TY - JOUR
T1 - Off-label use of medicines in neonates, infants, children, and adolescents
T2 - a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology
AU - Schrier, L
AU - Hadjipanayis, Adamos
AU - Stiris, Tom
AU - Ross-Russell, Rob I.
AU - Valiulis, Arunas
AU - Turner, Mark A.
AU - Zhao, Wei
AU - De Cock, Pieter
AU - de Wildt, Saskia N.
AU - Allegaert, Karel
AU - van den Anker, John
N1 - Funding Information:
Tjitske van der Zanden, BSc managing director of the Dutch Expertise Centre for Pharmacotherapy in Children (NKFK), is kindly thanked for her expertise and critical review of the manuscript.
Publisher Copyright:
© 2020, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - Health-care professionals who prescribe medicines have the professional duty to choose medicines that are in the best interest of their individual patient, irrespective if that patient is an adult or a child. However, the availability of medicines with an appropriate label for pediatric use is lagging behind those for adults, and even available pediatric drugs are sometimes not suitable to administer to children. Consequently, health-care professionals often have no other option than to prescribe off-label medicines to children. An important reason for use of off-label medicines is to improve access to (innovative) treatments or to address medical needs and preferences of patients, especially when no other options are available. However, off-label use of medicines is in general not supported by the same level of evidence as medicines licensed for pediatric use. This may result in increased uncertainty on efficacy as well as the risk for toxicity and other side effects. In addition, liability may also be of concern, counterbalanced by professional guidelines. Conclusion: The purpose of this joint EAP/ESDPPP policy statement is to offer guidance for HCPs on when and how to prescribe off-label medicines to children and to provide recommendations for future European policy.
AB - Health-care professionals who prescribe medicines have the professional duty to choose medicines that are in the best interest of their individual patient, irrespective if that patient is an adult or a child. However, the availability of medicines with an appropriate label for pediatric use is lagging behind those for adults, and even available pediatric drugs are sometimes not suitable to administer to children. Consequently, health-care professionals often have no other option than to prescribe off-label medicines to children. An important reason for use of off-label medicines is to improve access to (innovative) treatments or to address medical needs and preferences of patients, especially when no other options are available. However, off-label use of medicines is in general not supported by the same level of evidence as medicines licensed for pediatric use. This may result in increased uncertainty on efficacy as well as the risk for toxicity and other side effects. In addition, liability may also be of concern, counterbalanced by professional guidelines. Conclusion: The purpose of this joint EAP/ESDPPP policy statement is to offer guidance for HCPs on when and how to prescribe off-label medicines to children and to provide recommendations for future European policy.
UR - http://www.scopus.com/inward/record.url?scp=85077615528&partnerID=8YFLogxK
U2 - 10.1007/s00431-019-03556-9
DO - 10.1007/s00431-019-03556-9
M3 - Article
C2 - 31897842
AN - SCOPUS:85077615528
VL - 179
SP - 839
EP - 847
JO - European Journal of Pediatrics
JF - European Journal of Pediatrics
SN - 0340-6199
IS - 5
ER -