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Nilratan Sircar Medical College
Kolkata
National Pharmacovigilance Week
17th – 23rd September, 2022
Theme: Encouraging Reporting of ADR by Consumers
Under aegis of National Coordination Centre-Pharmacovigilance
Programme of India, Indian Pharmacopoeia Commission, Ministry
of Health & Family Welfare, Govt. of India
Pharmacovigilance in Real Life
Anindya Banerjee
Sr. Pharmacovigilance Associate
Dept of Pharmacology
NRS Medical College, Kolkata
And
National Coordination Centre – Pharmacovigilance Program of India
Indian Pharmacopoeia Commission, Ghaziabad
Ministry of Health & Family Welfare
Govt of India
Pharmacovigilance
Pharmacovigilance: It is a science and activity related
to
 Detection
 Assessment
 Understanding
&
 Prevention
of adverse drug reactions or any other drug related
problems
WHO 2002
Minimum Role of a Community and Hospital
Pharmacist to prevent Adverse reaction
Monitoring of Drug Utilization
Health Promotion
Alert Stakeholders
(Prescriber, Nurse and
Patient) regarding use of
Polypharmacy and Drug-
Drug Interaction, Drug-
Food Interaction
Full Filling the activity of Detection, i.e,
the first step of Pharmacovigilance
Contd..
If you, the Pharmacist or Clinical Pharmacist knows the
Pharmacology of Medicine, then you can possibly assess the
upcoming ADVERSE DRUG REACTION, which is going to be
happen
Refer Primary, Secondary or Tertiary sources of Drug
Information from DIC, thus you can Understand
ADR
Occurred
ADR going to be
Occurred
YES Not YET
Prevent ADVERSE REACTION
ADR
Occurred
ADR going to be
Occur
Before the Occurrence
of ADR
After Occurrence of
ADR by Treatment
A Glimpse of an ADVERSE DRUG
REACTION
* 23yr old female patient got Wykoryl induced
Toxic Epidermal Necrolysis (TEN), No other
medication history for last 2 months, no early
history of drug rxn.
* Therapy period: 4 days
* Indication: Common Cough & Cold
* ADR Period: 7 Days.
•SERIOUS ADVERSE REACTION???:
- YES, Admitted to Hospital due to the incident
(Reason 1)
During Hospital stay her eyes were
permanently damaged (Reason 2).
On 7th Day Patient Died (Reason 3).
Disclaimer : The Snapshot has been taken with permission of Patient party and Medical
Super of NRSMCH
As a Consumer – Whom and/or Where to
report?
• Red colored Suspected Adverse Drug Reaction
Reporting Form is available at the website of
NCC-PvPI, IPC – Download and fill up, and send
the filled in Form at pvpi.ipcindia@gmail.com
or
• You may dial the mobile number: 8670117829
or
• Drop Email: anindyabanerjee1988@gmail.com
or
• Contact at: Pharmacovigilance Centre, Dept of
Pharmacology, 4th Floor, Academy Building, NRS
Medical College, 138, AJC Bose Road, Kolkata –
14
or
• PvPI Toll Free Number: 1800-180-3024
Or
• Through Mobile (ADR-PvPI App) from
downloadable via Google Play Store
Or
• Blue Coloured Consumer Reporting Form is
downloadable from the website of NCC-PvPI, IPC
and send report to NCC-PvPI through mail :
pvpi.ipcindia@gmail.com
Process of reporting Adverse Drug Reaction at
NRSMCH and/or National Coordination Centre - In
Nutshell
Acknowledgement
• Dr. Ananya Mandal, Associate Professor, Dept of
Pharmacology and AMC Coordinator under National
Coordination Centre - Pharmacovigilance Programme of India
(NCC-PvPI), Indian Pharmacopoeia Commission (IPC)
• Dr. Suman Chattopadhyay, Assistant Professor Dept of
Pharmacology and CAC Member under NCC-PvPI, IPC
• Prof & Head, Dept of Pharmacology, Nilratan Sircar Medical
College, Kolkata
• Dr. Jai Prakash, Sr. Principal Scientific Officer, NCC-PvPI,
IPC
Questions???
