B.PHARMACY
SEMESTER 8
PHARMACOVIGILANCE
UNIT I
Regulatory terminologies of Pharmacovigilance:
• Side Effect: A mild or moderate adverse reaction that is known to be associated with a medication and is usually tolerable.
• Overdose: Taking more than the prescribed amount of a medication, which can cause adverse effects and potentially be life-threatening.
• Allergy: An abnormal immune response to a medication that can cause a range of symptoms, from mild rash to severe anaphylaxis.
• Tolerance: A reduced response to a medication over time, requiring higher doses to achieve the same effect.
• Withdrawal: The development of adverse effects when a medication is discontinued or the dose is reduced too quickly.
• Black Box Warning: The strongest warning issued by the FDA for a medication, indicating that it carries a significant risk of serious or life-threatening adverse effects.
• Monitoring: The process of regularly checking and evaluating a patient's response to a medication, including any adverse effects that may occur.
• Reporting: The process of informing healthcare providers, regulatory agencies, or the manufacturer of a medication about any adverse reactions experienced by a patient.
• Prevention: The implementation of measures to minimize the risk of adverse reactions, such as proper dosing, monitoring, and patient education.
• Adverse Drug Reaction (ADR): Any unintended or harmful response to a drug, which occurs at doses normally used in humans.
• Signal: Information about a new or known adverse drug reaction that suggests a causal association with the drug and requires further investigation.
• Risk Management Plan (RMP): A plan that outlines the actions and measures taken to minimize the risks associated with the use of a drug.
• Periodic Safety Update Report (PSUR): A report that provides an overview of the safety profile of a drug, based on data collected from clinical trials and post-marketing surveillance.
• Risk Evaluation and Mitigation Strategy (REMS): A program implemented by the manufacturer of a drug to minimize the risks associated with its use.
• Pharmacovigilance System Master File (PSMF): A document that describes the pharmacovigilance system in place for a drug, including the processes and procedures used to monitor and report adverse drug reactions.
• Good Pharmacovigilance Practice (GVP): A set of guidelines issued by regulatory agencies that outline the best practices for conducting pharmacovigilance activities.
• Signal Detection: The process of identifying new or unknown adverse drug reactions based on data collected from various sources, such as clinical trials, spontaneous reports, and literature review.
• Risk Benefit Assessment: The process of evaluating the benefits and risks of a drug, taking into account the severity of the condition being treated, the available treatment options, and the potential impact on public health.
• Adverse Drug Reaction (ADR): Any unintended or harmful response to a drug, which occurs at doses normally used in humans.
• Serious Adverse Event (SAE): An adverse drug reaction that is fatal, life-threatening, requires hospitalization, results in disability, or is a congenital anomaly.
• Suspected Adverse Reaction (SAR): An adverse drug reaction that is suspected to be caused by the drug but has not yet been confirmed.
• Unexpected Adverse Drug Reaction (uADR): An adverse drug reaction that is not consistent with the known safety profile of the drug or is not listed in the product label.
• Adverse Event of Special Interest (AESI): An adverse drug reaction that is of particular interest to regulators or healthcare professionals due to its severity or potential impact on public health.
• Adverse Drug Reaction Reporting System (ADRRS): A system used by regulatory agencies and healthcare professionals to collect and analyze reports of adverse drug reactions.
• Post-Marketing Surveillance (PMS): The monitoring of the safety and effectiveness of a drug after it has been approved and marketed to the public.
• Pharmacovigilance: The science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions