

5. Describe event or problem : ___________________________________________________________________________
_________________________________________________________________________________________________
_________________________________________________________________________________________________
6. Relevant tests/laboratory data, including dates : ___________________________________________________________
_________________________________________________________________________________________________
7. Other relevant history, including pre-existing medical conditions (eg. Allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) : _______________________________________________________________________
_________________________________________________________________________________________________
C. Suspected medication(s)

8. 1. Brand and/generic name _________________ Labelled strength_____________
Manufacturer ___________________ Dose ____________ Frequency _______ Route used _________
Lot # (if known) __________ Exp. Date (if known) __________ Therapy dates : From ____________ To ____________

Diagnosis for use (separate indications with commas) ____________________________________________________

Event abated after use stopped or dose reduced:
Yes  No  Not applicable 

Event reappeared after reintroduction:
Yes  No  Not applicable 

2. Brand and/generic name _________________ Labelled strength_____________

Manufacturer ___________________ Dose ____________ Frequency _______ Route used _________
Lot # (if known) __________ Exp. Date (if known) __________ Therapy dates : From ____________ To ____________
Diagnosis for use (separate indications with commas) ____________________________________________________
Event abated after use stopped or dose reduced: Yes  No  Not applicable 
Event reappeared after reintroduction: Yes  No  Not applicable 

9. Concomitant medical products and therapy dates including self medication & herbal remedies (exclude those used to treat event) ___________________________________________________________________________________________
_________________________________________________________________________________________________
D. Clinical (if not the reporter)
10. Name and Professional Address _______________________________________________________________________
____________________________________________________________ Pincode _____________________________
Tel. No. with STD Code: ______________________ Specialty _____________________________________________
E. Reporter (See confidentiality section below)
11. Name and Professional Address _______________________________________________________________________
____________________________________________________________ Pincode _____________________________
Tel. No. with STD Code: ______________________
12. Date of this report ______________ Health Professional? Yes  No  Occupation ___________________
(dd/mm/yy)
13. Also reported to : No one else Manufacturer User facility Distributor
14. If you do not want your identity disclosed to the manufacturer tick this box 
Confidentiality: The patient’s identity is held in strict confidence and protected to the fullest extent. Programme is not expected to & will not disclose the reporter’s identity in response to a request from the public. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the event.

This form completed in all respects may kindly be sent to the IMA Pharmaco vigilance cell as per communication details as above. For any further query or clarifications, please feel free to contact : Dr. S.C.L.Gupta, Director, IMA Pharmaco Vigilance Cell; Mob.No.+91-9810003807

For IMA office use only :
Date of receipt of Form ___________________ Report No. _____________________ Sign. ___________________