This document discusses methods and tools for adverse drug reaction (ADR) reporting. It defines ADR reporting and its importance. Anyone can report ADRs by filling out a standard form available online or offline and submitting it to their nearest monitoring center. Common tools for ADR reporting include Argus Oracle and Aris G software used by drug manufacturers, and Vigiflow and Vigibase databases maintained by the WHO. Healthcare professionals and consumers can report any suspected ADRs using spontaneous reporting or other methods to national pharmacovigilance centers.

1. DISCOVER . LEARN . EMPOWER
UNIVERSITY INSTITUTE OF PHARMA SCIENCES
Master of Pharmacy (Pharmacology)
Clinical Research and Pharmacovigilance
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Topic:-Methods and Tools for ADR Reporting
Presented To:- Dr. Payal Mittal
Presented By:- Pankaj(22MPH20016)

2. Introduction
• Clinical trial study of the drug detects ADR but, the reactions occurs
after long duration in a specific population remains undetected.
• So, Pharmacovigilance is a activity which keeps constant watch on the
drug throughout its life cycle.
• In India , IPC and NCC through the CDSCO regulate the PV activity.
• Then Pharmacovigilance programme in India have been proposed in
2010. Anyone can report ADR by filling the suspected ADR reporting
form available online or offline to the nearest centres in suitable
languages.
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3. Adverse Drug Reaction
• According to WHO, an adverse drug reaction defined as,
“ Any responses to a drug which is noxious unwanted effect of drug
doses used in human for prophylaxis, diagnosis and therapy”.
For example; when drug metabolism is temporarily inhibited by a
disorder or another drug
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4. Why ADR Reporting?
• ADRs are among the leading causes of death in many countries
(World Health Organization, 2008).
• Account for 5% of all hospital admissions in India.
• Constitutes a significant economic burden on the patient
and government.
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5. Benefits of ADR Reporting
• Assess the safety of drug therapies, especially recently approved
drugs.
• Provides updated drug safety information to health care professionals
and other stakeholders
• Measuring the economic impact of ADR prevention as manifested
through reduced hospitalization, optimal and economical drug use,
and minimized organizational liability.
• Regulatory action on the basis of ADR reports to ensure patient’s
safety.
• Marketing Authorization Recall (withdrawal), Batch recall based on
clustering of ADR
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6. Information required for ADR Reporting
The minimal standard information to be provided for the proper
estimation of the ADR case report are:
• 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. ADR Reporting Procedure
• Who can report?
• What to report?
• How to report?
• Where to report?
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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. Allopathy,
Ayurvedic, Vaccines, Medical devices etc.
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10. How to Report?
• Report should be on a standardized ADR reporting form.
• Dully filled the ADRs in the reporting from when an ADR is encountered.
• Use a separate from for each patient and filled with the complete
information.
• The completed ADR form is then returned to the nearest adverse drug
reaction monitoring Centre (AMC) or to National Coordinating Centre.
• 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. Where to Report?
Report any suspected ADRs for any marketed pharmaceutical products
or new drug to the appropriate channels are as follows:
• Preferably directly to the Pharmacovigilance center of a hospital.
• National Pharmacovigilance center.
• Zonal drug information centers.
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15. Workflow for reporting ADR
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16. Methods for ADR Reporting
• Spontaneous reporting: Mostly used ADR for monitoring, it records
the safety of a drug based on post marketing surveillance to identify
new, rare, serious ADRs of a drug.
• Case series reporting: It is used to develop a hypothesis between
approved drugs and it outcomes.
• Stimulated reporting: It encourages and facilitates health
professionals report ADRs under special situation.
• Active surveillance: It is pre-designed process which is conducted in
addition to process passive surveillance to find out more serious
adverse drug events.
• Comparative observation studies: Includes study designs such as
cross- sectional, cohort and case study to compare the possible ADR
associated with drug use with other group etc.
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17. Tools for ADR Reporting
1. Argus oracle:
It is a software for ADR monitoring, mainly used by drug manufacturer
in USA.
It is a comprehensive pharmacovigilance platform enabling
manufactures to make faster and better safety decision and risk
management.
In other words it is necessary for clinical and post marketing
surveillance.
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18. 2. Aris G
It is a software for ADR monitoring, and is mainly used by drug
manufacturer in Europe.
Aris G is a leading pharmacovigilance and clinical safety system that
helps companies efficiently process all safety cases and generate
appropriate global reports for distribution to regulatory authorities and
partners.
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19. 3. Vigiflow , Vigibase
Vigiflow: It is a management system for recording, processing and
sharing reports of adverse effects. It supports the domestic collection
and processing of individual case safety report data.
Vigibase: It is the single largest drug safety data repository in the world.
Since 1978, the Uppsala Monitoring Centre on behalf of WHO, have
been maintaining Vigibase, used to obtain the information about a
safety profile of a medicinal product.
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21. REFERENCES:
1. Thürmann, P A. “Methods and systems to detect adverse drug
reactions in hospitals.” Drug safety vol. 24,13 (2001): 961-8.
doi:10.2165/00002018-200124130-00003
2. Mulchandani, Rubina, and Ashish Kumar Kakkar. “Reporting of
adverse drug reactions in India: A review of the current scenario,
obstacles and possible solutions.” The International journal of risk &
safety in medicine vol. 30,1 (2019): 33-44. doi:10.3233/JRS-180025
3. Indian Pharmacopoeia Commission Pharmacovigilance Program of
India.
4. World Health Organization (2002) World Health Organization
Collaborating Centre for International Drug Monitoring. The
Importance of Pharmacovigilance Safety Monitoring of Medicinal
Products, Geneva. 21
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