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Pharmacovigilance01:19

Pharmacovigilance

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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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Overview of Metabolism01:40

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Living cells constantly carry out various chemical reactions which are necessary for their proper functioning. These reactions are interlinked to one another via multiple pathways. The collection of these chemical reactions is known as metabolism.
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Functional groups are a group of atoms with characteristic properties, which when linked to the carbon skeleton of a molecule, alter the properties of that molecule. For example, certain functional groups will make a molecule hydrophilic, whereas others will make them hydrophobic. These functional groups are an indispensable part of organic chemistry and important components of biological molecules, such as carbohydrates, proteins, lipids, and nucleic acids. Each functional group is a unique...
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Pharmacokinetics: Overview01:10

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Pharmacokinetics is a scientific discipline that focuses on the journey of a drug within the body, encompassing four key stages: absorption, distribution, metabolism, and elimination. The first stage, absorption, involves the drug's transfer into the bloodstream. Several factors dictate the extent and speed of this process. For example, the liver often metabolizes oral drugs before they reach systemic circulation, leading to only partial absorption. In contrast, intravenous (IV)...
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Bioavailability: Overview01:13

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Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
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In analytical chemistry, we often perform repetitive measurements to detect and minimize inaccuracies caused by both determinate and indeterminate errors. Despite the cares we take, the presence of random errors means that repeated measurements almost never have exactly the same magnitude. The collective difference between these measurements - observed values - and the estimated or expected value is called uncertainty. Uncertainty is conventionally written after the estimated or expected value.
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An historical overview over Pharmacovigilance.

Giulia Fornasier1, Sara Francescon1, Roberto Leone2

  • 1Pharmacy Unit, Centro di Riferimento Oncologico CRO Aviano, National Cancer Institute - IRCCS, Aviano, Italy.

International Journal of Clinical Pharmacy
|June 28, 2018
PubMed
Summary

Pharmacovigilance, the monitoring of drug safety, has evolved over 170 years from simple clinician warnings to sophisticated electronic systems. This evolution has significantly improved patient safety and drug risk-benefit assessment.

Keywords:
Adverse drug reactionsHistoryLegislationPharmacovigilancesSignal detectionThalidomide

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Area of Science:

  • Pharmacology
  • Public Health
  • Drug Safety Monitoring

Background:

  • Pharmacovigilance, crucial for drug safety, has a history spanning approximately 170 years.
  • It is a structured health activity with significant social and commercial implications.

Observation:

  • Early pharmacovigilance involved clinicians sending letters or warnings to scientific journal publishers.
  • Modern pharmacovigilance utilizes highly structured electronic registries for drug safety monitoring.

Findings:

  • The historical evolution of pharmacovigilance has been traced through key milestones.
  • Understanding these phases reveals pharmacovigilance's contribution to human health and pharmacology.

Implications:

  • Pharmacovigilance enhances the risk-benefit ratio assessment of medications.
  • It plays a vital role in improving patient safety and quality of life.
  • Future challenges and advancements in pharmacovigilance are identified.