TAKE HOME MESSAGE:
To keep AWAKE or ALERT, to KEEP WATCH
Anindya Banerjee
Sr. Pharmacovigilance Associate
Dept of Pharmacology
NRS Medical College, Kolkata
And
National Coordination Centre – Pharmacovigilance Program of India
Indian Pharmacopoeia Commission, Ghaziabad
Ministry of Health & Family Welfare
Govt of India

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Pharmacovigilance in real Life.ppt

  • 1. Nilratan Sircar Medical College Kolkata National Pharmacovigilance Week 17th – 23rd September, 2022 Theme: Encouraging Reporting of ADR by Consumers Under aegis of National Coordination Centre-Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt. of India
  • 2. Pharmacovigilance in Real Life Anindya Banerjee Sr. Pharmacovigilance Associate Dept of Pharmacology NRS Medical College, Kolkata And National Coordination Centre – Pharmacovigilance Program of India Indian Pharmacopoeia Commission, Ghaziabad Ministry of Health & Family Welfare Govt of India
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  • 5. Pharmacovigilance Pharmacovigilance: It is a science and activity related to  Detection  Assessment  Understanding &  Prevention of adverse drug reactions or any other drug related problems WHO 2002
  • 6. Minimum Role of a Community and Hospital Pharmacist to prevent Adverse reaction Monitoring of Drug Utilization Health Promotion Alert Stakeholders (Prescriber, Nurse and Patient) regarding use of Polypharmacy and Drug- Drug Interaction, Drug- Food Interaction Full Filling the activity of Detection, i.e, the first step of Pharmacovigilance
  • 7. Contd.. If you, the Pharmacist or Clinical Pharmacist knows the Pharmacology of Medicine, then you can possibly assess the upcoming ADVERSE DRUG REACTION, which is going to be happen Refer Primary, Secondary or Tertiary sources of Drug Information from DIC, thus you can Understand ADR Occurred ADR going to be Occurred YES Not YET Prevent ADVERSE REACTION ADR Occurred ADR going to be Occur Before the Occurrence of ADR After Occurrence of ADR by Treatment
  • 8. A Glimpse of an ADVERSE DRUG REACTION * 23yr old female patient got Wykoryl induced Toxic Epidermal Necrolysis (TEN), No other medication history for last 2 months, no early history of drug rxn. * Therapy period: 4 days * Indication: Common Cough & Cold * ADR Period: 7 Days. •SERIOUS ADVERSE REACTION???: - YES, Admitted to Hospital due to the incident (Reason 1) During Hospital stay her eyes were permanently damaged (Reason 2). On 7th Day Patient Died (Reason 3). Disclaimer : The Snapshot has been taken with permission of Patient party and Medical Super of NRSMCH
  • 9. As a Consumer – Whom and/or Where to report? • Red colored Suspected Adverse Drug Reaction Reporting Form is available at the website of NCC-PvPI, IPC – Download and fill up, and send the filled in Form at pvpi.ipcindia@gmail.com or • You may dial the mobile number: 8670117829 or • Drop Email: anindyabanerjee1988@gmail.com or • Contact at: Pharmacovigilance Centre, Dept of Pharmacology, 4th Floor, Academy Building, NRS Medical College, 138, AJC Bose Road, Kolkata – 14 or • PvPI Toll Free Number: 1800-180-3024 Or • Through Mobile (ADR-PvPI App) from downloadable via Google Play Store Or • Blue Coloured Consumer Reporting Form is downloadable from the website of NCC-PvPI, IPC and send report to NCC-PvPI through mail : pvpi.ipcindia@gmail.com
  • 10. Process of reporting Adverse Drug Reaction at NRSMCH and/or National Coordination Centre - In Nutshell
  • 11. Acknowledgement • Dr. Ananya Mandal, Associate Professor, Dept of Pharmacology and AMC Coordinator under National Coordination Centre - Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission (IPC) • Dr. Suman Chattopadhyay, Assistant Professor Dept of Pharmacology and CAC Member under NCC-PvPI, IPC • Prof & Head, Dept of Pharmacology, Nilratan Sircar Medical College, Kolkata • Dr. Jai Prakash, Sr. Principal Scientific Officer, NCC-PvPI, IPC
  • 13. TAKE HOME MESSAGE: To keep AWAKE or ALERT, to KEEP WATCH Anindya Banerjee Sr. Pharmacovigilance Associate Dept of Pharmacology NRS Medical College, Kolkata And National Coordination Centre – Pharmacovigilance Program of India Indian Pharmacopoeia Commission, Ghaziabad Ministry of Health & Family Welfare Govt of India