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Related Concept Videos

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.
In some cases, there...
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Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

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In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
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Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

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Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
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Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

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In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
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Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

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Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
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Guidelines for Elective Pediatric Fiberoptic Intubation
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Pharmacovigilance in pediatrics.

Émilie Bouquet1, Kristina Star2, Annie Pierre Jonville-Béra1

  • 1Department of clinical pharmacology and regional pharmacovigilance center, university hospital, CHRU Tours, 37044 Tours, France.

Therapie
|March 31, 2018
PubMed
Summary
This summary is machine-generated.

Pediatric pharmacovigilance requires tailored approaches due to unique child drug safety profiles and off-label use. Continuous monitoring and child-specific studies are crucial for preventing adverse drug reactions (ADRs) in children.

Keywords:
Adverse drug reactionsChildrenPharmacoepidemiologyPharmacovigilance

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Area of Science:

  • Pediatric Pharmacology
  • Pharmacovigilance
  • Drug Safety

Background:

  • Pediatric drug safety profiles are often less understood than adult profiles due to limited clinical trials.
  • Off-label drug use, inappropriate dosage forms, and dose adjustments in children increase medication error risks and adverse drug reactions (ADRs).
  • Child-specific ADRs, such as growth disorders, and effects of in utero exposure necessitate dedicated monitoring.

Purpose of the Study:

  • To highlight the necessity for adapting pharmacovigilance practices for the pediatric population.
  • To emphasize the importance of monitoring safety for drugs used in children, including those with in utero exposure.
  • To underscore the need for child-specific pharmacoepidemiological studies.

Main Methods:

  • Review of characteristics of pharmacology and drug evaluation in pediatric age groups.
  • Analysis of factors contributing to medication errors and ADRs in children.
  • Consideration of incidence variations based on age, medical setting, and country.

Main Results:

  • Antibiotics and vaccines are frequently associated with ADRs in children.
  • Commonly reported ADRs include skin, neurological, and general disorders.
  • ADR incidence varies significantly with age, medical setting, and geographical location.

Conclusions:

  • Pediatric pharmacovigilance demands specialized strategies to address unique challenges in children.
  • Spontaneous reporting and robust child-specific pharmacoepidemiological studies are essential for ensuring pediatric drug safety.
  • Adjusting pharmacovigilance to pediatric specificities is critical for preventing avoidable adverse drug reactions.