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Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
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FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Drug Toxicity: Risk factors

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Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...

Drug Discovery: Overview

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Related Experiment Video

Updated: May 20, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Advances in drug safety.

J Adam Cartwright¹, Steven Aniskevich, Christopher B Robards

¹Mayo Clinic College of Medicine, Jacksonville, FL, USA.

Current Pharmaceutical Design

|July 6, 2012

Summary

Anesthesiologists enhance patient safety by improving anesthetic drugs and delivery methods. Continuous advancements aim for safer surgical procedures and anesthesia administration globally.

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Published on: December 11, 2016

A Semi-Quantitative Drug Affinity Responsive Target Stability (DARTS) assay for studying Rapamycin/mTOR interaction

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Published on: August 27, 2019

Area of Science:

Anesthesiology
Pharmacology
Patient Safety

Background:

The operating room environment involves complex interactions between anesthetics, medications, patient conditions, and surgical procedures.
Anesthesiologists integrate these factors to ensure dependable and safe patient care.
Drug formulation and administration have seen significant improvements, aiding anesthesiologists.

Purpose of the Study:

To review advancements in anesthetic and analgesic drugs, drug delivery systems, and medication reevaluation.
To highlight methodologies enhancing the safety and efficacy of anesthetic practices.
To address the growing global demand for safer drug application in healthcare.

Main Methods:

Review of novel anesthetics and analgesics.
Examination of advancements in drug delivery, including infusion pumps.
Reappraisal of existing medications in anesthesia.
Consideration of regulatory recommendations for drug safety evaluation.

Main Results:

Significant enhancements in drug formulation and administration have improved anesthesiologists' capabilities.
Novel anesthetics, analgesics, and advanced drug delivery systems contribute to safer practices.
A global call for more rigorous, patient-centered drug safety evaluations is increasing.

Conclusions:

Continued advancements in anesthetic drugs and delivery systems are crucial for patient safety.
Regulatory bodies and patient safety organizations advocate for comprehensive drug life-cycle safety assessments.
The collective efforts of stakeholders aim to ensure safer anesthesia for millions undergoing surgery worldwide.