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Adverse Event Reporting

This adverse event reporting form collects information about adverse reactions or product problems related to medications. It requests details about the patient, suspected reaction or product issue including description, dates and outcomes. It also collects information about suspect medications, other health products used, and the reporter. The form notes that all reports are kept strictly confidential and help assess the risks and benefits of medicines on an ongoing basis. It encourages reporting even without all details and provides contact information to submit completed forms.

Uploaded by

Sanjay Navale
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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296 views2 pages

Adverse Event Reporting

This adverse event reporting form collects information about adverse reactions or product problems related to medications. It requests details about the patient, suspected reaction or product issue including description, dates and outcomes. It also collects information about suspect medications, other health products used, and the reporter. The form notes that all reports are kept strictly confidential and help assess the risks and benefits of medicines on an ongoing basis. It encourages reporting even without all details and provides contact information to submit completed forms.

Uploaded by

Sanjay Navale
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Check all that apply:

 Adverse Event
 Product Problem
 Both

ADVERSE EXPERIENCE REPORTING FORM


Report Date:

Company Ref No. ______________

Local Ref No. ___________

Patient information
Relevant tests/ laboratory data (with date)
Patient Initials

_____________________

Age at time of
Event: ______
(or)
Date of
Birth: _________

Sex:  M

F

Weight_____

B. Suspected Adverse Reaction


Date of Event Onset:

Other relevant history, including pre-existing medical conditions

Date of Resolution:
Describe Event, Problem or Product Use Error

Seriousness

 Death (dd/mmm/yyyy)_________ Congenital anomaly






Life threatening
Hospitalization-initial
or prolonged
Disability

Required intervention
to prevent permanent
impairment/ damage
Other (specify)____________

Outcome

 Fatal


Ongoing

 Recovering

 Unknown

 Recovered

Other (specify)____________

Suspect Medications (including indication, therapy dates, action taken)

D. Reporter (see confidentiality section in first page)


Lot No. & Expiry date

Reaction abated after use stopped or dose reduced

Reaction reappeared after reintroduction

Yes  No 

Yes  No 

Does not apply

Concomitant health products, excluding treatment of reaction


(name, dose, frequency, route and therapy dates)

Does not apply

Reporters Information:
Name:
Address:

Contact Number:
Email ID:
Relationship with
patient (if any)
Occupation _____________________
Qualifications:

Confidential

______________

ADVICE ABOUT REPORTING


 Report even if:
 Youre not certain the product caused adverse reaction
 you dont have all the details

Confidentiality: The patients identity is held in strict confidence and


protected to the fullest extent. Company shall not disclose the reporters
identity in response to a request from the public.

Who can report:




Any health care professional


(Doctors, Dentists, Nurses, Pharmacists, etc)

Non healthcare professional


(Patient, relative, friend, etc)

Did you know?

Adverse drug reactions are


the 4th - 6th leading
causes of death

Submission of a report does not constitute an


admission that medical personnel or manufacturer or
the product caused or contributed to the reaction.

Your

5 minutes

could help in
ensuring Safer
Medicines

What happens to the submitted information?

The information generated on the basis of these reports helps in


continuous assessment of the benefit-risk ratio of medicines.

Pharmacovigilance
can only
be effective through
the active
participation of
practitioners!!

Where to report:
After completing, please return this form to the representative of Sun Pharmaceutical Industries Ltd.
Else, you may contact:
Sun Pharmaceutical Industries Ltd.
Global Pharmacovigilance Department
Address: 17/B, Mahal Industrial Estate,
Mahakali Caves Road,
Andheri (East), Mumbai 400 093. India.
Fax No. +91-22-66455699
E-Mail: [email protected]

Confidential

Need
more
Forms?

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