Adverse Drug Reaction (ADR) reporting is a vital process in pharmacovigilance that involves the identification, documentation, and analysis of adverse effects or unexpected reactions to medications. Healthcare professionals, including clinical pharmacists, play a crucial role in reporting ADRs to regulatory authorities. Timely and accurate reporting helps enhance patient safety, contributes to the continuous monitoring of drug safety profiles, and facilitates informed decision-making in healthcare. ADR reporting is a proactive measure to ensure the ongoing assessment and improvement of medication safety for the benefit of patients and the broader healthcare system.

1. ADR REPORTING
PRESENTED BY- MOHD ABUTAHA ANSARI
PHARM.D. (INTERN)
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2. Introduction
1. Clinical trial study of the drug detects ADR but, their actions occur after a long
duration in a specific population and remain undetected.
2. So, (PV) Pharmacovigilance is an activity that keeps a constant watch on the drug
throughout its life cycle.
3. In India, IPC through the CDSCO regulate the PV activity.
4. The Pharmacovigilance program in India was proposed in 2010. Anyone can
report ADR by filling out the suspected ADR reporting form available online or
offline to the nearest centers in suitable languages.
5. Then, the reported ADRs are collected and processed at the centers in vigiflow
software. The centers detect signals that are reported to CDSCO and WHO.
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3. Adverse drug reaction
According to WHO, an adverse drug reaction is defined as,
“Any response to a drug which is a noxious unwanted effect of drug doses used in
human for prophylaxis, diagnosis and therapy”.
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4. Types of ADR
TYPE Type of Effect Characteristics
A Augmented Dose dependent, Predicted from the known
pharmacology of the drug
B Bizzare Unpredictable, Dose independent, Rare.
C Chronic Prolong treatment.
D Delayed After years of treatment.
E End of use Withdrawal effects
F Failure Unexpected failure of therapy
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5. Adverse drug reaction reporting tools
Adverse drug reactions reporting tools or
monitoring is a process of continuously
monitoring undesirable effects suspected
to be associated with the use of medical
products. ADR reporting covers all
pharmaceutical products, biological,
herbal drugs, cosmetics, and medical
devices.
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6. Information required for ADR monitoring
1. Patient Information
2. ADRs Description
3. Information Related to Suspected Drug(s)
4. Information on Management of ADR
5. Information about the reporter
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7. Methods of ADR monitoring
1. 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.
2. Case series reporting: It is used to develop a hypothesis between approved
drugs and their outcomes.
3. Stimulate reporting: It encourages and facilitates health professionals to
report ADRs under special situations.
4. Active surveillance: It is a pre-designed process that is conducted in addition
to passive surveillance to find out more serious adverse drug events.
5. 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 groups etc.
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8. What to report
1. All ADRs as a result of Prescription and Non-prescription medicinal products
2. All suspected ADRs regardless of product information provided by the
company.
3. Unexpected reactions with the product regardless of its nature or severity
4. A serious reaction, whether expected or not
5. All suspected ADRs associated with drug-drug, drug-food, or drug-food
supplement interactions.
6. ADRs occurring from overdose or medication error.
7. Unusual lack of efficacy or when suspected pharmaceutical defects are
observed.
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9. Who should report
1. Health care Professionals and Providers
2. Manufacturers of Product
3. Health care centers
When to Report
1. ADR should be reported as soon as possible
2. Delays in reporting make the report inaccurate and unreliable
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10. How to report
1. Report should be on a standardized ADR reporting form.
2. Dully filled the ADRs in the reporting from when an ADR is encountered
3. Use a separate form for each patient and fill it in the complete information
4. The completed ADR form is then returned to the nearest adverse drug reaction monitoring
Centre(AMC) or to the 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.
6. Follow-up reports should be identifiable and the following should be indicated on the report
a) Follow-up Information
b) Date of Original Report
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11. ADR reporting form,IPC
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12. What happens to submitted information
1. The causality assessment is carried out at Adverse Drug Reaction Monitoring
Centers (AMCs) by using WHO-UMC scale
2. The analyzed forms are forwarded to the National Coordinating Centre
through the ADR database.
3. Finally the data is analyzed and forwarded to the Global Pharmacovigilance
Database managed by WHO Uppsala Monitoring Center in Sweden.
4. The reports are periodically reviewed by the National Coordinating Centre
(PvPI).
5. The information generated on the basis of these reports helps in the
continuous assessment of the benefit-risk ratio of medicines.
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13. Argus oracle method of ADR reporting
It is a software for ADR monitoring, mainly used by drug manufacturers in the
USA. It is a comprehensive pharmacovigilance platform enabling manufacturers
to make faster and better safety decisions and risk management.
In other words, it is necessary for clinical and post-marketing surveillance.
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14. Vigiflow and 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, has been maintaining
Vigibase, used to obtain information about the safety profile of a medicinal
product.
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