Roles & responsibilities in PV

1. Clinical Research & Pharmacovigilance
Roles & Responsibilities In
Pharmacovigilance
Presented By Guided By
Samiksha Hamane Pranali Chandurkar
(M. Pharm) (Assistant Professor)
Dr. Rajendra Gode Institute of Pharmacy, Amravati.
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2. Content -
• Introduction
• Definition & importance
• Aim & objectives
• Roles of pharmacovigilance
• Responsibilities of pharmacovigilance
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3. Introduction to Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any
other drug-related problems. It is a critical process that ensures the safe
and effective use of medications.
Definition and Importance
1.Definition
Pharmacovigilance is the pharmacological science and
activities relating to the detection, assessment,
understanding and prevention of adverse effects or any
other drug-related problems.
2.Importance
Pharmacovigilance helps to identify and manage risks
associated with the use of medicines, ultimately improving
patient safety and enhancing public health.
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4. Aim and Objectives
Aim
The primary aim of pharmacovigilance is to enhance
patient care and safety in relation to the use of
medicines, and to support public health programs.
Objectives
 Identify and quantify the risks associated with the use
of medicines
 Detect, assess, understand and communicate the
information on the benefits, risks, and effective use of
medicines
 Promote the safe and effective use of medicines
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5. Roles of Pharmacovigilance
1. Monitoring
• Continuously monitoring the safety of medicines to identify any potential adverse events or risks.
• Drug safety monitoring is the process of identifying expected and unexpected adverse reactions resulting
from the use of medicines in the post-marketing phase.
• It is a risk mitigation exercise in which the ADRs caused by therapeutic drugs, biologicals or devices can
explored, prevented or minimized.
• Before releasing into the market, a medicine is tested using a limited population ranging from 500 to 5000.
• Once the medicine comes into the market it becomes legally available for consumption by the general
population. The population may be children, pregnant women, patients suffering from other diseases and the
elderly.
• The drug is taken in different therapeutic situations and physiological conditions.
• It is therefore, very much necessary to observe and record the effectiveness and safety of the medicine under
real-life conditions.
• A close and effective monitoring is required to assess the risks associated with the use of medicines.
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6. 2. Data Collection
• Collecting data on suspected adverse drug reactions is crucial for identifying safety concerns and
minimizing risks to patient health
• This information helps regulatory agencies, healthcare providers, and pharmaceutical companies make
informed decisions about drug safety and efficacy
Sources
of
Adverse
Drug
Reaction
Data
Clinical Trials
Data from the controlled testing of new
drugs during development
Spontaneous Reporting
Voluntary reports from healthcare
professionals and patients about
suspected reactions
Literature Review
Analysis of published studies and case
reports on drug-related adverse events
Post-Marketing Surveillance
Ongoing monitoring of drug safety after
products are approved and in use
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7. Drug Interactions
Detecting potential interactions
between drugs that may lead to
increased adverse reactions
High-Risk Populations
Recognizing groups of patients
who may be more susceptible to
certain adverse events
Demographic Trends
Analyzing how adverse events
vary by age, gender, and other
patient characteristics
Temporal Patterns
Identifying seasonal or time-
related changes in the
occurrence of adverse events
Identification of
Patterns and
Trends
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8. Implementing Risk Monitoring and Reporting Processes
Continuous Surveillance
Proactively monitor for new
or evolving safety signals
through various data
sources.
Timely Reporting
Ensure adherence to regulatory
timelines for reporting adverse
events and safety issues.
Risk Communication
Collaborate with healthcare
providers, patients, and authorities
to share critical safety information.
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3. Risk Management
Developing and implementing strategies to manage and mitigate the risks associated with the use of
medicines

9. 4. Communication
• Effectively communicating safety information to healthcare providers, regulatory authorities, and the
public.
• Communications play a crucial role in pharmacovigilance to ensure the safe and effective use of
medicines and protect public health. Effective communication channels are essential for transmitting
safety information to patients and healthcare professionals, promoting transparency, and fostering
understanding and accountability.
• The exchange of information & knowledge between different stakeholder involved in the monitoring,
assessment & prevention of adverse effects or other drug-related problem.
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10. Responsibilities of Pharmacovigilance
Identification
• Identifying
potential safety
issues and adverse
drug reactions
through various
sources
Assessment
• Assessing the
causal relationship
between the drug
and the adverse
event, and
determining the
severity and
likelihood of
occurrence.
Reporting
• Reporting
identified safety
concerns to
regulatory
authorities and
other relevant
stakeholders in a
timely and accurate
manner.
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