EXPERIMENT 3
Aim: To study and fill the IPC’s ADR Reporting Form and perform causality assessments using various
scales (orthopedics).
Reference:
•https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdfdocuments/Consumer_SectionPDFs/AD
RRF_2.pdf
• https://website.aiimsraipur.edu.in/Downloads/
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5061681/
Theory
What is ADR reporting form?
ADR reporting is an important aspect of an efficient and effective pharmacovigilance program.
Although Medwatch, Yellow Card, CDSCO form, etc. are the protocol forms of ADR collection and
reports, a number of countries design and use their respective ADR forms.
What should I report in ADR?
ADRs related with the use of allopathic medicines, vaccines, traditional medicines, medical devices,
contrast media, etc., can be reported.
What should I report in ADR?
ADRs related with the use of allopathic medicines, vaccines, traditional medicines, medical devices,
contrast media, etc., can be reported.
When should ADR be reported?
Report if the patient was at substantial risk of dying at the time of the adverse reaction or it is suspected
that the use or continued use of the product would result in the patient's death. Report if admission to
the hospital or prolongation of a hospital stay results because of the suspected adverse reaction.
How to fill ADR Reporting Form and Causality Assessment?
Different Types of ADR Reporting Forms
• 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)
Who can report?
Doctor, Dentist, Pharmacist, Patient, Nurse.
Where to report
• Nearest ADR Monitoring Center (AMC)
– AIIMS Raipur
– Pt. JNMC, Raipur
• Directly to NCC, IPC Ghaziabad
•
[email protected] [email protected]
• Toll free no. – 1800 180 3024