Related Experiment Video

Updated: May 8, 2026

Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump
06:08

Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump

Published on: March 11, 2017

Pharmacovigilance knowledge in family paediatricians. A survey study in Italy

Paolo Pellegrino1, Carla Carnovale, Dario Cattaneo

  • 1Unit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.

Health Policy (Amsterdam, Netherlands)
|September 10, 2013
PubMed

Insights

Family pediatricians have poor knowledge of pharmacovigilance (PV) and low compliance in reporting adverse drug reactions (ADRs) in children, despite recognizing PV's importance. This highlights a need for better training to improve pediatric drug safety.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety and Pharmacovigilance

Background:

  • Pediatric drug prescriptions carry risks of rare adverse drug reactions (ADRs).
  • Spontaneous reporting of suspected ADRs is vital for detecting safety signals in children due to limited clinical trials.
  • Family pediatricians (FPs) are key in ADR reporting but show low compliance.

Purpose of the Study:

  • To assess Italian FPs' knowledge, attitudes, and compliance regarding ADR reporting.
  • To identify barriers to ADR reporting among FPs.

Main Methods:

  • A nationwide survey of 552 Italian FPs.
  • Data collection on FPs' knowledge, feelings, and compliance with ADR reporting.

Main Results:

  • FPs demonstrated poor pharmacovigilance (PV) knowledge, primarily due to inadequate academic training.
  • Most FPs expressed interest in PV and understood its clinical value.
  • ADR reporting compliance was low, with significant regional variations potentially linked to educational program disparities.

Conclusions:

  • Inadequate training is a major barrier to effective pharmacovigilance among Italian FPs.
  • Improved educational programs are needed to enhance ADR reporting compliance and pediatric drug safety.
  • Addressing regional disparities in PV education is crucial for consistent ADR surveillance.

Keywords:
Adverse drug reactionPaediatricsPharmacovigilanceUnderreporting

Related Concept Videos

Pharmacovigilance01:19

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.
In some cases, there...
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

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, compared...
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

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...
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

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...
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

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 a challenge in...
Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...