Community Development Medicinal Unit
West Bengal

Suspected adverse drug reaction reporting form

The adverse drug reaction MUST pertain to an identifiable patient. Fill in as much details as are possible - the patient particulars, nature of event and the names of suspect drug(s) are the minimum necessary.

REPORTER'S IDENTITY WILL REMAIN CONFIDENTIAL

What to report: Report all reactions to recently introduced drugs and / or uncommon or severe reactions to older drugs. Also report reactions to vaccines and all suspected drug interactions resulting in ADRs.
A reaction is to be regarded as SERIOUS if it is fatal, life-threatening, permanently or significantly disabling or incapacitating, requires or prolongs hospitalization or requires intervention to prevent one of the above consequences. Events that are in the nature of birth defects are also serious.


Patient's Name
Age : Years Months Days       Sex:  Male  Female     Weight : kgs.

If hospitalized, Name of hospital:
Address of hospital: 
Reg. No.:
Ward and Bed no.: 
Admission date:

Suspected adverse drug reaction (ADR) - State diagnosis (if known) or principal sign-symptoms:
Date of onset: Date of resolution:


Suspect drug(s): Drug or drugs suspected to have caused the adverse event in question with a reasonable possibility of a causal relation to it. Give generic name, brand name and lot number, if known, in the 'Name' column.

 
Concomitant drug(s): Other drugs (including self-medication and over-the-counter medication) being received by the patient at the time of taking the suspect drug or taken in the last 3 months. Give generic name, brand name and lot number, if known, in the 'Name' column.

Additional information: Relevant additional information including medical history, investigations, known allergies and suspected drug interactions. For congenital anomalies and events during pregnancy, state all other drugs taken and the LMP if known.


Reported by:

Name:
 
Designation:     
Doctor  Pharmacist   Nurse  Other healthcare provider 
                                                                                                                    (specify if other)


Address:


Phone: 

Fax: 
    
E-mail:
 
Please fill-in the online version of this form or fill-in the print version and mail it to:
The Chief Manager, Community Development Medicinal Unit, 86C Dr Suresh Sarkar Road, Kolkata - 700 014
or to
The Adminsitrative Officer, Community Development Medicinal Unit, East Vivekananda Pally, Raja Rammohan Roy Road,
P.O. Rabindra Sarani, Siliguri - 743 406.