1. How to Fill an ADR Form Dr. Manish Barvaliya, Assistant Professor,
Department of Pharmacology,
GMERS Medical College,
Dharpur, Patan.
Mobile:

2. August 6, 2019

3. Pharmacovigilance CME : Bhavnagar
ADR Form
Standard form provided by CDSCO, Government of India
Four Sections
Patient Information
Suspected Adverse Reaction
Suspected Medications
Reporter
August 6, 2019
Pharmacovigilance CME : Bhavnagar

4. Pharmacovigilance CME : Bhavnagar
Patient Information
August 6, 2019
Pharmacovigilance CME : Bhavnagar

5. Suspected Adverse Reaction
August 6, 2019
Pharmacovigilance CME : Bhavnagar

6. Suspected Medications
Rechallenge may be incidental or planned prospective re-exposure. History is very important or review of past medical records is important for Rechallenge information
August 6, 2019

7. Pharmacovigilance CME : Bhavnagar
August 6, 2019
Pharmacovigilance CME : Bhavnagar

8. Pharmacovigilance CME : Bhavnagar
Reporter
August 6, 2019
Pharmacovigilance CME : Bhavnagar

9. Pharmacovigilance CME : Bhavnagar
Confidentiality
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Pharmacovigilance CME : Bhavnagar

10. Essential Requirements (point no. 1, 5, 7, 8, 11, 15, 16 & 18 )
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Pharmacovigilance CME : Bhavnagar

11. Essential Requirements
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Pharmacovigilance CME : Bhavnagar

12. Essential Requirements
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13. Essential Requirements
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Pharmacovigilance CME : Bhavnagar

14. Pharmacovigilance CME : Bhavnagar
August 6, 2019
Pharmacovigilance CME : Bhavnagar

15. Pharmacovigilance CME : Bhavnagar
It’s time for some activity!
August 6, 2019
Pharmacovigilance CME : Bhavnagar

17. CBC, LFT, RFT values √ KNP 67 years F _ Re-challenge not performed
08/02/2013
21/02/2013
Patient developed rashes on the backs of hands, arms, trunk, neck, and face and frank blistering in some areas after 2 months of taking gliclazide. Lesions on lips and inside mouth.
Diagnosis: Erythema Multiformae
DM for 4 years, Stroke 5 years back
Gliclazide
40mg oral once daily 2months back 10/02/2013 Type 2 DM √
Re-challenge not performed
Aspirin 75mg once daily for 5 years Ramipril 10mg once daily Simvastatin 40mg at night,Metformin 1g twice daily X for 4 years
Aditya Gajera, Second M.B.B.S,
Govt. Medical College, Bhavnagar
M):
Probable/likely /02/2013