ADR reporting tools and processing in india

1. Adverse drug reactions
Reporting
&
Tools available
Presented by :
K . Krushi Sangeeta
M.Pharm (Pharmacology)
Sir C.R.Reddy college of Pharmaceutical Sciences
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2. Contents of Slides
 Adverse drug reaction
Objectives of ADR reporting
ADR reporting tools
Types of ADR reporting forms
 Software Database
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3. Adverse Drug Reaction (ADR)
World Health Organization (WHO) defined ADR as
“A response which is noxious and unintended, and which occurs at
doses normally used in humans for the prophylaxis , diagnosis, or
therapy of disease, or for the modification of physiological function”
“
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4. Why ADR Reporting ?
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5. Benefits of ADR Reporting
 Regulatory action to ensure patient’s safety
- Marketing Authorization Recall (withdrawal)
- Batch recall based on clustering of ADR
- Upgrading package insert
 Provides updated drugs safety information to health
care professionals.
Measuring the economic impact of ADR prevention
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6. The minimal standard information to be provided for the proper
estimation of the ADR case report are :
Information required for ADR
Reporting
» Patient information
» Description of adverse reactions (include laboratory results if available)
» Information related to the suspected drug(s)
» Information on the management of the adverse reactions
» Information about the reporter
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7. Who can report ?
What to report ?
How to report ?
Where to report ?
ADR Reporting Procedure
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8. Who can report ?
• All healthcare professionals
(Clinicians, Dentist, Pharmacist, Nurses, Physician, Physiotherapist etc).
• All non- healthcare professionals including consumers/ patients etc can
report ADRs.
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9. What to report ?
 All types of suspected adverse reactions.
Known or unknown,
Serious or non-serious
Frequent or rare
 Reactions from all types of pharmaceutical products i.e.
Allopathic, Ayurvedic , Vaccines, Medical devices etc
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10. How to report ?
1. Report should be on a standardized ADR reporting form.
2. Dully filing the ADRs in the reporting from when an ADR is
encountered.
3. Use a separate from for each patient and filled it with the complete
information.
4. The completed ADR form is then returned to the nearest adverse
drug reaction monitoring Centre (AMC) or to National Coordinating
Centre.
5. Any follow-up information for an ADR case that has already been
reported can be sent on another ADR form, or communicated by
telephone, fax or e-mail.
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11. Report any suspected ADRs for any marketed pharmaceutical products or new
drug to the appropriate channels are as follows:
 Directly to NCC, IPC Ghaziabad
Official website: (www.ipc.gov.in)
Mail id:pvpi.ipcindia@gmail.com
pvpi@ipcindia.net
Toll free no:1800 180 3024
 Nearest ADR Monitoring Center (AMC)
Hospitals
Medical institutions
Where to report ?
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12. Android app for
ADR Reporting
It is a indigenously developed
application for all the
healthcare professionals and
consumers to report Adverse
drug reactions
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13. • Suspected Adverse Drug Reaction Reporting Form
(For voluntary reporting of Adverse Drug Reactions by Healthcare Professionals)
• ADR Reporting Form for Consumer
• Transfusion Reaction Reporting Form (TRRF)
(Haemovigilance Program of India)
• Medical Device Adverse Event Reporting Form
(Materiovigilance Program of India)
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17. The communication of drugs safety information among
HCPs, patients, MAHs, and PV officials is essential for
ADR Reporting. To ease this process, NCC-PvPI, IPC had
developed several other tools for ADR-reporting and
understanding.
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18. Vigiflow – Medical data base
∞ Vigiflow is a web-based Individual Case Safety Report (ICSR) management
system that is specially designed for use by national centers in the WHO programme
for International drug monitoring .
∞ it is a complete, easy management system
∞ Vigiflow can be used by any authority or company as a database for report
management and data analysis.
∞Subscription for vigiflow is free in India.
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