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ADR Form PDF

This document is a suspected adverse reactions form used to report adverse drug reactions to the FDA. It collects information about the patient, suspected adverse reaction, suspected and concomitant medications, management of the reaction, outcomes, and reporter details. Key details include fields for patient name, age, suspected medications, description of reaction, consideration of seriousness, management and outcome of the reaction, and contact information of the reporter. Complete information is required for FDA review and all reports are kept confidential. Guidelines specify what types of reactions should be reported.

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Cha Tuban Diana
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
1K views

ADR Form PDF

This document is a suspected adverse reactions form used to report adverse drug reactions to the FDA. It collects information about the patient, suspected adverse reaction, suspected and concomitant medications, management of the reaction, outcomes, and reporter details. Key details include fields for patient name, age, suspected medications, description of reaction, consideration of seriousness, management and outcome of the reaction, and contact information of the reporter. Complete information is required for FDA review and all reports are kept confidential. Guidelines specify what types of reactions should be reported.

Uploaded by

Cha Tuban Diana
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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SUSPECTED ADVERSE REACTIONS FORM v 5 (4/2012)

Saving Lives Through Vigilant Reporting


*FIELDS MUST BE COMPLETED.
PATIENTS PARTICULARS

For FDA use only


All reports are confidential.
AER No. 2012-0001
Date received: _____________________

*Patient's Name or Initials___________________________ * Sex:

Male

Address or Contact Number: _____________________________________

Female
*Age________

Medical History/Admitting Diagnosis: _______________________________________


Any Known Allergy:

No

Yes, Specify:______________________________

Weight ______Kg

Height (cm) _____

Date of Birth (mm/dd/yr)__________________

Ethnic group: Filipino Chinese Caucasian


Pregnancy Status: ___ No
___ Yes (1st, 2nd, 3rd trimester)

Hospital/facility , if admitted:_______________________________________________
*DETAILS OF THE ADVERSE REACTION

Date
of onset:____________; ____am, ____pm
*

Do you consider the reaction to be serious?

Describe the reaction, including pertinent laboratory data:

Yes, if yes indicate why:

No

Patient died due to reaction


Involved or prolonged in-patient hospitalization
Life threatening
Involved persistent or significant disability
Congenital anomaly in the newborn
Other outcome, please give details:
Can this be due to Medication Error?
Yes, if yes, which type:

No

___Prescribing
___Transcription
___Dispensing
___Administration
Can the adverse reaction be due to :
1. Product quality defect ___No

___Yes, Specify, encircle: color change ; caking; powdering ; counterfeit; odor change; defective

container; contaminants; separation of components; undissolved suspension/powder


2. Therapeutic failure: ___No ___Yes, Specify, encircle: antimicrobial resistance, drug interaction, poor compliance, counterfeit, expired;
improper storage; under-dosing, inappropriate medication; inappropriate route of administration; excipients/preservatives
*Suspected drug product(s)
Indicate brand name

Daily Dose

Route

Date
started

Date
stopped

List all other drug/s taken at the same time and/ or 3 months before. If none, check box.
Brand name of the drug

Daily Dose

Route

Date
started

Date
stopped

Reason (s) for using


the product
(Indication)

Manufacturer and
Batch/Lot #

No Other drug/s taken

Reason/s for using the


drug

Manufacturer and
Batch & Lot No.

*MANAGEMENT OF ADVERSE REACTION


Was treatment given? No
Yes (If yes, please specify): ___________________________________________
Outcome:
Recovered (Date of recovery):___________________
Unrecovered
Other diseases: _____liver _____renal
Fatal (Date of death):______________________

Unknown

Sequela/e: (any permanent complications or injuries as a result of the ADR)


Yes (Please specify)_________________________
* REPORTERS PARTICULARS

No

Signature of reporter:

_______________________________________

Date reported (mm/dd/yr): _______________________________________

____Cancer

Re-challenge? Yes Result______________________

Unknown

*Printed Name of Reporter: _______________________________________

______HPN

_____ Diabetes _____CVS ____Endocrine


No

*Contact no:_________________________________________
Email address: ______________________________________
*Profession: __MD ___ RPh ___RN___Patient ___Dentist ___other
*Facility: ___Clinic ____Trial site _____Other

National Pharmacovigilance Center


Saving Lives Through Vigilant Reporting
Send completed form to: ADR Unit, FDA, Civic Drive, Filinvest Estate, Alabang, Muntinlupa ,1781.
Or fax to: (02) 807-85-11, c/o The ADR Unit. Send sample, if any, of suspect drug for analysis.
Website: www.fda.gov.ph

CONFIDENTIALITY
Any information including attachment/s related to the identities of the reporter and patient will be kept
confidential.
GUIDELINES FOR REPORTING
Please report any of the following:
All suspected adverse drug reactions for medicines and vaccines, including established medicines, traditional
medicines, household and herbal remedies & suspected counterfeit
All serious expected and/or unexpected adverse drug reactions
All suspected adverse drug reaction for new medicines
All suspected adverse drug reaction occurred in special populations including children, pregnant women and
elderly
All medication errors that result in an adverse reaction
Report even if you are not sure that the drug caused the event

For follow-up reports:


Any follow-up information that has already been reported may be sent to us in another form or through other
reporting channels. Please indicate follow up report.

Send this report thru:

Mail or Direct submission to:


Pharmacovigilance Unit
Center for Drug Regulation and Research
FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest Corporate City,
Alabang, Muntinlupa City

Fax: (02) 809 5596


Telephone: (02) 809 5596
Email: [email protected]
Online reporting:
http://www.fda.gov.ph/adr-report-new

This form can be downloaded from FDA website http://www.fda.gov.ph/industry-corner/downloadables/265suspected-adverse-reaction-form


For more information :
Contact the National Pharmacovigilance Center at (02) 809 5596

Thank you for reporting

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