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Suspected Adverse Drug Reaction Reporting Form

Posted by admin on Friday, 19 February 2016

A. PATIENT INFORMATION ?

  • Year
    Months
  • (Kg)

B. Suspected Adverse Reaction ?

C. Suspected Medication (S) ?

8 Name (brand and/
or generic name)		 Manufacturer Dose used Route used Frequency
1.*
2.
3.
4.
Batch No./Lot No. Exp. Date (If known) Therapy dates (if unknown, give duration) Reason for Use or prescribed for
Date started Date stopped
1.*
The Therapy started Date should always be prior to the Stop Date
The Therapy stop Date should always be prior to Recovery Date
Therapy Start date must be on or before Reaction Start date in Section B.
2.
The Therapy started Date should always be prior to the Stop Date
The Therapy stop Date should always be prior to Recovery Date
Therapy Start date must be on or before Reaction Start date in Section B.
3.
The Therapy started Date should always be prior to the Stop Date
The Therapy stop Date should always be prior to Recovery Date
Therapy Start date must be on or before Reaction Start date in Section B.
4.
The Therapy started Date should always be prior to the Stop Date
The Therapy stop Date should always be prior to Recovery Date
Therapy Start date must be on or before Reaction Start date in Section B.
  • Drug 1.
  • Drug 1.

D. Reporter (see confidentiality section overleaf) ?

  •  
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ADVICE ABOUT REPORTING

  • Report adverse experiences with medications
  • Report serious adverse reactions. A reaction is serious when the patient outcome is:
    • Death
    • Life-threatening (real risk of dying)
    • Hospitalization (initial or prolonged)
    • Disability (significant, persistent or permanent)
    • Congenital anomaly
    • Required intervention to prevent permanent impairment or damage
  • Report even if:
    • You’re not certain the product caused adverse reaction
    • You don’t have all the details however point nos. 1, 5, 7, 8, 11, 15, 16 & 18 (see reverse) are essentially required.
  • Who can report:
    • Any health care professional (Doctors including Dentists, Nurses and Pharmacists).
  • Where to report:
    • After completing, please return this form to Micro Labs Ltd, Pharmacovigilance Cell
  • What happens to the submitted information:
    • Information provided in this form is handled in strict confidence. PV cell at Micro Labs will carry out causality analysis and the data is statistically analysed and finally submitted to CDSCO.

Confidentiality:

The patient’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and 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 reaction.

If you would like to send us information by post, please download the form here and mail to the following address:

Download Adverse Drug Reaction Reporting Form Adverse Drug Reaction Reporting Form

MICRO LABS LIMITED

Pharmacovigilance Cell
31, Race Course Road, Bangalore-560001
Phone No : 080-22343023
E-mail : drugsafety@microlabs.in
Website : www.microlabsltd.com