Farmaci e utilizzo "wrong-label" in pediatria - L'esempio del paracetamolo, del salbutamolo e dell'amoxicillina

Ines L'Erario; Anna Di Benedetto; Jenny Bua; Stefania Norbedo; Egidio Barbi; Federico Marchetti

Farmaci e utilizzo "wrong-label" in pediatria - L'esempio del paracetamolo, del salbutamolo e dell'amoxicillina

Translated title of the contribution: Wrong-label drug use in paediatrics: The examples of acetaminophen, salbutamol and amoxicillin

Ines L'Erario, Anna Di Benedetto, Jenny Bua, Stefania Norbedo, Egidio Barbi, Federico Marchetti

IRCCS pediatrico Burlo Garofolo

Research output: Contribution to journal › Article › peer-review

Abstract

Two thirds of the drugs prescribed for children are off-label. However, off-label is not synonymous with incorrect, since it often represents the most rational, evidence-based therapy. One aspect of the off-label problem in paediatrics depends on the lack of updating the drugs specific Summary Product Characteristics (SPC). This is a frequent problem in Italy. The Authors give the example of three of the most commonly prescribed drugs in paediatrics (acetaminophen, salbutamol and amoxicillin), the SPC which recommends wrong dosages compared to those based on the to-date evidence and recommended by clinical guidelines ("wrong-label"). Reviewing and updating of SPC should be one of the priorities to tackle the off-label problem in the Italian reality.

Translated title of the contribution	Wrong-label drug use in paediatrics: The examples of acetaminophen, salbutamol and amoxicillin
Original language	Italian
Pages (from-to)	580-585
Number of pages	6
Journal	Medico e Bambino
Volume	26
Issue number	9
Publication status	Published - Nov 30 2007

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health

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title = "Farmaci e utilizzo {"}wrong-label{"} in pediatria - L'esempio del paracetamolo, del salbutamolo e dell'amoxicillina",

abstract = "Two thirds of the drugs prescribed for children are off-label. However, off-label is not synonymous with incorrect, since it often represents the most rational, evidence-based therapy. One aspect of the off-label problem in paediatrics depends on the lack of updating the drugs specific Summary Product Characteristics (SPC). This is a frequent problem in Italy. The Authors give the example of three of the most commonly prescribed drugs in paediatrics (acetaminophen, salbutamol and amoxicillin), the SPC which recommends wrong dosages compared to those based on the to-date evidence and recommended by clinical guidelines ({"}wrong-label{"}). Reviewing and updating of SPC should be one of the priorities to tackle the off-label problem in the Italian reality.",

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AU - L'Erario, Ines

AU - Di Benedetto, Anna

AU - Bua, Jenny

AU - Norbedo, Stefania

AU - Barbi, Egidio

AU - Marchetti, Federico

PY - 2007/11/30

Y1 - 2007/11/30

N2 - Two thirds of the drugs prescribed for children are off-label. However, off-label is not synonymous with incorrect, since it often represents the most rational, evidence-based therapy. One aspect of the off-label problem in paediatrics depends on the lack of updating the drugs specific Summary Product Characteristics (SPC). This is a frequent problem in Italy. The Authors give the example of three of the most commonly prescribed drugs in paediatrics (acetaminophen, salbutamol and amoxicillin), the SPC which recommends wrong dosages compared to those based on the to-date evidence and recommended by clinical guidelines ("wrong-label"). Reviewing and updating of SPC should be one of the priorities to tackle the off-label problem in the Italian reality.

AB - Two thirds of the drugs prescribed for children are off-label. However, off-label is not synonymous with incorrect, since it often represents the most rational, evidence-based therapy. One aspect of the off-label problem in paediatrics depends on the lack of updating the drugs specific Summary Product Characteristics (SPC). This is a frequent problem in Italy. The Authors give the example of three of the most commonly prescribed drugs in paediatrics (acetaminophen, salbutamol and amoxicillin), the SPC which recommends wrong dosages compared to those based on the to-date evidence and recommended by clinical guidelines ("wrong-label"). Reviewing and updating of SPC should be one of the priorities to tackle the off-label problem in the Italian reality.

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KW - Salbutamol

KW - Wrong-label

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Farmaci e utilizzo "wrong-label" in pediatria - L'esempio del paracetamolo, del salbutamolo e dell'amoxicillina

Abstract

ASJC Scopus subject areas

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