Suspected Adverse Reactions Form 0

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SUSPECTED ADVERSE REACTIONS FORM For BFAD use only All reports are confidential.

Saving Lives Through Vigilant Reporting AER No. _________________________


Date received: _____________________
Patient Particulars
Patient's Surname_ __________________________________________________________________________________________
First Name __________________________________________________________________________________________________
Age _________ Date of Birth (mm/dd/yyyy) ___________________ Sex:  Male  Female Weight _________Kg

Contact Number________________________________ Ethnic group:  Filipino  Chinese  Amerasian


 Other (please specify) : ________________________
Details of the Adverse Reaction
Outcome:
Date of onset: ______________________  Recovered (Date of recovery):___________________  Unrecovered
mm/dd/yyyy
 Fatal (Date of death):______________________  Unknown
Sequela/e (any permanent complications or injuries as a result of the ADR):
Time:_________AM ___________PM
 Yes (Please specify)_________________________  No  Unknown

Describe the reaction/s:________________________________________________________________________________________________


____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________
Suspected drug product(s) Dose Frequency Route Date Date Reason (s) for Manufacturer:
Indicate brand name started stopped using the product Include: Batch/Lot
#
             
     
              
   
             
     
             
      

List all other drug/s taken at the same time and/ or 3 months before No Other drug/s taken

Brand name of the drug Dose Frequency Route Date Date Reason/s for using Manufacturer/Batc
started stopped the drug h & Lot No.

MANAGEMENT OF ADVERSE REACTION


Hospitalization (following the ADR):  Yes  No  Already hospitalized before ADR occurred
Do you consider the reaction to be serious?  Yes  No
If yes, please indicate why the reaction is considered to be serious (please tick ✓ all that apply):
 Patient died due to reaction  Involved or prolonged in-patient hospitalization
 Life threatening  Involved persistent or significant disability or incapacity
 Congenital anomaly  Other outcome, please give details: _____________________________________
Treatment given:  Yes  No (If yes, please specify): ________________________________________________________________
REPORTER’S PARTICULARS

Printed Name of Reporter: Contact no:_________________________________________


Email address: ______________________________________
Signature of reporter:
Profession: __MD ___ RPh ___RN___ Patient ____Others
Date reported (dd/mm/yr):

Send completed form to: The ADR Unit, BFAD, Civic Drive, Filinvest Estate, Alabang, Muntinlupa 1781. Or fax to: (02) 807-85-11, c/o The
ADR Unit. Remaining sample of the drug can be sent to BFAD for analysis.

National Pharmacovigilance Center


“Saving lives through Vigilant Reporting”
Bureau of Food and Drugs
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
www. bfad.gov.ph

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